Stanislaw Rajmund Burzynski, Stanislaw R. Burzynski, Stanislaw Burzynski, Stan R. Burzynski, Stan Burzynski, S. R. BURZYNSKI, S. Burzynski, Arthur Burzynski, Hippocrates Hypocrite Hypocrites Critic Critics Critical HipoCritical
Category Archives: Texas Medical Board / State Office of Administrative Hearings
—————————————————————– “Orac” and David H. Gorski, M.D., Ph.D., FACS,
collectively, “GOrac” a/k/a GorskGeek thinks that signs of “Getting Worse is Getting Better” [1]๐
That’s right ! ๐
I almost couldn’t believe my eyes, but GorskGeek seems to have come around to Burzynski’s way of thinking (according to “Dr.” Bob๐)
GorskGeek describes it thusly:
—————————————————————– “Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation”
“A patient who isnโt familiar with this phenomenon may assume her tumor is growing”
“When that swelling subsides, patients may assume itโs because of Burzynski, Adamson says”
“In reality, the tumor was just returning to its previous size”
“Pseudoprogression can be a real confounder in assessing the response of brain tumors to therapy, being observed up to 28% of the time”
—————————————————————–
Here’s how GorskGeek’s“brother” in blatherskite; I’m NOT a doctor, ๐ท (but I play one on The Other Burzynski Patient Group), Robert J. (don’t call me “Bobby”) “Bob” Blaskiewicz Blatherskitewicz, describes it [2] ๐:
—————————————————————– 8/27/2012, Monday[2]
“On the 27th, we hear:”
“Firstly, Amelia hasnโt quite been herself unfortunately”
“She has been very reluctant to walk, a lot more tired, slow and pretty lethargic”
“She was sick on Saturday night also”(8/25/2012)
“We are reasonably confident we have probably gone too far with the steroid reduction so we have actually increased these slightly again today”
“We decided we would rather have a happy and more alert Amelia than one who doesnโt want to do too much โ so we made this decision today in coordination with the Burzynski clinic“
“Weโll see how she does”
“There is a small chance it is the tumour growing, but much more likely given the scans we have that this is due to swelling of the tumour caused by the treatment”
“Time will tell. […]”
“The symptoms we are seeing right now are a direct result of the tumour, hopefully due to it swelling, and the steroids will fix this”
“They are also what we would see if it has grown”
—————————————————————–
(Below comments by: I’m NOT a doctor, ๐ท (but I play one on The Other Burzynski Patient Group), Bob Blaskiewicz ๐)
And hereโs another example of something that isโฆdesperately, desperately wrong at the Clinic ๐ฆ
The patient is being told that the tumor is swelling because of the treatment ๐ณ
How is it that only at the Burzynski Clinic that getting worse is indistinguishable from getting better?๐ก
Second point:
this is a tumor on the brainstem
If a possible side effect were swelling of the thing pressing against the brainstem, youโd expect that to be on the informed consent form, right? ๐
The type of thing that would be among the โserious side effects,โ right? ๐ฎ
—————————————————————–
So, to recap ๐:
โโโโโโโโโโโโโโโโโโโโโโ David H. Gorski
โข ( โGetting Worse is Getting Betterโ) ๐
โขโConventional cancer treatment can also cause tumors to swell temporarily, due to inflammationโ
—————————————————————– Amelia Saunders
โขโ . . . but much more likely given the scans we have that this is due to swelling of the tumour caused by the treatmentโ
โขโThe symptoms we are seeing right now are a direct result of the tumour, hopefully due to it swelling . . . โ
—————————————————————– “Dr.” Bob Blaskiewicz (I’m NOT a doctor, ๐ท but I play one on The Other Burzynski Patient Group)
โข The patient is being told that the tumor is swelling because of the treatment
โข How is it that only at the Burzynski Clinic that getting worse is indistinguishable from getting better?
โข If a possible side effect were swelling of the thing pressing against the brainstem, youโd expect that to be on the informed consent form, right? “O”
——————————————————————
The problem with this is:
In support of this “phenomenon”, the article provides a link to a Canadian web-site [3] ๐ถ
——————————————————————
The site posits:
—————————————————————— “RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”
“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ” ๐
——————————————————————
Additionally, the site cites the reference as:
Sanghera, Perry, Sahgal, et al., “Sunnybrook Health Sciences Odette Cancer Centre” (in press, Canadian Journal of Neuroscience)
(“In press” refers to journal articles which have been accepted for publication, but have not yet been published)
However, the journal article in question was published 1/2010, so it has NOT been “in press” for over 3 years and 7 months [4] ๐
Get your act together, aye, CAN-A-DUH! ๐
——————————————————————
โบ
๐
—————————————————————–
I gave Liz Szabo and USA TODAY the chance to act like a Spike Lee joint and “Do the Right Thing”, the same day their article came out [1]
I gave them the opportunity to prove that their article was a legitimate piece of journalism with some semblance of integrity, and NOT just akin to one of “The Skepticsโข phoned-in “rubber-stamped” yellow journalism hit pieces
Instead, it seems that Liz Szabo and / or USA TODAY decided to act as if they had rolled a Spike Lee joint
I sent an e-mail with 2 editorial corrections, and only one (correcting Lisa Merritt’s comment link from taking the reader to the 1999 Mayo Clinic report instead of to her comments), was corrected [2]
The 2nd correction which they #FAILED to do, earns them well deserved INSOLENCE
——————————————————————
The articleclaims:
—————————————————————— “Burzynski, 70, calls his drugs “antineoplastons” and says he has given them to more than 8,000 patients since 1977.”
