Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…
Big Pharma’s Dirty Little Secret Mon, 27 Dec 2004 Dr. Peter Rost, Vice-President marketing, Pfizer, has taken a principled stand by speaking out against his industry’s “drity little secrets:” “Our dirty little secret is that the drug industry already sells its products, right here in the U.S., at the same…
“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…
Congressional Investigations Senate Finance Committee Investigates FDA Aug 4: Sen. Grassley letter (416 K pdf) to 8 drug companies requests list of all antidepressant tests on children (1/1/1990–7/23/2004) Aug 3: Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data Jul 15: Senate Letter to FDA re: disclosure of risks…
FDA Commissioner Nominee told Senate He’s Open to Independent Safety Unit / Biogen issues Avonex Warning Fri, 18 Mar 2005 It would be impossible to gain insight into Lester Crawford’s confirmation hearings by the Senate Health, Education, Labor and Pensions committee if one read only one news report. The Los…
FDA Is Flexing Less Muscle where Safety is the Issue – Wash Post Thu, 18 Nov 2004 The Washington Post examines FDA’s record of surveillance and the evidence is clear: since 1992 when Congress required drug companies to pay users fees to the FDA, the agency’s focus changed from safety…
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…
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…
Recycled drugs: failed antidepressants– Stratera marketed for ADHD; Cymbalta for incontinence Mon, 26 Apr 2004 A front page article in The Wall Street Journal (excerpt below) provides a roadmap of failed Eli Lilly drugs which the company repackaged for a different condition than the one for which the drugs had…
FDA’s Lethal Weakness Requires More than Committees Sun, 7 Nov 2004 Bloomberg News reports that New York State Attorney General Eliot Spitzer requested information from Pfizer about the promotion of some of its drugs for unapproved uses – the recalled diabetes drug, Rezulin and the antidepressant, Zoloft were named. In…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 10a, 2002 U.S. Bio-Tech Start-ups Conducting CheapPreliminary Studies in China FYI Harvard University is not the only one exploiting China’spoor population for medical experiments. Violations of…
Pharma Efforts to Bar Placebo Responders from Trials – WSJ Fri, 25 Jun 2004 A clinical trial report in The Lancet debunks the value of Aricept, a popular drug prescribed for Alzheimer’s patients. The findings of a three-year placebo controlled trial show that: “Although the patients taking the drug did…
