Tag Archives: Pharma

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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Turkey Lurkey Thanksgiving Title

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Traditionally, Thanksgiving is best known as the Holiday that the Detroit Lions get the “stuffing” knocked out of them

However, this year, it’s time to tender the tainted twisted trophy of Thanksgiving Turkey-Lurkey to Detroit’s toasted triumvirate treat of two-faced twerk-salad troll turpitude, and I have the temerity to tinker and tamper until I pay tribute with therapeutic levels of Thoreauness in response to GorskGeek’s misinformation, disinformation, and MisDisInformation (Missed ‘Dis Information)

Wednesday, 12/21/2005, Indianapolis, Indiana-based Eli Lilly and Company was treated to truthification, in connection with their illegal promotion (misbranding) of pharmaceutical drug EVISTA; (FDA approved for prevention and treatment of osteoporosis in post-menopausal women), in the:

a. prevention in risk of breast cancer

b. reduction in risk of breast cancer

Alleged in information, promoted drug as effective for reducing risk of breast cancer EVEN AFTER PROPOSED LABELING FOR THIS USE SPECIFICALLY REJECTED by FDA [1]

GorskGeek, being the breast cancer oncology specialist he claims to be, and so concerned about breast cancer patients that he is that “guy” who speaks out passionately about issues like the 10-year American Cancer Society Cancer Facts & Figures, “Estimated Breast Cancer Deaths for Women”, which reflect that in 2002, 39,600 (15%) women were estimated to die from breast cancer, and this year, 2013, the estimate is 39,620 (14%), which is 20 women MORE than 10-years ago, and who rails tirelessly about the ACS’s “Estimated New Breast Cancer cases in Women”, which 10-years ago was 203,500 (31%) in 2002, and now, in 2013 is 232,340 (29%), which is ONLY
28,840 MORE than 10-years ago [2]

Now THAT’s progress !

GorskGeek, of course, must accomplish all this under his breath

But I’m sure you’re wondering, dear reader, what was GorskGeek’s outraged blog about this American pharmaceutical manufacturer coughing up $36 MILLION ?

Well, let me tell you … just as soon as I find it

Wait for it

Wait for it

Wait for it

GorskGeek was unable to bring himself to blog about Evista until exactly one year later, on 12/21/2006, and even then, he was “mum’s the word” about the breast cancer claims [3]

Perhaps GorskGeek just “knew” that eventually Evista would finally be approved by the FDA for Eli Lilly’s preventing or reducing risk of breast cancer claims on 9/13/2007, and who were those paper-pushing FDA apparatchiks to prevent Lilly from implementing their “Internal business plan” ? [4-9]

GorskGeek wouldn’t want to damage his slim and non-existent chance of getting some Eli Lilly money for research, by blogging anything that might in any way be possibly construed as him saying anything negatory about the BIG Pharma teat he longs to suck off of

After all, Bob ‘n’ Weave Blaskiewicz (who sees every molehill as a mountain), did say about GorskGeek, 9/28/2013 [10]:
——————————————————————
1:58:04
——————————————————————
“But he is a, the thing is, the thing is, you thing you have to understand is Gorski, Gorski is a genuine expert, in matters re re regarding on oncology studies“

“I mean, he has a”

“He, He’s able to convince people, he’s able to convince people, on the strength of his record, to give him money to carry out research”

“People who know what they’re talking about”

“To give him money to carry out his research”

“Right ?”
——————————————————————
1:59:00
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Yeah, right

Bobby 🙂

GorskGeek is hoping for a Happy Thanksgiving Golden Parachute; which is where he helps whistleblow about illegal BIG Pharma activity regarding some drug(s), which leaves him as the beneficiary of some funds like Mr. H. Dean Steinke, former Merck employee and his $68,190,000 MILLION from the federal government and states share of settlement amounts:
——————————————————————
$44,690,000 MILLION – Mr. H. Dean Steinke, former Merck employee from federal share of settlement amount (1997 – 2001)
——————————————————————
$23.5 MILLION – Mr. H. Dean Steinke, former Merck employee from the states share of settlement amount (1997 – 2001)
——————————————————————
Next, GorskGeek goes off on his fave autism prescription antipsychotic drug Risperdal, and the 11/4/2013, Monday, allegations concerning Global health care giant Johnson & Johnson (J&J) and its subsidiaries, $2.2 BILLION + fine regarding J&J Subsidiary Janssen (1999 – 2005) actions [11]
======================================
REFERENCES:
======================================
[1] – 12/21/2005
——————————————————————
EVISTA (FDA approved for prevention and treatment of osteoporosis in post-menopausal women)
——————————————————————
Eli Lilly and Company, Indianapolis, Indiana-based company
——————————————————————
12/21/2005, Wednesday
——————————————————————
$36 MILLION
——————————————————————
In connection with illegal promotion of pharmaceutical drug
——————————————————————
Pleading guilty to criminal count of violating Food, Drug, and Cosmetic Act by misbranding drug
——————————————————————
In addition to criminal plea
agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
——————————————————————
Charged in criminal information filed with violation of Food, Drug, and Cosmetic Act, following investigation by Food and Drug Administration’s (FDA) Office of Criminal Investigations
——————————————————————
Plea agreement signed by Lilly and United States

