New Paper on Sperm Donor Anonymity and Mandatory Paternal Testing for Coital Sex

I have a new peer-commentary paper in the American Journal of Bioethics, entitled “Of Modest Proposals and Non-Identity: A Comment on the Right to Know Your Genetic Parents.”  This is a response to An Ravelingien and Guido Pennings’s very interesting article “The Right to Know Your Genetic Parents: From Open-Identity Gamete Donation to Routine Paternity Testing” in the same journal, wherein they argue that the same arguments underlying mandatory sperm donor identification should support a regime of mandatory routine paternity testing to deal with the phenomenon of misattributed paternity.

My new piece is behind a pay-wall, but if you’d like to read it shoot me an email as I have a limited number of “free passes” from the publisher. I have also written about these issues in greater depth in this article in the Georgetown Law Journal which is available for free download. Finally, I hope to soon blog about a new paper forthcoming in the Journal of Empirical Legal Studies and co-authored with Travis Coan, where we use experimental methods to examine whether reluctance to become a sperm ‘donor’ where identification is required can be overcome with increased payments to potential ‘donors’.

Big Data and Pharmacovigilance, Part I

By Dov Fox

So much new data are created every day that 90 percent of all data worldwide has emerged in just the last two years. This information revolution has the potential, argues Bill of Health guest blogger Ryan Abbott, to transform how we develop new drugs, set clinical practices, and finance health care. His interesting new article paints an alluring “vision of a drug regulatory system powered by big data”:

“When the Food and Drug Administration (FDA) approved the cholesterol-lowering drug simvastatin in 1991, it was based on pre-marketing controlled clinical studies that included a total of 2,423 patients. In 2011 alone, just in the United States, almost a hundred million prescriptions were written for the drug. Imagine the impact of being able to analyze data from every one of those patients to evaluate whether simvastatin is safe and effective.”

The surveillance of pharmaceuticals after they’ve gone to market will matter more and more, Abbott argues, as personalized medicines become more difficult – and perhaps less necessary – to regulate before they’re released. He proposes a new plan for the post-market regulatory system that relies on the health information exchanges (HIE) created by the HITECH and Affordable Care Acts. These exchanges are slated to amass a vast repository of data on individual patients. Their large size and inclusive nature will enable more accurate analyses in observational research, Abbott suggests, and in ways that minimize the bias and selectivity problems associated with current data sets.

There are at least three obstacles to the integration of these exchanges in drug regulation. First, HIEs will be expensive. While the federal government provided considerable funding to get these exchanges off the ground, Abbott recognizes that in order to remain viable, they will probably have to sustain themselves financially. Second, their meaningful impact on post-marketing surveillance will require consistent reporting standards and information-sharing mechanisms. Third are important patient concerns about the privacy of their personal health information. States are experimenting with different patient participation models to address privacy concerns. For example, Abbott notes that in some states HIEs are free to exchange information without patient consent, while in others patients can opt-out of information exchange altogether. Either is permitted by HIPAA, so long as the information is de-identified so it can’t be used to identify individual patients.

Abbott argues that it’s worth tackling such concerns that the adoption of HIEs pose for citizens, policy makers, health care providers, and the health care industry, so we don’t squander the opportunity to use health information exchanges to their full benefit. Public support for data collection isn’t enough. That data must be translated into a format that regulators can use—something I’ll address tomorrow in my next post on the subject.

Call for Abstracts on Research Methods for Evaluating Patient Health Outcomes in Rare Diseases

The Effective Health Care Program within the US Department of Health and Human Services’ Agency for Healthcare Research and Quality is accepting abstract submissions for a journal supplement on research methods for evaluating patient health outcomes in rare diseases. The proposed supplement will focus on innovative patient-centered health outcomes research methodology and its application to rare diseases or drugs/devices used to treat such patients.  Topics areas of interest include:

1. Rare disease patients’ health outcomes in clinical trials, including outcomes arising from novel trial designs, such as adaptive clinical trials or n-of-1 trials

2. Emerging data sources for observational research on rare disease patients’ health outcomes, including the process of data aggregation and building disease registries or federated data networks

3. Novel analytic methods for observational research and prospective observational monitoring for rare disease patients’ health outcomes

4. Integrating stakeholder involvement in assessing rare disease patient health outcomes, particularly studies that describe or test how patient-centered health outcomes can be applied to enhance the development or evaluation of therapeutics for rare diseases

5. Economic, regulatory, ethical, legal, and social issues related to the study of rare disease health outcomes.  Authors may present empirical data or seek to collaborate in developing consensus statements outlining basic principles in these areas.

