Art Caplan: Condoms Should Be Encouraged, Not Used as Evidence

Art Caplan has a new opinion piece up at NBC News on the increasing use of condoms as evidence of a crime by police in the United States. From the article:

Why do we shoot ourselves in the foot when it comes to public health? The latest example of what not to do in the war against disease comes from the world of sex: All over the United States, police and prosecutors are discouraging safer sex by using the possession of condoms as evidence of a crime.

For decades, police officers have been regularly confiscating condoms from people they believe are engaged in prostitution to either justify an arrest or to use as evidence at trial. District Attorneys routinely mention the number of condoms a person had on them when arrested to help cinch prostitution charges.

Prostitutes are far more likely to be infected with HIV and other sexually transmitted diseases than are the general population. That is why health departments spend a lot of money distributing condoms and trying to convince sex workers to use them.

Read the full article.

FRIDAY & SATURDAY: Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, & Health Policy”

Petrie-Flom Center 2014 Annual Conference: Behavioral Economics, Law, and Health Policy

May 2-3, 2014

Wasserstein Hall, Milstein East ABC, Harvard Law School, 1585 Massachusetts Ave.

Richard H. Thaler and Cass R. Sunstein’s book  Nudge: Improving Decisions About Health, Wealth, and Happiness brought behavioral economics to the masses, beginning a discussion of libertarian paternalism and the many ways that “choice architects” can help nudge people to make better choices for themselves without forcing certain outcomes on anyone. Some of their examples fall in the realm of health policy, as is also the case of Daniel Kahneman’s recent book, Thinking, Fast and Slow, which examines various cognitive errors people make in their judgments, choices, and conclusions, as well as how we might correct them.  But the conversation has only just begun.

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On Patents, Patients and the Public Interest

By Michael Young

Earlier this month, a U.S. District Court in Delaware issued an injunction to bar sales of a minimally invasive Medtronic replacement heart valve that putatively infringed on competitor’s Edwards Lifesciences valve system patent.  After this ruling was issued, Medtronic filed an emergency motion requesting stay and expedited appeal of this injunction, contending that that “if the injunction were permitted to go into effect, treatable patients [with aortic annuli larger than 25mm for whom Edwards’ valve is not suited] may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights” (Medtronic v. Edwards, 08-CV-0091, 2014).  Shortly thereafter, The Federal Court Circuit of Appeals agreed to postpone the injunction and to expedite Medtronic’s appeal.

While still unraveling, this case offers unique insights into the important yet often overlooked dialectic between patient safety and patent rights.

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The Alexis Shapiro Case: Divergent Perspectives on Coverage Decisionmaking

Alexis Shapiro is a 12 year old girl who started gaining weight uncontrollably due to a rare condition caused by damage to her brain during the removal of a brain tumor.  Her and her parents’ struggle to get her gastric bypass surgery to curb the weight loss made national news for much of the winter in several outlets.  Happily, in March she had the surgery and she now appears to be doing well.  A good outcome, but boy was the process by which we got here a painful one, largely because the insurer understood the coverage decisionmaking process differently than the rest of us.  Here’s a timeline, and some reflections: Continue reading

Is Nonmedical Sex Selection Always Sexist?

Nonmedical sex selection is a thorny topic. Usually used to favor males, it has harmed women and resulted in sex ratio disparities in India, China, and other nations where son preference is strong. Sex selection is also troubling because it relies on infanticide, abortion, or the discarding of embryos based on their sex.

Since sex ratio imbalances are not a danger in the United States and equal rights and opportunities for women, though imperfect, are increasingly well-established, nonmedical sex selection in some circumstances, e.g., for gender variety in a family, may be more acceptable. That position, however, runs into the claim that any deliberate choice or preference about the sex/gender of offspring, even for a girl, is inherently sexist or gendered (see Glenn Cohen’s recent post). That position, however, is controversial.[1]

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Mental Health in Law School

By Deborah Cho

I was recently pointed to this poignant post on mental health within the legal profession.  The post is the first of a three-part series that is titled “We Need To Start Talking About Why So Many Lawyers Are Killing Themselves.”  Parts 2 and 3 can be found here and here, respectively.  Please refer to the original posts for a deeper exploration of the original author’s experience with depression and anxiety as a legal professional.  I am by no means an expert on this topic, nor am I able to fully grasp everything the author has written about, but I want to explore some of what is touched upon as it relates to law students.

The author, law professor Brian Clarke from Charlotte School of Law, cites the following statistics: “[B]y the spring of their 1L year, 32% of law students are clinically depressed, despite being no more depressed than the general public (about 8%) when they entered law school. By graduation this number had risen to 40%. While this percentage dropped to 17% two years after graduation, the rate of depression was still double that of the general public.”

What this signals to me is confirmation of something I’ve suspected all along: There is something wrong with our law school experience.

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Petrie-Flom Intern’s Weekly Round-Up, 4/18-4/25

By Chloe Reichel

This Thursday the Food and Drug Administration (FDA) proposed new regulations for the sale of e-cigarettes. These regulations would prohibit sales to minors and make health warnings on packages mandatory.

