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…
By Ross D. Silverman Earlier this week, the World Health Organization, responding both to the international outcry over the rapidly rising number of Ebola cases and deaths across sub-Saharan Africa (and critiques of the speed of their action), and the news that western health care workers and ministry had found ways to get access to…
By Arthur Caplan As the WHO announced today that medical ethicists will convene next week in New York to discuss the use of experimental medicines in the West African Ebola outbreak, Art Caplan has a timely new opinion piece in the Washington Post asking why only white American victims of the Ebola outbreak have been treated with an experimental…
