My review of C0nc0rdance

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Orac (David H. Gorski) blogged:

(although we do have C0nc0rdance)
http://www.sciencebasedmedicine.org/index.php/three-myths-about-stanislaw-burzynski-and-the-skeptics

as if C0nc0rdance is a reliable source

1/24/2013 – C0nc0rdance posted a video on YouTube

The Burzynski Clinic

“Feel free to pass this on to anyone considering their options in alternative cancer treatments at the Burzynski Clinic

It’s also CCMA, so feel free to mirror or repost

AUTHOR’S NOTE:

I caught an error in post-production:

The Burzynski Clinic has only started 61 clinical trials, not 62

The last came up in my query because one of the authors has the same name

Otherwise the figures are correct”

“Fact 1:

The Burzynski Clinic has attempted 61 clinical trials, but only completed 1

Check it out here:”
http://www.clinicaltrials.gov/ct2/results?term=Burzynski&Search=Search

“Fact 2:

The Burzynski Clinic charges
its patients to participate in a study of their patented medication that exposes them to risk”
http://scienceblogs.com/insolence/2010/05/05/harnessing-peoples-good-to-pay-for-woo

“Fact 3:

The Burzynski Clinic makes heavy use of marketing techniques not normally associated with clinical practices and not in the best spirit of research medicine

For example, you can see here that they are abusing libel laws to silence critics”
http://www.guardian.co.uk/commentisfree/cifamerica/2011/nov/30/burzynski-clinic-cancer-libel-laws

“And threatening and bullying of a 17 year old blogger by a media consultant:”
http://rhysmorgan.co/burzynski-morally-reprehensible

1:10-I want to present the case of Dr. Stanislaw Burzynski in my home state of Texas

1:30-cancer researcher

Maybe you should consider sticking to cancer research

1:32_3 red flags

Hearing this raised a “red flag” that your claims might be suspect

1:57_3 undisputed facts

And this proved it

2:00-Fact 1 clinical trials

The “FACT” one should know is that 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:

61 TOTAL
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)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)
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951

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

On clinicaltrials . gov, if you select one of the “Unknowns,” it displays:

“Verified ____, ____ by National Cancer Institute (NCI)”

“Information provided by:
National Cancer Institute (NCI)”

“Further study details as provided by National Cancer Institute (NCI):”

Contact: Stanislaw R. Burzynski, MD, PhD

Investigators
Study Chair: Stanislaw R. Burzynski, MD, PhD

2:33-Every clinical trial has to register before starting

FALSE: I contacted the National Cancer Institute (NCI) at the National Institutes of Health (NIH) and was advised:

Not every cancer clinical trial taking place in the United States is listed on our NCI clinical trials database

The investigators must apply and follow guidelines to be included

4:08-Fact 2 – The Burzynski Clinic charges patients to receive clinical trial medications

FALSE: Burzynski does NOT charge for antineoplastons

By comparison:

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

Tax-Exempt
Receives Federal Grants / Funds
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=b7e79bb8a0cf5110VgnVCM1000001e0215acRCRD&cpsextcurrchannel=1

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

FORBES: CEO – $742,718
http://www.forbes.com/fdc/welcome_mjx.shtml

Burzynski does NOT receive Federal Grants / Funds, is NOT Tax-Exempt, and you can NOT write off a contribution as a tax deduction on your Tax Return

6:32-Burzynski movie
doesn’t examine the issue from both sides

FACT: None of the oncologists who originally diagnosed each patient presented in this film would agree to go on-camera, or submit a written statement
1:44:44 – 1:44:52
(http://www.burzynskimovie.com)

6:41-Conspiracy

FACT: See these 2 links:

Click to access BurzynskiTriesToExposeNCI.pdf

http://stanislawrajmundburzynski.wiki-site.com/index.php/Main_Page

Fact 3: it is referred to as “Beating a Dead Horse” when a point that is moot, is be labored by critics

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13 thoughts on “My review of C0nc0rdance”

  1. This is a useless response. You address “fact 1” by pointing to a website which simply states that the status of most of the trials is unknown. That is a useless designation that does nothing to disprove the fact that of the 61 studies you have conducted, only 1 has ever reported results. Do you deny this fact? Do you have an explanation for it?

    You try to deflect the question by linking to another website, reporting the same information (cancer.gov). But as it says on that very site:

    Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials.

    The only advantage to going to the cancer.gov site you recommend over the clinicaltrials.gov site is that the former doesn’t list completed trials.

    Then you say that not all studies have been registered. That doesn’t help your case. If you have concluded trials and not registered them, please show us where we can access their peer-reviewed results.

    You justify your outrageously high costs (typically many tens of thousands of dollars) to participate in clinical trials by pointing out that some other research institutes receive money from federal and private grants, tax exemption, and private donations. Again, this does not help your case. Clearly, such a source of funding is far preferable to the way Burzynski trials are funded, by the participants. Additionally, your inability to get grants for an allegedly life-saving cancer cure is indicative of flawed methodology or just a lack of efficacy.

    Furthermore, most drug trials are largely funded by the companies intended to sell the drugs. If you intend to profit off an approved drug, you should be willing to make an investment or get other investors for real science. But instead you are profiting off the trials themselves, which have been recruiting endlessly and never report results. It shouldn’t even be legal.

    Your evidence of a scientific conspiracy against your work is not evidence at all. It consists of a letter written by Burzynski and a disorganized list of links showing various NCI agreements spanning more than three decades. Your definitions of “advanced cancer” were not in accordance with standard definitions, and when the NCI tried to correct this, you painted it as persecution. You obliquely reference tumors shrinking by more than 50%, but show no evidence that any performed better than control. And you make wild claims about what the NCI’s (accurate) report on your seven best cases is “calculated to make the reader think,” rather than respond to the actual facts it determined.

    But what disgusts me the most is your response to Fact 3. You do not deny that your clinic attempted to bully numerous critics into silence by abusing libel laws. To my knowledge, you have never recognized or apologized for this reprehensible and repeat activity which is antithetical to the scientific method. You even attempted to silence C0nc0rdnace when he made this video, filing a DMCA complaint on illegitimate grounds (and potentially committing a felony in the process), removing his video, and quibbling over a single low-res image that qualifies as fair use. Will you make no attempt to justify or apologize for this behavior, or will you just sweep it under the rug?

    Reply ↓

    • Michael has replied to your comment on Burzynski, skepticism, false DMCAs and the Streisand effect – mirrored for C0nc0rdance

      I made a nice reply to your “review”.

      I’m sure it will be approved soon, right?

      It sure will, because unlike Dr. Peter A. Lipson and / or his Censor(s), Dr. David A. Gorski, Adam Jacobs, Kier Liddle, _Josephine Jones, etc., I do NOT censor, because I actually believe in “Free Speech”

      “This is a useless response”

      REALLY ?

