Conference Announcement and Call for Abstracts, 2014 Petrie-Flom Center Annual Conference

The Petrie-Flom Center has released the description and call for abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:

  • Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions?  What is a “best” decision, i.e., whose perspective should be paramount?
  • What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
  • Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
  • What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa?  Where should the nudges push?
  • Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture?  When nudges are not plausible, what is the best way to overcome bounded rationality?
  • When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
  • How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
  • What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?

Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.

Abstracts are due by December 2, 2013.

For a full conference description, including the call for abstracts and registration information, please visit our website.

A New Film on HIV Criminalization

By Scott Burris

A new documentary from the HIV Justice Network gets the views of researchers on the impact of HIV criminalization.  Call it Evidencer-Based film-making.  It premiered last night at the US Conference on HIV and can be seen here. made by Edwin Bernard and Nick Feustel, it captures the issues and what we know in 30 minutes of interviews with some excellent researchers.

On a personal note: sometimes, you know, people who are, you know, being filmed at, you know, the end of the day are, you know, not always as eloquent as, you know, they would like.

Good News for HIV Prevention Policy: Syringe Access Update

By Scott Burris

In documenting how often public health law research does influence legislation, I’ve used syringe exchange programs as an example of evidence NOT guiding policy.  Despite the consensus in health research that increasing access to sterile syringes has helped reduce HIV, state drug paraphernalia laws, and pharmacy regulations remain a barrier, as does the lack of strong and stable funding for the programs that are working.  The case was just made again in an article in the Annals of Health Law. Rachel Hulkower and Leslie Wolf retell the story of the federal funding ban, going over the evidence yet again, and argue that state inaction would best be overcome with money: replacing the federal ban with a positive endorsement and real funding.  (As long as we are in an optimistic mood, I would add strings – no HIV funding for states that don’t remove legal barriers to syringe access.  This would balance the scales a bit for Congress’ past sin in requiring state recipients of HIV funds to provide for criminalization of exposure and transmission.)

But today I type to tell a happier story. This summer, the state of Nevada passed a statute authorizing syringe exchange and pharmacy sales.  There are now 16 jurisdictions whose laws explicitly authorize syringe exchange programs (CA, CO, CT, DC, DE, HI, MA, MD, ME, NJ, NM, NV, NY, RI, VT, WA) and the number of states that require a prescription for retail purchase without exception has dwindled to ONE (Chris Christie’s New Jersey – Delaware, the other hold out, changed its law this year.)  But the important thing is not the next halting steps in this slow trend, but the quality of Nevada’s legal contribution.  This is going to get a little bit wonky in parts, but let me just take you on a quick tour of this marvelous statute, which drew from a model created several years ago by the Canadian HIV/AIDS Legal Network.

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End the Ban on Blood Donation by Gay Men

By Dov Fox

86 members of the U.S. Congress have requested an end to the federal policy that prevents men who have had sex with men from giving blood. Advances in blood screening technology have discredited the medical justification for this exclusion. And our country’s current critical blood shortage makes it dangerous for public health.

The antidiscrimination objection is more complicated. The policy wasn’t born of illicit motivations and doesn’t seriously disadvantage gay men. That it doesn’t reflect bad intentions or effects, does not, however, vindicate the policy on equality grounds. The blanket exclusion, independent of individual risk levels, reflects a disparaging stereotype that gay men are sexually promiscuous or use illegal drugs, I argued in an op-ed last week. I have elsewhere called this objectionable social meaning the expressive dimension of donor deferral.

Secretary Sebelius should answer the congressional plea to end our exclusionary blood donation policy. In the meantime, those who already enjoy the opportunity to help save lives can serve the causes of public health and social equality by making an appointment to give today.

Art Caplan: Ease US Blood Supply Shortage by Lifting Gay Donor Ban

Art Caplan has published an opinion piece at NBCNews.com calling for an end to the ban on blood donation by gay men in the United States:

The United States is facing a health care crisis.

Our supply of blood is dangerously low. The American Red Cross reports that across the nation blood donations were down an estimated 10 percent in June — about 50,000 fewer donations than in May.

In the face of a blood supply shortage that is bad and likely to get worse, there is a group of people — gay men — who might ease the situation, if only they were allowed to help.

Gay men who want to donate blood are forbidden because of an outdated, non-scientific regulation that bans anyone who has had sex “even once” with another man since 1977.

It is long past time to let those who want to help others by donating blood do so.

Read the full column.

Too Young For Sex, But Old Enough For The Sex Offender Registry, Part III

By Michele Goodwin

I conclude Part III in this series from Uganda—a nation recovering from what one doctor describes as a “genocide” from HIV and AIDS. Parts I and II can be found here and here.

As a society, do we really care that teens and preteens have sex? On the one hand we care too much—so much so that the criminal law is the central form of regulating teen sex. This form of regulation is derived from statutes that treat all sexual behavior alike, even though consent and context may drastically vary.  In Law’s Limits: Regulating Statutory Rape Law, found here, I articulate why the criminal law approach, filtered through the judiciary, leads to absurd results. These absurd results include the extralegal punishments inflicted on youth who are punished for participating in consensual sexual activity, such as lifelong registration as a sex offender. These types of consequences and outcomes are problematic because they are morally wrong and foster significant harms across a series of areas, including creating social status harms, by reifying racial and homosexual stereotypes. The criminal law approach also leads to cruel and unusual punishments in an era where sex offender registries are increasingly the norm and a condition of release from prison.  On inspection, such punishments are disproportionate and unjustified.

