Useless Studies, Real Harm
The Obama Administration has embarked on an aggressive course of action that will accelerate the pace at which the integrity of American medicine–is sullied beyond repair.
The Obama Administration has embarked on an aggressive course of action that will accelerate the pace at which the integrity of American medicine–is sullied beyond repair.
The primary promoters–inventors, one might say– of diagnosing children with "bipolar" disorder, who for over a decade, aggressively promoted the biopolar diagnosis and use of antipsychotics in children, were disciplined by Harvard University and its affiliated Massachusetts General Hospital.
Public Citzen petitioned FDA Commissioner to immediately removal from market Pfizer’s Alzheimer’s drug, Aricept 23 mg dose, because of serious safety hazards and failure to demonstrate efficacy. The petition also urges FDA to add a label warning on Aricept and generic donepezil (5 mg and 10 mg) stating: "Use of 20 mg per day is counter indicated."
This year alone, because of patent expirations, the drug industry will lose control over more than 10 megamedicines whose combined annual sales have neared $50 billion.
"Shocking as it may seem, U.S. government doctors once thought it was fine to experiment on disabled people and prison inmates." Associated Press, Feb 27, 2011
CORRECTION: An Associated Press article about a federal criminal case accusing Dr. P. Trey Sunderland III of improperly accepting consulting fees from a drug maker, misstated the level of the charge against him. Dr. Sunderland was charged with "non-willful" criminal violation, a misdemeanor which carries a maximum one year prison term and $100,000 fine. It is NOT a felony, which is punishable by more than one year prison term.
From 1991-2000 qui tam law suits accounted for only 9% of settlements with the government. But from 2001-2010, qui tam settlements comprised 67% of the billions in payouts
In 2008, 6,485 trials were conducted off shore with almost no FDA oversight. Seventy-eight percent of all human test subjects were enrolled at foreign sites.
"When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”
Five weeks after publishing a grossly dis-informative front-page report by Gina Kolata about Alzheimer’s research,The New York Times published a lengthy three paragraph correction.
According to a report by the Associated Press, the FDA has approved expanded use of Merck’s toxic antipsychotic drug, Saphris, for treating acute manic-depressive behavior in adults. Antipsychotics (neuroleptics) are a controversial class of drugs: Risperdal (approved in 1993), Zyprexa (1994), Seroquel (1997), Abilify (2002), and Saphris (2009). These drugs’…
The catalyst for Dr. Elliott’s article was the tragic case of Dan Markingson, a 26-year old who committed suicide in May 2004, while enrolled in the CAFE trial, prescribed Seroquel. This case encapsulates the tragic consequences of a broken system which is not designed to detect the hazards for human subjects posed by market-driven research.