      “You address “fact 1″ by pointing to a website which simply states that the status of most of the trials is unknown”

      SERIOUSLY ?

      My review of C0nc0rdance | Didymus Judas Thomas’ Hipocritical Oath Blog
      https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-c0nc0rdance
      Let’s review together, shall we?

      (c0nc0rdance video)

      2:00-Fact 1 clinical trials

      The “FACT” one should know is that 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:

      61 TOTAL
      1 – Not Yet Recruiting (Open)(Phase 3)
      1 – Closed
      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)

      (I added this in “parenthesis”)
      The below 1 st link: 10 Active (Open):
      http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
      (I added this in “parenthesis”)
      The below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
      http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
      NONE of the above are “UNKNOWN” per the above 2 National Cancer Institute (NCI) at the National Institutes of Health (NIH) links

      10 – Recruiting (Open)
      11 – Open (1 Not Yet Recruiting / 10 Recruiting)
      40 – Active, not recruiting (Closed)

      10=Open
      11=1 Not Yet Recruiting / 10 Recruiting
      40=Closed
      61-TOTAL

      “That is a useless designation that does nothing to disprove the fact that of the 61 studies you have conducted, only 1 has ever reported results”

      “I” have NOT conducted ANY studies because “I” am NOT Burzynski; a fact you would known if you had “researched” it

      Ever heard the saying:

      “When you ASSume, you make an ASS out of you and me?

      “Do you deny this fact?”

      Yes, do you deny this fact?

      “Do you have an explanation for it?”

      An explanation for what?

      The above information I provided previously is still correct:

      The above 1 st link: 10 Active (Open):
      The above 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen

      “You try to deflect the question by linking to another website, reporting the same information (cancer.gov). But as it says on that very site:”

      “Information about this trial is from the ClinicalTrials.gov database.”

      “The versions designated for health professionals and patients contain the same text.”

      “Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts.”

      “Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials.”

      “The only advantage to going to the cancer.gov site you recommend over the clinicaltrials.gov site is that the former doesn’t list completed trials.”

      WHATEVER !!

      And you are a “researcher” ?

      “Then you say that not all studies have been registered.”

      SURE ?

      FALSE: I contacted the National Cancer Institute (NCI) at the National Institutes of Health (NIH) and was advised:

      Not every cancer clinical trial taking place in the United States is listed on our NCI clinical trials database

      “That doesn’t help your case.”

      That does NOT hurt my case

      ” If you have concluded trials and not registered them, please show us where we can access their peer-reviewed results.”

      Would you like to see what I have posted on my blog?

      This link reflects:

      11/25/1997 – Filing Date: FORM 10-SB

      11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing

      And it lists the 72 clinical trials

      Burzynski Clinical Trials (The SEC filings) | Didymus Judas Thomas’ Hipocritical Oath Blog
      https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
      “You justify your outrageously high costs (typically many tens of thousands of dollars) to participate in clinical trials by pointing out that some other research institutes receive money from federal and private grants, tax exemption, and private donations.”

      Well, NO I do NOT, because I am NOT “You”

      “Again, this does not help your case. Clearly, such a source of funding is far preferable to the way Burzynski trials are funded, by the participants.”

      What evidence do you have that Burzynski has or has NOT attempted to:

      “receive money from federal and private grants, tax exemption, and private donations.”?

      “Additionally, your inability to get grants for an allegedly life-saving cancer cure is indicative of flawed methodology or just a lack of efficacy.”

      NOPE, NOT “your”

      What evidence do you have that Burzynski has or has NOT attempted:

      “to get grants for an allegedly life-saving cancer cure”?

      “Furthermore, most drug trials are largely funded by the companies intended to sell the drugs.”

      And how big are those “companies” as far as net worth?

      “If you intend to profit off an approved drug, you should be willing to make an investment or get other investors for real science.

      What evidence do you have that Burzynski has or has NOT attempted

      “to make an investment or get other investors for real science.?”

      Have you read his Securities and Exchange Commission filings like I have?

      “But instead you are profiting off the trials themselves, which have been recruiting endlessly and never report results. It shouldn’t even be legal.”

      NO, “you” is NOT profiting

      Have you read his Securities and Exchange Commission filings like I have?

      Burzynski (The SEC filings) | Didymus Judas Thomas’ Hipocritical Oath Blog
      https://stanislawrajmundburzynski.wordpress.com/2013/04/16/burzynski-the-sec-filings

      “Your evidence of a scientific conspiracy against your work is not evidence at all.”

      “It consists of a letter written by Burzynski and a disorganized list of links showing various NCI agreements spanning more than three decades.”

      (c0nc0rdance video)

      6:41-Conspiracy

      POSITIVE ?

      Let’s review the links I provided, shall we?

      FACT: See these 2 links:

      Click to access BurzynskiTriesToExposeNCI.pdf

      http://stanislawrajmundburzynski.wiki-site.com/index.php/Main_Page
      10/2/1991
      11/2/1993
      3/1/1994
      3/23/1994
      4/19/1994
      1/31/1995
      4/3/1995
      8/23/1995
      9/19/1995
      10/5/1995
      10/25/1995
      10/27/1995

      10/2/1991-10/27/1995 is NOT

      “spanning more than three decades.”

      “Your definitions of “advanced cancer” were not in accordance with standard definitions, and when the NCI tried to correct this, you painted it as persecution.”

      Nada, “Your”

      You will need to do better than this with what Americans consider appropriate “citation(s),” “reference(s), and / or “link(s)”

      “You obliquely reference tumors shrinking by more than 50%, but show no evidence that any performed better than control.”

      Zip, NOT “You”

      See above

      “And you make wild claims about what the NCI’s (accurate) report on your seven best cases is “calculated to make the reader think,” rather than respond to the actual facts it determined.”

      No, “you” did NOT “make wild claims,” since I am NOT “you”

      See above

      “But what disgusts me the most is your response to Fact 3.”

      “You do not deny that your clinic attempted to bully numerous critics into silence by abusing libel laws.”

      Nice try, but NOT “your clinic”

      Take it up with the person responsible

      “To my knowledge, you have never recognized or apologized for this reprehensible and repeat activity which is antithetical to the scientific method.”

      And “I” will NOT, since I ain’t (that’s a “Texas” word) “you”

      “You even attempted to silence C0nc0rdnace when he made this video, filing a DMCA complaint on illegitimate grounds (and potentially committing a felony in the process), removing his video, and quibbling over a single low-res image that qualifies as fair use.”

      So, now I am Eric Merola ?

      Try again, buckaroo

      “Will you make no attempt to justify or apologize for this behavior, or will you just sweep it under the rug?”

      Will you make no attempt to justify or apologize for this behavior, or will you just sweep it under the rug?

