FDA: Regulatory Protections for Children. Comments by Sharav, Noble, & Fishman for AHRP

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

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…

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AHRP Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising

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:  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

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

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

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

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…