Complaint for permanent injunction

Consent decree of permanent injunction signed by company and United States
——————————————————————
Information alleges 1st year’s sales of drug in U.S. were disappointing compared to original forecast
——————————————————————
According to information
10/1998 – company reduced forecast of drug’s 1st year’s sales in U.S. from $401 million to $120 million
——————————————————————
Internal business plan noted:

“Disappointing year versus original forecast.”
——————————————————————
Information alleges in order to expand sales of drug, Lilly sought to broaden market for drug by promoting it for unapproved uses
——————————————————————
Information alleges strategic marketing plans and promotion touted drug as effective in preventing and reducing risk of diseases for which drug’s labeling lacked adequate directions for use
——————————————————————
According to information: Evista
1. brand team
2. sales representatives
promoted drug for:
a. prevention in risk of breast cancer
b. reduction in risk of breast cancer
c. reduction in risk of cardiovascular disease
——————————————————————
Under provisions of Food, Drug, and Cosmetic Act, drug misbranded when labeling didn’t bear adequate directions for each of intended uses
——————————————————————
Alleged in information, promoted drug as effective for reducing risk of breast cancer even after proposed labeling for this use specifically rejected by FDA
——————————————————————
Information alleges executed illegal conduct using number of tactics, including:

1. One-on-one sales pitches by sales representatives promoting drug to physicians about off-label uses of drug

2. Sales representatives trained to prompt or bait questions by doctors in order to promote drug for unapproved uses

3. Encouraging sales representatives promoting drug to send unsolicited medical letters to promote drug for unapproved use to doctors on their sales routes

4. Organizing “market research summit’ during which drug was discussed with physicians for unapproved uses, including reducing risk of breast cancer

5.
a. Creating
b. distributing
to sales representatives “Evista Best Practices” videotape, in which sales representative states “Evista truly is the best drug for the prevention of all these diseases” referring to:

1). osteoporosis
2). breast cancer
3). cardiovascular disease
——————————————————————
Complaint for permanent injunction alleges executed illegal conduct using number of tactics, including:

1. Training sales representatives to promote drug for prevention and reduction in risk of breast cancer by use of medical reprint in way that highlighted key results of drug and thereby promoted drug to doctors for unapproved use

2. Some sales representatives were instructed to hide disclosure page of reprint which noted:

a. “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,”

b. “The prescribing information provides that “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.””

3. Organizing “consultant meetings” for physicians who prescribed drug during which unapproved uses of drug discussed

4. Calculating incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998

5. advisory board meetings included discussion of unapproved uses for drug

6. By measuring and analyzing incremental new prescriptions for doctors who attended advisory board meetings, Lilly was using this intervention as tool to promote and sell drug
——————————————————————
In addition to agreeing to plead guilty to criminal information and plea agreement signed by Lilly, settlement with United States includes following components:

(a) agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction

(1). As part of consent decree, agreed to comply with terms of permanent injunction, which will require company to implement effective training and supervision of marketing and sales staff for drug, and ensure any future off-label marketing conduct is detected and corrected

(2). agreed to be permanently enjoined from directly or indirectly promoting drug for use in:

a. preventing or reducing risk of breast cancer

b. reducing risk of cardiovascular disease

c. or for any other unapproved use in manner that violates Food, Drug, and Cosmetic Act unless and until FDA approves drug for additional use or uses
——————————————————————
(b) as part of consent decree, agreed to hire and utilize independent organization to conduct reviews to assist Lilly in assessing and evaluating Lilly’s