——————————————————————
——————————————————————
However, if you select the “8,000 patients” link, the referenced page does NOT indicate that at all [2]
——————————————————————
—————————————————————— It advises:
—————————————————————— “That same year, Dr. Burzynski founded his clinic in Houston where he’s since treated over 8,000 patients.”[3]
——————————————————————
—————————————————————— Nowhere does it indicate that he “treated 8,000 patients” with antineoplastons
——————————————————————
——————————————————————
The question that Liz Szabo and USA TODAY should answer, is:
1. Who is your “fact-checker”, and 2. are they smarter than a 5th grader ?
——————————————————————
In fact, Burzynski’s 2002 Securities and Exchange Commission (SEC) filing advises:
โ โฆ in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene targeted therapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Companyโs Antineoplaston clinical trials”[4]
——————————————————————
The article continues:
—————————————————————— “Individual success stories can be misleading, said Arthur Caplan, a professor and head of the division of bioethics at NYU Langone Medical Center”
——————————————————————
The question Arthur Caplan should be asking is:
Why has the United States Food and Drug Administration required Burzynski’s clinical trial patients to fail conventional therapies; such as surgery, chemotherapy, and radiation, BEFORE they are allowed to be treated with antineoplaston therapy ?
If the F.D.A. did NOT impose these restrictions upon Burzynski’s clinical trials, then the question Arthur Caplan raises would be moot
——————————————————————
The article quotes Dr. Jan Buckner as saying:
—————————————————————— “When I hear a story that is way out of the norm, the first question I ask is,
‘OK, is the diagnosis even correct?‘ ”
“Buckner said”
“If the diagnosis wasn’t right to start with, it doesn’t matter what the treatment was.”
“Brain tumors are notoriously difficult to diagnose, Buckner says”
“When dealing with rare brain cancer, doctors may disagree about how to interpret imaging results up to 40% of the time”
——————————————————————
I wonder if Dr. Jan Buckner would agree with David Gorski; who is a BREAST cancer oncology specialist, and NOT a BRAIN cancer oncology specialist, who has the presumptiveness to speculate that 3 different medical opinions could have misdiagnosed Tori Moreno in August 1998; who was diagnosed with a very large tumor, about 3 inches in the largest diameter and located in the brain stem, which was too risky for surgery, and about which her parents were told by ALL 3, that Toriโs brain cancer was fatal and, she would die in a few days or at the most, 2-6 weeks, and that there was nothing that could be done, and was finally put on Burzynski’s antineoplaston therapy in October, when she was about 3 ยฝ months old, and in such condition that they were afraid that she might die at any time, David H. Gorski, M.D., Ph.D., FACS; who claims, “I do know cancer science”, has the audacity, because of his “book learnin'” has the temerity to postulate his “science-based medicine theory” that Millerโs Children at Long Beach Memorial misdiagnosed Tori Moreno’s inoperable stage 4 BSG
David Gorski has the gall to profer that City of Hope misdiagnosed Tori Moreno’s inoperable stage 4 brain stem glioma
David Gorski has the chutzpah to pontificate that Dr. Fred Epstein in New York misdiagnosed Tori Moreno’s inoperable stage IV brainstem glioma [5]
——————————————————————
The article then quotes Peter Adamson, chair of the Children’s Oncology Group:
—————————————————————— “But these therapies may have delayed benefits, taking weeks or months to shrink a tumor“
“So patients treated by Burzynski may credit him for their progress, just because he was the last doctor to treat them, says Peter Adamson, chair of the Children’s Oncology Group, an NCI-supported research network that conducts clinical trials in pediatric cancer“
“Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation“
“A patient who isn’t familiar with this phenomenon may assume her tumor is growing“
“When that swelling subsides, patients may assume it’s because of Burzynski, Adamson says”
——————————————————————
This is laughable
In support of this “phenomenon”, the article provides a link to a Canadian web-site [6]
The site posits:
—————————————————————— “RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”
“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ”
——————————————————————
Additionally, the site cites the reference as:
Sanghera, Perry, Sahgal, et al., “Sunnybrook Health Sciences Odette Cancer Centre” (in press, Canadian Journal of Neuroscience)
(“In press” refers to journal articles which have been accepted for publication, but have not yet been published)
However, the journal article in question was published 1/2010, so it has NOT been “in press” for over 3 years and 7 months [7]
Get your act together, aye, Canada!
——————————————————————
The articlerants and raves on and on about FDA inspection reports from as far back as 1998, but at least they did quote Richard A. Jaffe:
“The FDA has not yet issued final conclusions”
——————————————————————
The article posts this ridiculous claim:
—————————————————————— “Yet the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer“
——————————————————————
That’s NOT what this seems to suggest [8]
——————————————————————
Then the article quotes pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia, in what will no doubt soon be known as a “classic”:
—————————————————————— “He’s a snake oil salesman,” says pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia”
——————————————————————
All I’d like to know is, which rock did this clown crawl out from under ?
Dr. Adamson, please advise which “snake oil” has been granted Orphan Drug Designation (“ODD”) from the United States Food and Drug Administration [9], and which “snake oil” has been approved for, and used in, phase III clinical trials ? [10]
—————————————————————— Q: Is it, it the phase 2 trial is finished ?
A:“Mhmm”
Q: but theyโre still accepting people ?
A:“Yeah”
Q: on more like a special ?
A:“Special basis, and, um, sometimes compassionate grounds“
A:“(compassion exception)”
A:“Uh, exceptions“
Q: Thatโs normal ?
A:“Yes” “So”
A:“(Yes I guess it is a funding issue ?)”
Q: Right
A:“(Like FDA, during the 2nd phase of clinical trials they found the data to be, real, real one, and they gave him the ok to go for 3rd phase of clinical trials, but just to go through this process you would probably need $100,000)”
——————————————————————
——————————————————————
Oh, wait !!
Dr. Adamson, when you say “snake oil”, I take it you are referring to the low-dose chemotherapy that Burzynski uses ?
