The FDA and Drug Safety: A Proposal for Sweeping Changes
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
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
An editorial in today's New York Times is a follow-up to its riveting report by Ian Urbina on the recommendation by an Institute of Medicine panel to
lift 1978 federal restrictions on medical experiments on prisoners. http://www.nytimes.com/2006/08/13/us/13inmates.html?
The Washington Post reveals that a shocking secret investigative report by a Nigerian government panel of medical experts concluded that Pfizer Pharmaceuticals conducted an unethical drug experiment in Nigeria in 1996.
The answer given by Dr. Joseph Britto, a pediatric intensive care physician, hits the nail on the head: "Unlike pilots, doctors don’t go down with their planes."
Three reports illustrate the wide and deepening disconnect between medicine under the influence of pharmaceutical industry marketing goals and scientific evidence that contradicts current practice and public health policies:
Newly published results (phase II) from the CATIE schizophrenia treatment efficacy study sponsored by the National Institute of Mental Health comparing the most commonly used second generation drug treatments for schizophrenia and depression, is highly disturbing.
In a blistering letter addressed to the Secretary of Health and Human Services, Senator Grassley calls upon Michael Leavitt to give “immediate attention” to the serious issues raised by a Northfield Laboratory, non-consensual artificial blood experiment.
The Wall Street Journal reports: “The FDA is allowing Northfield [Laboratories, Inc] to test its blood substitute without the consent of the trauma patients, who often are unconscious.”
"The subpoena shows that the government is investigating Guidant for possible violations of health care statutes
"The internal Medtronic documents filed as part of the suit offer an unusually detailed glimpse of the intense campaign that device makers wage to win doctors’ loyalty."
In what appears to be a re-run of the Katrina rescue disaster–The New York Times front page report provides yet another example of mindless and heartless shot gun public polices that are being tested on a vulnerable population of citizens:
Two items in today’s New York Times illustrate the contrast between what the Administration claims it’s legislative / regulatory proposals will do for health care, and what they actually do after they’ve taken effect.