Bill Moyers: the Real Show…Congressional hearing was abruptly cancelled Tue, 27 Jul 2004 Congressman Greenwoods’ retirement statement indicates that he had negotiated his contract with Biotechnology Industry Org–a company that represents the very industry he was in the middle of investigating–on Tuesday. http://www.house.gov/greenwood/press_releases/2004/pr040722.html Tuesday was the precise day that Greenwood…
“The scariest thing is that nobody knows” risks of depression drugs for children Mon, 10 May 2004 Forest Laboratories, manufacturer of the antidepressant, Celexa / Lexapro, is the latest manufacturer to issue warnings (April 2004) about the possibility that “patients with major depressive disorder, both adult and pediatric, may experience…
Update: 19 year old volunteer suicided in Eili Lilly laboratory Wed, 11 Feb 2004 Traci Johnson, a native of Bensalem, Pa., committed suicide while a subject of an Eli Lilly drug experiment. She was one of about 25 “healthy volunteers” who had been physically and psychologically screened before the test…
Hoffman LaRoche Rebuffed Call to Monitor Accutane Users – USA Today Tue, 7 Dec 2004 An investigative cover story in USA Today – Drugmaker Rebuffed Call to Monitor Users–affirms the indispensable role of litigation in bringing the facts about adverse drug effects to public knowledge. Lawsuits against Hoffman-La Roche, manufacturer…
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…
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…
“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…
Critics of NIH Studies Prompt Senate Hearing – WashPost Mon, 19 Jan 2004 Accountability is a controversial concept for officials at the National Institutes of Health (NIH). Dr. Elias Zirhouni, director of NIH, is scrambling to explain recent revelations of impropriety: First, the agency approved taxpayer money for highly questionable…
Smallpox Vaccine Reactions Jolt Experts – WashPost Thu, 5 Dec 2002 The Washington Post reports that even experts conducting clinical trials of the smallpox vaccine found the side effects “startling”: “If Bush moves forward with vaccination, Dr. Kathy Edwards the Vanderbilt University physician overseeing the study, warns doctors to expect…
NIH sponsored hypertension trial incites controversy: COI Thu, 21 Nov 2002 Controversy has erupted around the research disclosure process of a government sponsored, clinical trial that gave drug companies the manuscript of the report 30 days prior to its submission for publication in the Journal of the American Medical Association….
October 29, 2001 FYI Widely disparate perspectives are presented in an article in the Maryland Daily Record re: The Court of Appeals of Maryland decision (Gimes v Kennedy Krieger Institute, Aug 16, 2001). That 6-to-1 landmark decision severely criticized the practice of exposing healthy children to risks of harm in…
Director of OHRP Dr. Greg Koski resigns Date: Wed, 16 Oct 2002 Dr. Greg Koski has tendered his resignation as director of the federal Office of Human Research Protections. We agree, in principle, with Dr. Koski’s assessment: “to preserve public trust in research, the scientific community must go beyond a…
