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Archive for Politics and Regulation

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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FDA approval of drugs and transparency in clinical trial results

ResearchBlogging.orgNote: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.

One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.

Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at ClinicalTrials.gov at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.
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Posted in: Clinical Trials, Medical devices, Politics and Regulation, Science and Medicine

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Pitfalls in Regulating Physicians. Part 1

I had intended today’s posting to be a summary of a real case faced by a state medical board. It is a case of licensed physicians treating patients with a substandard, dangerous, and unequivocally illegal method. My intent was to use it as an illustration of how difficult it can be for medical boards to discipline such practitioners, even when the treatment involved is obviously, blatantly bad. Only yesterday, I was informed by the pertinent board that because this case has yet to be resolved, I may not discuss it. So be it: I’ll save the specifics for another time. Instead I’ll offer a general example of a dubious treatment as a prelude to Part 2 of this series,† which will attempt to discover some of the reasons that medical boards might, under such circumstances, be ineffectual.

Intravenous Hydrogen Peroxide

Hydrogen peroxide (H2O2) is a highly reactive compound that is caustic to living tissues. It spontaneously decomposes to water and oxygen, a reaction that is greatly accelerated in the presence of peroxidases (mainly catalase), which are ubiquitous in human blood and tissues. It has been used as a disinfectant for superficial skin wounds and in the mouth, and also for fabric and medical equipment. It has been used as a bleaching agent for teeth and hair. When used as an irrigant in surgical fields, in other large wounds, or consumed in any form (including intravenously), however, it has resulted in predictable, catastrophic complications: arterial and venous gas emboli, emphysema, respiratory arrest, strokes, multiple cerebral infarcts, seizures, colonic ulcers, intestinal gangrene, acute hemolytic crises, shock, cardiac arrest, and death.[1-7]

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

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Bisphenol A in Plastics – Should We Worry?

Bisphenol A (BPA) is a chemical used in the manufacture of hard plastics which can be found in a wide range of products, including baby bottles, plastic utensiles, and plastic food containers. It has been the focus of some controversy over its safety, and the resulting debate reveals much about how the current system deals with such issues.

The concern is that BPA can leech from plastic containers into the food or liquid it contains, and when consumed can have negative health effects. The debate is over how to interpret existing evidence about BPA safety, which gives conflicting results. Essentially it is a debate about how to weight different kinds of evidence, and where safety thresholds should be.

The Science of Toxins

Toxicity is always a function of dose. Anything is toxic at high enough dose, and safe at a low enough dose.  Regulatory agencies concerned with protecting the public health, therefore, typically use scientific evidence to establish doses that are likely to cause toxicity in humans and then set safe levels of exposure significantly below that level to create a buffer of safety. But what kind of evidence is used?

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Posted in: Politics and Regulation, Public Health

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Threats to science-based medicine: When clinical trials for new drugs are designed by the marketing division

ResearchBlogging.orgTHREATS TO SCIENCE-BASED MEDICINE

The theme of this blog is science-based medicine. It’s even the name given the blog by our fearless leader, Steve Novella. By “science-based” medicine we generally mean medicine that is both grounded in scientific plausibility based on our best understanding of human physiology and disease as well as in strong evidence from well-designed clinical trials, both of which are extremely important We SBM bloggers tend to concentrate mainly on so-called “alternative,” “complementary and alternative,” or “integrative” medicine because it does indeed represent a major threat to the consensus among medical professionals that medicine should be science- and evidence-based. Moreover, the infiltration of pseudoscientific and antiscientific woo into medical schools, academic medical centers, and medicine at large, coupled with large amounts of money going to promote CAM, both from the government and wealthy private foundations, does represent an extremely worrisome trend that makes all of us, who range from mid-career to retired physicians, fear for the future generation of physicians and their ability to apply science and critical thinking to the evaluation of implausible health claims, such as reiki, homeopathy, applied kinesiology, and the large variety of woo that falls under the rubric of CAM. Worse, this trend began not long after a concerted push to make medicine more science- and evidence-based and less dogma- and authority-based.

Unfortunately, though, the antiscience of implausible health claims is not the only threat that science-based medicine faces. We bloggers here at Science-Based Medicine concentrate on it because its resurgence and infiltration into the very heart of academic medicine represent a sea change in the culture of scientific medicine, which once rightly and without reservation rejected much of what CAM represents as quackery. Also, I can’t speak for others, but pseudoscience interests me; it brings up questions of why people believe irrational and clearly false propositions. That being said, at the risk of ruffling a few feathers among my co-bloggers, I have observed that, if there is one thing that this blog has not to this point emphasized sufficiently, it’s that the commerce of medicine, the very manner in which we develop new therapies, can, if not carefully observed and regulated, represent a threat to science-based medicine even more potent than Andrew Weil, David Katz, and their all-out assault on the very foundations of scientific medicine and drive to return medicine to the days of anecdote-based rather than science-based medicine.

I’m talking about pharmaceutical companies. I’m also about to destroy any opportunity I might ever have to work for or receive any funding from Merck & Company. C’est la vie. A skeptical doc’s got to do what a skeptical doc’s got to do. Not that I won’t at least partially protect myself by adding the disclaimer that the following represents my opinion, and my opinion alone. It does not represent the opinion of my university, cancer institute, or partners.

Now that that’s taken care of, let’s start with a little primer on a pernicious phenomenon known as the “seeding trial.”
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Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Politics and Regulation

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