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Health Care Freedom

Freedom is a cherished commodity in our culture, as it should be. Our laws are largely based upon the premise that individuals should have the liberty to do what they want, unless there is a compelling public or governmental concern that overrides such liberties.

It is therefore no surprise that freedom is a common marketing theme – selling the idea of individuality or personal freedom of choice.

The marketers of dubious, unscientific, or fraudulent health care products and services are savvy to the marketing theme of freedom and have used it to great effect. It is all ultimately, however, a deception. There is an ulterior motive that has nothing to do with the freedoms of the public but rather is an end run around regulations meant to protect the public.

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Posted in: Politics and Regulation, Science and Medicine

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“Integrative Medicine Experts”: Another Barrier to Effective Discipline

This is the final entry in the current series having to do with state regulation of physicians.† It is the final one merely because I’m tired of the topic, for now. There is plenty more to write about, including an event that occurred only yesterday right here at my own hospital. I’ll give a preview of that at the end of this post, but first we’ll look at another recent event.

Dazing Arizona  

Arizona’s citizens, more than most, can expect to be bamboozled by pseudomedicine. We’ve seen that the Arizona Board of Homeopathic Medical Examiners has, for years, provided a regulatory safe haven for quacks with MD and DO degrees. Although I haven’t previously mentioned it in this series, which is about quack medical doctors, Arizona is also a haven for another group of quacks: “naturopathic doctors.” Like its homeopathy board, Arizona’s Naturopathic Physicians Board of Medical Examiners has been less than committed to protecting the public from its licensees. In each board’s case, the state Office of the Auditor General has suggested numerous fixes, but there has been little indication of improvements.

Nor would improvements be expected: in the words of Edzard Ernst,

Those who believe that regulation is a substitute for evidence will find that even the most meticulous regulation of nonsense must still result in nonsense.

Arizona is also the home of one of the first academic “integrative medicine” programs, begun by Andrew Weil at the University of Arizona. We have previously seen examples of misleading language emanating from that program. We’ve also seen the program’s inordinate effect on the Federation of State Medical Boards (FSMB). We’ve seen examples of the writings of Kenneth Pelletier, one of the U of Arizona program’s consultants to the FSMB. A recent disciplinary case in Arizona illustrates the potential danger of a state medical board seeking consultation from another “integrative medicine expert” from that program.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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Vitamin Cocktail with a Meme Twist (Supplement my gimlet with a dash of dissonance)

A trail of recent reports is trying to tell us something. But are we listening, and are “they” listening? If so, does it mean the same to “them” as it does to us?

The report trail is telling us that multiple vitamins fail as preventatives against cardiovascular disease, cancer, or even for anything other than for dietary vitamin deficiency. And that is what we were saying in the first place – forty and more years ago.

Here is a partial list of these recent reports –  followed by an odd turn

Vitamins E and C were ineffective in preventing `cardiovascular disease in men. Sesso HD, Buring JE, Christen WG et al. JAMA, 2008;300 (Physicians’ Health Study II, mong 14,641 male physicians. [...] The study participants were randomized to receive 400 IU of vitamin E every other day or a placebo and 500 mg of vitamin C daily or a placebo.

B Vitamins (B12, B6, folate) May Not Reduce Cardiovascular Events For Coronary Artery Disease Patients Ebbing M, et al, JAMA 2008, Aug 20 — In a large clinical trial involving patients with coronary artery disease, use of B vitamins B6, B12, folate was not effective for preventing death or cardiovascular events. Patients were randomly assigned to one of four groups receiving a daily oral dose of one of the following treatments: folic acid, 0.8mg, plus vitamin B12 , 0.4mg, plus vitamin B6 , 40mg (n= 772); folic acid plus vitamin B12 (n = 772); vitamin B6 alone (n = 772); or placebo (n = 780).The study was stopped early because of concerns among the participants about preliminary results from another similar Norwegian study suggesting no benefits from the treatment and an increased risk of cancer from the B vitamins. Daily supplementation combination that included folic acid and vitamin B6 and B12 had no significant effect on the overall risk of cancer, including breast cancer, among women at high risk of cardiovascular disease. Zhang M et al, JAMA 2008 Nov. 5.

Certain Vitamin Supplements May Increase Lung Cancer Risk, Especially In Smokers. November 11, 2008, from American Thoracic Society. March of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

Selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer; these results came from initial, independent review of study data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT), funded by the National Cancer Institute. (publication  Feb. 1 in the Journal of Clinical Oncology.)

