Politics and Regulation

Archive for Politics and Regulation

Diet Supplements or Nutritional Supplements: A Ruse by Any Other Name is Still a Ruse

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly. Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again; and maybe by writing this post I can make it easier for new readers to find the information.

Posted in: Herbs & Supplements, Politics and Regulation

Leave a Comment (47) →

The NCCAM Strategic Plan 2011-2015: The Good, The Bad, and The Ugly

As hard as it is to believe, it’s been nearly a year since Steve Novella, Kimball Atwood, and I were invited to meet with the director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Josephine Briggs. Depending upon the day, sometimes it seems like just yesterday; sometimes it seems like ancient history. For more details, read Steve’s account of our visit, but the CliffsNotes version is that we had a pleasant conversation in which we discussed our objections to how NCCAM funds dubious science and advocacy of complementary and alternative medicine (CAM). When we left the NIH campus, our impression was that Dr. Briggs is well-meaning and dedicated to increasing the scientific rigor of NCCAM studies but doesn’t understand the depths of pseudoscience that constitute much of what passes for CAM. We were also somewhat optimistic that we had at least managed to communicate some of our most pressing practical concerns, chief among which is the anti-vaccine bent of so much of CAM and how we hoped that NCCAM would at least combat some of that on its website.

Looking at the NCCAM website, I see no evidence that there has been any move to combat the anti-vaccine tendencies of CAM by posting pro-vaccination pieces or articles refuting common anti-vaccine misinformation. Of all the topics we discussed, it was clearest that everyone, including Dr. Briggs, agreed that the NCCAM can’t be perceived as supporting anti-vaccine viewpoints, and although it doesn’t explicitly do so, neither does it do much to combat the anti-vaccine viewpoints so ingrained in CAM. As far as I’m concerned, I’m with Kimball in asserting that NCCAM’s silence on the matter is in effect tacit approval of anti-vaccine viewpoints. Be that as it may, not long afterward, Dr. Briggs revealed that she had met with homeopaths around the same time she had met with us, suggesting that we were simply brought in so that she could say she had met with “both sides.” Later, she gave a talk to the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP), which is truly a bastion of pseudoscience.

In other words, I couldn’t help but get the sinking feeling that we had been played. Not that we weren’t mildly suspicious when we traveled to Bethesda, but from our perspective we really didn’t have a choice: if we were serious about our mission to promote science-based medicine, Dr. Briggs’ was truly an offer we could not refuse. We had to go. Period. I can’t speak for Steve or Kimball, but I was excited to go as well. Never in my wildest dreams had it occurred to me that the director of NCCAM would even notice what we were writing, much less take it seriously enough to invite us out for a visit. I bring all this up because last week NCCAM did something that might provide an indication of whether it’s changed, whether Dr. Briggs has truly embraced the idea that rigorous science should infuse NCCAM and all that it does, let the chips fall where they may. Last week, NCCAM released its five year strategic plan for 2011 to 2015.

Truly, it’s a case of The Good, The Bad, and The Ugly.

Posted in: Basic Science, Clinical Trials, Politics and Regulation

Leave a Comment (54) →

Breast implants and anaplastic large cell lymphoma (ALCL): Is there a link?


I must admit that I have a bit of a love-hate relationship with breast implants. On the one hand, as a breast cancer surgeon, I see them as a major benefit to my patients who are unfortunate enough to require mastectomy in order to control their disease. The armamentarium of techniques for reconstructing breasts after mastectomy generally falls into one of two categories, either various form of muscle flaps or breast implants. However, some women are, for various reasons, not eligible for various muscle flap reconstructions. That leaves either breast implants–or nothing. Certainly, some women are perfectly fine with no reconstruction after mastectomy, but many, if not most, women are not. For these women, it would be difficult to overstate how much of a boon to body image and self-esteem reconstruction can be, particularly given how much better at it plastic surgeons have become over the last couple of decades.

On the other hand, breast implants make my life as a breast cancer surgeon more difficult for a variety of reasons. First, they tend to make mammography more difficult by obscuring part of the breast, thus decreasing the sensitivity of mammography. Good mammography facilities can get around this to some extent by using various displacement techniques, but it takes some effort, and it doesn’t completely correct the problems that implants cause for mammographic screening. Moreover, when a woman who has had implants placed for cosmetic reasons comes to see me for a breast mass or an abnormal mammogram, the presence of the implants can complicate treatment decisions. If the abnormality or mass is close to the implant, we worry about rupturing it in the process, particularly if the implant is not below the pectoralis major muscle. Even when the implant is subpectoral, the muscle overlying it frequently ends up being so stretched out that the muscle in essence forms part of the capsule around the implant and ends up being a lot thinner than you might expect. Let me tell you, my anal sphincter tone is always much tighter when operating near an implant, particularly a silicone implant. True, I’m perfectly capable of removing an implant if it’s accidentally ruptured, but such an outcome is not desirable, particularly with silicone implants, where cleaning up the leaking silicone can be difficult.

