FDA: regulatory protections for children. Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP August 6, 2001 To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,…
Evidence-based medicine? Overdosed America: The Broken Promise of American Medicine Thu, 17 Mar 2005 Dr. John Abramson is a physician who spent more than twenty years as a clinician treating patients in Appalachia and Massachusetts before writing “Overdosed America: The Broken Promise of American Medicine.” “When I first read of…
Public Comments: Dr. William J. Bicknell, Professor of International Health, Boston University Dear Dr. Ball: I am submitting these comments in reference to the announcement published in the Federal Register, Vol. 67, No. 211, Thursday, October 31, 2002 regarding the Solicitation of Public Review and Comment on Research Protocol: A…
“The scariest thing is that nobody knows” risks of depression drugs for children Mon, 10 May 2004 Forest Laboratories, manufacturer of the antidepressant, Celexa / Lexapro, is the latest manufacturer to issue warnings (April 2004) about the possibility that “patients with major depressive disorder, both adult and pediatric, may experience…
Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP…
July 12, 2002 Babies Exposed to Toxic Vaccines FYI Several recent articles focus on unsafe vaccines: ABC News reports (below) that 3,400 people, half of them children, “received the questionable vaccines from Park Nicollet Clinic in the Minneapolis metropolitan area. The vaccines included polio booster shots, hepatitis A and B…
Duke Survey Clinical trials: Research Conflicts of Interest Violate ethical Guidelines_UPI Sun, 27 Oct 2002 A major Duke University survey of 108 U.S. medical schools reveals that medical institutions fail utterly to meet international standards aimed at ensuring the integrity of clinical research and the safety of the subjects. Conflicts…
Conflicts of Interest Rampant in Medical Research – NEJM / News Tribune (Wash) Thu, 24 Oct 2002 A Duke University survey published in The New England Journal of Medicine today, confirms the claims made by critics: clinical research at academic institutions is not governed by ethical standards–clinical research is entirely…
Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…
Lilly's aggressive marketing of Xigris does indeed epitomize the worst ofthis industry's mission.
"Academic officials acknowledged in the published guidelines that Lilly gave more than 90 percent of $861,000 in grants for the campaign and medical recommendations. About a fifth of the 46 guidelines writers acknowledged previously taking money from Eli Lilly for speaking, consulting or research."
"The drugs most commonly used to soothe agitation and aggression in people with Alzheimer’s disease are no more effective than placebos for most patients, and put them at risk of serious side effects, including confusion, sleepiness and Parkinson’s disease-like symptoms, researchers are reporting
today."
