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June 2005 BMJ Editorial Calls for Fundamental Changes to Drug Regulation
Current Drug-safety Methods Used by Regulators are Out-dated The July 2, 2005 edition of BMJ, a British medical journal, contains a thoughtful editorial entitled "Drug safety and regulation: New powers and resources are needed".…
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Vioxx Recall Showed Inadequacy of FDA’s Current Drug-safety Monitoring Systems
Expert: Post-marketing Studies Must be Strengthened to Find Meaning of "Signals" Early On On June 29, 2005 Dr. David Wofsy, a rheumatologist associated with the University of California at San Francisco, told an audience…
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Novantrone: FDA MedWatch Alert Regarding Heart Damage Risks
April 2005 "Dear Doctor" Letter Also Addressed an Increased Risk of AML In late May 2005 the FDA warned patients of the risk of heart damage from Serono’s multiple sclerosis drug Novantrone. In a…
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Pfizer Maintains There is No NAION / Blindness Risk from Viagra
Bayer Has Not Decided Whether to Add NAION Warning for Levitra On June 27, 2005 Pfizer Inc. issued a press release asserting that there is no evidence of any increased risk of developing non-arteritic…
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European Drug Regulators Want Increased Warnings on All COX-2 Inhibitor Drugs
Bextra: Suspension of Marketing in European Union to Continue In a June 27, 2005 press release issued by the European Medicines Agency (EMEA), the Agency’s Committee for Medicinal Products for Human Use (CHMP) said…
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Congressman Henry Waxman’s June 2005 NEJM Article About Vioxx and Merck’s Sales Tactics
Tells How Merck’s Drug Reps Did Their Vioxx "Spin" for Concerned Doctors In the June 23, 2005 issue of The New England Journal of Medicine (NEJM), is "The Lessons of Vioxx — Drug Safety…