It doesn’t help that silicone breast implants have been the subject of controversy since the late 1980s and early 1990s, when thousands of women with silicone implants reported a variety of ailments, including autoimmune disease and a variety of other systemic illnesses. These reports led to a rash of lawsuits and, ultimately, the banning of silicone breast implants for general use in 1992. After that, silicone breast implants were only permitted in women requiring breast reconstruction or women enrolled in clinical trials studying breast implants. This ban was partially lifted in 2006, as evidence accumulated that the claims of autoimmune diseases and increased cancer risk due to silicone breast implants were not supported by clinical and scientific evidence and two products made by Allergan Corp. (formerly Inamed Corp.) and Mentor Corp. Not surprisingly, given that the furor over silicone breast implants as a cause of autoimmune and other systemic diseases is based on about as much solid scientific evidence as the antivaccine furor over vaccines as a cause of the “autism epidemic,” there was widespread criticism of this decision. Even now, it is not difficult to find articles about breast implants with titles like Breast Implants: America’s Silent Epidemic and websites like the Humantics Foundation and Toxic Breast Implants . I do note, however, that the number of such sites and articles does appear to be declining and, at least to my impression, seems to have decreased markedly over the last 10 years or so.

Having reviewed the literature and found evidence for a link between silicone breast implants and the systemic diseases attributed to them to be incredibly weak at best, I had little problem with the FDA’s decision. Actually, the only thing I had a problem with at the time, my opinions of how breast implants interfere with breast cancer detection and treatment notwithstanding, is that the FDA was probably being more cautious than the evidence warranted after 14 years.

Was I wrong?

Posted in: Cancer, Epidemiology, Politics and Regulation, Public Health

Leave a Comment (14) →

The English government cracks down on alternative pet remedies

One cannot play charades forever.

European veterinary groups have long been more skeptical about “alternative” veterinary practices than their American counterparts. For example, the European Board of Veterinary Specialties refuses to grant continuing education credits for non-scientific endeavors attempting to masquerade as a way to improve one’s clinical knowledge, and the practice of veterinary homeopathy is forbidden in Sweden.

Now comes good news (for pets, and pet owners), out of the UK. In an effort to improve animal health and welfare, the Veterinary Medicines Directorate’s (VMD) has targeted “alternative” remedies, which, of course, pose both real and potential dangers to pets. The VMD is the body responsible for the authorization of veterinary medicinal products in the United Kingdom.

Specifically, the VMD is targeting a number of unauthorized products that lack scientific proof of effectiveness, including:

Posted in: Politics and Regulation, Veterinary medicine

Leave a Comment (20) →

Energy Drinks

My stimulant of choice is coffee. I started drinking it in first-year university, and never looked back. A tiny four-cup coffee maker became my reliable companion right through graduate school. But since I stopped needing to drink a pot at a time, an entirely new category of products has appeared — the energy drink. Targeting students, athletes, and others seeking a mental or physical boost, energy drinks are now an enormous industry: from the first U.S. product sale in 1997, the market size was $4.8 billion by 2008, and continues to grow. (1)

My precious coffee effectively has a single therapeutic ingredient, caffeine. Its pharmacology is well documented, and the physiologic effects are understood. The safety data isn’t too shabby either: it’s probably not harmful and possibly is even beneficial. (I’m talking about oral consumption — no coffee enemas. Please.) In comparison, energy drinks are a bewildering category of products with an array of ingredients including caffeine, amino acids, vitamins, and other “natural” substances and assorted “nutraceuticals,” usually in a sugar-laden vehicle (though sugar-free versions exist). Given many products contain chemicals with pharmacologic effects, understanding the risks, signs of adverse events, and potential implications on drug therapy, are important.

So are energy drinks just candied caffeine delivery systems? Or are these syrupy supplements skirting drug regulations?


Posted in: Herbs & Supplements, Nutrition, Politics and Regulation

Leave a Comment (27) →

Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?


This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”


Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

Leave a Comment (49) →

CAM and the Law Part 3: Malpractice

It is with some trepidation I venture into the next subject in this series — malpractice law. This is a touchy subject for healthcare providers, for obvious reasons. Regardless of the flaws in the system, however, malpractice law is one of the mechanisms put in place by government to regulate the practice of medicine. Like the other such mechanisms touched on so far, licensure and scope of practice law, malpractice laws apply to alternative medicine practices in ways that are broadly similar, but sometimes subtly and significantly different, from how they apply to scientific medicine. 