      Michael has replied to your comment on The Burzynski Clinic

      “It may not charge for the “antineoplastons”, but it charges for genetic “testing” that does absolutely nothing.

      (c0nc0rdance video)

      4:08-Fact 2 – The Burzynski Clinic charges patients to receive clinical trial medications

      FALSE: Burzynski does NOT charge for antineoplastons

      PROVE IT

      “Do you dispute that people who want to participate in your trials must raise en”
      http://m.youtube.com/#/inbox?feature=em-comment_reply_received&desktop_uri=%2Finbox%3Ffeature%3Dem-comment_reply_received
      WOT ?

      I refer you to the statement I made in my “review” in re me being “Burzynski” or “Merola:”

      Fact 3: it is referred to as “Beating a Dead Horse” when a point that is moot, is be labored by critics

      Reply ↓

      • The “FACT” one should know is that 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:

        And yet the site itself claims the information is the same. The difference, as I stated, is that the NCI site only lists open trials.

        You have not addressed my question. You say you dispute that only one study out of the 61 has reported results. You seem to agree that the 61 total is correct, so it seems you are claiming that more than one has reported results. In fact, I was giving you the benefit of the doubt here. Upon closer inspection, none of the 61 trials have been published; however, one was concluded. Many more are still active or have been withdrawn. This is a pitiful number.

        Please do not repeat those same statistics again. Simply conducting a study and labeling it as perpetually “active” (but closed) is not a result. Please provide a source showing any published studies.

        “I” have NOT conducted ANY studies because “I” am NOT Burzynski; a fact you would known if you had “researched” it

        As far as I can tell, I have no way of knowing this. You don’t sign your name anywhere, blog under a pseudonym, and have a blank “About” page. Since the blog’s name is “stanislawrajmundburzynski,” I’m sure you will forgive my confusion.

        I wouldn’t think this was a big deal, except you seem to use my incorrect pronoun as an excuse to disregard large portions of my text. I’m sorry I confused you with someone else, but that has no bearing on the truth of my arguments. And to be clear, I did not think you were Dr. Burzynski himself. When I referred to “you,” I mean “you” in the general sense of your company. If you are not affiliated, then again, that’s just a mistake.

        This link reflects:

        11/25/1997 – Filing Date: FORM 10-SB

        11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing

        And it lists the 72 clinical trials

        Those are not results. Those are ongoing studies. I am asking for results of concluded studies. I don’t know why these are difficult to procure.

        As I understand it, Dr. Burzynski has been performing trials for nearly forty years, and has never published results demonstrating the efficacy of his treatment in a peer-reviewed journal. If I am mistaken, please direct me to the publication. Please stop listing registration for studies as if that were a result.

        What evidence do you have that Burzynski has or has NOT attempted to:

        “receive money from federal and private grants, tax exemption, and private donations.”?

        I do not suggest that he has not applied for grants, and I am sure he has accepted donations. However, it appears he has not received grant money. As I said, being unable to procure grants is evidence of an ineffective or unproven treatment, not evidence of persecution. Furthermore, he cannot have tax-exempt status, because his clinics turn a profit.

        What evidence do you have that Burzynski has or has NOT attempted

        “to make an investment or get other investors for real science.?”

        Have you read his Securities and Exchange Commission filings like I have?

        Again, it feels like you are deliberately misreading me. I never suggested he had not made these attempts. I do not care what he has “tried” to do. The fact is he has not done so. As I have said, passing the cost on to his patients is not an acceptable alternative. It seems he has turned to both private and public sources and not received support for his unproven treatments, so instead he draws the support from the most vulnerable.

        FALSE: Burzynski does NOT charge for antineoplastons

        According to the ACS, “Antineoplastons are given by mouth, injection into a vein or muscle, and by other routes. The treatment usually lasts from 8 – 12 months. Treatment can cost from $7,000 to $9,500 per month or more . . . .”

        Here is a reprint of parts of a page curiously removed from the internet, telling the story of one patient whose Burzynski trial drugs cost in excess of $4k a month each.

        Either way, the point is moot. In order to enroll in these studies, you must receive your cancer treatment from the Burzynski Clinic, and that clinic charges around $7500 a month for chemotherapy for a typical patient.

        I would like to note that you failed to respond in any substantive fashion to the claims that:
        1. There are no peer-reviewed results of Dr. Burzynski’s many trials.
        2. At least 61 trials have been registered.
        3. The evidence you presented for a conspiracy against Dr. Burzynski’s work is nothing of the sort.
        3a. Specifically that Dr. Burzynski used inappropriate definitions for “advanced cancer.”
        4. Eric Merola has on a number of occasions abused libel and copyright law to suppress criticism online.

      • “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.”‘

        Right now I am one of the “credulous”

        Please let me know if you fit into one of the above categories

        So, “Orac” requested that I comment on the video:

        #6 – Didymus Judas Thomas – At the Tu-Quack Center IMAX 3-D Video Viewing Velodrome – January 28, 2013

        …and then (ahem) “C0nc0rdance” commented:

        #49 – c0nc0rdance – January 29, 2013
        @Orac
        “Many, many thanks for sharing my video.)…”
        http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-of-how-dubious-stanislaw-burzynskis-activities-are/
        “And yet the site itself claims the information is the same.”

        “The difference, as I stated, is that the NCI site only lists open trials.”

        And this is why I am “credulous”

        Would you like the opportunity to again read my previous reply to you and select the 2nd link I provided?

        Because this type of situation sort of reminds me of “Orac,” Guy Chapman, Boris Ogon, Wikipedia, etc., in that they use this tactic of posting a lot, instead of dealing with one issue at a time

        They should really learn to deal with one issue at a time instead of trying the “scattergun” approach, unless a consensus is made by all parties to “agree to disagree”

        “…the NCI site only lists open trials.”

        Did you select the 2nd link I provided and view the trials which were NOT open?

  2. What is your point? I am quoting the website directly. If you think their words are in error, take it up with them.

    They say they only list sites that are actively recruiting. The Burzynski Clinic is actively recruiting, so maybe they include all their trials, including the ones that have now closed. Or maybe they include all active trials (whether or not they are still recruiting), and just not those that have been concluded or withdrawn.

    Either way, there is nothing to be gained by going to cancer.gov over clinicialtrials.gov.

    And either way, this is a microscopic issue, irrelevant to the main point of your blog or C0nc0rdance’s video. Why do you keep distracting from the main points, like those I listed at the bottom of my post?

    Reply ↓

      • I have followed all the links you have provided.

        Are you going to address the questions, or just pretend they don’t exist?