Dr. Adamson, do you know what a “hack” is ?
——————————————————————
In regards to the Merritt’s, the article has:
—————————————————————— “The couple say that Burzynski misled them about the type of treatment that would be offered, as well as the cost”
My questions about the Merritt’s are:
1. Where is their complaint to the Texas Medical Board ?
2. Where is their lawsuit ? Couldn’t they find an attorney to take their case pro bono ?
——————————————————————
The article continues:
—————————————————————— “Yet even Jaffe has acknowledged that the trial โ now in its 17th year โ was more about politics than science”
“In his 2008 memoirs, Galileo’s Lawyer, Jaffe called it “a joke.””
“”It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment,” Jaffe said“
——————————————————————
What Liz Szabo and her friends at USA TODAY fail to let the readers know, is that this only applied to one trial:
—————————————————————— Burzynskiโs lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynskiโs 11/25/1997 Securities and Exchange Commission (SEC) filing [11]
—————————————————————— One trial that is retrospective is CAN-1 Clinical Trial
—————————————————————— CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN
PATIENTS WITH REFRACTORY MALIGNANCIES
133 patients
—————————————————————— Clinical trial of patients treated by Dr. Burzynski through 2/23/1996
—————————————————————— FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
——————————————————————
The article continues in the same vein:
——————————————————————
“In an interview, Burzynski said developing new drugs is complex and takes time”
“Yet the FDA has approved 108 cancer drugs since Burzynski began his trial”
—————————————————————— Ms. Szabo and “pals” conveniently “forgets” to educate their audience that Burzynski was using Fleming’s One-sample multiple testing procedure for phase II clinical trials [13], which requires that if the 1st 20 patients meet certain criteria, 20 additional patients are added [14]
—————————————————————— “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 thatโs 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“[15]
——————————————————————
Then Fran Visco, president of the National Breast Cancer Coalition makes an outlandish statement, which is quoted in the article:
—————————————————————— “Fran Visco, president of the National Breast Cancer Coalition, describes the FDA’s tolerance of Burzynski as “outrageous.””
“They have put people at risk for a long time,” says Visco, an attorney and breast cancer survivor”
“That’s completely unacceptable”
“How can anyone look at these facts and believe that there is a real clinical trial going on … rather than just using the FDA and the clinical trial system to make money?”
——————————————————————
I have a suggestion for Ms. Visco
Take your hypocrisy and ask the American Cancer Society if they are still engaged in this kind of activity:
1.AMERICAN CANCER SOCIETY: More Interested In Accumulating Wealth Than Saving Lives [15]
2.National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest [16]
——————————————————————
Then, ask the American Cancer Society, why is it that 10 years ago, estimated breast cancer deaths were expected to be 39,800 (15%), and this year it was 39,620 (14%), which is ONLY 180 LESS than 10 years ago ?
—————————————————————— Estimated Breast Cancer Deaths (Women)-USA
—————————————————————— 2013โ39,620 (14%)
2012๐39,510 (14%)
2011๐39,520 (15%)
2010๐39,840 (15%)
2009๐40,170 (15%) 2008โ40,480 (15%)
2007๐40,460 (15%) 2006โ40,970 (15%)
2005๐40,410 (15%) 2004โ40,110 (15%)
2003โ39,800 (15%)
2002 – 39,600 (15%)
—————————————————————– American Cancer Society Cancer Facts & Figures (2002-2013)
—————————————————————–
And then ask the American Cancer Society, why is it that 10 years ago, the estimated NEW breast cancer cases were expected to be 211,300 (32%), and this year it was 232,340 (29%), which is 21,340 MORE than it was 10 years ago ?
—————————————————————— Estimated New Breast Cancer (Women) – USA
—————————————————————— 2013โ232,340 (29%)
2012๐226,870 (29%) 2011โ238,480 (30%)
2010โ207,090 (28%)
2009โ192,370 (27%)
2008โ182,460 (26%)
2007๐178,480 (26%) 2006โ212,920 (31%)
2005๐211,240 (32%) 2004โ215,900 (32%)
2003โ211,300 (32%)
2002_-_203,500 (31%)
—————————————————————– American Cancer Society Cancer Facts & Figures (2002-2013)
——————————————————————
And after that, ask Susan G. Komen how much is spent on legal action to protect her brand, compared to how much is spent on breast cancer research and prevention ?
—————————————————————— Visco, the breast cancer advocate
“I do NOT know why it took YOU so long.”
——————————————————————
The article continues with:
—————————————————————— “Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades”
——————————————————————
Yet, “The Skepticsโข” refuse to discuss:
—————————————————————— 2/13/2013 โ The frequency, cost, and clinical outcomes of hypernatremia in patients hospitalized to a comprehensive cancer center
Over 3 month period in 2006 re 3,446 patients, most of the hypernatremia (90 %) was acquired during hospital stay [19]
Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA
Department of General Internal Medicine, University of Texas MD Anderson Cancer Center
Division of Endocrinology, Mayo Clinic
—————————————————————— 9/1999 – The changing pattern of hypernatremia in hospitalized children [20]
Department of Pediatrics, Texas Childrenโs Hospital, Baylor College of Medicine, Houston, Texas, USA
——————————————————————
So, after all that, my question for USA TODAY is, does Liz Szabo, Michael Stravato, Jerry Mosemak or Robert Hanashiro have a journalism degree ?
