Three Questionable FDA policies: drug factory inspection rules/ clinical trials/ Paxil ads Thu, 22 Aug 2002 Three news items highlight questionable FDA policies that are in conflict with consumer health interests. 1) Poor quality control standards in American drug and vaccine manufacturing plants is a disgrace. The Associated Press reports…
Linguistic Tinkering with Regulatory Terminology Increases Risk of Harm for Children: "minimal risk" "minor increment of minimal risk" and "disorder or condition" January 28, 2001 A cornerstone of the Declaration of Helsinki (adopted by the World Medical Association in 1964, and reaffirmed on Oct. 2000) is the distinction between research…
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…
10 of 32 FDA Vioxx Panelists Had Industry Ties_NYT / Cozy NIH Review “Clears” NIH Industry Ties_WashPost Fri, 25 Feb 2005 The latest example of the corrupting influence of the pharmaceutical industry on health care policy is the composition of FDA’s advisory panel that last week endorsed the marketing of…
Janssen Pharma Admits Hiding Risperdal Drug Risks / TMAP & Illinois Mental Health Screening Plan Sat, 24 Jul 2004 The Miami Herald reports (below) that in a letter to doctors, Janssen Pharmacia, manufacturer of the highly promoted drug, Risperdal (risperidone), admitted “misleading doctors and other healthcare providers about the safety…
FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle Mon, 29 Nov 2004 The Food and Drug Administration is the epicenter of a collision between medical officers in the drug safety office and senior officials in managerial positions whose focus is on facilitating new drug approvals. Officials at the…
Integrity of Scientific Findings Marred Tue, 2 Dec 2003 Two cases shed light on a cultural malaise and the price we pay when scientists fail to adhere to scrupulous scientific methods: Dr. Thomas Butler, chief of infectious diseases division of Texas Tech University, ran afoul of the law; Dr. George…
Anatomy of an Epidemic: Psychiatric Drugs and the Astonishing Rise of Mental Illness in America by Robert Whitaker, Ethical Human Psychology and Psychiatry, Volume 7, Number I , Spring 2005 Mon, 29 Aug 2005 Some uncritical promoters of psychiatry and its current biological treatment paradigm have declared that the introduction…
Integrity of Medical Regulators Wed, 8 Jun 2005 The UK MHRA (equivalent of US FDA) has been caught in flat out public deception. The MHRA–which is entirely funded by the pharmaceutical industry–had claimed that two thirds of professional organizations it consulted favored selling a heart medication (Zocor Heart-Pro) without a…
A Special Article By Curt D. Furberg, MD, PhD; Arthur A. Levin, MPH; Peter A. Gross, MD; Robyn S. Shapiro, JD; Brian L. Strom, MD, MPH
Two actions by the FDA last week demonstrate where the agency’s priority lies—and that priority is NOT to protect public safety, NOT to protect children’s safety. FDA’s priority—as demonstrated by its actions—is approval of new drugs or approval for expanded even dubious uses of patented drugs.
“a study published yesterday overturns conventional wisdom about antipsychotic drugs, which cost the United States $10 billion a year.”
