Critiquing: Experts dismiss doctor’s cancer claims (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY)

I found it humorous that the USA TODAY article by Liz Szabo [1], used the same line that “The Skeptics™ Guy Chapman tried to use on me during his #FAILED “debate” attempt against me, where he decided he didn’t want to play anymore, and grabbed his balls and went home [2] 😛

But I knew without a shadow of a doubt that something smelled rotten in Denmark, when the article quoted Jan Buckner, a professor and chairman of oncology at the Mayo Clinic in Minnesota

Jan Buckner took part in the Mayo study that was published in 1999, which Burzynski has called into question, and which Eric Merola covered in the original Burzynski: Cancer is Serious Business [3]

Jan Buckner, if you’re so interested in providing quotes, you’ve got some ‘splainin’ to do 😃
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Let the bodies hit the floor 😳
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Here comes the Insolence 😝
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REFERENCES:
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[1] – 11/15/2013 – USA TODAY NEWS, NATION
Experts dismiss doctor’s cancer claim
Liz Szabo, USA TODAY
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http://www.usatoday.com/story/news/nation/2013/11/15/burzynski-cancer-science/2994731/
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[2] – 11/10/2013 – @vGuyUK @SceptiGuy Guy Chapman goes “Down, Under” (guychapman grabs his balls and goes home):
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https://stanislawrajmundburzynski.wordpress.com/2013/11/10/httpsmobile-twitter-comvguyuk-httpsmobile-twitter-comsceptiguy/
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[3] – 9/19/2013 – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
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Interview with Dr. Burzynski, M.D., Ph.D. Biochemistry (12/2002)

Interview with Dr. Burzynski (M.D., Ph.D. Biochemistry)
Interviewer: Gavin Phillips ©
Distributed 12.05.03

Anyone may post this interview to their website, as long as it remains
unaltered and freely available. Please place a link back to this webpage.

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This telephone interview with Dr. Burzynski was held in December 2002. The purpose of the interview is to inform people about Dr. Burzynski’s cancer treatment, Antineoplastons. It will be circulated for free on the Internet. I have no affiliations with Dr. Burzynski either personally or professionally.

Hello Dr. Burzynski. I would like to thank you for taking the time to inform people about your cancer treatment Antineoplastons, and your experiences in the area of cancer over the last 25 years.

Is it true that you were the youngest person in Poland in the 20th century to earn two advanced degrees, an M.D. (Medical Doctor) and Ph.D. in biochemistry at only 24?

I’m not sure if I was the youngest, I was among the youngest. In Poland, its 15 years average (Gavin. For a Ph.D.) after you receive an M.D.

What motivated you to come to the United States? When did you arrive here?

Well basically freedom. You see, I could easily stay in Poland. I was a prominent student, one of the best they ever had in medical school and certainly if I would become a member of the Communist Party I would accomplish a lot in Poland. But I didn’t want to be a Communist and after I declared, “forget it, I’m not going to be a Communist”, they persecuted me. So, practically, it would not be possible for me to do any research in Poland. I arrived in the United States on the 4th of September 1970.

You began working at Baylor College of Medicine in Houston?

I was not employed for 6 weeks, then I got the appointment at Baylor in the position of research assistant. A couple of years later I became Assistant Professor.

I have read that your cancer research was motivated by your observation of a cancer patient in Poland that was missing a particular peptide in their blood, is this correct?

Well Yes. First I discovered some peptide fractions in blood and then I was trying to determine their significance. This means that I was screening the blood samples from people who suffer from various illnesses, among them cancer patients. I found some remarkable changes in concentration of these Peptides in cancer patients. Basically there was a great deficiency of these Peptide fractions in the blood of cancer patients.

What are peptides and how did your research develop from there to developing Antineoplastons?

Peptides are chains of Amino Acids, so if you put together 2 Amino Acids, you have a Peptide.

You have said, “Cancer is really a disease of cells that are not programmed correctly. Antineoplastons simply reprogram them so that they behave normally again.”

They do, but we are not really interested in making normal cells out of cancer cells. What we are interested in is correcting one basic difference between cancer cells and normal cells, and this is the mortality of normal cells and the immortality of cancer cells. Cancer cells are immortal. And if you change them into mortal cells again they will die and the tumor will disappear.

I read a humorous part in Daniel Haley’s chapter about you in his book, “Politics in Medicine.” He says that initially you derived Antineoplastons from your friends blood, but had to change because your friends stopped coming around, is that correct?

Certainly it was difficult to obtain a lot of blood for the research. It was a necessity to look for a source that is widely available. I realized from the very beginning that once I use urine, my critics will use this against me; try to just smear me, “That’s the doctor who is using urine to treat cancer.” But there was no other way to do it.

There are plenty of ignorant remarks about your treatment because it used to be derived from human urine. The process you use now does not involve collecting human urine. Please describe the complete process you use.

Ever since 1980, we are using synthetic analogues of Antineoplastons, made in a state-of-the art biomedical manufacturing facility. These have nothing to do with urine or blood.

Would you describe Antineoplastons as natural?

They are natural of course, they exist in our body.

Your treatment does require a strong commitment from your patients as they must be infused with Antineoplastons for many weeks or months, is that correct?

But most of our patients are taking oral formulations. I would say that perhaps 15% of our patients are taking intravenous infusions of Antineoplastons; the rest take capsules or tablets.

The patients who have the most advanced type of cancer will require heavy dosages. There is a limitation of how much medicine you can take by mouth. Fifty or sixty tablets a day, that’s pretty much all you can take by mouth. But if you give intravenous infusion you can deliver the equivalent of 3,000 tablets a day.

You went into private practice in 1977. How was this funded?

Well, I started private practice in 1973. It was not necessary for me to have any funding, because I joined with other physicians.

Is it true that Dr. Mask at a hospital in Jacksboro, Texas ran your first human clinical trial? What types of cancers did you treat? What were the results of these trials?

I would not call it a clinical trial, because only two patients received initial treatment. They were very advanced, close to death and unfortunately, both of them died. But these cases were not lost because we found we can administer Antineoplastons without having bad side effects.

What is the general side effect experienced by your patients when using Antineoplastons? Does it damage the immune system as chemotherapy does?

We are not talking about one medicine; we tried 12 different pharmaceutical formulations. Basically it depends what formulation we use, but when we give them orally, we see practically no side effects at all. Patients may develop skin rash, which may last for a day or two.

But, when we give large dosages intravenously, we have to watch fluid balance…and electrolyte balance. We don’t see any delayed toxicity once the treatment stops. Everything practically goes back to normal within say a day or two. It does not even come close to the adverse reactions that you experience with chemotherapy.

What is the cost today for a patient using your treatment in a pill form and do insurance companies pay for it? *

Well basically, we do not charge patients for medicines, Antineoplastons are given free of charge. What we are charging for are supplies, and we are charging for standard services such as office visits, nursing services, Lab tests, consultation, evaluation etc. And these services are priced the same way as the average medical services, and they are covered by the insurance.

*(Gavin. Insurance companies will rarely pay for Antineoplastons, which is considered an experimental treatment. It also depends on the type of insurance plan someone may be on.)

So if a patient were using the pills, what would it normally cost per month.

About $2,000 a month.

Antineoplastons is most effective against brain cancer, is that correct?

Well, it’s not really correct. Because brain tumors are very difficult to treat, we concentrate our efforts on the toughest type of cancers. Out of our clinical trials, we have eight that came to the final point, which means they proved that there is some efficacy, and six of these are in various types of brain tumors. But there is another clinical trial, which deals with advanced colon cancer, which also proved efficacy and another one with liver cancer. But we still need to wait a little longer to have a larger number of patients treated and then statistically find out if this is going to work.

Basically the treatment works when we have involvement of the gene, which can be activated by Antineoplastons, and such genes, like gene p 53, are involved in 50% of all cancers. The treatment turns on gene p 53. So it has more to do with what kind of gene the patient has in his cancer cell, rather than the type of cancer.

Is there a special diet to follow when using your treatment?

Yes, since we are expecting there may be some changes in minerals, we usually emphasize a diet that is relatively low in sodium. We treat every patient individually. Every patient has a consultation with a dietary expert who tries to individualize his diet

Is your treatment being used in any other countries?

Yes, we have people coming to us from all over the world. I think we can probably count easily 70 to a 100 countries from which people are coming. But the main effort is now in Japan, outside the US. In Japan there are 2 clinical trials being conducted by Japanese doctors. Also, a group of doctors in Mexico obtained approval from the FDA and Mexican government to do clinical trials.

Now I have several related questions about brain cancer in children.

Dustin Kunnari and Dr. Burzynski. Dustin is one of Dr. Burzynski’s great success stories.

Dustin had brain surgery at 2 ½ years old. The surgery removed only 75% of the tumor.

Dustin’s parents, Mariann and Jack, were told that Dustin would only live for 6 months. Chemotherapy and radiation may extend Dustin’s life slightly, but at a very high cost in quality of life with very serious side effects.

Mariann and Jack decided to look into alternatives. They found out about Antineoplastons and after only 6 weeks of intravenous treatment, Dustin’s MRI showed he was cancer free.

One year later another tumor appeared on the MRI. By this time Dr. Burzynski had developed a more concentrated form of Antineoplastons. After 5 months the tumor was gone. Dustin has remained cancer free ever since and was taken off Antineoplastons when he was 7. Dustin is 12 today.

About how many children suffer from brain cancer in the US each year?

The statistics are available for 1999. The new cases of brain tumors in children were counted as 2,200. Now around 3,000, I would say.

Approximately what percentage of children is still alive after 5 years using orthodox treatments for brain cancer?

It depends on the type of tumor and it’s location, some of the toughest are those that are located in the brain stem. Up to 5 years, you have practically no survival when you use the best treatment available, which is radiation therapy. Chemotherapy usually doesn’t work for such patients. After 2 years, 7 % survival. After 5 years, practically none.

Dustin, after brain surgery.

To further complicate matters, Dustin’s oncologist kept threatening his parents with a court proceeding to take Dustin away and force him to take Chemotherapy/Radiation treatment.

This continued for a year, even after Dustin’s success with Antineoplastons.

Please see the Burzynski Patients web site for more information,
http:// http://www.burzynskipatientgroup.org

You may also e-mail Mary Jo Siegel, the lady who runs the web site. Mary is also a cancer survivor using Antineoplastons.
maryjo@siegel.net

Is it correct to say you have had very good results when treating brain cancer in children?

Yes we have. I gave you the example of the toughest, which is located in the brain stem. We get about 40% survival rates after two years. After 5 years at the moment we have about 20% survival rate. The reason is that most of the patients who come to us, have received prior heavy radiation therapy, or chemotherapy. They usually die from complications from these treatments. Those who survive the longest are patients who previously did not receive radiation therapy or chemotherapy. The longest survivor in this category is now reaching 15 years from the time of diagnosis; and she’s in perfect health.

With the more common variety, which is aciotoma located outside the brain stem, we get much, much better. We have 75% of patients who are objectively responding to the treatment. This means that the tumor will disappear completely or will be reduced by more than 50%.

This is another strong point. It’s extremely important. Children are usually damaged for life after radiation therapy, when we can avoid it and bring them back to life.

What criteria must parents of children with brain cancer meet before being able to have their children treated by you?

Well, practically all of these brain tumors must be inoperable. This means that it’s not possible to remove them with surgery. Except for one category, they should have advanced disease. The tumor should have the size of more than 5 mm in diameter and be located in a place that cannot be operated upon.

There is one category of these tumors, medulloblastoma, where the FDA requires that the patients would receive prior standard treatment and fail before we can accept them. In the rest of these children we can accept them without failure of prior treatment.

Roy , a more recent patient of Dr. Burzynski’s.

Please see the Burzynski Patients web site for more information,
http:// http://www.burzynskipatientgroup.org

You may also e-mail Mary Jo Siegel, the lady who runs the web site. Mary is also a cancer survivor using Antineoplastons.
maryjo@siegel.net

Let us talk a little about some of your most successful stories using Antineoplastons with children. Probably the most remarkable case is that of Tori Moreno . In August 1998 Tori was diagnosed with a stage 4 brainstem glioma that was inoperable. Her parents were told she would die in a few days or at the most, a few weeks. When did you start treating her?

Tori had Stage 4 brain stem glioma. The tumor was too risky for surgery. She was diagnosed shortly after her birth. The tumor was very large, about 3 inches in the largest diameter and located in the brain stem. Her parents consulted the best centers in the country and they were told there was nothing to be done. So finally she was brought to us, when she was about 3 ½ months old. This was in October 5 years ago. She was in such condition that we were afraid that she might die at any time. Fortunately she responded, and about 5 months later we determined that she obtained a complete response, which means complete disappearance of active tumor by
MRI criteria. She is a perfectly healthy child and tumor free. She still takes small dosages of capsules of Antineoplastons, but we will discontinue this shortly.

Tori Moreno 9.28.98. Temporarily enlarged due to taking Decadron.

Tori’s parents were told there was nothing that could be done for her and she would be dead in a few weeks.

Tori is alive and well today thanks to Antineoplastons. See photo below.

At the end of this interview, there is a short interview with Kim Moreno, Tori’s mother.

Kim Moreno has set-up a Yahoo e-mail account to answer peoples cancer related questions.
kimmoreno5@yahoo.com

And today she is over 5 years old?

Yes, she’s 5 years old and living a pretty much normal life.

Tori 22.10.02. A perfectly healthy child. Orthodox treatment consists of high does of radiation therapy and possibly toxic chemotherapy as well. Most of the children are dead in a few years. The ones that survive suffer from permanent retardation, along with other serious side effects from the radiation.

Please do not forget about the interview with Kim Moreno, Tori’s mother, at the end of this interview.

But mainstream medicine has been trying to kill the cancer cell using chemotherapy and radiation, is that correct?

That’s right, yes.

Chemotherapy and radiation cannot differentiate between healthy and cancerous cells?

They can differentiate to some point, but basically, this difference is very small, so ultimately, the normal cells will be killed.

Is that why they have such a terrible effect on the immune system?

That’s right, not only the immune system, but also many other systems in the body. Practically, the treatment is destroying healthy parts of the body.

Chemotherapy and radiation also cause cancer, don’t they?

Yes. For instance right now we see a lot of patients who in childhood were successfully treated for leukemia or for Hodgkin’s disease. Then they develop cancer that is practically incurable, like lung cancer, breast cancers; I even encountered a patient in my practice that developed three different types of cancers, and was only 28 years of age. First she was treated for Hodgkin’s Disease, then she developed bone cancer in the places which were radiated for Hodgkin’s Disease, and then she developed breast cancer after that; it’s really horrible. So there is increased incidence of secondary cancers in patients who were treated previously with chemotherapy and radiation.

Shontelle Huron. In remission for several years after using Antineoplastons.

Please see the Burzynski Patients web site for more information,
http:// http://www.burzynskipatientgroup.org

You may also e-mail Mary Jo Siegel, the lady who runs the web site. Mary is also a cancer survivor using Antineoplastons. maryjo@siegel.net

Ric and Paula Schiff write about the torture their daughter Crystin had to endure during chemotherapy/radiation treatment.

Crystin was diagnosed with perhaps the most malignant tumor known, which is a rhabdoid tumor of the brain. Of course, historically, there was no case of such a tumor ever having a long response to chemotherapy or radiation therapy. She received extremely heavy does of radiation therapy and chemotherapy, because nobody expected that she would live longer than a year or so. So unfortunately she was terribly damaged with this. She responded very well to Antineoplastons. We put her in complete response. But unfortunately she died from pneumonia. Her immune system was wiped out, so when she aspirated some food, she died from it. The autopsy revealed that she didn’t have any sign of malignancy.

But there are also likely permanent severe health concerns related to taking chemotherapy and radiation.

In young children there is permanent damage to the brain. Unfortunately some oncologists who are dealing with such cases are really cruel to the parents, because they are saying, “well, your child will survive, but you are going to have a jolly idiot for the rest of your life.”

Is it true that if parents refuse chemotherapy/radiation treatment for their children the hospital, via the courts, could have the child removed from the parents care and forced to take chemotherapy/radiation treatment?

Yes, unfortunately in some States, the law may require taking children away from the custody of the parents to send them to such treatments.

Jared Wadman. In remission for several years after using Antineoplastons.

Please see the Burzynski Patients web site for more information,
http:// http://www.burzynskipatientgroup.org

You may also e-mail Mary Jo Siegel, the lady who runs the web site. Mary is also a cancer survivor using Antineoplastons.
maryjo@siegel.net

Isn’t this what happened to Donna and Jim Navarro when they chose your treatment over orthodox treatments?

That is correct. Thomas Navarro was diagnosed with medulloblastoma. He was operated on and the tumor was removed. Then he was scheduled for radiation therapy. Since he was only 4 years old, the parents knew that he’d be damaged by radiation therapy. Nobody at his age survives this type of tumor anyway after radiation therapy. So that’s why they decided to come to our clinic. Unfortunately I could not treat him because FDA requires failure of radiation therapy for such patients.

And tragically he died in November 2001.

What happened was, the parents decided not to take any treatment. We asked the FDA several times to allow administration of Antineoplastons, because we have already had successful treatments for some other children without any prior radiation. Then ultimately he developed numerous tumors in May the following year. Then we suggested to the parents of Thomas, that if they are not going to take our treatment, they should go for at least chemotherapy. They went for chemotherapy to one of the best centers in the country, to Beth Israel Hospital in New York. The chemotherapy was successful, but he almost died from it. It severely affected his bone marrow. I remember a phone call from Thomas’s father telling me that the doctors are thinking that they won’t do anything else for him and that Thomas will die within a week because of severe suppression of bone marrow.

But I encouraged his father to do whatever is possible because such patients may turn around. Fortunately he turned around, but about a month or two later he developed 15 tumors in the brain and the spinal cord. Then, when he was close to death, when nothing was available for him, the FDA called us and told us now we can treat Thomas. When we treated Thomas he survived 6 months, and the tumors had substantially decreased, but ultimately he died from pneumonia.

Is it accurate to say that the initial orthodox treatment for brain cancer is surgery to remove the tumor?

If the tumor is located in the proper part of the brain. For some locations it is out of the question. But, you are right, that is the first step.

Does surgery alone ever cure a patient with brain cancer?

Well, some cases, with benign brain tumors, when the tumor can be completely dissected, yes, it’s possible. But in most cases it’s not possible.

How much of a risk does surgery present regarding spreading the cancer more quickly and other complications?

Well, not so much regarding spreading the cancer more quickly in the case of brain tumors. Such a spread may happen only with a small percentage of brain tumors that have the highest aggressiveness. But for most of the patients the tumor is not going to spread just because of surgery. Certainly surgery may damage the brain and patients may even die during the surgery. It’s not the ideal thing to do of course because you are removing the tumor and you are removing a healthy part of the brain at the same time. The patient may be permanently damaged by such procedures.

Would you warn against rushing into surgery in light of how effective your treatment is? Would you most times recommend trying your treatment first?

We really would like to know what we are dealing with. This means that we would like to have at least a biopsy; if by chance it’s not going to create sufficient risk for the patient. If the tumor was located in such a place in the brain where surgery is possible, then certainly we could try to remove the tumor. But I think it would be best if we can treat the patient with brain intact and get rid of the tumor completely, because then we risk the least damage possible.

Now I will turn my attention to your legal battles with the FDA. They began in 1983 when they sued you in civil court, is this correct?

In 1983, that was the first court battle with the FDA. The FDA sued us. It took about 6 weeks in court and again, we won.

Then there was an enormous raid by the FDA at your offices on July 17, 1985. What was the reason for this raid?

We were never given a reason. I think there was a concentrated action against a few alternative medicine centers because at the same time there were similar actions in the Bahamas and in some other places.

In the four court cases the FDA has brought against you, have any of your patients testified against you?

Well, on their own will, nobody testified against us. But the FDA encouraged some of our patients, and threatened them in various ways. They forced them to come to the witness stand. But really, once they were on the witness stand they behaved more like our witnesses, not FDA witnesses.

According to Daniel Haley, after the FDA lost its last court case against you in 1997, Congressman Richard Burr said it was “one of the worst abuses of the criminal justice system”. Did Burr ever speak to you about it?

Yes, we talk with Congressman Burr. I believe he is right, because certainly there was no reason for such massive action on the part of the FDA. They knew that the treatment works; that the treatment helps patients, that the patients will die if they win, so they should not do it. All of this was with the taxpayer’s money.

So the FDA has wasted many millions of taxpayer dollars trying to convict you on false charges of transporting Antineoplastons across State lines. What was the motivation for this vendetta?

Well, it’s hard to tell, because it was never properly investigated; why they did it. But, we have some leads. For instance, on one side you have a large pharmaceutical company, which was very interested in getting hold of our patents; this is Elan Pharmaceutical. It happened that I treated successfully a close relative to the CEO of Elan. Elan became very interested in what we have. They came close to signing a final license agreement. But after they learned what we have, they decided to withdraw and then suddenly the FDA and NCI gave their full support to Elan, to do clinical trials with one of the ingredients of Antineoplastons, phenylacetate.

This was a large pharmaceutical company that was trying to appropriate my invention. On the other hand, within the FDA and NCI you have had people who were working closely with this company. For instance Mary Pendergast, who was responsible for the legal action against us, became Vice President of Elan. Also Doctor Michael Friedman, who was initially in charge of NCI cancer research, and who knew that our treatment works, later became commissioner of FDA and he did whatever he could to put us out of business. Not only that, but to simply destroy me.

On the other hand, suddenly the government decided to file for the patents, which claimed the same thing that our patents did. Never in the history of the United States do you have the issuance of two patents for the same invention. It was really a breach of patent procedure. The patent office allowed them to patent something I invented, and which I patented. And dishonest scientist Dr. Dvorit Samid, who initially worked for us, was receiving funds from us and finally went for the higher bidder (Elan).

So you have a lot of leads, which indicate that there was something between the government, dishonest scientists like Dvorit Samid and the large pharmaceutical company, Elan. And it was in best interests for them to get rid of me, destroy me, so they could appropriate my discoveries and benefit from that.

When did you initially apply for your Investigational New Drug (IND)?

We applied in May 1983.

When did you receive it?

Well, it took an extremely long time. Ultimately most of our clinical trials began in 1996, a long time after that. FDA did not allow us to proceed with clinical trials for an extremely long time. Please click here to read the
conclusion of this interview

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Tony Tondelli. In remission for several years after using Antineoplastons.

Please see the Burzynski Patients web site for more information,
http:// http://www.burzynskipatientgroup.org

You may also e-mail Mary Jo Siegel, the lady who runs the web site. Mary is also a cancer survivor using Antineoplastons.
maryjo@siegel.net

It is important for everyone to understand the economics of the drug industry. I have heard that the cost today for bringing a drug to market is upwards of 500 million and takes about 12 years, is that true?

Yes, you’re right.

The drug company is then given a 17-year patent so that it can make a profit on the drug. It is little wonder the drug companies fight against natural treatments such as Laetrile, because they are unable to patent them and they pose a serious threat to their profit margins. But you are able to patent your treatment, so why was there no interest in it from the drug companies?

Basically you have 17 years from the time when you have approval of the patent and this is independent from FDA’s approval process. You file the patent, once you make a discovery, and then you go through FDA procedure. You spend say 12 years or 15 years for the approval process, then you have only 2 years license from the FDA, because license is going to expire in another 2 years. Certainly the pharmaceutical companies are spending a lot of money in this process.

In our case I decided to develop this on my own, to generate money from my private practice and use the money to support the research of Antineoplastons. Again we were approached by many different pharmaceutical companies, which were interested in working with us. Certainly after the bad experience (with Elan) we are very cautious with whom to deal. On the other hand pharmaceutical companies were afraid of action from the FDA.

The NCI put off testing Antineoplastons using the fact that it failed their standard P388 leukemia mouse test, is that correct?

Yes

What is the P388 leukemia mouse test and why did Antineoplastons fail it?

Well we had informed the NCI that this was a bad type of test for antineoplastons. Antineoplastons seems to be specific for species. Different animals have different antineoplastons; mice have a different composition of antineoplastons than humans. Practically, human antineoplastons may work well in humans, but they may not have much activity in mice. We knew this, even before the NCI began testing. On the other hand we didn’t have good results at all in the acute form of leukemia and we didn’t even accept such patients. It was known that if they only do this type of test, it was not going to work. They still tested and used this to say that Antineoplastons don’t work against cancer. Certainly the fact that something works or doesn’t work against mice leukemia is irrelevant.

I’d like the reader to bear with me in the next few questions, as the point will become clear. One of the chemicals you identified in the peptides was phenylacetate. But it was far inferior to the others and you chose not to patent it, is that correct?

This is not a peptide, this is a metabolite of our antineoplastons and it’s an organic acid. So this is a final metabolite of antineoplastons. It has some anti-cancer activity, but the weakest of all antineoplastons. We knew about it and that’s why after some preliminary experience in the treatment of phenylacetate back in 1980, we decided that it’s not worth pursuing this and then we used antineoplastons that have higher activity.

But didn’t you later find out that the NCI actually holds the patent for phenylacetate?

You’re right. NCI is the owner of the patent, Dr. Samid is the author but Elan has the license to use these patents. All of these three work together.

Why did the NCI patent something that was far inferior to your other Antineoplastons?

Because they knew that this was the only chance that they can get hold of something which has to do with antineoplastons.

The NCI ran clinical trials on phenylacetate in 1992 and found it to be worthless, is that correct?

Well, the clinical trials began in 1992 but it took a few years to have the results. It shows some effectiveness in brain tumors and in prostate cancer. But of course it was far away from the results that we can get with antineoplastons.

When did the NCI eventually start clinical trials of Antineoplastons?

In 1994.

I assume you gave the doctors running the trials all the information about correct dosages, is that true?

Yes, well, basically they used dosages that were 50 times lower than what we feel are effective dosages. We have some patient’s relatives who were present when the treatment was administered. Formulations of antineoplastons were badly diluted. This means that the patient was receiving very little antineoplastons and some of these patients were removed from the treatment after a short period of time because they were overloaded with fluid. Well normally we see fluid overload in perhaps less than 2% of our patients. So it makes sense that perhaps the formulations of antineoplastons were diluted and when the Mayo Clinic (1999) determined the concentration of antineoplastons in blood, we realize that it was something like 50 times lower than what it should be.

Do you think the NCI purposely sabotaged your trials?

I have no doubt about it. They sabotaged the trial; they accepted patients who were too advanced. Their main effort was to give a low dose of the medicine for a short period of time and to stop treatment just for some minor problem, like if a patient developed a skin rash. They were trying to give the treatment only for a very short period of time, like for instance a couple of weeks or a month. And then of course the patient was dying after that. It was completely unethical, it was horrible. As you probably heard recently, the pharmacist who was diluting an anti-cancer drug, was sentenced to 10 years in prison. I think the same should happen to these guys who really were trying to use this for their political manipulations.

Jessica Kerfoot. In remission for several years after using Antineoplastons.

Please see the Burzynski Patients web site for more information,
http:// http://www.burzynskipatientgroup.org

You may also e-mail Mary Jo Siegel, the lady who runs the web site. Mary is also a cancer survivor using Antineoplastons.
maryjo@siegel.net

How much influence do the pharmaceutical companies wield in medicine in the US?

Extreme influence. Most of the oncologists, I’m talking about reputable oncologists, they work for pharmaceutical companies, they work in clinical trials, they receive various type of incentives from pharmaceutical companies. And basically these doctors are approving medicine, FDA may approve the medicine, but finally this advisory board may advise FDA to go ahead with this or do not approve that medicine. So really the doctors who are deciding if the medicine should be approved or not, practically all of them have some type of relation with large pharmaceutical companies.

Is there a conspiracy to suppress other treatments or is it just a case of avaricious businesses, the pharmaceutical and hospital industry’s, doing everything in their power to protect their bottom line?

Well certainly they have a lot of power. When I filed my application for IND, the standard FDA policy was such that they would never approve a new drug for an individual owner, only for the large pharmaceutical companies. And that’s why I believe we waited for such a long time to receive the go-ahead for our clinical trial. So certainly there were obstruction tactics. Whether this is a conspiracy or not is hard for me to tell. As you can see, the leads which I presented, like for instance a researcher who worked for me initially and then decided to go to the higher bidder, which was a pharmaceutical company; then the relationship between the pharmaceutical company and governmental agencies. All of this indicates that there is some type of conspiracy. I think a Congressional committee should study this.

Turning our attention to the doctor/oncology profession. When reading Thomas Elias’s excellent book, “The Burzynski Breakthrough”, I was struck by how many times patients said that their oncologists were aggressively opposed to them taking your treatment.

Even after a patient’s success with your treatment, very few doctors give you the credit. Is this due to jealousy, arrogance, plain old denial or something else?

Probably a lot of arrogance. We have some prominent specialists, the best specialists in the world who really acknowledge our results and would like to work with us. On the other hand you have some doctors who hate to see a patient with success on our treatment. The fact that the patient is coming to their office, years after the patient should be dead, is something like a slap in the face. They hate it.

They will do everything they can to lie, to obstruct the information about this patient. We have a lot of evidence that oncologists were lying about the patient’s condition. For instance the patient recovered completely from highly malignant cancer and the oncologist was telling us the patient died from cancer. So certainly, we have a lot of evidence about some of these doctors who are dishonest, who are liars, who cheat. But on the other hand you can’t really put the same label on the entire profession. There are many other doctors who are honest and who like to know about what we have. Of course our clinic has board certified oncologists who are taking care of our patients.

I found an interesting quote by David Stewart, a philanthropist who helped fund Gaston Naessens cancer research in the 70’s. He says,
“I can say categorically that most scientific researchers with whom I have had to deal are highly opinionated, arrogant, condescending, and have built-in, insurmountable prejudices.”

Would you agree with these sentiments? What have your experiences been?

Well certainly, I think he’s right; unfortunately that’s the truth.

We spoke about Crystin Schiff briefly before. This is a particularly despicable story, because when Ric Schiff asked Dr. Michael Prados, then head of neuro-oncology at University of California at San Francisco Medical Center (UCSF), if he knew of any other treatment besides chemotherapy/radiation for Crystin’s brain tumor, Prados replied in the negative. But a few years before, he had sent you 14 letters documenting the effectiveness of Antineoplastons on Jeff Keller, another patient with brain cancer. Is this story true?

Yes, it’s true; of course Jeff Keller had an extremely malignant brain tumor. He had a high-grade glioma of the brain; he failed radiation therapy and additional treatments. He responded extremely well to our treatment. He was one of the patients whose case was presented to the NCI. So there was no doubt about his response. Dr. Prados knew about it. If he was dealing with a hopeless tumor like Crystin Schiff, why didn’t he call us?

Ryan and mother Cindy. Ryan is in remission for several years after using Antineoplastons.

Please see the Burzynski Patients web site for more information,
http:// http://www.burzynskipatientgroup.org

You may also e-mail Mary Jo Siegel, the lady who runs the web site. Mary is also a cancer survivor using Antineoplastons.
maryjo@siegel.net

Do you know why Prados did not tell them about Keller’s success with your treatment?

