FDA's Dr. Steven Galson, like his predecessor who now occupies a position in the Commissioner's office, demonstrates disconnectedness from reality, much like Nero who fiddled while Rome burned…
"UK regulators did not receive findings that might have warned them of damage TGN1412 could do."
The battle lines were drawn between those who recognize the corrosive effect that the pharmaceutical industry is having on the safety and integrity of medicine and medical research, and the powerful stakeholders–the pharmaceutical-academic industrial complex.
FDA issued an advisory stating that the concealed study results demonstrate "that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes."
“The Drug Trial That Went Wrong” is an investigative report by Chanel 4 (UK) about the circumstances surrounding the near fatal drug trial testing the safety of TGN1412, a monoclonal antibody drug, conducted in March 2006 at London’s Northwick Park Hospital. [1] http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/5377226.stm It airs momorrow.
A report by the Institute of Medicine is sharply critical of FDA’s drug safety monitoring system: "The report’s conclusions are striking and often damning – particularly when discussing the agency’s Center for Drug Evaluation and Research, known as C.D.E.R."
"This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave."
The Los Angeles Times has uncovered yet additional evidence of financial misconduct and corrupt practices at the National Institutes of Health (NIH).
AIR: America’s Investigative Reports, is a new Public Broadcasting System (PBS) series whose first report, "A Bitter Pill," airs Friday, Sept. 8.
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?
A Boston Globe report (below) focuses on three recent reports in the Journal of the American Medical Association (JAMA) by Harvard researchers who violated the journal’s disclosure policy by failing to disclose their financial ties to companies that had the most to gain from their purported findings.
Tune in tonight–Monday– to Court TV: the subject is medical experimentation on prisoners–What does this say about our moral climate?
