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. Continue reading

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

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).

Video Now Available: “Gene Patenting, the Supreme Court’s Myriad Decision, and the Future of Biotechnology”

In case you missed it live on Monday evening, video from the Petrie-Flom Center’s event “Gene Patenting, the Supreme Court’s Myriad Decision, and the Future of Biotechnology” (co-sponsored by the Broad Institute) is now available here.

09/27/13 UPDATE: Our intern Fatima Mirza also wrote up this summary:

At this event, a distinguished panel of law and biotechnology experts convened to discuss the landmark Supreme Court Myriad decision and its implications on the future of scientific innovation and development.

The discourse began with an introduction of the high-profile case that extended beyond simply the scientific, political, or legal spheres.

“A broad coalition of people came to file this case,” said Tania Simoncelli, former Science Advisor to the ACLU. “Everyone from clinical geneticists, genetic counselors, individual women who could not access testing, the American Medical Association, the American Association of Human Genetics, and the March of Dimes were involved.”

In order to provide context for the case, Glenn Cohen, Professor at Harvard Law School and Faculty Co-Director of the Petrie-Flom Center, offered a brief history of biotechnology and patent law.  He highlighted developments from as early as 1911 when adrenaline, a naturally occurring compound, could be patented and distributed commercially based on the principle of purification. Emphasizing paradigm shifts in a rapidly advancing society, Cohen further outlined the role of the Patent and Trademark Office. “At the heart of patent law is whether we will have a pro-innovation or anti-innovation effects,” said Cohen.

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Petrie-Flom Intern’s Weekly Round-Up: 9/20-9/27

By Fatima Mirza

Introducing Guest Blogger Kuei-Jung Ni

Kuei-Jung Ni will be a contributor at Bill of Health during his time as a Visiting Scholar at the Petrie-Flom Center in the 2013-2014 academic year. His current research explores the systems of governmental food safety regulation in the United States and Europe, with the goal of developing a suitable regulatory system for the Taiwanese government. Ni is visiting the Center with support from a Fulbright grant and the Top University Strategic Alliance (TUSA) of Taiwan.

Professor Ni holds an LL.M. from the University of California, Berkeley, School of Law, and a Ph.D. in Law from the University of Edinburgh School of Law. He is currently on leave from his role as Professor and Director at the Center for Technology Law, National Chiao Tung University, Taiwan.

The priorities in the benefit packages vs. the priorities of those who dole out the benefits

In my last post I promised I would provide details about the new piece of statutory legislation that was recently enacted by the Colombian Congress on the right to health, but first I should talk a little more about the prior jurisprudence that set the stage for it–especially since there’s so much of it. Every year, hundreds of thousands of right-to-health cases go before judges in Colombia, and some estimate that up to one out of every five Colombians has used the judicial system to gain access to health services.

By far, most of these cases are won by the plaintiff. And they should be.

Nearly 90% of the cases that involve procedures, and over 30% of the cases for medications, involve benefits that are actually already covered by the public benefit package (plan obligatorio de salud, or POS). And most of these aren’t over particularly expensive, complicated, or scarce benefits in the POS. The most frequently litigated medications are omeprazole (Prilosec) and oxygen. The most frequently litigated procedures aren’t even the procedures themselves, but specific parts of the procedures that aren’t explicitly listed in the bundle of benefits covered by the POS. For example, the POS covers colostomies, but the insurance companies systematically deny the colostomy bags. “We’ll open the hole in your flank, but it’ll be on you to figure out what to do with the excrement that’ll start oozing out. . .”

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Twitter Round-Up

By Sara Providence (PFC Intern)

As another way to keep you up to speed on what’s happening in the world of health policy, we’ll be compiling relevant tweets from our bloggers and posting them here on a bi-weekly basis.  Take a look:

Richard Epstein (@RichardAEpstein) tweeted a policy report from the Manhattan Institute concerning FDA regulation of stem-cell procedures. The report rebuts, among other arguments, the FDA’s position that stem-cell treatments are within its purview of preventing communicable diseases. (9/24)

Frank Pasquale (@FrankPasquale) tweeted an article about potentially limited choice of provider under the new health law. According to the authors, the Affordable Care Act keeps premiums low by restricting the number of doctors and hospitals available to patients. (9/24)

Arthur Caplan (@ArthurCaplan) tweeted about the “exploitation of women in poor, underdeveloped nations for surrogacy,” alongside his post of this article. The piece describes the growing phenomenon of wealthy Chinese families paying American women to be surrogate mothers. (9/23)

Michelle Meyer (@MichelleNMeyer) tweeted an article about Penn State’s decision not to sanction employees for non-compliance in a wellness plan. Employees were previously required to respond to a controversial survey administered by a health management company, or pay a fine. (9/18)

Arthur Caplan (@ArthurCaplan) tweeted a piece about continuing bias against gay blood donors. “Gay-rights advocates are fighting to amend the U.S. ban on blood donations by gay and bisexual men, which dates from the first years of the AIDS epidemic,” the author writes. (9/16)

HBR/NEJM online forum on health care innovation

For those of you who haven’t seen it yet, there’s a great ongoing online forum over at the joint Harvard Business Review and New England Journal of Medicine Insight Center on Leading Health Care Innovation.  It’s online at HBR here, and will feature an ongoing series of posts about innovation in high-value health care through November 15.  Short articles from scholars in various fields will focus on three main areas: Big Ideas (foundational principles of high-value health care); Managing Innovations (organization and delivery); and From the Front Lines (stories of specific case solutions from practitioners).

They’re looking to host a lively forum, so comments seem both quite welcome and unusually thoughtful so far.

 

OHRP Revises Guidance on Remuneration for Human Research Subjects

by Suzanne M. Rivera, Ph.D.

The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation.  And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human research studies.   Under its list of Frequently Asked Questions (FAQ) related to informed consent, there is a question (7) which reads, “When does compensating subjects undermine informed consent or parental permission?”  (http://www.hhs.gov/ohrp/policy/consentfaqsmar2011.pdf).

Aside from the fact that it’s still a very leading question (asking “when does it?” implies that, in fact, it does…), the new answer provided by OHRP clarifies that compensation in and of itself is not necessarily coercive or a source of undue influence.  It says that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for some individuals agreeing to participate in research.

That is a real paradigm shift. Continue reading

Worth Reading This Week

By Nicolas Terry

“Patient Discrimination against Medical Personnel” event featured in Harvard Crimson

Harvard’s student newspaper, the Harvard Crimson, covered last week’s Petrie-Flom event on “Patient Discrimination against Medical Personnel” featuring Kimani Paul-Emile of Fordham Law School. You can read the full article here.

Video of the full event is also available online.

Video of “Patient Discrimination against Medical Personnel” Now Available

If you weren’t able to join us for the panel discussion of “Patient Discrimination against Medical Personnel” on September 17, 2013, featuring Kimani Paul-Emile (Fordham Law), Renee Landers (Suffolk Law), and Fidencio Saldana (Harvard Medical School), you can watch it online here.