Breggin had repeatedly attempted to obtain the FDA study through FOIA requests. The FDA finally wrote and said the documents could not be found.
The rise in Prozac reports occurred before any controversy arose concerning Prozac and violence, and the studies include graphs showing a 40-fold relative increase in reports of suicide attempts, overdose and psychotic depression with Prozac compared to trazodone.
Other documents reviewed by Breggin, included an in-house Lilly memoranda by Claude Bouchy written in November 1990, showing that the firm consciously hid Prozac-induced suicidal acts under misleading categories, such as "no drug effect," and remained undisclosed to the FDA.
According to Breggin, Lilly had completed all of the above studies by the time of the 1991 FDA hearing to evaluate the risk of antidepressant-induced suicidality.
In fact, the company continued to hide the data during the 2004 FDA hearings on suicides related to SSRIs. At the hearings, Tom Laughren of the FDA said that he knew of no data linking SSRIs to suicide or hostility.
Breggin openly contradicted Laughren and told him that suicide data did exist in regard toLilly's Prozac, but the FDA continued to act unaware of the existence of any such documents in 2004 and did not ask Breggin any details about the data.
In addition, Breggin reports that Lilly has secretly settled every lawsuit, and until now has been successful in keeping the documents sealed.
On top of the serious risks of placing kids on SSRIs, study after study has shown that they do not work. Irving Kirsch and his associates at the University of Connecticut used a FOIA request to obtain the studies submitted to the FDA for the purpose of gaining approval of SSRIs, and found that the difference between the response to a placebo verses an SSRI was statistically insignificant.
Their findings were published in Prevention and Treatment, where they explained that the miniscule difference between a placebo and medication is commonly referred to by researchers, FDA reviewers, and critics, as the "dirty little secret."
According to Robert Whitaker, author of Mad In America, a "question that has to be asked is why it has taken 15 years to find out about this data," he told Insight News. "Why are we learning about these increased suicides in clinical trials 15 years after the drugs were approved?"
The way things are going, that question might be answered at some point. The hidden studies are drawing the attention of all kinds of regulatory officials. On September 27, 2004, the Boston Globe reported that evidence showing that drug manufacturers and the FDA concealed negative clinical trial data and deceived physicians, consumers, and shareholders about failure to demonstrate the safety and effectiveness of SSRI antidepressant drugs has caught the interest of the Securities and Exchange Commission.
The FDA is as secretive as their partners in crime. "The FDA is as obstructionist as the drug companies, if not more so," says CBS reporter Sharly Attkisson, according to Judy Lieberman, in the July-August 2005, Columbia Journalism Review. "That may be the biggest scandal behind these drug stories," Attkisson said.
On another front, last summer, New York Attorney General, Eliot Spitzer, charged GlaxoSmithKline, with "repeated and persistent fraud," for failing to disclose clinical trials about Paxil, and specifically that it suppressed trials showing Paxil ineffective in treating depression in children. The lawsuit said that in 2002, over 2 million prescriptions for Paxil were written for children in the US.
According to the results of the report, Pediatric and Adolescent Antidepressant Drug Use in the US, presented at a February 18, 2004 FDA hearing by Dr. Gianna Rigoni from the Office of Drug Safety of the FDA, in 2002, Zoloft was the most commonly prescribed product, accounting for about 31% of dispensed antidepressants, followed by Paxil and then Prozac. The adolescent population accounted for approximately "8.1 million prescriptions dispensed" in 2002, Rigoni told the panel.
Next Page 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8
(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).
