Prosecuting Rape Victims, What Next?

Representative Cathrynn Brown (Arizona)

By Michele Goodwin

In the wake of an election season peppered with references to rape by legislators vying for reelection or elevation to more prominent political positions: Representative Todd Akin’s woefully unscientific claim that “legitimate” rapes rarely result in pregnancy because women can “shut that whole thing down” or Richard Mourdock, Indiana state treasurer, reminding voters that when pregnancies result from rape “that it is something God intended to happen,” the deeply political intersections of criminal and health law became more visible.  Representative Joe Walsh (Ill), for example, claimed that “with modern technology and science, you can’t find one instance” where a woman’s life can be saved with an abortion.   Problematically, such comments to unwitting constituents parade as fact and stand contrary to vetted medical studies.   For example, a recent study found that “women were about 14 times more likely to die during or after giving birth to a live baby than to die from complications of an abortion.” An abstract of the study can be found here.

Months ago, I wrote that it would be a mistake to isolate these politically-charged comments to republicans or even male legislators; on inspection, recent personhood amendments and the passage of fetal protection laws expose bipartisan collaboration on laws that may be unconstitutional, undermine women’s reproductive health, and prioritize criminal law interventions over healthcare and rehabilitation. More of that work can be found here, here, and here.

Most recently, Representative Cathrynn Brown of New Mexico stepped into the political fray on rape, exposing once more the ways in which women’s reproduction can become hostage to political pandering.  Last week, Brown proposed House Bill 206, a law that would criminally punish rape victims who seek abortions.  According to Brown, obtaining an abortion after sexual victimization amounts to “tampering with evidence.” Rape victims could face felony charges and up to three years in prison for violating the law.

Likely, Brown’s rape bill will not gain sufficient political support for passage.  Nevertheless, recent political efforts to redefine rape, blame victims, and use the criminal law as a sword to regulate victims’ responses to rape deserve serious scrutiny and sustained critical engagement.

Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?

By Jonathan J. Darrow

Questionable baldness remedies have been peddled since the beginning of medicine. According to Pliny (23-79 A.D.), ashes of seahorse could cure baldness.  Almost 2000 years later, the British Medical Association warned the public of the increasing “number of preparations put forward for the cure of baldness,” particularly those which “are not applied locally but taken internally.”  The purported active ingredient? “[H]aemoglobin.”  (see Secret Remedies (1909), page 114).

While the medicinal use of a seahorse or dried blood matter may sound fanciful to modern ears, one has to wonder whether today’s public is any less credulous: Worldwide, consumers have spent over $400 million per year on a modern baldness remedy known by the trade name Propecia (finasteride).  Has science finally triumphed over a medical condition that has persisted through millennia? Today’s consumers might rationally believe that its has, given that Propecia is FDA-approved for the treatment of alopecia (baldness).  FDA-approved remedies must, according to federal law (21 U.S.C. § 355(d)), prove their efficacy in well-controlled, clinical investigations.

Yet one need only walk through a crowded street to see that, if a baldness cure has truly arrived, a surprising number of people have not availed themselves of it. Is Propecia, then, not effective? Let us take a look at the official data. Read More

Petrie-Flom Center to Work with NFL Players Association

The Petrie-Flom Center at Harvard Law School is pleased to announce our involvement with the new “Harvard Integrated Program to Protect and Improve the Health of NFLPA Members.”  The Program will be created through a $100 million grant to Harvard Medical School from the National Football League Players Association in order to launch a transformative 10-year initiative.  The Petrie-Flom Center will work to address the critical ethical, legal, and policy issues relevant to the health of current, future, and retired players.

Read more from Harvard Law School:

Petrie-Flom Center will participate with HMS and University partners in 10-year project with NFL Players Association

[HLS Assistant Professor of Law I. Glenn Cohen, faculty co-director of the Center and] one of this year’s Fellows of the Radcliffe Institute for Advanced Study at Harvard University, will be a co-investigator on the 10-year project along with Holly Fernandez Lynch, the Center’s executive director.

The project, which will be known as the Harvard Integrated Program to Protect and Improve the Health of NFLPA Members, was announced on Jan. 28 by Harvard Medical School and the National Football League Players Association (NFLPA).