1. systems
2. processes
3. policies
4. procedures
relating to promotion of drug and company’s compliance with consent decree
——————————————————————
FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
——————————————————————
“No postmenopausal woman who has taken Evista for the prevention or treatment of osteoporosis is affected by this action, as this matter today relates only to unapproved uses of Evista.”
——————————————————————
Defendant agreed to plead guilty to charge in information
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Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
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http://www.justice.gov/opa/pr/2005/December/05_civ_685.html
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[2] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
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[3] – 12/21/2006 – On the messiness of evidence-based medicine
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http://scienceblogs.com/insolence/2006/12/21/the-messiness-of-evidencebased-medicine/
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[4] – 9/13/2007 – FDA Approval for Raloxifene Hydrochloride (Brand name(s): Evista®): Approved for breast cancer risk reduction:
——————————————————————
http://www.cancer.gov/cancertopics/druginfo/fda-raloxifene-hydrochloride
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[5] – 9/14/2007 – FDA Approves New Uses for Evista: Drug Reduces Risk of Invasive Breast Cancer in Postmenopausal Women:
——————————————————————
http://www.fda.gov/newsevents/newsroom/pressannouncements/2007/ucm108981.htm
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[6] – 9/17/2007 – Evista Approved for Reducing Breast Cancer Risk:
——————————————————————
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
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[7] – 2007
——————————————————————

Click to access 020815s018lbl.pdf

======================================
[8]
——————————————————————

Click to access ucm088593.pdf

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[9] – 2007
——————————————————————

Click to access 022042lbl.pdf

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[10] – 10/18/2013 – Deconstructing Dr. David H. (Orac) Gorski – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/deconstructing-dr-david-h-orac-gorski-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
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[11] – 11/4/2013
——————————————————————
http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
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All’s fair in Drugs and War

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GlaxoSmithKline
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$3 BILLION
——————————————————————
7/2/2012
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(4/1998 – 8/2003)
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United States alleges GSK participated in
preparing
publishing
distributing
misleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
——————————————————————
At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
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(2001 – 2007)
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United States alleges GSK failed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
——————————————————————
missing information included data regarding certain post-marketing studies
——————————————————————
data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
——————————————————————
United States alleges GSK stated drug had positive cholesterol profile despite having no well-controlled studies to support that message
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Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.
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$2.2 BILLION +
——————————————————————
11/4/2013, Monday
——————————————————————
Johnson & Johnson (J&J) and Janssen
——————————————————————
complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
——————————————————————
For example, when J&J study of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssen combined study data with other studies to make it appear there was lower overall risk of adverse events
——————————————————————
year after J&J received results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautioned Janssen
——————————————————————
“[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
——————————————————————
complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns”
——————————————————————
When Janssen received initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
——————————————————————
J&J and another of its subsidiaries, Scios Inc.
——————————————————————
8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
——————————————————————
approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
——————————————————————
complaint alleged Scios had no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug
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Abbott Laboratories Inc.
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$1.5 BILLION
——————————————————————
5/7/2012, Monday
——————————————————————
(2001 – 2006)
——————————————————————
company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
——————————————————————
1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
somnolence
dehydration
anorexia
experienced by study participants administered drug
——————————————————————
funded 2 studies of use of drug
both failed to meet main goals established for the study
——————————————————————
When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results
======================================

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AstraZeneca LP / AstraZeneca Pharmaceuticals LP
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$520 MILLION
——————————————————————
4/27/2010, Tuesday
——————————————————————
engaged doctors to conduct studies on unapproved uses of drug
——————————————————————
recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
——————————————————————
then used
studies
articles
as basis for promotional messages about unapproved uses of drug
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REFERENCE:
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11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/26/united-states-department-of-justice-versus-big-pharma-big-pharma-fought-the-law-and-the-law-won/
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Pete Cohen chats with Dr. Stanislaw Burzynski – Interview #2

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Dr. B interview #2
2/7/2013 (10:31)
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Why do you continue to do this ?
Why haven’t you just, given up ?

Because I am right
Why should I stop when I have 100’s of people who are cured

Mhmm

from incurable brain tumors
Ok
We have over 100 people, who are surviving over 5 years, just in the supervised clinical trials with brain tumors
So obviously this works (laughing)
It works in great way
So why should I stop because, some evil people like me to stop ?
It doesn’t make any sense
Evil will lose
So we are right, and we’re going to win
Not, uh, no matter how soon this will be established, but we are going to win

Well, for what it’s worth, and this is something, this is why I wanted to put myself, uh, in front of the camera with you
Obviously I spent 8 months, um, and I’ll try and not get too emotional about it, because that’s unprofessional (laughs)

Yes

but I spent, I spent a long time, looking into this, speaking to people,

Yes

You have very kindly given me access to everything here

Sure

Speak to anyone
Speak to patients
To see medical records, and I have, uh, been amazed by what I, what I’ve seen
I know the statistics are now showing, in the world, that one in two men, will have cancer
One in 3 women, will have cancer

Yes

It’s a, it’s a massive problem

That’s right

And I can see that you’ve genuinely found, uh, a cure for cancer

(?)

