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Archive for 2008

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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Is medical academia just following academia?

Is Medical Academia repeating Academia’s history? In a recent essay in a small-circulation, specialized periodical, Academic Questions, Prof. John M. Ellis, emeritus Professor of Literature at the University of California, Santa Cruz, recounts the past 4-5 decades of changes in liberal arts departments in US colleges. (How Preferences Have Corrupted Higher Education, Acad Quest, 2008; 21(2):265-274)  One modern academic controversy not needing recounting is the takeover of liberal arts departments by post-modernist theology and the partial takeover of universities themselves by radical politics dating from the 1960s.  But as recounted by Prof. Ellis, the fifty-year metamorphosis has not only changed universities, but has produced a branching network of intended and unintended consequences.

We have noted before that medicine is both a science and a practice that reflects current social attitudes and mores. (I minimize the aliquot of art, persisting from prior centuries; cultural influences being a more accurate term.) But the changes in universities now reflect in the normative thinking and mores of the modern medical school – at least a nucleus of them.  Thus Dr. Ellis’s observations may be a metaphor or template for a medicine of the next several decades.

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Posted in: Medical Academia

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Cognitive Dissonance at the New York Times

Humans have the very odd ability to hold contradictory, even mutually exclusive, ideas in their brains at the same time. There are two basic processes at work to make this possible. The first is compartmentalization – the ideas are simply kept separate. They are trains on different tracks that never cross. We can switch from to the other, but they never crash into each other.

When contradictory ideas do come into conflict this causes what psychologists call “cognitive dissonance.” We then typically will relieve cognitive dissonance, which is an unpleasant state, through the second process – rationalization. We happily make up reasons why the two conflicting ideas actually don’t conflict at all. People are generally good at rationalization. It is a supreme intellectual irony that greater intelligence often leads to a greater ability to rationalize with both complexity and subtlety, and therefore a greater capacity to maintain contradictory beliefs.

In fact the demarcation between science and pseudoscience is often determined by the difference between sound scientific reasoning and sophisticated rationalization.

While cognitive dissonance refers to a process that takes place within a single mind, it is a good metaphor for the contradictory impulses of groups of people, like cultures or institutions. I could not help but to invoke this metaphor when reading two editorials published in the same day in the New York Times.

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Posted in: Clinical Trials, Science and Medicine

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What’s for Dinner?

Diet advice changes so fast it’s almost a full-time job to keep up with it. Avoid cholesterol; no, avoid saturated fats; no, avoid trans-fats. Avocados are bad; no, avocados are good. Wheat germ is passé; now omega 3s are de rigueur. The supermarket overwhelms us with an embarras de richesses, a confusing superabundance of choices from “organic” to low-sodium. How can we decide what to have for dinner?

Michael Pollan, the author of The Omnivore’s Dilemma, has written a new book: In Defense of Food: An Eater’s Manifesto. He argues for a simplification of diet advice. He hones it down to seven words: Eat food. Not too much. Mostly plants. (more…)

Posted in: Book & movie reviews, Nutrition

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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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Update on the NIH “Trial to Assess Chelation Therapy”

A few days ago, while gathering information for last week’s post about intravenous hydrogen peroxide, I noticed this:

ACAM Supports NIH Decision to Suspend TACT Trial

September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false.  ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.

“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.

I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:

The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.

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Posted in: Clinical Trials, Medical Ethics

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A Budget of Anecdotes

Anecdotal evidence. An oxymoron? Or a valid approach to understanding data?

The problem is there are different kinds of anecdotes, used for different purposes, but the purpose of anecdotes is rarely if ever defined explicitly. Anecdotes are used for one purpose by one speaker/writer but interpreted in a different context by the listener/reader. People love anecdotes, especially if the anecdotes are about them or their beliefs. Anecdotes are how patients transmit the particulars of their disease to their health care providers. The medical history, as taken from the patient, is an extended anecdote, from which the particulars of the disease have to be extracted. Anecdotes are how physicians explain disease and treatments. Anecdotes are a tool with which teachers instruct their students. Anecdotes are how CAM proponents validate their particular system, and how skeptics invalidate them.

Anecdotes are useful tools for presenting yourself and your ideas. The convention season is over and is was striking how the candidates attempted to win over voters with anecdotes about their lives rather than the particulars of their policies. Using variations of ‘anecdote’ as a pubmed search term yields little of substance. The predominant theme on medline is to contrast anecdotes with evidence, always to the detriment of anecdotes. Anecdotes have power to influence far greater than evidence.

On The Skeptics Guide to the Universe #165 there was an interview with Ben Goldacre, who noted that there was the popular misbelief that the MMR vaccine was a cause of autism. The belief waned not when the voluminous data on the safety and lack of association with autism and the MMR was released, but when it was discovered that the primary proponent of the MMR/autism link received large sums of money to testify about that MMR/autism link. It was the anecdote about his conflict of interest that invalidated the idea, not the science.

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Posted in: Science and Medicine

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Acupuncture for Hot Flashes – Or, Why So Many Worthless Acupuncture Studies?

In yet another round of science by press release, a particularly unimpressive acupuncture study is making the rounds of the major news outlets proclaiming that acupuncture works. I guess that is a sort-of answer to my title question – why are so many scientifically worthless acupuncture studies being done?

Let’s take a look at this particular study to see why it is so weak. All I have to go on is the press release, since the study is not published. It was presented at a scientific meeting – which is legitimate, I just don’t have access to it. (The bar for publication in a peer-reviewed journal is much higher than presentation at a meeting, and there may, in fact, be changes to the text prior to publication.) But we can still say a great deal about this study from the information provided.

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Posted in: Acupuncture, Clinical Trials, Energy Medicine

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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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Misleading Ads in Scientific American

I’m frequently asked, “Is what that ad says really true?” Three recent inquiries have been about products advertised in Scientific American. An ad may acquire a certain cachet by appearing in a prestigious science magazine, but that doesn’t mean much. Scientific American’s editorial standards apparently don’t extend to its advertising department. I remain skeptical about the claims for all three of these: Juvenon, the StressEraser, and the ROM exercise machine. I discussed the ROM machine last week.

Juvenon

This product is advertised as “The Supplement That Can Slow Down the Clock on Aging Cells.” Andrew Weil also sells this on his website. It supposedly helps keep your mitochondria from decaying, promotes brain cell function, sustains energy levels, and is a powerful antioxidant.

The first time I noticed an ad for Juvenon in Scientific American I wrote the following letter to the editor: (more…)

Posted in: Health Fraud, Herbs & Supplements, Science and the Media

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