dougsmith - 26 January 2012 08:16 AM

traveler - 26 January 2012 08:14 AM

I respect this forum, which is why I asked for help in understanding why Burzynski is a quack. So far, I’m left wanting…

What about the material in the OP?

Well, I only read the first paragraph… I’M KIDDING!

That material was not as convincing for me as the evidence in the movie. I admit that I am a bit leery of some of these attacks on Burzynski after being exposed to the Barry Marshall fiasco. Interestingly, Barry was suspicious of a conspiracy against him by the FDA and Pharma (see S.I. 11/2004).

For example, the initial claim that the movie relies on three testimonials for its “proof” that Burzynski’s antineoplastons work is simply not true. Also, many very relevant facts in the movie are simply ignored by the OP links.

NB! I’m not saying Burzynski is not a quack. I just want a non-emotional, fact-based reason to believe he is a quack.

Could you list some of the very relevant facts presented in the movie? I’m assuming these facts are backed up by something approaching independently verifiable evidence.

And what was the Barry Marshall fiasco?

dougsmith - 26 January 2012 08:46 AM

Could you list some of the very relevant facts presented in the movie? I’m assuming these facts are backed up by something approaching independently verifiable evidence.

And what was the Barry Marshall fiasco?

Ok, I’ll make a list.

I’m sure you know of Dr. Marshall, but the fiasco part (perhaps overstated?) has to do with the irrational reaction of the mainstream scientists to his H. pylori theory. From Barry Marshall’s autobiography:

BARRY MARSHALL: I was met with constant criticism that my conclusions were premature and not well supported. When the work was presented, my results were disputed and disbelieved, not on the basis of science but because they simply could not be true. It was often said that no one was able to replicate my results. This was untrue but became part of the folklore of the period. I was told that the bacteria were either contaminants or harmless commensals.

1. The FDA brought (at least) four trials to court against Burzynski that did not result in any indictment, but they continued to go to trial. The presiding judge was shown in the movie saying that this was absurd.

2. Elan pharmaceutical’s desire to develop Burzynski’s work (but would not, only because they did not believe they could get one of the chemicals patented). Elan pharmaceuticals sought out Burzynski because one of the heads of the company had a relative who was successfully treated by Burzynski.

3. Dr. Samid’s relationship with Elan pharmaceuticals.

4. The fact that Dr. Samid did get several patents based on Burzynski’s work.

5. Dr. Friedman did not follow protocols dictated by the Mayo clinic’s contract with Dr. Burzynski. By not following the protocols agreed to, Friedman could be sabotaging clinical trial success.

6. Documents were shown that indicated that the FDA was aware that if an individual, rather than a pharmaceutical company, came up with a successful treatment then the money would be lost by pharma and the FDA relationship.

7. There were also some peer-reviewed articles cited Burzynki’s work. (I don’t recall the details here)

Traveler,

If you are interested in the skeptical response to the film, HERE is a detailed article addressing it.

From the point of view of scientific evidence, the reality is there is none of any reliable quality. Despite the fact that Burzynski has been running registered “clinical trials” for years without making public the results, there really is no convincing esearch evidence concerning “anti-neoplastons.”  And the point is somewhat moot since the majority of what Burzynski uses as treatment consists of conventional chemotherapy drugs applied in idiosyncratic ways, so the idea that somehow he is working on an alternative that might threaten Big Pharma is not consistent with what is actually happening at his clinic.

In general, the phenomenon of Burzynski and his clinic is a lot larger than what is covered in the film. He uses emotional appeal very effectively, but he also misrepresents what he is doing. The sins of Big Pharma, numerous as they are, have no bearing on the atrocious behavior of Dr. Burzynski.

Though not as moving as a film, here is a story about an elderly woman with advanced cancer who is now suing Dr. Burzynski for stealing her money with false promises and blatantly unethical conduct. This is not about a brave maverick against the pharmaceutical industry, it is about desperate cancer patients being taken advantage of and bilked out of their money and the last weeks of their lives.

mckenzievmd - 26 January 2012 01:25 PM

Traveler,

If you are interested in the skeptical response to the film, HERE is a detailed article addressing it.

