© Photobucket: Cheap_Trick77
The lawsuit accuses the drugmaker of knowing there were "serious issues" with Zoloft efficacy and that early clinical studies demonstrated its pill was no better than a placebo. But Pfizer allegedly concealed this from regulators, physicians and patients with an elaborate scheme that included ghostwritten articles that were published in medical journals and a deceptive advertising initiative, according to the lawsuit.
"Pfizer engaged and continues to engage in a deliberate, systematic practice of suppressing unfavorable results for its drug and misleading the state, healthcare providers, consumers and policy makers about the actual efficacy of its drug," according to the lawsuit. "The defendant caused thousands of false and deceptive claims to be made to the state by manipulating published efficacy data, paying key opinion leaders to bolster Zoloft's efficacy and deceptively concealing Zoloft's inefficacy" (here is the lawsuit).
Pfizer is currently facing numerous personal injury lawsuits in state and federal courts that allege Zoloft was responsible for birth defects, among other things. However, this appears to be the first case filed by a state attorney general charging that the drugmaker committed fraud that affected a Medicaid program.
A Pfizer (PFE) spokesman sends us this: "Zoloft was first approved by the FDA in 1991 based on the agency's review of the efficacy and safety data from more than 20 clinical studies involving more than 5,000 patients. There is extensive science supporting the safety and efficacy of Zoloft and the medicine carries accurate, science-based and FDA-approved information on its benefits and risks."
In its lawsuit, the state cites an internal Pfizer document purporting to illustrate the drugmaker wanted to mask the alleged inefficacy of the antidepressant and selectively report results. The e-mail states "...but now we need some help in dealing with the most important issue... i.e. the huge placebo response in the continuation phase, which wiped out the significant superiority of Zoloft at six weeks."
The e-mail then lists several ways to address the placebo response, such as "using less stringent criteria for relapse," suggesting that a table "certainly must be deleted" and requests "the list of French investigators identifying the proposed authors," according to the lawsuit.
The lawsuit also charges that Pfizer offered some physicians "luxurious dinners" to talk up the drug and advertised Zoloft as having helped millions of people cope with depression, while omitting information about the alleged inefficacy.
FDA, is not sued?