Conference Announcement: Institutional Financial Conflicts of Interest in Research Universities

On November 2 at Harvard Law School, the Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Francis Collins, Derek Bok, and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!

 

Congratulations to Our Greenwall Scholar, Glenn Cohen!

The Greenwall Foundation has selected Bill of Health co-editor, Glenn Cohen, to receive a Faculty Scholar Award in Bioethics for 2012-2015. 

This career development award is intended to enable outstanding junior faculty members to carry out original research that will help resolve important policy and clinical dilemmas at the intersection of ethics and the life sciences.  Congrats, Glenn!

 

Research Participation as a Responsibility of Citizenship

by Suzanne M. Rivera, Ph.D.

For legitimate reasons, the human research enterprise frequently is regarded with suspicion.  Despite numerous rules in place to protect research participants’ rights and welfare, there is a perception that research is inherently exploitative and dangerous.

Consequently, most people don’t participate in research.  This is not only a fairness problem (few people undergo risk and inconvenience so many can benefit from the knowledge derived), but also a scientific problem, in that the results of studies based on a relatively homogeneous few may not be representative and applicable to the whole population. Larger numbers of participants would improve statistical significance, allowing us to answer important questions faster and more definitively.  And more heterogeneous subject populations would give us information about variations within and between groups (by age, gender, socio-economic status, ethnicity, etc.).

Put simply, it would be better for everyone if we had a culture that promoted research participation, whether active (like enrolling in a clinical trial) or passive (like allowing one’s data or specimens to be used for future studies), as an honorable duty.    (Of course, this presumes the research is done responsibly and in a manner consistent with ethical and scientific standards, and the law.) Read More

New Product Liability Regime for Stem Cell Products?

By Hyeongsu Park

In May 2012, Health Canada granted market authorization for Prochymal. This decision is the world’s first regulatory approval of a stem cell drug (as well as the first therapy for acute graft-vs-host disease, a serious complication of bone marrow transplantation that kills up to 80% of children affected). Like Prochymal, many stem cell products have exciting therapeutic potential, such as bone regeneration and cartilage formation. And the global stem cell product market is estimated to reach $6.6 billion by 2016. However, side-effects remain unknown, and the regulations for such products are largely non-existent. So what should happen if a patient gets hurt?

Stephen R. Munzer (UCLA School of Law) discusses this question in his latest article in the Boston University Journal of Science and Technology Law, and recommends that qualified strict liability should govern product liability for stem cell products. Read More

The Supply of American Doctors

Following up on his post on Australia, Al Roth notes that American medicine is a market with tightly restricted entry, at all levels. Proposed legislation offers a glimpse: Bill Would Create More Medical-Residency Slots, Potentially Easing Physician Shortage

Legislation introduced in Congress on Monday would expand the number of Medicare-sponsored training slots for new doctors by 15,000, a step that two medical-education groups said would go a long way toward easing a projected shortage of physicians. The bill, the Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act (HR 6352), is sponsored by Rep. Aaron Schock, an Illinois Republican, and Rep. Allyson Schwartz, a Pennsylvania Democrat. Medical schools have been expanding their enrollments and new schools have been opening up as concerns have grown about a shortage that could reach more than 90,000 physicians by 2020, according to the Association of American Medical Colleges. Those worries have intensified with passage of the Affordable Care Act, which will greatly increase the number of people seeking medical care by providing insurance coverage to 32 million more people. But while more students are making their way through the medical-school pipeline, they’re likely to run into bottlenecks because of a cap on the number of Medicare-supported residency training slots that Congress imposed in 1997.

[cross-posted on Market Design]

Is the USTR Trading Away Doctors’ Rights to Freely Perform Medical Procedures?

By Adriana Lee Benedict 

The 14th round of negotiations for the Trans-Pacific Partnership Agreement (TPPA, a multilateral trade agreement currently being negotiated by the USTR and 10 other countries) is currently underway in Leesburg, VA.  Last month, KEI posted a brief video blog about an interesting provision (Article 8.2) of the TTPA’s leaked draft IP chapter calling for patentability of diagnostic, therapeutic and surgical methods.  Critically, KEI pointed out that current US law (35 U.S.C. 287(c))—which was amended after widespread concern from physicians’ associations regarding the adverse public health effects of medical method patent liability were brought to light with Pallin v. Singer, 36 U.S.P.Q.2d (BNA) 1050 (D. Vt. 1995)—immunizes medical practitioners from patent infringement suits concerning medical methods, although the draft TPPA provision makes no such exception.  The proposed provision is also contrary to Article 27(3) of TRIPS and Article 1709(3)(a) of NAFTA, all of which allow countries to exclude such medical methods from patentability, as well as Rule 39.1 of the 1970 PCT, which exempts International Searching Authorities from having to conduct patent searches relating to medical methods.

Medical professional societies, including the WMA, AMA, AAOS, ACOG and ASRC, have also opposed medical procedure patents on ethical grounds.  The WMA has explained that patents are not necessary to incentivize innovation in medical procedures: “Unlike device development, which requires investment in engineers, production processes, and factories, development of medical procedures consists of physicians attaining and perfecting manual and intellectual skills… physicians already have both obligations to engage in these professional activities as well as rewards for doing so.”  The WMA has also noted a number of adverse effects on access to medical care resulting from medical procedure patents, including higher costs, fewer physicians available and/or willing to perform patented procedure, and less innovation in medical procedures.

So what does this mean for the TPPA negotiating parties? Read More

Yale’s Friday Newsletter

So…it’s a bit late today, but each Friday we’ll be posting some highlights from the Yale Interdisciplinary Center for Bioethics newsletter (AKA “Frimail”), a really fantastic resource for those of us interested in what’s been going on in the bioethics world each week (both in the popular media and in the journals). They also have job and conference announcements, etc. Enjoy!

Read More

Market Design Flaw in Australia

Al Roth has come across a troubling phenomenon in Australia, where medical internships are in short supply.

Medical students languish in a critical condition

The Australian Medical Students’ Association estimates almost 500 students will miss out on an internship next year because of insufficient places. Under the internship system students must work for a year under supervision in a hospital before they can work as doctors. … Australian Medical Association president Steve Hambleton points to the curious situation where the nation has a shortage of doctors, yet there are too few internships.  … The placement system has fallen apart, he says, because the federal government regulates the number of students universities can enrol while its state counterparts oversee the provision of internships. 

[cross-posted on Market Design]