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Johnson & Johnson stung by its own Advisory Committee–Natrecor should be strictly limited Fri, 12 Aug 2005 Kudos go to Dr. Eugene Braunwald and the 10 members of the advisory committee that he heads. Contrary to Johnson & Johnson expectations, the committee recommended extensive warnings to physicians against prescribing Natrecor…
Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee Department of Health and Human Services Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c) Dissenting opinion of Vera…
FDA Commissioner Lester Crawford Resigns – AP Fri, 23 Sep 2005 The Associated Press reports that the embattled FDA commissioner, Lester Crawford, a veterenarian, who headed the agency since Marc McLellan moved over to the Center for Medicare & Medicaid Services, has resigned effective immediately. Contact: Vera Hassner Sharav 212-595-8974…
Spitzer Expands drug Probe: Johnson & Johnson / New FDA analysis Confirms SSRI Risks to Kids – WSJ Thu, 5 Aug 2004 A front page article in The Wall Street Journal reports that a second FDA analysis of 25 clinical trials of SSRI antidepressants in children was conducted after a…
Lies & Broken Promises_Drug firm Websites Fail to Disclose Test Data Sun, 9 Jan 2005 One year after PhRMA’s publicized proclamation of its “commitment to transparency” The Boston Globe reviewed pharmaceutical company websites searching for disclosure of clinical trial data. The Globe found that this voluntary approach failed miserably: “Last…
Conflicts of Interest Rampant in Medical Research – NEJM / News Tribune (Wash) Thu, 24 Oct 2002 A Duke University survey published in The New England Journal of Medicine today, confirms the claims made by critics: clinical research at academic institutions is not governed by ethical standards–clinical research is entirely…