You know, it might not work for everyone, but if you’re given the su

Yeah

given the support

Yes

If you’re given, uh, the, uh, I don’t know, just the support basically, and the funds maybe, you could really, do some work, that could change, the whole (nature ?)

Absolutely, and then we can get better, and better
Of course, what you have now is not yet the finished products
We understand that
That’s something we can substantially improve
The response rate can be improved
So, certainly, all of this can be done, but, obviously, we need the resources
We need time to do it, and most of my time is spent with such silly thing like, uh, uh, protecting ourselves against attacks from, the people who are hired to destroy us
Ok
Obviously, there are some companies who are working on the payroll of pharmaceutical business, who are trying to smear us
To spread bad publicity about us
To generate lies about us
These people are criminals, and they are still flourishing
The end for them will come soon, but they are still hurting the other people
because the other people will not take treatment
They will not come, and they will die
Ok
There is no cure for, uh, uh, malignant brain tumors which are inoperable, ok, and we can cure at least, good percent of these people
We presented, our results, at many, many, 1st class
scientific congresses, like nuero-oncology congresses, cancer congresses, and it’s important for U.K.
I showed you yesterday, eh, presentation on brainstem glioma in children

Yeah, I have it here

and at the same, uh, Congress, in Edinburgh, we presented also another, eh, eh, paper, on the treatment of glioblastoma multiforme, and the survival on, about 88 patients, in glioblastoma multiforme
So obviously, I make, I make this available to everybody , they would like to listen, come to my presentation
They, they, they know about it, but they don’t want to know about it

Why not ?

(laughs) Because they are working
They are slaves of the big pharmaceutical cartels, ok, and on the payroll of big companies
They hate to see somebody else outside, the slavery, who can do it
I’m free man
I can, ah, do the research because, I am spending my own money for it
I don’t need to beg pharmaceutical companies or government to give me the money
I can do it on my own
They hate it
These people
They hate it because they have slave mentality

Mmm

They arch their back for scraps of money from the table, of some powerful companies, from the government, and they, how can you deal with s, slaves
They don’t want to see something new because this would disrupt, slavery system
Ok
So, current medical education s, system is manufacturing robots
They don’t think on their own, they use only what, the government, or the lawyers of the government, or what the administrators will tell them to do, ok, and if they don’t then they get punished, ok (laughs), and that’s a great system for a ph, pharmaceutical companies, because obviously they can make a lot of money, but it’s not a great system for people who have cancer because they don’t have good results

So you’ve presented at these conferences, and people don’t come up to you afterwards and say:

Mhmm

“I want to come and see what you’re doing
I’ve got to see this for myself”

Ah, well, uh, at each of these Congresses I meet a few doctors who are top specialists in their area who will come to me and say: “Ok, this looks very interesting
We’d like to know more about it
Please send me some, eh, results and a few cases that I can review,” and that’s what you do

Yeah

You send them these cases, and that’s the end of it
I don’t hear from them anymore because they’re afraid to move any

Mmm

further, ok, because they know if they move further, they get punished
They don’t receive grants
They’d be scrutinized by their peers
They’re afraid
Ok (laughs)

Yeah

They work for us

Yeah

they work for us undercover
We have over 100 telephone callers who used to work with us, but they don’t want anybody to know about it because they’d be immediately attacked by the other guys

And the pharmaceutical world as well

Ah, well, the other guys are obviously working for cartels
Uh, they’re on the payroll, a, oh, of big business, which is cancer business, and they don’t want to lose it
Uh, in average, uh, city you might have say about 20 oncologists
One of them may work for us, but he does not no, want to tell anybody that he’s doing this because he would be destroyed by the other guys
These 20 guys will jump on him and he will, won’t have practice anymore
Ok

Yeah

So that’s, uh, the travesty, but, uh, uh, I believe that this is coming to the end
Ultimately, su, more and more doctors will learn what we do

Yeah

and more and more patients will benefit, and the breakthrough will come, but before the breakthrough will come, you have the toughest time

