Pete Cohen talks with Doug Olson

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My name is Doug Olson
I’m from Nebraska
Western Nebraska
And, uh, my mother has been diagnosed with pancreatic cancer
So, we, uh, middle of November, now this is first of, first of the year, eh, but in the middle of November her weight, she was losing weight, you know
She was suffering from indigestion and, and stomach pain, and so we started to have her checked, uh, for problems with her stomach for ulcers and that kind of thing, and all that proved negative, and they put her on an ulcer medicine anyway, thinking that maybe that would solve the inflammation in her stomach, and, uh, then we decided that we (?) better see another physician, and so we did that, and they then ultra sounded and then CAT scanned and found that she had tumors in her pancreas and in her liver
Uh, many years ago, back in, in the late 70’s, my parents had been involved with, with the cancer, uh, subject in regards to my father’s sister, and then his cousin
He started researching cancer and cancer treatments when his sister passed away, and then, uh, they got in contact with a doctor in Orden, Nebraska, that treated cancer patients with Laetrile, and he also did other, not so ordinary things
He did duculation therapy
Uh, a number of things that were really treatments for the disease rather than just treatments for the symptoms, and, uh, during that time, dad testified at the state legislature; they were trying to work against Dr. Miller’s license
This was the Dr. Miller in Orden, and, uh, so dad testified on, on his behalf
Uh, dad’s cousin was, uh, a patient of his, and she had a brain tumor the size of a lemon, and Dr. Miller put her on, uh, Laetrile treatments on a, on a special diet and some things, uh
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And this was what, in the 70’s ?
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This was back in the, probably the late 70’s, and, so, when they
Well they cured her
She had been sent home from the Mayo Clinic
Given 3 to 6 months to live, and, uh, they had, uh, burned with radiation and cobalt I believe is what they were treating her with at that time
Uh, they burned the, uh, nerves in her eyes so that her eyes crossed
Uh, they sent her home to die
They, uh
She was in a wheelchair
She was a young woman and she had a young child
Wasn’t able to hold that child, and so when my dad saw her, met her, she was in that condition
She was it, in the last 6 months of her life
Gave her a book about, uh, the subject, and told her about Dr. Miller, and her family
She then went to Dr. Miller to see if there was any help for her, and he, and he immediately put her on Laetrile treatment then and, and, uh, the interesting thing about it, looking at his doctor’s protocol; because I’ve come across his protocol, uh, Dr. Miller was also giving his patients antineoplastons, and
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Yeah, because we’ve got this thing here that you gave me
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Mhmm
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Just explain to me what this is
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This was his physician’s protocol, to list, uh, the different medicines a person should, should be on
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If they had cancer
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Uh, if they had cancer, and so, uh, this was given to another friend of ours, a friend of the family, uh, the folks that rented one of our properties, uh, the woman got a, a tumor as well, and this was given to her as part of the regimen she should follow, and she was given Laetrile injections, and then as soon as the injections, uh, were over they went then to pills as the size of the dosage went down, and when you got to pills you got to go home
So, uh, I remember speaking to her at the time
I had a
I was in high school, and I had a summer job with her husband, who was the county engineer
So, uh, we saw them all the time, and she told us, uh, the circumstances when, when she was allowed to come home
She was feeling strong
She said: “I haven’t felt better”
As a part of the diet and the things that, that they had her doing
She said she felt better than she had in many years
So she and her daughter, started a business in town in order to pay for the treatments, and, uh, she recovered
The tumor continued to shrink and shrink until it was nothing
Uh, what had been listed as inoperable, uh, after it shrunk halfway they decided, well maybe we can operate on you
Uh, we think it’s operable now
She said: “Why would I let you operate when what I’m doing is working” ?
But, uh, she is alive yet today and in her mid-80’s and, uh, so, uh, when it came to my mother’s illness, we contacted her, and asked her how she’s doing, and she’s sent this protocol she’s been keeping all these years
Uh, as a result of my parents knowing Dr. Miller back when he was alive
He is, he has passed away, uh, 7 maybe years ago, and, uh, many years ago when they were taking chelation therapy from him, he had given my mother, uh, a flyer on Dr. Burzynski, and, uh, said if anything ever happens to you after I’m gone, this is the man to contact, and so we’ve had that flyer in a file for many years at my parents house, and so when mom got sick she immediately began digging that out and found
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So your mom immediately started thinking, well I need to find that leaflet
That’s what we were told to do
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Yes
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And did, and did she go and speak to an oncologist ?
Did she say that she wanted to come here, or ?
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We had a local physician, who was not an oncologist, that had, that was the 2nd physician we, we consulted, that did the ultrasound and the CAT scan for her and, and they knew that she had tumors, and no we did not go to an on, oncologist from there
