TODAY! 12-1:30pm Austin Hall, Room 111 Harvard Law School On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for…
by Jonathan J. Darrow Until recently, most ordinary people had never heard of “pharmacy compounding.” Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis…
Friday, November 2, 2012 8:30am – 6:30pm (reception to follow) Milstein Conference Rooms, 2nd Floor Wasserstein Hall 1585 Massachusetts Avenue Cambridge, MA 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 Derek Bok and Zeke…
By Michelle Meyer As most readers of this blog well know, health disparities of various kinds are rampant in the U.S. — in obesity, infant mortality and morbidity, cardiovascular health, and many other areas. In most cases, however, we seem to know more about the extent of health disparities than we do about what causes…
By Holly Fernandez Lynch Next Tuesday, those of us registered in Massachusetts will have the opportunity to vote on “Question 2” – prescribing medication to end life, otherwise known as physician-assisted suicide. As described by the state secretary, “This proposed law would allow a physician licensed in Massachusetts to prescribe medication, at a terminally ill…
By Suzanne M. Rivera, Ph.D. In August of 2011, the Public Health Service updated its rules to address the kind of financial conflicts of interests that can undermine (or appear to undermine) integrity in research. The new rules, issued under the ungainly title, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health…
By Suzanne M. Rivera Federal regulations and ethical principles require that Institutional Review Boards (IRBs) consider the anticipated risks of a proposed human research study in light of any potential benefits (for subjects or others) before granting authorization for its performance. This is required because, prior to the oversight required by regulation, unethical researchers exposed…
By Michelle Meyer A while back, over at PrawfsBlawg, Martin Pritikin had a useful post collecting advice for legal academics looking to break into increasingly popular empirical legal studies (ELS). As Jeremy Blumenthal notes in the comments, Step 1 is to be sure to get IRB approval. This post addresses what I’ll call, with a…
By Brendan Abel, JD Countless regulations have been enacted over the past 35 years to protect children from unnecessary clinical testing. Federal regulations, the Belmont Report, and professional guidelines all state that children should be enrolled in clinical trials only when the research is a high imperative. Federal research regulations insist that absent a potential…
By Leslie P. Francis In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements. A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The…
