Can it be real? The FDA brings the hammer down on bogus cancer cures

I’m a cancer surgeon, and if there’s one thing that drives me straight to the liquor cabinet it has to be quack cancer “cures.” Very early in the history of this blog, I discussed one of the biggest quacks of all time, a woman who thinks that all cancer is caused by a liver fluke (but only if the patient has propyl alcohol in his body, which, according to her, allows the fluke to become established) and that she can cure all cancer with a combination of herbs and the use of a device that she calls a “Zapper” (which looks suspiciously like a Scientology E-meter). I’m referring, of course, to Hulda Clark. Of course, Clark’s ambitions extend beyond mere cancer. She also claims that she has the cure for AIDS and even the cure for “all diseases.” Let’s also not forget the Hoxsey therapy, a concoction made of various plants and oils that seduced what seems like an otherwise intelligent and motivated young man named Abraham Cherrix away from effective medicine because the successors to Harry Hoxsey at the Bio-Medical Clinic in Tijuana claim that it is 80% effective in curing cancer (conveniently also adding that if it fails it’s because the patient didn’t believe enough). Then, of course, there are the dubious claims of Dr. Lorraine Day, who proclaims to have beaten recurrent breast cancer with a combination of prayer and “natural remedies.” The list goes on, as there seems to be something about cancer that quacks can’t resist and that drives them to make claims that they can cure it.

The reason is not too hard to figure out. Cancer is a scary, scary disease, even to medical professionals. It can cause death in many most unpleasant ways, and, worse, modern scientific medicine is relatively powerless against many different tumors, particularly once they have metastasized. It can palliate, but not cure, such advanced tumors. Because the survival instinct, the desire for life, is one of the strongest of natural instincts, people are quite naturally often unwilling to give up when faced with a diagnosis of cancer. Worse, for some, but not all, cancers the treatments are almost as unpleasant as the disease, if not more so. Chemotherapy can cause serious nausea, immunosuppression, and neuropathy, along with a general sense of extreme fatigue. Many regimens cause patients to lose all their hair, to produce a characteristic look that advertises their plight to the world. Radiation therapy can also cause fatigue, as well as skin rashes and even burns. It burns normal tissue almost as much as cancerous tissue; so if the cancer is close to vital structures it’s not possible to spare normal organs completely from collateral damage. Putting it all together, it’s not at all surprising that cancer is among the diseases that most tempt even otherwise rational people to believe in pseudoscientific or spiritualistic nonsense, and, believe me, the quacks know this and take full advantage of it.

One of the most frustrating aspects of cancer quackery is that the agencies charged with protecting the public from it seem either powerless against it or unwilling to get down and dirty taking it down. That’s why I rejoice at the announcement from a couple of days ago that the FDA is going after cancer quacks in a big way and hope that it isn’t just another threat that comes to nothing:

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Those companies and individuals warned, the complete list of fake cancer ‘cure’ products and their manufacturers along with a consumer article on health scams can be found here, http://www.fda.gov/cder/news/fakecancercures.htm.

I perused the list of bogus cancer cures whose manufacturers got warning letters and was distinctly disappointed that none of them appear to be ones that I’ve discussed on this blog. One thing I did note, however, is that among the 125 products made by the 23 companies warned by the FDA was the infamous black salve that featured so prominently in my series of posts about Chad Jessop, a youth who chose woo over effective therapy for his scalp melanaoma.

It’s unclear what spurred this new crackdown. This is what the FDA states:

“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret O’K. Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.”

Of course, such bogus “cures” have been flourishing on the Internet for at least 10 years now. I sometimes think that the second thing that drove the growth of the World Wide Web after pornography was dubious health information, but I could be wrong about that. So why now? Who knows? This is what the FDA says:

The Warning Letters are part of the FDA’s ongoing efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent deceptive products from reaching consumers. The initiative originated from consumer complaints and a web search for fraudulent cancer products conducted by the FDA, FTC and members of the Mexico-United States-Canada Health Fraud Working Group. Earlier this year, FTC sent Warning Letters to 112 Web sites falsely promoting cancer “treatments” and referred several others to foreign authorities.