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Why ?
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because we knew that we did not want to take their treatments, uh, so we immediately contacted the clinic here in, in Houston, Texas, and, uh, we had to wait on, uh, certain things to be completed
CAT scans
Different things had to be done, and, and information had to be sent down here and examined, and then, uh, after a period of maybe 2 weeks, hassling with information, we were told that, yes, uh, we, they would accept her as a patient, and we were getting in towards the holidays at that time
Would we like to wait until the holidays were over, because Christmas
You know, there would be 5 days off for Christmas, uh, over a weekend and 5 days off for New Years over a weekend, and we would be down here in Houston over those times, but we elected to come anyway because we could get the treatment started right away
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Mhmm
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rather than to wait another month before starting treatments, and, uh, so they, uh, immediately put, put her on antineoplastons and, uh, they sent away the tissue samples to Arizona to have a CARIS test done, and determine what medications would be
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So did you have those results come back ?
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Yes, those results came back quicker than what we expected
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And wh, what did they show ?
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Well they, they show a, a list of treatments that are effective, and against it, and then a list of treatments actually that encourage it’s growth
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Yeah
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So you end up with a list of, uh, approximately 7 on each side
7 good
7 bad
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And these are all different cancer drugs
So what they’re looking at is all
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Yes
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is all the different cancer drugs, and which ones
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And whether we’ve got a, a thousand or 2 thousand different drugs that person might try, and, uh, so
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So the (?) for how to, to try a few of these chemotherapies, but in very small doses
Is that right ?
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There’s 2, 2 chemotherapies
One is an, is an oral chemotherapy that is, uh, quite mild in its side effects, and then, uh, there’s another much stronger one that was, uh, also one of th, the top 2, and, uh, the side effects for it are more varied and more violent, uh, if you will, and, uh, my mother’s had one treatment of that so far, and the treat, the side effects
She did, is suffering from side effects from that particular
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Yeah
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It’s Oxaliplatin, and, uh, some people have very violent side effects but she’s thankfully not had any violent side effects
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So why didn’t you go down the conventional road of having high-dose chemotherapy ?
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Well, when you research the, uh, success rate, with pancreatic cancer, going the normal way, uh, or the normal, uh, road, the success rate is very, very small, and so you’re just guaranteeing, in my opinion, if, if the success rate is 5% or under, uh, you’re introducing yourself to a, a road to death, that’s very unpleasant
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Yeah
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You know, you just want to go home and make yourself very comfortable on painkillers and, and enjoy the rest of your life, uh, if that’s the, if that’s the road you’re planning to take
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Yeah
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Uh, that was our opinion, and so
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What do you think about all the resistance then of, of Dr. Burzynski and all of the kind of, uh, ?
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We have
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(?) people just calling him a
What’s the word ?
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Charlatan
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Charlatan
Yeah
Fraud
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Yes, we, uh, we have seen course, of course these things through our, our life
Dr. Miller
The whole Laetrile treatment thing was something that was, uh, thrown out
You know, it’s pretty well suppressed now
You can go to Mexico and get those treatments
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Why do you think they were, pushed aside ?
This Laetrile
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It’s
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What is Laetrile ?
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Well Laetrile is a naturally occurring, uh, substance that you find in some of our foods
It’s, they call it B17 although, vitamin B17, although there’s some discussion as to whether it’s really a vitamin
Another name for it is Amygdalin
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Amygdalin
Yeah
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Uh, it’s found in peach pits and apricot pits in high levels but there’s a number of other foods that you find it in
Uh, it, it,
I’m not sure, whether this is 100% accurate, but my understanding of it is it’s associated with, with cyanide, and it would be, uh, like an encapsulated cyanide, that as it travels through your body, the cyanide portion, um, does not become available to your body until it becomes in, uh, associated with a cancer cell
