I’m no fan of quackery, whether it’s of the homeopathic, naturopathic, chiropractic, craniosacral, ayurvedic, or other woo-tastic flavour. I’m even less of a fan when it’s practiced by people with the letters MD or DO after their name. I think it’s deceptive and unethical to promote these unproven and often disproven practices to patients who come to you for professional advice.
Earlier this year, a Florida-based lawyer wrote a piece at SBM arguing that many quacktitioners are likely committing misrepresentation, in the legal sense, and possibly fraud in some cases. This was followed up with a series examining the background and historical legal status of naturopathy, acupuncture, and chiropractic, and now a proposal to enshrine science-based medicine in law.
Read the whole blog post to get a better sense for what’s proposed. The short version is that the proposed law would limit the scope of practice of licensed healthcare professionals by imposing a two-part test to be interpreted “according to its generally accepted meaning in the scientific community”:
- Is it (a diagnosis, treatment, procedure, medication, etc.) plausible, based on “well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology?”
- If not, is it “supported, to a reasonable degree of scientific certainty” by either “good quality randomized, placebo-controlled trials” or “by a Cochrane Collaboration Systematic Review or a systematic review or meta-analysis of like quality.” If not… it’s verboten.[a trial that would pass the legal test would have a placebo control group, random assignment, no more than 25% attrition, at least 50 participants in each study arm, and publication in a “high-impact, peer-reviewed journal.”]
If so, has its ineffectiveness been “demonstrate[d], within a reasonable degree of scientific certainty” by the aforementioned controlled trials or Cochrane Reviews? If so, plausibility won’t save it from being forbidden.
With a scheme like this, the devil is usually in the details. In this case, I don’t think one needs to dive in too deep to realize why this is a bad idea.
Politics is a sausage factory, and the science-based medical community should be hesitant to get it unnecessarily involved. Just because something is wrong/a bad idea (like quackery) does not necessarily mean that it should be forbidden in an ideal world. Just because something wouldn’t exist in an ideal world (like quackery), it doesn’t mean that it’s a good idea to use the force of law to ban it.
As narrowly-tailored as it aims to be, this proposed law will have the effect of legislating scientific truth. What constitutes scientific consensus? Plausibility? A high-impact journal? Do we really want these and other scientific questions that are now debated in the literature and the public sphere to be decided definitively by judge and jury? Do we want to give the power to certify science to our legislatures? The same legislatures that have already licensed all sorts of quacks at the behest of their lobbyists?
Science is politicized too easily. Where a scientific conclusion is translated by law into an inevitable legal and policy consequence, the science will make a better political target than the legislation. See this piece on the Endangered Species Act for an example of what I mean.
The best of policies can be undone by politics. I’ve given a fair bit of thought to how one might design an anti-quack law that doesn’t have the potential to go drastically awry. I can’t, though this is likely a result of insufficient creativity on my part.
In general, there are two types of people in government. “Our people” and “their people.” Who they are may vary based on the party or based on the issue, but both types will always be there. And both types win and lose elections.
Here’s the question: do you trust “their people” to exercise good stewardship of scientific truth? If not, let’s not be too hasty in handing over the reins to the politicians.
[My efforts at live-blogging/tweeting have been foiled by the fact that this conference occurs two levels below ground where there is no connectivity of any sort. I guess this means the hotel has me on tape delay…]
The first talk of the morning was by a second-year medical student (Shahram Ahari, UC Davis)who spent some time as a sales rep for Eli Lilly after graduating from Rutgers. He went into sales because he thought it would be an opportunity to connect with clinicians at an intellectual level and discuss the science. Because that’s what a private-sector sales job is all about. Needless to say, he was somewhat disillusioned, especially upon finding that most of his salesforce colleagues weren’t scientists, but… salespeople. Go figure.
The presentation wasn’t irrationally hostile to pharm companies, though I might have caught the suggestion at the end that physicians have an “obligation” to vote the interests of their patients. He explained the many ways in which pharm sales people use the same techniques employed by salespeople in any industry: appeals to emotion backed up by data about the client that is never overtly mentioned.
