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 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…
Twin Pharma Give-A-Ways: Biodefense Vaccine /Drug Development Act–S. 1873_ $7 bill Bird Flu Plan Wed, 2 Nov 2005 If the Administration were serious about preparing for an avian flu pandemic–or for ANY health disaster for that matter–the money would be spent on developing reliable infrastructures at the state and local…
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) August 21, 2002 Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth" Grant Number I R01 DK59234-01 The proposed experiment would involve 450 children healthy children, aged 8-10 years old, 300 of Japanese ancestry…
Children in "Hot Demand" for Clinical Trials May 31, 2002 FYI Rachel Zimmerman of The Wall Street Journal reports about the "frenzy" to recruit children for drug trials. The inclusion of children in drug trials allows pharmaceutical companies to cash in on six month patent exclusivity extensions worth hundreds of millions of dollars….
Concealed Drug Trial Results Mislead Doctors & Put Children’s Lives at Risk – NYT Thu, 22 Jul 2004 The inordinate influence that drug companies wield on government healthcare regulatory policies–through campaign contributions to elected officials and lucrative job offers to public officials–has seriously compromised children’s safety in numerous ways. An…
NYSOMH Issues Alerts, Guidelines re Antidepressant Use in Children, Teens Wed, 29 Dec 2004 The NYS Office of Mental Health has issued letters and an advisory to state mental health providers “explaining” FDA’s warning and the use of antidepressants in children. As you will note, OMH downplays the meaning of…
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…
Antidepressant Controversy: Media Conflicts of Interest – New York Times Thu, 25 Mar 2004 FDA’s advisory warning about antidepressant drugs received wide press coverage nationally. But few in the national media mentioned conflicts of interest as the obstacle to disclosure of evidence showing these drugs’ adverse effects. Among the few…
