Prosecuting Rape Victims, What Next?

Representative Cathrynn Brown (Arizona)

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. Continue reading

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 This lecture and discussion is free and open to the public.

Contact: Lisa Matthews,  lisa_matthews at 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.”

Continue reading

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.

Continue reading

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.

Playing Sports Now a Civil Right

Art Caplan and his colleagues at the NYU Sports & Society Program have an interesting new essay up at Forbes:

Obama Administration: Playing Sports Is Now A Civil Right

The United States Department of Education has released aguidance requiring schools to make “reasonable modifications” to include students with disabilities in mainstream athletics programs or provide parallel options. That may sound like just another boring piece of paper that oozes off the desk of a government bureaucrat on any given day. But this is very different. The guidance proclaims that access to interscholastic, intramural, and intercollegiate athletics is a civil right.
Asserting access to athletic programs as a civil right is a big step forward for our education system and, of course, for people with disabilities. It highlights the important role that sports can play in the development of young people as functioning and contributing members of society. It also serves to help decrease the stigma too often associated with physical, mental, and emotional disabilities.

The limitation of a guidance is that it clarifies existing laws, but doesn’t create new ones. So, although it’s not a “toothless tiger,” it’s questionable as to whether anyone will be able to file a lawsuit based on it. And there are sure to be lawsuits because it’s inevitable that the guidance is going to create a host of issues about classification and definition such as: What is a disability? What is a “reasonable modification”? What is a reasonable “accommodation”? What will get modified: the sport, the arena, or the people eligible to play?

Keep reading…

The ACA’s Immigration Quirk

I was amused but not surprised to read that in announcing her support for expanding Arizona’s Medicaid program, Governor Jan Brewer pointed to the fact that without the expansion, only non-citizens with incomes under the poverty level would be eligible for insurance under the ACA. What Brewer didn’t say, was that the ACA’s apparent preference for non-citizens results from precisely the type of anti-immigrant laws with which Gov. Brewer is usually associated.

 In 1996, shortly after California passed the notorious Proposition 187 which denied state public benefits to undocumented immigrants, Congress enacted the Personal Responsibility and Work Opportunity Reconciliation Act, better known as the Welfare Reform Act.  Among other things, this law imposes a 5 year waiting period before most legal permanent residents can enroll in the federal Medicaid program. The law also barred many other immigrants who are lawfully residing within the U.S. from Medicaid altogether.

The ACA did not repeal the provisions in the Welfare Reform Act limiting immigrants’ access to Medicaid. Instead, Congress sought to provide coverage to lawfully residing immigrants by permitting those with incomes under 100% of the Federal Poverty Level to receive subsidies to purchase insurance on the exchanges. Those subsidies were not necessary for citizens with such low incomes because Congress assumed that they would be brought into the Medicaid program.

Continue reading

Reverse settlements, part 2: drug company profits

In my second post, I want  continue my discussion of reverse settlements.  Recall that the basic argument against reverse settlements is that they extend the duration of a pioneer drug company’s patent beyond what it might expected to be if there were no settlement.  (Elhauge and Krueger (Texas Law Review, 2012) have a nice description of the settlement process that yields this result.  For now I will take it as given.)  In my first post I questioned whether drug patents reduce total welfare.  In this post I question whether extending drug patents raise producer welfare at the expense of consumer welfare.  I will argue that the profits pioneer drug companies make under patents overstate producer surplus.  Producer surplus depends on not competition in the drug market but rather on how competitive the market for research and development for the drug was.  But we have little evidence on how competitive that market is.  It is possible that that market is perfectly competitive, in which case, in expectation, drug companies are making no supra-competitive profits.  No such profits would mean no excessive producer surplus, and no antitrust concern, even with its consumer surplus focus.