Proposals for original research articles and insightful reviews will be given highest priority.  Submissions are encouraged from authors with expertise in a broad range of study designs and from across multiple disciplines, including authors with methodological expertise in clinical trials, health outcomes studies, health services research, health policy, biostatistics, epidemiology, social science, and qualitative research.  The selected authors will be invited to submit a complete manuscript for peer-review and publication in the Journal of General Internal Medicine, a widely indexed journal with an international audience among practicing clinicians and general medical researchers. Abstract submissions are due by May 31, 2013.

More information and the submission form are available on the Effective Health Care Web site at: https://www.effectivehealthcare.ahrq.gov/index.cfm/call-for-abstracts-rare-diseases/

Effective Health Care Program
https://effectivehealthcare.ahrq.gov

PERINATAL HOSPICE: NEW THEORIES ABOUT WHAT CHOICE MEANS

Guest Blogger: Allison M. Whelan*

So much of the political and legal debate about reproductive choice centers on abortion.  In doing so, these debates obscure so many other reproductive choices women must make.  And the choices are not easy—and the stakes are even greater in an era where any prenatal missteps might lead to aggressive state action, including criminal sanctions.  There are thorny situations that confront medicine and ethics.  For example, how should we think about families that choose to carry terminal fetuses to delivery only for the fetus to expire shortly after birth?  Should such pregnancies be terminated early given that doctors and even the intended parents know the fetus will not survive?  Where does the law stand on such issues?  What is morally permissible?

Thousands of women and families face lethal prenatal diagnoses and perinatal loss every year. In 2006, there were 25,972 reported fetal deaths at twenty weeks or later.  An additional 19,041 live-born infants died at less than twenty-eight days.  Birth defects such as congenital malformations and chromosomal abnormalities are the leading cause of fetal-infant deaths. Lethal anomalies (i.e., Trisomy 13; anencephaly; hypoplastic left heart syndrome) are a subset of birth defects characterized by a radically shortened lifespan. In 2005, there were 6,925 fetal and infant deaths attributable to lethal anomalies in the U.S.

Advancements in prenatal diagnosis coinciding with improved access to legal abortions create medical options for patients, but also spur challenging ethical questions.  For example, therapeutic abortions have become the “management of choice” for many women whose fetuses experience a “lethal condition”.  However, termination may not be the preferred choice for all women and families.  The concept of perinatal hospice fills this void and offers women valid options after a terminal fetal diagnosis. Although the concept is still relatively novel and unknown in much of the health profession and lay population, the development of perinatal hospice programs is growing.

Perinatal hospice is worth taking seriously.  For example, perinatal hospice programs are multidisciplinary and their services begin at the time of diagnosis (rather than death), in recognition of “anticipatory grief,” a term describing the grieving process that begins prior to death when a death is probable or imminent. Those who have used these services say that perinatal hospice provides a supportive environment for parents to grieve and appreciate any time they have with their infant.  Further, they say It affirms their role as parents and acknowledges that their loss is “as real” as the loss of any other loved one.  Maybe perinatal hospice is a safe place where parents can “be parents.”  It’s worth thinking about.

*Allison Whelan is a graduate student, University of Minnesota School of Law and Center for Bioethics

Petrie-Flom Interns’ Weekly Round-Up: 3/29-4/5

By Hyeongsu Park and Kathy Wang

Health Law and Policy Workshop: Petrie-Flom Fellow Nicholson Price on Making Due in Making Drugs

The Petrie-Flom Center at Harvard Law School is happy to announce the penultimate session of this year’s Health Law Policy, Biotechnology and Bioethics Workshop in the Spring 2013 semester. We’re delighted to welcome a stellar lineup of leading researchers and opinion-makers in the fields at the intersection of health and law.  Professors Elhauge and Cohen lead the 2012-13 workshop series.

This spring’s next presenter is Petrie-Flom Academic Fellow Nicholson Price. He will be presenting his paper “Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing” on Monday, April 8th  at 5pm in Hauser 105. The full text of the paper is available here, and the abstract is copied below the “read more”

The workshop will conclude on Monday, April 15th with a lecture from WilmerHale Professor of Intellectual Property Law at HLS and Faculty Director of the Berkman Center, Terry Fisher. Workshops are open to the public and copies of papers will generally be posted a week in advance on the Petrie-Flom Website: https://www.law.harvard.edu/programs/petrie-flom/workshop/index.html.

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