It’s hard for me to tell. It happens that Dr. Prados and Dr, Friedman, who became the boss of the FDA, came from the same medical school. So they work closely together, and perhaps there is something to do with the general action against us. It would be inconvenient for Dr. Prados to say that the treatment works if FDA was trying to get rid of us and when his friend was Commissioner of the FDA at that time. Perhaps that’s the connection….

One of your greatest critics is Saul Green (Ph.D. Biochemistry), a retired biochemist from Memorial Sloan Kettering. In 1992 the Journal of the American Medical Association (JAMA), published Green’s article, “Antineoplastons: An Unproved Cancer Therapy.” What were his conclusions about Antineoplastons?

Well, Green is not a medical doctor, he’s a retired biochemist; he never reviewed our results. He got hold of some of our patents and that’s what he based his opinion on.

He was hired by another insurance company (Aetna) that was in litigation with us. He’s like a hired assassin. Not telling the truth. So really to argue with him is good for nothing. Even if something were completely clear he would negate it. He is simply a guy who was hired by our adversaries. He would do whatever they paid him to do.

Paul Leverett was diagnosed with a glioblastoma multiforme grade 4 brain stem tumor in May 1999. The prognosis was that he would probably be dead before the end of 1999. Orthodox medicine gave him no hope of survival.

Paul was given the maximum amount of radiation he was capable of receiving. It slowed the tumors growth slightly, but this did not alter Paul’s prospects for survival at all.

After completing some research on the Internet Paul learned about Dr. Burzynski’s Antineoplastons. Paul began taking Antineoplastons intravenously, administered by his wife, in September 1999. After 6 weeks Paul’s tumor had grown by only 2 %, Glioblastoma’s normally double in size every 2 weeks.

A PET scan in December 2000 confirmed that Paul was in complete remission. He stayed on Antineoplastons until August 2001 to ensure the tumor would not reoccur. There is just under 20% tumor necrosis remaining in his brain stem, which is probably scar tissue.

Paul’s oncologist (at MD Anderson, Houston) initially wanted to show his scan’s to his hospitals (MD Anderson) tumor review board. But then, for whaever reason, he refused further contact with Paul and did not go ahead with it.

The photo was taken with his wife Jennie. Paul had a web site created in order to inform people about his cancer experiences.
http://www.dontevergiveup.com

E-mail: pjleverett@ev1.net

Did Green ask to look at your patients’ files or even talk to any of your patients themselves?

No.

You responded with an article with 137 references, did JAMA publish even part of it?

JAMA refused to publish the article. They decided that they would publish a short letter to the editors. And obviously this is another dirty thing, because letters to the editors are not in the reference books. If you look in the computer and try to find letters to the editor from JAMA, you’ll never find it. So people who are interested will always find Green’s article, but they will never find our reply to Green’s article, unless they go to the library. Then they can look in the JAMA volume in which the letter was published, and then they will find it. So many doctors were asking me why I did not respond to Saul Green’s article because they never found my letter to the editors.

Are they obligated to publish your rebuttal?

Certainly they are, because they put Green’s article in JAMA in the first place, they accepted it without any peer review and then they did not allow me to honestly respond to it. I should be allowed to publish my response to the article in JAMA.

At the time of the publication Green was working as a consultant to Grace Powers Monaco, Esq., a Washington attorney who was assisting Aetna insurance agency in its lawsuit against you. What was the Aetna lawsuit about?

One of our patients sued Aetna because Aetna refused to pay for my treatment. Then Aetna got involved and Aetna sued us. Aetna really became involved in what you can call racketeering tactics because they contacted practically every insurance company in the US. They smeared us, they advised insurance companies to not pay for our services. So based on all of this, our lawyer decided to file a racketeering suit against Aetna. This was a 190 million dollar lawsuit against Aetna. So certainly Aetna was trying to discredit us by using people like Saul Green. And they hired him to work on their behalf.

So there was an obvious conflict of interest for Green because he worked for Monaco who was assisting Aetna. Was this information published in the JAMA article?

No.

Green also questions the fact that you have a Ph.D.. At the American Association for Clinical Chemistry Symposium, July 1997, Atlanta, GA., he says in part

“Burzynski’s claim to a Ph.D. is questionable. Letters from the Ministry of Health,
Warsaw, Poland, and from faculty at the Medical Academy at Lublin, Poland, say,
respectively:

1. At the time Burzynski was in school, medical schools did not give a Ph.D.
2. Burzynski received the D.Msc. in 1968 after completing a one-year laboratory
project and passing an exam. (3) Burzynski did no independent research while in medical school.”

He cites the people below as giving him some of this information.

1. Nizanskowski, R. ,Personal communication. Jan 15, 1992.
3. Bielinski, S., Personal communication, Nov. 22, 1987

First of all, do you have a Ph.D.?

Well, the program in Poland is somewhat different than the US. What I have is equivalent to a US Ph.D. When a medical doctor in the US graduates from medical school, he receives a medical doctor diploma. In Poland it’s a similar diploma, but it’s called a physician diploma, which is equal to medical doctor. And after that, if you would like to obtain a Ph.D., you have to do independent research, both in the US and in Poland. So you have to work on an independent project, you have to write a doctorate thesis and, in addition, to that in Poland, you have to take exams in medicine, in philosophy and also you have to take exams in the subjects on which you have written your thesis, in my case this was biochemistry.

As you can see from the letter from the President of the medical school from which I graduated, this is a Ph.D..

Saul Green got information from the guys who were key communist figures in my medical school. The second secretary of the communist party in my school, hated my guts, because I didn’t want to be a communist. So, somehow, Green got hold of “reputable” communist sources (laugh) to give him that information. It is exactly the President of the medical school who certified that I have a Ph.D..

So you are saying that theses people he received his personal communication from, Nizanskowski R, and Bielinski S, are both Communists, is that correct, or they were?

Not only communists, but Bielinski was one of the key players in the communist party in my medical school. So certainly he was extremely active as a communist. And, you know that communists, they usually don’t tell the truth.

So there is absolutely no question about it, you have a Ph.D. and Green’s doubts are totally without foundation. Has he ever acknowledged publicly the fact that you have a Ph.D.?

He’s never got in touch with me regarding this.

There are some mainstream oncologists who have stated publicly that your treatment works such as Dr. Robert Burdick, oncologist and professor at the University of Washington Medical School.

He is one of the top experts in this field.

Dr. Burzynski, there are undoubtedly many people alive today solely because of your treatments, but there could be many hundreds or thousands more alive if the public was given free access to your treatment. Do you see this ever happening?

I see this happening within a few years. We already have 8 clinical trials that prove efficacy of the treatment. However, we still need to treat more patients, because in each of our clinical trials it is required that we treat 40 patients. If we are talking about 78 clinical trials, then the number of patients that need to be treated is about 3,000. We are moving forward, probably in another 2 to 3 years we will have final approval.

A group shot of some of Dr. Burzynski’s patients. Please see the Burzynski Patients web site for more information,
http:// http://www.burzynskipatientgroup.org

You may also e-mail Mary Jo Siegel, the lady who runs the web site. Mary is also a cancer survivor using Antineoplastons.
maryjo@siegel.net

You have fought the government on behalf of your patients’ rights for over 25 years. There must have been a few times when you considered calling it quits. What has sustained you over the years and kept you fighting?

Well you see, basically the principle. Certainly I could practice just regular medicine and not
spend millions of dollars for the research, which I did. And I could go to some other country and practice. But I feel that this is my obligation because what I am doing is right. I’m saving peoples lives. So why should I give in to some mediocre characters, to liars, to people who really misrepresent what I do. And if I fail, then America will fail also. Because really America is the bastion of Democracy in the world. If America is rotten, then the whole world will go down to hell. So if something is rotten in the Patent office, in the NCI and FDA, it is the duty of the citizen to show that this is rotten and should be corrected.

There are a number of good people who can make it work, so why should bad people erode and destroy the entire system. I felt that this was my obligation; I felt that I was right and even if I had to go to prison, I would fight for it, because this is the right thing to do. Otherwise I could not look at myself in the mirror. I would despise myself.

Do you think we will we ever have medical freedom of choice in the US, where we can choose whatever treatment we want for cancer?

I am not sure if this will ever happen. But at least I am hoping that the movement, which we pioneered, like this alternative medicine movement, will bring a lot of good to the American people. After all, now you have official recognition of alternative treatment, more or less, and this is because of our fight. If we wouldn’t fight at that time, then perhaps it would not happen, but maybe it would happen another ten years from now.

Standard medical practices and the observations of physicians who are outside the medical establishment are extremely important, because anybody can make a discovery and improve the health of people. This I think is an important movement, but whether the people of America will ever have a chance to select whatever treatment they want, is another story.

Finally Dr. Burzynski, a hearty thanks to you for keeping your treatment available to cancer patients, for keeping your oath as a doctor and putting the patient ahead of financial gain, and of course, for saving lives. Please keep up the great work. Thank you for giving me the time to conduct this interview and inform people about your work and treatment.

Thank you.

End of interview.

Gavin.

Please be aware. Orthodox medicine often states that people who have recovered from cancer by unapproved methods did so due to a “spontaneous remission”. This means that the cancer just disappears for no apparent reason. First of all, I do not know of any documented cases of spontaneous remissions in brain cancer. In other serious cancers it is so rare as to be unworthy of discussion.

But here is the most crucial point. A true spontaneous remission is when the cancer goes away without any treatment, either approved or unapproved. It’s absurd to suggest that someone who received large amounts of Antineoplastons, and is then cancer free, had a spontaneous remission. If someone has surgery to remove a tumor and they are cancer free for years, we know it was because of the surgery.

Also remember that in many cases cancer patients turn to Antineoplastons (and other so-called alternatives) after chemotherapy and/or radiation have failed. If the patient goes into remission, oncologists often state that it was a delayed response to their treatment. This is a very convenient situation for oncologists. When their treatments fail, they still claim the credit for the patient’s recovery, even after the patient has been on Antineoplastons (or other treatments) for months/years.

Read about Dr. Burzynski’s treatment from the most important sources, the patients who had cancer and who are alive today because of Antineoplastons. The Burzynski Patients Web Site
http:// http://www.burzynskipatientgroup.org

Dr. Burzynski’s clinic can be reached at 713-335-5697.
His web site is http://www.cancermed.com

Kim Moreno’s short interview is below.

Kim also has an e-mail account she specifically set-up for people to contact her about her experiences with Dr. Burzynski, oncologists, Antineoplastons and cancer treatments in general. Any e-mail unrelated to these subjects will be deleted.
kimmoreno5@yahoo.com

Gavin Phillips non-profit web site
http://www.cancerinform.org

Some other Internet links that may be of use to you in your research.

http://naturalhealthline.com/

http://www.ralphmoss.com/

While searching the Internet for links related to Koch’s glyoxylide, I found a recent article on Dr. Mercola’s web site related to a drug called Methylglyoxal (the lead ingredient, which is a metabolite in our body) that has been tested in India for over ten years. Please see,
http://www.mercola.com/2001/jun/13/methylglyoxal.htm

http://www.drwhitaker.com/

http://www.dr-gonzalez.com/

http://www.gerson.org/

Interview with Kim Moreno

Thank you for taking the time to inform people about your family’s experiences while your daughter Tori was taking Antineoplastons.

Tori was first diagnosed with a Stage 4 brain stem glioma in August 1998, is that correct?

Yes

What was the prognosis?

The doctor’s basically told us to take her home and prepare for her to die.

Were there any records of anyone surviving with this type of cancer, using orthodox treatments?

None that they could provide us with.

How many cancer centers did you visit?

We originally were at Miller’s Children at Long Beach Memorial and then went to City of Hope. We also sent her MRI’s to Dr. Fred Epstein in New York to be looked at.

And they all said the same thing, Tori’s brain cancer was fatal and nothing could be done? How long was she expected to live?

Yes, they all said there was nothing we could do. She was given 2-6 weeks to live.

How did you find out about Dr. Burzynski and Antineoplastons?

On the Internet on a brain tumor support group. We read a letter from a father whose daughter was on the treatment.

Did you ask your doctors about Burzynski? Had they heard of him or researched his treatment?

Yes, we asked all of them about it. Most frowned at the idea, the oncologist refused to see her if we took her to see Dr. Burzynski. The only one who told us that he thought Dr. B might have a good chance with helping us was Dr. Fred Epstein.

When did you first visit him?

In October 1998

Did he tell you he could cure Tori?

No. He said he thought Antineoplastons would help her, but he wasn’t sure he had enough time. He was very upfront and honest with the statistics he had with her type of cancer but offered no promises.

How much Antineoplastons was Tori taking?

I can’t even remember what dose she ended up on when she was taking it intravenously.

What were the side effects? In the photos you sent me, Tori is greatly enlarged, I assume due to fluid retention. Is that what it was? How was that alleviated? Were there any other side effects due to the Antineoplastons?

We always had to monitor her potassium and sodium. So, she had to drink a lot of water and therefore we went through a lot of diapers. Those were the worst of the side effects. In the picture, she was so large due to being on Decadron, which we were able to wean her off of in January 1999.

Were you surprised when Tori started responding?

Yes, I have to say I was. It is hard to believe something great is going to come out of something so painful. I guess she taught me not to lose faith in life.

How soon was it before Tori’s brain tumor started reducing in size?

Immediately. It had shrunk in size by 20% after the very first MRI, which I believe was in 6-8 weeks…it’s been a long time and a lot of MRI’s later.

For how long did Tori continue to take Antineoplastons intravenously? Did you administer this yourself at home?

She took them through IV for 2 years and yes; we did this all at home.

Does your insurance company pay for the treatment? Did they try to avoid paying for it?

No, they do not pay for the treatment.

I understand Tori is 5 today. Is she still taking Antineoplastons? Has the tumor completely gone?

Yes, she just turned five in June. She still takes Antineoplastons orally…. she takes 40 capsules a day. Her tumor has decreased in size by 86% and they believe what is left may be scar tissue.

Has Tori suffered any permanent side-side effects from Antineoplastons?

Not one. In fact, it decreased her symptoms dramatically and never caused her any harm.

So Tori is cancer free and side effect free today?

Absolutely….

This is an incredible story Kim. Your child was diagnosed with a fatal brain cancer and the best oncologists and surgeons in America told you it was hopeless. Yet you found a cure for your child, without the billions, and so-called cancer specialists, that the NCI has at its disposal. Have any oncologists or doctors asked you about Dr. Burzynski’s treatment?

They tend to ask very quietly, but never really respond to what I have to tell them. There is curiosity there, just no one is really willing to step up to the plate and believe that the antineoplastons had something to do with her survival.

What do they say now that Tori is alive and well?

The neurologists told us that sometimes it happens and they called it “spontaneous remission”. Again, I asked them to provide some statistics and there were none to be seen.

That is of course the height of absurdity. To my knowledge, there has never been a documented case of any brain cancer going into spontaneous remission. Have you ever mentioned that to them?

Yes, again with no intelligent response.

So they are quite content to administer the same cancer causing, toxic treatments, when they know about your daughter’s success with Antineoplastons?

Absolutely. It amazes me that some of them can sleep at night.

Has your opinion about the medical profession, specifically cancer specialists, changed since Tori’s recovery? If it has, in what manner?

Yes, it has changed a lot. I guess the biggest change would be that I no longer sit back and believe anything a doctor tells m e and that we have to take our healthcare into our hands by searching for legitimate options. I believe we have the right to choose.

What do you think about the fact that some 3,000 children in the US (untold thousands worldwide) this year will be diagnosed with some form of brain cancer, and their families will have to face the same horror you did, the horror of losing a child. But virtually all of them will not be told about Antineoplastons, the treatment that cured Tori?

It really makes me sick to my stomach. That is why I want to talk to anyone who wants to listen about Tori’s Story

Finally, I commend you and your husband for finding a way to cure your daughter, when all the “experts” said it was hopeless. You gave her life when she was born, and then you saved her life by finding Antineoplastons.

I thank you once again Kim for answering my questions and sending me the photos of Tori. Give my best to your family.

Gavin Phillips opinion

Dr. Burzynski is a great rarity these days. He is a courageous man who risked everything battling the FDA for over 15 years so as to allow cancer patients access to his treatment. A doctor who puts his patients well being before financial gains. But how many people diagnosed with cancer this year will ever find out about Antineoplastons? A tiny percentage, because very few mainstream oncologists will inform their patients about a treatment that has yet to be approved. And why is that? The NCI and ACS have supposedly been searching for decades for any and all treatments that are effective against cancer. For over 15 years Dr. Burzynski’s treatment has shown that it is effective. Many cancer patients, including some very young children with supposedly hopeless brain cancers, are alive today because of Antineoplastons.

Here we come to the most crucial questions of all. Why did the FDA try their utmost to ruin Dr. Burzynski by involving him in 4 court cases? Why did the NCI make certain Burzynski’s clinical trials failed by diluting his treatment and enrolling patients who were the least likely to respond to Antineoplastons? If this was a one-time only event, we could dismiss it as an aberration; on overzealous government agencies. But the persecution of Dr. Burzynski is not an aberration, but the norm. There have been many well-documented cases in the last 70 some years of doctors/healers who discovered an effective cancer treatment, only to find the full force of the cancer agencies trying to destroy them and their discoveries. I have learned about several during my research. Dr. William Koch/Glyoxylide, Dr. Andrew Ivy/Krebiozen, Harry Hoxsey method/herbs, Royal Rife/radio waves, Ernst Krebs/ Laetrile/Amygdalin, Gaston Naessens/714 X, Dr. Lawrence Burton/Immuno-Augmentative Therapy, Dr. Max Gerson method/diet.

What, if anything, does Dr. Burzynski’s Antineoplastons have in common with these other treatments? Most of them are natural; all of them are inexpensive to produce, especially when compared to the enormous costs of conventional treatments. If cheap cancer treatments with virtually no side effects were allowed to freely compete with the cancer causing offerings of the pharmaceutical companies, the outcome is obvious. The pharmaceutical companies, and the hospitals that administer their drugs, will lose tens of billions in profits. And this I believe is the reason Dr. Burzynski, and the people who have gone before him, have been publicly vilified as “quacks” and their treatments discredited. The fact is that the pharmaceutical companies control American medicine, and they are only interested in treatments from which they can derive a profit.

Every cancer patient in America, and the world, should have free access to Antineoplastons. It is intolerable, not to mention totally un-American, to give a profit obsessed industry a monopoly over Americans healthcare. Nobody should have the right to force toxic chemicals down our family’s throat, especially when Dr. Burzynski’s treatment has proven effective (for some cancers) and does not have appalling side effects.

One point, in which I disagree with Burzynski about, is the possibility of medical freedom of choice happening in America. It would happen in a year or two if enough Americans demanded it. You can help make that a reality. Please forward this interview to as many people as you know, as well as media outlets. Around ten thousand Americans die every week from cancer; we simply must have medical freedom of choice. Thank you for your time.
Sincerely,
Gavin Phillips.
http://www.cancerinform.org

E-mail this sites address to someone and help spread the word

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E-mail me: cancerinfo11@yahoo.com
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REFERENCES:
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A Message to Guy “Can’t Git-R-Done” Chapman

Guy “Crapman” Chapman is a SkeptiCoward©

I’m NOT “Astroturfwatch” you twit
——————————————————————
“Guy” blogged another one of “The Skeptics™” #Fails [1]

He has a blog full of essentially misinformation, disinformation, misdirection, and lies regarding Burzynski, but the gist of it is that so far he has demonstrated to the entire world that he is that “Guy”, that “Yellow-Back” Chap, man, who has NOT demonstrated that he has the “Grapefruits”, to answer for his actions [2-4]

He claims my blog is “full of essentially incoherent commentary,” yet he offers NO explanation as to why it is that since its inception 2/14/2013, the Didymus Judas Thomas’ Hipocritical Oath Blog has had 9,626 visitors

Where’s your stats, Guy ?

Lets “review” his latest piece of propaganda and Dezinformatsiya, shall we ?
——————————————————————
“The FDA approved a phase 3 trial, therefore Burzynski’s antineoplastons definitely work”
——————————————————————
#fail [5]

“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
——————————————————————
“The Lancet rejected publication of the sole paper known to have been sumbitted from the one completed phase 2 trial, therefore there is a global conspiracy to suppress Burzynski”
——————————————————————
#Fail [6]

Bob Blaskiewicz postulated during the Google+ Hangout on Saturday, that this is a generic, usual, normal course-of-business rejection letter

NO such example is on Al Gore’s Internet

Whose got one ?

Even in a Tweet, everybody must include all caveats and the full body of knowledge with footnotes, or stand convicted of lying
——————————————————————
#FaiL

Do NOT post deceptive Twits:

#faIL

@SceptiGuy, on 5/25/2013, what did you NOT understand about her 5/23/2013 Cease and Desist Tweet ?

A trial at a reputable cancer center once took several years to complete and publish, therefore failure to complete and publish a single trial in 40 years means nothing
——————————————————————
#FaiL

So, does this mean you wanted Burzynski to publish the phase 2 clinical trial final results before the trials were finished ?
——————————————————————
“Failure to participate on a partisan blog means you refuse to debate”
——————————————————————
#FAil [7]

Is this just another one of “The Skeptics™” Red Herring’s you like to use ?

The About page on my blog is crystal clear:

“The decision is that he is neither guilty nor innocent doesn’t mean he doesn’t need to do work within his practice, and the FDA obviously needs to pursue things as well”

As I said on the Saturday Google+ Hangout, I consider myself to be a Skeptic Skeptic [8]

In other words, if you are going to be a true Skeptic, at least police yourself and “fact-check” before you insert foot-in-mouth and spread misinformation, disinformation, misdirection, and / or lies all over social media

Making lame excuses for NOT debating on my blog is like an atheist stating that they would NOT debate on Earth because creationists claim it was created by God
——————————————————————
“Failure to complete and publish trials is the single biggest reputational issue Burzynski has and it cannot be waved away or covered with a fig leaf of a single rejected paper”

“If you can’t understand why this is a problem, then we’re all wasting our time even talking to you”
——————————————————————
#FaIL [9]

YOUR failure to provide any citation(s), reference(s), and / or link(s) from the Declaration of Helsinki, United States Food and Drug Administration, National Cancer Institute (NCI) at the National Institutes of Health (NIH), or any other source to support your claim as to when you think Burzynski is required to publish, says it all
——————————————————————
“The average time from commencement of a trial to completion is 3-5 years”

“If a trial is going to be completed and published, very few take longer than 8 years to final publication”
——————————————————————
3/29/1996, then United States Food and Drug Administration Commissioner, David Kessler told the American people [10]:

2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials

A. What is the FDA’s definition of “smaller trials”?

B. What is the FDA’s definition of “fewer patients”?

Burzynski’s 2006 publication lists 1652 adults and 335 children (1,799 Total) [11]

“A quick sample says that the first 60 of Burzynski’s phase 2 trials were all registered on the same day”

“1 November 1999, presumably following the consent decree which forbade him from administering antineoplastons outside of a registered clinical trial”
——————————————————————
fAil [11]

If you’re correct; which is rare, 3/29/1996, why did then US FDA Commissioner, David Kessler tell the American people [10]:

6. The uhh agency has … MANY … trials … has has approved trials … for patients … with antineoplastons ?

Why does Burzynski’s 11/25/1997 SEC Form 10-SB filing list 72 phase 2 clinical trials ? [12]

Could it be because you are wrong ?
——————————————————————
“The trial that completed, was finished in February 2005”
——————————————————————
Are you certain ? [13]

“The single phase 3 trial is withdrawn”
——————————————————————
Guy, did you contact the National Cancer Institute (NCI) at the National Institutes of Health (NIH) like I did, where they advised me: “Not every cancer clinical trial taking place in the United States is listed on our NCI Clinical Trials Database” ? [14]
——————————————————————
“I do not choose to debate on DJT’s blog”
——————————————————————
Guy, can you see the yellow stripe down your back ?

(I won’t say “spine,” because you haven’t shown that you have one)
——————————————————————
“He has a long history of misrepresenting differences of opinion as evidence of deceit (e.g. his claim that 0/61 is evidence that I can’t count, rather than what tit is, brevity during a rapid exchange of suggested questions during a Google hangout, where the person to whom the suggestion is made, is fully aware of the full context of 0/1/61 published/complete/registered”
——————————————————————
Guy, why don’t you just PROVE IT ?

#fAiL

Guy, hasn’t ONE been completed ?

You wanted him to publish before the clinical trials were finished ?
——————————————————————
“So that kind of stuff is not the actions of an honest broker”
——————————————————————
Guy, what do you call all of your above FAILS?
——————————————————————
“I wouldn’t expect DJT to debate here, nor would I be interested in giving him a platform; am happy to debate in an open forum where there are comprehensible questions and some sort of moderation to prevent tactics such as the Gish gallop”
——————————————————————
Talk about “Gish galloping”

First you post: “I wouldn’t expect DJT to debate here … “

and then you posted: ” … nor would I be interested in giving him a platform …”

which just shows that you were NOT sincere when you posted your 1st comment

What you are basically saying when you posted: ” … I am happy to debate in an open forum where there are comprehensible questions and some sort of moderation to prevent tactics such as the Gish gallop“, is that you are NOT competent enough to call “Gish gallop” and prove it during any debate

You want “Mommy” to protect you from someone who is more intelligent than you are ?

That’s what I hear you saying
——————————————————————
“Sorry, your blog is not an “open forum” and the majority of what’s written there is gibberish”
——————————————————————
I understand you

My blog is meant for intelligent people who can grasp ideas, dry wit, and other concepts humans use to communicate with each other

Unfortunately, I take it you are NOT like the other 9,600* people who have visited my blog
——————————————————————
“I recommend you stop trying to satirise someone else’s style and instead write in your own words”
——————————————————————
Why would I take any advice from you ?

You’re one FAIL after another

I’ll satirize (and spell it correctly) that Ph.D. FAIL “Orac” all I want
——————————————————————
“And read them back, if necessary to a friend, so that you get the general air of “what the hell does that even mean?””

“knocked out of it”
——————————————————————
It’s readily apparent who needs to check them self

Because you act as if you’ve been “knocked out of it” for quite some time

Maybe you should wear a helmet
——————————————————————
“Twitter is about rapid-fire debate”
——————————————————————
What the problem is ?

“The Skeptics™” think Twitter is a “debate forum”, but you do NOT have the cranial capacity to “debate”

What “The Skeptics™” do is called “mental bastardization”
——————————————————————
“Don’t pretend that any statement is ever intended to be a nuanced and scientifically rigorous statement of the prevailing consensus view, because it isn’t, and it’s not pretending to be”
——————————————————————
As far as I’m concerned, the vast majority of your twits are “pretending”
——————————————————————
“It’s fair to ask for a source or a clarification, it’s grossly misleading to cherry-pick individual tweets and misrepresent a lack of detail as deliberate malfeasance”
——————————————————————
The FACT is, a plethora of your twittering has as its source, your posterior
——————————————————————
“That’s the kind of tactic that gets you ignored and dismissed as a mendacious time-sink; if that’s the image you’re striving for then fine but I don’t think it is”
——————————————————————
Everyone already knows what you are

Guy “Crapman”
——————————————————————
“There you go”
——————————————————————
I could NOT have said it better myself
——————————————————————
“And now, if you don’t mind, I will get on with other things”
—————————————————————
LIKE THIS ?

EXPLAIN THIS [15]

Prove I spammed 🙂

Are you a man ?

Or are you a

SkeptiCoward© ?

======================================
REFERENCES:
======================================
[1] – 10/2013 – A Message to DJT
——————————————————————
http://t.co/Rd9CVSaKcq
——————————————————————
http://www.chapmancentral.co.uk/blahg/2013/10/a-message-to-a-djt/
======================================
[2] – 3/24/2013 – Critiquing “Burzynski: Another fact-blind troll, who predicted that?”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/critiquing-burzynski-another-fact-blind-troll-who-predicted-that/
======================================
[3] – 4/12/2013 – The dishonesty of Guy Chapman, “The Skeptics” shill:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/12/the-dishonesty-of-guy-chapman-the-skeptics-shill/
======================================
[4] – 5/5/2013 – guychapman (Guy Chapman) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/05/guychapman-guy-chapman-critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-9/
======================================
[5] – 4/25/2013 – Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective/
======================================
[6] – 9/30/2013 – Bob Burzynski Skeptic Sez Multiforme Manuscript Meme Message Memorable:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/30/bob-burzynski-skeptic-sez-multiforme-manuscript-meme-message-memorable/
======================================
[7] – About | Didymus Judas Thomas’ Hipocritical Oath Blog
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/about/
======================================
[8] – 10/3/2013 – “The Skeptics™” Definition of “Debate”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/03/the-skeptics-definition-of-debate/
======================================
[9] – 4/25/2013 – Burzynski: Declaration of Helsinki:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki/
======================================
[10] – 6/8/2013 – WHAT IS MISDIRECTION? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
======================================
[11] – Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies. Pediatric Drugs 2006;8:167-178. (Pediatr Drugs 2006; 8 (3)), 2.3. Targeted Therapy, pg. 174
——————————————————————
8/21/2013 – Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================
[12] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
======================================
[13] – 6/26/2013 – Burzynski: The Clinical Trials:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/26/burzynski-the-clinical-trials/
——————————————————————
http://clinicaltrials.gov/archive/NCT00003509/2009_05_26/changes
======================================
[14] – 4/26/2013 – Burzynski: Not Every Cancer Clinical Trial Taking Place In The United States Is Listed On Our NCI Clinical Trials Database:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-not-every-cancer-clinical-trial-taking-place-in-the-united-states-is-listed-on-our-nci-clinical-trials-database/
======================================
[15]
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/23408699/
======================================

The Skeptics™” Robert J. (don’t call me “Bobby”) Blaskiewicz wants to Debate

Bob thinks we can debate all this in an hour 🙂
======================================
3/4/2013 – 7:58pm – You posted on Colorado Public Television (CPT12):

“ANP is toxic as anything!”

So you’re saying what ?

ANP is as toxic as water ?

[1]
——————————————————————
“It gives people insanely high sodium, and Burzynski is currently not allowed to be dispensed by Burzynski because, according to a patient, it killed someone”

FAIL – provides no citation(s), reference(s), or link(s) to support “toxic” and “tons of chemo” statements

[1]
——————————————————————
“This is not harmless stuff”

“This is not non-toxic”

FAIL – provides no citation(s), reference(s), or link(s) to support “toxic” and “tons of chemo” statements

[1]
——————————————————————
“And most of Burzynski’s patients never qualify for his trials”

“That’s the lure”

“They all end up taking tons of chemo used off label”

FAIL – provides no citation(s), reference(s), or link(s) to support “toxic” and “tons of chemo” statements

“Tons of chemo” ?

Even your “man-crush” cancer oncologist has blogged that it’s “low-dose” chemo

======================================
12/13/2012 – Stanislaw Burzynski: “Personalized gene-targeted cancer therapy” for dummies
——————————————————————
http://scienceblogs.com/insolence/2012/12/13/stanislaw-burzynski-personalized-gene-targeted-cancer-therapy-for-dummies/
======================================
[1]
——————————————————————
3/5/2013 at 12:25pm – You posted on CPT12:

“How awful does your feedback need to be before you realize that you are going to endanger your viewership?”