These reports, along with those showing inefficacy of vitamin E in CV prevention and others, all in recent months, dovetail on more reported over the past decade. Now for the dissonance. A popular Web portal posted a brief questionnaire following one of last week’s reports. It asked readers to answer if they took vitamins regularly, infrequently, or not at all.
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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Nutrition, Politics and Regulation

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Robert F. Kennedy, Jr., vaccines, the EPA, and the interface with science-based medicine and public policy

This blog is entitled Science-Based Medicine for a reason, and that’s because we here at SBM believe that the best method to result in the most efficacious treatments for the most people is through the application of science to the evaluation of the biology, pathophysiology, and treatment of disease and disorders.

I may (or may not) be departing a bit from the views of my co-bloggers with this belief, but for purposes of this blog I consider “medicine” to go far beyond what we as physicians do when we undertake to treat patients. In fact, in my view, the purview of science-based medicine should not be so limited but should include any area where decisions, actions, or policy have a direct impact on health. Thus, my definition of science-based medicine encompasses environmental policy, because of the profound effect on human health environmental pollution and toxins can have. Unfortunately for those of us who don’t like its messiness, such a view drives me even more directly into politics than previous issues I’ve taken on. Like Dr. Novella, I rarely write about politics, but when it directly impacts science-based medicine. Mostly, such discussions here on SBM have involved the regulation of the medical profession by government, as Dr. Atwood discussed recently (1, 2, 3) in the context of the difficulties medical boards have in preventing quackery to my discussion of how a quack like Dr. Rashid Buttar could continue to practice in North Carolina, despite his despicable preying upon desperate cancer patients and the parents of children with autism, not to mention the frequent criticisms of the National Center for Complementary and Alternative Medicine. Dr. Sampson, on the other hand, was more than willing to examine a much more explicitly political issue, namely the number of Iraq War dead (1, 2), and that provoked a bit of disagreement with our commenters, not to mention me.

Recently, hot on the heels of the election of Barack Obama in the Presidential election last week, an issue relevant to several aspects of where science-based medicine intersects public policy popped up. Steve Novella has already commented on it on his own blog, as have numerous other medical bloggers, science bloggers, and political bloggers but I feel justified in commenting on it here, for the reasons that I’ve just mentioned. The controversy is that antivaccine activist and true believer in the scientifically discredited notion that mercury in the thimerosal preservative in vaccines causes autism, Robert F. Kennedy, Jr., is being seriously considered by Barack Obama either to head the Environmental Protection Agency or even to be Secretary of the Interior. Like our fearless leader Steve, I believe that such a selection would be an unmitigated disaster for science policy in government.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Wyeth vs. Levine: Should Drug Label Standards Be Determined By Juries?

It is with some degree of trepidation that I enter the fray on the Wyeth vs. Levine case. I’ve been watching the media frenzy about the lawsuit with interest – mostly because (for the first time in a while) I think that the pharmaceutical company is in the right on this one – and that most journalists (and even medical journal editors) have missed the salient points.

I think that a close review of the case is instructive in two ways. It shows: 1) the dangers of making legal decisions based on the perspective of the victim (a risk of harm equal to 1 in 20 million is unacceptable to that one person who suffered the consequence, but tolerable to the other 19,999,999 others) and 2) that a simple case of medical malpractice has made it all the way to the US Supreme Court because (as I discussed in my last post) a democratization of knowledge (juries reading a drug label) was believed to democratize expertise (how a physician would understand the label).
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health

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How State Medical Boards Shoot Themselves (and You) in the Foot

This is almost the final entry (for now) in a series of posts about the pitfalls of regulating physicians who peddle quackery.† In previous entries we’ve seen how quacks have portrayed an illegal and pseudoscientific treatment, intravenous hydrogen peroxide, as legitimate; how a physician who practiced that and other dubious methods eluded definitive regulatory sanctions for years; examples of quacks banding together to form pseudomedical pseudoprofessional organizations (PPOs) and bogus board-certification schemes to establish the appearance of professional legitimacy, for protection from regulatory scrutiny, to garner political clout, to attract funds from interested businesses, to dupe the Accreditation Council for Continuing Medical Education into granting continuing medical education credits (CMEs) for pseudoscientific conferences, and more.