      • Michael on April 29, 2013 at 2:07 pm “I have followed all the links you have provided.” “Are you going to address the questions, or just pretend they don’t exist?” Michael, now that I have dealt with the issue of Forbes censoring (deleting) comments, and the BIAS of their article, and “Orac” and “The Skeptic” “Oracolytes,” I now have time to address your comments, again “Michael on April 28, 2013 at 7:54 pm” “What is your point?” My point is that I covered this in detail in my original review article: My review of C0nc0rdance: https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-c0nc0rdance “I am quoting the website directly.” And “I am quoting the website directly:” On clinicaltrials . gov, if you select one of the “Unknowns,” it displays: “Verified ____, ____ by National Cancer Institute (NCI)” “Information provided by: National Cancer Institute (NCI)” “Further study details as provided by National Cancer Institute (NCI):” “If you think their words are in error, take it up with them.” And my reply is: “If you think their words are in error, take it up with them.” “They say they only list sites that are actively recruiting.” And you said: “Michael on April 29, 2013 at 2:07 pm” “I have followed all the links you have provided.” So, I take it that you found out that the info. I provided is correct “The Burzynski Clinic is actively recruiting, so maybe they include all their trials, including the ones that have now closed.” “Or maybe they include all active trials (whether or not they are still recruiting), and just not those that have been concluded or withdrawn.” “Either way, there is nothing to be gained by going to cancer.gov over clinicialtrials.gov.” “And either way, this is a microscopic issue, irrelevant to the main point of your blog or C0nc0rdance’s video.” “Why do you keep distracting from the main points, like those I listed at the bottom of my post?” It’s not distraction when you kept distracting from the main points, like those I listed throughout my post Michael on April 28, 2013 at 2:10 am The “FACT” one should know is that 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: “And yet the site itself claims the information is the same.” “The difference, as I stated, is that the NCI site only lists open trials.” “You have not addressed my question.” “You say you dispute that only one study out of the 61 has reported results.” Is THAT really what I said I “dispute”? “You seem to agree that the 61 total is correct, so it seems you are claiming that more than one has reported results.” Is THAT really what I am “claiming”? “In fact, I was giving you the benefit of the doubt here.” “Upon closer inspection, none of the 61 trials have been published; however, one was concluded.” Amazingly, as many times as “Orac” and “The Skeptic” “Oracolytes” mention this “one” concluded (or “completed”) trial, they seem to be unable to cite the date it was “completed” From the previous links I provided, this one lists 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 From the Securities and Exchange Commission (SEC) filings we can find this “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 2 Phase II COMPLETED Age 18 and over Protocol IDs CDR0000066552 BC-ME-2, NCT00003509 http://cancer.gov/clinicaltrials/BC-ME-2 COMPLETED Antineoplaston Therapy in Treating Patients With Stage IV Melanoma Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information Basic Trial Information Phase Phase II Type Treatment Status Completed Age 18 and over Sponsor Other Protocol IDs CDR0000066552 BC-ME-2, NCT00003509 Trial Description Summary RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory Antineoplastons may inhibit the growth of cancer cells PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with progressive or recurrent stage IV melanoma Further Study Information OBJECTIVES: Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with progressive or recurrent stage IV melanoma Describe response, tolerance to, and side effects of this regimen in these patients OUTLINE: This is an open label study Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached Treatment continues for at least 3 months in the absence of toxicity and disease progression Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR Tumors are measured every 2 months for the first year and every 3 months for the second year PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study Eligibility Criteria DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma that is recurrent or progressing and unlikely to respond to existing therapy Measurable disease by MRI or CT scan Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times the upper limit of normal No hepatic insufficiency Renal: Creatinine no greater than 2.5 mg/dL No renal insufficiency No renal conditions that contraindicate high dosages of sodium Cardiovascular: No chronic heart failure No uncontrolled hypertension No history of congestive heart failure No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No severe lung disease, such as chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study No serious medical or psychiatric disorders No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks) Surgery: Recovered from prior surgery Other: Prior cytodifferentiating agent allowed No prior antineoplaston therapy Trial Contact Information Trial Lead Organizations/Sponsors Burzynski Clinic Stanislaw R. Burzynski Study Chair Link to the current ClinicalTrials.gov record NLM Identifer NCT00003509 Information obtained from ClinicalTrials.gov on November 20, 2012 Note: Information about this trial is from the ClinicalTrials.gov database The versions designated for health professionals and patients contain the same text Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials Questions and comments regarding the presented information should be directed to ClinicalTrials.gov A search of ClinicalTrials . gov displays: 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 First received: November 1, 1999 Last updated: May 23, 2009 Last verified: May 2009 http://clinicaltrials.gov/ct2/archive/NCT00003509 History of Changes Purpose: Detailed Description: Criteria Contacts and Locations Locations: United States, Texas Burzynski Clinic Houston, Texas, United States Trial Contact Information Trial Lead Organizations/Sponsors Burzynski Clinic Stanislaw R. Burzynski Study Chair Link to the current ClinicalTrials.gov record NLM Identifer NCT00003509 Information obtained from ClinicalTrials.gov on November 20, 2012 Note: Information about this trial is from the ClinicalTrials.gov database The versions designated for health professionals and patients contain the same text Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials Questions and comments regarding the presented information should be directed to ClinicalTrials.gov Condition Melanoma (Skin) Intervention Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Phase: Phase 2 Study Type: Interventional Study Design: Masking: Open Label Primary Purpose: Treatment Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma Resource links provided by NLM: MedlinePlus related topics: Cancer Melanoma U.S. FDA Resources Further study details as provided by National Cancer Institute (NCI): Primary Outcome Measures: Response rate based on tumor measurements at 12 weeks [ Designated as safety issue: No ] Secondary Outcome Measures: Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ] Estimated Enrollment: 40 Study Start Date: March 1996 Primary Completion Date: February 2005 (Final data collection date for primary outcome measure) Detailed Description: OBJECTIVES: Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with progressive or recurrent stage IV melanoma Describe