Complaint Charges Paxil Article Was Ghostwritten

GlaxoSmithKline (GSK) is, again, accused of employing ghostwriters to pen articles about its antidepressant drug, <"">Paxil.

In 2009, we wrote that Paxil medical journal articles written by GSK consultants were prepared using a sophisticated ghostwriting program that allowed doctors to take credit for the work. The ironic name for the ghostwriting program was CASPPER.

In this recent case, a University of Pennsylvania professor, Jay Amsterdam, is accusing 5 psychiatrists—one a Harvard Medical School professor—of allowing their names to be used on journal articles whose content was controlled by SmithKline Beecham, a part of drug giant GSK, said Fierce Pharma.

Ghostwriting involves the act of a drug company producing a journal article aimed at either counteracting criticism of a drug or embellishing its benefits. Usually, a drug maker hires a professional writing company to draft the article, and recruits a physician to sign off as the author. Once the article has been published, drug sales reps often present copies of the piece to physicians as evidence that the drug covered in the article is safe and effective. Critics of the pharmaceutical industry claim ghostwriting is a common practice.

The new allegations, submitted in the form of an official complaint, have to do with an article that suggests Paxil might be an effective treatment for bipolar depression, Fierce Pharma explained. According to Professor Amsterdam, the 5 physicians gave Scientific Therapeutics, a medical writing firm, permission to write journal articles using their names. The complaint also indicates that SmithKline did not permit the physicians to review the article before it was published in 2001, said Fierce Pharma.

Paxil (generic: Paroxetine) is in a drug class called selective <"">serotonin reuptake inhibitors (SSRIs), which appears to relieve symptoms of depression by blocking serotonin reabsorption by certain nerve cells in the brain, leaving more serotonin available in the brain. Increased serotonin enhances neurotransmission—the sending of nerve impulses—and improves mood. SSRIs are called selective because they seem to affect only serotonin, not other neurotransmitters.

Paxil was brought to market by GSK in 1992 and was approved by the U.S. Food and Drug Administration (FDA) to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD).

In its response to the accusations, GSK said its staff were involved in the writing of the article; that it financially supported the research; and that, typically, primary authors have final article approval and “substantive assistance” received from employees is disclosed, according to the Harvard Crimson. “This article was written more than 10 years ago and we do not have details about the development of the manuscript,” the company said, wrote Fierce Pharma.

Meanwhile, documents from the CASPPER program uncovered by attorneys representing plaintiffs in Paxil lawsuits, include a company memo from April 2000 which stated the CASPPER program was designed to “strengthen the product positioning and overcome competitive issues.” The memo instructs GSK salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing Paxil, the Associated Press previously reported. according to the memo, CASPPER could help physicians with everything from “developing a topic,” to “submitting the manuscript for publication.”

Following this report, the Wall Street Journal reported that drug industry group PhRMA banned medical ghostwriting as part of new, voluntary clinical trial guidelines approved by PhRMA’s board, which includes officials from most of the larger drug companies.

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