Respectful Insolence

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.

Comments

  1. #1 Matt Penfold
    June 19, 2008

    There was a case in the UK a couple of years ago where a person was convicted and jailed for selling a cancer “cure” to a terminally ill patient. They charged something like £20,000 ($40,000) for a machine that did nothing more than produce static electricity. If I recall they got about four years, plus an order ceasing their assets they could not prove were not the proceeds of crime.

  2. #2 BB
    June 19, 2008

    I guess time will tell if Obama will restore the FDA to its pre-Bush functioning or if woo-loving Dems like Harkin will prevail.
    I suggest letting your senators and congressperson (if you are a US citizen) how you feel about woo, funding woo, funding biomedical research in general.

  3. #3 Cain
    June 19, 2008

    Great post, but Ron Paul’s a Congressman, not a Senator.

  4. #4 Orac
    June 19, 2008

    D’oh! Brain fart!

  5. #5 D. C. Sessions
    June 19, 2008

    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.

    That’s why it’s so important that the FDA placed emphasis on that demon of right-wing nightmares, The Internet! By emphasizing the crackdown on the evil of the intertubes, the FDA is covering its back. Assuming that some sort of legislative backlash occurs, the FDA may be able to play the NetPhobia card to either load the legislation down with enough anti-Net provisions to sink it or get anti-Net enforcement powers added that allow the FTC to continue the job.

  6. #6 Uncle dave
    June 19, 2008

    Examples of fraudulent claims for these products include:

    “Causes cancer cells to commit suicide!”

    Cells committing suicide is my personal favorite.
    Which cancers cells are more susceptable to self esteem issues?
    Do cells just get depressed and activate the trigger on thier tumor suppressor genes?

    Have we seriously addressed the Suicide issue with cancer cells?

    I have an image of the Saturday Night Live skit where they announce a artist sketch of todays court room procedings where they then show a 1930′s Mickey Mouse court room cartoon scene.

  7. #7 Linda
    June 19, 2008

    the fda cracking down on “fake” cancer cures is ridiculous. The chemo quacks are the ones who should be shut down. They are upset because people have heard the truth and are rejecting them. If Abraham Cherrix had listened to his first dr, he would have never reached 18.

  8. #8 Bronze Dog
    June 19, 2008

    Please, Linda, give us references for this “truth.” Considering all the failure stories for alties I’ve seen, and the number of holes in the “success” stories, I’m not exactly confident in alties.

    EBM, unlike the quackery of “alternative medicine,” has countermeasures against the caveat emptor attitude so many of you subscribe to. I’ve seen so many woos scream whenever we so much as suggest we level the playing field by requiring all medicine go through the same scientific hoops. They just won’t let go of their government-approved “supplement” loopholes. That’s why Big Pharma is taking a hint from them and investing in useless supplements and vitamins.

    What was the EBM cure rate for Hodgkin’s Lymphoma, again? 85% or thereabouts?

  9. #9 DLC
    June 19, 2008

    Orac: sometimes we get some good news, thanks for the post.

    Linda: you should read more. Abraham Cherrix is alive because he received a round of chemo followed by one or more rounds of radiation therapy, not because of idiotic supplements.

    What’s in these so-called supplements ?
    Chemicals . . . Chemical Therapy. . . Chemo Therapy . . .
    Yeah, kinda hard to swallow, ain’t it, Linda ?
    The people you give a shout-out to are pushing untested, impure drugs based solely on anecdotes.

  10. #10 Mac
    June 20, 2008

    It pains me that this has gotten to such a point that there needs to be a term such as “evidence-based medicine.” I was under the impression that that was the only kind.

  11. #11 Der Bruno Stroszek
    June 20, 2008

    Yeah, it’s like the phrase “alternative health”. The alternative to health is, of course, illness, so it’s quite honest in that way.

  12. #12 Rob W
    June 20, 2008

    Personally, I think there should be a decent chunk of money set aside by the government/FDA for investigating woo “cures”, alternative medicine, etc.. — for either bringing them into mainstream medicine if they actually do anything useful (e.g., herbal treatments etc. can have *some* effect depending on the ingredients) or to more definitively show that it’s a crock, and actively crack down on people selling it. I’m also a big fan of removing all possible perqs going from the major pharmaceutical companies to doctors, even the cheap pens and suchlike — NOT because it’s necessarily influencing doctor’s prescriptions (though obviously the larger “gifts” can…) but because the damage the *impression* does is huge. People get jumpy when they notice their doctor scribbles them a prescription with a pen that came from the pharmaceutical company who made the medication prescribed, along with a note on notepaper emblazoned with more corporate slogans. It’s not so much the facts that matter — it’s the impression it gives.