response, tolerance to, and side effects of this regimen in these patients OUTLINE: This is an open label study Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached Treatment continues for at least 3 months in the absence of toxicity and disease progression Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR Tumors are measured every 2 months for the first year and every 3 months for the second year PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma that is recurrent or progressing and unlikely to respond to existing therapy Measurable disease by MRI or CT scan Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times the upper limit of normal No hepatic insufficiency Renal: Creatinine no greater than 2.5 mg/dL No renal insufficiency No renal conditions that contraindicate high dosages of sodium Cardiovascular: No chronic heart failure No uncontrolled hypertension No history of congestive heart failure No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No severe lung disease, such as chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study No serious medical or psychiatric disorders No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks) Surgery: Recovered from prior surgery Other: Prior cytodifferentiating agent allowed No prior antineoplaston therapy Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00003509 Locations: United States, Texas Burzynski Clinic Houston, Texas, United States Sponsors and Collaborators: Burzynski Research Institute Investigators: Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute More Information Additional Information: Clinical trial summary from the National Cancer Institute’s PDQ® database No publications provided Responsible Party: Stanislaw R. Burzynski, Burzynski Clinic ClinicalTrials.gov Identifier: NCT00003509 History of Changes Other Study ID Numbers: CDR0000066552, BC-ME-2 Study First Received: November 1, 1999 Health Authority: United States: Federal Government Keywords provided by National Cancer Institute (NCI): stage IV melanoma recurrent melanoma Additional relevant MeSH terms: Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas ClinicalTrials.gov processed this record on May 06, 2013 Antineoplaston Therapy in Treating Patients With Stage IV Melanoma This study has been completed Sponsors: Burzynski Research Institute Information provided by: National Cancer Institute (NCI) ClinicalTrials.gov Identifier: NCT00003509 History of Changes PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with progressive or recurrent stage IV melanoma Condition Intervention Phase Melanoma (Skin) Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Phase 2 Study Type: Interventional Study Design: Masking: Open Label Primary Purpose: Treatment Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma Resource links provided by NLM: MedlinePlus related topics: Cancer Melanoma U.S. FDA Resources History of Changes and the ClinicalTrials.gov Archive Site Information in a ClinicalTrials.gov record can be modified at any time by the data provider The display at ClinicalTrials.gov shows the most recent version for each data element The date first received and the date last updated are listed at the top of each record The full history of changes since the record was first received is available in the archival version of the record on the ClinicalTrials.gov Archive Site Current Study: ClinicalTrials.gov Identifier: NCT00003509 Study Title: Antineoplaston Therapy in Treating Patients With Stage IV Melanoma First Received: November 1, 1999 Continue to the history of changes for this study on the ClinicalTrials.gov Archive Site http://clinicaltrials.gov/archive/NCT00003509 History of NCT00003509 Brief title: Antineoplaston Therapy in Treating Patients With Stage IV Melanoma Record State: RELEASED Updated View Type of info changed 2005_06_23 Study Nothing (earliest version on record) 2005_06_30 Study Changes Misc. 1 clinical_study see_also 2 initial_release_date 1999-11-01 last_release_date 2005-06-23 3 clinical_study http://clinicaltrials.gov/archive/NCT00003509/2005_06_30/changes 2005_07_25 Study Changes Protocol 1 clinical_study textblock 2 Fm: Antineoplaston Therapy in Treating Patients With Stage IV Melanoma To: Antineoplaston Therapy in Treating Patients with Stage IV Melanoma 3 textblock. clinical_study http://clinicaltrials.gov/archive/NCT00003509/2005_07_25/changes 2005_08_01 Study Changes Protocol 1 clinical_study textblock 2 Fm: Antineoplaston Therapy in Treating Patients with Stage IV Melanoma To: Antineoplaston Therapy in Treating Patients With Stage IV Melanoma 3 textblock clinical_study http://clinicaltrials.gov/archive/NCT00003509/2005_08_01/changes 2005_09_09 Study Changes Administrative, Misc. 1 clinical_study secondary_id 2 Deleted: secondary_id. NCT00003509 3 nct_id last_release_date 4 Fm: 2005-06-23 To: 2005-09-08 5 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2005_09_09/changes 2005_12_08 Study Changes Protocol 1 clinical_study textblock 2 Fm: Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Stage IV Melanoma To: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Melanoma 3 textblock clinical_study http://clinicaltrials.gov/archive/NCT00003509/2005_12_08/changes 2006_03_30 Study Changes Protocol, Misc. 1 clinical_study primary_name 2 Fm: biological response modifier therapy To: biological therapy Fm: 2005-09-08 To: 2006-03-29 3 primary_name last_release_date 4 Fm: 2005-09-08 To: 2006-03-29 5 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2006_03_30/changes 2006_05_23 Study Changes Recruitment, Misc. 1 clinical_study date 2 Fm: 1998-12 To: 2006-04 3 date last_release_date 4 Fm: 2006-03-29 To: 2006-05-23 5 last_release_date. clinical_study http://clinicaltrials.gov/archive/NCT00003509/2006_05_23/changes 2006_06_07 Study Changes Misc. 1 clinical_study last_release_date 2 Fm: 2006-05-23 To: 2006-06-07 3 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2006_06_07/changes 2006_09_29 Study Changes Recruitment, Misc. 1 clinical_study date 2 Fm: 2006-04 To: 2006-09 3 date last_release_date 4 Fm: 2006-06-07 To: 2006-09-29 5 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2006_09_29/changes 2006_11_08 Study Changes Protocol, Recruitment, Misc. 1 clinical_study textblock 2 Fm: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Melanoma To: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma 3 textblock oversight_info 4 regulatory_authority United States: Federal Government 5 oversight_info date 6 Fm: 2006-09 To: 2006-10 7 date design 8 condition Stage IV Melanoma 9 design Open Label primary_outcome Response rate based on tumor measurements at 12 weeks secondary_outcome Survival at 1, 2, and 5 years from the start of treatment 10 condition 11 Recurrent Melanoma Melanoma (Skin) 12 condition expected_enrollment 13 40 14 expected_enrollment maximum_age 15 N/A 16 maximum_age see_also 17 keyword stage IV melanoma keyword recurrent melanoma 18 initial_release_date last_release_date 19 Fm: 2006-09-29 To: 2006-11-08 20 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2006_11_08/changes 2007_01_11 Study Changes Misc. 1 clinical_study oversight_info 2 Added: regulatory_authority United States: Federal Government 3 oversight_info last_release_date 4 Fm: 2006-11-08 To: 2007-01-11 5 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_01_11/changes 2007_01_16 Study Changes Protocol, Misc. 1 clinical_study oversight_info 2 Deleted: regulatory_authority United States: Federal Government 3 oversight_info primary_name 4 Fm: biological therapy To: biological therapy 5 primary_name last_release_date 6 Fm: 2007-01-11 To: 2007-01-16 7 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_01_16/changes 2007_02_20 Study Changes Protocol, Recruitment, Misc. 1 clinical_study OBJECTIVES: 2 Fm: – Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with progressive or recurrent stage IV melanoma. – Describe response, tolerance to, and side effects of this regimen in these patients. To: * Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with progressive or recurrent stage IV melanoma. * Describe response, tolerance to, and side effects of this regimen in these patients. 