Asthma Drug trial Halted -Health Risk Are Suspected Mon, 17 Mar 2003 A spate of recent articles have shown that pharmaceutical companies suppress the publication of negative findings about their products. However, that is not the only way these companies keep physicians and patients uninformed about adverse drug effects. Another…
FDA Officials Tried to tone Down Report of 27,000 heart attacks on Vioxx – WSJ – WashPost Sun, 10 Oct 2004 The FDA attempted to block a senior medical officer from making his findings known about the lethal hazards of Vioxx: Senator Chuck Grassley stated: “Instead of acting as a…
FDA Forced Wyeth to REMOVE Suicide Warning from Effexor Label Wed, 8 Sep 2004 The Wall Street Journal reports that FDA officials forced Wyeth to remove the label warning stating: “In pediatric clinical trials, there were increased reports of hostility and, especially in Major Depressive Disorder, suicide-related adverse events such…
Former FDA Commissioner says FDA lost public trust Mon, 17 Oct 2005 The FDA’s failure to ensure drugs are properly tested in trials designed to detect serious adverse effects, and the agency’s failure to require follow-up post-marketing studies to be reasonably secure in the knowledge that no lethal drugs are unleashed on the public has…
At FDA, Graham is still the whistle-blower – USA Today Thu, 17 Nov 2005 On Nov. 18, 2004, Dr. David Graham, FDA’s associate director for science and medicine, blew the whistle in testimony before the Senate Finance Committee, on FDA’s “profound regulatory failure” to protect the public against lethal prescription…
FDA -Conflicts of Interest to be expanded May 23, 2002 FYI The Washington Post reports that the 1992 Prescription Drug User Fee Act that introduced coporate influence and corporate money into the FDA is about to be renewed and greatly expanded: "There’s no doubt in my mind that bigger and bigger [user fees] harm…
Did Zoloft make him do it? FDA Zoloft data Tue, 8 Feb 2005 At issue beyond a Charlsteon, SC court, is whether Christopher Pittman – who was 12 years old and under the influence of Zoloft, a powerful psychotropic drug, when he killed his grandparents–should have been charged with murder…
DANGEROUS DRUG LICENSING GAME THE FDA PLAYS Thu, 6 Mar 2003 In her column on Red Flags Weekly, Dr. Meryl Nass describes how the FDA in concert with the Justice Department have been lowering the bar for safety of drugs and vaccines used on military personnel. The significance is that…
Senate HELP Committee Votes to Send Children to Front Line of Drug Tests Sat, 22 Mar 2003 Washington Post columnist, Al Kamen, writes about the difficulty the Center for Disease Control (CDC) is having convincing its own staff members to be inoculated with the smallpox vaccine, despite (or perhaps because…
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…
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…
Another Child Devloped Cancer: SCID Trials Suspended – ABC Tue, 14 Jan 2003 ABC News reports that the FDA suspended 30 gene therapy trials after a second child developed leukemia. So far, two boys who had undergone the experimental gene therapy treatment for immunodeficiency, “bubble boy disease” — or SCID–developed…
