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