3 Fm: DISEASE CHARACTERISTICS: To: DISEASE CHARACTERISTICS: 4 Fm: – Histologically confirmed stage IV melanoma that is recurrent or progressing and unlikely to respond to existing therapy – Measurable disease by MRI or CT scan To: * Histologically confirmed stage IV melanoma that is recurrent or progressing and unlikely to respond to existing therapy * Measurable disease by MRI or CT scan 5 Fm: Age: To: Age: 6 Fm: – 18 and over To: * 18 and over 7 Fm: Performance status: To: Performance status: 8 Fm: – Karnofsky 60-100% To: * Karnofsky 60-100% 9 Fm: Life expectancy: To: Life expectancy: 10 Fm: – At least 2 months To: * At least 2 months 11 Fm: Hematopoietic: To: Hematopoietic: 12 Fm: – WBC at least 2,000/mm3 – Platelet count at least 50,000/mm3 To: * WBC at least 2,000/mm3 * Platelet count at least 50,000/mm3 13 Fm: Hepatic: To: Hepatic: 14 Fm: – Bilirubin no greater than 2.5 mg/dL – SGOT and SGPT no greater than 5 times the upper limit of normal – No hepatic insufficiency To: * Bilirubin no greater than 2.5 mg/dL * SGOT and SGPT no greater than 5 times the upper limit of normal * No hepatic insufficiency 15 Fm: Renal: To: Renal: 16 Fm: – Creatinine no greater than 2.5 mg/dL – No renal insufficiency – No renal conditions that contraindicate high dosages of sodium To: * Creatinine no greater than 2.5 mg/dL * No renal insufficiency * No renal conditions that contraindicate high dosages of sodium 17 Fm: Cardiovascular: To: Cardiovascular: 18 Fm: – No chronic heart failure – No uncontrolled hypertension – No history of congestive heart failure – No other cardiovascular conditions that contraindicate high dosages of sodium To: * No chronic heart failure * No uncontrolled hypertension * No history of congestive heart failure * No other cardiovascular conditions that contraindicate high dosages of sodium 19 Fm: Pulmonary: To: Pulmonary: 20 Fm: – No severe lung disease, such as chronic obstructive pulmonary disease To: * No severe lung disease, such as chronic obstructive pulmonary disease 21 Fm: Other: To: Other: 22 Fm: – Not pregnant or nursing – Fertile patients must use effective contraception during and for 4 weeks after study – No serious medical or psychiatric disorders – No active infection To: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study * No serious medical or psychiatric disorders * No active infection 23 Fm: PRIOR CONCURRENT THERAPY: Biologic therapy: To: PRIOR CONCURRENT THERAPY: Biologic therapy: 24 Fm: – At least 4 weeks since prior immunotherapy and recovered – No concurrent immunomodulating agents To: * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunomodulating agents 25 Fm: Chemotherapy: To: Chemotherapy: 26 Fm: – At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered – No concurrent antineoplastic agents To: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent antineoplastic agents 27 Fm: Endocrine therapy: To: Endocrine therapy: 28 Fm: – Concurrent corticosteroids allowed To: * Concurrent corticosteroids allowed 29 Fm: Radiotherapy: To: Radiotherapy: 30 Fm: – At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks) To: * At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks) 31 Fm: Surgery: To: Surgery: 32 Fm: – Recovered from prior surgery To: * Recovered from prior surgery 33 Fm: Other: To: Other: 34 Fm: – Prior cytodifferentiating agent allowed – No prior antineoplaston therapy To: * Prior cytodifferentiating agent allowed * No prior antineoplaston therapy 35 textblock last_release_date 36 Fm: 2007-01-16 To: 2007-02-20 37 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_02_20/changes 2007_06_04 Study Changes Protocol, Recruitment, Misc. 1 clinical_study date 2 Fm: 2006-10 To: 2007-04 3 date last_follow_up_date 4 last_data_entry_date date 5 phase_block primary_outcome 6 measure 7 Fm: Response rate based on tumor measurements at 12 weeks To: Response rate based on tumor measurements at 12 weeks 8 measure time_frame 9 primary_outcome secondary_outcome 10 measure 11 Fm: Survival at 1, 2, and 5 years from the start of treatment To: Survival at 1, 2, and 5 years from the start of treatment 12 measure time_frame 13 secondary_outcome 14 enrollment 40 15 condition healthy_volunteers 16 patients expected_enrollment 40 expected_enrollment 17 gender last_release_date 18 Fm: 2007-02-20 To: 2007-06-04 19 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_06_04/changes 2007_09_20 Study Changes Protocol, Recruitment, Misc. 1 clinical_study date 2 Fm: 2007-04 To: 2007-09 3 date primary_name 4 description textblock 5 intervention primary_name 6 description textblock 7 intervention intervent_type 8 Fm: Procedure To: Procedure/Surgery 9 intervent_type primary_name 10 description textblock 11 intervention intervent_type 12 Fm: Procedure To: Procedure/Surgery 13 intervent_type primary_name 14 description textblock 15 intervention intervent_type 16 Fm: Procedure To: Procedure/Surgery 17 intervent_type primary_name 18 description textblock 19 intervention intervent_type 20 Fm: Procedure To: Procedure/Surgery 21 intervent_type primary_name 22 description textblock 23 intervention intervent_type 24 Fm: Procedure To: Procedure/Surgery 25 intervent_type primary_name 26 description textblock 27 intervention intervent_type 28 Fm: Procedure To: Procedure/Surgery 29 intervent_type primary_name 30 description textblock 31 intervention last_release_date 32 Fm: 2007-06-04 To: 2007-09-20 33 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_09_20/changes 2007_10_17 Study Changes Protocol, Misc. 1 clinical_study primary_name 2 Intervention/procedure Procedure/Surgery 3 alternative product therapy primary_name 4 Fm: cancer prevention intervention To: cancer prevention 5 primary_name intervention 6 Procedure/Surgery preventive intervention 7 eligibility last_release_date 8 Fm: 2007-09-20 To: 2007-10-17 9 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_10_17/changes 2007_10_19 Study Changes Protocol, Misc. 1 clinical_study primary_name 2 Fm: cancer prevention To: complementary or alternative medical procedure 3 primary_name 4 complementary and alternative therapy Procedure/Surgery 5 differentiation therapy intervention 6 Procedure/Surgery preventive intervention 7 eligibility last_release_date 8 Fm: 2007-10-17 To: 2007-10-19 9 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_10_19/changes 2007_10_29 Study Changes Protocol, Misc. 1 clinical_study primary_name 2 Intervention/procedure Procedure/Surgery 3 alternative product therapy primary_name 4 biological therapy Procedure/Surgery biologically based therapies Procedure/Surgery complementary or alternative medical procedure Procedure/Surgery 5 differentiation therapy last_release_date 6 Fm: 2007-10-19 To: 2007-10-25 7 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_10_29/changes 2007_11_06 Study Changes Protocol, Misc. 1 clinical_study primary_name 2 Fm: alternative product therapy To: antineoplastons therapy 3 primary_name last_release_date 4 Fm: 2007-10-25 To: 2007-11-06 5 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_11_06/changes 2007_11_16 Study Changes Recruitment, Misc. 1 clinical_study date 2 1998-08 3 date last_release_date 4 Fm: 2007-11-06 To: 2007-11-16 5 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_11_16/changes 2007_12_26 Study Changes Protocol, Recruitment, Misc. 1 clinical_study date 2 Fm: 1998-08 To: 1996-03 3 date last_follow_up_date 4 primary_compl_date type=”Anticipated” date 2008-01 primary_compl_date 5 phase_block time_frame 6 safety_issue No 7 primary_outcome time_frame 8 safety_issue No 9 secondary_outcome last_release_date 10 Fm: 2007-11-16 To: 2007-12-25 11 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2007_12_26/changes 2008_01_11 Study Changes Recruitment, Misc. 1 clinical_study date 2 Fm: 2007-09 To: 2008-01 3 date last_release_date 4 Fm: 2007-12-25 To: 2008-01-10 5 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2008_01_11/changes 2008_04_09 Study Changes Recruitment, Misc. 1 clinical_study date 2 Fm: 2008-01 To: 2008-04 3 date last_release_date 4 Fm: 2008-01-10 To: 2008-04-09 5 last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2008_04_09/changes 2008_04_18 Study Changes Recruitment status, Misc. 