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Does Burzynski movie buzz come at the worst time for the FDA?

December 27, 2011 8:00 am by | 5 Comments

Burzynski.

To some the name evokes a sense of hope. But to others, the name conjures skepticism, even ridicule. For those who don’t know, Dr. Stanislaw Burzynski is a Texas physician who has spent the better part of the last 30 years developing what he and his supporters claim is a medical breakthrough in treating — even curing — cancer. His efforts have been confined to Texas and he’s had numerous skirmishes with the Texas Medical Board, which has called his work into question.

Burzynski’s work might have stayed relatively obscure if not for the movie “Burzynski: Cancer is Serious Business,” which details the doctor’s clashes with Texas regulators, pharmaceutical companies and the National Cancer Institute. The U.S. Food and Drug Administration comes off looking particularly bad, depicted as being in bed with Big Pharma and others in an effort to block a new cancer treatment from challenging the pharmaceutical industry paradigm.

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Since a 2010 release, the Burzynski movie has picked up steam. It has aired multiple times on the Documentary Channel and is among the nominees in the channel’s contest for best premier in 2011. Amazon.com sells the Burzynski movie and it’s now available as a Netflix selection. For those who don’t want to pay, several people have uploaded it to YouTube where it can be viewed for free. And the topic #Burzynski continues to light up Twitter.

Dr. Oz interviewed the Burzynski in mid-2011. Some of his intense followers asked: Could Burzynski have cured Steve Jobs?

All of this comes at bad time for the FDA. Even under the best circumstances, the FDA gets little love. Pharmas routinely blast the agency for being unclear about what it needs and the length of time it takes to get a drug approved, criticism that falls under the catchall “regulatory uncertainty.” Patient groups criticize the agency, claiming regulators hold back approvals of the drugs they need.

FDA Commissioner Margaret Hamburg has endeavored to root FDA decisions in science rather than politics. Nonetheless, the FDA and in turn Hamburg, have taken flak. The FDA’s decision earlier this year to withdraw Roche’s approval to market the drug Avastin for breast cancer was based on science — evidence that the drug posed serious health risks along with data showing that the drug’s benefit was marginal. Yet Hamburg was criticized by some patient groups for taking cancer drugs away from patients.

Hamburg again took fire for the FDA’s position on the emergency contraceptive Plan B. The agency had reviewed the drug to determine whether it was safe and effective to permit the drug to be an over-the-counter product for all females, regardless of age. Secretary of Health and Human Services Kathleen Sebelius overruled the agency. The FDA is doing its damnedest to be an apolitical agency whose decisions are based in science, evidence and data. But the agency is battered by interests that are not.

The Burzynski movie does not pretend to be objective and it casts the doctor as the victim of a wide-ranging conspiracy. Others could counter the conspiracy is against anyone who is treated by Burzynski and his followers.

By way of background, I’ve noted before that there is a particularly disturbing aspect of Burzynski’s practice. That’s how his patients, convinced that Burzynski can save them (or, if they’re parents, that he can save their child) will, understandably go to extreme lengths to raise the often hundreds of thousands of dollars Burzynski charges to apply his science-y-sounding woo to cancer. It is not at all uncommon for these families set up charities designed to raise money, or, as I put it a couple of years ago, to harness the generosity of kind-hearted strangers to pay for woo.

Nonetheless, Dr. Burzynski now does have clearance to proceed with phase 3 clinical trials. That means his research will be put up to scrutiny and analysis based in science. Whatever the political pressures that have shaped the past, the FDA’s decisions should be viewed in the same scientific light. That’s the only way that medicine can definitively make the progress that is in the best interest of patients.