From the point of view of scientific evidence, the reality is there is none of any reliable quality. Despite the fact that Burzynski has been running registered “clinical trials” for years without making public the results, there really is no convincing esearch evidence concerning “anti-neoplastons.”  And the point is somewhat moot since the majority of what Burzynski uses as treatment consists of conventional chemotherapy drugs applied in idiosyncratic ways, so the idea that somehow he is working on an alternative that might threaten Big Pharma is not consistent with what is actually happening at his clinic.

In general, the phenomenon of Burzynski and his clinic is a lot larger than what is covered in the film. He uses emotional appeal very effectively, but he also misrepresents what he is doing. The sins of Big Pharma, numerous as they are, have no bearing on the atrocious behavior of Dr. Burzynski.

Though not as moving as a film, here is a story about an elderly woman with advanced cancer who is now suing Dr. Burzynski for stealing her money with false promises and blatantly unethical conduct. This is not about a brave maverick against the pharmaceutical industry, it is about desperate cancer patients being taken advantage of and bilked out of their money and the last weeks of their lives.

That was the first link in the OP. I read that. I’ll look at the story of the elderly woman soon. Have you seen the movie? I am reserving final opinion on all of this until my brain is back to normal - I am currently fighting (for a few days now), a hell of a MO-FO chest cold. I trust both you and macgyver - and asanta. You’ll get me past this, I’m sure. 

Traveler its not easy to find time to watch a 2 hour movie and quite frankly i was so turned off by the obvious attempts to manipulate the viewer in the first 15-20 minutes that I need to really brace myself to watch the rest. I did take some time to try and research Burzynski though and found very little that he has published. There are a couple of patent applications in his name and some abstracts laying out his theories but precious little in terms of valid clinical trials. The only trial I found with his name on it was an open trial if you want to call it that ( basically he describes the outcome of ten patients he treated) but it was not blinded and there were no controls.

As far as Barry Marshal goes there was nothing at all that was a fiasco about that. What you see in his case is science butting up against human nature. His theory was unique and any such theory will require more evidence to convince the scientific community than a theory that is in line with the existing evidence. If the scientific community hadn’t met his ideas with skepticism they wouldn’t have been doing their job. We don’t accept theories based on one person’s opinion or one persons experiments. They need to be repeated and convincing the larger community takes time. I’m sure Darwin met with the same criticism. This sort of debate and critique is how science separates truth from fiction. If a theory has merit it will eventually win out over its critics and thats what happened with the H.Pylori theory of ulcers.

I find it frustrating that people are so willing to believe that the pharmaceutical industry and the FDA would actively try to bury evidence that a treatment was effective just because they thought it might not be patentable. It makes a nice story for conspiracy theorists and movie writers but its not real life. Pharma may not want to fund studies for such a treatment because they are after all in the business of making a profit or they go out of busniness, but why would they waste their time trying to discredit such treatments? The NIH often and quite rightly funds research into treatments regardless of their commercial potential and that is the proper place to get research funds for this sort of thing if there is no interest from the private sector but it seems that Dr. Bursynski is more interested in treating patients whether he can prove his treatment is effective or not.

I will watch the rest of the movie when i have some time but the fact that he is treating patients with a therapy that seems to have little legitimate research to support it makes me very suspicious of this doctor.

traveler - 26 January 2012 08:18 AM

asanta - 25 January 2012 10:30 PM

Traveller, the other thing you need to take into consideration is that after THIRTY years, the clinic is still conducting trials, without any serious publications in any peer reviewed journals, or publications of results. This is unheard of. In every other medical trial I have ever heard of, the patients are (nominally) paid for participation, this is the first medical trial I have ever heard of where the patient is charged…and they are charged 30+THOUSAND dollars for ‘treatments’.
These two issues should be HUGE redder than red flags.