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Yeah
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and the cancer cells attack the outer shell of that molecule, and the cyanide becomes, uh, uh, available then, and it kills the cancer cell that’s right there
So it was apparently a very nontoxic substance
Uh, you have regulated dosages
I mean, it seems to me interesting, uh, when a doctor prescribes a dose of chemotherapy, uh, there’s nothing that I can think of much more toxic than a, than a chemotherapy drug, and certainly they’ll kill you if they don’t, uh, give you the right dosage, but it was not seemed, deemed accessible that a byproduct of food; which a doctor could regulate the dosage of as well, could be used as a transfer, cancer treatment
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Yeah
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Uh, and we’ve seen things in the past, as well
When I was a, a very young child, I had a great aunt, that, uh, I was not even aware; at the time I was very young, she was traveling to Texas and getting treatments
Uh, one of them was called the Hoxsey treatment and, uh, she was living a very comfortable life on treatments that she got there
There were 2 treatments in Texas at that time, that, uh, were available
The FDA would come in and raid the clinics, and make just life miserable for them
They got one of them closed down, and that was the one that my great aunt was on, and that treatment was, was pills that she could take, uh, and live quite comfortably, in Nebraska
Once they closed that clinic down, then she had to go down, uh, to the other clinic in Texas, which was a supplement that was a liquid that tasted bad, and she had to make frequent trips, at that point, but still, as long as she could get that treatment she was comfortable and, and lived a normal life
A productive life
Uh, we knew her as our great aunt and, and didn’t even know her, uh, uh, that there was a health problem and, uh, but then the FDA got that clinic closed down
So, as soon as she lost access to those, her treatments, then her cancer which, uh, was no longer able to be controlled, came back strong and, and she died
So, uh, the family had been, had access to this knowledge and this, the FDA’s games with cancer treatments for many years
Um, I’m also married to, a, a gal whose father did blood research as a, he was a Ph.D and worked in university hospitals, in blood research all of his life
He, he discovered a blood protein that was associated with cancer
Uh, it was actually associated more with good health, maybe than you could say with cancer, but he discovered a, a blood coagulation protein, uh, or associated with blood coagulation that would, that could be used as a flag or a test, to see whether a person was healthy or not
Uh, as they applied it to patients in these hospitals, during their research trials, they found that this protein was an indicator whether a person had cancer or thrombosis
Uh, 2 of the very largest killers, and this protein, if present in high enough amounts in our blood, uh, was an indicator that you were healthy, and as the protein’s amount, uh, declined, then it was an indicator that something was wrong, and below a certain amount you knew something was wrong
You better be taking further testing
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Mhmm
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to find out what your problem was
Uh, that has run into resistance
Uh, that (?) has not been approved by the FDA, and, uh, th, our family’s experiences with cancer treatments, cancer drugs, as they’re affected by the FDA, we have determined by our opinion that, uh, it’s, un, unless there’s something that’s going to generate a, a lot of capital, and then a lot of tax money for the Federal Government, the FDA’s not very interested in it
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Yeah
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Uh, so, cynical attitude, but evidence bears it out
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Yeah
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and so we remain cynical until so, until something proves
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Yeah, absolutely
So this is this doctor in, uh, in the 70’s
This is information that he provided
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Yes
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and you can see here that he is obviously, antineoplastic enzymes
See, here obviously
Do you think he meant Dr. Burzynski ?
He just knew of him ?
You have no idea ?
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I have no idea
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He was obviously a fan, if he was someone that eventually said
He said it to you
Did you say he said it to your mum or to your dad?
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To my mom
Probably to mom and dad
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Yeah
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Uh, my mom was the record keeper, and so, she kept the flyer
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Yeah
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but they both took, uh, the, uh, the therapy from, uh, well, the blood therapy
I mentioned it earlier
Suddenly the name’s gone away
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Yeah
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but, uh
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That’s ok
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So
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So what about, um
You know, one of the barriers that we had is, when we spoke to oncologists, they just said, no, you mustn’t come to see this guy
His work isn’t peer-reviewed
He’s a charlatan
Why, why do you think they would say that ?
What
I mean I’m surprised, that these oncologists don’t actually come here, to actually see what, what’s going on
So your opinion about that ?