Because if any of them do, the institution they obtained it from most be so proud of this piece of “fish wrap” you produced
Thank you, USA TODAY, for censoring my 18 comments
I guess you must be (“intellectual”) cowards
At least Forbes had the GRAPEFRUITS to post some of my comments
โโโโโโโโโโโโโโโโโโโโโโ You’ve just been served, INSOLENTLY
โโโโโโโโโโโโโโโโโโโโโโ USA TODAY, GONE TOMORROW
โโโโโโโโโโโโโโโโโโโโโโ
====================================== REFERENCES:
====================================== [1] – 11/15/2013 – USA TODAY NEWS, NATION Doctor accused of selling false hope to families
Liz Szabo, USA TODAY
โโโโโโโโโโโโโโโโโโโโโโ http://www.usatoday.com/story/news/nation/2013/11/15/stanislaw-burzynski-cancer-controversy/2994561/
====================================== [2] – Mayo Clinic – 1999 – report: Lisa Merritt
โโโโโโโโโโโโโโโโโโโโโโ https://www.documentcloud.org/documents/816819-mayo-clinic-1999-report.html
====================================== [3] – 2012 – former Burzynski web-site screenshots, Pg 3 of 62;
โโโโโโโโโโโโโโโโโโโโโโ
I found it humorous that the USA TODAY article by Liz Szabo [1], used the same line that “The Skepticsโข Guy Chapman tried to use on me during his #FAILED “debate” attempt against me, where he decided he didn’t want to play anymore, and grabbed his balls and went home [2] ๐
But I knew without a shadow of a doubt that something smelled rotten in Denmark, when the article quoted Jan Buckner, a professor and chairman of oncology at the Mayo Clinic in Minnesota
Jan Buckner took part in the Mayo study that was published in 1999, which Burzynski has called into question, and which Eric Merola covered in the original Burzynski: Cancer is Serious Business [3]
====================================== 4/2012 – Pete Cohen chats with Rick Jaffe (33:59) 11/9/2012 Richard A. Jaffe, Esq.
======================================
How did you meet Dr. Burzynski?
A long time ago in 1988, um, he hired us to represent him in his Medical Board case, so, uh, started working for him then, and then there got to be more and more work, and, uh, at some point it was so much work, it was just easier for me to be down here
So I moved from New York to Texas, mostly just to, to represent him, and my wife was in the oil industry, so, it was a “no brainer” for her to move down here too
And how, were you intrigued by this whole case ?
I mean, did you work out straight away that this guy was genuine, and there was really something here ?
No (laugh)
How do you know, you know ?
At the time we represented, uh, a number of a alternative health practitioners around the country, and we heard a lot about Burzynski, but you don’t really know
I mean, um, um, there are a lot of stories out there
Every doctor seems to have a few patients, uh, that were helped
So initially, I mean, how do you know ?
His operation was larger than most of any, uh, health practitioners, alternative health practitioners in the country, and, uh, seemed a lot more sophisticated, but, uh, it’s not really until you dig in the medical records of the patients that you really see what’s going on
I mean, that’s what you really need
I mean,
It’s not really even, it’s
’cause this whole thing about anecdotal evidence, that everyone has testimony
so every doctor
You know what I mean ?
anybody
Even charlatans have testimony
people
one or two people
or 3 or 4 that’ll come, and say w
they were cured, and maybe, maybe the patients really believe that to be the case, but, um, oftentimes there’s other explanations
Prior treatment, um, the nature of the disease
Sometimes it’s such that their natural, the natural history is not straight linear, um, but after looking at some of the medical records, I mean, you know, I think
it’s just,
uh, anybody would become a believer, and indeed, I mean, government, government doctors have come down here and looked at
some of the records, and they were convinced that, that the treatment was causing remissions in some brain cancer patients
So, I mean, obviously lawyers, I imagine many lawyers all over the world would often take on a case, when they know, possibly the guy isn’t telling the truth, but they can see there’s still a story, and they, they, they, they, uh, represent that person, but for you, I suppose
that when you realized that there really was a story here, did you kind of get, emotionally caught up in this whole thing and think: “Right, th this guy’s got a cure for cancer, and I I need to bring this to, bring him to just, not bring him to justice, but, clear his name
Well, I think with Burzynski, more so than any client I’ve ever represented
He represents a unique constellation of medical services
He’s the only guy in the world doing what he’s doing with antineoplastons and now with this treatment, so, it’s really different
Uh, you know, with Burzynski, most of the patients, are in bad shape
They’re either dying, uh, they, or they have a disease for which there is no known cure, you know, like a lot of these brain tumors
So, even from the beginning, what’s different is their are many, many patients back then who were on the treatment, that uh, that felt that without this treatment they were going to die, and so that, that’s much different, than the average, any kind of lawsuit
Right ?
So th th these lawsuits, the Burzynski cases back then and now, uh, these cases matter, in a, in a deeper, and fundamental, and personal way than most anything, well I think that any lawyer does
I mean, any criminal defense lawyer, who defends an individual, is defending that person’s, uh, liberty
Alright ?
Versus incarceration
But here it, it wasn’t so much, or, it wasn’t exclusively about Burzynski, it was really about all these other patients, and they certainly believe they needed him, and, uh, uh, many of them, obviously did
So, so that, that, that’s a whole ‘nother dimension, which typically we lawyers don’t get involved in
So, I mean, it’s a responsibility but also a great privilege to be working on these kinds of cases
You’ve been representing him for how long ?
For a long time
Since 1988, continuously
And can you believe this is still going on ?
Well, you know, uh, it’s, you know, it’s, it’s just ongoing
I mean, until there’s a cure for cancer, for all cancer, either done by acknowledged
or, uh, uh, to be Burzynski’s cure or somebody else’s
I mean, this is ongoing
And I guess the problem is, you know, ultimately, there’s nobody yet
Not even Burzynski has the cure for every cancer or
even every stage, or even ev, every, ev, ev, every person that had cancer
So, because it’s such a tough battle, and because, it doesn’t work on everyone
So you have these open questions
Ah, so, so,
Yeah, I mean, I guess, I, I can’t believe he’s still messing around with these clinical trials
I mean, I think that if the drug didn’t have his name attached to it, it’d probably would have been approved by now
So, and I think, so that, that’s unfortunate, I think, that when you fight the FDA, and even if you win, you know, the F, the repercussions, you know, you know I, you know I
Hopefully the drug will be approved, sometime in the future, but, but who knows ?