It is clear that you too have not watched the movie. This is all very well explained by the movie.

What I find disappointing is that critical thinkers are making conclusions about a movie they have not even watched.

No…I did not watch ‘the movie’, but I know enough about the organization from trusted sources (along with my own knowledge as a medical professional) to know it should have been shut down years ago…
I don’t need to sit through a loooong movie explaining why the earth is really flat, to know it ain’t so. All the ‘splaining in the world isn’t going to change the truth.

asanta - 26 January 2012 06:20 PM

I know enough about the organization from trusted sources (along with my own knowledge as a medical professional) to know it should have been shut down years ago…

I don’t doubt that. But I think it might be interesting and instructive to hear what your sources have told you, and maybe a little background on them. (I don’t mean you should name names, but at least let us know why you trust them).

Just trying to make the discussion as information-rich as possible.

(I’m getting ready for work right now…but) off the top of my head…I read professional nursing and medical journals as a part of my profession. It gives you an idea of what is out there, the latest breakthroughs and almost breakthroughs…even studies which initially look promising, but later turn out to fall short. Burzinski has never published in any of these journals. The studies I do see (none in medical journals)are (as Mac says), poorly done and totally unblinded.  Quackwatch, Orac and Steven Novella are all good sources for information about, and delineating the problems with this ‘clinic’. I’ll post links after I get off work ..and sleep..

macgyver - 26 January 2012 04:09 PM

I find it frustrating that people are so willing to believe that the pharmaceutical industry and the FDA would actively try to bury evidence that a treatment was effective just because they thought it might not be patentable. It makes a nice story for conspiracy theorists and movie writers but its not real life. Pharma may not want to fund studies for such a treatment because they are after all in the business of making a profit or they go out of busniness, but why would they waste their time trying to discredit such treatments? The NIH often and quite rightly funds research into treatments regardless of their commercial potential and that is the proper place to get research funds for this sort of thing if there is no interest from the private sector but it seems that Dr. Bursynski is more interested in treating patients whether he can prove his treatment is effective or not.

The last sentence is a prejudicial opinion formed by reading works from those who disagree with him, and apparently some PR guy. I was unaware of any of that before I watched the movie. Regarding the conspiracy theorist, I am with you here - but as I said, even Dr. Marshall had his suspicions during his bout with his peers, so even reasonable persons sometimes think conspiracy as not too far-fetched.

I will watch the rest of the movie when i have some time but the fact that he is treating patients with a therapy that seems to have little legitimate research to support it makes me very suspicious of this doctor.

I do appreciate that. I believe that if you try to put aside the negative remarks you have read that you will find it worth watching. Yes, it’s 107 minutes but it does turn out to be powerful and it makes Drs. Kessler, Friedman, and Samid look like idiots. Some very reasonable experts (particularly one Chinese Ph.D.) side with Burzynski and against Samid. Also, there will then be at least one person besides me who has actually watched it. 

mckenzievmd - 26 January 2012 01:25 PM

Though not as moving as a film, here is a story about an elderly woman with advanced cancer who is now suing Dr. Burzynski for stealing her money with false promises and blatantly unethical conduct. This is not about a brave maverick against the pharmaceutical industry, it is about desperate cancer patients being taken advantage of and bilked out of their money and the last weeks of their lives.

Quackwatch has more about this HERE:

Her lawsuit (shown below), filed in Harris County, Texas, alleges:

• Burzynski pitched treatment with “antineoplastons” that would supposedly last three weeks.
• Brurzynski failed to inform the patient that the treatment would be part of a clinical trial.
• The defendants billed insurance companies fr some of the treatments but did not disclose that most of the cost would not be covered.
• The patient was coerced into buying certain drugs from Southern Family Pharmacy at “outrageous” prices and failed to disclose that Burzynski owned the pharmacy.
• The pharmacy charged $500 each for pills that could be purchased elsewhere for much less and charged the patient’s credit card without her knowledge.
• The patient was improperly led to believe the prescriptions would be covered by insurance.
• Side effects of Burzynski’s “treatment” included weakness, infections, vomiting, fatigue, mouth sores, dizziness, affected taste buds, joint pain, and skin sores.