At the risk of being repetitive (and thereby pedantic), let me restate the conventional tradeoff when setting patent duration, but from the perspective of producer versus consumer surplus as conventional antitrust analysis sees it.  An innovator – in drugs or another product – gets a patent if they come up with a valuable innovation.  This patent allows the innovator to charge a high (monopoly) price and thereby earn supra-competitive profits.  These profits are treated as producer surplus (though I will question that).  The high producer surplus comes at the cost of low consumer surplus.  This is partly because surplus is a zero sum game: total surplus is either consumer surplus or producer surplus.  This partly because the high prices that generate high producer surplus reduce total surplus by pricing consumers out of the market (ignoring my first post on reverse settlements).  When a patent ends, competition starts and the market price of the previously patented drug falls.  This increases consumer surplus, at the expense of producer surplus.  If total sales also rise, total surplus also rises, which also favors consumers.  Thus the duration of a patent determines how long producers enjoy high producer surplus and when high consumer begins.

Given this background, it is possible to see why antitrust law cares about the duration of patents.  Antitrust law and antitrust authorities – for distributional reasons it appears to me – favor consumer surplus over producer surplus; I will take this preference as given.  The more quickly a patent ends, the sooner consumers start earning higher surplus.  For this reason, antitrust law is opposed to reverse settlements if they increase the expected duration of patents.

The problem with this logic is that the producer surplus created by patents is not fully producer surplus.  The purpose of this producer surplus is to encourage innovation.  In the absence of innovation, consumers would be worse off because they would not have the innovation required to generate high consumer surplus once patents expire.  Thus, antitrust law should not judge producer surplus in the patent setting the same as it is in the non-patent setting.  It should not be judged against a baseline of zero-producer surplus.  Instead, it should be judged against a baseline of innovation with shorter patents.  If patent duration is shortened, consumers will obtain less innovation and less consumer surplus.  That reduced consumer surplus should be subtracted from producer surplus observed due to patents and credited as consumer surplus.  (If this were not the case, antitrust law would want to eliminate all patents!).

Continue reading

Twitter Round-Up (1/20-1/26)

By Casey Thomson

Though simply the consequence of bad translation, the story of the Harvard geneticist George Church looking for a woman to act as surrogate for a Neanderthal clone shocked the internet bioethics world. A look at the problems with this hypothetical situation is just one of the components of this week’s Twitter Round-Up.

  • Frank Pasquale (@FrankPasquale) linked to an opinion piece discussing the reasoning behind the United States’ place in the world rankings of life expectancy at different stages of life. The news is a big hit to ideas of American exceptionalism: according to a report by the National Research Council and the Institute of Medicine, Americans have a substantially higher death rate for those younger than 50 as compared to Western Europeans, Canadians, Japanese, and Australians, but once they reach the age of 80, they have some of the longest life expectancies globally. (1/20)
  • Arthur Caplan (@ArthurCaplan) shared his article on why Neanderthal cloning is a bad idea, both in terms of safety and in terms of avoiding cruelty. (1/22)
  • Arthur Caplan (@ArthurCaplan) posted a news story on the reopening of bird flu experimental procedures for vaccine creation. Caplan was quoted in the article as stating: “I have no issue with restarting the research but some issue with where they are going to publish it and where they present it because bad guys can use it too.” (1/23)
  • Daniel Goldberg (@prof_goldberg) included an evaluation as to the medical disparities occurring in Colorado, particularly between races. The article emphasized in its conclusion that the existence of the disparities themselves is quite clear, but discussion on how to erase such differences is noticeably absent. (1/23)
  • Michelle Meyer (@MichelleNMeyer) retweeted a post that attempted to quantifiably compare the quality of care in Medicare options, namely whether Medicare Advantage plans 1) will eventually shortchange patients by skipping out on care quality because of profit motive or 2) have incentives to improve care quality because of the newly implemented systematic quality monitoring, where poor ratings impact them financially. The author found that most existing data makes the second theory more compelling, though the amount of data regarding the subject in general is largely lacking. (1/24)
  • Michelle Meyer (@MichelleNMeyer) also shared a link to an explanation of the intricacies of “personalized regulation” in medicine, which aims to preserve patient choice in an era leaning more and more towards paternalistic medical oversight. Understanding that patients may choose to make rational decisions that diverge from the community or committee consensus is key towards improving medical care to better reflect patient wants, and rights. (1/24)
  • Arthur Caplan (@ArthurCaplan) included a story on the large imbalance in misconduct reports in research between the genders. Men overwhelmingly led the charge, with only nine women out of the 72 faculty members who committed research misconduct. (1/24)
  • Michelle Meyer (@MichelleNMeyer) additionally shared a letter written by the Editor of The Hastings Center’s Bioethics Forum on the reasoning behind publication of a controversial article on the social pressures leading to obesity. The letter calls for the importance of recognizing that publication means that an article contributes to the larger debate on an issue, though does not affirm that the publication medium agrees with the views espoused within; it also encouraged responses to the ideas of the article. (1/25)
  • Stephen Latham (@StephenLatham) posted a video link from Comedy Central on the perils of WebMD and vegetarianism. (1/25)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Petrie-Flom Interns’ Weekly Round-Up: 1/19-1/25

