Minnesota initiative: Compulsory newborn congenital testing Mon, 24 Mar 2003 The Minnesota House Health and Human Services Policy Committee will vote tomorrow on a law requiring the screening of every newborn baby to ascertain who may have a congenital disorder. It is important to note that this “public health” initiative…
At FDA, Graham is still the whistle-blower – USA Today Thu, 17 Nov 2005 On Nov. 18, 2004, Dr. David Graham, FDA’s associate director for science and medicine, blew the whistle in testimony before the Senate Finance Committee, on FDA’s “profound regulatory failure” to protect the public against lethal prescription…
Statin-Cholesterol Guidelines–Industry influenced? Wed, 14 Jul 2004 Scientific journal editors are scrambling about how to react to bad publicity emanating from public disclosure that the scientific reports they have published are likely to be biased because the authors’ had financial ties to the companies whose drugs / devices they report…
Commonly recommended Treatments found Worthless Wed, 19 Mar 2003 Independent analyses of the clinical studies upon which widely recommended drug treatments have been based, have now been found to be fatally faulty, and the drugs are deemed worthless. An analysis of 83 studies found that drugs used to treat 90,000…
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…
Tonight PBS Is Science for Sale? Fri, 22 Nov 2002 Bill Moyers Now, a PBS program will discuss the influence of the pharmaceutical industry and its PR companies on science. The discussion explores how the scientific literature and the process of reporting the scientific findings of research have been rendered…
Research dispute prompts patient-trials debate_Seattle Times Mon, 19 May 2003 Newhouse News Service reports that the continuing dispute about the ethics and design of a multi-site lung ventilation experiment sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and conducted by the ARDSNetwork on 861 critically ill patients with…
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…
The Crawford Resignation Mystery Sat, 24 Sep 2005 Merrill Goozner of Center for Science in the Public Interest provides insight into what may lie behind the sudden resignation of FDA Commissioner, Lester Crawford. Goozner surggests, “One possible clue to the administration’s thinking comes from the appointment of Andrew von Eschenbach,…
Doctors Without Borders: Why you can’t trust medical journals anymore Tue, 13 Apr 2004 Related link: Hear an interview with Shannon Brownlee on NPR at: http://www.npr.org/features/feature.php?wfId=1874563 Doctors Without Borders in the Washington Monthly (excerpt below), looks at the intricate web of collaborating players in medicine who are financially tied one…
August 26, 2002 OHRP Retreats from Providing Public Info re: Compliance Activities FYI A newly posted announcement by the Office of Human Research Protection (OHRP), dated July 15, rescinds the agency’s announced policy of making public the content of its letters of determination following the agency’s investigation of compliance /…
FDA Standards – Good Enough for Government Work? Fri, 23 Sep 2005 An essay in The New England Journal of Medicine, by Jerry Avorn, M.D., professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, chalolenges FDA’s “minimalist” drug…
