FDA Urges Florida Not to Bar Foster Kids From Psych Drug Trials
How many children in foster care serve as human guinea pigs in commercial drug trials?
How many children in foster care serve as human guinea pigs in commercial drug trials?
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.”
There is no evidence to indicate that children have been the beneficiaries of the Pediatric Exclusivity Provision of FDAMA (enacted in 1998): there is evidence that pharmaceutical companies have increased their profits from the legislation by at least $14 billion.
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.
"He was one of the most prolific investigators in the area of postoperative pain management. His fraud sets back our knowledge in the field tremendously.” Dr. Steve Shafer, the editor in chief of Anesthesia & Analgesia.
"The study started out with 20 subjects…For about a week there were 14 subjects. Then they started dropping…Now, we’re down to 7."
Pfizer’s smoking cessation drug, Chantix (varenicline), may be the most dangerous drug ever to carry the government seal of approval–it poses a danger, not just to those who ingest the drug, but to people in the community in which they live.
The FDA announced that the postmarketing trial of Avandia, known as TIDE, has been placed on "partial clinical hold." No new patients may be enrolled in the trial.
New York Times reporter Gina Kolata, broadcasts medical hype on the front page of the paper much the way Judith Miller broadcast hype fed to her by Ahmed Chalabi and the Iraq war lobby.[1]
"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.”