State of Louisiana sues Pfizer, claims Zoloft ineffective

The State of Louisiana is suing Pfizer, the manufacturer of Zoloft, for fraud claiming damages caused by the drug company’s "fraudulent and wanton marketing, selling and labeling." The suit claims Zoloft is no more effective than a placebo in treating depression. In asserting this claim, Louisiana contends that it has internal documents showing Pfizer used a ghostwriting campaign to boast efficacy and suppress conflicting studies.

Zoloft is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It is speculated that low serotonin levels are linked to depression and that SSRIs extend the length of time that serotonin stays in the body. In its lawsuit, Louisiana claims that no actual evidence has been found to prove this theory. "These early trials showed that ‘placebo still seems to be the most effective group’ and that ‘there is still no striking evidence of beneficial drug effect with placebo often being the superior treatment,’" the lawsuit alleges. The state further asserts that Pfizer decided to market Zoloft by "manufacturing ‘research’ and articles that enhance Zoloft’s safety and credibility."

"Pfizer’s ghostwriting operation and its selective publication of data, prevented healthcare providers, consumers, and ultimately the State of Louisiana from obtaining accurate information regarding the efficacy of Zoloft. Pfizer’s scheme directly influenced the prescribing practices of healthcare providers through its misleading and inaccurate information bolstering Zoloft’s efficacy.” Attorney General James "Buddy" Caldwell explains in the petition, "Ghostwriting is a process where someone with a vested interest in an article, like Pfizer, that does not want their association with the article to be known, provides a written draft to an author who then publishes the article under that author’s name. The published article contains no express or implied association with the interested person – Pfizer’s involvement in drafting the article is unknown to the public. Not surprisingly, ghostwritten articles tout the benefits and efficacy of the drug in question."

To support its case, Louisiana claims that internal documents exist that “Demonstrate its ghostwriting and selective publication scheme in full effect.” The lawsuit further states, "First, the document clearly reveals the intent to manipulate inefficacy results in a published manuscript:
‘…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 state claims that the ghostwritten articles lead to FDA approval, "Publication of clinical findings is the ultimate basis for treatment decisions; thus Pfizer’s misleading publications regarding Zoloft efficacy are a key component of its fraudulent scheme."

The lawsuit was filed in East Baton Rouge Parish on last Tuesday. It seeks a court order barring Pfizer from making misleading claims about Zoloft’s efficacy, restitution for money paid by the state for Zoloft under the Medicaid program and civil penalties.

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