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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Published Clinical Trials Contradict Claimed Benefits – Front Page Pill Pushers
Published Clinical Trials Contradict Claimed Benefits – Front Page Pill Pushers Tue Aug 16, 2005 Two items from the BMJ A systemic review of 22 randomized clinical trials of Alzheimer’s disease treatments in the BMJ found the studies to have suffered from flawed methodology and to have revealed that commonly…
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Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report
Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report Wed, 5 Jan 2005 FDA officials could not maintain their iron grip in an effort to suppress evidence of far reaching lethal effects of Vioxx when their actions were in full public…
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Superiority of Zyprexa (Olanzapine) Challenged
Superiority of Zyprexa (Olanzapine) Challenged Mon, 1 Dec 2003 “The profound issue in health care is do we pay anything — regardless of the price — for a statistically significant benefit?” A major 12 month randomized study compared the effectiveness and cost effectiveness of Eli Lilly’s $3.7 billion blockbuster schizophrenia…
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Randomized Controlled Trials: Evidence Biased Psychiatry
Randomized Controlled Trials: Evidence Biased Psychiatry By David Healy, MD MRCPsych Introduction A new drug gets introduced to the market. It has been approved after stringent scrutiny by the FDA, which requires ever more convincing evidence that it works and that its safe. The new treatment will always cost more…
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Doctors On the Take-Engaging in Vairous Dubious Activities for Cash / Stock Options
Doctors On the Take-Engaging in Vairous Dubious Activities for Cash / Stock Options Tue, 16 Aug 2005 A series of current articles in The Wall Street Journal, the Journal of the American Medical Association (JAMA), and the New York Times describe the many questionable non-medical income-producing activities that America¹s physicians…
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"Black Hole" of medical research–Negative Results Don’t get Published – JAMA, WSJ
“Black Hole” of medical research–Negative Results Don’t get Published – JAMA, WSJ Sat, 5 Jun 2004 “No one likes bad news. But in science, there is an ethical imperative to publish research, even if the findings aren’t what the researcher had hoped for.” The New York Times, which tends to…
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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: 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…