This Wednesday a law was passed in Vermont that requires the labeling of genetically modified foods. Vermont is the first state to pass such a regulation.

Estimations for state spending on Medicaid have been reduced by the Congressional Budget Office. The office is now predicting that the cost of Medicaid expansion will be $46 billion, compared with their previous estimate of $70 billion.

Researchers at King’s College London have grown human skin in the lab from stem cells. Animal rights proponents herald these developments as a potential end to testing on animals.

Sovaldi, a medication for hepatitis C that costs $1,000 for one day’s dosage, has had the most successful drug launch ever. From its FDA approval in December to March 31, its manufacturer sold $2.27 billion worth of the drug, though the drug has faced criticism for its high price.

The FDA is considering banning electrical stimulation devices, used to discourage aggressive behavior in people with disabilities. Students from the Judge Rotenberg Educational Center testified against the use of these devices, though some parents of children at the Center and administrators there defend the use of these devices.

Following an audit of Illinois Medicaid expenditures, it was found that the program paid $12 million for medical services for dead people. These findings have led some to support stricter scrutiny in determining Medicaid eligibility.

Pervasive use of pesticides and genetically modified seeds in Hawaii has led to unrest among the state’s residents. Groups have been organizing to prevent the cultivation of genetically modified crops, and in Hawaii County such a law has already been adopted.

How should we label these “cognitive errors” that are particularly common among MDs?

Behavioral economists are really into giving the cognitive errors they study, and the corrective policy interventions they favor, labels. “Status quo bias,” “availability bias,” “recall bias,” etc., can all be fixed through “nudges” that involve “asymmetric paternalism” and the like.

Here’s an interesting “cognitive error” that I’m trying to crowd-source a label for: When America’s joint surgeons were challenged to come up with a list of unnecessary procedures in their field, their selections shared one thing: none significantly impacted their incomes.

And here’s another odd cognitive anomaly that seems to be especially limited to ophthalmologists: forgetting there’s a $50 dollar alternative that works just as well as the $2,000 injection they get 6% commission on. 

I’ve thought of my own labels (or rather, euphemisms) for the policy interventions I would suggest in response: “continuing medical education”  for the first of these neat little errors, and “resocialization” for the second.

Animals are Already Legal Persons: On Steven Wise, the Nonhuman Rights Project, and Misguided Personhood Debates

The New York Times Magazine has just published an interesting piece on the Nonhuman Rights Project and Steven Wise, whose mission is to change the common law status of at least some nonhuman animals from “mere things” to “legal persons.”  (I have previously written on their work here).  It is widely agreed, among both advocates and opponents of Wise’s work, that granting legal personhood to animals would be revolutionary.  I think that this view is mistaken.  To understand why, it is helpful to clarify and differentiate between three possible conceptions of what it might mean to be a “legal person”—a term that is often used in imprecise ways.  Doing so reveals that animals are already legal persons, and that personhood does not itself count for very much. Continue reading

The Neuroethics of Unintentional Memory-Modification

By Matthew L Baum

At least since the publication of the President’s Commission on Bioethics’ report in 2003, “Beyond Therapy: Biotechnology and the Pursuit of Happiness”, there has been an ongoing debate about the ethics of using drugs to modify emotional memories.  Rather than focus on the Hollywood-type total memory erasure featured in the Eternal Sunshine of the Spotless Mind, many ground the debate in the molecular neuroscience of memory reconsolidation (for an excellent overview, see here). In the process of memory reconsolidation, a newly reactivated memory triggers certain molecular events that are necessary for it to return to long-term storage; during these events, the memory is temporarily susceptible to disruption by certain drugs like the beta-blocker, propranolol. Further work with people with Post-Traumatic Stress Disorder (PTSD) suggests that using propranolol in this way doesn’t erase a memory, but may blunt the reconsolidation of the memory’s negative emotional content. In the ethical discussion, most agree that 1) it should usually be acceptable to use drugs to modify memories in cases of PTSD where the emotional content of memories becomes debilitating, but 2) the use of memory modifying drugs is usually morally problematic when the target is everyday unpleasant memories, disappointments, and rejections.

Existing debate has focused on intentional memory modification. But what about those who modify memories in these problematic ways unintentionally? Conspicuously under-discussed is the ethics of continuing to use drugs with potential memory-modifying properties for the treatment of other medical conditions. Propranolol, for example, is on the Department of Veterans Affairs (VA) National Formulary for treatment of patients with severe liver disease (liver cirrhosis). This (not-small) population of people, in theory, risks unintentionally (and pre-emptively) modifying memories every day!

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WEDNESDAY, 4/23: Reforming Brazilian Pharmaceutical Patent Policy

Reforming Brazilian Pharmaceutical Patent Policy: Lessons from the Past and the Road for the Future

April 23, 12:00pm 

Wasserstein Hall 1010, Harvard Law School, 1585 Massachusetts Ave.

