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Posts Tagged ‘research’

Is it worth legislating science to have science-based regulation?

October 23, 2011 3 comments

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”:

  1. Is it (a diagnosis, treatment, procedure, medication, etc.) plausible, based on “well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology?”
  2. 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.

AMSA Follies: Marketing Misadventures

March 11, 2011 2 comments

[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.

 

“The kids don’t know how to read a case-control”

January 23, 2011 2 comments
The re-drawn chart comparing the various gradi...

Image via Wikipedia

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.

***

Title taken from Sam Roberts‘s ever-so-catchy song “Them Kids.” [second link will stream the song]

As I’ve blogged before, “the kids also don’t know how to make payroll.

Adult “Selective Eating Disorder” to be included in DSM-V?

December 23, 2010 3 comments

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.

Heaven forfend!

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.

Les Douleurs de la Demagogue

December 13, 2010 Leave a comment

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.

This is perhaps best encapsulated in this snippet from a Vanity Fair piece (h/t John Goodman) decrying the practice of “outsourcing” drug trials to countries with weaker regulatory oversight.

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…

 

Cavalcade of Risk #112: The Cavalcade Gets Schooled

August 24, 2010 5 comments

It truly is an honour to have been asked to host the 112th edition of the Cavalcade of Risk blog carnival!  After all, I am but a lowly, economics-trained fledgling first-year medical student who has been blogging here for less than six months (still considerably longer than my time as a med student to date!) and who still has the occasional blog formatting issue or two.

The excitement surrounding the start of medical school is far from wearing off; as a result of that continued excitement, I decided to take the Cavalcade with me to classes.  Remember:  everything you read here is fair game for the final (and the licensing exam)!

Cavalcade of Risk #112:  Medical School Edition

Behaviour and the Brain

The workers' comp adjuster described this case as "a major headache."

Brains are important.  There are several pre-clinical courses that deal with them, and not just because the subject has a starring role in the licensing exam (and on the menu at the Bistro Zombie).  The brain is the seat of our behaviour, emotion, rational capacity, and risk assessment capability.  Even with this fascinating organ working at full tilt, dealing with risk rationally can be difficult.  Of course, we humans are far from perfectly rational, which makes for even greater challenges.  GrrlScientist links to a TED talk in which a researcher tries to gain insight into the root of human irrationality by examining decision-making in monkeys.  [CONGRESS JOKE DELETED]

Regulatory Compliance

Perhaps the most fun part of medical school orientation is the parade of sessions required by law, by the university, or by the medical school, for little other purpose than to be able to check off a box and say “the students are aware of the policy.”

If legislation had animal mascots, you would be looking at the HIPAA Hippo and the Son of HIPAA Hippo HIPAA Hippo

Of course, some of this compliance information is actually high-stakes.  For instance, this year’s HIPAA training session included a portion on medical identity theft red flags.  However, as well-trained and as eagle-eyed as the medical students are, you are your best first line of defence when it comes to preventing medical identity theft.  Ryan from CashMoneyLife has a post that explains how patients can both detect and protect themselves from medical identity theft.

Physiology

The Physiology of the Medical Student

“Phys” is all about how stuff works.  The typical first-year physiology course is a detailed overview of how the body works under normal conditions.  It’s easy to take for granted the complexity and intricacy of the processes that keep us alive, in part because most of the time, it all works without any effort on our part (knock on wood).

Protecting the normal physiology of business partnerships is the subject of the next post.  Jacob at My Personal Finance Journey explains how a combination of buy-sell agreements and properly-structured life insurance contracts can be used to make small business partnership succession go much more smoothly with much less effort at a stage where there will already be so much in flux.

Histology

The upperclassmen tell me that we look at a lot of slides in histology. As you can see, I'm trying to get a head start.

Histology, the study of tissues, typically involves lots of staining, sketching, and microscopy.  While advances in technology means that some slides are digitized for ease of review, there’s still plenty of opportunity to get your hands dirty with “the real deal,” just like the Disease Management Care Blog did with his submission to this week’s Cavalcade.  Dr. Jaan Sidorov has found the National Association of Insurance Commissioner’s “Blank” proposal defining the medical-loss ratio, stained it, and put it under the digital microscope for all to view.