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My opinion is, that physicians are, very much, tied up, with large pharmaceutical corporations
Uh, I spoke with my father-in-law
My father-in-law had to have research done in, in his Ph.D work, and he had to get cooperation from hospitals, from doctors, and, uh, all of these organizations in order to have the research done that he needed done, ’cause past his lab, when he wants to introduce research, onto a patients, uh, live blood, and he needs to collect specimens from patients, then a whole ‘nother group of, uh, set of authorizations have to be signed and, and he being a Ph.D working with the medical profession all his life, he knew how tied up the medical profession is, by, generally by M.D.’s, that control the money flow, uh, in the medical profession
Ph.D’s do the research, but they have to apply for grants, and typically the grants are controlled by M.D.’s, and so if an M.D. Decides that your, your particular research is either applicable to, uh, something they think will make a lot of money, or it’s the, the quote, uh, popular, popular item of the day
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Yeah
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Politically correct, you name it, then you’re going to get funded
Otherwise, uh, my father-in-law noticed at different times, his research had to be funded out of his own pocket, and at other times, it looked like, it was something that doctors would like, and so they would, he would get funding, but I think that, ah, as he commented, any doctor, coming out of med school, has been contacted by a pharmaceutical company, and has probably signed a contract, that when that pharmaceutical company wants to test a drug, or test an item, that that medical, uh, doctor, will be accessible to them, to test their products
So, with the number of pharmaceutical companies that you have, and all of them recruiting M.D.’s as they come out of med school, and saying, you know, would you be part of our group, you end up under contract with the large pharmaceutical companies
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Mhmm
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and if, if 90% of the doctors are under contract with pharmaceutical companies, to, uh, to cooperate with their drug testing, then large Pharma, has control of virtually all doctors, and so, uh, uh, if you have large Pharma saying, we don’t want to see a cancer cure, that we’re not in control of, we don’t want to see something that makes curing disease cheap, and easy, and food related, then you’re not gonna
They’re going to put the word out to all their doctors: Don’t have any wo, don’t have anything to do with this
Uh, they can come up with, some written material for their, their doctors to read
They send them the evidence
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Mmm
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It may be accurate
It may not be very accurate, and, uh, but it’s just a smear campaign to destroy reputations so that they don’t get hurt financially
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Mhmm
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and, uh, so, uh, that’s the reason I believe
You know, most of these doctors, they don’t have the time, or the expertise to do the research themselves
They can’t read everything, and so when someone they trust, or someone that they’re financially, uh, obligated to, comes down and says: Here’s the stand that we want you to take, and it’s against this particular treatment, or against this doctor, they do what they’re told
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Yeah
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They do what they know best
Uh, my father-in-law, for instance, was, uh, also involved as a professor in these med centers
He taught nutrition, and he said it’s always a, been amazing to me that you can get through med school, and never take a class on, on nutrition
So you can become an M.D., and not understand the value, of nutrition, to a person’s health
That’s a problem
Uh, he recognized it as a problem
I recognize it as a problem because I particularly believe that most of our ill health is because how we treat our bodies
What we eat
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Mhmm
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Whether we exercise or don’t
Whether we provide our body with a way to flush the poisons or not
Uh, healthy living, and if you don’t teach our medical profession, healthy living, how can they teach their patients
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Mhmm
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So this, this whole system is, is just flawed in some ways, and weak in other ways, and, uh, controlled, for the purposes of commerce, instead of the public
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Yeah
So you, you think it’s a good idea treating people as an individual and finding out what they need as opposed to like carpet bombing them ?
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Absolutely
When we understood the, the individualized approach, here at the Burzynski Clinic, that they would take where they would test the cancer cells, uh, against all of these treatments and all of these chemotherapy treatments and, and anything else that might be out there that would, would treat cancer, and come back with a, a individualized care approach to the individualized cells of cancer that my mother has, that’s when we knew that we had to come here
We wondered, and I’ve told my friends, and everybody wonders, that oughta be the standard approach everywhere
Why wouldn’t you test, every cancer, and see what it is that’s gonna treat it best ?
You, you tell me
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Doug Olson chats with Pete Cohen
January 2011
25:00
11/9/2012
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Count de Money: What Are the Costs of Cancer ? (American Cancer Society Cancer Facts & Figures 2002-2013)

