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Glaxo used ghostwriting to promote Paxil

Offered to help doctors publish articles on drug

By Matthew Perrone
Associated Press / August 20, 2009

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WASHINGTON - Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by the Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from “developing a topic’’ to “submitting the manuscript for publication.’’

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

A spokeswoman for London-based Glaxo said the published articles made note of any assistance to the main authors.

“The program was not heavily used and was discontinued a number of years ago,’’ said Mary Anne Rhyne.

According to the memo, which dates from April 2000, the CASPPER program was designed to “strengthen the product positioning and overcome competitive issues.’’

At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly’s Prozac and Pfizer’s Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.

Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author, and then find a publisher to unwittingly publish the work.

According to a ghostwriting specialist, Dr. Leemon McHenry, Glaxo’s program was unusually intertwined with its internal sales and marketing department.

“We know that GSK has engaged in ghostwriting for many years,’’ said McHenry, who works as a research consultant for Baum Hedlund. “But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients.’’

McHenry acknowledged that ghostwriting is legal in principle, but said it could contribute to illegal activity.

“If these ghostwritten publications are contributing to the harm of patients because they’re making false claims, then that’s illegal,’’ McHenry said.

Articles from the company’s program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.

Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.

Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo’s memo seems to acknowledge: “Physicians will be eager to participate in CASPPER regardless of their professional stature,’’ the brief notes.

The use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Senator Charles Grassley, Republican of Iowa and longtime critic of the industry’s influence over physicians. Grassley and Senator Herb Kohl, Democrat of Wisconsin, are pushing a bill that would require companies to disclose all payments to physicians over $100.

Last week Grassley sent a letter to the National Institutes of Health complaining that five university professors who received federal grants helped assemble ghostwritten articles for drugmaker Wyeth. Grassley has been pressuring the NIH to crack down on ghostwriting among researchers getting federal money.

The researchers were named in documents connected with a lawsuit in Arkansas court, alleging a Wyeth estrogen drug caused breast cancer in 8,000 women.

The documents show that Wyeth hired medical-writing firms to ghostwrite articles about the drug Premarin that were then published in journals under the bylines of the researchers.