So, um, why do you think, why was it, I mean, obviously I came over here as you know, for this case, which is now not going ahead at the moment
Why, why, why is that ?
Wha, what has the judge, said ?
Well, of course, you have to (under)stand, this case involves a different type of treatment
It doesn’t involve antineoplastons,the drug Dr. Burzynski invented, and your friend is receiving, and it involves a new approach to cancer, which is sort of like personalized medicine, where they take a bunch of FDA approved drugs, that have shown some promise, on a particular cancer, but are not, uh, approved for that indication, and based on these early clinical trials showing promising results for genetic testing they give these combinations of FDA approved drugs, off-label to patients, and that’s really what the, this case is about, and, uh, you know I think, I don’t think they, they never had a case
I mean, they never had a case
The, the main allegation, in each, of the 2 patients involved, is that they used this treatment, which wasn’t sufficiently tested, and was non-therapeutic, and whatnot, and we had a, what I would call a dry run
We presented the evidence to the Board, or 2 members of the Board, in both of these cases
In each, in each case, the Board members felt that the treatment, was within the standard of care, given the advanced condition of the patient, or one patient, and given how rare the other patient’s tumor was
So, we had our dry run in each case, and the Board found in our favor on the main charge
They had some technical issues with medical records or whatnot, and, uh, the Board basically said, they took the position, ok, agree to some kind of sanction on these little charges, or, or we’re going to go after you on everything
So, we refused the honor, and, uh, the Board then charged him with the same thing that they already cleared him with, or on, and, and so we had to do, you know, basically the same case again, and, uh, the irony in, is in these 2 cases Burzynski wasn’t even in the country
He was, he was, he was away for, uh, in both, for both cases, when the patientscame
So, uh, the question is how do you hold someone responsible
Even if you own the clinic, for treatment administered and prescribed, by other doctors, and that concept of vicarious liability does not, uh, exist in jurisprudence, and in the law governing professional re, responsibility, anywhere in this country
So, the Board’strying to start that
You know, I think they just got in over their heads, they
Most people just knuckle under
You know, most people don’t, are afraid to go to court, so they’ll sign anything just to, you know, not to go forward, but, you know, Burzynski faced serious stuff
I mean, he set, faced, 5, 10, 15 years in jail
So he wasn’t going to be intimidated, by the Medical Board, and he refused to give in
So when I told the Board at the time, and I told them all along, they have no case, and o on the merits they have no case
We already won, and they have no case now, and, and slowly I think, the Board is starting to understand that
And what sort of a person would you say Dr. Burzynski is ?
Well I think he’s a complicated person
I mean, I think, uh, uh, you know, he, I think like a lot of mavericks; I represent a lot of mavericks around the, uh, uh, country
One of the main characteristics of these guys, is that they have absolute and total certainty, in what they believe in, in what they do, um, and no doubt
Uh, they all think they’re right
They all think that history is going to vindicate them
Now, I’ve represented some people where I personally doubt (laugh) that, uh, uh, that belief, but not in Dr. Burzynski’s case
I mean, I think he’s all, he’s definitely helping people
He’s definitely, uh, uh, uh, making, extending people’s lives, and curing some people that otherwise would have died, and so I think he, and so I think he happens to be right
So, uh, you know, so, but, but he’s a human
He’s got a big ego
He thinks he’s, uh, he thinks he has made an important, contribute to medicine, and he’s not shy about sharing that sentiment
So, uh, I think, and I think that he’s, uh, not American
So he comes with a completely different mentality towards, say, the government
Alright, he grew up in communist Poland, where everyone, where everyone, has to work around, the government, and I think that’s much harder here, and, you know, I think he has expectations that, that he would have a lot more freedom, than it turned out he had, too, and he thought he would not have to deal with the kind of government, uh, rigamarole that you have to deal with in communist, Poland
And, and how do you think it might all pan out for him ?
I mean, I know you don’t have a crystal ball, but if you could look, 5 or 10 years down into the future, and, do you think that he will have got somewhere, to be accepted in the medical (?) of oncology ?
Well, I certainly hope so
I mean, 5, 10 years from now
I mean, I think, at a minimum, what’s going to happen, there will be many, many patients who will be alive, and continue to be alive because of him
Some, will have their lives extended
Some will be cured
Some wi, won’t be cured, and will die
So, I think that’s for sure, going to happen
You know, is there going to be an end to, uh, all this ?