Damning if true. And I don’t know if this was mentioned earlier in the thread but there’s also THIS hearing before the Texas Medical Board, which Barrett says is ongoing ...

OK. I stil havent been able to sit through the whole thing but here’s my not so brief summary of the first 1/2 hour or so.

Father of young girl – Claims he has expertise in fraud but his expertise has nothing to do with medicine and his opinion is worthless. His greatest claim is that the FDA said his treatments are non-toxic but does not provide evidence. Claims his duaghter died from radiation treatments and was cancer free. Facts that can not be verified. Claims there is a governement institution that disseminates false information but provides no documentation to back up that claim

Julian Whitaker, MD. ( Whitakers Wellness Institute - http://www.whitakerwellness.com/) – This is an Alternative Medicine Organization. Not sure what the term Institute means in this case as many doctors put that word in the name of their business to make it sound bigger and grander than it is and often its a one man operation that does no legitimate research of any sort. He offers various quack therapis at his “institute” including Chelation therapy. All he provides as support is that he claims he went to the Burzynski facility and saw 7 charts of patients who were in complete remission. Again there is no evidence to support these calims and even so they are nothing more than useless anecdotal reports with no controls and yet he says he was “astounded”.  He’s not exactly the most critical thinker is he? He’s a poor excuse for physician if this is how he approaches new research. He then goes on to state that it was “Obvious to me that Dr. Burzyski had made the most important discovery in cancer treatment EVER” Really? The most important discovery ever? And he makes this conclusion from 7 charts that were hand picked by Dr Burzynski.

Burzynski’s Theory – He found a strain of peptides that had never been seen before and cancer patients supposedly had lower levels of these peptides. This is a correlation not causation but he developed a theory that maybe the peptides could treat cancer. A reasonable conjecture. But Whitaker then goes on to say that the discovey of these peptides came as a big surprise and that he was “besmirched” as the urine doctor but as he is saying this he provides no evidence to back that up he mearly shows a letter from Aetna saying they wont cover this therapy because there are no studies validating the treatment in peer reviewed journals. And what does he mean when he says it was a bog surprise? Every new discovery is a surprise since by definition a discovery uncovers something you didn’t know was there before.  He then goes on to contradict himself. After saying the medical community made fun of him for studying something in the urine he then admits that the same medical community is using horse urine to extract estrogen to treat menopausal women.

Burzynski tries to bring credibility to his treatment by claiming he is using gene targeted therapy and that there are now 25 such treatments that are FDA approved in the U.S. . The difference is that those other targeted therapies are all backed by placebo controlled trials where as there are no such trials of his treatments which I can locate in the literature.

The next claim is that “The FDA Permits cancer patients to be treated using Antineoplastins in FDA approved clinical trials”. That’s not really much of a claim. You can treat anyone with anything as long as its an FDA approved trial. It doesnt say that any trials have actually been approved and while they next claim that he “places a heavy focus on brain cancer in his clinical trials” they don’t actually reference any of those trials.

This is followed by an anecdotal report from another patient. She claims that Dr. Burzysnki “cured” her but we don’t know that because we dont know what would happen if she wasnt treated. Lots of talk of studies but all he does is provide anecdotal reports rather than actual studies. They claim she was palced into a trial with Dr. Burzynski but no mention of where the trial was published. No reference is given.

