P&G Osteoperosis Drug Trials Spark Major Academic Research Debate Re: Concealed Data

P&G Osteoperosis Drug Trials Spark Major Academic Research Debate Re: Concealed Data Friday, November 25, 2005 Dr. Aubrey Blumsohn: “No self-respecting scientist could ever be expected to publish findings based on data to which they do not have complete and full access.” Sri David Weatherall, Professor Emeritus, Oxford: “People need…

Infomail Archive 2004

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…

Practice Guidelines: Can We Trustthe Evidence in Evidence-Based Medicine?

Practice Guidelines: Can We Trustthe Evidence in Evidence-Based Medicine? Sun, 25 Sep 2005 “Research and Clinical Practice Guidelines: Can We Trust the Evidence in Evidence-Based Medicine?” is an article by Dr. John Abramson* (Harvard) and Dr. Barbara Starfeld (Distinguished Professor, Johns Hopkins), published in the Journal of the American Board…

FDA’s Lethal Weakness Requires More than Committees

FDA’s Lethal Weakness Requires More than Committees Sun, 7 Nov 2004 Bloomberg News reports that New York State Attorney General Eliot Spitzer requested information from Pfizer about the promotion of some of its drugs for unapproved uses – the recalled diabetes drug, Rezulin and the antidepressant, Zoloft were named. In…

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UK Doctors told to stop giving antidepressants to children – Glaxo Warns of Paxil Birth Defects

UK Doctors told to stop giving antidepressants to children – Glaxo Warns of Paxil Birth Defects Wed, 28 Sep 2005 Related Link – See Guidelines at: http://www.nice.org.uk/page.aspx?o=273073 The UK National Health Service has taken a decisive, responsible step to protect the lives of children who are being exposed to serious risks…

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FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle

FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle Mon, 29 Nov 2004 The Food and Drug Administration is the epicenter of a collision between medical officers in the drug safety office and senior officials in managerial positions whose focus is on facilitating new drug approvals. Officials at the…

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UK reports the FDA Conceals Vital Data on Prescription Drugs – Independent

UK reports the FDA Conceals Vital Data on Prescription Drugs – Independent Sun, 12 Jun 2005 The entire world has trusted the FDA to ensure that only safe and effective drugs are approved for marketing–other agencies, lacking the necessary resources often followed FDA’s lead. However, such deferrence is no longer…

Integrity in Scientific Research : Peer review ineffective

Integrity in Scientific Research : Peer review ineffective – Institute of Medicine / Lancet / Science August 25, 2002 Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct This report and by the Institute of Medicine (IOM) and two current editorials in major scientific journals-the Lancet (Aug 17)…

Medicare Will cover New Treatments But Patients Will be Required to Enroll in Clinical Trials

Medicare Will cover New Treatments But Patients Will be Required to Enroll in Clinical Trials Fri, 5 Nov 2004 Dr. Mark McClellan, Director of Medicare, estimates that of Medicare’s $320 billion budget, “a third of all medical expenditures are for unnecessary or ill-advised treatments.” Medicare’s chief medical officer, Dr. Sean…

House Votes to Prevent Pharma-tied Scientists on FDA Advisory Panels

House Votes to Prevent Pharma-tied Scientists on FDA Advisory Panels Thu, 9 Jun 2005 The House passed an amendment introduced by Congressman Maurice Hinchey (NY) to rein in pharmaceutical industry influence on FDA advisory panels whose recdommendations have resulted in the approval of lethal drugs. Below Merrill Goozner write: “The…