Abbott Seeks FDA approval for cancer drug despite failed trials – WSJ

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…

Joint Commission on Accreditation of Healthcare Orgs & NCQA

Joint Commission on Accreditation of Healthcare Orgs & NCQA Fri, 9 Sep 2005 After much hand wringing following public disclosrure that the current IRB (institutional review board) research review and approval process is so inadequate and unreliable, the (then) outgoing Secretary of Health and Human Services, Donna Shalala, acknowledged in…

2005: “Cheaper than Chimpanzees” by Vera Sharav

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,

AHRP Speaks Out

AHRP Speaks Out Dec 12, 2005: Mental Health Screening: A PhRMA Friendly Remedy for Societal Problems. Presentation by Vera Sharav, American Public Health Association Nov 2005: Analysis of S. 1873 – The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 – Karen R. Effrem, MD June 1-3, 2005:…

"Lilly is Hiding Negative Information About Zyprexa" – SAPS

“Lilly is Hiding Negative Information About Zyprexa” – SAPS Wed, 2 Nov 2005 From our colleague in Sweden: A published interview with Dr. Curt Furberg, Professor of Public Health Sciences Wake Forest University Baptist Medical Center, and Chair, Steering Committee, and Principal Investigator, of one of the most important studies…

Vioxx Fallout: Merck Officials Intervened–NYT / FDA Officials Intervened–Mother Jones

Vioxx Fallout: Merck Officials Intervened–NYT / FDA Officials Intervened–Mother Jones Mon, 25 Apr 2005 Mother Jones and The New York Times focus on the Vioxx fall out–a case that encapsulates the corrupt practices in drug research. Merck and FDA officials intervened to conceal the lethal cardiac effect of Vioxx. Mother…