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: 2008-04-09 To: 2008-04-18 7last_release_date clinical_study http://clinicaltrials.gov/archive/NCT00003509/2008_04_18/changes 2008_05_26 Study Changes Protocol, Misc. 1 clinical_study intervention 2 intervention intervent_type Procedure/Surgery intervent_type primary_name antineoplastons therapy primary_name description text block description intervent_type Procedure/Surgery intervent_type primary_name Wa aoaidifferentiation therapy primary_name description textblock. description interventions 3 eligibility last_release_date 4 Fm: 2008-04-18 To: 2008-05-23 5 last_release_date. clinical_study http://clinicaltrials.gov/archive/NCT00003509/2008_05_26/changes 2008_07_23 Study Changes Misc. 1 clinical_study design 2 number_of_arms 1 3 primary_outcome secondary_outcome 4 enrollment 5 enrollment type=”Anticipated” 6 40 last_release_date 7 Fm: 2008-05-23 To: 2008-07-23 8 last_release_date. clinical_study http://clinicaltrials.gov/archive/NCT00003509/2008_07_23/changes 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/m/pubmed/23404230 Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay 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 “Many more are still active or have been withdrawn.” “MANY MORE” ? Let’s NOT take YOUR word for it, since you are BIASED 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 – CLOSED 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 “Many more are still active” So, your definition of “MANY MORE are still ACTIVE” = 11 OPEN (ACTIVE) “or have been withdrawn.” 2 – WITHDRAWN (Withdrawn due to slow enrollment) 7 – WITHDRAWN (This study has been withdrawn prior to enrollment) = 9 WITHDRAWN “This is a pitiful number.” 20 = “a PITIFUL NUMBER” “Please do not repeat those same statistics again.” 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 “Simply conducting a study and labeling it as perpetually “active” (but closed) is not a result.” The below 1 st 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 From the Securities and Exchange Commission (SEC) filings we can find these 10 “MANY MORE are still 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 Click to access 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 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 are set forth below (as of May 1, 2012) 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 “Please provide a source showing any published studies.” Drugs in R and D (Drugs in Research and Development) 2003 – 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 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 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/m/pubmed/15911929 Integr Cancer Ther. 2005 Jun;4(2):168-77 3/2006 – 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 2007 – Recent clinical trials in diffuse intrinsic brainstem glioma Review Article http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html Cancer Therapy Vol 5, 379-390, 2007 Click to access 1252.pdf “I” have NOT conducted ANY studies because “I” am NOT Burzynski; a fact you would known if you had “researched” it “As far as I can tell, I have no way of knowing this.” THAT is why it’s called “research” “You don’t sign your name anywhere, blog under a pseudonym, and have a blank “About” page.” THAT is because some of “The Skeptics” are from irrational island, so I take the @_JosephineJones approach “Since the blog’s name is “stanislawrajmundburzynski,” I’m sure you will forgive my confusion.” THAT is because I wanted to apply the military policy of “K.I.S.S.” (Keep It Simple, Stupid), for “The Skeptics” “I wouldn’t think this was a big deal, except you seem to use my incorrect pronoun as an excuse to disregard large portions of my text.” Your pal “Orac” posted: “I also know that … Didymus Judas Thomas” “(whose identity I’m probably about 75% sure of…” http://scienceblogs.com/insolence/2013/04/19/eric-merola-issuing-bogus-dmca-takedown-notices-against-critics-of-stanislaw-burzynski/ If you really thought Burzynski; a 70 year old, would be engaging you at ridiculous hours, or Merola, or anyone working for either of them… “I’m sorry I confused you with someone else, but that has no bearing on the truth of my arguments.” What “truth” ? “And to be clear, I did not think you were Dr. Burzynski himself.” “When I referred to “you,” I mean “you” in the general sense of your company.” “Your company” Wrong again “If you are not affiliated, then again, that’s just a mistake.” As I commented on Forbes: As former President Ronald Reagan used to say: “Well, there you go again.” Let me make this perfectly clear and unambiguous as I can. 1. I am NOT Dr. Stanislaw R. Burzynski, I have never worked for him, I have never met him. 2. I am NOT AstroTurfWatch. 3. I am NOT Eric Merola, I have never worked for him, I have never met him. 4. I am NOT Randy Hinton, I have never met him, this article is the first place I have seen his name. http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics This link reflects: 11/25/1997 – Filing Date: FORM 10-SB 11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing And it lists the 72 clinical trials “Those are not results.” “Those are ongoing studies.” “I am asking for results of concluded studies.” “I don’t know why these are difficult to procure.” So … you are NOT a researcher? “As I understand it, Dr. Burzynski has been performing trials for nearly forty years, and has never published results demonstrating the efficacy of his treatment in a peer-reviewed journal.” WOW “Dr. Burzynski has been performing trials for nearly forty years…” Where did you come up with THAT doozy? Let’s see what we find here, shall we? Burzynski Clinical Trials (The SEC filings): https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2/ 2/28/2010 Form 10-K for fiscal year ended: http://www.sec.gov/Archives/edgar/data/0000724445/000110465910031825/0001104659-10-031825-index.htm Company began Phase II clinical studies in 1994 with 4 studies “If I am mistaken, please direct me to the publication.” How about THESE publications? “Trial results are not always publicly available, even after a clinical trial ends:” http://www.nlm.nih.gov/services/ctresults.html U.S. National Library of Medicine National Institutes of Health National Cancer Institute (NCI) at the National Institutes of Health (NIH) Cancer Clinical Trials 15. What happens when a clinical trial is over? “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” The Declaration of Helsinki does NOT indicate WHEN the final results of human clinical trials MUST be published: World Medical Association http://www.wma.net/en/30publications/10policies/b3 PDF: Click to access 17c.pdf PDF: Click to access 79(4)373.pdf National Institutes of Health-HISTORY: Click to access helsinki.pdf “Please stop listing registration for studies as if that were a result.” What evidence do you have that Burzynski has or has NOT attempted to: “receive money from federal and private grants, tax exemption, and private donations.”