The feedback was:

241 – Yes
97 – No
2 – Undecided

What was your point ?

[2]
——————————————————————
3/12/2013 – Why did “The Skeptics™” on CPT12 resort to adolescent name-calling:

“trolls,” “spammers,” “disingenuous,” “dishonest,” “profoundly dishonest,” “sheer stubborn stupid,” “stupid,” “spambot,” “fools,” “shills, “conman” ?

Don’t they have the intelligence a “Professor of Writing” should have ?

[3]
——————————————————————
3/12/2013 – Why did “The Skeptics™” on CPT12 and elsewhere whine about publication when the Declaration of Helsinki

30. addresses publishing human clinical trial data

does NOT indicate WHEN the data should be published, leaving it open to interpretation as to if it should be done piecemeal, or when all trials re a specific drug or drugs are completed after Phase I, II, or III, for example ?

[3]
——————————————————————
Why did “The Skeptics™” on CPT12 and elsewhere rant about scientific peer-reviewed journals and their “Impact Factors” but did NOT know what to do about this ?:

National Cancer Institute
at the National Institutes of Health

Cancer Clinical Trials

15. “The results of clinical trials are OFTEN published in peer-reviewed scientific journals”

” … whether or NOT the results are published in a peer-reviewed scientific journal … “
http://m.cancer.gov/topics/factsheets/clinical-trials

[4]
——————————————————————
Blaskiewicz, do you have this many honors / awards ?

20 – HONORS AND AWARDS

LIFETIME ACHIEVEMENT AWARD. March 2012. Dallas /Ft. Worth, TX

The Order of Merit of the President of Poland – Officer’s Cross, October, 2004

Decoration of Polish Medical Association, November, 2001

The Order of Saint Brigida – Grand Cross with Star, November, 2001

The Order of Saint Stanislas – Grand Cross with Star, November, 2000

The Order of Reconciliation – Noember, 2000

The Cross Virtus Nobilitat, June, 1999

The Wisdom Award of Honor, December, 1998

The Medal of the President of City of Lublin, Poland, December, 1998

The Order of Saint Stanislas- Commander’s Cross with Star, December, 1997

The Lady Liberty Award “for engaging in invigorating the Right to be Secure in their Effects by fourteen years of perseverance in practicing his Profession free of interference by a government having no probable cause and in the determined resistance to that interference,” Libertarian Party of Texas, Dallas, TX, July, 1997

The Gold Medal from the American Institute of Polish Culture for outstanding achievements in the field of medicine and discovery of anti-cancer drugs antineoplastons, Miami, FL, February, 1997

The Medal “Heart for Hearts” for saving human lives, Lublin, Poland, August, 1997

The Memorial Medal of Zamoyski’s Lyceum in appreciation of outstanding contribution to increase scientific ranking of the school, Lublin, Poland, November, 1997

The Heritage Award by Polish American Congress in recognition of extraordinary achievement in the research, treatment, and prevention of cancer, Chicago, IL, October, 1993

Special Medal from the Polish government’s Institute for Drug Research and Control for achievement in the field of cancer research, Bialvstok, Poland, September, 1989

Honorable Membership in the Academia del Medeterraneo, Rome, Italy, 1984

Recipient of commendation for Dedicated Service and for Personal Contribution made in the
Advancement of Medical Education, Research and Health Care, Baylor College of Medicine, Houston, TX, April, 1977

Recipient of Medical Doctor Diploma with Distinction, Medical Academy, Lublin, Poland, 1967

Co-winner of the prize for best paper presented at the 7th Conference of Polish Medical Student Research
Societies, Poanan, Poland, 1966

[5]
——————————————————————
Why do some Burzynski critics claim they are NOT a “group” when they comment on each others blogs?

“That’s why I like the idea of the campaign that Bob Baskiewicz has come up with to wish Dr. Burzynski a happy birthday this year, skeptic style:”

(Citing and linking to 1/4/2013 blog)

1/4/2013 – Bob Blaskiewicz @rjblaskiewicz
Happy Birthday, Dr. Burzynski!
http://thehoustoncancerquack.com/2013/01/04/happy-birthday-dr-burzynski

3/15/2013 – Bob Blaskiewicz @rjblaskiewicz

https://twitter.com/gorskon/status/312601559647281154
retweeted David Gorski @gorskon Orac @oracknows (David H. Gorski) #sciencebasedmedicine

1/7/2013
Post #2 – rjblaskiewicz @rjblaskiewicz (Bob Blaskiewicz) – Wisconsin – Thanks, PZ

Posted by PZ Myers 1/6/2013
Let’s make Houston cancer quack Burzynski pay!

1/7/2013
Post #2 – Robert Blaskiewicz @rjblaskiewicz (Bob Blaskiewicz) –
“The Skeptics” non-group activity on Forbes:

[6]
——————————————————————

https://twitter.com/rjblaskiewicz/status/310589187797700608
Except YOU have NOT yet actually demonstrated that you believe in “interesting and civil discussions

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/310856694525730817
Bobby, please point out where the Declaration of Helsinki supports your tweet?
http://www.wma.net/en/30publications/10policies/b3
[7]
——————————————————————
Please point out where the National Cancer Institute (NCI) at the National Institutes of Health (NIH) supports your tweet
http://m.cancer.gov/topics/factsheets/clinical-trials
[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/310923414175105024

https://twitter.com/rjblaskiewicz/status/311317995861442560
Do you mean THIS present ?

“Let’s make Houston cancer quack Burzynski pay!”

PZ Myers

“there is a plan to remind him of the grief he has caused”

“his snake oil”

“bilk people out of buckets of money”

“Crime does pay”

“This fraud”

“The Burzynski clinic is a place you go to die”

“The lies”

“his quackery”

======================================
Let’s make Houston cancer quack Burzynski pay!
Posted by PZ Myers on January 6, 2013
——————————————————————
http://scienceblogs.com/pharyngula/2013/01/06/lets-make-houston-cancer-quack-burzynski-pay/
======================================
[7]
——————————————————————
Do you mean THIS St. Jude ?
St. Jude:
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=403c6f9523e70110VgnVCM1000001e0215acRCRD

2/15/2012 – the U.S. Department of Health and Human Services has awarded St. Jude Children’s Research Hospital $4,314,800 for a childhood cancer survivor study

The new federal funds will be distributed by the National Cancer Institute (NCI)
http://cohen.house.gov/press-release/cohen-st-jude-receive-43-million-childhood-cancer-survivor-study

Burzynski does NOT receive Federal Funds

[7]
——————————————————————
Tax-Exempt: Receives Federal Grants / Funds
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=b7e79bb8a0cf5110VgnVCM1000001e0215acRCRD&cpsextcurrchannel=1
Burzynski does NOT receive Federal Grants

Burzynski is NOT Tax-Exempt

[7]
——————————————————————
Donations to St. Jude are tax deductible as allowed by law
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=6f8afa3186e70110VgnVCM1000001e0215acRCRD&vgnextchannel=2f62940504f9a210VgnVCM1000001e0215acRCRD

Burzynski donations can NOT be deducted from a U.S. Tax Return

[7]
——————————————————————
FORBES: St. Jude CEO – $742,718
http://www.forbes.com/fdc/welcome_mjx.shtml
[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/310964881253867521
THIS Phenylbutyrate (PB) ?

Phenylacetylglutaminate (PG) and Phenylacetate (PN) are metabolites of PHENYLBUTYRATE (PB) and are constituents of antineoplaston AS2-1

SODIUM PHENYLBUTYRATE was given an orphan drug designation by the FDA for use as an adjunct to surgery,
radiation therapy, and
chemotherapy
for treatment of individuals with
primary or recurrent malignant glioma

Cumulative List of all Products that have received Orphan Designation: Total active designations: 2002 Effective: 5/5/2009
http://www.fda.gov/downloads/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/ucm162066.xls
PHENYLBUTYRATE and SODIUM PHENYLBUTYRATE are listed alphabetically in the lower 1/4th of this document

Pubmed 110 entries
Sodium Phenylbutyrate
“Sodium Phenylbutrate (aka PB) …”
Sodium Phenylbutyrate (PB)

Year – Pubmed (110 entries)
1958 1st entry
1995 1st clinical trial
2001 Phase 1
2009 Phase 2
2012 Phase 3

Bob, you do know that the research only took off once Dvorit D. Samid (Burzynski I) learned about it from Burzynski, right ?

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/310979838372626432
THESE trials ?

2003 – 2006 Phase II preliminary reports

2003 – Phase II
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma:

a preliminary report
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101

recurrent diffuse intrinsic brain stem glioma

antineoplaston A10 and AS2-1

6 months median duration of treatment
of all 12 patients

2 years / 33.3% – Survival

2 / 17% – alive and tumour free for over 5 years since initial diagnosis
from the start of treatment

5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities were observed, which included
3 cases of skin allergy
2 cases of:
anaemia
fever
hypernatraemuia
single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003 – Protocol – recurrent diffuse intrinsic brain stem glioma

12 – Patients Accrued
10 – Evaluable Patients

2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004 – Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma :

a preliminary report
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26

incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma
4 with low-grade astrocytoma
1 with astrocytoma grade 2
1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy
19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans
1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

10 patients are alive and well from 2 to >14 years post-diagnosis

Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described

2004 – Protocol – incurable recurrent and progressive multicentric glioma

12 – Patients Accrued

33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

2005 – Phase II – Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77

13 children with recurrent disease or high risk

6 (46%) survived more than 5 years

2005 – Protocol – recurrent disease or high risk

23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – % of Patients Showing Progressive Disease

2006 – Phase II – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7

Brainstem glioma carries the worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG
14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy

Antineoplastons, A10 (A10I) and AS2-1 injections
5 months median duration
Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography
Antineoplastons tolerated very well
1 case of grade 4 toxicity (reversible anemia)

2006 – Protocol – high-grade pathology (HBSG)

18 – Evaluable Patients

11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

Or did you expect Burzynski to publish the final clinical trial results before they were finished, Bob?

[7]
——————————————————————
2/24/2013
http://www.skeptical.gb.net/blog/?p=1442
2/27/2013
http://www.skeptical.gb.net/blog/?p=1798
3/9/2013
http://www.thetwentyfirstfloor.com/?p=8001

https://twitter.com/rjblaskiewicz/status/311091486349475840
Bobby, oh REALLY ?

“The Skeptics” (Burzynski: Cancer is Serious Business, Part II)

The “group” “The Sketics” claims is NOT a “group” and which allegedly does NOT spread “misinformation”
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/the-skeptics

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/311524673819144192
No Bobby, you did NOT

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/311543395556409344
“VAMPIRE” ?

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/311594720373645312
Bobby, like THIS ?

Stanislaw Rajmund Burzynski, M.D., Ph.D and “Freedom of Speech”

“The most stringent protection of free speech would not protect a man in falsely shouting ‘fire’ in a theater and causing a panic.”

United States Supreme Court ruled 3/3/1919

Schenck v. United States, 249 U.S. 47 (1919)
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/stanislaw-rajmund-burzynski-m-d-ph-d-and-freedom-of-speech

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/311681213934997505
Bobby, like THIS ?
David H. Gorski and the Cult of “MISINFORMATION”
Colorado Public Television 12 – PBS: Part II
https://stanislawrajmundburzynski.wordpress.com/2013/03/10/david-h-gorski-and-the-cult-of-misinformation
Orac and the Cult of “Misinformation” (Part III)
David H. Gorski
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/orac-and-the-cult-of-misinformation-part-iii
Josephine Jones and the Cult of Misinformation
JJ recently blogged:
https://stanislawrajmundburzynski.wordpress.com/2013/03/13/josephine-jones-and-the-cult-of-misinformation
Keir Liddle and the Cult of MISINFORMATION
https://stanislawrajmundburzynski.wordpress.com/2013/03/09/keir-liddle-and-the-cult-of-misinformation
The Cult of “Misinformation”
Review of “disinformation,” “misinformation,” and “misdirection” posted by #Burzynski critics
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/the-cult-of-misinformation
The cult of “Misinformation” continued
Adam Jacobs
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/the-cult-of-misinformation-continued

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/311854061550960642
Bobby, where’s your
Citation(s),
Reference(s), and / or
Link(s) ?

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/311859126965788672
Bobby, Adam Jacobs does NOT care about “FREE SPEECH,” he censors it:
http://dianthus.co.uk/burzynski-qa

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/311931318629986305
Well, Bobby, We know a lot of the skeptics seem to “hate” the truth

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/312013682408292354
Bobby, maybe you should have actually watched THIS:

Burzynski Infomercial on Colorado PBS 12
http://www.skeptical.gb.net/blog/?p=2401

[7]
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https://twitter.com/rjblaskiewicz/status/312052091407433728
Bobby, maybe you should ACTUALLY listen to it

[7]
——————————————————————
https://twitter.com/rjblaskiewicz/status/31212153099585536

Yeah, riiiiiiiiight, Bobby
rjblaskiewicz:

“Response to the release of Burzynski 2, Havanna Nights”
http://t.co/t9WMpNRN9L
Skeptical Humanities

Learning is Cool

Response to the release of Burzynski 2, Havanna Nights

Posted by Bob

On this week’s episode of the Virtual Skeptics, I replied to what was learned at the premiere of the new Burzynski movie

The text of my segment follows the episode

This week, the new Burzynski movie premiered in San Luis Obispo, California

We largely knew what was going to be in the movie since a couple of trailers had been released, the patients who appeared had talked about the filming, and there was a sort of credulous review had appeared a few days ahead of time and I believe the director may have mentioned it on a PBS fundraising specual a few days earlier

So we had a pretty good idea of what our proxies should be looking for

We really wanted to see if certain people who had been filmed, like Amelia Saunders or Hannah Bradley appeared and especially what was said about them

We wanted lists of people who appeared, to see if we might be able to put together who said what

Most of these people’s stories are well known, and we doubted there would be anything new

Also our people took down key quotes that struck them as important, like

(those notes did NOT seem very “key” considering Orac’s (David H. Gorski @gorskon #sciencebasedmedicine @ScienceBasedMed @oracknows)

“Second-Hand” “review” of Burzynski: Cancer is Serious Business, Part II)

“skeptics are hiding behind their BS free speech.”

(Yep, TRUE)

[7]
——————————————————————
This is my takeaway, after talking to the people who I know were there

We are wiggly little scumbags who are hateful and slimy

(some skeptics seem to be “hateful” of the truth)

[7]
——————————————————————
We ridicule the desperate and dying

Some of us are paid by big pharma

Others are deluded and think that we are doing good but are being misled

(that is a fair description of “misinformation,” “disinformation,” and “misdirection”)

[7]
——————————————————————
But make no mistake–and this was hammered home to me by everyone I talked to–we are to them pure evil

One of my big concerns going into the movie was how I was going to be portrayed and whether or not I was going to receive death threats

That my family was going to receive death threats or that I was going to be harassed at work

I feared this because of a letter that, as you know, was sent to my employer promising that I would be featuring prominently in the Burzynski movie

[7]
——————————————————————
Nobody asked me for my opinion or to give a statement or to respond or clarify; they went straight to my boss

Maybe they figured out your “opinion” and didn’t need any “clarification”

[7]
——————————————————————
Fine

I’ve had wacky people contact my employers in the past

I fully expect it to happen in the future

Clips of this show, episode 13, were included in the movie

This is the episode that was quoted in the letter on my university chancellor

As it turned out, our faces were blurred, our names obscured, and our voices were altered

No real identifying information

Which, you know, I’m OK with

However, there are some problems here

1) What was served by contacting my employer other than to scare me

How dare the filmmakers say that we’re terrorizing people when they are doing just that

Filmmakers ?

[7]
——————————————————————
2) Someone asked me about a quote,

“we’re coming for you, you little polish sausage you.”

The thing is, the quote is patently absurd if my name is shown, something that everyone here jumped on, like I hoped you would during the original episode

That joking was not conveyed to the skeptics in the theater audience

This might be due to the fact that not only were we given scary voices but also that apparently every time we appeared scary music played in the background

That might be funny to you but maybe not to your Human Resources Department, and if that was “scary voices” and “scary music” to you, what’s the last scary movie you saw?

Scooby Doo, Where are You?

[7]
——————————————————————
It’s clear that the reason I’m in the movie in the capacity I am, as chief bad guy, is because I’m on video talking about the Burzynski Clinic

Are you sure it’s not because you are somewhere behind Gorski with the disinformation?

After all, he was invited to appear in the movie

Were you ?

[7]
——————————————————————
And this leads me to another thing that Brian mentioned

That when we kind of appeared on the screen, they put up a title card type thing that said,

“skeptical teleconference”

or something like that, and that a woman at the end of the show, wanted to know,

“How did you get this footage of these scheming skeptics?”

Um….we publicize our show constantly?

If you can’t have real clandestine drama, you might as well make it up

My favorite bit was a tweet that I got around this time where a new account who followed like 10 people I do said,

“It’s really interesting when you talk about Burzynski on the show

Could you do that more?”

Really, Eric?

(Do you know it was Eric ?

After all, you thought I was Eric)
Bob Blaskiewicz

[7]
——————————————————————
Yeah, I have a feeling it’s Merola

That’s just me though

He’s way too invested in the hashtag in his movie to just let it drop
http://www.chapmancentral.co.uk/blahg/2013/03/burzynski-another-fact-blind-troll-who-predicted-that/#comments

Do you think I’m two years old?
(Your “fact-checking” ability makes me wonder)

[7]
——————————————————————
I am interested in ultimately seeing it

I’m asking that the producer send a review copy to the James Randi Educational Foundation so a proper review can be done

(As if jref is a “reliable source”)

[7]
——————————————————————
Or you could screen it in Minneapolis

Next week works for me, Eric, if you’re free

I guess he wasn’t

[7]
——————————————————————
Another thing

News broke on the 7th of January in skeptical circles that the FDA was conducting an audit of the clinic

A patient in the movie apparently said that she had been receiving a brain scan when she heard that the Clinic was being investigated again

This means that material was added to the movie after the 7th of January

The Burzynski Birthday Fundraiser was announced by PZ Myers on the 6th

So there was more than enough time for the filmmaker to clarify exactly what was meant in that episode when I said that there was going to be a little present on his birthday

(That “present” PZ Myers was offering up ?)

[7]
——————————————————————
Skeptics evilly, and with malice aforethought, raised $14.5K dollars for St. Jude’s

We then challenged the Clinic to match us, and it didn’t

That the director did not mention this fact seems to me inexcusable, making us look like we are big meanos who hate babies and morality

(He could have mentioned your “Fave,” PZ Myers)

[7]
——————————————————————
This demonization is unfair and at the expense of the truth–if you ever read theotherburzynskipatientgroup blog you know whose side I’m on

P Z who ?

[7]
——————————————————————
If he used the video clip of us that he cited in his letter to my employer, about us bringing a “present” to Burzynski and knowing what it actually was without clarifying it, well, that just speaks to his regard for completeness and accuracy

I don’t think you really wanted P Z’s “present” “clarified”

[7]
——————————————————————
No messiah should need such fudging

It suggests to me that he’s forcing evidence into a pre-existing narrative of persecution

(And what do you call what YOU are doing ?)

[7]
——————————————————————
References:

PZ Myer’s announcement of the Houston Cancer Quack
http://scienceblogs.com/pharyngula/2013/01/06/lets-make-houston-cancer-quack-burzynski-pay/
The Virtual Skeptics episode that appears in the movie:
http://www.youtube.com/watch?v=IK-yF8w6nLo

RJB
rjblaskiewicz:
http://t.co/F79zndTjuZ

https://twitter.com/rjblaskiewicz/status/312234423288487936
Bob Blaskiewicz retweeted

https://twitter.com/jref/status/312255856928509953
Bobby, did you know that I tried to post a comment on the James Randi Educational Funding (jref) article Written by Brian Thompson, about this, but they did NOT post my response ?

Did you post something about “FREE SPEECH” ?

“Burzynski II” Fails to Convince
Swift”
http://www.randi.org/site/index.php/swift-blog/2050-qburzynski-iiq-is-more-of-the-same.html

[7]
——————————————————————
My 1st-hand Review of Orac’s 2nd-Hand Review – Burzynski: Cancer is Serious Business, Part II

Burzynski critic Orac blogged about “Burzynski: Cancer is Serious Business, Part II”
https://stanislawrajmundburzynski.wordpress.com/2013/03/14/my-1st-hand-review-of-oracs-2nd-hand-review-burzynski-cancer-is-serious-business-part-ii

https://twitter.com/rjblaskiewicz/status/312998393259622402
Bobby, does this mean it will be punctuated correctly, but NOT “Fact-Checked” ?

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313465677614817280
Bobby, it did NOT help

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313496736708583424
rjblaskiewicz:
Not really. 🙂

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313508346399428608
That’s what I thought, Bobby

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313725494170361856

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313741293576667137

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/310589187797700608
Bobby, what was that about
“many interesting and civil discussions” ?

[7]
——————————————————————
Bobby, you can’t always get what you want

But if you try sometime, you just might find

you get what you need

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/314115938960154624
Bobby, let me guess

You are so busy tweeting about penises that you do NOT have enough time to “Fact-Check” ?

[7]
——————————————————————
You do know FDA required ?

” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as
chemotherapy,
gene targeted therapy,
immunotherapy and
hormonal therapy
in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s
Antineoplaston CLINICAL TRIALS
http://www.sec.gov/Archives/edgar/data/724445/000091205702038660/a2091272z10qsb.txt

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/315972148684529664
Yes it does, Bobby
You’ve just been Insolently pwned

[7]
——————————————————————
Skeptical Humanities
Learning is Cool

A Letter to the PBS Ombudsman about CPT12′s Airing of
“Burzynski”
http://t.co/RxDZHDN2RM
Posted by Bob

PBS Ombudsman Michael Getler

“To understand the complexities and history involved takes a lot of work, far more than we could possibly expect of Mr. Getler”

(or, as I have proven, of YOU)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii

[8]
——————————————————————
“That said, however, I do disagree with some of his conclusions”

(You could see that coming a mile away, couldn’t you?)

Getler starts off:

[ ” … It is about the decades-long struggle of a Polish-born physician and biochemist, Stanislaw Burzynski, who set up a clinic in Texas in 1976, to achieve acceptance for a cancer-cure therapy based on a treatment he developed based on what he calls “Antineoplastons.” [ANP]”

“I submit this is already wrong
There is little evidence that Burzynski is at all serious about developing antineoplastons for wider marketing”

THAT certainly explains the Phase III stuff

[8]
——————————————————————
“If that were true, surely he would have managed to have completed and published a single advanced trial in 35 years

Bob, who was ultimately in charge of the trials?

The FDA ?

[8]
——————————————————————
“If you look at the trials he’s been required to register at clinicaltrials.gov, you see over 60 trials, 1 completed, and none published

NONE”

Bobby, where is the
Citation(s),
Reference(s), and / or
Link(s)

that support your
“required to register”
statement ?

NONE ?

Are you a sociopath who thinks that people should believe you just because you blogged or twitted it ?

[8]
——————————————————————
“This is important because he is restricted to giving his ANP in clinical trials

But he apparently abandons his trials, almost all of them

This is not normal”

Bobby, how many is
“almost all of them” ?

[8]
——————————————————————
“He charges patients out the nose to participate in the clinical trials

This is not normal”

Does it cost as much as any of THESE ?

Cost cancer: The hospital wanted a $30,000 deposit
http://articles.cnn.com/2009-06-16/politics/health.care.hearing_1_health-insurance-post-claims-underwriting-individual-health?_s=PM:POLITICS
2008 – Cost cancer insurance: Avastin, made by Genentech, is a wonder drug. Approved for patients with advanced lung, colon or breast cancer, it cuts off tumors’ blood supply, an idea that has tantalized science for decades. And despite its price, which can reach $100,000 a year, Avastin has become one of the most popular cancer drugs in the world, with sales last year of about $3.5 billion, $2.3 billion of that in the United States. Avastin costs $50,000 a year and adds four months of life. “There is a shocking disparity between value and price,” he said, “and it’s not sustainable.”
http://www.nytimes.com/2008/07/06/health/06avastin.html?_r=0
Cost cancer chemo up-front: $45,000 to Come In
http://online.wsj.com/public/article/SB120934207044648511.html?mod=2_1566_topbox#articleTabs%3Darticle
3/2012 – Total Cost of Cancer Care by Site of Service: Physician Office vs Outpatient Hospital (22 pages)
http://www.avalerehealth.net/news/2012-04-03_COA/Cost_of_Care.pdf
CHEMOTHERAPY:
9/24/2012 – The newspapers found hospitals are routinely marking up prices on cancer drugs by two to 10 times over cost. Some markups are far higher. • Levine Cancer Institute, owned by Charlotte-based Carolinas HealthCare, this year collected nearly $4,500 for a 240-milligram dose of irinotecan, a drug used to treat people with colon or rectal cancer. The average sales price for that amount of the drug: less than $60.
• Carolinas Medical Center-NorthEast in Concord was paid about $19,000 for a one-gram dose of rituximab, used to treat lymphoma and leukemia. That was roughly three times the average sales price.
• Forsyth Medical Center in Winston-Salem, owned by Novant Health, collected about $680 for 50 milligrams of cisplatin. The markup: more than 50 times the average sales price. Treating a cancer patient with Avastin, for instance, costs about $90,000 a year, doctors say
http://www.charlotteobserver.com/2012/09/24/3549634/prices-soar-as-hospitals-dominate.html
5/14/2012 – Oral anti-cancer medications, on the other hand, are generally considered a pharmacy benefit. Instead of a co-payment, plan members often pay a percentage of the drugs’ cost — up to 50 percent, in some cases — with no annual out-of-pocket limit. And these drugs are expensive, often costing tens of thousands of dollars a year.
http://articles.washingtonpost.com/2012-05-14/national/35457286_1_lung-cancer-drug-drugs-work-multiple-myeloma-patients
RADIATION:
1/4/2013 – The new study was the most comprehensive cost analysis ever, and it compared the costs and outcomes associated with the various types of treatment for all forms of the disease, which ranged from $19,901 for robot-assisted prostatectomy to treat low-risk disease, to $50,276 for combined radiation therapy for high-risk disease.
http://www.ucsf.edu/news/2013/01/13370/how-prostate-cancer-therapies-compare-cost-and-effectiveness
3/15/2012 – Using Surveillance, Epidemiology and End Results (SEER)-Medicare data, the researchers looked at 26,163 women with localized breast cancer who had undergone surgery and radiation from 2001 to 2005. They found that Medicare billing for IMRT increased from 0.9% of patients diagnosed in 2001 to 11.2% of women whose breast cancer was diagnosed in 2005.
The average cost for radiation treatment during the first year was $7,179 for non-IMRT and $15,230 with IMRT. Moreover, billing for IMRT was more than five times higher in regions across the nation where the local Medicare coverage determinations were favorable to IMRT compared to regions where coverage was unfavorable. sorafenib (Nexavar) in kidney cancer as an example. “NICE evaluated sorafenib as it was indicated for kidney cancer and determined that it indeed had value, but not $80,000 per year’s worth. The agency said that it would reimburse one-third of the total cost, and if the drug company wants to market their product to 60 million British citizens, they will need to be price flexible,”
http://www.ascopost.com/issues/march-15-2012/rising-costs-in-radiation-oncology-linked-to-medicare-coverage.aspx

http://cancer.disease.com/Treatment/Radiation-Therapy

Bob, did you watch Burzynski 2 and hear the lady talk about how much it was costing someone she knew for “traditional treatment ?

[8]
——————————————————————
“This is not the behavior of someone who intends to market the product widely later and expects a return on an investment

It sure looks like someone taking the money while he can”

THAT sure explains THIS 7/5/2012 Marketing and Consulting Agreement contract:
http://www.sec.gov/Archives/edgar/data/724445/000110465912047927/a12-16018_1ex10d10.htm

[8]
——————————————————————
“I put the word “documentary” in quotes above because while the actual film does indeed document very well Burzynski’s seemingly endless battle to win acceptance and approval for his treatment against the FDA, National Cancer Institute, patent challenges and big pharmaceutical companies — and includes very powerful filmed interviews with cancer survivors who say his treatment (in Texas, where it was allowed) saved them — it doesn’t have the kind of critical other-side that one is used to in other documentaries

That last part is true
the movie is one-sided”

Bobby, you do know that Eric Merola offered oncologist and self-described researcher, David H. Gorski

(@gorskon @oracknows @ScienceBasedMed #sciencebasedmedicine http://www.scienceblogs.com/Insolence http://www.sciencebasedmedicine.org)

the opportunity to appear in
Burzynski: Cancer is Serious Business, Part II, and he REFUSED, right ?

[8]
——————————————————————
“Of course, why this is might be more apparent if Mr. Getler had realized that Merola’s cousin was a patient of Burzynski (she later died, of course) and that Merola raised funds for his cousin’s treatments on his website

Merola is not impartial

He has skin in the game

He has sunk an enormous amount into Burzynski”

Yeah, just like every other documentary film-maker or director of multiple movies re the same subject (Jaws, Terminator, Predator, Alien, etc.)

[8]
——————————————————————
“Mr. Getler mentions that Shari Bernson, the person responsible for the programming and who appeared in fundraising spots, described the movie as “controversial.”

To someone on the outside, it may appear to be controversial

To someone who understands the science and process of publication and who has found endless descriptions of how patients end up making really, really bad choices out of desperation at that clinic, however, there is no controversy”

The “controversy” is “The Skeptics” who do NOT know how to “Fact-Check,” and instead “Insert Foot in Mouth”

[8]
——————————————————————
“The fact remains that after 35+ years, the Clinic has never produced a single reproducible result that would constitute the barest minimum for serious consideration among experts

It just hasn’t”

That certainly explains the antineoplaston studies done in Poland, South Korea, Russia, Egypt, Japan, China, Taiwan (ROC), and the USA

That China published their most recent antineoplaston A10 study 10/1/2010
Journal of Radioanalytical and Nuclear Chemistry
October 2010, Volume 286, Issue 1, pp 135-140
#Burzynski References: 5. – 6.

[8]
——————————————————————
The Randomized Japan study is scheduled for publication THIS year

“Should that ever happen (I’m not holding my breath), then, hell, yes, we’ll be on board cheering the advance of science”

“But he has to play by the rules

And this is important too, playing by the rules that all real researchers abide to

Part of the FDA’s job is to ensure that Burzynski’s people are doing this

And on February 7th, they were doing just that; they were in the facility inspecting to make sure that Burzynski’s team was playing by the rules

In a FOIA release this week, the FDA revealed a number of things that had been found out and reported to the clinic by the time the movie aired

By law, the Clinic had 15 days to respond, so if they responded, it was before CPT12′s love-in

(The observational notes can be found here:”
http://skepticalhumanities.files.wordpress.com/2013/03/burzynskiform483feb2013.pdf)

“Two investigators observed:”

“The IRB [Institutional Review Board] used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB”

“Specifically, your IRB routinely provided expedited approvals for new subjects to enroll under Single Patient Protocols.”

“[2 adults and 3 pediatric patients are mentioned]”

“The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result”

“Specifically, your IRB gave Expedited Approval for several Single Patient Protocols (SPP) without all the information necessary to determine that the risk to subjects are minimized.”