I have no way of knowing if this is true or not, but I like to think that the rise of the skeptical blogosphere in general, and skeptical physician-bloggers in particular, has helped put the heat on the FDA, educating consumers about dubious and fraudulent sounding claims of cancer cures, claims such as these:

  • “Treats all forms of cancer”
  • “Causes cancer cells to commit suicide!”
  • “80% more effective than the world’s number one cancer drug”
  • “Skin cancers disappear”
  • “Target cancer cells while leaving healthy cells alone”
  • “Shrinks malignant tumors”
  • “Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments”

You know, claims I come across all the time, often in conjunction with horrific descriptions of the alleged harm done by “conventional” medicine.

There’s no doubt that the FDA is way late in taking action against these woo-meisters. Indeed, those of us who take an interest in unscientific medicine have often bristled with frustration and even felt that the quacks were laughing at the FDA. Even so, better late than never in warning consumers about the cancer quackery above.

When I first found out about this from Abel Pharmboy and Steve Novella yesterday, I started thinking about why it might be that such obvious quackery has been tolerated for so long with at best fitful and sporadic attempts to crack down. (Indeed, I hope that this isn’t yet another in a long line of such attempts.) Two main reasons suggested themselves to me. First is the rise of so-called “complementary and alternative medicine” (CAM) in academia and “conventional” medicine. Think about it. In a world where respected medical institutions aiming to put the word “once” before “respected” eagerly embrace pseudoscience that is not too far removed from some of the 125 “cancer cures” targeted by the FDA. Some academic centers are even offering homeopathy, the most useless of quackery! Meanwhile, the very language is changing under the influence of the CAM lobby, so that woo is made to sound plausible and it is no longer socially acceptable to call quackery quackery and “health freedom” is the rallying cry under which woo-meisters rally to proclaim the “right” of Americans to their quackery. True, the difference is that even the most enthusiastic purveyors of quackademic medicine won’t claim to be able to cure cancer, but their embrace of unscientific remedies blurs the line between scientific medicine and quackery and makes the quack’s job easier.

The second–and most important–reason for the impotence of the FDA against such cancer quackery and its subsequent rise is likely the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act, more than anything else, eviscerated the ability of the FDA to act upon many health claims involving dietary supplements because if it’s a supplement it’s not considered medicine but rather food. As long as purveyors of pseudoscience are careful not to make any blatant health claims for their supplements, wrapping their claims instead in vague terms like “boosts the immune system,” they’re safe. However, over the years, quacks have gotten bolder, and the companies targeted for enforcement blatantly stepped over the line. My guess is that the FDA finally couldn’t take it anymore and someone said, “Enough!”

As much as I applaud the FDA’s action, I worry about it. Powerful forces are arrayed against it, forces embodied by legislators like Congressman Ron Paul, champion of the DSHEA and many other “health freedom” measures; Congressman Dan Burton, the best friend of antivaccinationists and “alternative” medicine in all of Congress; and Senator Tom Harkin, whose love of woo and boosterism for it got the National Center for Complementary and Alternative Medicine (NCCAM) started as the embryonic Office of Alternative Medicine, whose continued attention fertilized it so that it grew into the $120 million a year behemoth that it is now, whose interference forced the NIH to fund useless and unethical clinical trials, including an unnecessary, poorly designed, and unethical trial of chelation therapy to the tune of as much as $30 million, and whose patronage continues to protect NCCAM from attempts to downsize or eliminate it. It would not surprise me in the least if this unholy trio of woo banded together to attack the FDA for “overreaching” and attacking “health freedom”–or even trying to reduce its budget or rewrite the law to hamstring the FDA and make crackdowns of this nature much harder, something that Republicans tend to like to do in general because of their philosophical belief in small government and less regulation. True, there is less of a chance of their being successful now, given that Ron Paul and Dan Burton are Republicans and Congress is currently controlled by the Democrats. Indeed, it makes me wonder if the FDA has decided that Barack Obama is likely to be the next President. Either way, cracking down like this is a risk. Woo-friendly legislators might well try to punish the FDA for its action.

My speculation aside, the FDA crackdown is a good start but doesn’t go nearly far enough. Of course, the FDA has to pick its battles. It’s been chronically (and intentionally) underfunded for several years now, and because of that it can’t carry out all the regulatory and enforcement actions with which the law charges it in an expeditious manner. Moreover, the FDA has had some high profile flame-outs because of drugs like Vioxx that were approved and later found to produce complications above and beyond what were predicted in clinical trials. Restoring its funding to levels that allow it to do what the law mandates that it do is imperative, but so is a real analysis of its regulatory machinery and the development of a plan to handle the onslaught of quackery enabled by the Internet while at the same time evaluating “conventional” new medicines expeditiously and accurately before approving them.