By Hyeongsu Park and Kathy Wang

A different perspective on reverse settlements

Before I begin my initial post, I want to thank Holly for inviting me to post on this blog.

I want to take up reverse settlements in litigation over pharmaceutical patents.  Circuits are divided on how to treat these settlements under antitrust law (Elhauge & Krueger, Texas L. Rev., 91:283, 285, 2012).  The Supreme Court has decided to take this the topic up this term; it will hear oral arguments in Federal Trade Commission v. Watson Pharmaceuticals on March 25, 2013.  However, this is a topic about which I believe the legal literature has lagged substantially behind the health economics literature.  As a result, I think the conventional (legal) views of such settlements get the economics of pharmaceutical patents and innovation wrong.  (That does not mean they are getting the law wrong. Although the law in this area is highly unsettled, the goal of the law may not coincide with economic prudence.  I am commenting primarily about economic prudence.)

Continue reading

Quick, Effective Public Health Measures

By Stephen Latham [cross-posted at his blog, A Blog on Bioethics]

I’m freshly back from the annual meeting of the Public Health Law Research program, sponsored by Robert Wood Johnson.

At most academic meetings, I prefer schmoozing in the halls to listening to the talks. That’s part personal vice, and part stage-of-career: at this point, it matters more who I talk to than whose paper I hear. This conference was different, though–perhaps because I’m new to it. A very large percentage of the papers (and posters!) repaid close attention.

But the best session of the conference, to my mind, was the “Critical Opportunities” session. The session, which is apparently an annual affair, is presented as a competition: a handful of public health law scholars are invited to present their best ideas for high-impact, evidence-based public health interventions that have a chance at actual enactment. The audience votes on which one they think is (to put it roughly) most worth peddling to health-policy folk under the banner, “Do it now!”

Upcoming event: Seminar on food subsidies and health at Tufts

Next Wednesday, Professor Sean Cash of the Friedman School of Nutrition Science and Policy at Tufts will deliver a seminar presentation titled, “Fat Taxes and Thin Subsidies: Can food price interventions improve health?” Professor Cash will discuss the efficacy and health impacts of food price interventions that increase the cost of undesirable foods and/or decrease the cost of desirable ones. (For a little advance reading, take a look at his 2005 article by a similar title, which argues that estimates of the cost per statistical life saved through such subsidies compare favorably with existing U.S. government programs). Here’s a brief description of the lecture:

Activists often argue that food prices drive the obesity epidemic, and call for a change in taxes to raise the cost of undesirable foods and subsidies to lower prices of more desirable ones. Do these fat taxes and subsidies actually work? This seminar will review the evidence on efficacy, producer and consumer responses, distribution of health impacts and financial gains or losses, as well as the role of non-price interventions in relation to price changes.

As an added bonus, the seminar will be broadcast via live stream here—so no need to brave the icy cold!