“[4 examples follow]”

“The IRB did not determine at the time of initial review that a study was in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’”

“Specifically, an IRB that reviews and approves research involving children is required to make a finding that the study is in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’”

“Your IRB approved research involving children without documentation of the IRBs finding that the clinical investigation satisfied the criteria under Subpart D.””

“[3 examples follow and there is a note that this is a repeat observation that had been found in an Oct 2010 Inspection.]”

“The IRB did not follow its written procedure for conducting its initial review of research”

“Specifically, the IRB is required to follow its written procedures for conducting initial and continuing review”

“Your IRB did not follow your written procedures for conducting initial and continuing review because these subjects received IRB approval via an expedited review procedure not described in your Standard Operating Procedures”

“If your IRB would have followed your own SOP for initial and continuing review, the following subjects would have received review and approval from the full board rather than an expedited review.””

“[2 adults and 3 pediatric patients are listed.]”

“The IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any unanticipated problems involving risks to human subjects or others”

“Specifically, your current SOP-2012 v2-draft doc does not describe the requirements on Investigators on how unanticipated problems are reported to the IRB, Institutional Official, and the FDA, such as time intervals and the mode of reporting, or otherwise address how the prompt reporting of such instances will be ensured.”

“The IRB has no written procedures [in the SOP-2012 v2-draft doc] for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with theses [sic] regulations or the requirements or determinations of the IRB.”

“A list of IRB members has not been prepared and maintained, identifying members by name, earned degrees, representative capacity, and any employment or other relationship between each member and the institution.”

“You have to play by the rules”

So, NOT as bad as THIS 9 pager ?
http://www.pharmalive.com/fda-warns-stem-cell-company-over-violations

Bob, you know these are just allegations, right ?

Not the final report ?

[8]
——————————————————————
“I’m not sure that this round of investigation is over yet, as the audience at the premier of the sequel was apparently told that the FDA was still on site”

“Researchers should not be playing fast and loose with the rules that protect children (a protected subject population, like prisoners and students–yeah, I’m IRB certified)”

“There should be procedures in place to see that proper oversight and reporting of unexpected events is ensured”

“Hell, there was apparently no document even saying WHO was on the IRB!”

“This is not a report on a serious research institution”

“It’s more like the observations of the IRB of a clown school”

How many more businesses with more IRB issues than Burzynski did you find during you intense “Fact-Finding” mission ?

Bob, did you read Burzynski’s publications with their notes about the IRB ?

“Back to Mr Getler’s letter:”

“On the other hand, Bernson’s sidekick on the in-studio, pledge-drive promotion who was interviewing the clinic spokesman, made me gag when she said,
“I’m Rebecca Stevens and I’m proud to be a journalist who asks the hard questions.”

There were no hard questions”

[I believe the question that followed up this statement was, “What is peer-review?”–RJB]

“And where Bernson may have gone too far, depending on who you believe, was in her statement that:

“Antineoplaston therapy has had significant success rates with terminal brain cancer patients and especially in children.”

No, she went too far no matter who you believe, and his next paragraph demonstrates this:”

“The National Cancer Institute, reporting last month on Antineoplastons, said, among other things:

“No randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals”
and that they are
“not approved by the U.S. Food and Drug Administration for the prevention or treatment of any disease.”

Aaaand…how’s that controversial?

In light of this, how could Sherri possibly be right?

My bottom line is that CPT12 obviously has a right to show this film

Nobody questions that

“What we wanted, and what was offered to the station, was the opportunity to have an independent oncologist in the studio at the time of the broadcast, you know, to stir up the kind of informed discussion the station says they want to have instead of settling for two True Believers talking to two CPT12 pitch people”

“When the station had that opportunity, they walked away from it”

“That’s indefensible”

Bob, like your man-crush oncologist who refuses to debate ?

[8]
——————————————————————
“Especially when you consider that the people we are worried about, patients and their families, may NOT be as discerning as your average viewer, as CPT President Willard Rowland suggests in his response to the ombudsman:

“The program’s airing is grounded in the station’s mission, specifically those portions about respecting our viewers as inquisitive and discerning citizens, addressing social issues and public concerns not otherwise adequately covered in the community, and cultivating an environment of discovery and learning.”

Some of them haven’t had good news since their diagnosis”

“Then they hear that some lone genius with the cure for cancer is operating in Houston and they are on the next flight down”

“I’ve seen it dozens of times, and I have hundreds more patients on deck to write about”

“These are vulnerable, vulnerable people who deserve the best information from their public broadcasters”

“I’m fairly disappointed by the tepid response, honestly”

“I have a hard time imagining that Mr. Getler, or Mr Willard Rowland for that matter, could possibly think that this program was anything but misleading if they spent a half hour at The OTHER Burzynski Patient Group, which chronicles, in patients’ own words, what goes on in that Clinic”

“All of the people told that getting worse is getting better”

“(for decades being fed the same line!),

the children having strokes

(unrelated to their tumors)

while on the medicine, the “terrifying” amounts of sodium that go into patients”

“The quasi-legalistic threats and phone calls to dissatisfied cancer patients”

“The untested chemo cocktails given to most of his patients”

“None of that was mentioned in the CPT12 fundraiser”

“Of course, that’s not Mr. Getler’s fight”

RJB
http://skepticalhumanities.com/2013/03/26/a-letter-to-the-pbs-ombudsman-about-cpt12s-airing-burzynski
Maybe you should go here and explain the critics actions:
https://www.facebook.com/questions/488444654552853

[8]
——————————————————————
HoustonCancerQuack proclaims:

“Fact-checking Burzynski II”

“DO YOU THINK YOU HAVE AN OPEN MIND?”

“DO YOU HAVE THE ALL THE FACTS?”

Let’s find out if they have all the “FACTS,” shall we?

“Basic claims about ANP”

“Antineoplastons are chemotherapy, regardless of what supporters say”

Bob, it is NOT “ordinary” chemotherapy”

[9]
——————————————————————
“Toxicity, reactions, and even patient deaths can and do happen due to their administration”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

“patient deaths can and do happen due to their administration”

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

Here is what the National Cancer Institute (NCI) at the National Institutes of Health (NIH) lists as POSSIBLE “Adverse Effects”:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6

[9]
——————————————————————
“The most common side effect of ANP, hypernatremia, is an effect of the sodium in the mixture”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “HYPERNATREMIA” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

Let’s see what we can find out about “HYPERNATREMIA,” shall we?

2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive cancer center
http://www.ncbi.nlm.nih.gov/m/pubmed/23404230
Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA
Department of General Internal Medicine, University of Texas MD Anderson Cancer Center
Division of Endocrinology, Mayo Clinic
Support Care Cancer. 2013 Feb 13. [Epub ahead of print]
(Supportive Care in Cancer)
DOI
10.1007/s00520-013-1734-6
http://link.springer.com/article/10.1007%2Fs00520-013-1734-6
This 3 month study of 3,446 patients in 2006 found that most of the HYPERNATREMIA (90 %) was acquired during hospital stay

HYPERNATREMIA in the U.S.:
http://www.nlm.nih.gov/medlineplus/ency/article/000394.htm
HYPERNATREMIA is the most common electrolyte disorder in the United States

In some cases, cancer may cause the condition

[9]
——————————————————————
“In order to maintain their doses of ANP, patients are required to drink obscene amounts of water every day (some report up to 12 quarts or more)”

“If they fail to do so, they may lapse into unconsciousness or die”

Let’s put this in perspective

FACT: Some sources indicate:

1) A man should drink about
3 liters (101.44 ounces / 3 quarts 5.44 ounces) per day
{12 quarts = 384 ounces = 11.356 liters}
[12 quarts in 24 hours = 1/2 quart or 16 ounces per hour]

2) Extremely healthy kidneys could process about 30 ounces (approx .9 liters) of water in an hour
{30 ounces in 24 hours = 720 ounces}
[720 ounces = 22.5 quarts per day]

3) A person with healthy kidneys could develop water intoxication by drinking about 2 to 3 times what their kidneys can process

So, if extremely healthy kidneys could process about 30 ounces per hour and 12 quarts per day would require one to only drink 16 ounces per hour, that means one is being asked to drink 14 ounces less per hour than what extremely healthy kidneys could process

So even if one drinks more than 16 ounces per hour so that one does not have to be awake hourly, there is still opportunity to do that

Of course, there are certain other factors that might have to be taken into consideration depending on the patient

“There are two cases of children (Haley S. and Elizabeth K.) at The OTHER Burzynski Patient Group who have had strokes unrelated to their tumors, likely because of the treatment”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “STROKE” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

FACT: This is only an “opinion” until it is supported by “FACTS”

[9]
——————————————————————
“For an example of a patient nearly overdosing, see Adam M’s story”

“Patients seem to often end up in the hospital because of the treatment”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “ENDING UP IN THE HOSPITAL” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

FACT: This is only an “opinion” until it is supported by “FACTS”

[9]
——————————————————————
“A surgical oncologist, researcher and patient advocate explains why physicians question Dr. Burzynski’s methods:”

My blog explains WHY I question this physician:
http://www.stanislawrajmundburzynski.wordpress.com

[9]
——————————————————————
“This physician and others declined to be interviewed for the movie because of Merola’s track record of slanted presentation and because of past threats issued by people hired by the Burzynski Clinic”

“Past threats issued by people hired by the Burzynski Clinic”?

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

excuses, Excuses, EXCUSES
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/david-h-gorskis-conspiracy-mongering-and-more-of-his-dr-stanislaw-burzynski-stories

[9]
——————————————————————
“What was the “present” from skeptics that was alluded to in the movie?”

“The “present” the Skeptics for the Protection of Cancer Patients (SPCP) delivered to Burzynski on his birthday, was a donation of $14,500 to St Jude Children’s Hospital for research into childhood cancers”

“They challenged Dr. Burzynski to match their donation”

“He did not”

“In fact, some of the interviews in the movie (conducted after the FDA inspection of the Burzynski Clinic, mentioned at the end) were filmed after the fundraiser had been announced, so Merola seems to have deliberately omitted the whole truth, because he certainly was aware of it”

“Doesn’t sound so sinister now, does it?”

“Also, Burzynski got a card”

Want to know what that “PRESENT” really was?

Critiquing Bob Blaskiewicz
(#Burzynski Cancer is Serious Business, Part II)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii

[9]
——————————————————————
“Are skeptics really calling out cancer patients, ridiculing and harassing them?”

You tell me:

https://twitter.com/Ac2cSheila/status/186164592676843520

https://twitter.com/RatbagsDotCom/status/304050113834262528

[9]
——————————————————————
“What about the 2-hour rejection from The Lancet?”

“The vast majority of papers that get rejected from The Lancet are rejected within 48 hours thanks to an editorial pre-screening process”

“Most researchers are thankful for this courtesy because it allows them to resubmit to other journals more quickly”

“Why does Merola try to convince the audience that this is evidence of a conspiracy against Burzynski?”

Why bring it up if you really have nothing to add that is relevant?

FACT: The Lancet Oncology will not discuss any submission that may or may not have been submitted to The Lancet Oncology with anyone other than the corresponding author

To do so would constitute a breach in confidentiality

[9]
——————————————————————
“Patients pay a lot of money upfront to enter his clinical trials, presumably believing that the trials will eventually be published”

Is that really the patients’
motivation?

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

[9]
——————————————————————
“Burzynski has never published the results of those trials but keeps the money:”

Really?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2

[9]
——————————————————————
“Burzynski’s abysmal trial completion record, over sixty abandoned trials, the trust of every patient who participated betrayed”

“If trial completion were a batting average, he’d be batting .016”

Really?

FACTS:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951

http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036

[9]
——————————————————————
“His publication average is .000”

“Really:”
http://clinicaltrials.gov/ct2/results?term=burzynski&pg=1
REALLY?
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/david-h-gorskis-conspiracy-mongering-and-more-of-his-dr-stanislaw-burzynski-stories

[9]
——————————————————————
“Speaking of harassment…”

“Merola does not mention that skeptics only caught wind of the Burzynski story in November 2011, after a teenaged blogger critical of the Clinic received phony legal threats from someone who had been hired by the Clinic to “clean up” its reputation”

“This person, Marc Stephens, sent this high school student images of his family’s home, the message clearly:”

“We know where you live.”

“These threats were well documented in the international press”

“Somehow Merola managed to not mention that in the movie”

Maybe it wouldn’t be so bad if the loquacious “teenaged” high school student got his “FACTS” straight:

TheSkeptiCritic (@TheSkeptiCritic) tweeted at 8:12pm – 16 Apr 13:
https://twitter.com/TheSkeptiCritic/status/324329482712391680

http://rhysmorgan.co/blog

http://rhysmorgan.co/burzynski-morally-reprehensible

http://thewelshboyo.wordpress.com
[9]
——————————————————————
“What really happened to Amelia Saunders?”

“Merola suggests that Amelia Saunders died as a result of her parents taking her off of antineoplaston therapy, that there “confusion and disagreement” between the doctors in the UK and Houston’s reading”

Really?

https://twitter.com/frozenwarning/status/312141313451634688

https://twitter.com/BurzynskiMovie/status/312256370936266752

https://twitter.com/BurzynskiMovie/status/312264347277737984

https://twitter.com/BurzynskiMovie/status/312270472341487616
Burzynski Movie (@BurzynskiMovie) tweeted at 11:49pm – 14 Mar 13:
http://t.co/wxU2PHJ3GD

https://twitter.com/BurzynskiMovie/status/312425208462049280
[9]
——————————————————————
“We hope this makes it clear that what you are seeing in the new Burzynski movie may not be entirely reliable”

So … like your blog?

[9]
——————————————————————
“As we get more information about the claims in the movie, we will add additional rebuttals and provide context for understanding what really goes on at the Burzynski Clinic”
http://www.anp4all.com
I can’t wait
http://thehoustoncancerquack.com/fact-checking-burzynski-ii
[9]
======================================
Burzynski referenced by other doctors:

Phase II trial of tipifarnib and radiation in children with newly diagnosed diffuse intrinsic pontine gliomas
http://neuro-oncology.oxfordjournals.org/content/13/3/298.full
University of California—San Francisco
Children’s Hospital Boston, Massachusetts
St Jude Children’s Research Hospital, Memphis, Tennessee
Seattle Children’s Hospital, Seattle, Washington
Children’s Hospital of Philadelphia, Pennsylvania
Children’s Hospital of Pittsburgh, Pennsylvania
Children’s National Medical Center, Washington, DC
Cincinnati Children’s Hospital Medical Center, Ohio
Neuro Oncol (2011) 13 (3): 298-306
doi: 10.1093/neuonc/noq202
5.723 Impact Factor
25. ↵ Burzynski SR
Treatments for astrocytic tumors in children: current and emerging strategies
Paediatr Drugs. 2006;8:167-178
http://link.springer.com/article/10.2165%2F00148581-200608030-00003
Pediatric Drugs
May 2006, Volume 8, Issue 3, pp 167-178

[10]
——————————————————————
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″

[11]
——————————————————————
9-10/2009 – Stable disease is a valid end point in clinical trials
http://www.ncbi.nlm.nih.gov/pubmed/19826356/
strong>10,675 – # of times “stable disease” found on PubMed
[12]
——————————————————————
costs (see above)

[13]
——————————————————————
rjblaskiewicz 1 week ago
(@rjblaskiewicz a/k/a Blatherskitewicz)

Mr. R.J. Blaskiewicz, is well known as:
“Bob Blaskiewicz, Faux Skeptic Exposed!”

There are numerous Internet pages and great pictures of him re Atlanta, Georgia, where he was called out, but hid behind his keyboard:

[14]
——————————————————————
Forbes – Waiting for the 10,000

Bob, I thought it funny that “The Skeptics” were allowed to comment freely on #Forbes, without citations, references, or links, while my comments were deleted

Did they ever have 10,000 views like Boris Ogon posted ?

[15]
——————————————————————
Forbes – rjblaskiewicz 6 days ago

“It’s not a thread about the inherent corruption throughout all of medicine.”

“It’s about some bully/man-child trying to shut up critics.”

Mr. rjblaskiewicz (also known as Bob Blaskiewicz), so, like Forbes was?

[16]
——————————————————————
c0nc0rdance – http://t.co/WDfUPtBpmz
56.�skeptical humanities
http://t.co/aMJ1HaUTfh
57.�skeptical humanities
http://t.co/EGhiG5WgQA
58.�skeptical humanities
http://t.co/Fwkd7x2E0C

Bob, how many times did y’all need to “mirror” the video ?

[17]
——————————————————————
David James (@stortskeptic) chat room
(@SkepticCanary)(@_JosephineJones)

Skeptic Canary – blogtalkradio

Man-crush

Freedom from Facts

Informed consent

Phenylbutyrate (PB)

Hypernatraemia

Skeptics are opposed to facts

Bob, you and Gorski did a great job of NOT cover these issues

BB claims his rbutr has been used to “Fair and utterly destroyed it,” in relation to “Burzynski: Cancer Is Serious Business

BB states:

“His son I believe trained in Poland”
Blatherskitewicz, with your phenomenal attention to detail, aren’t you positive?

BB mentions two (2) possible honorary professorships in China for Dr. Burzynski

Call in comments

[18]
——————————————————————
Faux Skeptic
Bob Blaskiewicz (@rjblaskiewicz)
6/3/13, 3:49 PM
@FauxSkeptic @bbc5live I believe he said, “Put up or shut up, you little bitch.” Something like that.

[19]
——————————————————————
March 29, 1996

Then United States Food and Drug Administration Commissioner, David Kessler told the American people:

1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators

2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials
I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials
3. We will accept … less information … up front –

4. we’re going to require further study AFTER … approval … because the science … has matured

5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point
You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works

6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons

7. We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
—————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?

B. What is the FDA’s definition of “smaller trials”?

C. What is the FDA’s definition of “fewer patients”?

D. What is the FDA’s definition of “evidence … of psrtial response”?

E. What is the FDA’s definition of “less information … up front”?

F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?

G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?

[20]
——————————————————————
?
Oncologist

Survival rate 776 15%

2 1/2 million pages

Phase 3 radiation

Lancet

1652 / 335 = 1,799

Accelerated approval

Bob, at least we talked about some of these

[21]
——————————————————————
IRB – FDA

Burzynski’s publications sometimes mentioned IRB was agreed on per FDA

[22]
——————————————————————
Bob Blaskiewicz (@rjblaskiewicz) tweeted at 10:44am – 31 Jul 13:

@TomLemley1 @AceofSpadesHQ @mikespillane The FDA won’t approve his drug until he ever finishes and publishes a trial. clinicaltrials.gov/ct2/results?te…

https://twitter.com/rjblaskiewicz/status/362599624596393984

[23]
——————————————————————
Robert J. (Bob) Blaskiewicz, Professor
Bob Blaskiewicz Faux Skeptic Exposed!
@rjblatherskiewicz
Blatherskitewicz
University of Wisconsin
rbutr
r-but-r
Eau Claire, Wisconsin
——————————————————————
http://www.skepticalhumanities.com/
——————————————————————
http://virtualskeptics.com/
——————————————————————
http://rbutr.com/
——————————————————————
http://blog.rbutr.com/
——————————————————————
http://www.uwec.edu/Staff/blaskir/
——————————————————————
http://www.csicop.org/author/rblaskiewicz
——————————————————————
http://necss.org/speakers/bob-blaskiewicz/
——————————————————————
http://www.centerforinquiry.net/speakers/blaskiewicz_bob
——————————————————————
http://lanyrd.com/2013/tam/sckkdy/
======================================
http://thehoustoncancerquack.com/

[24]
——————————————————————
Critiquing https://theotherburzynskipatientgroup.wordpress.com

[25]
——————————————————————
25. 6/20/2013 Mark Burger published a review:
——————————————————————
http://www.yesweekly.com/triad/article-16162-burzynski-cancer-is-.html
——————————————————————
As could be expected, The Skeptics™
showed up
======================================
ANONYMOUS: “I’m afraid you’ve fallen for Dr Burzynski’s PR efforts here”
——————————————————————
LIE: The documentary film is by Eric Merola, NOT “Dr. Burzynski’s Public Relations”
======================================
ANONYMOUS: “In reality, Dr B is a quack and a charlatan of the worst order, and the movie is nothing more than a desperate attempt to try to sell his snake oil to the gullible”
——————————————————————
LIE: After reading through the comments, this sounds like the infamous lying Professor Robert J. (Bob) Blaskiewicz of University of Wisconsin, Eau Claire, “infamy”, who is a charlatan of the first order, and belabors his ignorance by referring to “snake oil”, which as far as I know, has never been approved for phase III clinical trials, unlike Dr. Burzynski’s antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)
——————————————————————
Bob Blaskiewicz (Blatherskitewicz), Faux Skeptic Exposed!:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/bob-blaskiewicz-blatherskitewicz-faux-skeptic-exposed/
======================================
ANONYMOUS: “You have to ask why he’s never published any data showing that his treatment works”
——————————————————————
LIE: What people should ask is why does “Professor” @rjblaskiewicz and his other Skeptic pals continue posting idiotic statements like this on the Internet and social media (Twitter) ?
——————————————————————
Critiquing David H. Gorski, MD, PhD, FACS
http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================
ANONYMOUS: “Well, if you believe everything the movie tells you, then perhaps you think it’s because of a huge global conspiracy that prevents him from publishing in any journal anywhere in the world”
——————————————————————
If you want to talk Jesse Ventura type “conspiracy theory”:

1. Why are The Skeptics™ like you too afraid to debate ?

2. Why did your “pal” David H. “Orac” Gorski, MD, PhD, FACS block me on his blog for questioning his infallibility ?

3. Why did Forbes delete my comments when I questioned The Skeptics™? regarding your “pal” Gorski’s “bud”, Peter A. Lipson, MD’s article ?

4. Why did The Skeptics™ Josephine Jones block me from her blog ?

5. Why did The Skeptics™ Adam Jacobs block me from his blog ?

6. Why did The Skeptics™ Guy Chapman block me from his blog ?

7. Why did The Skeptics™ Keir Liddle block me from his blog ?

8. Why do The Skeptics™ whine to Twitter in order to get Twitter to suspend the accounts of people who question them ?

9. Why did Wikipedia block me, using lame excuses ?

10. Why did reddit act like wiki’s little bitch and delete my posts and block my comments because this reddiot davidreiss666 whined like a little bitch ?
——————————————————————
overview for DidymusJudasThomas (reddit.com)

submitted 4 days ago by davidreiss666 to reportthespammers

1 comment
======================================
ANONYMOUS: “Even if you are sufficiently conspiracy minded to believe that’s true, then it still doesn’t explain why he hasn’t published his results on the clinicaltrials dot gov website, where most of his trials are recorded as either “ongoing”, “withdrawn”, or “unknown status””
——————————————————————
Did you NOT appear on the below blog talk radio show with your “pal” Gorski who said at 29:00 that Burzynski should NOT publish the information himself ?
——————————————————————
Ep09 – Talking Burzynski – David Gorski and Bob Blaskiewicz 05/29/2013
Skeptic Canary Show – BlogTalkRadio
May 29, 2013 … This week, join your hosts as we talk about Dr. Stanislaw Burzynski and the Burzynski Clinic. Well be joined by two special guest, Doctor David Gorski and Bob Blaskiewicz
http://www.blogtalkradio.com/…/ep09–talking-burzynski–david-gorski-and-bob-blaskiewicz
——————————————————————
http://www.blogtalkradio.com/skepticcanary/2013/05/29/ep09–talking-burzynski–david-gorski-and-bob-blaskiewicz
——————————————————————
http://goo.gl/7pWIj
——————————————————————
http://bit.ly/15lv5zG
——————————————————————
Critiquing the #SkepticCanary: “The Skeptics™” (SkeptiCowards©) Bob Blatherskitewicz and the so-called, “self-proclaimed” “CANCER RESEARCHER”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/03/critiquing-the-skepticcanary-the-skeptics-skepticowards-bob-blatherskitewicz-and-the-so-called-self-proclaimed-cancer-researcher/
======================================
ANONYMOUS: “Only one of his trials is recorded as being completed, and that one doesn’t reveal it’s results”
——————————————————————
Did you notice that your above 5/29/2013 appearance was BEFORE this article was published 6/20/2013 ?
======================================
ANONYMOUS: “The fact is that Burzynski keeps is actual research data an extremely closely guarded secret”
——————————————————————
Like THIS ?
——————————————————————
Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
======================================
ANONYMOUS: “If is treatment were actually effective, do you seriously think he’d do that?”
——————————————————————
RATS!!!. Like this ?
——————————————————————
Burzynski: Oh, RATS!!!
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/26/the-lancet-oncology-peer-review-team-d-12-01519-fail-2/
======================================
ANONYMOUS: “Burzynski likes to cultivate his conspiracy theories because it helps his business of scamming vulnerable cancer patients”
——————————————————————
Is that like The Skeptics™ like to LIE to people ?
——————————————————————
Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
ANONYMOUS: “For Burzynski, at least, cancer is indeed serious business”
——————————————————————
And for you, it must be a joke, considering how you are too much of a coward to debate questions like these
——————————————————————
QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/23/questions-the-critics-and-cynics-the-skeptics-do-not-want-to-answer/
======================================
JEFF: “it has been tested independently in other countries, as the film shows”
======================================
ANONYMOUS: “The Japanese study remains unpublished, Jeff, just like all the over 60 studies Burzynski has started”

“Even if it were published, it would need to be replicated”
——————————————————————
Really ? Why not try pointing out where these studies were replicated before the FDA allowed these drugs to be used ?
——————————————————————
Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
======================================
ANONYMOUS: “Merola manipulated by voice, face and even what I said in his movie and never asked for my comments”

“Sure, he misrepresented me to my new employers, but that doesn’t actually count as consulting me, now does it?”

“The “birthday surprise” in the movie was a fundraiser for a children’s cancer research hospital that raised over $15K, something I’m rather proud of, actually”
——————————————————————
Nice TRY with your LIE
——————————————————————
Critiquing Bob Blaskiewicz (#Burzynski Cancer is Serious Business, Part II):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii/
======================================
ANONYMOUS: “I’d encourage you to look at the other side of the story at The OTHER Burzynski Patient Group”

“These are far more typical outcomes”
——————————————————————
Do you mean this one of a number of your blogs which I just critiqued ?
——————————————————————
Critiquing https://theotherburzynskipatientgroup.wordpress.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
======================================
ANONYMOUS: “You might also see what Merola got wrong/faked at the anp4all website”
——————————————————————
Oh, do NOT worry

I will critique this one also, and let people see what YOU got wrong
======================================
The Burzynski Skeptics:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/18/the-burzynski-skeptics/
======================================
CHEEZ WHIZ !!! http://anp4all.com is nothing more than Robert J. “Bob” Blaskiewicz (@rjblaskiewicz)’s thick processed cheese spread of http://thehoustoncancerquack.com
======================================
Where he asks:

DO YOU THINK YOU HAVE AN OPEN MIND? DO YOU HAVE THE ALL THE FACTS?
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/fact-checking-httpthehoustoncancerquack-com/
======================================
He is supposedly a “Professor of Writing”, but check out his writing gaffes here, as “ANONYMOUS”
======================================
Yes! Weekly: Burzynski: Cancer is Serious Business Part II:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/26/yes-weekly-burzynski-cancer-is-serious-business-part-ii/
======================================
Critiquing https://theotherburzynskipatientgroup.wordpress.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
======================================
“The skeptic who called Dr. Burzynski “my little Polish sausage” has a Polish last name, which the director Eric Merola scrubbed from the movie”

Just because you think that referring to someone as:

“my little Polish sausage”

is humorous, and therefor we should excuse your behavior because of your below excuse, does NOT mean that it makes it acceptable

“Literally one second after he said that, all of the other participants made jokes about that fact”

(which of course was the point)

“Instead allowing the audience to hear that ribbing, Merola inserted an evil laugh, which was lifted and spliced from minute 18:25 of Virtual Skeptics episode 13”

If you thought that was an “evil laugh”, you’ve got an overactive imagination

“Voices were altered to sound sinister, and menacing music was added”

If you thought voices sounded “sinister” and that was “menacing music”, you must not watch any scary movies

Do you think this is a fair representation or were you misled?

YES

I think it’s a fair representation that you try to mislead people

“What about the 2-hour rejection from The Lancet?”

“High impact journals like The Lancet receive huge numbers of submissions, as their journal is the most prestigious”

“The vast majority of papers that get rejected by The Lancet are rejected within 48 hours thanks to an editorial pre-screening process that helps accommodate this huge work load”

“Most researchers are thankful for this courtesy because it allows them to resubmit to other journals more quickly”

“Why does Merola try to convince the audience that this is evidence of a conspiracy against Burzynski?”

All of your above comments prove what a waste of time you are, based on:
======================================
See #13
——————————————————————
Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
2 hours 8 minutes and 51 seconds
The Lancet Oncology Peer Review Team D-12-01519: #FAIL
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/25/the-lancet-oncology-peer-review-team-d-12-01519-fail/
======================================
“Does Eric Merola have any conflicts of interest that he is not disclosing?”

“Eric Merola does not reveal a possible conflict of interest, one that a journalist would feel obliged to share”

“He fails to disclose in the movie that his cousin was a patient of Dr. Burzynski and that he has raised money on his movie’s website for patients to see Burzynski”

Sounds like someone failed to read the Frequently Asked Questions (FAQ) section on the BurzynskiMovie web-site:
======================================
http://burzynskimovie.com/index.php?option=com_content&view=article&id=75&Itemid=55
======================================
“Burzynski has never published the results of those trials but keeps the money:”

“Burzynski’s abysmal trial completion record, over sixty abandoned trials, the trust of every patient who participated betrayed”

“If trial completion were a batting average, he’d be batting .016”

“His publication average is .000.”

“Really:”
——————————————————————
http://clinicaltrials.gov/ct2/results?term=burzynski&pg=1
——————————————————————
Really ?

“over sixty abandoned trials” ?

This just shows that you do NOT even know the subject-matter

Have you even bothered to read Burzynski’s publications ?
======================================
Burzynski updates Scientific Publications page:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/burzynski-updates-scientific-publications-page/
======================================
Because if you had, you would know that Burzynski has used the clinical trial design proposed by Fleming
======================================
16. 2003 Trial design – Fleming (Pg. 94)
——————————————————————
17. 2004 Trial design – Fleming (Pg. 317)
======================================
Protocol Design

2-stage phase II clinical trial design proposed by Fleming used

Initially, 20 adequately treated patients to be assessed

If less than one Objective Response (Complete Response (CR) or Partial Response (PR)) observed, it’d be concluded there was less than desired activity and study would be discontinued

If one or more Objective Responses observed, 20 more patients would be accrued to study

If 4 or more responses observed among 40 patients, evidence would be sufficient to conclude the treatment has desired activity
======================================
One-sample multiple testing procedure for phase II clinical trials
http://www.ncbi.nlm.nih.gov/pubmed/7082756/
Journal
Biometrics. 1982 Mar;38(1):143-51
http://www.ncbi.nlm.nih.gov/m/pubmed/7082756/

http://www.jstor.org/discover/10.2307/2530297?uid=3739256&uid=2460338175&uid=2460337855&uid=2&uid=4&uid=83&uid=63&sid=21102589296903
======================================
“This person, Marc Stephens, sent this high school student images of his family’s home, the message clearly:”

“We know where you live.”

