By Zachary Shapiro Hello from the Post-Trial Responsibilities conference! I will be live blogging session 2: where speakers will be providing important perspectives on PTA. Barbra Bierer is monitoring the discussion. We started with Richard Klein calling in from FDA: Richard is talking about post-trial responsibilities. He points out that there is a justice issue…
By Holly Fernandez Lynch Today, the Multi-Regional Clinical Trials Center (MRCT) at Harvard University and the Petrie-Flom Center at Harvard Law School are co-hosting a daylong conference on “Post-Trial Responsibilities: Ethics and Implementation.” We’ll be live blogging the conference here at Bill of Health, and video/slides from the conference will be available soon. The conference…
By Art Caplan A new working group at the NYU Langone Medical Center has issued preliminary findings from their studies on the research ethics of compassionate use. Among their findings include: Biotechnology companies have no legal or regulatory obligation to provide access to unapproved treatments on the grounds of compassionate use. Some companies allow access under the…
Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 7:30 AM – 5:30 PM Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave. The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here. The term “post-trial access” is used broadly to connote a wide range…
By Rachel Sachs For all those who are interested in issues of global health, access to medicines, and drug pricing, yesterday Gilead formally announced its access program for enabling many developing countries to purchase its new Hepatitis C drug, Sovaldi, at low prices. This announcement is particularly noteworthy because Sovaldi represents a significant improvement over…
By Zachary Shapiro Post-Trial Access (PTA) is emerging as an important topic in the design of ethical clinical trial protocols. PTA refers to the provision of study drug to the participants in a successful clinical trial (and maybe others) during the crucial period after a clinical trial phase is over, but before the drug is…
Post-Trial Responsibilities: Ethics and Implementation Thursday, September 18, 2014 7:30 AM – 5:30 PM Wasserstein Hall, Milstein East AB, Harvard Law School, 1585 Massachusetts Ave. The conference is free and open to the public, but due to limited seating, registration is required to attend. Please register here. The term “post-trial access” is used broadly to…
By Kevin Outterson A short article in the New Yorker on my favorite topic – business models for antibiotic use and innovation.
By Arthur Caplan Art Caplan has a series of new opinion pieces out on the WHO ethics advisory committee meeting that approved the use of experimental drugs to treat patients ill with Ebola. He suggests deeper exploration of issues of informed consent, corporate responsibility, and resource allocation in this blog post for The Health Care…
By Arthur Caplan Amidst news from Spain that a 75-year-old Catholic priest has received the experimental treatment ZMapp for Ebola, Art Caplan critiques what he describes as the “bad science” behind choosing its recipients: ZMapp is not the answer to the Ebola epidemic ravaging West Africa. There is no chance of getting a significant amount of this drug…