The discussion was focused almost entirely on the prescriber-marketing interface; I was hoping for some evaluation of the appropriate nature of researcher-industry relationships, which is where (in my view) the controversy is much hotter. Nonetheless, it was an entertaining talk that explained the psychological basis behind all sorts of marketing techniques such as giving away free stuff…
Oh, right! Free stuff! AMSA might claim to be pharm-free, but a quick visit through their exhibition hall revealed a whole host of characters whose money AMSA was more than happy to accept in exchange for a booth. Some of these groups are more savoury than others.
Details to come… truly extraordinary.
In a world where everybody wants more of their pet cause in the medical school curriculum, it’s always enjoyable to find such a cause that actually merits support.
Jin Packard, blogging at Low-Yield Medical, makes the case that medical school needs to give statistics and epidemiology the respect they deserve, using his own training as an example of how not to do it.
I, for one, view statistical fluency as a basic life skill — though given my background in economics (with all the exposure to stats and econometrics it entails) I would be expected to say that. If you disagree with me as far as physicians are concerned, go read Jin’s piece… it’ll set you straight.
Where I seem to part ways with him, however, is on the advisability of trying to get all of this material in during medical school. When I think of how much I learned in two semester as an undergraduate (and how much more I taught myself afterwards), it seems like a whole lot for a medical school course. Given that many medical schools are shortening the amount of time spent in the classroom from the traditional 2 years to 1.5 (or even 1, in some cases!), when do you teach it?
Personally, I would change the pre-med requirements so that “two semesters of math” becomes “two semesters of statistics.” Advanced calculus is nice to know, but I have yet to use it once. Statistics, on the other hand, are all around us. If students have a good foundation upon entry, it makes the task of the med school that much more achievable, and gives them that many fewer excuses for failure.
And let’s be honest, failure is what we have right now.
As I’ve blogged before, “the kids also don’t know how to make payroll.”
Via John Goodman comes a story at LA Weekly reporting that the next released edition of the Diagnostic and Statistical Manual of Mental Disorders might include picky eating, or “Selective Eating Disorder.” One of the lead researchers into the “causes and severity of the disorder” explains it thusly:
She went on to explain that these finicky eaters often reject food not because of taste, but rather because they find the look or smell unappealing or have negative physical or emotional childhood associations with food.
I know I’m only one-eighth of the way to being a medical professional and so might be missing out on something here, but it seems to me that what she’s saying is that sometimes people base their eating decisions on subjective personal preferences about the food in question.
The implication seems to be that if you don’t like a given food for reasons other than taste, you may have a mental illness. I wonder if that covers my avoidance of foods like deep-fried Twinkies for the sake of my health.
I’ve blogged before about the conflict-of-interest issues raised by the various ways in which physicians interact with pharmaceutical and medical device companies. Since starting my medical training at SUMS, I’ve had the opportunity to think about these issues further, especially since SUMS has taken their approach to the issue to an extreme level of demagoguery that I had previously thought impossible outside the realm of parody. To wit, the first-years were recently subjected to a presentation on the school’s COI policy from a “researcher” who proudly described himself as an “anti-pharma zealot” [the Z-word is 100% verbatim]. The official reply letter to be sent to any vendor* with the temerity to send a holiday gift reads like a mix between a legal filing and a letter home from a high school principal outlining the sins of the schoolchild.
There is a very defensible (I would say persuasive) case that reactions such as SUMS’ go too far. Perhaps the best exposition of this side of the argument comes from Richard Epstein, an NYU law professor whose writings on the topic can be found here and here. The crux of his argument is that these regulations of COI are ostensibly designed to advance a goal, and that they should be considered in light of how well they advance that goal, not in terms of how well they stick it to the drug companies. His argument is that the most extreme reactions — those on display at SUMS, for instance — do more to retard the goal of human progress in the medical field than they do to advance it.