    The conspiracy theorists have much more power than they would otherwise because there’s a half-grain of truth behind their arguments — how much money for medical research is purely enterprise-driven? Those guys aren’t going to be so keen on researching treatments that can’t be patented.

    Obviously, the jump from there to “the dolphins will massage my feet to cure my liver disease” is huge… but people not getting what they want from “big pharma medicine” are ready to jump already.

    This isn’t my field of expertise (I’m a software developer) but this keeps striking me as a blind spot for arguing against the quacks… you can’t counter with scientific terms that won’t be understood anyway plus scorn — that just alienates them more and enforces their impressions. You have to think more like politicians (sorry) and work on your message — both spoken and otherwise.

  13. #13 TheProbe
    June 20, 2008

    Hmmmm…since supplements are chemicals, aren’t they a form of chemotherapy? Chuckle.

    When confronted by anyone who makes claims of a cancer cure, I always ask where are the legions of survivors?

  14. #14 Orac
    June 20, 2008

    Personally, I think there should be a decent chunk of money set aside by the government/FDA for investigating woo “cures”, alternative medicine, etc.. — for either bringing them into mainstream medicine if they actually do anything useful (e.g., herbal treatments etc. can have *some* effect depending on the ingredients) or to more definitively show that it’s a crock, and actively crack down on people selling it.

    There is just such a chunk of money, over $240 million a year ($120 million from the National Center for Complementary and Alternative Medicine and $120 million from the NCI). The problem is, at NCCAM and to a lesser extent at the NCI, advocates have taken over the farm. See:

    http://www.sciencebasedmedicine.org/?p=36

    http://scienceblogs.com/insolence/2008/05/why_arent_there_more_trials_studying_the.php

  15. #15 Shygetz
    June 20, 2008

    Dammit, my woo start-up was just about to get off the ground! After reading Orac for years, I had finally decided to ditch this scientific research stuff (it’s really hard) and just make some cash with a magical mystery cure. Stupid spoilsport FDA.

  16. #16 MarkH
    June 20, 2008

    Orac,
    They love cancer because it is the exception to the rule that CAM treatments tend to select for no effects as we’ve discussed before. The great thing about cancer therapies is that if they fail, or are harmful, or overly expensive that doesn’t affect their success as a CAM modality. After all, the patients will likely just move onto the next bogus treatment, or be dead, with no time for complaining to the authorities. It’s also a wonderful font of false hope, a sure-fire way to separate a scared person from their life savings.

  17. #17 anja
    June 21, 2008

    hmm.
    One of the companies being targeted in that list, is Ageless Cures.
    I have been ordering Curcumin from them – not to cure cancer but because this supplement helps keep my psoriasis under control (somewhat, as far as it CAN be kept under control).

    I don’t know if they claim health effects that they cannot deliver, but as far as the effect of curcumin on psoriasis, there is enough anecdotal evidence that, for a good number of people, it works well. Count me among those whose skin shows a clear improvement when taking the supplement!

    So, for me the situation is not black-white.

    I would like good guidelines for companies who sell supplements as to what health benefits they can actually claim, and certainly for quality of the supplements (production, dosage, standards for contamination, etc). I’d like most of all, for more research to be done into these kinds of supplements where people claim to observe a definite benefit. I would not mind at all if my tax money were used for such research.

  18. #18 Hyperion
    June 23, 2008

    I strongly suspect that lack of funding is the greater culprit here. It’s most likely that many FDA officials felt that their scant resources were better spent examining NDAs for treatments that might actually help people rather than investigating snake oil salesmen. There’s also the likelyhood that they placed a higher priority on policing claims and marketing (not to mention adverse effects reports) of legitimate prescription medications, given that those products are taken by orders of magnitude more people.

    It’s good that the FDA is taking action against these charlatans, but remember that these things have to be placed in perspective. I think that many in the FDA have believed, up until now, that actions like this would benefit fewer people.

  19. #19 Mike
    June 24, 2008

    This artticle is entirely self-serving. ORAC until you can cure cancer with a 100% success rate, you cannot claim to be an “expert” either. What is YOUR cancer cure success rate? The arrogance of the medical profession is appalling and articles like this one only exemplifies that aspect. The FDA has always agressively pursued “anti-medical treatments” in order to preserve the Medical monopoly for our health care.