On the other hand, maybe we care too little about teen sexuality. The notorious Steubenville, Ohio rape case bears this out (where the rape victim suffered backlash and threats), as do the high rates of HIV, sexually transmitted diseases, and syphilis infections among teens, and teens’ relatively high use of alcohol and drugs prior to sex. Parents fail to talk to their children about sexuality when children most need to understand it: prior to commencing sexual experimentation. Empirical data shows that fathers barely speak to their daughters about sex and these omissions may impact their daughters’ sexual attitudes and behaviors. Governors and prosecutors sometimes demonstrate selective interest in teen sexuality—when it involves specific ethnic populations or the poor. This failure to care enough is manifested in the criminal law approach to shaping teen sex norms, rather than the public health where it is most justified.

So, how might we move forward? Read More

The First Amendment Meets Public Health Again — The US AID Case

By Wendy Parmet

Sometimes it seems as if the First Amendment is the leading legal threat to public health. Not today. In Agency for International Development v. Alliance for Open Society International the Supreme Court in a 6-2 decision struck down on First Amendment ground the so-called “anti-prostitution pledge” imposed by § 7631(f) of the  Leadership Act which prohibited the award of anti-HIV grants to groups or organizations that do “not have a policy explicitly opposing prostitution and sex trafficking” constituted an unconstitutional condition. Critical to the Chief Justice Roberts’ opinion was the fact that § 7631(f) did not simply limit grantees’ ability to use federal funds to support prostitution. Rather, it compelled a “grant recipient to adopt a particular belief as a condition of funding.”  According to the Court, the government can limit what grantees do with federal funds, but it cannot restrict what they believe.

Although the Court ‘s opinion focused on core First Amendment issues, rather than the public health impact of the anti-prostitution pledge, its decision should remind us of the complex and sometimes ambivalent relationship between public health and the First Amendment. Since the early years of the HIV epidemic, the First Amendment has been a crucial public health ally, limiting government’s ability to censor controversial but critical public health information. In many other cases, however, such as those challenging regulations aimed at tobacco or pharmaceutical advertising, a robust interpretation of the First Amendment seems to hinder public health protection. For public health law advocates, a key question is whether the First Amendment can be interpreted so as to protect health in both sets of circumstances. Equally critical is understanding how we can achieve public health goals without relying on the regulation of speech. Alliance for Open Society may offer some clues, but it clearly does not provide the answers.

Live Blogging from FDA in the 21st Century Conference, Plenary 2: Alta Charo on Integrating Speed and Safety

By Michelle Meyer

[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

Day two of PFC’s FDA in the 21st Century conference begins with a morning plenary by the very fabulous Alta Charo, of the University of Wisconsin Law School, who is speaking on “Integrating Speed and Safety.”

Today Alta is presenting what she calls “more of an initial idea than an actual proposal,” and she notes that she’s very interested to hear responses to it, so comment away or contact her offline. She wants to integrate into the usual and longstanding “FDA speed versus safety” debate some concerns that should be of interest to industry. “In other words,” she said, “I’d like to be nice to the drug people.”

Alta begins with a brief history of the speed versus safety debate, which turns out to be quite cyclical. Before 1906, she asks us to recall, we had true snake oil: products with high toxicity and little or no efficacy. Often these products were nevertheless perceived as effective because they contained alcohol or other drugs, so made you feel better at least, but of course that’s part of what made these products so dangerous, especially for children.

And so with the Federal Food and Drugs Act of 1906, we get post-market remedies for misbranding, although they require proof of intent. And then in 1937 over 100 children die from elixir of sulfanilamide. And the following year we get the Food, Drug, and Cosmetic Act. But the FDCA targets only safety. (Although rightly Alta notes that it’s hard to see how regulators were truly only looking at safety and not also at some form of efficacy, since there is no such thing as safety in the abstract, only safety relative to purpose for which someone is taking the drug.) Read More

Of Evergreening and Efficacy, Part II

By Ryan Abbott

I wrote earlier this month about the case between Novartis and the Union of India, in which the Supreme Court of India affirmed denying a patent for Novartis’ anti-cancer drug Glivec. Adriana Benedict added an insightful post about the case last week.

In my last post, I talked about the theory behind the decision and what it means for a drug to be therapeutically efficacious. Today and tomorrow, I thought it would be interesting to focus on the practical outcome of the case. In other words, what does this case mean for the access to medicines more generally, both in India and around the world?

Judging by recent public comments, this will be a landmark case. On the Novartis website, where the company is hosting an impressive array of resources devoted to the Glivec patent case, it states that this “decision discourages innovative drug discovery essential to advancing medical science for patients.” Eric Althoff, a Novaris spokesman said, if “innovation is rewarded, there is a clear business case to move forward. If it isn’t rewarded and protected, there isn’t.” On the opposite side of the spectrum, Indian Trade Minister Anand Sharma called the ruling “a historic judgment” that reaffirmed the position of Indian law requiring substantive innovation for patent protection. The Supreme Court itself noted that the “debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our constitutional scheme) at a minimum.”

Despite the controversy, this case won’t necessarily have a wide ranging impact. It involved some unusual elements, which require historical background in India’s patent system to understand.

Read More