Deadly Medicine: Foreign Clinical Trials_Vanity Fair
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.
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 prescribed drugs transformed Kyle Warren from a rambunctious healthy child into a drooling, sedated, obese, “shell.”
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.
"any slipshod work involving volunteers in clinical trials sends a shudder through the field," said Dr. Gary Small, a professor of psychiatry and biobehavioral sciences at UCLA
“There could be a patient safety issue, for one, and there could be a scientific validity issue. If you’re exposing people to radiation and getting garbage data, then that becomes an ethical problem.”
"The resulting frenzy of psychiatric diagnoses has damaged the credibility of everyone in the field."
“The way Dr. Punjwani treated Emilio Villamar and the manner in which these drugs were prescribed is a picture of everything that’s wrong with this industry and the relationship between doctors and pharmaceutical companies.”
AHRP PROPOSAL:
Any FDA-approved drug, whose manufacturer has been found by a court of law or the Department of Justice–to have illegally marketed the drug by concealing risks or incidence of adverse effects, or making unsupported claims of clinical benefit–should be denied coverage by taxpayer funded insurance programs–including Medicaid, Medicare, VeteranstAffairs.