Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data Tue, 3 Aug 2004 A hearing about the possible connection between suicide and antidepressant drugs will be held on Aug 4, by the California Senate by Sen. Tom Torkalson, chairman of the Senate Task Force on Youth and Workplace Wellness…
FDA Issues Public Health Advisory Entitled Reports Of Suicidality in Pediatric Mon, 27 Oct 2003 The FDA issued a warning about the suicide risk for children prescribed an antidepressant of the SSRI class. These drugs have never been shown to be more effective than placebo for the treatment of depression–which…
Ex-NIH Director Lifted conflict of interest rules, Now favors limits on Drug-Company Ties – LAT Sun, 14 Mar 2004 Former Director of the National Institutes of Health, Harold Varmus, MD, appeared before a blue ribbon panel convened by his former agency, ostensibly to shed light on conflict of interest at…
Drug Testing Debate – Parenting Mag 4 Pt. Series Tue, 22 Oct 2002 Parenting Magazine published a 5-part report about the impact on children of FDA’s “The Pediatric Rule.” That Rule provides drug companies six month patent extension on drugs tested in children. This financial windfall could translate into some…
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…
Who is a Human Subject? Who has the Right to Informed Consent? March 11, 2002 "The voluntary consent of the human subject is absolutely essential." [Nuremberg Code, 1947] "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or…
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
Cong Hearing Re: Disclosure Pediatric SSRI Trials Wed, 7 Jul 2004 A hearing has been tentatively set for July 20th by the House subcommittee on oversight and investigations, chaired by Congressman James Greenwood. The hearing will address issues of disclosure involving pediatric antidepressant drug trials–or more accurately, non-disclosure of adverse…
Forbes: Face of The Year: David Graham Mon, 13 Dec 2004 Â Forbes magazine has named Dr. David Graham the Face of the Year’ for his “steadfast advocacy of drug safety and his willingness to blow the whistle on his bosses.” Dr. Graham took a courageous stand as a responsible…
FDA reviews depression drugs–Intense or Cautious? WashPost/ NYT/ Herald Wed, 29 Oct 2003 The Washington Post correctly reports: “The association between antidepressants, particularly the selective serotonin reuptake inhibitors (SSRIs), and suicide has been controversial since the first SSRI, Prozac, came on the market in the late 1980s.” But stakeholders in…
FDA Asks Antidepressant drug companies to add Cautions on labels Mon, 22 Mar 2004 The FDA has “requested” drug companies to put prominent warnings on the labels of 10 antidepressant drugs, “to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the…
Antidepressant Ban for Kids Puts Pressure On U.S. / Canada Mon, 15 Dec 2003 The British government ban for use of all but one SSRI antidepressant drug in children and teens (Dec 10, 2003) is reverberating wherever these drugs are widely prescribed. The action was taken after an independent committee…