“Holly and I will be assuming leadership over one of the six aims of the project, the one that will address the ethical, legal and policy issues relevant to the health and health care of current future, and retired players,” said Cohen. “We will begin the 10-year project by conducting ‘listening tours’ in collaboration with the NFLPA, where we will get current and retired NFL players and their families to help us shape the agenda for our legal and ethical analysis. We will also be involving our students and colleagues at HLS and across the university in trying to wrestle with some of the thorniest legal and ethical issues involved, including: the appropriate role of players and teams in the management and employment and accreditation of team doctors and other medical staff, the privacy of players’ medical information and the ethical development of testing for injury, and liability and compensation for injured players. I feel privileged that the players will be entrusting us and the rest of the team with this vital responsibility.”

Cohen and Lynch will also serve as ethics consultants for the entire project, to help ensure that the clinical research is performed according to the appropriate ethical standards.

Said Harvard Law School Dean Martha Minow: “I am delighted and proud that the Petrie-Flom Center will be working with Harvard Medical School and others across the University on this extraordinary and much-needed project, and I am confident that together they will do something important for football, its players, and the country.”

For more information, see these selected news articles announcing the partnership:

Save The Date: Making Science Work with Sir Paul M. Nurse

With Panelists:

  • Eric Lander, Broad Institute and Biology, MIT
  • Lisa Randall, Physics, Harvard University
  • Charles Rosenberg, History of Science, Harvard University

Moderated by: Sheila Jasanoff, Pforzheimer Professor of Science and Technology Studies, Harvard Kennedy School

Wednesday, February 6
5:00 – 7:00 pm

Pfizer Lecture Hall
Mallinckrodt Chemistry Lab B23
12 Oxford Street, Harvard University
Cambridge, MA

Making science work for human benefit requires making good decisions about what scientific research should be supported and giving good scientific advice for public policy. The term public good is meant in the widest possible sense, covering the contributions science makes to our culture and also the applications of science that benefit society: improving our health and quality of life, securing sustainability and protection of the environment, and driving innovation to support our economy.

Sir Paul Nurse is a British geneticist and cell biologist. He became the 60th President of The Royal Society in December 2010. As a geneticist, he studied the mechanisms which control the division and shape of cells. In 2001, he was awarded the Nobel Prize for Physiology or Medicine for the discovery of the key protein regulators of the cell cycle. He has been Professor of Microbiology at the University of Oxford, CEO of the Imperial Cancer Research Fund and Cancer Research UK, and President of The Rockefeller University, New York. Since 2011, he has been Director and CEO of the Francis Crick Institute in London. Nurse has received the Royal Society’s Copley Medal (2005), the French Legion d’Honneur (2002), and is a Foreign Honorary Member of the American Academy of Arts and Sciences (2006).  He was knighted in 1999 for services in cancer research and cell biology.

This event is organized by the Program on Science, Technology, and Society, at the Harvard Kennedy School and co-sponsored by the School of Engineering and Applied Sciences, the Graduate School of Design, and the Harvard University Center for the Environment.  For more information on Science, Technology, and Society events at Harvard University, please visit: www.ksg.harvard.edu/sts/. This lecture and discussion is free and open to the public.

Contact: Lisa Matthews, lisa_matthews@harvard.edu, 617-495-8883

Save the Date – May 17th “Issues and Case Studies in Clinical Trial Data Sharing – What Have We Learned?”

Please save the date for this upcoming conference at Harvard Law School on May 17, 2013:

Issues and Case Studies in Clinical Trial Data Sharing:

What Have We Learned?

Co-sponsored by the Multi-Regional Clinical Trial Center at Harvard University, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

LOCATION:  Wasserstein Hall, Milstein West A, Harvard Law School

1585 Massachusetts Avenue, Cambridge, MA

Speakers and registration information to be announced shortly

May 17, 2013 (8AM – 6PM)

Objectives:

  • To discuss opportunities for and implications of emerging clinical trial data disclosure standards
  • To review evidence from recent case studies in clinical trial data disclosure, especially related to disclosure of participant-level data
  • To review the rationale behind disclosure requirements of patient-level data and discuss whether the case studies demonstrate the goals have been met
  • To identify potential areas of collaboration among stakeholder groups, such as the formation of working groups to provide recommendations or standards in this area
  • To review variance in regulatory approaches and areas for possible harmonization
  • To identify other key areas of learning that may inform policy in this important area moving forward
  • To use conference findings as basis of a publication in a peer-reviewed journal that captures the case studies, provides insights into these issues and offers recommendations for moving forward

