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Archive for Science and Medicine

Supplement Regulation: Be Careful What You Wish For

A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.

Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:

Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

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Posted in: Herbs & Supplements, Politics and Regulation, Science and Medicine

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Acupuncture Pseudoscience in the New England Journal of Medicine

Here is the conclusion quoted from a recent New England Journal of Medicine (NEJM) review article on acupuncture for back pain:

As noted above, the most recent wellpowered clinical trials of acupuncture for chronic low back pain showed that sham acupuncture was as effective as real acupuncture. The simplest explanation of such findings is that the specific therapeutic effects of acupuncture, if present, are small, whereas its clinically relevant benefits are mostly attributable to contextual and psychosocial factors, such as patients’ beliefs and expectations, attention from the acupuncturist, and highly focused, spatially directed attention on the part of the patient.

Translation – acupuncture does not work. Why, then, are the same authors in the same paper recommending that acupuncture be used for chronic low back pain? This is the insanity of the bizarro world of CAM (complementary and alternative medicine). Yesterday David covered the same article, which I had also covered on NeuroLogica, but we both thought this issue important enough to document our thoughts and objections on SBM.

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Posted in: Acupuncture, Science and Medicine

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“Hard science” and medical school

One of the recurring themes of this blog, not surprisingly given its name, is the proper role of science in medicine. As Dr. Novella has made clear from the very beginning, we advocate science-based medicine (SBM), which is what evidence-based medicine (EBM) should be. SBM tries to overcome the shortcomings of EBM by taking into account all the evidence, both scientific and clinical, in deciding what therapies work, what therapies don’t work, and why. To recap, a major part of our thesis is that EBM, although a step forward over prior dogma-based medical models, ultimately falls short of making medicine as effective as it can be. As currently practiced, EBM appears to worship clinical trial evidence above all else and nearly completely ignores basic science considerations, relegating them to the lowest form of evidence, lower than even small case series. This blind spot has directly contributed to the infiltration of quackery into academic medicine and so-called EBM because in the cases of ridiculously improbable modalities like homeopathy and reiki, deficiencies in how clinical trials are conducted and analyzed can make it appear that these modalities might actually have efficacy.

Given this thesis, if there’s one aspect of medical education that I consider to be paramount, at least when it comes to understanding how to analyze and apply all the evidence, both basic science and clinical, it’s a firm grounding in the scientific method. Unfortunately, in medical school there is very little, if any, concentration on the scientific method. In fact, one thing that shocked me when I first entered what is one of the best medical schools in the U.S., the University of Michigan, was just how “practical” the science taught to us as students was. It was very much a “just the facts, ma’am,” sort of presentation, with little, if any, emphasis on how those scientific facts were discovered. Indeed, before I entered medical school, I had taken graduate level biochemistry courses for a whole year. This was some truly hard core stuff. Unfortunately, I couldn’t get out of taking medical school biochemistry my first year, but taking the course was illuminating. The contrast was marked in that in medical school there was very little in the way of mechanistic detail, but there was a whole lot of memorization. The same was true in nearly all the other classes we took in the first two years. True, for anatomy it’s pretty hard not to have to engage in a lot of rote memorization, but the same shouldn’t necessarily be true of physiology and pharmacology, for example. It was, though.

Over time, I came to realize that there was no easy answer to correcting this problem, because medical school is far more akin to a trade school than a science training school, and the question of how much science and in what form it should be taught are difficult questions that go to the heart of medical education and what it means to be a good physician. Clearly, I believe that, among other things, a good physician must use science-based practice, but how does medical education achieve that? That’s one reason why I’m both appalled and intrigued by a program at the Mt. Sinai School of Medicine for humanities majors to enter medical school without all the hard sciences. It’s a program that was written up in the New York Times last Wednesday in an article entitled Getting Into Med School Without Hard Sciences, and whose results were published in Medical Academia under the title Challenging Traditional Premedical Requirements as Predictors of Success in Medical School: The Mount Sinai School of Medicine Humanities and Medicine Program.

Let’s first take a look at how the NYT described the program:
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Posted in: Medical Academia, Science and Medicine

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Risibility. The Superior Therapeutic Intervention?

Dad always thought laughter was the best medicine, which I guess is why several of us died of tuberculosis.

