Art Caplan: Surgery to stop autistic boy’s screams was the right decision

Art Caplan has a new op-ed up at MSNBC.com:

A Wisconsin mother says that surgery helped quiet her autistic teenage son’s ceaseless screams, a decision that has attracted criticism from many, including families within the autism community. But for this particular teenager, and this particular family, it was the right choice to make. […]

Read the full article here.

Praise for Price’s “Making Do in Making Drugs”

Check out this nice write up of PFC Academic Fellow Nicholson Price‘s paper, Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing, over at the Written Description IP blog.  Says blogger , “Price’s paper leads to a host of new and interesting questions, and his thorough research revealing potential shortcomings of the FDA approval process is likely to be very useful . . . .”

Government Regulation of the Practice of Medicine: How the FDA overreaches the regulation of medical practice

By Richard Epstein

A sound scheme of public regulation seeks to find the best way to align the incentives of public regulators with the interests of the public at large.  That task has proven to be particularly acute with the U.S. Food and Drug Administration, which possesses vast powers to regulate the manufacture and distribution of drugs and medical devices in the United States, which it all too often overuses.

In a recent study for the Manhattan Institute entitled The FDA’s Misguided Regulation of Stem-Cell Procedures: How Administrative Overreach Blocks Medical Innovation, I examine the FDA’s over-regulation of new stem-cell technology in connection with the 2012 decision of Judge Rosemary Collyer (District Court of the District of Columbia) in Regenerative Sciences LLC v. United States.

That case examined the line between the regulation of pharmaceutical products on the one hand and the practice of medicine on the other. It is well established that the FDA has power over the former, but lacks power over the latter.  That distinction is of no small consequence because it allows, for example, for the rise of an extensive market in “off-label use” by physicians of drugs for purposes for which they have not received FDA approval.  This class of drug use is very large, and in cancer cases is thought to be more common than treatment using FDA-approved products.

The persistence of off-label drug use should caution people about allowing the FDA to exert extensive control over the drug licensing process.  It could be that the thousands of physicians, hospitals, and patients that use drugs off-label have, time after time, all made some major mistake.  Or it could just be possible that the accumulated level of institutional knowledge post-release demonstrates that the FDA has been too restrictive in its decisions as to whether a new drug should be allowed into the marketplace in the first instance. The FDA is heavily incentivized to be tough in its approval process lest it take heavy criticism for the all-too-visible injuries that may be caused by approved drugs. But in the social calculus, the individual losses that occur to people who are denied treatment by the heavy-handed actions of the FDA count every bit as much.  Yet these diffuse losses, often undocumented, bring much less heat to the FDA, which accordingly is prepared to shrug them off as a cost of supplying people the “protection” that is so central to the FDA mandate.

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Welcome, Genetics in Medicine!

We’re pleased to announce a new collaboration with the American College of Medical Genetics and its journal, Genetics in Medicine (under the Nature umbrella).  We’ll be highlighting medico-legal articles, podcasts, and the like from GIM, and in some cases, offering blog-only commentary from GIM authors.

Stay tuned, but for now, take a look at these recent pieces:

Personalized medicine and genetic malpractice by Gary E. Marchant PhD, JD and Rachel A. Lindor JD

Minimizing liability risks under the ACMG recommendations for reporting incidental findings in clinical exome and genome sequencing by Barbara J. Evans Ph.D., J.D.

Processes and factors involved in decisions regarding return of incidental genomic findings in research by Robert Klitzman MD, et al.

The undiscovered country: the future of integrating genomic information into the EHR by Joseph Kannry MD and Marc S. Williams MD (free full text)

Ethical, legal, and social implications of incorporating genomic information into electronic health records by Ribhi Hazin MD, et al.

Practical challenges in integrating genomic data into the electronic health record by Abel N. Kho MD, MS, et al.

Stakeholder engagement: a key component of integrating genomic information into electronic health records by Andrea Hartzler PhD, et al.

“When Truth Cannot Be Presumed” Burning Up SSRN

Make sure to check out “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment,” by our very own blogger – and former Petrie-Flom Center Academic Fellow – Christopher Robertson.  Chris presented this paper at our annual conference last year, blogged about it here, and must really be on to something, as his paper has already been downloaded from SSRN more than 1,100 times in the past 10 days.  Take a look for yourself.