No Access to Medicines without Access to Research

by Adriana Benedict

In December, I wrote a blog post noting that access to biomedical research is critical not only for informed patient care, but also for the sustainable development of pharmaceutical R&D responsive to local needs, especially in developing countries.  In recent years, open access issues have taken on an increasingly important role in global health discussions.  In 2009, the Institute for Information Law and Policy, the Justice Action Center and Health Information for All 2015 made the case for a rights-based approach to the issue in a report called Access to Health Information under International Human Rights Law.  In 2011, a medical student in the Right to Research Coalition explained 6 Reasons Open Access Matters to the Medical Community.  And the 2012 WHO CEWG Report recommending a binding treaty on Research and Development to Meet the Needs of Developing Countries includes as one of its proposals “open approaches to research and development and innovation which include precompetitive research and development platforms, open source and open access schemes.”

In response to the increasing demand for open access to biomedical research, PLOS Medicine partnered with WHO to issue a call for papers “intended to culminate in an open-access collection of original research and commentary articles to coincide with the launch … [of] World Health Report 2012: No Health without Research.”  However, the 2012 World Health Report was unexpectedly called off to be replaced by a 2013 report on “contributions to research to universal health coverage,” a far less politically polarizing topic.  In its editorial response to the cancellation of the 2012 Report, PLOS Medicine noted that “The reasons for these delays and for the changes in scope of WHO’s flagship publication, are unclear,” not in the least because “Previous World Health Reports … have represented bold political statements.”

Read More

Part II- Medicine’s Battle of the Experts: A Patient’s Perspective on Navigating Conflicting Medical Advice

In Part I, I described my testicular cancer diagnosis and pre-operation experience in an attempt to demonstrate how defragmentation in healthcare could reduce patient emotional and psychological stress.  In Part II, I describe my post-surgery experience, consulting specialists with conflicting opinions as to the optimal post-operation treatment regimen.

In various law school courses we discuss a problem sometimes referred to as the “battle of the experts.”  In a courtroom, a jury generally hears testimony from experts on both sides of a case, presenting different statistics and opinions for the jury to consider.  The jury, comprised of lay people, is likely ill-equipped to contextualize these opinions scientifically, and possibly resorts to heuristics, such as judging the experts’ levels of confidence, demeanors and comprehensibility, when deciding between them. A nuanced testimony delivered by a sweaty expert, when compared to a simple testimony delivered suavely, could be discredited for legally irrelevant reasons.[1]  As a patient weighing my post-surgery treatment options, I felt like a lay jury, asked to decide among the opinions of experts, with my own health hanging in the balance.

Read More

Upcoming, Feb. 6 – Drug Use and HIV: A Tale of Toxic Law

THE NORTHEASTERN PROGRAM ON HEALTH POLICY & LAW PRESENTS:

HIV/AIDS Policy Grand Rounds: Drug Use and HIV: A Tale of Toxic Law

In the wake of the HIV epidemic, legal and policy tools became critical in combatting the epidemic. The HIV/AIDS Policy Grand Rounds is an interdisciplinary series of workshops designed to explore the history, application, and current debates in the use of structural, human rights, biomedical, and public health approaches to combat the epidemic. Each workshop consists of a faculty presentation followed by comments by an invited expert and an open discussion.

The third workshop in the series will focus on the role of drug policy as a driver of the HIV epidemic among injection drug users. Leo Beletsky (Asst. Professor of Law and Health Sciences, Northeastern University School of Law and Bouvé College of Health Sciences) who will be joined by guest expert Robert Heimer (Professor, Yale School of Public Health). The speakers will will explore the interface of drug policy, HIV risk and human rights, with special focus on the role of law and law enforcement in fueling the epidemic in the US and Eastern Europe.

What: HIV/AIDS Policy Grand Rounds: Drug Use and HIV: A Tale of Toxic Law

When: Wednesday Feb 6 at noon; The workshop will run 90-100 minutes.

Where: 250 Dockser Hall, Northeastern University School of Law, 400 Huntington Ave.

Lunch will be served.

To assure an adequate food order, please RSVP by Feb. 5 by emailing Sue Council at s.council@neu.edu with “Grand Rounds” in the subject.