We had a period of maybe 10 years where there was very little action with the Board, but, uh, you know, it’s hard, frankly, I mean, just in, and again my perspective, like I’m in a, like a, a sergeant in the trenches, in trench (laugh) warfare
So, it’s hard for me to see the big picture
I mean, I just keep fighting these battles, and there’s one, after another, after another
So this is really just the latest, and on there’s civil lawsuits, and then there are people on the Internet, and then, you know, there could be more Medical Board investigations
So, lo, look there are a lot of people who don’t like what he’s doing
They think what he’s doing is either unethical or wrong, or shouldn’t be giving drugs, these drugs to people, except under clinical trial conditions, and, you know, he has detractors, and he has a lot of supporters
I mean, uh, mostly amongst the patients he’s cured
So, I don’t know that, that, that is gonna resolve itself
I mean, ultimately, he’s one of the few people in the country, that, or maybe the only person in the country that does what he does, and, it’s not the way medicine is practiced, in this country, typically
Right, and, you know, I think what he does, is, is more, is more patient oriented, in a sense that, once you’ve been told you’re terminal, why should you just get the palliative care that a medical oncologist thinks, you know, they should be given
even though when, no one ever gets cured of chemotherapy, once it’s palliative, once you have stage 4, solid tumor
Mmm
I mean, they give chemotherapy for what they call palliative reasons, which means, not curative
So, this concept of giving, just conventional chemotherapy to make you feel better, extend your life 9 weeks, I mean, y, not everyone wants to do that
Some people want a shot for a real cure, and, you know, based on the evidence with antineoplastons
, I mean, he seems to be giving people that shot, and curing some of the people
So, you, you know, I don’t see how, this thing gets resolved
Up until the time that the treatment, the antineoplastons is approved by the FDA and, you know,
it’s, it’s hard to see a clear path, for that, for a lot of reasons, not the least of which is financial
I mean, it takes dozens of 10’s of millions of dollars
Mmm
or 10, 100’s of millions
So, I mean, someone has to finance the clinical trials
The drug companies aren’t interested right now
They’d just as soon, buy a drug that’s been fully tested
So, I mean, the drug company response has not been overwhelming, because, even though this phase 2 phase, have resolved, and, and, uh, they have excellent results, the drug companies want to wait and see
So, uh, it’s, it’s big money
I don’t think there’s any way in the world Dr. Burzynski, himself, can fund phase 3
I mean, he, he funded everything else now, but phase 3 are, is a much bigger stage involving dozens and 100’s of patients, and that’s just within the financial means of any individual
it seems like it’s unlikely that its going to happen right
I mean, even from the point of view of, what, with phase 3 trials, they’ll be with children
with brainstem gliomas, right
and the FDA’s saying they’ve got to have radiation
Yeah I, um,
I unfortunately, I haven’t been involved in that process
I just see the result, and I, I, I just don’t see how any parent agrees to that, you know
I don’t see how any parent agrees to it
I don’t see how clinical investigator, agrees to do it
Um, I don’t know
I got so, I got some questions of the FDA as to, why they forced him into this particular protocol
I mean, I don’t know
I don’t have any facts or evidence, but I, I, just doesn’t make any sense to me
what’s you’re about that ?
I don’t know
I mean, I, it just doesn’t seem to me, that it’s a, that it’s a fair clinical trial that
Mmm
either an investigator would find ethical, or a patient, or a family, would agree to have their patient treat, their, their kid treated under
I mean, it just doesn’t make any sense to me
I mean, it’s worse than
I mean, both phases, both phases, both arms of the study, you get radiation
It’s radiation alone versus radiation with his stuff
So, I mean, it just doesn’t make any sense to me, given, given the clinical, the phase 2 clinical trial results
So just a, so just a few things, like, you know I’m going to talk about big Pharma, and then talk about the FDA
Right
They talk about the many people as if they’re one person, but, you know, they’re obviously a collective group of individuals who work for an organization, right ?
Well, I mean, I think, the concern is, that the FDA now, by statute is, in no small part funded, by the pharmaceutical industry
It’s like “Pay as you go”
So the, the pharmaceutical ind, industry now, pays for, the processing of the clinical trials by the FDA
So, and then you have the whole concept of the revolving door
You have a lot of government officials going into the drink, uh, drug companies
So I think that’s another problem
So, I mean, you know, I think conspiracy is too strong of a word, m, but, you know, I will say, I don’t think the system’s set up, for an individual like Burzynski, to get a drug approved
I, I, I just don’t see
There’s no support for that
I mean, the days
I mean, it’s like, Einstein, you know ?
He sat in a patent office, and, and doodled, and had his little theory
He could never get his, stuff published today, you know ?
Where did he go to school ?
Where was he teaching, you know ?
So Burzynski has a lot of the same problems
They say he doesn’t publish, but, they won’t let him publish
So, uh, or they won’t let him publish , in, in the mainstream journals
So, I, I, I think though, I think the, I think the system, has a strong bias, against a guy with a discovery
So, that’s not quite saying, there’s a conspiracy, but it’s, it’s sort of along the same lines, and, you know, the conspiracy implies some kind of, um, intentionality on the part of one or two, or some small group or coterie of people, and I don’t know, I don’t think that’s really the case
I think what happens is, the institutions are such that, they allow certain things, and disallow certain things
Alright ?
I think that’s just
there’s no
I don’t think there’s any 2, 3, 4, or some, coterie of Rocka, they’re like a Rockefellerconspiracy
People are saying that there are 12 industrials
That they control the world
I mean, I don’t see that happening, but, the whole system is such that, you know, it’s, it’s
I guess what, uh
The, there’s a book by, uh, a, a, Thomas Kuhn, the Structure of Scientific Revolutions, and he talks about, normal science, and how science progresses, in terms of paradigm shifts
So, normal scientific medicine, works, uh, by big institutions doing, studies about combinations of drugs, after drug companies, invent mostly, modifications of existing drugs, and, less commonly, completely new drugs, and, uh, less commonly, different classes of drugs
So, you have a whole, you have a whole pipeline from a drug company, a whole, uh, uh, mechanism of testing, by the universities, funded by the pharmaceutical company, uh, all the pharmaceutical companies, and that, that just doesn’t lend itself, to one guy, sitting someplace in Houston, or wherever, and having a drug, put through that process
That just doesn’t happen Burzynski is, so far as I can tell, the only person, to ever completed, a phase 2 trials on a drug he invented
I don’t think that’s ever happened, before, and I don’t think it’ll ever happen again
Ah, was it ’98, was it the chairman, uh
Kessler ?