“These threats were well documented in the international press”

“Somehow Merola managed to not mention that in the movie”

Yes

Marc Stephens’ actions were idiotic

My personal opinion is that he should have done what I am doing, which is showing how “The Skeptics™ lie, misinform, disinform, misdirect, deceive, misrepresent, etc.

Eric Merola did NOT mention your lame blogs either

Why don’t you complain about that ?

“Burzynski has a long history of patients believing that symptoms of getting worse are signs they are getting better”

“Follow any of the links at that site to hear how, in patients’ own words, this EXACT SAME misleading interpretation has been fed to patients for decades”

So, are you a doctor ?

No ?

I didn’t think so, quack

“Merola has publicly slandered Burzynski critics in a way a real journalist couldn’t”

Why can “real journalists” NOT slander someone ?

“We hope this makes it clear that what you are seeing in the new Burzynski movie may not be entirely reliable”

So, like this web-site
======================================
DEBATE E-Mails:
======================================
On Mon, Sep 23, 2013 at 8:04 PM, Didymos Thomas wrote:
So now you’re brave ?

Bob Blaskiewicz @rjblaskiewicz

@PDJudasT @robertquickert Hey, Judas. I have no respect for you as a person. Never address me.
1:56 PM – 18 Mar 2013
https://twitter.com/rjblaskiewicz/status/313725494170361856
——————————————————————
On Monday, September 23, 2013, Robert Blaskiewicz wrote:
You going to be a rotten little troll or do you want to debate?
——————————————————————
You’re the one who posted this on Twitter

Do NOT try to make me the COWARD

Bob Blaskiewicz @rjblaskiewicz

@PDJudasT @robertquickert Hey, Judas. I have no respect for you as a person. Never address me.
1:56 PM – 18 Mar 2013
——————————————————————
2/13/2013 (7/2013)
The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center

Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay
http://www.ncbi.nlm.nih.gov/pubmed/23404230
——————————————————————
6/3/2013 – “[I]f I had screwed up, I would have admitted it”
http://www.sciencebasedmedicine.org/stanislaw-burzynski-propaganda-versus-news
“Our only goal is to promote high standards of science in medicine”
http://www.sciencebasedmedicine.org/editorial-staff/
11/.2/2012 – “Personally, having pored over Burzynski’s publications … “
http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
5/8/2013 – “I’ve searched Burzynski’s publications … “
http://scienceblogs.com/insolence/2013/05/08/eric-merola-and-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni-part-2/
5/31/2013 – “Burzynski has a contingent of defenders who have targeted skeptics like me for special abuse, up to and including harassing me at work by calling my university to complain about my online verbiage critical of Burzynski and implying that I am somehow doing something wrong”
“(My university quickly realized that I was not.)”
http://scienceblogs.com/insolence/2013/05/31/on-helping-that-is-anything-but/
6/5/2013 – “ … I do know cancer science”
http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
6/7/2013 – “Unlike Mr. Merola, I am indeed very concerned with getting my facts correct”
http://scienceblogs.com/insolence/2013/06/07/i-want-my-anp/
.3/14/2013 – “Temodar and Avastin both had proper, completed, and published phase II trials before approval”
http://www.sciencebasedmedicine.org/burzynski-cancer-is-a-serious-business-part-2-like-the-first-burzynski-movie-only-more-so/
and
http://scienceblogs.com/insolence/2013/03/14/five-things-i-learned-second-hand-from-the-recent-screening-of-burzynski-cancer-is-serious-business-part-2/
I prove him wrong
https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
——————————————————————
6/4/2013 – “Dr. Elloise Garside, a research scientists, echoes a lot of the questions I have, such as”

“how Burzynski never explains which genes are targeted by antineoplastons … “
http://scienceblogs.com/insolence/2013/06/04/stanislaw-burzynski-versus-the-bbc/
I prove him wrong
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
and
https://stanislawrajmundburzynski.wordpress.com/2013/09/21/critiquing-the-institute-of-medicine-report-on-cancer-care-is-the-system-in-crisis/
——————————————————————
Bob, this is unsupported, just like when Gorski put it on his blog:
Bob Blaskiewicz (@rjblaskiewicz) tweeted at 10:44am – 31 Jul 13:

@TomLemley1 @AceofSpadesHQ @mikespillaneThe FDA won’t approve his drug until he ever finishes and publishes a trial.clinicaltrials.gov/ct2/results?te…

https://twitter.com/rjblaskiewicz/status/362599624596393984
Bob, “unable to publish”? Shouldn’t that be “able to publish” but The Lancet Oncology would NOT publish?
——————————————————————
Manuscript reference number: THELANCETONCOLOGY-D-12-01519

Title: Glioblastoma multiforme: a report of long-term progression-free survival and overall survival of 8 to 16 years after antineoplaston therapy and review of literature

Dear Dr. Burzynski,

Thank you for your recent submission to The Lancet Oncology. We have now had time to consider your manuscript and unfortunately, on this occasion, we have decided not to publish it because we believe the message would be better elsewhere.

Although the decision has not been a positive one, I thank you for your interest in the journal and hope it does not deter from considering us again in the future

Josephine Jones (@_JosephineJones) tweeted at.5:21pm – 11.Sep.13:

@Majikthyse @frozenwarning @drpaulmorgan @dianthusmed @oracknows It was about 1hr30 mins into Burzynski Movie II. pic.twitter.com/8n3fQkX0v0

http://pbs.twimg.com/media/BT6kM-zCcAAHsnV.png

https://twitter.com/_JosephineJones/status/377919961659764736
Eric Merola revealed in Burzynski: Cancer Is Serious Business, Part II (2), at (1:29:53), that The Lancet Oncology Peer Review Team D-12-01519, in 2 hours 8 minutes and 51 seconds, refused to publish Burzynski’s 11/26/2012 phase 2 clinical trial Progression-Free Survival (PFS) and Overall Survival (OS) re patients 8 – 16 years after diagnosis, results
——————————————————————
Temozolomide received accelerated approval by the U.S. Food and Drug Administration 1/1999 for treatment of ANAPLASTIC ASTROCYTOMA (brain cancer) patients

At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
http://clincancerres.aacrjournals.org/content/11/19/6767.full
Was the United States Food and Drug Administration’s 1/1999 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?

12/2000 – Temozolomide and ANAPLASTIC ASTROCYTOMA:

NO CLEAR PROOF OF EFFICACY
http://www.ncbi.nlm.nih.gov/pubmed/11475493/
NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide

The answer is: NO

1/1999 – FDA Accelerated Approval

9/1999 – Phase 2 publication

9/1999 – Multicenter phase II trial of temozolomide in patients with ANAPLASTIC ASTROCYTOMA or anaplastic oligoastrocytoma at first relapse

Temodal Brain Tumor Group
http://www.ncbi.nlm.nih.gov/pubmed/10561351/
M.D. Anderson Cancer Center
http://www.drugs.com/pro/temodar.html

http://www.temodar.com/temodar/index.do
2004 – Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:

two challenges for the pediatric oncologist
http://www.ncbi.nlm.nih.gov/pubmed/15047924/

http://m.theoncologist.alphamedpress.org/content/9/2/197.long
St. Jude Children’s Research Hospital

administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children

1/1/2005 (11/24/2004) – Role of temozolomide after radiotherapy for newly diagnosed diffuse BRAINSTEM GLIOMA in children:

results of a multiinstitutional study (SJHG-98)
http://www.ncbi.nlm.nih.gov/pubmed/15565574

http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/abstract;jsessionid=6717837591CCC8FCBD8E46163808E221.d03t01

http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children

Avastin (Bevacizumab):

5/6/2009 – U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with GLIOBLASTOMA (brain cancer) with progressive disease following prior therapy

effectiveness of Avastin in AGGRESSIVE form of BRAIN CANCER based on improvement in objective response rate

Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-combination-paclitaxel-chemotherapy-first-line-advanced-852.html
According to FDA analysis of study

Study AVF3708g

Study NCI 06-C-0064E
http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab

http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html
COMPARE COMBINED:

ANAPLASTIC ASTROCYTOMA

22% – Objective Response: Objective response = complete response and partial response – Antineoplastons

22% – response rate: Temodar

11% – Complete Response: Antineoplastons

9% – Complete Response rate: Temodar

17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons

50 weeks (16-114 weeks) – Median duration of all responses: Temodar

17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons

64 weeks (52-114 weeks) – Median duration of Complete Response: Temodar

6 months – 7 / 39% Progression-Free Survival: Antineoplastons

4.4 months – Median Progression-Free Survival: Temodar

5 years – 4 / 22% Overall Survival: Antineoplastons

2 years – 7 / 39% Overall Survival: Antineoplastons

2 years – Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer

15.9 months (1 year 3.9 months) – Median Overall Survival: Temodar

COMPARE COMBINED:

GLIOBLASTOMA

39% – Progression-Free Survival (PFS) at 6 months: Antineoplastons

5.28 months – Median Progression-Free Survival (PFS): Antineoplastons

11.3 months – Progression-Free Survival: Avastin

32% – % of Patients Showing Objective Response = complete response and partial response: Antineoplastons

26% – tumor responses observed Avastin

42% – special exception (SE): Overall survival (OS) – 2 years: Antineoplastons

36% – BT-11: Overall survival (OS) – 2 years: Antineoplastons

19% – special exception (SE): Overall survival (OS) – 5 years: Antineoplastons

25% – BT-11: Overall survival (OS) – 5 years: Antineoplastons

4.2 months – Median duration of response in patients: Avastin

9 / 32% – # and % of Patients Showing Objective response = complete response and partial response – Antineoplastons

11 / 20% of patients – Responses were observed: Avastin

5+ years – Maximum Survival : patient with GLIOBLASTOMA – Antineoplastons

3.9 months – Median duration of response: Avastin
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
Do “The Skeptics” believe Burzynski’s data will change from what he’s provided previously, in any FINAL phase 2 pub ?
——————————————————————
2004 – Cited by Burzynski

3/15/1999 – 40 / 30.9% – ARM 1: 1 year Patients Surviving: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 17 / 27.0% – ARM 2: 1 year Patients Surviving: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 6 months – ARM 1: Median time to Disease Progression: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 5 months – ARM 2: Median time to Disease Progression: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8.5 months – ARM 1: Median Overall Survival from start of Treatment (OST): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8.5 months – ARM 1: Median time to Death: Median Overall Survival from Diagnosis (OSD): Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8 months – ARM 2: Median Overall Survival from Diagnosis (OSD): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8 months – ARM 2: Median Overall Survival from start of Treatment (OST): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8 months – ARM 2: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997)

3/15/1999 – 8.5 months – Median Survival (MST): standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al.) (6/1992–10/1997) children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic brainstem tumors: results of a Pediatric Oncology Group phase III trial comparing conventional vs. hyperfractionated radiotherapy
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
======================================
REFERENCES:
======================================
[1] – 3/9/2013 – March 4 at 7:58pm – Colorado Public Television – PBS:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/09/colorado-public-television-pbs/
======================================
[2] – 3/10/2013 – March 5 at 12:25pm – CPT12 – The Cult of “Misinformation”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/the-cult-of-misinformation/
======================================
[3] – 3/12/2013 – CPT12 – FACTS Burzynski critics do NOT like:
——————————————————————
[4] – 3/12/2013 – CPT12
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/facts-burzynski-critics-do-not-like/
======================================
[5] – 3/17/2013 – Critiquing the Critics on Orac’s Respectful Insolence blog: Part II:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/17/critiquing-the-critics-on-oracs-respectful-insolence-blog-part-ii/
======================================
[6] – 3/24/2013 – “The Skeptics” (Burzynski: Cancer is Serious Business, Part II):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/the-skeptics/
======================================
[7] – 3/25/2013 – Critiquing Bob Blaskiewicz (#Burzynski Cancer is Serious Business, Part II):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii/
======================================
[8] – 3/26/2013 – My Critique of Bob Blaskiewicz (Colorado Public Television – PBS CPT12):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12/
======================================
[9] – 4/18/2013 – Fact-checking http://thehoustoncancerquack.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/fact-checking-httpthehoustoncancerquack-com/
======================================
[10] – 4/24/2013 – Burzynski referenced by other Cancer researchers:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-referenced-by-other-cancer-researchers/
======================================
[11] – 4/24/2013 – Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective/
======================================
[12] – 4/24/2013 – Burzynski: Stable Disease:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-stable-disease/
======================================
[13] – 4/24/2013 – Burzynski: Costs of Cancer treatments:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-costs-of-cancer-treatments/
======================================
[14] – 4/27/2013 – Bob Blaskiewicz (Blatherskitewicz), Faux Skeptic Exposed!:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/bob-blaskiewicz-blatherskitewicz-faux-skeptic-exposed/
======================================
[15] – 4/19/2013 (4/27/2013-4/28/2013) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 1):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-1/
======================================
[16] – 4/30/2013 – Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 6):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/30/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-6/
======================================
[17] – 5/6/2013 – Critiquing: Is Eric Merola issuing bogus DMCA takedown notices against critics of Stanislaw Burzynski?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/07/critiquing-is-eric-merola-issuing-bogus-dmca-takedown-notices-against-critics-of-stanislaw-burzynski/
======================================
[18] – 5/29/2013 (6/2) – Critiquing the #SkepticCanary: “The Skeptics™” (SkeptiCowards©) Bob Blatherskitewicz and the so-called, “self-proclaimed” “CANCER RESEARCHER”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/03/critiquing-the-skepticcanary-the-skeptics-skepticowards-bob-blatherskitewicz-and-the-so-called-self-proclaimed-cancer-researcher/
======================================
[19] – 6/6/2013 – Bob Blaskiewicz (Blatherskitewicz), Faux Skeptic Exposed!:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/bob-blaskiewicz-blatherskitewicz-faux-skeptic-exposed/
======================================
[20] – 6/8/2013 – (19. March 29, 1996) – MISDIRECTION: Critiquing “Antineoplastons: Has the FDA kept it’s promise to the American people?”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
======================================
[21] – 6/23/2013 – QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/23/questions-the-critics-and-cynics-the-skeptics-do-not-want-to-answer/
======================================
[ 22] – 7/2/2013 –
Burzynski: Institutional Review Board (IRB):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/02/burzynski-institutional-review-board-irb/
======================================
[23] – 7/31/2013 – Perfessor Robert J. (Bob) Blaskiewicz Blatherskitewicz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/31/the-burzynski-b-s-app/
======================================
[24] – 8/18/2013 – The Burzynski Skeptics:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/18/the-burzynski-skeptics/
======================================
[25] – 8/25/2013 – Critiquing https://theotherburzynskipatientgroup.wordpress.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
======================================
[26] – 8/26/2013 – Yes! Weekly: Burzynski: Cancer is Serious Business Part II:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/26/yes-weekly-burzynski-cancer-is-serious-business-part-ii/
======================================
“Orphan Drug”
phenylbutyrate
PB
“Orphan Drug”
phenylacetate
PN
Orphan Drug”
phenylacetylglutamine
“Orphan Drug”
phenylacetylisoglutimine
PG
“Orphan Drug”
phenylacetylisoglutiminate
PG
2011 – Orphan Drugs in Development
http://www.phrma.org/sites/default/files/pdf/rarediseases2011.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020645s000_ClinPharmR.pdf

http://www.hrsa.gov/opa/programrequirements/orphandrugexclusion/orphandruglist.pdf

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2764862/
Phenylbutyrate is a aromatic fatty acid, able to induce hyperacetylation of histones H3 and H4 and growth arrest, differentiation and apoptosis of AML cell lines and primary leukemic cells. It has been effectively used to induce fetal erythropoiesis in patients with sickle cell anemia and β-thalassemia [105]. The aromatic ring does not contribute to the antitumor activity, as butyric acid is of equal or greater potency at producing these biological changes, while shortening of the fatty acid carbon chain length, as demonstrated with phenylacetate, significantly diminished drug potency [106]. After administration phenylbutyrate is metabolized to phenylacetate, then to phenylacetylglutamine and eliminated by urine [107]. The maximum tolerated doses, when administered as a 7-day continuous infusion, was 375 mg/kg/day, while higher doses were associated with encephalopathy apparently attributable to accumulation of the metabolite phenylacetate. At the maximum tolerated dose (MTD), median steady state concentration of phenylbutyrate is 0.3 mM, which is less than the ED50 of 1-2 mM required for differentiation and cytostasis in vitro but in within the concentration range in which phenylbutyrate
induces acetylation of histones. Dose-limiting toxicities were mainly represented by neurocortical toxicity, including lethargy, confusion, and slurred speech, which completely disappeared within 24 to 48 h upon cessation of the infusion. Non dose-limiting toxicities were hyperammoniemia, hyperuricemia, hypocalcemia, skin abnormalities and interstitial pneumonia [108, 109].
Bobby Blaskiewicz Bows Up ‘Bout Burzynski;
https://stanislawrajmundburzynski.wordpress.com/2013/09/24/bobby-blaskiewicz-bows-up-bout-burzynski/

Critiquing David H. “Orac” Gorski, MD PhD and his Personalized MUD-Targeted Skeptic Therapy

I’ve made no secret of my opinion of a certain cancer “research” doctor named David H. Gorski, MD, PhD, of Wayne State University School of Medicine and Barbara Ann Karmanos Cancer Center / Institute, Detroit, Michigan fame

Gorski, as you may recall was responsible for this 6/3/2013 “Orac” posting:
======================================
In which the latest movie about Stanislaw Burzynski’s “cancer cure” is reviewed…with Insolence
——————————————————————
http://scienceblogs.com/insolence/2013/06/03/in-which-the-latest-movie-about-stanislaw-burzynskis-cancer-cure-is-reviewed-with-insolence/
——————————————————————
Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
When last we left Gorski, his propaganda, which I characterize as pure propaganda so incompetently made that it would make blush blush

After a couple of winks I changed my characterization to say that it would have made Penn and Teller vomit in revulsion at its sheer incompetence

Be that as it may, I view Gorski as highly unethical and pseudononsense, an incompetent purveyor of “personalized MUD-targeted medicine for dummies,” and someone who might at one time have been on to something but, like all hacks, just couldn’t let go when it became clear that his personalized MUD-targeted Skeptic therapy was far more toxic than advertised and way less efficacious, if it’s even efficacious at all, which is highly doubtful.

Gorski claimed:

“[I]f I had screwed up, I would have admitted it”

Data talks

BS walks

And there’s no doubt that Gorski, too, is pure BS

In fact, I think I’m being too kind

I have yet to see his admission that he lied when he posted:

“how Burzynski never explains which genes are targeted by antineoplastons … “
======================================
Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
======================================
8/12/2013 Gorski blogged:
======================================
A study of antineoplastons fails to be published. Stanislaw Burzynski’s propagandist Eric Merola whines about it. News at 11.
——————————————————————
http://scienceblogs.com/insolence/2013/08/12/antineoplaston-fails-publication/ ======================================
In regards to antineoplastons, Gorski states:

“antineoplastons are chemotherapy”

“They even have significant toxicity!”

What science based medicine publication(s) does Gorski cite in support of his “theory”?

NONE !!!

What do the science based medicine publications indicate?
======================================
[1] 4/1/1992 PHENYLACETATE-novel NONTOXIC inducer of tumor cell differentiation
——————————————————————
Sodium PHENYLACETATE found to affect growth and differentiation of tumor cells in vitro at concentrations achieved in humans WITH NO SIGNIFICANT ADVERSE EFFECTS
——————————————————————
PHENYLACETATE is effective in inducing tumor cell maturation and FREE OF CYTOTOXIC AND CARCINOGENIC EFFECTS, a combination that warrants attention to potential use in cancer intervention
——————————————————————
Sodium PHENYLACETATE is investigational new drug approved for human use by U.S. Food and Drug Administration
——————————————————————
DRUG ALREADY ESTABLISHED AS SAFE AND EFFECTIVE … we propose use may be extended to cancer preventation and therapy
======================================
[2] 8/20/1992 Difficulties may be overcome through exploitation of recent discovery of sodium PHENYLACETATE as NONTOXIC inducer of differentiation …
——————————————————————
(pro-drug) Sodium 4-PHENYLBUTYRATE can be given in oral doses of 0.3 to 0.6 g per kilogram of body weight per day with NO ADVERSE REACTIONS
——————————————————————
Drug rapidly metabolized to PHENYLACETATE and PHENYLACETYLGLUTAMINE
——————————————————————
PHENYLACETATE (but not PHENYLACETYLGLUTAMINE) … CAN POTENTIATE EFFICACY OF OTHER DIFFERENTIATING AGENTS, such as cytotoxic drugs …
======================================
[3] 9/15/1992 we explored efficacy of PHENYLACETATE, an amino acid derivative with LOW TOXICITY INDEX WHEN ADMINISTERED TO HUMANS
——————————————————————
PHENYLACETATE, used alone or in combination with other drugs, might offer safe and effective new approach to treatment …
======================================
[4] 5/1993 NONTOXIC differentiation inducer, sodium PHENYLACETATE (NaPA)
——————————————————————
In vitro antineoplastic activity was observed with drug concentrations that have been achieved in humans with NO SIGNIFICANT TOXICITIES, suggesting PA, used alone or in combination with other antitumor agents, warrants evaluation in treatment of advanced prostatic cancer
======================================
[5] 10/1/1993 Sodium PHENYLACETATE (NaPA) and its precursor, sodium 4-PHENYLBUTYRATE (NaPB), can enhance HbF production in cultured erythroid progenitor derived from normal donors and patients with SS anemia or beta-thal, when used at pharmacologic concentrations
——————————————————————
NaPA and NaPB, BOTH ALREADY PROVEN SAFE AND EFFECTIVE IN TREATMENT OF CHILDREN …
======================================
[6] 2/15/1994 sodium PHENYLACETATE can induce cytostasis and reversal of malignant properties of cultured human glioblastoma cells, when used at pharmacological concentrations that are WELL TOLERATED BY CHILDREN AND ADULTS
——————————————————————
Systemic treatment of rats bearing intracranial gliomas resulted in significant tumor suppression with NO APPARENT TOXICITY to host
======================================
[7] 4/1/1994 Pg. 1690
——————————————————————
protocol underwent several modifications over 6-month period
——————————————————————
Interest in PHENYLACETATE as anticancer agent generated by reports that ANTINEOPLASTON AS2-1, a preparation which by weight is 80% PHENYLACETATE, displayed clinical antitumor activity (13)
——————————————————————
17 patients (16 men / 1 woman) (36-75) median age 57
——————————————————————
Pg. 1693
——————————————————————
Clinical Toxicities. NO TOXICITY associated with bolus administration of drug
——————————————————————
Drug-related TOXICITY clearly related to serum
PHENYLACETATE concentration
——————————————————————
3 episodes of Central Nervous System (CNS)
TOXICITY, limited to CONFUSION
and LETHARGY and often preceded by emesis, occurred in patients treated at dose levels 3 and 4
——————————————————————
Symptoms resolved within 18 h of terminating drug infusion in all instances
——————————————————————
Pg. 1694
——————————————————————
PHENYLACETATE serum concentrations … were typically associated with CNS toxicity
——————————————————————
While ability to cross blood-brain barrier may underlie clinical improvement seen in patient with glioblastoma, could also explain dose-limiting side-effects of drug, i.e., nausea, vomiting, sedation, and confusion
——————————————————————
Limited experience with 150-mg/kg i.v. boluses suggests serum PHENYLACETATE concentrations occurring transiently
above 500 ug/ml are well tolerated
——————————————————————
Intermittent drug infusion should permit some drug washout to occur, thereby minimizing drug accumulation
——————————————————————
Predicts wide range of peak drug concentrations will be observed
——————————————————————
Possible these would be sufficiently transient so as not to produce CNS toxicity and troughs not prolonged as to abrogate antitumor activity of drug
——————————————————————
Dosing alternatives should be explored, our study indicates PHENYLACETATE can be safely administered by CIVI and result in clinical improvement in some patients with hormone-refractory
prostatic carcinoma and glioblastoma multiforme who failed conventional therapies
======================================
[8] 6/1/1994 PHENYLACETATE is naturally occurring plasma component that suppresses growth of tumor cells and induces differentiation in vitro
——————————————————————
Treatment with PHENYLACETATE extended survival … WITHOUT ASSOCIATED ADVERSE EFFECTS
======================================
[9] 9/1994 PHENYLACETATE, NONTOXIC differentiation inducer, can suppress growth of other neuroectodermal tumors, i.e., gliomas, in laboratory models and humans
======================================
[10] 4/1995 PHENYLACETATE, an inducer of tumor cytostasis and differentiation, shows promise as RELATIVELY NONTOXIC antineoplastic agent in models and humans
======================================
[11] 6/15/1995 Growth-inhibiting and differentiating effects of sodium PHENYLACETATE against hematopoietic and solid tumor cell lines has aroused clinical interest in use as anticancer drug
——————————————————————
In Phase I trial of PHENYLACETATE … commonly resulted in drug accumulation and REVERSIBLE DOSE-LIMITING NEUROLOGIC TOXICITY
——————————————————————
18 patients
——————————————————————
DOSE-LIMITING TOXICITY, consisting of REVERSIBLE CENTRAL NERVOUS SYSTEM DEPRESSION, observed for 3 patients at 2nd dose level
======================================
[12] 10/12/1995 aromatic fatty acid PHENYLACETATE, a common metabolite of phenylalanine, shows promise as a RELATIVELY NON-TOXIC drug for cancer treatment
======================================
[13] 10/1995 investigated effects of a NONTOXIC differentiation inducer, PHENYLACETATE (PA), on neuroectodermal tumor-derived cell lines
======================================
[14] 1995 Antineoplastons, firstly described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
——————————————————————
toxicological study of Antineoplastons A-10 and AS2-1 in combination with other anticancer agents or radiation in 42 patients
46 tumors with terminal stage cancer
——————————————————————
Antineoplaston A-10 oral formulation
14 – patients
A-10 injectable formulation
25 – patients
——————————————————————
Antineoplaston AS2-1 oral formulation
33 – patients
AS2-1 injectable formulation
10 – patients
——————————————————————
Major adverse effects that may have been related to agents used in combination with other conventional chemotherapeutic agents or radiation:
liver dysfunction
myelosuppression
general weakness
THESE EFFECTS WEREN’T SEEN WHEN EITHER ANTINEOPLASTON WAS ADMINISTERED ALONE
——————————————————————
MINOR ADVERSE EFFECTS OBSERVED IN SINGLE USE OF EITHER ANTINEOPLASTON A-10 OR AS2-1:
reduced albumin
increased alkaline phosphatase
increased amylase
reduced cholesterol
peripheral edema
eosinophilia
fingers rigidity
excess gas
headache
hypertension
maculopapullar rash
palpitation
adverse effects didn’t limit to continuation of either agent
——————————————————————
Antineoplaston A-10 and AS2-1 LESS TOXIC THAN CONVENTIONAL CHEMOTHERAPIES and useful in maintenance therapy for cancer patients
======================================
[15] 1996 Antineoplastons, first described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
——————————————————————
reported cytostatic inhibitory effect of A10 on human hepatocellular carcinoma cells and differentiation inducing effect of AS2-1 on various tumor cells suggest potential benefit for treatment of human hepatocellular carcinoma since tumor recurs frequently despite initial successful treatment
——————————————————————
Clinical experience of hepatocellular carcinoma (HCC) patient whose tumor, after incomplete trancathere arterial embolization (TAE) for a 7cm 7cm HCC, has been stable for more than 15 months during which time he has been taking Antineoplaston AS2-1 continuously WITHOUT ANY SERIOUS ADVERSE EFFECTS
======================================
[16] 5/1996
——————————————————————
In pursuit of alternative treatments for chemoresistant tumor cells, tested response of multidrug-resistant (MDR) tumor cell lines to aromatic fatty acids phenylacetate (PA) and phenylbutyrate (PB), 2 differentiation inducers currently in clinical trials
——————————————————————
Both compounds induced cytostasis and maturation of multidrug-resistant breast, ovarian, and colon carcinoma cells with no significant effect on cell viability
——————————————————————
MDR cells generally more sensitive to growth arrest by PA and PB than their parental counterparts
——————————————————————
PA and PB potentiated cytotoxic activity of doxorubicin against MDR cells
——————————————————————
Taken together, in vitro data indicate PA and PB, differentiation inducers of aromatic fatty acid class, may provide alternative approach to treatment of MDR tumors
======================================
[17] 12/1996 PHENYLACETATE (PA) and related aromatic fatty acids constitute novel class of RELATIVELY NONTOXIC antineoplastic agents
======================================
[18] 8/1997 aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB) are novel antitumor agents currently under clinical evaluation
————————————————————
ability to induce tumor differentiation in laboratory models and LOW CLINICAL TOXICITY PROFILE makes them promising candidates for COMBINATION WITH CONVENTIONAL THERAPIES
======================================
[19] 1997 PHENYLACETATE and analogs represent new class of pleiotropic growth regulators that alter tumor cell biology by affecting gene expression at both transcriptional and post transcriptional levels
————————————————————
Based on findings, NaPA and NaPB entered clinical trials at National Cancer Institute
————————————————————
Ongoing phase I studies with NaPA, involving adults with prostate and brain cancer, confirmed therapeutic levels can be achieved WITH NO SIGNIFICANT TOXICITIES, and provide preliminary evidence for benefit to patients with advanced disease (Thibault et al., submitted)
======================================
[20] 10/1997 Sodium PHENYLACETATE (PA) and sodium PHENYLBUTYRATE (PB) are aromatic fatty acids that can effect differentiation in a variety of cell lines at doses that may be clinically attainable
——————————————————————
Pg. 1760
——————————————————————
PB has been successfully administered to patients with urea acid cycle disorders and sickle cell anemia for extended periods of time, and NO HEMATOLOGICAL TOXICITY has been reported
——————————————————————
Significant HEMATOLOGICAL TOXICITY was not reported in a Phase I trial of PA in patients with malignancy
——————————————————————
Pg. 1761
——————————————————————
Because of its ATTRACTIVE CLINICAL TOXICITY PROFILE, PB represents an excellent candidate for clinical trials in this group of disorders
======================================
[21] 11.–.12/1997 Antineoplaston AS2-1 exhibits cytostatic growth inhibition of human hepatocellular carcinoma cells in vitro and SHOWED MINIMUM ADVERSE EFFECTS in phase I clinical trial
======================================
[22] 6/1999 Burkitt’s lymphoma (BL) is readily treated malignancy, recurrences, as well as disease arising in immunosuppressed patients, are notoriously resistant to conventional therapeutic approaches
——————————————————————
Using in vitro models of EBV-transformed lymphoblastoid as well as BL cell lines, we demonstrate increased expression of genes coding for HLA class I and EBV latent proteins by differentiation inducer PHENYLBUTYRATE (PB)
——————————————————————
Aromatic fatty acid also caused cytostasis associated with sustained declines in c-myc expression, a direct antitumor effect that was independent of EBV status
——————————————————————
Findings may have clinical relevance because in vitro activity has been observed with PB concentrations that are
WELL TOLERATED and nonimmunosuppressive in humans, a desirable feature for different patient populations afflicted with this disease
======================================
[23] 8/2001 PHENYLBUTYRATE (PB) is aromatic fatty acid with multiple mechanisms of action including histone deacetylase inhibition
——————————————————————
Overall DRUG WELL TOLERATED with most common TOXICITIES being grade 1-2 DYSPEPSIA and FATIGUE
——————————————————————
Nonoverlapping dose-limiting TOXICITIES of NAUSEA/VOMITING and HYPOCALCEMIA were seen at 36 g/day
——————————————————————
PB (p.o.) IS WELL TOLERATED and achieves concentration in vivo shown to have biological activity in vitro
======================================
[24] 10/2001 Sodium PHENYLBUTYRATE (PB) demonstrates potent differentiating capacity in multiple hematopoietic and solid tumor cell lines
——————————————————————
Pharmacokinetics performed during and after first infusion period using validated high-performance liquid chromatographic assay and single compartmental pharmacokinetic model for PB and principal metabolite, PHENYLACETATE
——————————————————————
24 patients with hormone refractory prostate cancer being predominant tumor type
——————————————————————
All evaluable for TOXICITY and response
——————————————————————
Dose escalated 150 to 515 mg/kg/day
——————————————————————
One patient at 515 mg/kg/day and one at 345 mg/kg/day experienced this DLT
——————————————————————
Maximum tolerated dose 410 mg/kg/day for 5 days
——————————————————————
Recommended Phase II dose 410 mg/kg/day for 120 h
——————————————————————
Dose-limiting TOXICITY (DLT) was neuro-cortical, exemplified by EXCESSIVE SOMNOLENCE and CONFUSION and accompanied by clinically significant HYPOKALEMIA, HYPONATREMIA, and HYPERURICEMIA
——————————————————————
Other TOXICITIES mild, including FATIGUE and NAUSEA
——————————————————————
DLT in Phase I study for infusional PB
given for 5 days every 21 days is neuro-cortical in nature
——————————————————————
TOXICITY resolved < or =12 h of discontinuing infusion
======================================
[25] 2003 Case of survival for nearly 8 years after treatment of unresectable multiple liver metastases from colon cancer, using microwave ablation and NONTOXIC ANTITUMOR AGENT, ANTINEOPLASTONS
——————————————————————
72-year-old man diagnosed with adenocarcinoma of ascending colon and 14 bilateral liver metastases underwent right hemicolectomy combined with microwave ablation of 6 metastatic liver tumors
——————————————————————
Antineoplaston A10 given intravenously, followed by oral antineoplaston AS2-1
——————————————————————
Patient underwent 2nd and 3rd microwave ablation of recurrent tumors, and has survived for nearly 8 years WITHOUT SUFFERING ANY SERIOUS ADVERSE EFFECTS
——————————————————————
Currently FREE FROM CANCER
——————————————————————
Demonstrates potential effectiveness of NONTOXIC ANTITUMOR AGENT, ANTINEOPLASTONS, for controlling liver metastases from colon cancer
======================================
[26] 4/2005 Determined maximum tolerated dose (MTD), TOXICITY profile of … oral sodium PHENYLBUTYRATE (PB) in patients with recurrent malignant gliomas
——————————————————————
All PB doses of 9, 18, and 27 g/day WELL TOLERATED
——————————————————————
At 36 g/day, 2 of 4 patients developed dose-limiting grade 3 FATIGUE and SOMNOLENCE
——————————————————————
At MTD of 27 g/day, one of 7 patients developed reversible grade 3 SOMNOLENCE
======================================
[27] 4/2007 PHENYLBUTYRATE (PBA), and its metabolite PHENYLACETATE (PAA), induce growth inhibition and cellular differentiation in multiple tumor models
——————————————————————
Conversion of PBA to PAA and PHENYLACETYLGLUTAMINE (PAG) documented without catabolic saturation
——————————————————————
THERAPY WELL TOLERATED OVERALL
——————————————————————
Common ADVERSE EFFECTS included grade 1 NAUSEA/VOMITING, FATIGUE, and LIGHTHEADEDNESS
——————————————————————
Dose limiting TOXICITIES were SHORT-TERM MEMORY LOSS, SEDATION, CONFUSION, NAUSEA, and VOMITING
——————————————————————
Administration of PBA twice-daily infusion schedule is SAFE
======================================
None of the above publications indicate that antineoplastons are toxic as Gorski would have people believe