Now we’ll look at several examples of how state medical boards in the U.S. have abdicated their responsibility to protect the public from such practitioners. A few caveats: first, in most cases I can only guess why that has happened. Some of it has probably been due to naiveté, or to political or legal pressures. To some extent it has probably been due to faddism and its close relative, misleading language. Next, the examples given here are by no means exhaustive. Next, a state medical board can only be as effective as the language in the state’s medical practice act allows it to be, and that is determined by legislators (politics), not board members. Finally, state medical boards have not uniformly made the wrong choices regarding quack practices and practitioners.

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Posted in: Health Fraud, Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine

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A New Twist for Autism: A Bogus “Biomedical” Board

Here’s a short addition to the topic of Pseudomedical Pseudoprofessional Organizations (PPOs).† New pseudo-board-certification schemes pop up like mushrooms after a spring rain, but just last week there was an announcement of one with a difference:

The American Medical Autism Board

AMAB offers the first of its kind board/diplomate certification program for medical doctors specializing in biomedical treatment of autism and related disorders. These disorders are known collectively as the Autism Spectrum Disorders (ASD). Thus, medical doctors who become certified by the American Medical Autism Board show that they specialize in biomedical treatment of ASD, and will have met the Board’s high levels of criteria for training and experience, and will have passed its rigorous certification examination.

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Posted in: Health Fraud, Politics and Regulation, Science and Medicine

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The Pseudomedical Pseudoprofessional Organization (PPO*)

(*Not to be confused with “Preferred Provider Organization,” which shares the acronym)

This is part of an ongoing series† discussing pitfalls of regulating physicians, but I’ve decided, in the interest of flexibility, to vary the title. A couple of weeks ago I gave some examples of how individual physicians practicing substandard, implausible medicine manage to avoid or delay being disciplined by state medical boards. I observed that the boards themselves seem reluctant or slow to act against such practices, even those that are illegal, and that this stands in contrast to their prompt actions against other types of malfeasance: those of the “low-hanging fruit” variety. In a comment, David Gorski reminded me that he had previously offered a few reasons for that discrepancy, with which I agree. Nevertheless, it seems odd that state boards don’t do better.

In an attempt to find more explanations, this week we’ll look at another tactic of practitioners of pseudomedicine: banding together to create pseudomedical pseudoprofessional organizations (PPOs), complete with pseudo-legitimate names, pseudo-legitimate conferences, pseudo-legitimate appearing websites, pseudo-”board certifications,” protocols for pseudo-therapies, patient brochures hyping pseudo-therapies, pseudo-consent forms for pseudo-therapies, pseudo-Institutional Review Boards to approve pseudo-research, pseudo-journals to publish reports of pseudo-research, very real financial contributions from pseudoscientific corporations to help pay for very real advertising, very real lobbying, very real legal representation, and more.

There are many more PPOs than we’ll be able to examine, but they have common features. We’ll also look at how some Institutions That Should Know Better respond to PPOs, which can be frightening. (more…)

Posted in: Health Fraud, Politics and Regulation, Science and Medicine

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Pitfalls in Regulating Physicians. Part 2: The Games Scoundrels Play

A Few Things that No Doctor Should Do

When a physician is accused of DUI, “substance abuse,” being too loose with narcotic prescriptions, throwing scalpels in the OR, or diddling patients, the response of a state medical board† tends to be swift and definitive. Shoot first, ask questions later. After all, the first responsibility of the board is to the public’s safety, not to preserving the physician’s livelihood. One might therefore expect that a physician accused of using dangerous, substandard treatments would face a similar predicament. As you’ve undoubtedly guessed, such is not the case.

Here on Science-Based Medicine I’ve discussed at least 4 risky and implausible treatments: Laetrile, the “Gonzalez Regimen,” Na2EDTA “chelation therapy,” and intravenous hydrogen peroxide. Any medical board worth its salt ought to recognize each of those as dangerous and sub-standard, and therefore ought quickly to impose serious disciplinary measures upon any licensed physician found using them. Sometimes that is the case, but all too often it isn’t.

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Posted in: Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

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Autism’s false prophets revealed

appIn the brief time that Science-Based Medicine has existed, I’ve become known as the vaccine blogger of the group. True, Steve Novella sometimes posts about antivaccine pseudoscience and fear-mongering (unlike me, he’s even been directly attacked by David Kirby) and both Mark Crislip and Harriet Hall have each done one post about it, but, at least this far, hands down I’ve done more posts about the misinformation, pseudoscience, and outright quackery spread by antivaccine activists such as J. B. Handley’s Generation Rescue and his recently recruited empty-headed celebrity spokesperson Jenny McCarthy, not to mention a number of others who promote the resurgence of infectious disease by sowing doubts about the safety of the most effective weapon the mind of humans have ever devised against it. Truly, few uses of “alternative” medicine bother me as much as the antivaccine orientation of so much of the movement supporting it, a movement that has also led to all manner of “biomedical” treatments (quackery).

