Abbott Seeks FDA approval for cancer drug despite failed trials – WSJ Mon, 12 Sep 2005 Abbott Laboratories is asking the FDA to approve a cancer drug even though it failed in clinical trials to demonstrate a benefit greater than placebo–which is a minimal FDA requirement. The Wall Street Journal…
On behalf of the Alliance for Human Research Protection, or AHRP, I want to thank the members of the Committee, for this opportunity to share with you our understanding of the complex problems presented by medical research involving vulnerable populations, such as prisoners and children. We appreciate your difficult job, and recognize that you will need to exercise courage in your assigned mission, which is to protect prisoners from research abuse and exploitation.
“Courage,” in this context, means the courage to acknowledge uncomfortable facts about current practice and to speak truth to power,
Infomail Archive 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Dec 18, 2003:…
Internal Documents: Bayer Knew of Baycol Dangers _NYT Sun, 23 Feb 2003 The New York Times reports that internal company documents show that Bayer Pharmaceuticals continued to sell the lethal anti-cholesterol drug, Baycol, despite knowledge that it caused rhabdomyolysis, which causes muscle cells to break down and their contents to…
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department and The Henry M. Jackson Foundation for the Advancment of Military Medicine
The cornerstone of public trust in medical research is the integrity of academic institutions and the expectation that universities, which rely on public funding, have a responsibility to serve the public good. Financial conflicts of interest affect millions of American people – those who are subjects of clinical trials testing new drugs and those who are prescribed drugs after their approval.