Kessler
I saw, an interview he gave, press, a press conference where he was explaining about, being able to fast-track
The FDA trying to make it possible to fast-track, you know, drugs that have shown, you know, positive, rather than going through all of this sort of clinical trial, and there’s a guy in the, in the press conference who started asking questions about Burzynski
Right
and you could just see quite clearly he was very uncomfortable
Right
asking questions about, uh, about Dr. Burzynski
How do you think someone like him,
would view, someone like Dr. Burzynski?
Not favorably
I think that, uh,
Do you think they must know ?
Do you think they must, even he, let’s just say, if he were on his own, he, he knows there’s something there
That he’s obviously got something
I,
I don’t know, uh
I think, that, the guys in conventional medicine, because Burzynski came from orthodox medicine
He was at Baylor
He was a researcher at Baylor
So, I think, they’re not going to Burzynski, is that, he didn’t go about it, the way, other physicians would have done it, other scientists would have done it
So normally what would happen, is, uh, uh, I mean, I think the critical, point in his story is that, when he was at Baylor, and his, uh, professor was supporting him, this Unger, left, you know, they had space for him
They wanted him to go in the Oncology, uh, Department, but, they wanted the patent, to his drug, and he wouldn’t do it
So, that would have been the more conventional approach
You give up the patent rights, you become part of the team, then some big institution, uh, uh, shepherds the drug through, and then they find some drug company support, who will split the patent with the university
So, had he done that, uh, you know, I think the drug woulda been approved by now, but, you know, it was his drug
He came to America with it, and he wasn’t going to give it all away
So, I mean, I just think that’s, you know, I mean and that’s, you know, I think he wasn’t expecting that kind of thing in America
Maybe in communist Poland, but not in America
So I think that really, you know, set him down the path of being a, a, an alternative health practitioner
And wha, wha, what was it like for you when, uh, winning, the case, in was it, 199, 3, 1998 ?
’97
1997
Well, you know, there wasn’t just one case
I mean, I mean, it was everyone
I mean, I analogize it to, like whack-a-mole, or whack-a-rat, you know
You have, like a rat come out of, of a hole, and you bang him, and one comes out of this hole, and all of a sudden you’ve got 2, and then 3, and, so, you know, during the early ’90’s, I mean, I mean, there were 3 grand juries, uh, we had the Medical Board action, which went to hearing in ’93
The Texas Department of Health sued him in ’92
Half a dozen insurance companies had sued, uh, uh, sued him for, for some, for Racketeering
Uh, Texas Air Quality Department went after him
I’m trying to think who else
So, all of this happened, over the course of 3, or 4, or 5 years, and it was just, continuous, and so, one agency would, would get active, and then, they get beaten down
Then somebody else would come, uh, come up, and surface, and indeed, I mean, you know, it, you know, some of them flat out said they were waiting to see what happened, with this oth, wha, what happened with this other agency, and they weren’t gonna do anything, and then when they got tired, they decided, that this new agency had to do something
So, I mean, that was flat out, what happened
So, yeah, I mean, it culminated in the criminal case, I suppose, but even there it was up and down
I mean, the judge ordered, uh, ordered, prohibited him from giving the treatment to anybody else, because the Texas Medical Board case, ultimately went against us, and then we had to go Congress, and Congress forced the FDA to put all his patients on clinical trials which made the Medical B, Board case moot, and then we won the criminal case
So, after we won the criminal case in, uh, ’97, things got quiet for a little bit
So that, that, that was good
I mean, it was quiet
I mean, relatively quiet, and then, uh, lately in the last couple years it’s been very active again
So the worst case scenario would have been
What would have been the worst case scenario ?
For when ?
And this, this
What could have happened this week if the case had gone ahead ?
Well, the worst case scenario would be, there would be a finding, that, that it’s a depart, it’s a departure from the standard of care to use, uh, off-label drugs, that haven’t been approved by the FDA for an indicated use, and you can’t use the combination of the drugs until someone gives the stamp of approval saying that their safe and effective, which means, you know, you couldn’t, it couldn’t, you couldn’t give the treatment anymore to patients
So you have 100’s of patients that are on this multi-agent gene-targeted therapy, and ultimately that form of treatment is only available at the Burzynski Clinic
I mean, I don’t think that even clinical trials Burzynski, depending on how you look at it, he’s a few years ahead of, of, uh, well, even the clinical trials
I mean, they’re some clinical trials now on different kinds of cancer where they’re doing 1, 2, or 3 agents
He’ll use 4 or 5, albeit, lesser dosages
So he’s treated 1,000’s of patients like that, but there’s no place else in the world where people can get, the treatment
So it’s kinda the same thing as back in the ’90’s
We have people on drugs, uh, which are unavailable, uh, and, only available through Burzynski
So, if he couldn’t give them, to people, then they wouldn’t get ’em, and, they’re terminal, and, they’re doing well
I mean, or they’re not going to do as well, or they’re going to die
So, it’s, I guess it, it’s sort of the same thing here, ah, uh, only, uh, the irony is all these drugs are, approved by the FDA, and most cancer patients get off-label, uh, drugs Drugs off-label
So that’s, very common in cancer
It’s just that not common with the drug used on these patients, and in the combinations used
So, this finally
Whe, when you’ve, uh, won these cases, I mean, there must be, it must be good, right ?