So far, alternative practitioners are sued for malpractice relatively infrequently compared with physicians, presumably because they represent a much smaller fraction of the care provided, they tend to be utilized by those with an ideological bias in favor of their approaches, and they are not viewed as nearly as rich a target for litigation. But this may change if the political and cultural winds blow in the direction of greater utilization of alternative medical approaches. 


Posted in: Legal, Politics and Regulation

Leave a Comment (19) →

Resident’s Working Hours- Should We Let Sleeping Docs Lie?

The Accreditation Council for Graduate Medical Education (ACGME) has released proposed new standards to limit working hours for medical residents. Bus drivers are allowed to drive for 10 hours and then are required to have 8 hours off duty. Airline pilots can be scheduled for up to 16 hours on duty — being at work, ready to fly — and up to eight hours of actual flight time in a 24-hour period, with a minimum of eight hours for rest between shifts. Physicians in residency training work 80 hours or more a week (compared to 75 hours a month for airline pilots) and are regularly on duty for more than 24 hours at a time. If adequate rest is an important safety measure for drivers and pilots, isn’t it important for doctors too?

When I was an intern and resident, my hours were a little better than some. Instead of every other night, I was on call every third night. I had to work from about 7 AM one day to 5 PM the following day (34 consecutive hours). I stayed in the hospital: there was a call room with a bed, but if we got to lie down it was never for very long. When I got off duty, my sleep-deprived body demanded that I go home and crash. It was only every third day when I worked “only” a 10 hour shift, that I could devote an evening to all the other activities of my life like laundry, grocery shopping, and trying to read medical journals. One memorable weekend I worked from Saturday morning to Monday evening and only got to lie down for about 20 minutes. I don’t think I made any fatigue-induced mistakes that hurt patients, but by Monday afternoon I was groping my way through brain fog and running on fumes. (more…)

Posted in: Politics and Regulation

Leave a Comment (53) →

CAM and the Law, Part 1: Introduction to the issues

When I write or talk about the scientific evidence against particular alternative medical approaches, I am frequently asked the question, “So, if it doesn’t work, why is it legal?” Believers in CAM ask this to show that there must be something to what they are promoting or, presumably, the government wouldn’t let them sell it. And skeptics raise the question often out of sheer incredulity that anyone would be allowed to make money selling a medical therapy that doesn’t work. It turns out that the answer to this question is a complex, multilayered story involving science, history, politics, religion, and culture. 

While we science types tend to be primarily interested in what is true and what isn’t, that is a sometimes surprisingly minor factor in the process of constructing laws and regulations concerning medicine. What I hope to do in this series of essays is look at some of the major themes involved in the regulation of medical practice, particularly as they relate to alternative medicine. I will begin by touching on some of the general philosophical and legal issues that have defined the debate among the politicians and lawyers responsible for shaping the legal environment in which medicine is practiced. The I will review some of the specific domains within this environment, including: medical licensure and scope-of-practice laws; malpractice law; FDA regulation of drugs, homeopathic remedies, and dietary supplements; truth-in-advertising law; and anti-trust law.


Posted in: Legal, Politics and Regulation, Science and Medicine

Leave a Comment (7) →

Integrating patient experience into research and clinical medicine: Towards true “personalized medicine”

We advocate science-based medicine (SBM) on this blog. However, from time to time, I feel it necessary to point out that science-based medicine is not the same thing as turning medicine into a science. Rather, we argue that what we do as clinicians should be based in science. This is not a distinction without a difference. If we were practicing pure science, we would be theoretically able to create algorithms and flowcharts telling us how to care for patients with any given condition, and we would never deviate from them. It is true that we do have algorithms and flowcharts suggesting guidelines for care for a wide variety of conditions, but there is wide latitude in them, and often a physician’s “judgment” still ends up trumping the guidelines. While it is also true that sometimes physicians have an overinflated view of the quality of their own “clinical judgment,” sometimes to the point of leading them to reject well-established science, as Dr. Jay Gordon frequently does, what I consider to be physician’s judgment is knowing how to apply existing medical science to individual patients based on their circumstances and, yes, even desires and values.

Indeed, if there’s one area where SBM has all too often fallen short in the past, it’s in taking into account the patient’s experience with various treatments. What got me thinking (again) about this issue was an article by Dr. Pauline Chen in the New York Times last Thursday entitled Listening to Patients Living With Illness. She begins her article with an anecdote:

Posted in: Clinical Trials, Politics and Regulation

Leave a Comment (9) →
Page 31 of 50 «...10202930313233...»