At FDA, Changes In Name Only–Agency Puts Business interests Above Safety Fri, 30 Sep 2005 The sudden resignation of FDA Commissioner, Lester Crawford, after just two months in office, has prompted a bipartisan Senate investigation and requests both by the Senate committee HELP and by congressman Maurice Hinchey (NY) and…
Natrecor found to worsen kidney function, hasten death – NYT Tue, 17 May 2005 Natrecor, a drug approved by the FDA for treating patients with heart failure, is being widely prescribed off label for unapproved uses. The drug is prescribed for so-called “tune-ups” in outpatient clinics – although that use…
FDA Critics Slam Plan for Safety Reform – Nature Thu, 17 Feb 2005 This is smoke and mirrors and musical chairs. Vera Sharav Alliance for Human Research Protection, New York http://www.nature.com/news/2005/050214/full/050214-11.html Published online: 17 February 2005; | doi:10.1038/news050214-11 FDA critics slam plan for safety reform Emma Marris Calls grow for…
Pharma Ethics: Merck CEO Resigns – Vioxx deceptive Marketing / AIDS drug experiments Foster Kids Fri, 06 May 2005 Merck CEO Raymond Gilmartin, resigned abruptly after he spent 11 years at the helm. The Washington Post reports the resignation “came on a day when Merck was sharply criticized in a…
Medicare Will cover New Treatments But Patients Will be Required to Enroll in Clinical Trials Fri, 5 Nov 2004 Dr. Mark McClellan, Director of Medicare, estimates that of Medicare’s $320 billion budget, “a third of all medical expenditures are for unnecessary or ill-advised treatments.” Medicare’s chief medical officer, Dr. Sean…
Trial Lawyers Are Taking Aim at the Drug Industry_NYT Sun, 18 May 2003 It appears that trial lawyers will produce the results that government oversight agencies–in particular, the FDA–have failed to do. Namely, to protect the public against an increasing number of unsafe drugs. The pharmaceutical industry whose efforts to…
Grassley Calls for Safety Review /Unsafe Drugs Marketed to Consumers / FDA Lacks Leadership Sun, 19 Dec 2004 “We expect the FDA to not put a drug on the market that’s not safe. And you can’t compromise safety, regardless of how much pressure there is to get more drugs on…
Practice Guidelines: Can We Trustthe Evidence in Evidence-Based Medicine? Sun, 25 Sep 2005 “Research and Clinical Practice Guidelines: Can We Trust the Evidence in Evidence-Based Medicine?” is an article by Dr. John Abramson* (Harvard) and Dr. Barbara Starfeld (Distinguished Professor, Johns Hopkins), published in the Journal of the American Board…
Jeffrey Drazen editor NEJM Turns Activist on Drug Trials Thu, 26 May 2005 Journal editors, one by one are trying to retrieve the integrity of their publications, at last recognizing that the pharamaceutical industry is a corrupting factor in medical research and the information disseminated about medicine. Jeffrey Drazen who…
http://www.nj.com/news/ledger/index.ssf?/base/news-20/1108104141208160.xml Star-Ledger 14 deaths force halt to drug in Canada Hyperactivity remedy called threat to kids Friday, February 11, 2005 BY CAROL ANN CAMPBELL Safety concerns have clouded the future of another blockbuster medication, this one a hyperactivity drug prescribed to 700,000 Americans, most of them children. Health officials in…
’91 Merck Memo Warned of Mercury in Baby Vaccines – LAT Tue, 8 Feb 2005 The Los Angeles Times reports that a 1991 internal Merck memo obtained from a whistleblower by James Moody, a Washington lawyer who works with parent groups on vaccine safety issues, provides the “first hard evidence…
VIOXX WITHDRAWAL: FDA TO JOIN AUDIO CONFERENCE ON NOVEMBER 10 Mon, 8 Nov 2004 To hear from FDA Office of New Drugs Acting Director Sandra Kweder, MD, in an interactive discussion of what the withdrawal of the blockbuster drug means for the agencys drug safety programs, the COX-2 inhibitor class…