The Response of WTO Members toward the Codex Alimentarius Commission’s 50th Anniversary

By Kuei-Jung Ni

The Codex Alimentarius Commission (Codex) that governs the making of international standards on food safety will reach its 50th anniversary in October 2013. The international institution was established in 1963 under the auspice of the World Health Organization (WHO) and the United Nations Food and Agriculture Organization (FAO). Its mandate is to approve food standards with a view to ensuring food safety and promoting food trade by harmonizing national food regulations. As of 2013, the Codex consists of 186 members.

Compliance with Codex standards used to be on a voluntary basis; the standards initially gave nations guidance in building up their food safety regulatory regimes without exerting legally binding force. However, the status of the standards has been drastically changed in the wake of the effectiveness of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organization (WTO) in 1995. That agreement explicitly requires WTO members to base their SPS measures on international standards, including those of Codex, and gives national measures that comply with Codex standards a presumption of SPS-consistency. Since then, the Codex has gained much weight, especially in the determination of the legality of WTO members’ disputable measures.

From a global governance perspective, WTO and Codex institutionally should be in a cozy and mutually supportive relationship. Thus, it is not surprising to see the SPS Committee of the WTO, at its recent session, send the Codex a quite polite and encouraging message, calling for continued support for the body, and for trade measures to be based on science. The US, Argentina, Australia, New Zealand, Canada, Belize, Russia, Chile, Senegal, the EU, Burkina Faso, Pakistan, Switzerland, Norway, South Africa, Argentina, Dominican Rep, China, Cuba and Lebanon (a WTO observer) echoed the key message mainly articulated by Brazil in praise of Codex’s work.

Yet, not all WTO members were overwhelmed by the message. In particular, the European Union (EU), even while it agreed that the tasks of the Codex are significant, maintained that Codex standards are not one size fits all, and emphasized that countries still have the right to adopt appropriate measures that deviate from Codex. Read More

My L.A. Times Op-Ed: In Defense of the Evidence-Based Nudge

By Michelle Meyer

The op-ed, which will appear in tomorrow’s print edition, is online here. It’s co-authored with Christopher Chabris (who happens to be my husband). Here—where I’m writing only for myself—I thought I’d say a bit about what motivated us and elaborate on a few points whose force may have been blunted by the process of condensing our thougts into our allottted 1,000 words.

The news hook for the article was an August memo leaked to Fox News in which the Obama administration announced that it is looking to hire behavioral scientists to help shape policy. Notwithstanding that the explicit model for this initiative is the U.K.’s “Behavioral Insights Team,” formed in 2010 by Conservative Prime Minister David Cameron, in the U.S., some on the right went completely off the rails about the Obama announcement.

A typical reaction was from Fox News’s Monica Crowley, who described the initiative as “really frightening,” “insane,” “outrageous,” “unconstitutional,” “an Orwellian horror show”—and all of the aforementioned mostly because, so far as I can tell, she believes that nudges constitute a form of “psychological warfare” akin to “what our military does to our enemies.” There are certainly legitimate criticisms of nudges to be made by both the right and the left, but that they are a form of Communist mind control is not among them. (For starters, even if nudges did rely on something like subliminal messages, those messages have been shown to have no effect on consumer behavior, much to the chagrin of marketers.)

The impetus for our piece, then, was to disabuse the Crowleys of the world (or at least that portion of them who are open to persuasion on this matter) of that notion, and then to offer some affirmative reasons why conservatives and libertarians should embrace the nudge (its preservation of all options in the choice set; its ability to incentivize personal responsibility; its efficiency), especially relative to its often perfectly viable alternative: the shove. (To that end, the piece was originally intended for a periodical with a right-of-center audience but wound up in the L.A. Times, where some of it may admittedly amount to preaching to the choir.)

In making our case…

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Informed consent workshop today and tomorrow; papers available

The first session on “vulnerable populations” just wrapped up at the workshop on “Frontiers of Informed Consent” at Northeastern University in Boston—with great talks on migrant, refugee, and indigenous communities and conflicts between law, ethics, and logistics of informed consent.

Today and tomorrow, there will be talks and discussion on IRBs and community-based research; information, autonomy, and risk; securing informed consent; and confidentiality. In the spirit of a workshop on “applied ethics,” discussion has been energetic and, thankfully, useful. In part this is because the participants range from staff at NIH to members of community review boards.

Stop by or get the pre-circulated papers (email the organizers for the password).