Many U.S. medical investigators who manage drug trials abroad say they prefer to work overseas, where regulations are lax and “conflict of interest” is a synonym for “business as usual.” Inside the United States, doctors who oversee trials are required to fill out forms showing any income they have received from drug companies so as to guard against financial biases in trials. This explains in part why the number of clinical-trial investigators registered with the F.D.A. fell 5.2 percent in the U.S. between 2004 and 2007 while increasing 16 percent in Eastern Europe, 12 percent in Asia, and 10 percent in Latin America. In a recent survey, 70 percent of the eligible U.S. and Western European clinical investigators interviewed said they were discouraged by the current regulatory environment, partly because they are compelled to disclose financial ties to the pharmaceutical industry. In trials conducted outside the United States, few people care.
I see two evils here, and have a pretty good sense of which one I feel to be the lesser. I wonder how many lives SUMS’ local “zealot” would be willing to sacrifice on the altar of anti-corporate ideological purity…
* – Given that I’m paying tuition to SUMS in exchange for an education, I can’t help but wonder if I should consider them to be my “educational services vendor,” and if this COI business holds for the vendors to my vendor. All those verboten food baskets have to go somewhere…
What with this whole commencement of medical school, it’s been a while since the last edition. So I bring you slightly more than usual
Fun tidbits, health-related and otherwise, from around the ‘tubes:
- Worthwhile Canadian Initiative reminds us that counterintuitive though it may be, there is an optimal amount of forgetting. Dr. Bob Centor suggests that proposed performance payment for physicians forgets the role of patient preferences in steering therapy. Sticking with patient preferences, two posts at KevinMD argue that the long-term viability and feasibility of the PCMH care model should be determined by patient desires. That is, if the PCMH model is workable to begin with… an arguable proposition. Of course, if recent trends with retail clinics are any indicator… well, it could indicate many things. You be the judge.
- Beware economists bearing dynamic stochastic general equilibrium macroeconometric models! Beware surrogate endpoints in clinical research! Beware constitutional challenges to the PPACA! Beware Robin Hood… libertarian rebel? Beware overly alarmist bullet points!
- End-of-life spending has gotten some attention. The DMCB and Health Affairs alike aren’t convinced that reducing this spending will be easy, or that the savings are in fact possible to realize, at least as conventionally measure. Relatedly, a guest poster at KevinMD points out that in medicine, sometimes “more is more.” Not all potential cost-savings are “free lunches.”
- The Happy Hospitalist argues that data on physician reporting on impaired colleagues shows that the profession’s ethical standards are quite high. Dr. Wes points out the ethical shortcomings of conducting large-scale policy experiments without any concept of research subject welfare as found in clinical research. Arguably least ethical of this bullet point is Congressional exemption of the SEC from most FOIA requests.
- Pretty pictures! Congressional Republicans give us charts explaining new government agencies created by the PPACA and the criteria for obtaining small business health insurance tax relief under the act. The Denver Post posts some extraordinary colour photos from the Depression era. Of course, sometimes making use of pretty pictures (and text) will cause one to run afoul of the federal government, as with the ADA actions taken against universities piloting Kindle usage among their students.
- Let’s talk unintended consequences of government actions. Start by guessing which Senator takes exception to certain provisions of the PPACA? Hint: his name rhymes with “Hairy Reed.” Elsewhere, the recession has forced two entrepreneurs to decamp to Canada because of the arcana of the E-2 visa. What happened to new bond issues after the passage of the Dodd-Frank financial reform bill? Would “disaster” be hyperbolic? Becker and Posner ponder the effects of the administration’s pro-union attitude on business uncertainty and the recovery. Megan McArdle discusses the optimal level of regulatory enforcement, whereas another blogger discusses the “tyranny of big ideas” in the context of regulatory change and improving human welfare.
- On lighter notes, we have a farmer who reminds the world that old-school farming isn’t all it’s cracked up to be, and a brief history of Tibetan Buddhism that is markedly different from the sort of thing you’d probably expect.
- Rounding out this week’s edition… Medical schools, broadly speaking, do three things. They educate physicians, produce research, and care for patients. As someone just starting medical school, it’s nice to read things like this post from Dr. Centor arguing that the primary mission of medical schools should in fact be medical education.