Role of Litigation in Defining Drug Risks_JAMA / BMJ
Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known.
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Are Lipid lowering (Statins) Guidelines Evidence-Based? Lancet
The authors argue that recommendations for the expanded use of statins to stave off cardiovascular disease are NOT supported by the evidence.
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Theory suggests that a shortage of vitamin D triggers outbreaks of flu
The Baltimore Sun reports (below) that in a paper scheduled for publication in the journal Epidemiology and Infection, a Harvard University-led team proposes that a vitamin D deficiency caused by inadequate winter sun exposure may predispose people to infection.
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Ethical Violations and Investigations Today
Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP…
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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: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….
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ADHD drug Cylert withdrawn from market due to Liver Toxicity
ADHD drug – Cylert withdrawn from market due to Liver Toxicity, a Major Risk of Psychotropic Drugs Tue, October 25, 2005 The FDA announced that another drug prescribed for ADHD–Cylert–was removed from the US market for safety reasons. On September 25, 2005, the Associated Press reported: “Eli Lilly said it…
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Zolft pediatric study in JAMA challenged by peers – JAMA letters
Zolft pediatric study in JAMA challenged by peers – JAMA letters Fri, 9 Jan 2004 At the time that two manufacturers publicly acknowledged that their antidepressant drugs (Paxil / Seroxat and Effexor) were unsafe, and ineffective for children, the Journal of the American Medical Association (JAMA) published a clinical trial…
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Wyeth Pharma Warns Doctors Against Rx Effexor to Kids
Wyeth Pharma Warns Doctors Against Rx Effexor to Kids Tue, 2 Sep 2003 View Wyeth Warning Letter The Hartford Courant reports that the latest warning against prescribing an antidepressant drug for children comes from Wyeth Pharmaceuticals, makers of Effexor, a drug just like Prozac, Zoloft, and Paxil–a class known as…
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Risks: Drugs / Vaccines / Trials / Treatments
Risks: Drugs / Vaccines / Trials / Treatment Evidence of antidepressant harm Oct 14, 2005: Andrew Finkelstein Letter to Dr. Russell Katz, Director, Neuropharmacological Drug Products, FDA about FDA’s Failure to Warn about Neurontin-Suicides Aug 29: FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks…
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European perspective: Bird Flu–BBC Panoarama / German skeptics / Rumsfeld Tamiflu stock $5 to $25 million
European perspective: Bird Flu–BBC Panoarama / German skeptics / Rumsfeld Tamiflu stock $5 to $25 million Sat, 5 Nov 2005 As the media continues its senstional coverage of the “Bird Flu pandemic”, healthy skeptics are examining the evidence. Two European examinations–The BBC Panorama will air a program, Lessons from Vietnam,…
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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…
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How Did the Vioxx Debacle Happen? USA Today / Lancet
How Did the Vioxx Debacle Happen? USA Today / Lancet Tue, 12 Oct 2004 Dr. Eric Topol of the Cleveland Clinic: “The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public…