~Jack Handey, “Deep Thoughts

We have a saying in medicine that you can’t kill a jerk.  Not that we try to kill anyone, but that particularly unpleasant individuals, rife with psychopathology, survive whatever illness comes their way.  The corollary is that particularly nice people are prone to having horrible diseases with unpleasant outcomes.  We all know intellectually that it is not true, but there is an ongoing feeling in health care providers that somehow patient personality determines the consequences of their diseases.  As an aside, I am often  left with the explanation for patients that the reason for their odd infection comes down to bad luck.  Everyone responds something to the effect that “Typical. I get all the bad luck.”  I have never had a patient say, “That’s odd, I am usually so lucky.”

On the question of nurture versus nature, raising two children has convinced me of the relative lack of importance of nurture in the personalities of my children.  While abusive/pathologic environments will certainly lead to pathologic personalities,  for the average child raised in middle class America I can’t help but think that, to quote Popeye, “I yam what I yam and that’s all what I yam.”  I expect to be schooled in the comments on that subject.  Yes, I read the Blank Slate and have some understanding of the literature.  And yet.  My kids, my friends kids.  I watch them grow in what is (and isn’t) a similar environment and end up with diverse personalities that often appear present before they can speak.  I am well aware of the multiple logical fallacies that lead to that conclusion.  Parenthood and medical practice (where people seem to do the same damn stupid things over and over) have lead me to the conclusion that free will is mostly a myth and we are mostly programmed to behave the way we do. Discuss.  It is not the main point of the post, but my bias.

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Posted in: Clinical Trials, Faith Healing & Spirituality, Humor, Science and Medicine

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Open Letter to Dr. Josephine Briggs

Josephine P. Briggs, M.D.

Director, National Center for Complementary and Alternative Medicine

Dear Dr. Briggs,

As you know, we’ve met twice. The first time was at the Yale “Integrative Medicine” Symposium in March. The second was in April, when Drs. Novella, Gorski and I met with you for an hour at the NCCAM in Bethesda. At the time I concluded that you favor science-based medicine, although you are in the awkward position of having to appear ‘open-minded’ about nonsense.

More about that below, but first let me address the principal reason for this letter: it is disturbing that you will shortly appear at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP). It is disturbing for two reasons: first, it suggests that you know little about the tenets and methods of the group that you’ll be addressing; second, your presence will be interpreted as an endorsement of those methods and of that group—whether or not that is your intention. If you read nothing more of this letter or its links, please read the following articles (they’re “part of your education,” as my 91 y.o. mother used to say to me):

Naturopathy: A Critical Appraisal

Naturopathy, Pseudoscience, and Medicine: Myths and Fallacies vs Truth

The first article is an introduction to the group to which you will be speaking; the second is my response to complaints, from that group and a few of its apologists, about the first article. It was a surprise to me that the editor, George Lundberg, preferred that I make my response a comprehensive one.

Thus the second article inevitably became the crash course—call it CAM for Smarties—that your predecessors never offered you, replete with examples of useless and dangerous pseudoscientific methods, real science being brought to bear in evaluating such methods, proponents’ inaccurate or cherry-picked citations of biomedical literature, bits of pertinent but little-known history, the standard logical fallacies, embarrassing socio-political machinations, wasteful and dangerous ‘research’ (funded—unwittingly, I’m sure—by the NCCAM), bait-and-switch labeling of rational methods as “CAM,” vacuous assertions about ‘toxins’ and ”curing the underlying cause, not just suppressing the symptoms,” anti-vaccination hysteria, misleading language, the obligatory recycling of psychokinesis claims, and more.

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Posted in: Homeopathy, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine, Science and the Media, Vaccines

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Californians give a whoop – or I hope they do.

I’m certain by now many of our readers have come across news of the current pertussis, aka whooping cough, epidemic in California.  Beginning this February and accelerating dramatically through May and June, California has so far seen a ~500% increase in pertussis cases compared to last year, and only two days ago announced the death of a sixth baby from infection.  Public health officials in California are currently working to control its spread and determine the factors that allowed this outbreak to occur, unfortunately, at this time the available data is very rough.