They talk about clinical trials supposedly comparing standard treatment vs Burzynski’s treatement. The comparison claims that 5/54 patients who underwent Standard treatment were cancer free at the end of treatment and 5/20 patients with Burzynski’s treatment were cancer free at the end of treatment. This is a very poor quality comparison. The studies were very small. The comparison was not double blinded and the patients were not randomly selected to get one treatment or the other. I wanted to look at his study to see what the treatment protocol was ie. Does he use standard therapy along with his treatments, but I can’t find the study he cites anywhere. Pub Med does not list it and when I looked up that edition of the Neuro-Oncology in their archives I can find no mention of him or the study in the table of contents (http://www.ncbi.nlm.nih.gov/pmc/issues/177892/). Keep in mind also that Burzynski claims at one point that his treatment will cure ALL cancers but 15/20 patients were NOT cancer free at the end of the treatment. Later in the video he admits he can’t cure everyone.

This is followed by another anecdotal report from a very sympathetic family where they lay out a horrible set of possible side effects from standard treatment while showing a healthy girl who was treated “successfully” by Burzynski. The family claims that very few doctors were happy to hear that their daughter was seeing Burzynski. Of course they wouldn’t. He is doing something irresponsible. He is treating patients without any proof that his treatment works. Again this fmaily claims that Burzynski saved her life but we dont know that.

The video then claims that its one thing to provide anecdotal evidence and another to have studies showing better outcomes but all they do here is show you a table that is supposedly from some book on childhood drugs comparing studies done elsewhere to numbers that are supposedly from studies that Burzynski has done. No reference is given to these studies so I can’t look them up to see what the details are but again these patients were not randomly assigned and these were not double blinded studies so any comparison is of limited usefulness.

Then another anecdotal presentation of a cute little girl.

I’m not going to anotate every single one of these but you can see where this is going.  I’m not saying his treatment is worthless but his approach is. The only way to determine if a treatment is safe and effective is to do proper studies and his presentation in this long infomercial is strangely devoid of any legitimate studies. Good researchers don;t do what this man is doing. They don’t start treatments and then look for evidence and very weak evidence at that, to support them.

I’ll look at the rest of the video later but so far I am not impressed.

Thanks macgyver. Keep watching - the anecdotes were the least interesting part and there is much more to the movie. I want to know what you think about the trials, patents, and Drs. Kessler, Samid, and Friedman. Again, thanks.

PART 2

Claim – The U.S. Government prohibits the use of any tax payer funds for clinical trials involving Burzynski’s treatments. I assume they are referring to the National Cancer Institute’s funds, but as is par for the course with this infomercial they don’t cite sources or provide any documentation for this claim. I am not aware of any procedure where the NIH or the NCI actually put prohibitions in place for certan kinds of research. It may be that he applied for a research grant ant couldnt get one but only about 30% or less of grant proposals are approved and the review process is based on a scientific review of the proposal and its merits. He uses the cost of the trials as an excuse for not doing them apparently but if that’s the case then that’s where it should end. Responsible scientists don’t proceed to treat patients without the data to support what they are doing. On a personal note my own brother had a son who had a very rare childhood cancer which is almost universally fatal. There is little money to support research into this cancer because of the small number of children who get it. Despite that he and other parents were able to raise money through fund raisers to develop a new investigational drug and run clinical trials so I am very skeptical of Burzynski’s claims that he can;t fund trials. He has a lot of dedicated patients. If he really cared to prove the efficacy of his treatments he would find a way to fund research.

What I find really offensive is that this guy Whitmore at 31 minutes in starts to play out the traditional conspiracy theory that its the medical establishment standing in the way of an effective treatment in order to preserve the status quo. If he were standing in front of me I think I would punch him in the face at this point.