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What Are the Costs of Cancer?
——————————————————————
National Institutes of Health (NIH) estimates:
——————————————————————
overall costs of cancer:
——————————————————————
2010 – $263.8 billion (2011)
2010☝$263.8 billion (2010)

2008👇$201.5 billion (2013)
2008☝$228.1 billion (2009)
2007☝$226.8 billion (2012)
2007☝$219.2 billion (2008)

2006👇$206.3 billion (2007)
2005☝$209.9 billion (2006)
2004☝$189.8 billion (2005)
2003☝$189.5 billion (2004)
2002☝$171.6 billion (2003)
2001☝$156.7 billion (2002)

——————————————————————
direct medical costs
(total of all health expenditures)
——————————————————————
2010 – $102.8 billion (2011)
2010☝$102.8 billion (2010)

2008👇$77.4 billion (2013)
2008👇$93.2 billion (2009)
2007☝$103.8 billion (2012)
2007☝$89.0 billion (2008)
2006☝$78.2 billion (2007)
2005☝$74.0 billion (2006)
2004☝$69.4 billion (2005)
2003☝$64.2 billion (2004)
2002☝$60.9 billion (2003)
2001☝$56.4 billion (2002)

——————————————————————
2008-2011 – indirect morbidity costs
(cost of lost productivity due to illness)
——————————————————————
2010 – $20.9 billion (2011)
2010☝$20.9 billion (2010)
2008☝$18.8 billion (2009)
2007☝$18.2 billion (2008)
2006☝$17.9 billion (2007)
2005☝$17.5 billion (2006)
2004☝$16.9 billion (2005)
2003☝$16.3 billion (2004)

2002👇$15.5 billion (2003)
2001☝$15.6 billion (2002)
——————————————————————
indirect mortality costs
(cost of lost productivity due to premature death)
——————————————————————
2010 – $140.1 billion (2011)
2010☝$140.1 billion (2010)
2008☝$124.0 billion (2013)

2008👇$116.1 billion (2009)
2007☝$123.0 billion (2012)
2007☝$112.0 billion (2008)

2006👇$110.2 billion (2007)
2005☝$118.4 billion (2006)
2004👇$103.5 billion (2005)
2003☝$109 billion (2004)
2002☝$95.2 billion (2003)
2001☝$84.7 billion (2002)

——————————————————————
According to US Census Bureau:
——————————————————————
Americans uninsured
2012-2013 had no health insurance coverage
——————————————————————
2010👇approximately 50 million (2013)
2009 – almost 51 million (2012)
2009☝almost 51 million (2011)
2008☝46 million (2010)
——————————————————————
2008 – approximately 28% aged 18 to 34 years (2010)
——————————————————————
2010👇almost one-third of Hispanics (31%) (2013)
2009 – almost one-third of Hispanics (32%) (2012)
2009☝almost one­-third of Hispanics (32%) (2011)
——————————————————————
2011-2012 (17 years of age and younger)
2010-2012had no health insurance coverage
——————————————————————
2010 – one in 10 children (2013)
2009 – one in 10 children (2012)
2009 – one in 10 children (2011)
2008 – 10% of children (2010)
——————————————————————
2012-2013 PLEASE NOTE:

These numbers are not comparable to those published in previous years as of 2011, NIH calculating estimates using different data source:

2012 – NIH is using a different data source:

2012-2013 Medical Expenditure Panel Survey (MEPS) of the Agency for Healthcare Research and Quality

2012-2013 MEPS estimates based on more current, nationally representative data used extensively in scientific publications

2012-2013 direct and indirect costs will no longer be projected to current year, estimates of indirect morbidity costs discontinued