  20. #20 mike
    June 24, 2008

    Matt: Regarding your $40,000.00 cancer curing machine. Yes, something like that (if true) is appalling as well. But keep in mind that every single day a cancer patient dies in any given hospital after spending hundreds of thousands of dollars in treatments.

  21. #21 Gerald
    July 2, 2008

    IMO, Orac and Oracs’ patients would be better off if he just stayed in his liquor cabinet. As for the FDA, I suspect that they will soon be thoroughly restructured – because of the continuing concerns over their incompetence and ethics.

    This fellow seems to have said it best:

    About Orac

    Orac is the nom de blog of a humble pseudonymous surgeon/scientist with an ego just big enough to delude himself that someone, somewhere might actually give a rodent’s posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That Orac has chosen his pseudonym based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a nearly 30 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

    Respectful Insolence™ is a repository for the ramblings of the aforementioned pseudonymous surgeon/scientist concerning medicine and quackery, science and pseudoscience, history and pseudohistory, politics, and anything else that interests him (or pushes his buttons). Orac’s motto is: “A statement of fact cannot be insolent.” (OK, maybe it can be just a little bit insolent. Sometimes. OK, fairly often. Orac tries to keep his insolence respectful most of the time, but readily admits that he sometimes fails in cases of obvious quackery and pseudoscience, responding to personal attacks on him, examining poor critical thinking skills, bigotry or racism, and just general plain stupidity. When the stupidity to which Orac is responding reaches a certain very high level, he just can’t help it and makes no apologies. You will know this is happening when Orac uses the phrase “the stupid, it burns” or some variant thereof.

    Finally, Orac’s “real” identity is more or less an open secret among some parts of the blogosphere, but he nonetheless keeps using the Orac pseudonym because (1) he doesn’t want his blog to be the first thing that comes up when patients Google his “real” name; (2) he has a long history on the Internet under this particular pseudonym; and (3) he likes the persona that the “Orac” pseudonym allows him to take on. Indeed, even if Orac ever decides to ditch the whole anonymity thing, he will likely retain the pseudonym and simply place a link to his faculty page somewhere on the blog.
    Disclaimer

    This is a personal web log, reflecting the sometimes prickly opinions of its author. Statements on this blog do not represent the opinions of anyone other than the author. They most definitely do not represent the opinions or position of the author’s hospital, university, cancer institute, surgical practice, partners, or research colleagues. The information on this blog is intended for discussion and entertainment purposes only and not as recommendations about how to diagnose or treat illnesses. Any personal medical issues the reader may have should be referred to the reader’s physician. If the reader freely chooses to follow the opinion of a pseudonymous blogger like the author (who has also not done a proper history or physical examination and whose credentials cannot be verified) over that of his or her own personal physician, it is the reader’s decision alone, for which the reader must bear full responsibility.

  22. #22 stewardy
    July 2, 2008

    ‘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.’ You never can tell though, if you have an open mind…my spouse developed an ugly, itchy and fast growing mole/wart while I was overseas and when I saw it I immediately made an appointment with a medical practitioner. Knowing we had two weeks to wait and idly searching the internet as you do, I came across an ad for black salve complete with pictures of actual cases. I perceived we had nothing much to lose in trying it except a few dollars and ordered it. To cut a long story short, the thing was totally removed from the back within about 17 days exactly as in the pictures. I e-mailed my brother who has had melanoma and he passed our pictures on to his surgeon who advised that we should have the thing looked at immediately. Except that by the time we got his advice there was nothing to look at except a small and rapidly healing scar.
    Don’t bag blacksalve so hard, it might be someone’s cure!
    So while I heartily agree there is woo in abundance and also unscrupulous or incompetent practioners in both conventional and alternative medecine, there is nothing like taking responsibility for one’s own health with an attitude of curiosity. Openness to trying (and discarding when necessary) offerings from both side of the divide is a good place to start. The human body/mind is a wondrous thing and I don’t think we know enough to be so hard line about what works or doesn’t work.
    Natural medecines took an enormous leap forward in Australia due to the efforts of one surgeon, Dr. Patel, who purported to be one of your trained scientific minds.
    Check out:
    http://www.smh.com.au/news/National/The-doctor-who-left-a-town-for-dead/2005/05/27/1117129901058.html
    For every alternative horror story there is a conventional one. and there are marvellous practitioners as well.

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