They imply that FDA user fees put the FDA in the pharmaceutical companies back pocket but I disagree. Pharmaceutical companies SHOULD pay user fees since they are the ones who benefit. I don’t think that causes a conflict of interest in itself since they have to pay the same fee wether their drug is approved or not and they don’t have an alternative place to go for approval so there is no quid pro quo here and no pressure on the FDA to approve anything. Burzynski claims he has tried everything possible to get the FDA to cooperate in getting their treatment approved but have been unable to make any progress. He has since used a loophole in the law to allow himself to give unapproved drugs to people who are have “no other viable” treatment.  Then he goes on to claim that the Texas medical board was trying to coerce patients to file a complaints against him. Again unsupported and undocumented. The case that was brought against him was decided in his favor but the decision said that the plaintiffs had not shown evidence that his treatments were not safe and effective. This is exactly the opposite of the way science is supposed to work.The onus is on the researcher to prove his treatments are safe and effective. Its not the job of the medical community to prove they are not safe and effective. The final decision was simply that the doctor wasn’t breaking any laws but that proves nothing except that there are big loop holes in the aws governing what doctors can do to their patients in Texas.

Then they get back to their argument that the FDA and Pharma would lose a great deal of money if these treatments were approved giving no evidence to support that argument. Where is the real analysis of this. How much would the industry stand to gain if they found a more effective treatment than what is currently being used. Keep in mind this is not a revolutionary treatment. The majority of patients still die according to Burzynski’s own numbers. Then they quote FDA Bureau of drugs director Richard Crout who says he wouldn’t approve a new drug to an individual but only to a large company with unlimited resources. Its hard to know what context this was said in or even if this is really FDA policy but if taken out of context I can think of a rational explanation for what he said. If there was a drug that was highly effective or showed great promise, granting exclusive rights to someone with very limited resources might limit access or development of that drug and deprive the public of its benefits. I’m not saying I totally agree with that but again these words were taken out of context so we dont know what the intent was.

Next you see Burzynski and his lawyer on CBS morning show being interviewed and again the same stupid argument. “The FDA isn’t saying the drugs aren’t safe and effective they are just saying there are no controlled trials” Well duh!!!  The FDA is actually being very reasonable here. How can they say the drug isnt safe or effective if there are not trials? Its not their job to prove that though. Its Burzyski’s job to prove they ARE safe and effective. Burzynski then parades a bunch of patients that support him but they offer no evidence for anything.

They make several comments which imply that the government is missing the point when they say that the issue of whether the drug works or not isnt important in the trial but the fact is that its NOT. Whats important is whether Burzynski has done the necessary studies. Without those you can’t determine whether the treatment is safe or effective.  This is a completely manipulative and misleading argument.

It seems Burzynski has no interest in science. He wants to be exempt from the standard method of evaluating therapies and would like us to go back to the old snake oil days where any physician can sell or provide any treatment he likes and let his patients decide what works and what doesn’t. He is conducting a trial by public opinion and using his religious following to sway opinion.  At 72 minutes in Burzynski’s lawyer claims that every patient from this point on that Burzynski treats will be in a clinical trial yet here we are in 2012 and I can’t find any significant studies published by this man.

It seems the biggest problem here is not that antineoplastins dont work or that they are dangerous. The biggest problem is that we dont know and the reason we don’t know is because largely Burzynski tried to take shortcuts that put his patients at risk. The result was a great deal of animosity between him and the FDA which later scared off commercial companies who have to look at the bottom line. When you a deal evaluate who’s success requires the prime investigator to get along with the FDA and he’s already pissed them off most prudent companies will shy away from that. Burzynski really shot himslef in the foot. You can almost understand why I said earlier that I could almost agree with the FDA not giving approval for a drug to a single individual. One person who is misguided can really derail the investigation of a potentially useful drug.

As the story goes on the reason for a lack of study becomes more clear. The NCI tried to run some studies on the antineoplasitons but Burzynski seems to be unable to get along with anyone. Multiple clinical investigators in this story have very terse correspondences back and forth with Burzynski. What a shame. Burzynski’s personality seems to be the real problem here and because he couldn’t play nice with others he has actually been both the developer and the destroyer of what may or may not be a very useful treatment. In the end he complains that others have since earned patents on antineoplastons and have stolen his work, and they probably have to a some degree, but if he had done the research the way he should have from the begining this would have never happened. I have little sympathy for him.