2012-2013 For more information, please visit nhlbi.nih.gov/about/factpdf.htm.
——————————————————————
Lack of health insurance and other barriers prevents many Americans from receiving optimal health care
——————————————————————
2008 – early release estimates from National Health Interview Survey (2009)
2006 – early release estimates from the National Health Interview Survey (2008)
2004National Health Interview Survey data (2007)
2003National Health Interview Survey data (2006)
——————————————————————
2008 – about 24% aged 18 to 64 years (2009)
2006☝about 24% aged 18-64 (2008)
2004 – about 17% younger than age 65 had no health insurance coverage (2007)
2003☝about 17% younger than age 65 have no health insurance coverage (2006)
——————————————————————
2004 – 27% 65 and older had Medicare coverage only (2007)
2003☝24% 65 and older have Medicare coverage only (2006)
——————————————————————
2008 – 13% of children had no health insurance coverage for at least part of past year (2009)
2006☝13% of children had no health insurance coverage for at least part of past year (2008)
——————————————————————
2008 – More than 36% of adults who lack high school diploma were uninsured in past year (2009)
2006☝Almost 34% of adults who lack high school diploma were uninsured in past year (2008)
——————————————————————
2008 – 23% of high school graduates (2009)
2006☝23% of high school graduates (2008)
——————————————————————
2008👇14% of those with more than high school education (2009)
2006 – 15% of those with more than high school education (2008)
——————————————————————
2008 – Lack of health insurance is not only a concern of unemployed; almost one-quarter of employed individuals (aged 18 to 64 years) were uninsured sometime during past year (2009)
——————————————————————
2004 – Persons in lowest income group 10 times as likely as persons in highest income group not to receive needed medical care because of cost (2007)
——————————————————————
2004 – Almost 16 million citizens (6%) were unable to obtain needed medical care due to cost (2007)
——————————————————————
2003 – In survey, nearly 20% aged 18-44 years reported not having usual place to go for medical care (2006)
——————————————————————
2010-2013 – Uninsured patients and ethnic minorities substantially more likely to be diagnosed with cancer at later stage, when treatment can be more extensive and more costly
——————————————————————
2012-2013 – For more information on relationship between health insurance and cancer, see Cancer Facts & Figures 2008, Special Section, available online at cancer.org/statistics.
2010 – cancer.org.
2009 – (5008.08), Special Section, available online at cancer.org.
2008 – see special section page 22

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20131122-005752.jpg
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REFERENCES:
======================================
2013:
——————————————————————
http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf
======================================
2012:
——————————————————————
http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf
======================================
2011:
——————————————————————
http://cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf
======================================
2010:
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/acspc-024113.pdf
======================================
2009:
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/500809webpdf.pdf
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2008:
——————————————————————
http://www.oralcancerfoundation.org/facts/pdf/worldcancer.pdf
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2007:
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/caff2007pwsecuredpdf.pdf
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2006:
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/caff2006pwsecuredpdf.pdf
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2005:
——————————————————————
http://cancer.org/acs/groups/content/@nho/documents/document/caff2005f4pwsecuredpdf.pdf
======================================
2004:
——————————————————————
http://www.pink-ribbon-pins.com/CancerRates2004.pdf
======================================
2003:
——————————————————————
http://www.whyquit.com/studies/2003_ACS_Cancer_Facts.pdf
======================================
2002:
——————————————————————
http://www.uhmsi.com/docs/CancerFacts&Figures2002.pdf
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[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman

This page is linked to:
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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman
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Dear Dr. Friedman,

In response to your letter of 10/20/1993, it is difficult for me to understand why the entire 1st page of your letter is used to discuss the simplest issue:

that adults should use a different dosage than that used for children

Since you agreed to the study procedure of Protocol BT-6 as recommended in my letter of 6/9/1993, we have not requested any changes in the structure of treatment which was accepted by Memorial-Sloan-Kettering Cancer Center (MSKCC)

As you confirmed in your letter of 10/20/1993, you know very well that since 4/1/1993 of this year my recommended dosage of Antineoplaston AS2-1 for adults is 0.4g/kg/24h

Again, I confirmed that this is the right dosage for adults in my letter to Dr. Shoemaker of 8/24/1993

Yet, for no apparent reason, you insist on using in the adult treatment protocol the dosage 0.6g/kg/24h which I recommend for children

It is generally known that a child’s body weight is much lower than that of adults

This should be reflected in the escalation of the dosages

My recommendation as to how to escalate the dosages for adults was submitted to the NCI on 6/4/1992

Yet, for no apparent reason the MSKCC protocol, which is designed for adults, escalates the dosages in the small increments recommended for children

The principle behind dose escalation is to accomplish the maximum dosage in 3 to 5 days, not 3 to 4 weeks, which would expose the patient to the unnecessary risk of tumor progression