The number of confirmed cases as of 6/30/2010 is growing rapidly (1,377), with an additional ~700 cases pending investigation.  General geographic location, ages, and ethnicity have been identified, and general vaccination rates and exemption rates are known, but other important demographic and epidemiologic data, including vaccination status of infected children and adults, has yet to be fully described.  Lack of data notwithstanding, I have read equally hasty stories and comments blaming the outbreak on vaccine refusal, a large immigrant population, an inadequate adult vaccination program, and normal cyclical variation in pertussis incidence, among other factors.  Finding where the system has broken down enough to allow this resurgence is exceedingly important, but in this situation pointing fingers is not as important as taking action. (more…)

Posted in: Science and Medicine

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Terrible Anti-Vaccine Study, Terrible Reporting

One of my goals in writing for this blog is to educate the general public about how to evaluate a scientific study, specifically medical studies. New studies are being reported in the press all the time, and the analysis provided by your average journalist leaves much to be desired. Generally, they fail to put the study into context, often get the bottom line incorrect, and then some headline writer puts a sensationalistic bow on top.

In addition to mediocre science journalism we also face dedicated ideological groups who go out of their way to spin, distort, and mutilate the scientific literature all in one direction. The anti-vaccine community is a shining example of this – they can dismiss any study whose conclusions they do not like, while promoting any horrible worthless study as long as it casts suspicion on vaccines.

Yesterday on Age of Autism (the propaganda blog for Generation Rescue) Mark Blaxill gave us another example of this, presenting a terrible pilot study as if we could draw any conclusions from it. The study is yet another publication apparently squeezed out of the same data set that Laura Hewitson has been milking for several years now - a study involving macaque infants and vaccinations. In this study Hewitson claims a significant difference in brain maturation between vaccinated and unvaccinated macaque infants, by MRI and PET analysis. Blaxill presents the study without noting any of its crippling limitations, and the commenters predictably gush.

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Posted in: Science and Medicine, Vaccines

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Bought and Sold: Who Should Pay for CME

There are two topics about which I am a crank. The first, as you might have guessed, is alternative medicine. The other is pharmaceutical reps. Drug companies are somewhat schizophrenic. They have amazing scientists who invent drugs that treat an astounding array of diseases. Then, they take these drugs and turn them over to marketing, to be sold with all the enthusiasm and truthiness of a late night infomercial.

In the spirit of openness, I will say that I have not talked to a drug rep in 20 years. As far as industry supported gifts and food, I have not taken a pen or eaten pizza from industry in almost 30 years, since I was a fourth year medical student. I have accepted one gift over the years. Years ago, when the Pfizer rep left, he sent me Fleets enema with a Unasyn sticker on it. I still have it in my office, unused. But you never know when it might come in handy.

Being an absolutist about industry gifts does have downsides. It is distracting to sit in an auditorium filled with the smell of pizza and not eat any; somehow the PB&J I bring with me doesn’t smell as sweet. Administration has received one letter complaining about me that was ostensibly from an employee, but curiously was printed from a windows folder that had the same name as the levofloxacin rep. Just a coincidence, I am sure.
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Posted in: Medical Academia, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski. ;-)

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.”

Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.”

A “Patient-Centered Extremist”

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”:

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

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HuffPo blogger claims skin cancer is conspiracy

I was a bit torn when trying to figure out how to approach this piece.  A reader emailed me about an article in the Huffington Post, and there is so much wrong with it that I felt overwhelmed.  My solution is to focus on a few of the problems that can help illuminate broader points.

There is a small but vocal movement of people who refuse to believe that skin cancer caused by sunlight is a significant health risk.  These people tend to also believe that the risk is being purposely hyped by others, and that our current approach to skin cancer prevention is causing an epidemic of vitamin D deficiency. Leaving aside the seemingly insane denialism regarding sunlight and cancer, there are two broad problems with this article.  The first is pretty bad.

With the summer months upon us I wanted to find out firsthand what exactly the mantra is that dermatologists are telling patients. So I went undercover to several San Francisco dermatologists in order to see if there is legitimate concern about the sun-scare media hype. Are these doctors being sensible or going overboard when it comes to advice on sunscreen use and skin cancer prevention? Is the sky falling with dangerous UV rays or are we being induced into a media panic?

He goes on to give links to recorded conversations, and prints out partial transcripts.  He does not specify whether or not he received permission to record these conversations, as required by California law.  Whether or not the law requires it, the writer should have disclosed to his readers whether or not he had received permission.  This information is important in interpreting the conversations he reports to us.

The next problem is broader, and deals with physicians’ willingness to lie on behalf of patients.  The author’s presumably-clandestine recordings of his deceptive visits to dermatologists (catching my breath—this is striking and requires a digression.  The act of deceiving these doctors is not only unethical, but can influence the outcome of the visit.  Doctors make the assumption that most patients are interacting with them out of good faith, and are not intentionally deceiving them.) (more…)

Posted in: Science and Medicine

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