Copyright 2014 MedCity News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

By Frank Vinluan

Frank Vinluan is the North Carolina Bureau Chief for MedCity News.
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5 comments
Eddi Monzon
Eddi Monzon

Lets be clear. Dr. Burzynski has been given permission to start Phase III trials. However, it is not the ideal testing he originally requested. FDA is still requiring that the patients get treated with chemotherapy while under going the Phase III trial. This will have obvious effects to Dr. Burzynski's treatment method. Honestly, the facts line up, his patients have given permission, and FDA still plays loose with their own rules.

anarchic teapot
anarchic teapot

Burzynski may have permission to start Phase III trials, but I doubt he ever will - or if he does, nothing will get piublished, just like the 61+ Phase II trials over the last 34 years. He makes his money - millions of dollars a year - from posing as a brave maverick doctor and selling dubious therapies that only he holds patents for. It's not in his financial interest to pu_blish. Meanwhile, as patients approach the end, they're quietly sent home to die. Frequently penniless. Those who realise they've been scammed get shouted down, but Burzynski must reckon: what the hell, they'll die anyway so it's not going to make much of a difference. That the Discovery Channel should repeatedly broadcast such dangerous nonsense as a documentary and even give it an award does them no credit whatsoever.

h jones
h jones

Well said Steve Walker. Watch the movie before you decide.

laurie pederson
laurie pederson

This movie and others like it will help shine the light on this situation, share this important message, and find a way to make change. The newest compelling documentary film to feature Dr. Burzynski is CUT POISON BURN, which is a heart-wrenching look at why we are losing the war on cancer and how the FDA is in cahoots with big pharmaceutical. This story centers around the Navarro's - a family who's son Thomas was an unwilling victim in their sick war, as the one treatment that might have helped was withheld from him until it was too late. Finfd out more at www.cutpoisonburn.com - where you can order a dvd or download a copy at any price - even free.

Steve Walker
Steve Walker

Good article, with one problem. The Avastin decision was not scientific. It was judgmental and heavy-handed. Looking at exactly the same data and outcomes, the European Union retained approval, and the leading coalition of cancer doctors in the US recommended its continued use, which lead to a decision by Medicare/Medicaid to continue covering its use for metastatic breast cancer. All the trials reviewed by FDA showed that Avastin delayd progression of the disease. None of the trials, by prior agreement with FDA, were designed to measure overall survival, but that is the criterion FDA decided to use to withdraw its approval. The appeals process was controlled entirely by the FDA, with a number of serious irregularities. Avastin remains approved by FDA for several other cancers, where it has precisely the same side effects and risks, and was recently approved by FDA again for use in ovarian cancer. The FDA's decision was a rigid policy enforcement move made by the chief of the agency's cancer drug office, and it was actually very poorly supported by the science. Hamburg erred by backing him up on it. It is important to fully research and understand FDA's resgulatory decisions instead of just taking their word that what they did was based on "science." They never admit mistakes, and they never correct them. They make a lot of mistakes, and their action on Avastin was one of them. In fact, the person behind it, Dr. Richard Pazdur, Director of FDA's cancer drug office, was also involved in the suppression of Burzynski's research, and is in the movie, coming off as what he is, a prickly, difficult to deal with regulator with too much power and no respect for anyone who disagrees with his views and decisions. On the cost of Burzynski's treatment, the FDA and others did such an extreme hatchet job on his research, it has been difficult for him to fund the clinical trials needed to gain approval, so patients are left with the bill. Had the FDA and others not tried so hard to kill it, his treatments would have been tested in clinical trials by now, and if they worked, they would be approved, covered by insurance, and in additional well-funded clinical trials to test for expanded uses. It is a good thing that the real FDA is being exposed in the Burzynski movie. And don't be too quick to blame the phrama and bio industries for this. The FDA and the clinical research community (the latter being an enormous, and enormously powerful, financial special interest) are quite capable of crushing promising research on their own, and were aggressively involved in trying to crush Burzynski. Perhaps the worst result of all this is that the campaign against Burzynski prevented the research that was needed to move it forward, by many years. We can't afford that kind of nonsense with so many lives at stake. A better question would have been to ask why the FDA hasn't been investigated and dragged in front of Congress to explain itself.