? “I do not suggest that he has not applied for grants, and I am sure he has accepted donations.” “However, it appears he has not received grant money.” “As I said, being unable to procure grants is evidence of an ineffective or unproven treatment, not evidence of persecution.” And your citation(s), reference(s), and / or link(s) which support your statement are? “Furthermore, he cannot have tax-exempt status, because his clinics turn a profit.” He has “clinics,” plural ? Well, at least you seem to differ from “The Skeptics” who keep insisting that the clinical trials turn a profit, as opposed to the non- clinical trial operations: Burzynski (The SEC filings): https://stanislawrajmundburzynski.wordpress.com/2013/04/16/burzynski-the-sec-filings What evidence do you have that Burzynski has or has NOT attempted “to make an investment or get other investors for real science.?” Have you read his Securities and Exchange Commission filings like I have? “Again, it feels like you are deliberately misreading me.” Nope, I read this: “If you intend to profit off an approved drug, you should be willing to make an investment or get other investors for real science.” If you review the Securities and Exchange Commission (SEC) filings you will find BRZY:OTC US stock for Burzynski “I never suggested he had not made these attempts.” “I do not care what he has “tried” to do.” “The fact is he has not done so.” So, you are wrong because BRZY exists “As I have said, passing the cost on to his patients is not an acceptable alternative.” THAT is your opinion, and you are entitled to your opinion, but that’s all it is “It seems he has turned to both private and public sources and not received support for his unproven treatments, so instead he draws the support from the most vulnerable.” Maybe you and “The Skeptics” can help raise the necessary funding FALSE: Burzynski does NOT charge for antineoplastons “According to the ACS, “Antineoplastons are given by mouth, injection into a vein or muscle, and by other routes.” “The treatment usually lasts from 8 – 12 months.” “Treatment can cost from $7,000 to $9,500 per month or more . . . .” “Here is a reprint of parts of a page curiously removed from the internet, telling the story of one patient whose Burzynski trial drugs cost in excess of $4k a month each.” “Either way, the point is moot.” “In order to enroll in these studies, you must receive your cancer treatment from the Burzynski Clinic, and that clinic charges around $7500 a month for chemotherapy for a typical patient.” And for comparison purposes, you can refer to THIS: Burzynski: Costs of Cancer treatments: https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-costs-of-cancer-treatments “I would like to note that you failed to respond in any substantive fashion to the claims that:” “1. There are no peer-reviewed results of Dr. Burzynski’s many trials.” Michael, what relevance does your question have after reading THESE? FAQ: Clinical Trial Results: https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-faq-clinical-trial-results/ What happens when a clinical trial is over?: https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over Declaration of Helsinki: https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki “2. At least 61 trials have been registered.” So ? “3. The evidence you presented for a conspiracy against Dr. Burzynski’s work is nothing of the sort.” I would like to note that you failed to respond in any substantive fashion to the claims that I provided, as evidenced by your response: “Your evidence of a scientific conspiracy against your work is not evidence at all.” “It consists of a letter written by Burzynski and a disorganized list of links showing various NCI agreements spanning more than three decades.” (c0nc0rdance video) 6:41-Conspiracy POSITIVE ? Let’s review the links I provided, shall we? FACT: See these 2 links: Click to access BurzynskiTriesToExposeNCI.pdf http://stanislawrajmundburzynski.wiki-site.com/index.php/Main_Page 10/2/1991 11/2/1993 3/1/1994 3/23/1994 4/19/1994 1/31/1995 4/3/1995 8/23/1995 9/19/1995 10/5/1995 10/25/1995 10/27/1995 10/2/1991-10/27/1995 is NOT “spanning more than three decades.” And now you can add to those: “The Skeptics:” Your problem is, Wikipedia IS censored: https://stanislawrajmundburzynski.wordpress.com/2013/04/14/the-skeptics-your-problem-is-wikipedia-is-censored Wikipedia, what’s your motivation?: https://stanislawrajmundburzynski.wordpress.com/2013/05/02/wikipedia-whats-your-motivation/ Forbes censors Peter Lipson “Speech is best countered by more speech” article comments: https://stanislawrajmundburzynski.wordpress.com/2013/04/23/forbes-censors-peter-lipson-speech-is-best-countered-by-more-speech-article-comments/ Dr. Peter A. Lipson and / or his censor(s) is a coward: Critiquing A Film Producer, A Cancer Doctor, And Their Critics: https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics Forbes Learns a Lesson, but Not the Right One: Censorship and Bias re: A Film Producer, A Cancer Doctor, And Their Critics: https://stanislawrajmundburzynski.wordpress.com/2013/05/05/forbes-learns-a-lesson-but-not-the-right-one-censorship-and-bias-re-a-film-producer-a-cancer-doctor-and-their-critics/ “Orac” and the “Oracolytes” Cult of Misinformation: https://stanislawrajmundburzynski.wordpress.com/2013/04/29/orac-and-the-oracolytes-cult-of-misinformation/ Orac, a lilady, the Oracolytes: “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics: https://stanislawrajmundburzynski.wordpress.com/2013/05/01/orac-a-lilady-the-oracolytes-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics/ 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/ “3a. Specifically that Dr. Burzynski used inappropriate definitions for “advanced cancer.”” I’ve said it before and I’ll say it again: THAT is your opinion, and you are entitled to your opinion, but that’s all it is You will need to do better than this with what Americans consider appropriate “citation(s),” “reference(s), and / or “link(s)” “4. Eric Merola has on a number of occasions abused libel and copyright law to suppress criticism online.” I’ve said it before and I’ll say it again: THAT is your opinion, and you are entitled to your opinion, but that’s all it is until such time as it may be proven in a court of law My review of C0nc0rdance: https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-c0nc0rdance

  3. I will not even attempt to read your 6000+ word rant, which is so poorly formatted that I cannot even distinguish your words from words you are quoting.

    I will however point out for the third time that just because a study is no longer actively recruiting does not mean it produced any results. You can close a trial and then open a new one at no cost. The Burzynski clinic has never published a single in vivo study supporting the effectiveness of antineoplastons to treat anything. You clearly do not have even a basic understanding of this process, and thus continue to repeat inane nonsense.

    This conversation is over. I hope when you turn twelve years old, you will understand why I am so frustrated.

    Reply ↓

    • This is the response one would expect from one of “The Skeptics”
      Your “pal” “Orac” frequently posts epistles of verbosity, and I take the time to read them
      Yet you, a Skeptic, can NOT handle the same thing in return, and seem unable to grasp the concept of why “quotation” marks are put at the beginning and end of certain sentences and words
      Once you’ve grown up and been around half a century, let me know

      Reply ↓

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