I appreciate very much that you have finally decided to follow my recommendation regarding dosage and dosage escalation

Regarding the number of patients to be treated at MSKCC, the contradictory, incomplete, and inconsistent information is being supplied by you

The MSKCC’s protocol of 4/16/1993, 7/13/1993, and 8/30/1993 describe the treatment of 35,

Pg. 2

but not 70 patients

(please see paragraph 12.1, pg. 10 of the protocol, which is attached)

It was our understanding that 35 patients would be treated at MSKCC and at the Mayo Clinic

I never agreed for the treatment of 70 patients at MSKCC

Since I have to produce the medicine for the trial and pay for it, it is vitally important to me to know how many patients will be treated

The treatment of an additional 35 patients may cost up to 2 million dollars

Contrary to the information given by NCI that we received the money for the production of medicine, this money went apparently into a “black hole”

(“Black Holism,” The Village Voice, 7/29/1993, enclosed)

We have received none of the money which the Office of Alternative Medicine gave to the NCI for funding the trials with our medicine

Contrary to the opinion expressed in your letter, we see no reason for modifying Fleming’s Phase II clinical trial design and introducing more stringent than usual criteria for response evaluation

We request that Fleming’s original design be used, which calls for the initial treatment of 15 patients with at least one responder, instead of 20 patients and 2 responders

Given the fact that there is no existing treatment effective in this type of cancer, one responder in 15 is certainly significant and would be reason enough to expand the trial

I found your your requirement for 14 days to complete scans and laboratory tests prior to treatment very interesting

It is a very well known fact that glioblastoma multiforme is such an active tumor that if 2 weeks elapses from the time of the scan and the beginning of treatment, the tumor may increase by more than 50%

This means that even before the patient begins treatment, he can be classified as an increasing disease case

In most of the hospitals in the U.S., including out tiny clinic, all pretreatment tests including the scans can be done in one day

Therefore, I insist that the pretreatment evaluation, including brain scans, be done within 7 days from the time treatment begins

Regarding the Karnofsky Performance Status (PS), it is unclear to me why you have backed off from your own recommendation in your letter of 5/5/1993 (copy attached) that “patients with Karnofsky PS of below 70% should be excluded”

I am requesting that as recommended by NCI, the patient’s PS should be 70% to 100%

I agree that both scan data and neurological assessment can be described in the analysis of response, but the decision of how to classify response should be based on tumor measurements alone

All of these patients will have been extensively treated before

As the result of previous neurotoxic treatments, a number of these patients will deteriorate neurologically even if the Antineoplastons eradicate the

Pg. 3

tumor

The purpose of the protocol is to evaluate the antitumor effect, not to prove that Antineoplastons can repair brain damage resulting from chemotherapy and radiation

In this 1st independent study with Antineoplastons, in order to assure that patients will derive the most benefit from the treatment, it is critically important to schedule more frequent evaluations of the data than waiting until after the accrual of 14 patients, i.e. waiting 9 months

(Based on an accrual of 2 patients per month, if we wait until 14 patients are accrued and treated, 9 months will pass before the 1st evaluation takes place)

Therefore, I request that reviews of the studies be performed after the treatment of each group of 5 patients, i.e. after 6 months

I agree, however, that you will provide the Theradex printout to us as you receive it

In addition to patient welfare, there is another reason for more frequent patient evaluations

As you stated in your letter, I have no doubt that the investigators at MSKCC have extensive experience treating glioma

However, MSKCC is known to be biased against Antineoplastons

At least 3 researchers associated with MSKCC published willful misrepresentations and distortions about Antineoplaston research

Because of the controversial nature of the upcoming Antineoplaston clinical trials, it is essential that they are conducted in a manner beyond any suspicion of bias

Contrary to the opinion expressed in your letter, NCI is responsible for the trial’s delay

As you well know, the NCI selected an MSKCC investigator in 9/1992

In spite of our repeated requests, 8 months were waisted before the NCI produced the 1st draft of the protocol

As promised in my letter to you of 11/11/1992, the supply of Antineoplastons has been prepared and was shown to Ms. Mary McCabe of NCI during the site visit on 2/9/1993

The medicine was ready to be released pending final approval approval of the labels by the FDA and our final QC inspection