Mmm

because, the opposition is mounting the attacks
Whenever we came up with an announcement that was in the 20th century, we have such and such success, you are furiously attacked by the other guys, who are on payroll, uh, of cartels
Ok (laughs), for no apparent reason
You should be congratulated but we are attacked, because they see we are going to win, and they hate to see this because this means they won’t see money anymore for them, ok, or at least they think they won’t, they won’t have their payroll anymore
—————————————————————
Dr. Burzynski on publishing (6:18)
—————————————————————
So why does, why does, ev, everyone hide behind this thing of saying about publishing, because that’s the thing you hear all the time

Well, we cannot publish until the time is right (laughs)

Yeah

If you would like to publish the results of, of a
10 year survival, for instance

Mmm

Which we have
Nobody has over 10 year survival in
malignant brain tumor, but we do, and if you like to do it right, it takes time to prepare it, and that’s what we do now
What we publish so far
We publish numerous, uh, publications which were, interim reports when we are still continuing clinical trials
Now we are preparing, a number of publications for final reports
Eh, many of my publications were rejected by known publi, by known journals like

Why ?

like Lancet, like JAMA,
like New England Journal of Medicine
Why ?
Because they say: “Sorry, but you didn’t receive enough priority to be published“, and if you look in these journals and 1/2 of the, these journals, they are advertising for pharmaceutical companies
Obviously if this would come from a pharmaceutical company, this would be published on the 1st page

Mhmm

Ok
Because this, you don’t have objectivity with these guys
They are on the payrolls of the big cartels, ok, and again and if you try again to send, oh, oh, my manuscript to good journals, if they reject it, we go on Internet and you describe what are these guys
So then everybody will know, because I have very good evidence
that we tried many times to publish in 1st class journals, and we are always rejected

It’s just, persistent

And not, and not because of lack of scientific knowledge
No, because of lack of priority
And who has priority ?
The guys who are paying money for advertising
Ok
So that’s, unfortunately what I think will end sometime
—————————————————————
And we are now preparing publication, on some of these results
We have already published the results on the technique of very difficult variety of breast cancer, which is triple-negative breast cancer
Now we are preparing another article on the technique of
gynecological cancer, which is best series of over 100 patients treated with incurable ovarian cancer, uterine cancer, (?)
So this, has now been prepared for press
Eh, of course, I would like to, give everybody intravenous antineoplastonssee, if they qualified, but, this is limited by the government, because the government limits us to only the patients who are
have
brain tumors, but the other patients, they can be treated through this combination of medication which work on the genes
Antineoplastonswork on over 100 different genes
That’s why they give us, very good advantage
There are medications that also work on a number of different genes, and we can combine them together, and use them in the right way
So
that’s what we’ll continue to perfect, and that’s, uh, most of our patients
been treated with just combination of targeted medications
—————————————————————
The Future (9:00)
—————————————————————
Why do you continue to do this ?
Because you know the truth, and you want to get the truth out there ?

Absolutely, because we understand we on the right track
Somebody has to do it
I was lucky enough to, find out about it
We have evidence that we are right, and, uh, I don’t think, why should I stop if, people that don’t have sufficient knowledge, who are working, on behalf of some big business, would like to stop us
We are right, and we would like to continue to help people, and, uh, that is what is going to happen
Of course, probably the best reason to make a discovery, and let it stay as it is and ask the other people to publish after I die

Yeah

That’s what happened with the discovery of Nicolaus Copernicus, who was my countryman
Eh, his book was published, sss, when he died, and, uh, for good reason, because of such fears for execution of the people who followed him
like

Hmmm

Galileo, Giordano Bruno, that it took the church, uh, only until recently to agree that, uh, they made the error, in the case
Ok
So if you come up with some breakthrough, you have a choice
Keep it quite until the other guys who understand what you do
or try to use it
In my case, I decided to use it, because I would like to, help people, and now that we can save people, so why should I keep quiet, ok, but certainly if, my work won’t get published because it keeps getting rejected by some of the journals, then we wait until I die, and then we let the other guys publish it
So, ok
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Pete Cohen chats with Sonali Patil, Ph.D., Research Scientist at The Burzynski Clinic

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1/2012 – Sonali Patil, Ph.D., Research Scientist at The Burzynski Clinic
(18:22) 9/18/2012
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So you, you, you’re a scientist here ?

I’m a scientist here

And, and you work, just with antineoplastons ?