What you might not know is how I developed my interest in this particular area of dangerous pseudoscience. After all, I’m a cancer surgeon and an NIH-funded cancer investigator, not a pediatrician, immunologist, or neurologist. As hard as it is for me to believe, given that it seems today that I’ve always been refuting this nonsense, I only first discovered the antivaccine movement about three and a half years ago. True, I had been a regular on certain Usenet newsgroups for at least four or five years before that and had encountered antivaccinationists there before, but my contact with them online had been sporadic, and they seemed “out there” even in comparison to the usual run-of-the-mill alt-med maven. But then in the spring of 2005 I started to notice in a big way the cadre of pseudoscientists, parents of autistic children, and others who pushed the myth that thimerosal-containing vaccines or vaccines in general cause autism. Oddly enough, it started out with the Huffington Post, of all places. In May 2005, Arianna Huffington started a large group blog, chock full of famous pundits and celebrities writing blog posts. Within three weeks of its formation, I had noticed a very disturbing aspect of the Huffington Post, and that was that it appeared to be providing a major soapbox for antivaccinationists, including a post by Janet Grilo of Cure Autism Now, two posts by that propagandist of antivaccinationists David Kirby (with whom our fearless leader Steve Novella has managed to get into a bit of a tussle), and posts by that Santa Monica pediatrician to the children of the stars, Dr. Jay Gordon, a man who assiduously denies being “antivaccine” but parrots the most blatantly obvious talking points of the antivaccine movement and is currently best known as being the pediatrician for Jenny McCarthy’s son Evan. At the very least, Dr. Gordon is an apologist for the antivaccination movement, and he has become one of the “go-to” guys for the media looking for physicians who are “vaccine skeptics,” making numerous radio and TV appearances to promote his “skepticism.”

The next phase of my “awakening” to just how pervasive antivaccine fearmongering and pseudoscience were came when Robert F. Kennedy, Jr. wrote an incredibly dishonest and deceptive screed that got wide coverage in the summer of 2005. His article, called, charmingly enough, Deadly Immunity was a rehash of all the misinformation about thimerosal in vaccines and autism wrapped up with in a bow of conspiracy-mongering worthy of a 9/11 Truther with a penchant for quote-mining that would make a creationist blush. The article appeared simultaneously on Salon.com (which normally doesn’t publish such nonsense) and Rolling Stone, a magazine that really should stay away from science and stick to covering entertainment and politics. It was followed by a media blitz by RFK Jr. and antivaccine propagandist David Kirby, best known for his credulous treatment of the thimerosal/autism link, Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy, published a few months before RFK, Jr.’s article, and his subsequent activities posting antivaccine nonsense on Huffington Post and, more recently, on the quackery-promoting antivaccine blog Age of Autism.

I’ve alluded to the fact before that I have quite a bit of blogging experience under another guise. Indeed, I’m sure many of the readers here know what that guise is. Suffice it to say that at the time I prefaced a post about RFK, Jr.’s article by saying that Salon.com had “flushed its credibility down the toilet” and referred to the article itself as the “the biggest, steamingest, drippiest turd Salon.com has ever published.” Clearly (and fortunately), I use much less–shall we say?–colorful language on this blog, but I bring this up so that the reader knows where I am coming from. Indeed, since that time in the summer of 2005, I’ve been wondering when scientists, public health officials, and physicians supporting science-based medicine would finally wake up and start to push back against this tide of antivaccine nonsense, which is starting to result in the resurgence of measles and other vaccine-preventable diseases. This year, I’ve seen some hopeful signs, including organizations like Voices for Vaccines and Every Child By Two, as well as other signs of push-back against the antivaccine movement, which, I hate to admit, has been clearly winning the P.R. war. What there hasn’t been yet is a book written from a scientific viewpoint that directly addresses the history of the recent resurgence of the antivaccine movement and refutes the pseudoscience that it promotes.

Until now, that is.
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Posted in: Book & movie reviews, Neuroscience/Mental Health, Politics and Regulation, Public Health, Vaccines

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