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,…
Guidant Didn’t Disclose a Flaw in Defibrillator for 3 Years_NYT / FDA Wrong on Crestor Safety Tue, 24 May 2005 The New York Times reports that the maker a a heart defirillator knew for 3 years about a malfunction and failed to inform physicians about It because the company “had…
AHRP Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising Wed, 02 Nov 2005 FDA is holding public hearings (Nov 1, 2) Re:Â Direct-to-Consumer Promotion of Medical Products at: National Transportation Safety Board Boardroom and Conference Center 429 L’Enfant Plaza, SW., Washington, DC 2 Time: 9:00 –5:00….
Was Traci Johnson driven to suicide by anti-depressants? That’s a trade secret, say US officials Sun, 19 Jun 2005 The dirty secret is finally tumbling out: Government agencies that are supposed to protect the public interest are shielding drug manufacturers by helping to conceal deaths and suicides in drug experiments….
Cash Interests Taint Drug Advice – NATURE / Death a Risk of Antipsychotics – AP Sun, 23 Oct 2005 An investigation by the journal, NATURE (the largest of its kind) reveals that not only do conflicts of interest taint the conduct and outcome of clinical trials, the authors who formulate…
Lilly duloxetine drug trial–19 Quit after a suicide – Philadelphia Inquirer Fri, 13 Feb 2004 19-year old Teri Johnson’s suicide occurred one week after an FDA advisory committee had urged the FDA to issue warnings about prescribing antidepressant drugs for children under 18 because of an increased risk in suicide….
Children and antidepressants – CNN Financial Today Fri, 12 Nov 2004 When CNN was looking for an expert with a responsible, balanced view about the concerns of prescribing psychotropic drugs for children, they turned to AHRP. We recommended psychiatrist, Dr. Joseph Glenmullen, a practicing clinician and Harvard faculty member, whose…
Prozac Revisited: Concerns About Suicides Surface – Boston Globe Eli Lilly’s denial about the risk of suicide for some patients prescribed Prozac was the subject of a series of reports in the Boston Globe. The article (Sunday, June 11) revealed the irony behind the duplicity. Dr. Martin Teicher, who first…
British Government Issues New Warnings Re: Use of antidepressant drugs for children Tue, 23 Sep 2003 related link: U.K. Government Document – New SSRI Warnings for Children In light of evidence from previously unexamined data from controlled clinical trials, the British Committee on Safety of Medicines (CSM), an arm of…
Protecting Human Subjects in Research: Are Current Safeguards Adequate? AHRP Testimony submitted to Congressional Committee April 23, 2002 Vera Hassner Sharav, President, and John H. Noble, Jr., Ph.D., steering committee member, The Alliance for Human Research Protection (AHRP), before the Subcommittee on Public Health, Committee on Health, Education, Labor, &…
Treating children as young as 4 for bipolar – WSJ Thu, 26 May 2005 A report in The Wall Street Journal should raise serious concerns about the legitimacy of psychiatric diagnosing and drug prescribing for children. The Journal reports that close to 20,000 US children are being diagnosed with bi-polar…
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…