Not necessarily
This is our cell biology lab, and in molecular biology we do basic research on the antineoplastons
Sometimes we also study it in combination with the other, uh, medicines that Dr. Burzynski is interested in
So, but mostly antineoplaston
This is looking at mechanism for action
Trying to understand how it treats the cancer cells, is able to kill the cancer cells without damaging the other cells of the body
So mostly antineoplaston is the target here

And what do you think about
antineoplastons ?

We have found, uh, very interesting, uh, molecular pathways targets that antineoplaston is targeting, working very effectively to kill the cells, um, probably better than many other drugs, because, um, it has multiple targets, and so attacks the cells from many different angles, and is able to kill the cancer cells, more effectively

So, can I ask you, how did you come to work in, th, the Burzynski
the institution ?

Through an advertisement, it was
My position was advertised
I started 8 years ago, and

So ok
So it was advertised

Mhmm

So when you applied for the job, were you aware of the controversy of, (comments to self: learn to talk)
So when, when did you find out ?

Uh, eh, as soon as I joined (laughing)

Oh yeah ?

Few months later
I thought, it’s easy to find
It’s not hard

Of course

It’s not even, uh

Wha, what about any of you other colleagues, that prior to coming here ?
I mean, did they say anything to you, like, you know ?

Well they brought something up
(?) in, uh, uh, being there for him during this trial, my boss, my previous boss was here before me
Uh, so I have a very open picture of it, and it doesn’t bother me
He came up against it and won

Yeah

So that’s a good thing

An, and why do you think, it kinda hasn’t been, kinda lost the word, hasn’t taken off, you know ?
Has the scientific community hasn’t really embraced ?

Well anything that is non-traditional always, you know, takes its own time to get to people
Besides, the traditionalists don’t want it coming out because, uh, it affects, a lot of other things, um, finance, in, in the big Pharma

Right

that is affected by this
So, um, if it, if it were, um, a medicine already with another big company, it probably would already be out in the market by now, but, uh, it’s because it’s one man’s show
He’s fighting against, uh, traditional medicine, big, big centers like M.D. Anderson right here in Houston
So, most people want to believe, uh, what the other doctors, the oncologists, are telling them, because that’s what everybody does
So very few filter out of that and come looking for him, because they’ve lost hope there, and they’ve tried everything else, and they come because; which I wish they wouldn’t, come here as a last resort, you know

Mmm

and, by then, sometimes, uh, enough damage has been done that is sometimes even he cannot cure
It’s not magic
It’s
There’s a logic to the way the medicine works
The science behind it is not, it’s not just a magic bullet
So, and you have to target it at the right time
Catch cancer at the right time

So I have a, friend of my mother’s at home, whose spent, her whole, academic career, 20, 30 years, researching, astrocytomas

Mhmm

And, uh, you know, I did my research, and, I was no doubt that we were coming here
No question
My, my research was more based on people

Excuse me

On people
Talking to people who had been treated, and seeing the results, and then looking at the research afterwards, and she was just saying that “I’ve spent all my years, research, and research, and research, I can’t find anything, that validates, this, this treatment”
Now I’m not asking you to comment on what she said, but,

No, validation, validation basically means, uh, proof in scientific community
If you’re not accepted into the scientific community, you’re not going to be able to present that truth, and we go and present at conferences all the time, eh, when it comes to publishing papers, uh, we haven’t been very successful
Dr. Burzynski has published, uh, a lot of data of his patients
So it’s out there

Yeah

If you, if you want to believe it, and you’re looking for it, you’ll find it

Yeah

It’s just, um, it’s not in the mainstream places, because it gets rejected out of there
Um, it’ll probably take some time to get into those spots where everybody else is publishing, and everybody else is talking about it, but it doesn’t mean that it’s not true

So obviously you’re here on a daily basis
So when was the 1st

Last 8years

So the last 8 years
When was the 1st time you actually saw, was it in the dish where you actually saw it ?

Well we see it, we’ve seen it for years before I came here

Yeah, but when was the 1st time you saw it, when you came here yourself and you saw ?

Well we see it every day
Um, we have cancer cells in the lab, that we treat, with the medicine
We see them dying
We see them undergoing a necrosis, which is the cancer deaths, pathway, that most people study and talk about

So

So, it’s happening, it’s happening in front of our eyes everyday
So, we have proof for it
you know (?)
We just have to get it out there, and there’s a, there’s a system to all that

Um

and were trying to, get it through the system, and get it out there

So what, when you 1st realized there is something here, did you not just feel like just shouting from the rooftops and telling everybody?