12/12/2011 Gorski published his attempt at trying to explain why antineoplastons are supposedly toxic
======================================
What Dr. Stanislaw Burzynski doesn’t want you to know about antineoplastons
——————————————————————
http://scienceblogs.com/insolence/2011/12/12/what-dr-stanislaw-burzynski-doesnt-want/
======================================
Gorski posited:

“He’s also prescribing huge doses of antineoplastons (up to 25 g/kg/d for A10 and 80 mg/kg/d for AS-2.1, as we have seen). both of these are so far above the maximal tolerated dose of 300 mg/kg/d determined in the phase I trial I cited above as to be terrifying”

In support of his “theory”, Gorski provided a link to the National Cancer Institute (NCI) at the National Institutes of Health (NIH):
——————————————————————
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/Table1
——————————————————————
However, as is the case with a lot of Gorski’s lame research, he makes you search for what he is referring to:

[14]Ba Primitive neuroectodermal tumor (13)

A10/AS2-1

Max dose: A10: 25 g/kg/d; AS2-1: 0.6 g/kg/d

Does this support Gorski’s “toxic theory”?
======================================
[28] 2005
——————————————————————
5 years 7 months (1-11) median age
——————————————————————
13 / 100% – children with recurrent disease or high risk
——————————————————————
5 / 38% – weren’t treated earlier with radiation therapy or chemotherapy
——————————————————————
3 / 23% – Complete Response
1 / 8% – Partial Response
4 / 31% – Stable Disease
5 / 38% – Progressive Disease
——————————————————————
6 / 46% – Survived 5+ years from initiation of ANP
——————————————————————
Serious side effects:
1 – anemia
1 – fever
1 – granulocytopenia
——————————————————————
average dosage of A10 was 10.3 g/kg/d and of AS2-1 was 0.38 g/kg/d
——————————————————————
REDUCED TOXICITY MAKES ANP PROMISING for very young children, patients at high risk of complication of standard therapy, and patients with recurrent tumors
======================================
The above sure does NOT support Gorski’s “toxic theory”

When science based medicine keeps saying the following:
======================================
[9] 9/1994 increasing incidence of melanoma and POOR RESPONSIVENESS OF DISSEMINATED DISEASE TO CONVENTIONAL TREATMENT CALL FOR DEVELOPMENT OF NEW THERAPEUTIC APPROACHES
======================================
[29] 9/27/1995 (7/17/2006) Alterations in expression of ras oncogenes are characteristic of wide variety of human neoplasms
——————————————————————
Accumulating evidence has linked elevated ras expression with disease progression and FAILURE OF TUMORS TO RESPOND TO CONVENTIONAL THERAPIES, INCLUDING RADIOTHERAPY AND CERTAIN CHEMOTHERAPIES
——————————————————————
observations led us to investigate response of ras-transformed cells to differentiation-inducer PHENYLACETATE (PA)
——————————————————————
Interestingly, IN CONTRAST TO THEIR RELATIVE RESISTANCE TO RADIATION and doxorubicin, ras-transformed cells were significantly more sensitive to PA than their parental cells
======================================
[30] 5/1996 CYOTOXIC CHEMOTHERAPIES OFTEN GIVE RISE TO MULTIDRUG RESISTANCE, WHICH REMAINS MAJOR PROBLEM IN CANCER MANAGEMENT
————————————————————
IN PURSUIT OF ALTERNATIVE TREATMENTS FOR CHEMORESISTANT TUMOR CELLS, we tested response of multidrug-resistant (MDR) tumor cell lines to aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB), 2 differentiation inducers currently in clinical trials
======================================
[15] 1996 Antineoplastons, first described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
——————————————————————
reported cytostatic inhibitory effect of A10 on human hepatocellular carcinoma cells and differentiation inducing effect of AS2-1 on various tumor cells suggest potential benefit for treatment of human hepatocellular carcinoma since TUMOR RECURS FREQUENTLY DESPITE INITIAL SUCCESSFUL TREATMENT
======================================
[31] 7/1997 Children with malignant GLIOMAS THAT PROGRESSED AFTER CONVENTIONAL THERAPY
——————————————————————
0 / 0% – EXHIBITED CLEAR-CUT TUMOR regression
======================================
[32] 2000 treatment combination PRODUCED NO SIGNIFICANT CHANGE in overall POOR prognosis of patients
——————————————————————
Most tumors responded initially to treatment but RECCURED as study progressed
——————————————————————
Based on POOR RESULTS, recommend ALTERNATIVE TREATMENTS be tested in patients with this type of tumor
======================================
[33] At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
======================================
[34] 12/2000 NO CLEAR PROOF OF EFFICACY
——————————————————————
NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide
======================================
[35] 2002 p53 tumor suppressor gene plays important role in protecting cells from developing undesirable proliferation
——————————————————————
Mutant p53 gene or malfunctioning p53 protein found in more than 50% of cancer cells impedes DNA repair or apoptosis induction
——————————————————————
MAY BE WHY SOME CANCERS GAIN RESISTANCE TO CHEMOTHERAPY AND RADIATION AND BECOME MORE RESISTANT AFTER FREQUENT CANCER TREATMENTS
======================================
[36] 2004 outcome for patients with either type of tumor is POOR when STANDARD multimodality THERAPY IS USED
——————————————————————
children are ideal candidates for INNOVATIVE TREATMENT approaches
——————————————————————
33 / 100% – DIED OF DISEASE PROGRESSION
——————————————————————
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
======================================
[37] 2/2008 addition of vincristine and oral VP-16 to standard external beam radiation causes moderate toxicity and DOESN’T IMPROVE SURVIVAL OF CHILDREN WITH DIFFUSE INTRINSIC BRAIN STEM GLIOMA
======================================
[38] 5/6/2009 Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
======================================
[39] 10/12/2011 Afinitor (ubependymal giant cell ASTROCYTOMA (SEGA) brain tumor)
——————————————————————
none of their tumors went away completely
======================================
[18] 8/1997 aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB) are novel antitumor agents currently under clinical evaluation
————————————————————
ability to induce tumor differentiation in laboratory models and LOW CLINICALTOXICITY PROFILE makes them promising candidates for COMBINATION WITH CONVENTIONAL THERAPIES
======================================
So what does Gorski think is going to fill the void?

His clinical trial drug ?

The potentially profitable drug Gorski is in the process of conducting a clinical trial for is the ALS drug Riluzole, made by Sanofi-Aventis and marketed as Rilutek

Apparently, David Gorski has had his eye on that drug for a long time, but as a possible treatment for breast cancer

As suggested by a 2008-2009 webpage of a breast cancer website:

“Three years ago in another cancer (melanoma), Dr. Gorski’s collaborators found that glutamate might have a role in promoting the transformation of the pigmented cells in the skin (melanocytes) into the deadly skin cancer melanoma”

“More importantly for therapy, it was found that this protein can be blocked with drugs, and, specifically, in melanoma cell lines and tumor models of melanoma using a drug originally designed to treat ALS and already FDA-approved for that indication (Riluzole) can inhibit the growth of melanoma.”
————————————————————
http://www.ageofautism.com/2010/06/david-gorskis-financial-pharma-ties-what-he-didnt-tell-you.html
————————————————————
Better luck next time with your personal MUD-targeted Skeptic therapy Gorski

� � � � � � � � � � � � � � � � �
References:
————————————————————
Dvorit D. Samid learned about antineoplastons from Burzynski
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[1] 4/1/1992
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SAMID, D., Shack, S., and Sherman, l.. T.
http://www.ncbi.nlm.nih.gov/pubmed/1372534/
Cancer Res., 52: 1988-1992, 1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
Cancer Res 1992;52:1988-1992
http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract
Cancer Res April 1, 1992 52; 1988v I
http://cancerres.aacrjournals.org/content/52/7/1988
Cancer Res. 1992 Apr 1;52(7):1988-92
http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf
Cancer Res 52:1988,1992
http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf#page=1
SAMID D, Shack S, Ti-Sherman L
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland
PHENYLACETATE-A novel nontoxic inducer of TUMOR CELL differentiation
↵1 Supported by Elan Pharmaceutical Corporation Grant G174ED
Reference: 12 (SAMID, D.)
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[2] .8/20/1992
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Dover GJ, Brusilow S, SAMID D. Increased fetal hemoglobin in patients receiving sodium 4-PHENYLBUTYRATE. N Engl J Med. 1992 Aug 20;327(8):569–570
http://www.ncbi.nlm.nih.gov/pubmed/1378939/
N Engl J Med. 1992 Aug 20;327(8):569-70
http://www.ncbi.nlm.nih.gov/m/pubmed/1378939/
August 20, 1992
N Engl J Med 1992; 327:569-570
http://www.nejm.org/doi/full/10.1056/NEJM199208203270818
N Engl J Med 327569, 1992
Dvorit Samid, Ph.D
National Cancer Institute, Bethesda, MD
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[3] 9/15/1992
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SAMID D, Yeh A, Prasanna P. Induction of erythroid differentiation and fetal hemoglobin production in human leukemic cells treated with phenylacetate. Blood. 1992 Sep 15;80(6):1576–1581
http://www.ncbi.nlm.nih.gov/pubmed/1381630/
Blood. 1992 Sep 15;80(6):1576-81
http://www.ncbi.nlm.nih.gov/m/pubmed/1381630/
Blood September 15, 1992 vol. 80 no. 6 1576-1581
http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pd
Blood 80:1576, 1992
http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.abstract
Blood 80(6):1576–1581
http://m.bloodjournal.hematologylibrary.org/content/80/6/1576.full.pdf
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD
SAMID D References: 15, 20-21 and 34
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[4] 5/1993
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SAMID D, Shack S , Myers CE . Selective growth arrest and phenotypic reversion of prostate cancer cells in vitro by NONTOXIC pharmacological concentrations of PHENYLACETATE . J. Clin. Invest . 1993;91:2288
http://www.ncbi.nlm.nih.gov/pubmed/8486788/
J Clin Invest. 1993 May;91(5):2288-95
http://www.ncbi.nlm.nih.gov/m/pubmed/8486788/
J Clin Invest. 1993 May; 91(5): 2288–2295
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC288233/
Published in Volume 91, Issue 5 (May 1993)
http://m.jci.org/articles/view/116457
J Clin Invest. 1993;91(5):2288–2295
1993, The American Society for Clinical Investigation
http://m.jci.org/articles/view/116457/pdf.mobile
J Clin Invest 91:2288, 1993
PMCID: PMC288233
doi:10.1172/JCI116457
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland
SAMID D References: 9, 13-14, 17 and 33
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[5] .10/1/1993
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Enhanced fetal
hemoglobin production by PHENYLACETATE and 4-PHENYLBUTYRATE in erythroid precursors derived from normal blood donors and patients with sickle cell anemia and P-thalassemia
http://www.ncbi.nlm.nih.gov/pubmed/7691251/
Blood. 1993 Oct 1;82(7):2203-9
http://www.ncbi.nlm.nih.gov/m/pubmed/7691251/
Blood 822203, 1993
http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.full.pd
Blood October 1, 1993 vol. 82 no. 7 2203-2209
http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.abstract
1993 82: 2203-2209
http://m.bloodjournal.hematologylibrary.org/content/82/7/2203.full.pdf
Blood 82(7):2203–2209
Department of Hematology, Hadassah University Hospital, Jerusalem, Israel
Fibach E, Prasanna P, Rodgers GP, SAMID D
SAMID D References: 15, 19-21 and 32
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[6] 2/15/1994
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SAMID, D., Ram, Z., Hudgins, W. R., Shack, S., Liu, L., Waibridge, S., Oldfield, E. H., and Myers, C. E. Selective activity of PHENYLACETATE against malignant gliomas: resemblance to fetal brain damage in phenylketonuria. Cancer Res., 54: 891-895, 1993
http://www.ncbi.nlm.nih.gov/pubmed/8313377/
Cancer Res. 1994 Feb 15;54(4):891-5
http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/
Cancer Res February 15, 1994 54; 891
http://cancerres.aacrjournals.org/content/54/4/891/
Cancer Res 1994;54:891-895
Clinical Pharmacology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
Work supported by funds from Elan Pharmaceutical Research Corporation through Cooperative Research and Development Agreement (CACR-0139)
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[7] 4/1/1994
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A phase I and pharmacokinetic study of intravenous PHENYLACETATE in patients with cancer
http://www.ncbi.nlm.nih.gov/pubmed/8137283
Cancer Res. 1994 Apr 1;54(7):1690-4
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283
Cancer Res 54(7):1690-4 (1994), PMID.8137283
http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract
Clinical Pharmacology Branch, National Cancer Institute, NIH, Bethesda, Maryland
http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf
Thibault A, Cooper MR, Figg WD, Venzon DJ, Sartor AO, Tompkins AC, Weinberger MS, Headlee DJ, McCall NA, SAMID D, et al.
http://cancerres.aacrjournals.org/content/54/7/1690
Study supported in part by grant from Elan Pharmaceutical Research Co
SAMID D
References: 8-12
BURZYNSKI
Reference: 13
13. BURZYNSKI, S. R., Kubove E., Burzynski, B. Treatment of hormonally refractory cancer of the prostate with antineoplaston AS2-1. Drugs Exp. Clin. Res., 16: 361-369, 1990
http://www.ncbi.nlm.nih.gov/pubmed/2152694/
Drugs Exp Clin Res. 1990;16(7):361-9
http://www.ncbi.nlm.nih.gov/m/pubmed/2152694/
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[8] 6/1/1994
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Growth inhibition, tumor maturation, and extended survival in experimental brain tumors in rats treated with PHENYLACETATE.
http://www.ncbi.nlm.nih.gov/pubmed/8187079/
Cancer Res 54:2934-2927, 1994
http://www.ncbi.nlm.nih.gov/m/pubmed/8187079/
Cancer Res. 1994 Jun 1;54(11):2923-7
http://m.cancerres.aacrjournals.org/content/54/11/2934.abstract?ijkey=03bc67e581ef77536842806b949046916458d548&keytype2=tf_ipsecsha
Cancer Res 54(11):2923–2927
http://m.cancerres.aacrjournals.org/content/54/11/2923.abstract
Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, Maryland
http://m.cancerres.aacrjournals.org/content/54/11/2923.full.pdf
Ram Z, SAMID D, Walbridge S, et al:
http://cancerres.aacrjournals.org/content/54/11/2923
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[9] 1994
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Liu L , Shack S , Stetler-Stevenson WG , Hudgins WR , SAMID D . Differentiation of cultured human melanoma cells induced by the aromatic fatty acids PHENYLACETATE and PHENYLBUTYRATE . J. Invest. Dermatol . 1994;103:335
http://www.ncbi.nlm.nih.gov/pubmed/8077698/
J Invest Dermatol. 1994 Sep;103(3):335-40
http://www.ncbi.nlm.nih.gov/m/pubmed/8077698/
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland
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[10] 4/1995
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Disposition of PHENYLBUTYRATE and its metabolites, PHENYLACETATE and PHENYLACETYLGLUTAMINE.
J Clin Pharmacol 35:368-373, 1995 Abstract
http://www.ncbi.nlm.nih.gov/pubmed/7650225/
J Clin Pharmacol 35:368-373, 1995 Abstract
http://www.ncbi.nlm.nih.gov/m/pubmed/7650225/
The Journal of Clinical Pharmacology
Volume 35, Issue 4, pages 368–373, April 1995
http://m.jcp.sagepub.com/content/35/4/368.abstract?ijkey=74bff0d86ce76b404728762fe2a1bfde1641fa41&keytype2=tf_ipsecsha
J Clin Pharmacol. 1995 Apr;35(4):368-73
http://onlinelibrary.wiley.com/doi/10.1002/j.1552-4604.1995.tb04075.x/abstract;jsessionid=DFDEF1599D764E2845EC2897269C198B.d01t01
Article first published online: 8 MAR 2013
http://onlinelibrary.wiley.com/doi/10.1002/j.1552-4604.1995.tb04075.x/abstract;jsessionid=43600D49608A093971D675F3DB5FF13D.d01t03
Piscitelli SC, Thibault A, Figg WD, et al: (SAMID D)
http://jcp.sagepub.com/content/35/4/368
Pharmacy Department, National Institutes of Health, Bethesda, Maryland, USA
DOI: 10.1002/j.1552-4604.1995.tb04075.x
http://m.jcp.sagepub.com/content/35/4/368.abstract?ijkey=74bff0d86ce76b404728762fe2a1bfde1641fa41&keytype2=tf_ipsecsha
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[11] 6/15/1995
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Phase I study of PHENYLACETATE administered twice daily to patients with cancer
http://www.ncbi.nlm.nih.gov/pubmed/7773944/
Cancer. 1995 Jun 15;75(12):2932-8
http://www.ncbi.nlm.nih.gov/m/pubmed/7773944/
Cancer 75(12):2932–2938
Clinical Pharmacology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
Thibault A, SAMID D, Cooper MR, Figg WD, Tompkins AC, Patronas N, et al
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[12] 10/12/1995
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Cytostatic activity of PHENYLACETATE and derivatives against tumor cells:
Correlation with lipophilicity and inhibition of protein prenylation.
http://www.ncbi.nlm.nih.gov/pubmed/7488244/
Biochem Pharmacol. 1995 Oct 12;50(8):1273-9
http://www.ncbi.nlm.nih.gov/m/pubmed/7488244/
Biochem Pharmacol 50:1273-1279, 1995
http://www.sciencedirect.com/science/article/pii/0006295295020133
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD, USA
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[13] 10/1995
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Stockhammer G, Manley GT, Johnson R, et al: (SAMID D) Inhibition of proliferation and induction of differentiation in medulloblastoma and astrocytoma-derived cell lines with PHENYLACETATE. J Neurosurg 83:672-681, 1995
http://www.ncbi.nlm.nih.gov/pubmed/7674018/
J Neurosurg. 1995 Oct;83(4):672-81
http://www.ncbi.nlm.nih.gov/m/pubmed/7674018/
Cotzias Laboratory of Neuro-Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York, USA
http://thejns.org/doi/abs/10.3171/jns.1995.83.4.0672?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed&amp;
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[14] 1995
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Toxicological study on antineoplastons A-10 and AS2-1 in cancer patients
http://www.ncbi.nlm.nih.gov/pubmed/8667595
Kurume Med J. 1995;42(4):241-9
http://www.ncbi.nlm.nih.gov/m/pubmed/8667595
The Kurume Medical Journal
Vol. 42 (1995) No. 4 P 241-249
https://www.jstage.jst.go.jp/article/kurumemedj1954/42/4/42_4_241/_article
JST.Journalarchive/kurumemedj1954/42.241
https://www.jstage.jst.go.jp/article/kurumemedj1954/42/4/42_4_241/_pdf
Department of Anesthesiology, Kurume University School of Medicine, Japan
http://dx.doi.org/10.2739/kurumemedj.42.241
Tsuda H, Hara H, Eriguchi N, Nishida H, Yoshida H, Kumabe T, Sugita Y
https://www.jstage.jst.go.jp/article/kurumemedj1954/42/4/42_4_241/_article/references
Burzynski References: 1 – 3 and 5
Nishida et al. (Japan) A-10 Reference: 4 and 7
Muldoon et al. A-10 Reference: 6
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[15] 1996
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Inhibitory effect of antineoplaston A10 and AS2-1 on human hepatocellular carcinoma
Tsuda H (Japan)
http://www.ncbi.nlm.nih.gov/pubmed/8755117
Kurume Med J. 1996;43(2):137-47
http://www.ncbi.nlm.nih.gov/m/pubmed/8755117
Department of Anesthesiology, Kurume University School of Medicine, Japan
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article
Burzynski References: 1 – 3, 5 and 7
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_article/references
SAMID Reference: 13 (who learned from Burzynski re PHENYLACETATE)
http://www.jstage.jst.go.jp/article/kurumemedj1954/43/2/43_2_137/_pdf
Nishida et al. (Japan) A10 Reference: 4 and 10
Muldoon et al. A10 Reference: 8
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[16] 5/1996
� � � � � � � � � � � � � � � �
Vulnerability of multidrug-resistant tumor cells to the aromatic fatty acids phenylacetate and PHENYLBUTYRATE
http://www.ncbi.nlm.nih.gov/pubmed/9816242/
Clin Cancer Res. 1996 May;2(5):865-72
http://www.ncbi.nlm.nih.gov/m/pubmed/9816242/
Clin Cancer Res 2(5):865–872
http://m.clincancerres.aacrjournals.org/content/2/5/865.abstract
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland, USA
http://m.clincancerres.aacrjournals.org/content/2/5/865.full.pdf
Shack S, Miller A, Liu L, Prasanna P, Thibault A, SAMID D
http://clincancerres.aacrjournals.org/content/2/5/865
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[17] 12/1996
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Gorospe M, Shack S, Guyton KZ, et al: (SAMID D)
Up-regulation and functional role of p21Waf1/Cip1 during growth arrest of human breast carcinoma MCF-7 cells by PHENYLACETATE. Cell Growth Differ 7:1609-1615, 1996
http://www.ncbi.nlm.nih.gov/pubmed/8959328/
Cell Growth Differ. 1996 Dec;7(12):1609-15
http://www.ncbi.nlm.nih.gov/m/pubmed/8959328/
Cell Growth Differ 7(12):1609–1615
http://cgd.aacrjournals.org/cgi/reprint/7/12/1609.pdf
Laboratory of Cellular and Molecular Biology, Gerontology Research Center, National Institute on Aging, NIH, Baltimore, Maryland, USA
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[18] 8/1997
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Miller AC, Whittaker T, Thibault A, et al: (SAMID D)
Modulation of radiation response of human tumor cells by the differentiation inducers, PHENYLACETATE and PHENYLBUTYRATE. Int J Radiat Biol 72:211-218, 1997
http://www.ncbi.nlm.nih.gov/pubmed/9269314/
Int J Radiat Biol. 1997 Aug;72(2):211-8
http://www.ncbi.nlm.nih.gov/m/pubmed/9269314/
Armed Forces Radiobiology, Research Institute, Bethesda, MD, USA
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[19] 1997
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PHENYLACETATE and PHENYLBUTYRATE as novel, NONTOXIC differentiation inducers
http://www.ncbi.nlm.nih.gov/pubmed/9547596
Adv Exp Med Biol (1997), PMID.9547596
http://www.ncbi.nlm.nih.gov/m/pubmed/9547596
Adv Exp Med Biol. 1997;400A:501-5
http://link.springer.com/chapter/10.1007%2F978-1-4615-5325-0_67
DOI
10.1007/978-1-4615-5325-0_67
http://link.springer.com/content/pdf/10.1007%2F978-1-4615-5325-0_67.pdf
Eicosanoids and Other Bioactive Lipids in Cancer, Inflammation, and Radiation Injury 2
Advances in Experimental Medicine and Biology Volume 400, 1997, pp 501-505
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD USA
D D SAMID, W R WR Hudgins, … C E CE Myers
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[20] 10/1997
� � � � � � � � � � � � � � � �
Impact of the putative differentiating agents sodium PHENYLBUTYRATE and sodium PHENYLACETATE on proliferation, differentiation, and apoptosis of primary neoplastic myeloid cells
http://www.ncbi.nlm.nih.gov/pubmed/9815560/
Clin Cancer Res. 1997 Oct;3(10):1755-62
http://www.ncbi.nlm.nih.gov/m/pubmed/9815560/
Clin Cancer Res October 1997 3; 1755
http://m.clincancerres.aacrjournals.org/content/3/10/1755.full.pd
Clin Cancer Res. 1997a;3:1755–1762
http://m.clincancerres.aacrjournals.org/content/3/10/1755.abstract
The Johns Hopkins Oncology Center, Baltimore, Maryland, USA
http://m.clincancerres.aacrjournals.org/content/3/10/1755.full.pdf
Gore SD, SAMID D, Weng LJ
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[21] 11.–.12/1997
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Antineoplaston AS2-1 for maintenance therapy in liver cancer
H Tsuda phase I clinical trial
http://www.ncbi.nlm.nih.gov/pubmed/21590224
Oncol Rep. 1997; 4:1213- 1216
http://www.ncbi.nlm.nih.gov/m/pubmed/21590224
Oncol Rep. 1997 Nov-Dec;4(6):1213-6
http://www.spandidos-publications.com/or/4/6/1213
Oncol Rep 4 (6):1213-6 (1997)
Oncology Reports
4 (6):1213-6
KURUME UNIV,SCH MED,DEPT SURG,KURUME,FUKUOKA,JAPAN. KURUME UNIV,SCH MED,DEPT INTERNAL MED,KURUME,FUKUOKA,JAPAN. KURUME UNIV,SCH MED,DEPT RADIOL,KURUME,FUKUOKA,JAPAN
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[22] 6/1999
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PHENYLBUTYRATE induces cell differentiation and modulates Epstein-Barr virus gene expression in Burkitt’s lymphoma cells
http://www.ncbi.nlm.nih.gov/pubmed/10389940/
Clin Cancer Res. 1999 Jun;5(6):1509-16
http://www.ncbi.nlm.nih.gov/m/pubmed/10389940/
Clin Cancer Res 5(6):1509–1516
http://m.clincancerres.aacrjournals.org/content/5/6/1509.abstract
Clin Cancer Res June 1999 5; 1509
http://m.clincancerres.aacrjournals.org/content/5/6/1509.long
Pediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland, USA
http://clincancerres.aacrjournals.org/content/5/6/1509
Bar-Ner M, Thibault A, Tsokos M, Magrath IT, SAMID D
Supported in part by funds from Elan Pharmaceutical Research Corporation
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[23] 8/2001
� � � � � � � � � � � � � � � � �
A phase Idose escalation and bioavailability study of oral sodium PHENYLBUTYRATE in patients with refractory solid tumor malignancies
http://www.ncbi.nlm.nih.gov/pubmed/11489804
Clin Cancer Res. 2001 Aug;7(8):2292-.300
http://www.ncbi.nlm.nih.gov/m/pubmed/11489804
Clin Cancer Res 7(8):2292-.300 (2001), PMID.11489804
http://m.clincancerres.aacrjournals.org/content/7/8/2292.long
Division of Medical Oncology, Department of Oncology, The Johns Hopkins University School of Medicine, Baltimore, USA
J Gilbert, S D Baker, … M A Carducci
SAMID D References: 2-3, 5-6, 15 and 20
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[24] 10/2001
� � � � � � � � � � � � � � � � �
A Phase I clinical and pharmacological evaluation of sodium PHENYLBUTYRATE on an 120-h infusion schedule
http://www.ncbi.nlm.nih.gov/pubmed/11595694
Clin Cancer Res. 2001 Oct;7(10):3047-55
http://www.ncbi.nlm.nih.gov/m/pubmed/11595694
Clin Cancer Res 7(10):3047-55 (2001), PMID.11595694
http://m.clincancerres.aacrjournals.org/content/7/10/3047.long
Division of Medical Oncology, The Johns Hopkins Oncology Center, Bunting-Blaustein Cancer Research Building, Baltimore, MD, USA
M A Carducci, J Gilbert, … R C Donehower
SAMID D References: 10-11, 13-14, 17-18, 23-24, 27, 33, 40-41 and 47
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[25] 2003
� � � � � � � � � � � � � � � � �
Long-term survival following treatment with antineoplastons for colon cancer with unresectable multiple liver metastases: report of a case
http://www.ncbi.nlm.nih.gov/pubmed/12768372
Long-Term Survival Following Treatment with Antineoplastonsfor Colon Cancer with Unresectable Multiple Liver Metastases:
Report of a Case
A10 and AS2-1 – Phase II Clinical Trial
Hideaki Tsuda
http://www.springerlink.com/content/b48ch3ha165nbrqp
Surg Today. 2003;33(6):448-53
http://link.springer.com/article/10.1007%2Fs10595-002-2503-2
Surg Today 2003; 33:448–53
http://link.springer.com/content/pdf/10.1007%2Fs10595-002-2503-2
Surg Today. 2003; 33:448-453
http://link.springer.com/article/10.1007%2Fs10595-002-2503-2?LI=true
33 (6):448-53
http://link.springer.com/content/pdf/10.1007%2Fs10595-002-2503-2
Surgery Today, Springer
http://sciencelinks.jp/j-east/article/200313/000020031303A0389449.php
Surg Today 2003
http://sciencelinks.jp/j-east/article/200313/000020031303A0389449.php
DOI: 10.1007/s10595-002-2503-2
http://ci.nii.ac.jp/naid/10015483373
Department of Surgery, Kurume University School of Medicine, Kurume, Fukuoka, Japan
http://ci.nii.ac.jp/naid/10015483373
� � � � � � � � � � � � � � � �
[26] 4/2005
� � � � � � � � � � � � � � � �
Oral sodium PHENYLBUTYRATE in patients with recurrent malignant gliomas:

A dose escalation and pharmacologic study
http://www.ncbi.nlm.nih.gov/pubmed/15831235/
Neuro Oncol. 2005 Apr;7(2):177-82
http://www.ncbi.nlm.nih.gov/m/pubmed/15831235/
Neuro-oncol. 2005 April; 7(2): 177–182 PMCID: PMC1871887
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1871887/pdf/neu0702p177.pdf
The New Approaches to Brain Tumor Therapy CNS Consortium, Winship Cancer Institute, Emory University, Atlanta, GA, USA
Buckner Reference: 3
SAMID D References: 12, 17 and 19-21
� � � � � � � � � � � � � � � � �
[27] 4/2007
� � � � � � � � � � � � � � � � �
Phase I dose escalation clinical trial of PHENYLBUTYRATE sodium administered twice daily to patients with advanced solid tumors
http://www.ncbi.nlm.nih.gov/pubmed/17053987
Invest New Drugs. 2007 Apr;25(2):131-8. Epub 2006 Oct 20
http://www.ncbi.nlm.nih.gov/m/pubmed/17053987
Investigational New Drugs
April 2007, Volume 25, Issue 2, pp 131-138
http://link.springer.com/article/10.1007%2Fs10637-006-9017-4
Invest New Drugs 25(2):131-8 (2007), PMID.17053987
Department of Medicine, Memorial Sloan-Kettering Cancer Center, Joan and Sanford I. Weill Medical College of Cornell Medical Center, New York, New York, USA
Luis H LH Camacho, Jon J Olson, … Mark G MG Malkin
SAMID D References: 4-5, 7, 20, 24, 30 and 32-38
� � � � � � � � � � � � � � � � �
[28] 2005
� � � � � � � � � � � � � � � � �
14. Burzynski SR, Weaver RA, Janicki T, et al.: Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1. Integr Cancer Ther 4 (2): 168-77, 2005
http://www.ncbi.nlm.nih.gov/pubmed/15911929/
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929/
� � � � � � � � � � � � � � � � �
[29] 9/27/1995
� � � � � � � � � � � � � � � � �
Increased susceptibility of ras-transformed cells to PHENYLACETATE is associated with inhibition of p21ras isoprenylation and phenotypic reversion. Int J Cancer 63:124-129, 1995
http://www.ncbi.nlm.nih.gov/pubmed/7558439/
Int J Cancer. 1995 Sep 27;63(1):124-9
http://www.ncbi.nlm.nih.gov/m/pubmed/7558439/
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD, USA
http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/abstract
Int J Cancer 63:124-129, 1995
Int J Cancer. 1995 Sep 27;63(1):124-9.
http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/references
International Journal of Cancer
Volume 63, Issue 1, Article first published online: 17 JUL 2006
DOI: 10.1002/ijc.2910630122
Shack S, Chen L-C, Miller AC, et al: (SAMID D)
http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/abstract
Shack, S., Chen, L-C., Miller, A. C., Danesi, A., and SAMID, D. Int. J. Cancer, 63: 124-129, 1995
� � � � � � � � � � � � � � � � �
[30] 5/1996
� � � � � � � � � � � � � � � � �
Shack, S., Miller, A., Liu, L., Prasanna, P., Thibault, A., and SAMID, D.. Vulnerability of MULTIDRUG-RESISTANT TUMOR CELLS to the aromatic fatty acids PHENYLACETATE and PHENYLBUTYRATE. Clin. Cancer Res., 2: 865-872, 1996
http://www.ncbi.nlm.nih.gov/pubmed/9816242/
Clin Cancer Res. 1996 May;2(5):865-72
http://www.ncbi.nlm.nih.gov/m/pubmed/9816242/
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland 20892, USA
http://m.clincancerres.aacrjournals.org/content/2/5/865.abstract

http://m.clincancerres.aacrjournals.org/content/2/5/865.full.pdf
� � � � � � � � � � � � � � � � �
[31] 7/1997
� � � � � � � � � � � � � � � � �
A phase I study of high-dose tamoxifen for the treatment of refractory malignant gliomas of childhood
http://www.ncbi.nlm.nih.gov/pubmed/9815790/
Clin Cancer Res. 1997 Jul;3(7):1109-15
http://www.ncbi.nlm.nih.gov/m/pubmed/9815790/
Clin Cancer Res July 1997 3; 1109
http://m.clincancerres.aacrjournals.org/content/3/7/1109.full.pd
Department of Neurosurgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA
http://clincancerres.aacrjournals.org/content/3/7/1109
� � � � � � � � � � � � � � � � �
[32] 2000
� � � � � � � � � � � � � � � � �
Radiation therapy and high-dose tamoxifen in the treatment of patients with diffuse BRAINSTEM GLIOMAS:

results of a Brazilian cooperative study
http://www.ncbi.nlm.nih.gov/pubmed/10715294/
Brainstem Glioma Cooperative Group
http://www.ncbi.nlm.nih.gov/m/pubmed/10715294/
J Clin Oncol 18, 1246-1253
http://m.jco.ascopubs.org/content/18/6/1246.long
� � � � � � � � � � � � � � � � �
[33]
� � � � � � � � � � � � � � � � �
http://clincancerres.aacrjournals.org/content/11/19/6767.full
� � � � � � � � � � � � � � � � �
[34] 12/2000
� � � � � � � � � � � � � � � � �
Temozolomide and ANAPLASTIC ASTROCYTOMA:

new indication
http://www.ncbi.nlm.nih.gov/pubmed/11475493/
Prescrire Int. 2000 Dec;9(50):170-1.
http://www.ncbi.nlm.nih.gov/m/pubmed/11475493/
� � � � � � � � � � � � � � � � �
[35] 2002
� � � � � � � � � � � � � � � � �
A novel strategy for remission induction and maintenance in cancer therapy
A10 and AS2-1
H Tsuda
http://www.ncbi.nlm.nih.gov/pubmed/11748457
Oncol Rep 2002;9:65–8
http://www.ncbi.nlm.nih.gov/m/pubmed/11748457
Oncol. Rep. 2002;9:65-68
http://www.spandidos-publications.com/or/9/1/65
Oncol Rep 9(1):65-8 (2002)
Oncology Reports, Spandidos Publications
Department of Anesthesiology, Kurume University, School of Medicine, Fukuoka-ken, Japan
� � � � � � � � � � � � � � � � �
[36] 2004
� � � � � � � � � � � � � � � � �
Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:

two challenges for the pediatric oncologist
http://www.ncbi.nlm.nih.gov/pubmed/15047924/
Oncologist. 2004;9(2):197-206.
http://www.ncbi.nlm.nih.gov/m/pubmed/15047924/
Oncologist 9, 197-206
http://m.theoncologist.alphamedpress.org/content/9/2/197.long
Division of Neuro-Oncology, Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
1/1/2005 (11/24/2004) – Role of temozolomide after radiotherapy for newly diagnosed diffuse BRAINSTEM GLIOMA in children:

results of a multiinstitutional study (SJHG-98)
http://www.ncbi.nlm.nih.gov/pubmed/15565574
Cancer. 2005 Jan 1;103(1):133-9.
http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
Cancer 103, 133-139
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/abstract;jsessionid=6717837591CCC8FCBD8E46163808E221.d03t01
Cancer
Volume 103, Issue 1, pages 133–139, 1 January 2005
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
Article first published online: 24 NOV 2004
References:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/references
Cited By:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/citedby
DOI: 10.1002/cncr.20741
Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
——————————————————————
Cancer 103, 133-139
� � � � � � � � � � � � � � � � �
[37] 2/2008 (Article first published online: 2/2/2007)
� � � � � � � � � � � � � � � � �
Treatment of children with diffuse intrinsic BRAIN STEM GLIOMA with radiotherapy, vincristine and oral VP-16:

a Children’s Oncology Group phase II study
http://www.ncbi.nlm.nih.gov/pubmed/17278121
Pediatr Blood Cancer. 2008 Feb;50(2):227-30
http://www.ncbi.nlm.nih.gov/m/pubmed/17278121
University of Rochester Medical Center, Rochester, New York, USA
http://onlinelibrary.wiley.com/doi/10.1002/pbc.21154/abstract;jsessionid=DE7A67EFBAC1A184F6805F11CFC4F30B.d02t02
Article first published online: 2 FEB 2007
DOI: 10.1002/pbc.21154
� � � � � � � � � � � � � � � � �
[38] 5/6/2009
� � � � � � � � � � � � � � � � �
U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with GLIOBLASTOMA (brain cancer) with progressive disease following prior therapy
——————————————————————
effectiveness of Avastin in AGGRESSIVE form of BRAIN CANCER based on improvement in objective response rate
——————————————————————
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-combination-paclitaxel-chemotherapy-first-line-advanced-852.html
According to FDA analysis of study
——————————————————————
Study AVF3708g
——————————————————————
Study NCI 06-C-0064E
——————————————————————
Efficacy of Avastin in GLIOBLASTOMA that progressed following prior therapy supported by another study that used same response assessment criteria as AVF3708g
——————————————————————
http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab
——————————————————————
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html
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[39] 10/12/2011 (Published online: 8/1/2011)
� � � � � � � � � � � � � � � � �
Everolimus tablets for patients with subependymal giant cell ASTROCYTOMA
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3389821/
Expert Opin Pharmacother. Author manuscript; available in PMC 2012 July 5.
Published in final edited form as:
Expert Opin Pharmacother. 2011 October; 12(14): 2265–2269.
Published online 2011 August 1. doi: 10.1517/14656566.2011.601742
PMCID: PMC3389821
NIHMSID: NIHMS385824
——————————————————————
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm231967.htm
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Is Dr. David H. “Orac” Gorski Down and Out in Detroit and an Ethically Bankrupt Researcher ?

After Gorski’s “research” of Burzynski’s phase I (1) clinical trials:

Critiquing: How Stanislaw Burzynski became Burzynski the Brave Maverick Doctor, part 1:
https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-how-stanislaw-burzynski-became-burzynski-the-brave-maverick-doctor-part-1/
he asserts:

“For one thing, in 1976 Burzynski had no animal data to speak of”

“In fact, the question of animal studies is an interesting one”

“Both Elias and Jaffe recount a story in which ANPs didn’t work in animal tumors, and Burzynski has been quoted in multiple places as claiming that ANPs are species-specific and that ANPs derived from human blood and urine don’t work in animal tumor models”

“This is in contrast to what Null reports in his near-contemporaneous account, in which he stated that in tissue culture and animal models Burzynski’s ANPs worked “specifically against certain types of cancer,” all with “no toxic side effects”

“It makes one wonder whether the “species specificity” was an excuse developed later to explain the lack of animal data”
� � � � � � � � � � � � � � � � �
National Cancer Institute (NCI) at the National Institutes of Health (NIH)

Laboratory/Animal/Preclinical Studies:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page4
“Burzynski states that antineoplaston A is species-specific because it had no therapeutic effect when the human preparation was tested on animal tumor systems”

“Although this finding limits the usefulness of animal model testing, the developer has suggested that a “marked” therapeutic effect was produced in a xenograft bearing human tumor tissue.[1]”

“This claim is made only for antineoplaston A”

“Other formulations of antineoplastons have not been tested in animal models”

Gorski should REALLY read his own blog:
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons/
Comment #158 – Didymus Judas Thomas

At the Tu-Quack Center Educate Orac Oracle Phase I

February 4, 2013

.11/15/1982.- 2 Toronto physicians, Martin E. Blackstein, Head of the Division of Oncology at Mount Sinai Hospital & Daniel E. Bergsagel, Chief of Medicine at Princess Margaret Hospital, visited the Burzynski clinic & research institute
.
Both were powerful & respected physicians in the Canadian cancer establishment
.
They returned with a blistering, critical report
.
The essence of their critique was
.
(1) there was little evidence that antineoplastons had significant antitumor activity against human or animal cancers;
.
(2) SRB’s argument that antineoplastons were species-specific created a line of argument for avoiding standard animal & tissue culture screens & required testing in humans
.
SRB cooperated but was dubious
.
There were several test-tube & preventative models in which the drug had showed effectiveness, but the standard NCI pre-screen, P388 mouse leukemia, was not 1 of them. …
.
As he had predicted, these compounds were not effective against mouse leukemia
.
SRB reasonably suggested that NCI try the Antineoplastons in cell-culture assays that were similar to “human solid tumors, especially adenocarcinoma of the breast” …
.
SRB was hardly alone in voicing doubts about the P388 mouse model
.
1983 – Ironically, it was Dr. John Vendetti himself, chief of the NCI’s Drug Evaluation Branch, who coauthored an article in which he argued the limitations of this very mouse system
.
Scientists at NCI had found, for instance, that of 79 drugs which had previously been judged negative in the P388, 14 showed “significant activity” when retested in cell culture assays [1] [2]

Comment #163 – Didymus Judas Thomas

February 4, 2013

Orac’s blog hates links reformatting (www removed)
.
[1] http://www.commonweal.org/pubs/choices/21.html
[2] 9 Moss, The Cancer Ind., 14, 299-300
(Ralph Moss, The Cancer Industry)
�
27. Burzynski SR, Hendry LB, Mohabbat MO, et al. Purification of structure determination, synthesis and animal toxicity studies of antineoplaston A10. In: Proceedings of the 13th International Congress of Chemotherapy. Vienna, Austria; 1983:17, PS. 12.4 11-4.
�
34. Burzynski SR, Mohabbat MO, Burzynski B. Animal toxicology studies on oral formulation of antineoplaston A10. Drug Exptl Clin Res. 1984;10:113-118.
�
40. Ashraf AQ, Liau MC, Kampalath BN, et al. Pharmacokinetic study of radioactive antineoplaston A10 following oral administration in rats. Drugs Exptl Clin Res. 1987;13(suppl 1):45-50.
http://www.ncbi.nlm.nih.gov/pubmed/3569015/
�
http://www.ncbi.nlm.nih.gov/m/pubmed/3569015/
43. Ashraf AQ, Kampalath BN, Burzynski SR. Pharmacokinetic analysis of antineoplaston A10 injections following intravenous administration in rats. Adv Exptl Clin Chemother. 1988;6:33-39.

Burzynski: The Clinical Trials

(Being added to)

clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:
� � � � � � � � � � � � � � � � �
50 – Unknown
7 – Withdrawn
2 – Terminated
1 – Not yet recruiting
1 – Completed
61 – TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Completed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
61 – TOTAL
� � � � � � � � � � � � � � � � �
Below 1 st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
� � � � � � � � � � � � � � � � �
Below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
� � � � � � � � � � � � � � � � �
1 – Completed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
9=WITHDRAWN
1 – Not Yet Recruiting (Open)
10 – Recruiting (Open)
11=OPEN (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
61 – TOTAL
� � � � � � � � � � � � � � � � �
1=COMPLETED
9=WITHDRAWN
11=OPEN
40=CLOSED
61-TOTAL
� � � � � � � � � � � � � � � � �
The “one” COMPLETED trial:

The below 2nd link: 25 Closed-1st screen / 15 Closed-1 COMPLETED-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Phase: Phase II
Type: Treatment
Status: COMPLETED
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066552, BC-ME-2, NCT00003509
http://clinicaltrials.gov/ct2/results?term=&recr=Completed&rslt=&type=&cond=&intr=&titles=&outc=&spons=&lead=Burzynski+&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&phase=1&rcv_s=&rcv_e=&lup_s=&lup_e=
COMPLETED

Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

Condition: Melanoma (Skin)

Interventions:

Drug: antineoplaston A10
Drug: antineoplaston AS2-1

1 study: Melanoma
1 study: Neoplasms, Germ Cell and Embryonal
1 study: Neoplasms, Nerve Tissue
1 study: Neuroectodermal Tumors
1 study: Neuroendocrine Tumors
1 study: Neuroepithelioma
1 study: Nevus
1 study: Nevus, Pigmented

1 study found, shown on map

Region Number of
Name Studies
World 1
North America 1
United States [map] 1 [studies]

Found 1 study with search of:

COMPLETED | Burzynski [Lead] | Phase 2

Recognized Terms and Synonyms:
burzynski: 61 studies
http://clinicaltrials.gov/ct2/show/NCT00003509?recr=Completed&lead=Burzynski&phase=1&rank=1
Trial record 1 of 1 for:

COMPLETED | Burzynski [Lead] | Phase 2

Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

This study has been COMPLETED

Sponsor: Burzynski Research Institute

Information provided by:
National Cancer Institute (NCI)

ClinicalTrials.gov Identifier: NCT00003509

11/1/1999 – First received

5/23/2009 – Last updated

5/2009 – Last verified
http://clinicaltrials.gov/ct2/archive/NCT00003509
Securities and Exchange Commission (SEC) filings “one” COMPLETED trial:

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
Certain prospective protocols which have reached a Milestone as of May 1, 2012

Antineoplaston Therapy in Treating Patients With Stage IV Melanomau
Melanoma (Skin)
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
COMPLETED
Age 18 and over
Protocol IDs
CDR0000066552
BC-ME-2, NCT00003509
http://cancer.gov/clinicaltrials/BC-ME-2
2009_05_26 Study Changes Recruitment status, Recruitment, Misc.
1 clinical_study study_id
2
is_fda_regulated Yes
is_section_801 Yes
delayed_posting No
resp_party name_title Stanislaw R. Burzynski
name_title organization Burzynski Clinic
organization resp_party

Fm: Active, not recruiting
To: COMPLETED

status date
Fm: 2008-04
To: 2009-05

date
Fm: 2008-01
To: 2005-02

last_release_date
Fm: 2008-07-23
To: 2009-05-23
http://clinicaltrials.gov/archive/NCT00003509/2009_05_26/changes
So, we know the “COMPLETED” date is:

2009-05-23 (5/23/2009)

To put this in perspective, the below study done in 2006, was NOT published until about 7 years later, in 2013

2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center
http://www.ncbi.nlm.nih.gov/pubmed/23404230
Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay
http://www.ncbi.nlm.nih.gov/m/pubmed/23404230
Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA

Department of General Internal Medicine, University of Texas MD Anderson Cancer Center

Division of Endocrinology, Mayo Clinic

Support Care Cancer. 2013 Feb 13. [Epub ahead of print]

Supportive Care in Cancer
February 2013

DOI
10.1007/s00520-013-1734-6
http://link.springer.com/article/10.1007%2Fs00520-013-1734-6
� � � � � � � � � � � � � � � � �
Let’s look at “FACTS” which are supported by citation(s), reference(s), and / or link(s)
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting
(OPEN)(Phase 3)
1 – COMPLETED
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
10 – Recruiting
(10=OPEN)
40 – Active, not recruiting –
(40=CLOSED)
61 =TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting + 10 – Recruiting –
(11=OPEN)
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
40 – Active, not recruiting –
(40=CLOSED)
(1=COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting –
(1=OPEN)
10 Active –
(10=OPEN)
(9=WITHDRAWN)
25 CLOSED +15 CLOSED –
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
10 – Recruiting
(OPEN)
1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
(9=WITHDRAWN)
40 – Active, not recruiting
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
11=1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
(9=WITHDRAWN)
(40=CLOSED)
(1= COMPLETED)
61=TOTAL
� � � � � � � � � � � � � � � � �
11 – OPEN (ACTIVE)
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
= 9 WITHDRAWN
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting
(1=OPEN)(Phase 3)
10 – Recruiting
(10=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting + 10 – Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
1 – Not Yet Recruiting –
(1=OPEN)
10 Active –
(10=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
10 – Recruiting
(OPEN)
1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
11=1 Not Yet Recruiting / 10 Recruiting –
(11=OPEN)
11=TOTAL
� � � � � � � � � � � � � � � � �
The below 1st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
� � � � � � � � � � � � � � � � �
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453

2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457

3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458

4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468

5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470

6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473

7. Antineoplaston Therapy in Treating PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475

8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476

9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477

10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
� � � � � � � � � � � � � � � � �
Securities and Exchange Commission (SEC) filings 10 “ACTIVE” (OPEN) trials:

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing
� � � � � � � � � � � � � � � � �
1. AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

2. BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN TUMORS
11 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

3. BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH BRAIN TUMORS
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

4. BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised

5. BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
9/5/97 – Revised

6. BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH MIXED GLIOMA
12 40
7/26/96 – Revised
10/4/96 – Revised
12/9/96 – Revised
4/14/97 – Revised

7. BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
19 40
9/5/95 – Partially Amended, pg.
9/10/96 – Revised
4/14/97 – Revised
8/25/97 – Revised

8. BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
4 40
11/5/97 – Partially Amended, pg.
4/14/97 – Revised
9/10/97 – Revised

9. BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised

10. BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9 40
4/14/97 – Revised
9/15/97 – Revised
� � � � � � � � � � � � � � � � �
1. – 10. (2) CONSOLIDATED:
� � � � � � � � � � � � � � � � �
1. AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453

2. BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN TUMORS
11 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457

3. BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH BRAIN TUMORS
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458

4. BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468

5. BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470

6. BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH
MIXED GLIOMA
12 40
7/26/96 – Revised
10/4/96 – Revised
12/9/96 – Revised
4/14/97 – Revised
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473

7. BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
19 40
9/5/95 – Partially Amended, pg.
9/10/96 – Revised
4/14/97 – Revised
8/25/97 – Revised
7. Antineoplaston Therapy in Treating PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475

8. BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
4 40
11/5/97 – Partially Amended, pg.
4/14/97 – Revised
9/10/97 – Revised
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476

9. BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477

10. BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9 40
4/14/97 – Revised
9/15/97 – Revised
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
� � � � � � � � � � � � � � � � �
Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/
Certain prospective protocols which have reached a Milestone as of May 1, 2012

The results of Protocols

10. BT-08
2. BT-09
3. BT-10
4. BT-13
5. BT-15
6. BT-18
7. BT-21
8. BT-22
9. BT-23

5/1/2012 – set forth below

1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066489
BC-BT-9, NCT00003457
http://cancer.gov/clinicaltrials/BC-BT-9
· Protocol BT-09, involving the study of Antineoplastons A10 and AS2-1 in PATIENTS WITH BRAIN TUMORS
BT-09 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
4 / 14.3% – # and % of Patients Showing Complete Response
5 / 17.9% – # and % of Patients Showing Partial Response
13 / 46.4% – # and % of Patients Showing Stable Disease
6 / 21.4% – # and % of Patients Showing Progressive Disease

3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066490
BC-BT-10, NCT00003458
http://cancer.gov/clinicaltrials/BC-BT-10
· Protocol BT-10, involving the study of Antineoplastons A10 and AS2-1 in CHILDREN WITH BRAIN TUMORS
BT-10 – Protocol #
30 – Patients Accrued
22 – Evaluable Patients
3 / 13.6% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
7 / 31.8% – # and % of Patients Showing Stable Disease
11 / 50.0% – # and % of Patients Showing Progressive Disease

4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066504
BC-BT-13, NCT00003468
http://cancer.gov/clinicaltrials/BC-BT-13
· Protocol BT-13, involving the study of Antineoplastons A10 and AS2-1 in CHILDREN WITH LOW GRADE ASTROCYTOMA, a type of PMBT
BT-13 – Protocol #
17 – Patients Accrued
14 – Evaluable Patients
6 / 42.9% – # and % of Patients Showing Complete Response
1 / 7.1% – # and % of Patients Showing Partial Response
5 / 35.7% – # and % of Patients Showing Stable Disease
2 / 14.3% – # and % of Patients Showing Progressive Disease

5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066507
BC-BT-15, NCT00003470
http://cancer.gov/clinicaltrials/BC-BT-15
· Protocol BT-15, involving the study of Antineoplastons A10 and AS2-1 in adult PATIENTS WITH ANAPLASTIC ASTROCYTOMA, a type of PMBT
BT-15 – Protocol #
27 – Patients Accrued
20 – Evaluable Patients
3 / 15.0% – # and % of Patients Showing Complete Response
2 / 10.0% – # and % of Patients Showing Partial Response
9 / 45.0% – # and % of Patients Showing Stable Disease
6 / 30.0% – # and % of Patients Showing Progressive Disease

6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066510
BC-BT-18, NCT00003473
http://cancer.gov/clinicaltrials/BC-BT-18
Protocol BT-18, involving a study of Antineoplastons A10 and AS2-1 in the treatment of “MIXED GLIOMA,” a type of PMBT
BT-18 – Protocol #
20 – Patients Accrued
13 – Evaluable Patients
3 / 23.1% – # and % of Patients Showing Complete Response
1 / 7.7% – # and % of Patients Showing Partial Response
3 / 23.1% – # and % of Patients Showing Stable Disease
6 / 46.2% – # and % of Patients Showing Progressive Disease

7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066512
BC-BT-21, NCT00003475
http://cancer.gov/clinicaltrials/BC-BT-21
· Protocol BT-21, involving the study of Antineoplastons A10 and AS2-1 in adults with PRIMARY MALIGNANT BRAIN TUMORS
BT-21 – Protocol #
40 – Patients Accrued
23 – Evaluable Patients
2 / 8.7% – # and % of Patients Showing Complete Response
2 / 8.7% – # and % of Patients Showing Partial Response
9 / 39.1% – # and % of Patients Showing Stable Disease
10 / 43.5% – # and % of Patients Showing Progressive Disease

8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066513
BC-BT-22, NCT00003476
http://cancer.gov/clinicaltrials/BC-BT-22
· Protocol BT-22, involving a study of Antineoplastons A10 and AS2-1 in CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
BT-22 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
1 / 4.2% – # and % of Patients Showing Complete Response
3 / 12.5% – # and % of Patients Showing Partial Response
9 / 37.5% – # and % of Patients Showing Stable Disease
11 / 45.8% – # and % of Patients Showing Progressive Disease

9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· Protocol BT-23, involving a study of Antineoplastons A10 and AS2-1 in CHILDREN WITH VISUAL PATHWAY GLIOMA)
BT-23- Protocol #
16 – Patients Accrued
12 – Evaluable Patients
3 / 25% – # and % of Patients Showing Complete Response
2 / 16.7% – # and % of Patients Showing Partial Response
6 / 50.0% – # and % of Patients Showing Stable Disease
1 / 8.3% – # and % of Patients Showing Progressive Disease

10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Recruiting
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066585
BC-BT-8, NCT00003537
http://cancer.gov/clinicaltrials/BC-BT-8
· Protocol BT-08, involving the study of Antineoplastons A10 and AS2-1 in patients with ANAPLASTIC ASTROCYTOMA
BT-08 – Protocol #
19 – Patients Accrued
14- Evaluable Patients
4 / 28.6% – # and % of Patients Showing Complete Response
0 / 0.0% – # and % of Patients Showing Partial Response
6 / 42.9% – # and % of Patients Showing Stable Disease
4 / 28.6% – # and % of Patients Showing Progressive Disease
� � � � � � � � � � � � � � � � �
1. – 10. (3) CONSOLIDATED:
� � � � � � � � � � � � � � � � �
1. AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND
7/20/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months and over
Sponsor: Other
Protocol IDs: CDR0000066485, BC-AD-2, NCT00003453
1. Antineoplaston Therapy in Treating Patients With Stage IV ADRENAL GLAND Cancer
Adrenocortical Carcinoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months and over
Protocol IDs
CDR0000066485
BC-AD-2, NCT00003453
http://cancer.gov/clinicaltrials/BC-AD-2
2. BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN TUMORS
11 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066489, BC-BT-9, NCT00003457
2. Antineoplaston Therapy in Treating PATIENTS WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066489
BC-BT-9, NCT00003457
http://cancer.gov/clinicaltrials/BC-BT-9
· Protocol BT-09, involving the study of Antineoplastons A10 and AS2-1 in PATIENTS WITH BRAIN TUMORS
BT-09 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
4 / 14.3% – # and % of Patients Showing Complete Response
5 / 17.9% – # and % of Patients Showing Partial Response
13 / 46.4% – # and % of Patients Showing Stable Disease
6 / 21.4% – # and % of Patients Showing Progressive Disease

3. BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH BRAIN TUMORS
5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066490, BC-BT-10, NCT00003458
3. Antineoplaston Therapy in Treating CHILDREN WITH BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066490
BC-BT-10, NCT00003458
http://cancer.gov/clinicaltrials/BC-BT-10
· Protocol BT-10, involving the study of Antineoplastons A10 and AS2-1 in CHILDREN WITH BRAIN TUMORS
BT-10 – Protocol #
30 – Patients Accrued
22 – Evaluable Patients
3 / 13.6% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
7 / 31.8% – # and % of Patients Showing Stable Disease
11 / 50.0% – # and % of Patients Showing Progressive Disease

4. BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066504, BC-BT-13, NCT00003468
4. Antineoplaston Therapy in Treating CHILDREN WITH LOW-GRADE ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066504
BC-BT-13, NCT00003468
http://cancer.gov/clinicaltrials/BC-BT-13
· Protocol BT-13, involving the study of Antineoplastons A10 and AS2-1 in CHILDREN WITH LOW GRADE ASTROCYTOMA, a type of PMBT
BT-13 – Protocol #
17 – Patients Accrued
14 – Evaluable Patients
6 / 42.9% – # and % of Patients Showing Complete Response
1 / 7.1% – # and % of Patients Showing Partial Response
5 / 35.7% – # and % of Patients Showing Stable Disease
2 / 14.3% – # and % of Patients Showing Progressive Disease

5. BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066507, BC-BT-15, NCT00003470
5. Antineoplaston Therapy in Treating PATIENTS WITH ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066507
BC-BT-15, NCT00003470
http://cancer.gov/clinicaltrials/BC-BT-15
· Protocol BT-15, involving the study of Antineoplastons A10 and AS2-1 in adult PATIENTS WITH ANAPLASTIC ASTROCYTOMA, a type of PMBT
BT-15 – Protocol #
27 – Patients Accrued
20 – Evaluable Patients
3 / 15.0% – # and % of Patients Showing Complete Response
2 / 10.0% – # and % of Patients Showing Partial Response
9 / 45.0% – # and % of Patients Showing Stable Disease
6 / 30.0% – # and % of Patients Showing Progressive Disease

6. BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH
MIXED GLIOMA
12 40
7/26/96 – Revised
10/4/96 – Revised
12/9/96 – Revised
4/14/97 – Revised
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066510, BC-BT-18, NCT00003473
6. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory MIXED GLIOMAs
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066510
BC-BT-18, NCT00003473
http://cancer.gov/clinicaltrials/BC-BT-18
Protocol BT-18, involving a study of Antineoplastons A10 and AS2-1 in the treatment of “MIXED GLIOMA,” a type of PMBT
BT-18 – Protocol #
20 – Patients Accrued
13 – Evaluable Patients
3 / 23.1% – # and % of Patients Showing Complete Response
1 / 7.7% – # and % of Patients Showing Partial Response
3 / 23.1% – # and % of Patients Showing Stable Disease
6 / 46.2% – # and % of Patients Showing Progressive Disease

7. BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS
19 40
9/5/95 – Partially Amended, pg.
9/10/96 – Revised
4/14/97 – Revised
8/25/97 – Revised
7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066512, BC-BT-21, NCT00003475
7. Antineoplaston Therapy in Treating Patients With PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066512
BC-BT-21, NCT00003475
http://cancer.gov/clinicaltrials/BC-BT-21
· Protocol BT-21, involving the study of Antineoplastons A10 and AS2-1 in adults with PRIMARY MALIGNANT BRAIN TUMORS
BT-21 – Protocol #
40 – Patients Accrued
23 – Evaluable Patients
2 / 8.7% – # and % of Patients Showing Complete Response
2 / 8.7% – # and % of Patients Showing Partial Response
9 / 39.1% – # and % of Patients Showing Stable Disease
10 / 43.5% – # and % of Patients Showing Progressive Disease

8. BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
4 40
11/5/97 – Partially Amended, pg.
4/14/97 – Revised
9/10/97 – Revised
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066513, BC-BT-22, NCT00003476
8. Antineoplaston Therapy in Treating CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066513
BC-BT-22, NCT00003476
http://cancer.gov/clinicaltrials/BC-BT-22
· Protocol BT-22, involving a study of Antineoplastons A10 and AS2-1 in CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS
BT-22 – Protocol #
40 – Patients Accrued
24 – Evaluable Patients
1 / 4.2% – # and % of Patients Showing Complete Response
3 / 12.5% – # and % of Patients Showing Partial Response
9 / 37.5% – # and % of Patients Showing Stable Disease
11 / 45.8% – # and % of Patients Showing Progressive Disease

9. BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 6 months to 17 years
Sponsor: Other
Protocol IDs: CDR0000066514, BC-BT-23, NCT00003477
9. Antineoplaston Therapy in Treating CHILDREN WITH VISUAL PATHWAY GLIOMA
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· Protocol BT-23, involving a study of Antineoplastons A10 and AS2-1 in CHILDREN WITH VISUAL PATHWAY GLIOMA)
BT-23- Protocol #
16 – Patients Accrued
12 – Evaluable Patients
3 / 25% – # and % of Patients Showing Complete Response
2 / 16.7% – # and % of Patients Showing Partial Response
6 / 50.0% – # and % of Patients Showing Stable Disease
1 / 8.3% – # and % of Patients Showing Progressive Disease

10. BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9 40
4/14/97 – Revised
9/15/97 – Revised
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Phase: Phase II
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Other
Protocol IDs: CDR0000066585, BC-BT-8, NCT00003537
10. Antineoplaston Therapy in Treating Patients With Residual or Recurrent ANAPLASTIC ASTROCYTOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Recruiting
Phase II / Phase 2
ACTIVE
Age 18 and over
Protocol IDs
CDR0000066585
BC-BT-8, NCT00003537
http://cancer.gov/clinicaltrials/BC-BT-8
· Protocol BT-08, involving the study of Antineoplastons A10 and AS2-1 in patients with ANAPLASTIC ASTROCYTOMA
BT-08 – Protocol #
19 – Patients Accrued
14- Evaluable Patients
4 / 28.6% – # and % of Patients Showing Complete Response
0 / 0.0% – # and % of Patients Showing Partial Response
6 / 42.9% – # and % of Patients Showing Stable Disease
4 / 28.6% – # and % of Patients Showing Progressive Disease
� � � � � � � � � � � � � � � � �
http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:

16. 2003

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

BT-11

BRAIN STEM GLIOMA

Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:

a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M.
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
6 months – median duration: treatment

12 patients:
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from start of treatment:
5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities observed:
3 – skin allergy
2 – anaemia
2 – fever
2 – hypernatremia
1 – agranulocytosis
1 – hypoglycaemia
1 – numbness
1 – tiredness
1 – myalgia
1 – vomiting

2003 – Protocol – recurrent diffuse intrinsic BRAIN STEM GLIOMA
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease
� � � � � � � � � � � � � � � � �
RECURRENT DIFFUSE INTRINSIC BRAIN STEM GLIOMA

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
10/1997 – clinical trials reached Milestone

Clinical Trial BT-11

trial of Clinical Trial BT-11 involves patients with BRAIN STEM GLIOMA

5/1996 – trial approved by FDA

10/1997 – Protocol – BRAIN STEM GLIOMA
12 – Patients Accrued
12 – Evaluable Patients
1 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
8 / 50% – # and % of Patients Showing Stable Disease or Progressive Disease

BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN STEM GLIOMA
15 40
5/15/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
5/10/97 – Revised
� � � � � � � � � � � � � � � � �
5/1/2012 – prospective protocols which have reached Milestone

results of Protocols:

BT-11

5/1/2012 – set forth below

Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
RECURRENT DIFFUSE INTRINSIC BRAIN STEM GLIOMA

Antineoplaston Therapy in Treating Patients With BRAIN STEM GLIOMA
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months and over
Protocol IDs
CDR0000066491
BC-BT-11, NCT00003459
http://cancer.gov/clinicaltrials/BC-BT-11
· Protocol BT-11, involving the study of Antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA

BT-11 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
5 / 17.9% – # and % of Patients Showing Complete Response
4 / 14.3% – # and % of Patients Showing Partial Response
12 / 42.9% – # and % of Patients Showing Stable Disease
7 / 25.0% – # and % of Patients Showing Progressive Disease
� � � � � � � � � � � � � � � � �
BT-11 (RECURRENT DIFFUSE INTRINSIC) BRAIN STEM GLIOMA (3) CONSOLIDATED:
http://clinicaltrials.gov/show/NCT00003459
8/1998 – Study Start Date
� � � � � � � � � � � � � � � � �
BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH BRAIN STEM GLIOMA
15 40
5/15/96 – Revised
7/11/96 – Revised
9/28/96 – Revised
5/10/97 – Revised

10/1997 – Protocol BT-11 – BRAIN STEM GLIOMA
12 – Patients Accrued
12 – Evaluable Patients
1 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
8 / 50% – # and % of Patients Showing Stable Disease or Progressive Disease

2003 – Protocol – recurrent diffuse intrinsic BRAIN STEM GLIOMA
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

5/1/2012 – Protocol BT-11
Antineoplaston Therapy in Treating Patients With BRAIN STEM GLIOMA
Brain and Central Nervous System Tumors
http://cancer.gov/clinicaltrials/BC-BT-11
· Protocol BT-11 patients with BRAINSTEM GLIOMA
BT-11 – Protocol #
40 – Patients Accrued
28 – Evaluable Patients
5 / 17.9% – # and % of Patients Showing Complete Response
4 / 14.3% – # and % of Patients Showing Partial Response
12 / 42.9% – # and % of Patients Showing Stable Disease
7 / 25.0% – # and % of Patients Showing Progressive Disease
http://clinicaltrials.gov/archive/NCT00003459/2007_10_17/changes
10/17/2007 – Updated
1 clinical_study status
2
Fm: No longer recruiting
To: Active, not recruiting
� � � � � � � � � � � � � � � � �

Scientific Publications
(former web-site screenshots)
http://www.circare.org/info/bri/burzynski_fdauntitled_promo_2012.pdf

http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:

2003 – NEURO-ONCOLOGY

2003 – Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive multicentric glioma

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
Neuro-Oncology. 2003; 5: 358

2004 – NEURO-ONCOLOGY

Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V.

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent glioblastoma multiforme
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
Neuro-Oncology. 2004; 6: 384

2004 – NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
Neuro-Oncology. 2004; 6: 386

2004 – NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf
Neuro-Oncology. 2004; 6: 427

2004 – NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.

Treatment of primitive neuroectodermal tumors (PNET) with antineoplastons A10 and AS2-1 (ANP)

Preliminary results of phase II studies
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf
Neuro-Oncology. 2004; 6: 428

2004 – DRUGS IN R&D

Burzynski, S.R., Weaver, R., Lewy, R., Janicki, T. Jurida, G., Szymkowski, B., Khan, M., Bestak, M.

Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma

A Preliminary Report
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf
Drugs R&D 2004;5(6):315-326

2004 – INTEGRATIVE CANCER THERAPIES

Review Articles on Clinical Trials:

Burzynski, S.R.

The Present State of Antineoplaston Research
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
Integrative Cancer Therapies 2004;3:47-58

2004 – INTEGRATIVE CANCER THERAPIES

Burzynski, S.R., Lewy, R.I., Weaver, R., Janicki, T., Jurida, G., Khan, M., Larisma, C.B., Paszkowiak, J., Szymkowski, B.

Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf
Integrative Cancer Therapies 2004;3:257-261

2004 – DRUGS IN R&D
Drugs in R and D (Drugs in Research and Development)

2004 – Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma :

a preliminary report
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs R D. 2004;5(6):315-26
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – median age

6 – pilocytic astrocytoma

4 – low-grade astrocytoma
1 – astrocytoma grade 2

1 – visual pathway glioma: biopsy not performed due to dangerous location

16 months – average duration intravenous ANP therapy

19 months – average duration oral ANP

1 – non-evaluable due to only 4 weeks of ANP: lack of follow-up scans

1 – stable disease discontinued ANP against medical advice: died 4.5 years later

10 – alive and well from 2 to >14 years post-diagnosis

1 – serious toxicity of reversible tinnitus, 1 day’s duration

2004 – Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

CHILDREN WITH INCURABLE RECURRENT AND PROGRESSIVE MULTICENTRIC GLIOMA
6 – pilocytic astrocytoma
4 – low-grade astrocytoma
1 – astrocytoma grade 2
1 – visual pathway glioma: biopsy not performed due to dangerous location
12 – TOTAL

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised

BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY
GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised

5/1/2012 – prospective protocols which have reached Milestone

results of Protocols:

BT-13
BT-23

5/1/2012 – set forth below

Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
CHILDREN WITH INCURABLE RECURRENT AND PROGRESSIVE MULTICENTRIC GLIOMA (3) CONSOLIDATED:
6 – pilocytic astrocytoma
4 – low-grade astrocytoma
1 – astrocytoma grade 2
1 – visual pathway glioma: biopsy not performed due to dangerous location
12 – TOTAL
http://clinicaltrials.gov/show/NCT00003468
5/1996 – Study Start Date

BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH LOW GRADE ASTROCYTOMA
7 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
9/5/97 – Revised
Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066504
BC-BT-13, NCT00003468
http://cancer.gov/clinicaltrials/BC-BT-13
· Protocol BT-13, involving the study of Antineoplastons A10 and AS2-1 in children with low grade astrocytoma, a type of PMBT
BT-13 – Protocol #
17 – Patients Accrued
14 – Evaluable Patients
6 / 42.9% – # and % of Patients Showing Complete Response
1 / 7.1% – # and % of Patients Showing Partial Response
5 / 35.7% – # and % of Patients Showing Stable Disease
2 / 14.3% – # and % of Patients Showing Progressive Disease
http://clinicaltrials.gov/show/NCT00003468
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)
6/9/2009 – Updated
1 clinical_study date
2
Fm: 2008-12
To: 2009-06
3 date last_release_date
4
Fm: 2008-12-23
To: 2009-06-09
5 last_release_date clinical_study
http://clinicaltrials.gov/show/NCT00003477
6/1996 – Study Start Date

BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN CHILDREN WITH VISUAL PATHWAY
GLIOMA
2 40
5/22/96 –
11/18/96 – Revised
4/14/97 – Revised
Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
ACTIVE
Age 6 months to 17 years
Protocol IDs
CDR0000066514
BC-BT-23, NCT00003477
http://cancer.gov/clinicaltrials/BC-BT-23
(· Protocol BT-23, involving a study of Antineoplastons A10 and AS2-1 in children with visual pathway glioma)
BT-23- Protocol #
16 – Patients Accrued
12 – Evaluable Patients
3 / 25% – # and % of Patients Showing Complete Response
2 / 16.7% – # and % of Patients Showing Partial Response
6 / 50.0% – # and % of Patients Showing Stable Disease
1 / 8.3% – # and % of Patients Showing Progressive Disease
http://clinicaltrials.gov/show/NCT00003477
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)
http://clinicaltrials.gov/archive/NCT00003477/2009_06_09/changes
6/9/2009 – Updated
1 clinical_study date
2
Fm: 2008-12
To: 2009-06
3 date last_release_date
4
Fm: 2008-12-23
To: 2009-06-09
5 last_release_date clinical_study
� � � � � � � � � � � � � � � � �
2005 – INTEGRATIVE CANCER THERAPIES

Burzynski, S.R., Weaver, R.A., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.

Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with Antineoplastons A10 and AS2-1
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf
Integrative Cancer Therapies 2005;4(2):168-177

2005 – INTEGRATIVE CANCER THERAPIES

6/2005 – Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Phase II / Phase 2 studies

Primitive neuroectodermal tumors (PNETs)
usually successfully treated with craniospinal radiation and chemotherapy

difficulties with standard treatment can be encountered in:

1. very young children
2. adult patients at high risk of complication from standard treatment
3. patients with recurrent tumors

13 children – recurrent disease or high risk

treated with antineoplastons (ANP)

5 years, 7 months (range, 1-11) – median age

8 – Medulloblastoma
3 – pineoblastoma
2 – other PNET

Previous treatments:

12 – surgery (1 had biopsy only, suboccipital craniotomy)
6 – chemotherapy
6 – radiation therapy
6 – had not received prior chemotherapy or radiation

treatment – intravenous infusions of 2 formulations of ANP, A10 and AS2-1

20 months – administered for average

6 (46%) survived more than 5 years from initiation of ANP

5 – not treated earlier with radiation therapy or chemotherapy

serious side effects:
1 – fever
1 – granulocytopenia
1 – anemia

study ongoing and accruing additional patients

percentage of response is lower than standard treatment of favorable PNET

long-term survival in poor-risk cases and reduced toxicity makes ANP promising for:
1. very young children
2. patients at high risk of complication of standard therapy
3. patients with recurrent tumors

2005 – Protocol – Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors
13 – Patients Accrued
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – # and % of Patients Showing Progressive Disease

LONG-TERM SURVIVAL OF HIGH-RISK PEDIATRIC PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMORS:
8 – Medulloblastoma
3 – pineoblastoma
2 – other
PNET (Primitive neuroectodermal tumors)
13 – TOTAL

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)

5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised

5/1/2012 – prospective protocols which have reached Milestone

results of Protocols:

BT-12

5/1/2012 – set forth below

Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
LONG-TERM SURVIVAL OF HIGH-RISK PEDIATRIC PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMORS:
8 – Medulloblastoma
3 – pineoblastoma
2 – other PNET (Primitive neuroectodermal tumors)
13 – TOTAL
http://clinicaltrials.gov/show/NCT00003460
9/1995 – Study Start Date

BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)

5 40
7/11/96 – Revised
9/28/96 – Revised
4/14/97 – Revised
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
· Protocol BT-12, involving the study of Antineoplastons A10 and AS2-1 in Children With Primitive Neuroectodermal Tumors
http://clinicaltrials.gov/show/NCT00003460
12/2011 – Estimated Primary Completion Date (Final data collection date for primary outcome measure)

7/14/2009 – Updated
1 clinical_study oversight_info
2 regulatory_authority
United States: Federal Government
3 oversight_info status
4
Fm: Recruiting
To: Active, not recruiting
5 status last_release_date
6
Fm: 2009-06-09
To: 2009-07-14
7 last_release_date
8 init_disposition_release_date
9 init_results_release_date clinical_study

Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
· Protocol BT-12, involving the study of Antineoplastons A10 and AS2-1 in children with primitive neuroectodermal tumors (PNET)

BT-12 – Protocol #
13 – Patients Accrued
11 – Evaluable Patients
3 / 27.3% – # and % of Patients Showing Complete Response
1 / 9.1% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease

5/1/2012 – prospective protocols which have reached Milestone

results of Protocols:

BT-12

5/1/2012 – set forth below

Form 10-Q (For the fiscal year ended February 29, 2012)
(as of May 1, 2012) Protocol BT
http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
CLOSED
Age 6 months to 17 years
Protocol IDs
CDR0000066492
BC-BT-12, NCT00003460
http://cancer.gov/clinicaltrials/BC-BT-12
BT-12 – Protocol #
13 – Patients Accrued
11 – Evaluable Patients
3 / 27.3% – # and % of Patients Showing Complete Response
1 / 9.1% – # and % of Patients Showing Partial Response
3 / 27.3% – # and % of Patients Showing Stable Disease
4 / 36.4% – # and % of Patients Showing Progressive Disease
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

Iwaaaa.pdf
Neuro-Oncology. 2006; 8:466

2006 – INTEGRATIVE CANCER THERAPIES

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B.

Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive brainstem glioma
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf
Integrative Cancer Therapies 2006;5(1):40-47

2006 – PEDIATRIC DRUGS

Burzynski, S.R.

Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
Pediatric Drugs 2006;8:167-178

2006 – NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R.A., Szymkowski, B., Janicki, T.J., Khan, M.I., Dolgopolov, V.

Complete response of a diffuse intrinsic brainstem tumor and von Hippel Lindau (VHL) disease to antineoplastons A10 and AS2-1 (ANP):

a case report
http://www.burzynskiclinic.com/images/stories/Publications/2104.pdf
Neuro-Oncology. 2006; 8:439

3/2006 – INTEGRATIVE CANCER THERAPIES

3/2006 – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Brainstem glioma carries worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment even more challenging when inoperable tumor of high-grade pathology (HBSG)

patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival – patient with anaplastic astrocytoma

5+ years – patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem in small group of patients

18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG

14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy

Antineoplastons A10 (A10I) and AS2-1 injections

5 months – median duration

Responses assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography

Antineoplastons tolerated very well:
1 case – grade 4 toxicity (reversible anemia)

2006 – Protocol – high-grade pathology (HBSG)
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

INOPERABLE TUMOR OF HIGH-GRADE PATHOLOGY (HBSG), RECURRENT, AND PROGRESSIVE BRAINSTEM GLIOMA:
4 – glioblastomas (patient with glioblastoma)
14 – anaplastic HBSG (patient with anaplastic astrocytoma)
18 – TOTAL ; evaluable)
14 – diffuse intrinsic tumors
12 – recurrence
(recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem)
6 – did not have radiation therapy or chemotherapy
18 – TOTAL

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 PHASE 2 TRIALS:

INOPERABLE TUMOR OF HIGH-GRADE PATHOLOGY (HBSG), RECURRENT, AND PROGRESSIVE BRAINSTEM GLIOMA:
4 – glioblastomas (patient with glioblastoma)
14 – anaplastic HBSG (patient with anaplastic astrocytoma)
18 – TOTAL ; evaluable)
14 – diffuse intrinsic tumors
12 – recurrence
(recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of brainstem)
6 – did not have radiation therapy or chemotherapy
18 – TOTAL

Wikipedia, your Burzynski BIAS is showing

As I have proven previously, Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia is BIASED, when it comes to the Burzynski Clinic Wikipedia article:
http://en.m.wikipedia.org/wiki/Burzynski_Clinic
WikipediA or WikipediAin’t ?:
https://stanislawrajmundburzynski.wordpress.com/2013/05/16/wikipedia-or-wikipediaint/
Wikipedia, what’s your motivation?:
https://stanislawrajmundburzynski.wordpress.com/2013/05/02/wikipedia-whats-your-motivation/
I show JzG what a “FACT” is: Burzynski: FAQ (Frequently Asked Questions): Clinical Trial Results:
https://stanislawrajmundburzynski.wordpress.com/2013/05/14/i-show-jzg-what-a-fact-is-burzynski-faq-frequently-asked-questions-clinical-trial-results/
guychapman (Guy Chapman) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9):
https://stanislawrajmundburzynski.wordpress.com/2013/05/05/guychapman-guy-chapman-critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-9/
12/26/2012 I requested that Wikipedia add the below Houston’s KPRC News article re Lola A. Quinlan, to the Burzynski Clinic Wikipedia article, considering that they had previously posted there:
http://en.wikipedia.org/wiki/Burzynski_Clinic
Lawsuits

“In January 2012, Lola Quinlan, an elderly, stage IV cancer patient, sued Dr Burzynski…”

“Please add re WP:NPOV that Burzynski’s attorney, Richard Jaffe has disputed Lola Quinlan’s claims:
“On February 1, 2012, Dr. Burzynski’s attorney, Richard Jaffe, disputed Lola Quinlan’s allegations on Houston’s KPRC News.”
http://m.click2houston.com/news/Houston-cancer-doctor-draws-new-complaints-from-patients/-/16714936/8581480/-/hmrbjk/-/index.html

http://www.jag-lawfirm.com/burzynski-suit-kprc-02012012.html
Thank you very much.” Didymus Judas Thomas 15:03, 26 December 2012
http://en.wikipedia.org/w/index.php?title=Talk:Burzynski_Clinic&diff=prev&oldid=529836971
So, what was Wikipedia’s NON-BIASED rational wiki reasoning for NOT including this Houston, Texas, news article reference?

Dear Didymus Judas Thomas,

The Wikipedia page Talk:Burzynski Clinic has been changed on
December 26, 2012 by Arthur Rubin

See
http://en.wikipedia.org/w/index.php?title=Talk:Burzynski_Clinic&diff=next&oldid=529836971
to view this change.

Editor’s summary: /* Law Suits */ So?

Contact the editor:
mail: http://en.wikipedia.org/wiki/Special:EmailUser/Arthur_Rubin
wiki: http://en.wikipedia.org/wiki/User:Arthur_Rubin
Arthur Rubin advised:

“:So? [OR] Disputing it in the media probably means he doesn’t have a case. [/OR] In any case, a lawyer disputing the allegations against his client is not even news.” — Arthur Rubin 15:24, 26 December 2012

I had the impression that Arthur Rubin had not even bothered to read the article in question, and replied:

“::Arthur Rubin, I’m not sure what relevance your above post has re WP:NPOV since the article includes statements from attorneys representing both sides.”. 17:51, 27 December 2012 Didymus Judas Thomas 12/27/2012

Arthur Rubin’s, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ response?

SILENCE

Well, you know the saying:

Silence IS Golden

(Wikipedia: Neutral Point of View)

WP:NPOV clearly indicates:
“Editing from a neutral point of view (NPOV) means representing FAIRLY, PROPORTIONATELY, and as far as possible WITHOUT BIAS, ALL significant views that have been published by reliable sources.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“ALL Wikipedia articles and other encyclopedic content MUST be written from a neutral point of view.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“NPOV is a fundamental principle of Wikipedia and of other Wikimedia projects.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“This policy is NONNEGOTIABLE and ALL editors and articles MUST follow it.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“The principles upon which this policy is based CANNOT be superseded by OTHER POLICIES or GUIDELINES, or by editors’ consensus.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

(Words CAPITALIZED for emphasis only.).

“1 Explanation of the neutral point of view.”

“This page in a nutshell:”

“Articles mustn’t take sides, but should explain the sides, fairly and without bias.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“This applies to both what you say and how you say it.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“Editors, while naturally having their own points of view, should strive in good faith to provide complete information, and not to promote one particular point of view over another.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“As such, the neutral point of view does not mean exclusion of certain points of view, but including all notable and verifiable points of view.”.

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

[[WP:NPOV]] “History of NPOV:” (Content # 6). “The relative prominence of each viewpoint among Wikipedia editors or the general public is not relevant and should not be considered.”

(Wikipedia: Simplified Ruleset)

[[WP:SR]] “Wikipedia does not have its own views, or determine what is “correct.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“Instead, editors try to summarize what good sources have said about ideas and information.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“Differing views are presented objectively and without bias as they are reported in reliable sources—sources that have a reputation for being accurate.”

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

“Good sources are the base of the encyclopedia, and anyone must be able to realistically check whether contributions can be backed up by one.”.

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

[[WP:NPOVFAQ]]

(Wikipedia: Neutral Point of View Frequently Asked Questions)

Wikipedia:Neutral point of view/FAQ
http://en.m.wikipedia.org/wiki/Wikipedia:Neutral_point_of_view/FAQ
[[WP:NPOVFAQ]]

See also Wikipedia:WikiProject Countering systemic bias.
http://en.m.wikipedia.org/wiki/Wikipedia:WikiProject_Countering_systemic_bias
[[WP:CSB]]

Did Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’ do this?

Is Wikipedia’s Burzynski BIAS showing?

YOU decide, because in my opinion it IS, since this piece of “Yellow Journalism” is referenced in the Burzynski Clinic Wikipedia article:

2010 film, Burzynski – Cancer is Serious Business

“Prior to the debut of “Burzynski”, Houston Press correspondent Craig Malisow mocked the film’s lack of objectivity, characterizing it as “a puff-piece paean that cherrypicks facts and ignores any criticism”, and criticized the project for presenting only Burzynski’s side of the story.” [60]
60^ Malisow, Craig (2010-06-02). “Stanlislaw Burzynski: New Movie Proves He’s A Cancer-Fighting Giant – Houston News – Hair Balls”. Blogs.houstonpress.com. Retrieved 2011-11-25.

Jun 2, 2010 – Houston’s Stanislaw Burzynski, who sells a so-called cancer …

(Hair Balls hasn’t seen the movie, but nowhere in the … )

So, in a nutshell, Wikipedia will reference “Yellow Journalism” by a “Hack” who posts an article about a movie he has NOT even seen, but will NOT reference a news article which is posted on Lola A. Quinlan’s attorney’s web-site, which contains comments from her attorney, as well as Dr. Stanislaw R. Burzynski’s attorney

Wikipedia, your BIAS is showing

“The U.S. v. Article’~ court stated that the FDA’s responsibility was to protect the ultimate consumer, which included protection of “the ignorant, the unthinking and the credulous.”‘

“the ignorant

the unthinking and

the credulous.”‘

Arthur Rubin, and Jimmy (call me “Jimbo”) Donal Wales’ Wikipedia whiners’, which are you?

Critiquing “All truth comes from public debate”: A corollary to crank magnetism

http://t.co/vh3cgAR6hW

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
The difference between Randy Hinton and I:

RH: Forbes (#Forbes) and Facebook
bloodsucker’s
child killer’s
COG’s
crap
GOBLIN’S
maggot’s
medical mafia
medical mafia internet propaganda minister’s
oral sex
pharmawhores
propaganda
smear
undermind

Me: Forbes
Dr.
Mr.

“Orac:”-“One also can’t help but note a similarity here between DJT and Mr. Hinton, but what that means I will leave to each individual reader to decide for him or herself”

Me:-Any questions?

The differences between Dr. David H. Gorski (also known as: Orac, @oracknows, @gorskon, @ScienceBasedMed, #sciencebasedmedicine,
http://www.scienceblogs.com/Insolence, http://www.sciencebasedmedicine.org) and I:
DHG:
anthropogenic global warming
anthropogenic global warming denialism
anti-GMO hysteria
antivaccine propagandist
antivaccinationism
antivaccinationist
antivaccinationists
ban hammers
banning
crank
cranks
crankery
crank magnetism
crank playbook
creationism
creationists
criticize
criticism
cynically
delusion
Gish gallop
HIV-AIDS denialist
Holocaust denial denialists go birther
“human shields”
kook
kooks
propagandist
pseudoscience
purveyors of “alternative medicine”
quackery
quacking
ramblings
stalked off
troll
troll’s
trolling
obnoxious troll
9/11 Truthers

Me:
I do NOT have 3 Twitter accounts like Dr. Gorski; who sometimes uses them to twit the same jargon, which is then sometimes retwitted by lemming “sheeple”

Any questions ?

“Orac:”-“… challenging my blog bud Peter Lipson (a.k.a. PalMD, who wrote a very good post about how Eric Merola …”

THIS “very good post” ?

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 1)
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-1/
Any questions ?

“Orac:“-Didymus did it in a mere month or two

Me:-1st post: #59 – Didymus Judas Thomas – The United States of America – November 28, 2012
http://scienceblogs.com/insolence/2012/11/26/significance-of-the-tmb-dismissal-case-against-burzynski/
Last post: #197 – Didymus Judas Thomas – At the Tu-Quack Center Selective Memory Maze – February 12, 2013
http://scienceblogs.com/insolence/2013/02/08/will-the-fda-finally-slap-down-stanislaw-burzynski-for-good/
I confess, in the past I have accused “Orac” of being “fact-challenged”

“Orac:”--“cowardice.”

IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics | Didymus Judas Thomas’ Hipocritical Oath Blog
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
#73 – Didymus Judas Thomas – At the Tu-Quack Center Oracles of Deny to Respond tree – January 30, 2013
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-of-how-dubious-stanislaw-burzynskis-activities-are
Me:-Any questions ?

“Orac”-“In any case, DJT quickly stalked off to WordPress to form his own blog, where he continued his ramblings in much the same way that he did in the comments of this blog…”

I confess, my “ramblings” consist of direct “quotes” and “facts” from the United States Supreme Court, Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), National Cancer Institute (NCI) at the National Institutes of Health (NIH), etc., and I understand that “Orac” considers that kind of information to be “ramblings,” and has difficulty comprehending them because of:

“Orac:”-“…my fragile eggshell mind…”

Me:-Any questions ?
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
“Orac’s” blogsplat:-PRICELESS

Me:-Any questions ?

4/19/2013 @ 9:43PM
Peter Lipson: “Speech is best countered by more speech”

Burzynski: What happens when a clinical trial is over?

National Cancer Institute (NCI) at the National Institutes of Health (NIH), Cancer Clinical Trials, 15. What happens when a clinical trial is over?,” advises:
“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”
” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … ”
http://m.cancer.gov/topics/factsheets/clinical-trials
This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”