The Food and Drug Administration yesterday issued new guidelines that make it easier for scientists working in universities and small companies to test promising therapies in humans without matching the hefty spending of large drug companies.
Authors of the American College of Neuropsychopharmacology Task Force on SSRIs and Suicidal Behavior in Youth: their known ties to the pharmaceutical industry
A critical editorial by Dr. Robert M Kacmarek, Head of Respiratory Care Services at Massachusetts General Hospital and professor at Harvard University—the coordinating center for the ARDS Network, calls into question the validity of the ARDS Network recommendation of treating all patients with ALI-ARDS with a fixed, low air ventilation setting (6 mL/ kg).
”SO WHY,” he asks, “DID American doctors prescribe $7 billion worth of Vioxx after Merck and the Food and Drug Administration knew all this?”
Even Dr. Robet Temple, FDA Medical Policy Director of the Center for Drug Evaluation & Research dismisses the claimed finidings of a flawed, but highly trumpeted recent SSRI study published in the American Journal of Psychiatry. The study was sponsored by the National Institute of Mental Health.
“First they ignore you, then they laugh at you, then they fight you, then you win.” – Mahatma Gandhi
"When you’re talking deaths in clinical trials, mistakes are not an option," said Dr. Arthur Caplan, a medical ethicist at the University of Pennsylvania. "It’s just an area where we have to have absolute, foolproof reporting in place."
"With conflicts of interest increasingly casting doubt on the credibility of medical research, a leading surgery journal is cracking down on authors who fail to disclose links to industry, threatening to temporarily blacklist them."
2005 was a year in which some of Big Pharma’s clandestine relationships with an army of bought-and- paid- for minions in academia,
government, congress, the media, and front organizations were uncovered–in courtrooms, investigative books, reports and films.
In its continuing coverage of corrupt clinical drug trial practices, Bloomberg News reports that all three founders of SFBC International, one of the largest clinical trial business operations that had failed to even screen human subjects for turberculosis, and threatened others with deportation if they refused to become guinea pigs, quit after the Senate Finance committee began investigating drug trial safety issues:
" A causal role for antidepressants in inducing suicidality has been established in pediatric patients."
A front page report in The Wall Street Journal underscores the inherent flaw in the "peer review" vetting system used by science journals.