Pharmacology

Is it just me, or do four of these look like they're glitter-filled?

I’ve always been impressed by the ability of nearly every physician I know to rattle off drug names (and their indications, side effects, etc.) with seemingly perfect, instantaneous recall.  I’d imagine that the months-long pharmacology course in year 2 has something to do with that.  “Better living through chemistry” can be tricky to achieve if you don’t know your chemicals.

Jason Shafrin, the Healthcare Economist, describes one set of efforts to improve the benefits of pharmacological therapy by involving pharmacists more directly with the patient’s medication therapy management.

Pathology

Not to be confused with "path-ology," a course taught at schools of engineering and urban planning.

“Path” examines how the body’s structures respond to a variety of stimuli, usually bad ones.  It seeks to answer the questions “what’s going on here?  What’s wrong?  What do these cells do when we [injure/mutate/slander] them?”  In this vein, the ever-intrepid InsureBloggers emerge from their basement labs to look at one state’s new PPACA-created Pre-existing Condition Insurance Pool, and provide a concise and focused overview of its pathologies.

Anatomy

I’m fortunate to be able to use so much of the material from my undergraduate vertebrate anatomy class to review terms for medical school anatomy.  Despite the fact that, in college, we worked on cows and cats instead of humans, the similarities between the vertebrates are such that a comparative approach to anatomy can yield great dividends.  For instance, courtesy of National Geographic TV, I know of a whale anatomist who works out of a human medical school in New York City.

First-year anatomy: a whale of a good time? Or the course that will have you sitting in lab all sad and blubbering?

Joel, our next poster, uses the techniques of comparative insurance anatomy to arrive at this tongue-in-cheek “Plea For Car Insurance Reform.”  As with the vertebrates, insights from one area of the insurance world may be able to tell you something about the others.

Biostatistics and Epidemiology

The Notwithstanding Blog would like to remind all visitors to wash their hands and observe universal precautions during their visit

Biostats teaches medical students how to use quantitative tools at a basic level.  Being able to critically evaluate new biomedical research is a crucial tool for those of us entering medicine at this time of seemingly-exponential change.  Epidemiology more broadly examines health status and disease in the aggregate, including surveillance of epidemics and monitoring of health trends.  Careful use of the tools of these fields can allow one to make reasonable predictions about the future of wellness trends and epidemics, or, if you’re Louise of Colorado Health Insurance Insider, the future of PPACA-grandfathered insurance plans.

Extracurriculars

The range of extra-curricular activities at SUMS (Sorta Urban Med School) seems nearly endless.  There are running clubs, research opportunities, student government positions, specialty interest groups… the list goes on.  However, one set of time-honoured activities among medical students is health outreach and education within the local community.  Many medical schools are located in or near areas in which there are major problems with access to healthcare and accurate health information; students can and do rise to the challenge of filling those gaps as best as they can.

These outreach projects can range in tone from the humour-filled to the gravely serious.  Julie Ferguson at Workers’ Comp Insider shares a feel-good breast cancer awareness video, along with some other chuckle-inducing medical parody videos.  David Williams, host of Cavalcade of Risk #113 in two weeks, posts a guest piece about the lies and dangers of so-called “pro-ana” websites.

Material unrelated to the course that nevertheless shows up on the final because it’s the professor’s niche research interest

"Syllabus? What syllabus?"

One of the risks of starting medical school, with its concomitant classes and extra-curricular activities, is that it will affect your blogging output.  Nonetheless, I plan to stick around.  I invite all of you CoR readers to poke around the rest of this site.  If you like what you see (and even if you don’t), I’d love nothing better than to have you stick around with me!

***

Cavalcade of Risk #113 will be hosted at the Health Business Blog.

Around the Mediverse: August 18, 2010

August 18, 2010 Leave a comment

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.
  • 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.”
  • 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.
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