The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested

Since you mentioned that patient recruitment has begun already, I would be glad to accept these patients immediately under my care and offer them free medicine as we wait for the protocol to be revised and the treatment at MSKCC to begin

The MSKCC protocol in its current form would threaten the welfare of these patients

In your letter you stated that your mission is to find and develop better therapies for cancer patients, and that your only obligation is to those patients

However, the way

Pg. 4

you proceed leads me to question that for the following reasons:

1) Out of numerous cancer treatment centers, you selected 2:

MSKCC and Mayo Clinic, which are known to be strongly biased against alternative treatments

In the past doctors associated with MSKCC have voiced strong opposition to Antineoplaston therapy and have published articles full of misrepresentations and distortions

2) The protocol approved by you will allow the disease to progress between the pretreatment evaluation and the beginning of treatment

3) Due to the slow escalation of dosages, patients will most likely have marked increase of tumor size beginning the treatment at the correct dosage level

4) In spite of my numerous requests (letters of 4/29/1993, 6/9/1993, and 8/24/1993) to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991 to have a separate clinical trial for glioblastoma multiforme and anaplastic astrocytoma, you continue to combine both types of tumors together

Even in your most recent stratification strategy submitted to the FDA, you are planning to treat initially 20 patients without specifying whether those 20 patients are per each stratum (glioblastoma vs. anaplastic astrocytoma), or whether this initial group of 20 patients consist of a mixture of glioblastoma and anaplastic astrocytoma

If the latter is the case, then we can expect that among these 1st 20 patients, most will have glioblastoma, which is more common and more difficult to treat

In case of treatment failure in these 20 patients, it will be easy to make the statement that Antineoplastons do not have therapeutic effect in both tumor categories

5) The protocol now states in paragraph 10.2, 10.3, and 10.4 that the objective decrease of tumor size is not enough to be considered a true response to treatment, that there must also be improvement in neurological function

As I explained in my letter of 10/13/1993 to Dr. Greenblatt, it is not unusual in my practice to see patients whose tumor has disappeared, but who have deteriorated neurologically as the result of delayed toxicity from radiation therapy and chemotherapy

Since these patients in the MSKCC study have been pretreated, and since there has been no indication that anything, including Antineoplastons, can repair brain damage caused by chemotherapy and radiation, I request that the criteria including restored neurological functioning be removed from paragraphs 10.2, 10.3, and 10.4 of the protocol

Pg, 5

6) Finally, by limiting our access to the data and not allowing review until after the 1st 14 patients have been treated, it would be easy to deviate from the protocol and supply inadequate treatment, and then claim that due to the the failure of the 1st 14 patients it would be a waste of the taxpayers money to proceed with further treatment

Your final statements that you are ready to proceed with the treatment with Antineoplastons without our participation caught me by surprise

It is hard to imagine that a Federal employee would consider patent infringement, thus infringing on the patent rights of thousands of our shareholders

Once again, I urge you to take our requests seriously, honor the guidelines of the NCI’s Decision Network on 12/2/1991, and make proper corrections to the protocol, so that objective clinical studies can begin immediately

In the meantime, I would be glad to treat for free all the patients presently recruited, and will submit progress reports weekly for the NCI’s review and evaluation

SRB/cf

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Dianne Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Samuel Broder
Dr. Jan Buckner
Dr. Bruce Chabner
Dr. Daniel Eskinazi
Dr. Jay Greenblatt
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
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1993 (10/26/1993) – SRB to [5]
1993 (10/26/1993) – SRB to [14]
1991 (12/2/1991) – guidelines of the NCI’s Decision Network [5 Pgs.]
1992 (6/4/1992) Burzynski to NCI
1992 (9/1992) – NCI selected MSKCC investigator
1992 (11/11/1992) – Burzynski to Dr. Michael A. Friedman
1993 (2/9/1993) – NCI Mary McCabe site visit
1993 (4/1/1993) –
1993 (4/16/1993) – MSKCC protocol
1993 (4/29/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (5/5/1993) – Dr. Michael A. Friedman to Burzynski
1993 (6/9/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (7/13/1993) – MSKCC protocol
1993 (7/29/1993) – “Black Holism,” The Village Voice
1993 (8/24/1993) – Burzynski to Dr. Dale Shoemaker
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (8/30/1993) – MSKCC protocol
1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski
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