It must be good feeling
I had a good feeling last week
I mean, I mean, you know, or I’ve been working non-stop, for months, every day
I mean, there’s no day off in this kind of stuff
It’s just constant
It’s just, his war
There’s always something to do, and then I’m a solo practitioner
So, when the judge cut the heart of the Board’s case out, I’ve been telling the Board, that they can’t, that they have no basis to, to, to bring charges against him, for several years, since 2010 , 2009, and they’re not listening, and, and, I was pretty sure that once you had a judge look at the case, they would, rule in our favor, you know, but the problem is the Board is, like a law unto themselves, and they think they can do anything, and, uh, they just changed the law, in September
So actually, the Board has no recourse
They, they used to be able to change findings of facts, and conclusions of law, but as of September, 2011, they can no longer do so
So, if the, judges’ ruling s, uh, stands, as I think they will, their only remedy is going to be to appeal to a State District Court, and they’re not used to that, because they, like exercising, uh, complete authority
So, they’re in a new position, and I’m sure this is the 1st case, that they’ve ever, not gotten what they want to, from, from a judge, administrative law judge, and not being able to correct it
So, I mean, that, this is a good ti, completely new experience for the Board, and I feel bad for them (both: laughing)
You, you, you do
As a Board they all sit down, and as a group of people, and talk about Dr. Burzynski, and, and, and work out how they’re gonna bring him down, and then ?
Well, that’s more the conspiracy
I, I, I, I think that, some of the Board members, may know of him
He, but, but, but like I say, he’s appeared in front of these informal settlement conferences, and basically, individually they, I mean, exonerate him, of, of the main charges, but I, I, I think that, you know, when we talk about the Board, the Board other than these a, acting informal settlement conferences, where you have one Board member, and one member of some district disciplinary review committee, we’re not really talking about the Board members, these doctors, and lay members of the Board, we’re talking about the Board staff, and that’s the lawyers and administrators of the Board, and I think, you know, I don’t know
I have some, uh, uh, they need to clean house
I mean, they’re getting some very, very bad legal advice, and I, I just think the legal advice at the top, is, is, is horrible, and, and they need to make some dramatic changes, and I think it would be better for the people of Texas if they, just did some house cleaning with the administrative staff there
And what do you think about the way that, uh, Dr. Burzynski’s been , what’s the word, in England, he’s got a very bad press there
(Alright ?)
and, um, why do you think that is ?
Uh, why, well, I mean, look
I mean, I think, people have opinions
They’re,
they have the right to express opinions
I mean, I think, uh, some of his agents did some things that I think, were not wise, in retrospect
I mean
Mhmm
Uh,
The stuff with the, this kid, this blogger
Yes
(?)
And I think that, uh
I think you have to be very careful, about what you tell people that are expressing opinions, and, you know, I mean, I, I, I think, you know, I think there’s a reason why, lawyers get involved in these cases, and should be involved, and I think what happens is, you know, I think there was a, you know, a well meaning, individual, who just went too far, and I think stirred things up unnecessarily so
You know, I mean, I think someone who had some legal training, acting on Burzynski’s behalf, might not have made some of the, you know, just faux pas that were made
So, I mean, that stirred, some things up, and I think
(?) stirred something up that was already there ?
You know, ’cause, I know, I’ve spoken to so many people in the U.K., and, uh, and you find very few people that have anything positive to say
In fact, a friend of mine who’s a famous doctor on television, when I was here, he was on British television with a little girl, and her father, who were trying to, uh, raise money to, um, come over here and, um, in fact, they couldn’t come anywhere, come, they couldn’t come anyway, because, the, uh, FDA said that this type of brain tumor, she couldn’t be treated anyway
But this doctor, who’s a friend of mine said, uh, Dr. Burzynski is, you know, he’s a medical pioneer
He’s, uh, uh, he said that and then literally, for 2 months, non-stop, I think especially on Twitter, they said that he never should have said this, and the guy is a quack, and he’s a, he’s a fraud, and
So your, your friend got in trouble for saying that he’s a pioneer ?
He didn’t get in trouble, but I mean he got a lot of bad press, for speaking on television with this child next to him, saying that, Dr. Burzynski was, you know, a pioneer, and pioneers often have a hard time, and
Right, right
And, you know, you look at Twitter, uh, you probably don’t
You could be (laugh) and you just see, it’s probably, probably the only, 30, hard, hard core people, who spend, all of their time, trying to
Yeah, I think that’s right
I think it’s a very small group, of people, that are making pretend it’s a big movement
I mean, we’ve looked, at some of the traffic
We’ve analyzed some of the traffic
I don’t even think it’s 30
I think it’s more like, 3, or 4, or 5, that are creating things, and then someone had some friend who’s an actor, who has, you know, 3 million followers, and all
So it’s really a very small group of people, but historically, medical doctors who have stood up for Burzynski, have had negative consequences
We had, someone from the National Cancer Institute, NIH testify, this Nick Patronas, and he got in a lot of trouble for doing that
So, you know, it’s not, it’s, unfortunately, you know, speaking up for Burzynski can have, uh, negative career consequences, or, or just some bad P.R., but that’s, part of being a pioneer
It doesn’t mean that, uh, Burz, I mean, if anything, I mean, it shows, it shows that’s like the medical mafia
Yeah
So, that’s what I call, the church of medical orthodoxy
So, that’s what I call
So
Well I, I think it’s gonna be so interesting when I get this film broadcasted, to see what kind of reaction we get
It, it’s just a story I felt I had to (?)
Where are, where are you going to try and get it ?
I’m going to try and get it
I know people at the BBC
Right
I’ve worked in television
So I’m going to try
Oh really, (?)
I’m gonna try those avenues, but you know what ?
Even if it doesn’t
You have cable
You have some kind of public access ?
Yeah
I’ve, I’ve worked in television for years
So I’ve, I have a very good stab at getting it out there, but if I don’t, I’ll get it broadcasted on the Internet
Oh sure
You do, do a YouTube or something, or do what Merola did as a documentary
(?)
That’s had an amazing impact
Yeah
He’s making a sequel Eric was just over in England
Oh really ?
I looked after him when he came over
Yeah
He wanted to talk to some of the patients and doctors
Eric, I said, ah, you know, so, we’ll see
But listen, I really appreciate the opportunity to ah
Ok, no problem
really, to be able to talk to you
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