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.
"Why are scientists coy about publishing negative data?
FDA's slip-shod approval of defective, harmful drugs, accompanied by rubber stampped endorsements by compromised FDA advisory committees may be reaching a boiling point.
Dr. E. Jane Costello, a professor of psychiatry and behavioral sciences at Duke University, acknowledges: “The system of diagnosis is still 200 to 300 years behind other branches of medicine.” Psychiatry also fails to be guided by an evidence-based positive benefit / risk assessment of its prescribed treatments.
The ethics of this radical drug experiment is being challenged by Dr. Jerald Block, a forthright psychiatrist and experienced system's analyst. His critical appraisal, published in the Bioethics Forum, Hastings Center Report.
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…
Former FDA Commissioner says FDA lost public trust Mon, 17 Oct 2005 The FDA’s failure to ensure drugs are properly tested in trials designed to detect serious adverse effects, and the agency’s failure to require follow-up post-marketing studies to be reasonably secure in the knowledge that no lethal drugs are unleashed on the public has…
Credibility Crisis:Survey FDA Scientists – Death in NIH-AIDS Trial – Tauzin Moves to PhRMA Thu, 16 Dec 2004 A credibility crisis in medical research is smoldering: like the Enron accounting scandal, the prescription-drug debacle is a matter of systemic corruption, including gross and widespread failure by the regulatory process. Unlike…
NIH Under Fire: Longtime Favorite of Congress – Wash Post / WSJ Sun, 27 Jun 2004 Under fire from Congress with evidence of NIH staff engaging in secret outside contracts and consultancies, NIH Director, Dr. Elias Zerhouni, turned a corner. He acknowledged the problem at a hearing (June 22) of…
Research Protection: SCIENCE / Fed Paper Mon, 28 Oct 2002 SCIENCE magazine (below) reported about “the bumpy road” of Dr. Greg Koski’s tenure as director of the federal Office of Human Research Protections (OHRP), and how his resignation is being perceived by some. An article in The FEDERAL PAPER focused…
OHRP Response to AHRP re: Surrogate Consent to Research Office of the Secretary Department of Health & Human Services Office of Public Health and Science Office for Human Research Protections Rockville, Maryland E-mail: mcarome@osophs.dhhs.gov August 28, 2002 Vera Hassner Sharav President, The Alliance for Human Research Protection John H. Noble,…
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…