In this lecture by Pedro Paranaguá, he will discuss the report issued by the Brazilian House of Representatives in 2013 as part of an effort to revamp the country’s patent law. Brazil does not want to be a mere exporter of commodities, neither does it want to be a simple consumer of knowledge goods. Brazil wants to be at the cutting edge of innovation; it wants to innovate to compete. Paranaguá’s presentation will introduce the current state of affairs of the Brazilian patent system, with a focus on pharmaceuticals. He will present the main findings and recommendations of the 2013 report, including the tabling of a bill to fix the mistakes of the 1990s.  The talk will be followed by discussion with a panel of experts. Panelists include:

  • Brook K. Baker, Professor of Law, Northeastern University School of Law; Policy Analyst for Health GAP (Global Access Project)
  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute

Pedro Paranaguá has been a Lecturer in Law at the LL.M. in Business Law at Fundação Getulio Vargas (FGV), Brazil, since 2007. Mr. Paranaguá is also the lead Advisor to the ruling Workers Party at the Brazilian House of Representatives for Internet, copyright, patent, data privacy, cybercrime, and related matters. He is responsible for drafting the Brazilian Internet Framework Bill (“Marco Civil”) for the rapporteur, including provisions on net neutrality, ISP liability, and privacy. He coordinated the 350-page report, “Brazil’s Patent Reform,” for the Brazilian House of Representatives. He has been an invited instructor at Duke University School of Law (2011), lecturer in law at FGV Rio, and has held numerous other lectureships in Brazil and abroad (Lecturer in Brazil and abroad (Brazil’s Supreme Court and Senate, Yale, UCLA, UNESCO, UNCTAD, WIPO). He was Director of the A2K Brazil Program at the Center for Technology and Society (CTS-FGV), and co-representative of Creative Commons in Brazil (2005-2010). He produced commissioned studies on copyright and technology for the country’s Culture Ministry, and served as FGV-delegate at the World Intellectual Property Organization (WIPO) in Geneva (2005-2009). He has also served as a member of the Brazilian Free Software Project. From 2001 to 2003, he was an IP lawyer at Gusmão & Labrunie, where he was Project Manager on patents and access to medicines. He is the author of the books Copyright Law (Portuguese) (with Sergio Branco) andPatent Law (Portuguese) (with Renata Reis). Mr. Paranaguá holds a LL.M. (cum laude) in Intellectual Property, Internet and Policy (London) and is a Doctoral candidate (S.J.D.) at Duke University School of Law, where he is finalizing his thesis, “Brazil’s Copyright Law Reform: Tropicália 3.0?”, under the supervision of Professor Jerome Reichman.

Sponsored by the HLS Brazilian Studies Association, with support from the Petrie-Flom Center.

Medical Malpractice or General Negligence? A Redux

By Alex Stein

Whether a tort action sounds in “medical malpractice,” as opposed to “general negligence,” or vice versa, is often critical. Medical malpractice actions must satisfy special requirements that include shortened limitations periods, statutes of repose, expert affidavits, and merit certificates. Suits sounding in ordinary negligence need not satisfy those requirements. Filing and prosecuting those suits is therefore not as onerous and expensive as filing and prosecuting medical malpractice actions.  Continue reading

Health Class and Personal Preferences

By Nathaniel Counts

High school health classes that are effective in preventing high-risk behaviors employ two educational models: the social influences model and the life skills model.  The social influences model teaches children about social norms and techniques for resisting social influences.  The life skills focuses on developing child autonomy, self-esteem, and self-confidence to help children resist social influences and gain a sense of self.  There are two explanations for why health classes premised on these models would be effective: either they replace the preferences the children were likely to develop with different preferences or they help children develop their own preferences which, for some reason, consistently disfavor high-risk behaviors.

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Check out the latest news from the Petrie-Flom Center!

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Check out the April 18 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Announcing 2014-2016 Petrie-Flom Academic Fellow Rachel Sachs

We are pleased to announce that Rachel Sachs will be joining the Petrie-Flom Center later this summer as an Academic Fellow for the 2014-2016 fellowship term. In 2013, Rachel earned her J.D. magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Masters in Public Health from the Harvard School of Public Health, during which she interned at the United States Department of Health and Human Services. She also holds an A.B. in Bioethics from Princeton University. After law school Rachel clerked for the Honorable Richard A. Posner of the United States Court of Appeals for the Seventh Circuit. Rachel’s primary research interests lie at the intersection of patent law and public health, with a particular focus on problems of innovation and access and the ways in which law helps or hinders these problems. Her past scholarship has examined the interactions between patent law and FDA regulation in the area of diagnostic tests, and explored the mechanisms behind the passage of patent-related legislation. Her current scholarship applies this focus on innovation and access to the intersection of patent law and drug reimbursement policies.
You can learn more about Rachel on our website.
Welcome Rachel!

Mental Therapist’s Duty to Prevent Patient’s Crime

By Alex Stein

A clinical social worker hears from his patient about the patient’s interest in child pornography, but does nothing to solve the problem. Later on, the police raids the patient’s house to find evidence that he illegally downloaded, viewed and possessed child pornography. The patient now faces criminal charges.

Can he sue the social worker for malpractice? Would a similar suit be available against a psychiatrist? Continue reading