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Ghostbusting in Paxil Birth Defect Litigation

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A month before the first Paxil birth defect trial against GlaxoSmithKline was set to begin, the Associated Press ran the headline, "Glaxo Used Ghostwriting Program to Promote Paxil," in reporting on a program called "CASPPER," which allowed doctors to "take credit for medical journal articles mainly written by company consultants."

"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," the Associated Press said on August 19, 2009. "Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective."

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: "Paxil Product Management has budgeted for 50 articles for 2000."

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual cause" of Lyam's heart defects. The family was award $2.5 million.

Ghostwriting 101

The world-renowned neuropsychopharmacologist from the UK, Dr David Healy, testified as an expert witness for the plaintiffs in the Kilker trial.

While testifying, Healy explained the process of ghostwriting to the jury. He said ghostwriting probably began seriously in the 1980s. "It's where an article appears under the name of usually a fairly distinguished person in the field," he testified.

But it involves more than just the true author being concealed, he told the jury. "It's a process where the ghostwriters work for companies who are very good at getting articles into the best journals in the field, like the New England Journal of Medicine, and recruiting some of the best known names in the field to be the apparent authors of the articles."

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"They may come from one of the big named universities like Princeton or whoever, but the actual fact the person who appears to be the author isn't the true author," he said. "If you were to read the article, you often don't get any hints of who the true author of the article actually was."

Ghostwriting impacts doctors in the real world trying to make decisions on whether to prescribe a drug in several ways, Healy told the jury. For instance, he said, if he was doing his own writing, he "would write an article on the drug, warts and all."

"But if the article has been written by a ghostwriter working for one of the pharmaceutical companies," he said, "the chances are the warts are somehow going to vanish."

"The article will talk about the good aspects of the drug and will leave out the risky issues which are probably the most important things for the practicing doctor to know," he explained.

If the ghost author comes from an extremely distinguished university, doctors reading the article will think it has to be right, he said. "The simple fact that the article is going to be apparently written by this big named person and appears in an extremely good journal means that most average doctors will think this has to be true," he told the jury.

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It's not just the case of the doctor who reads the article being deceived, he said. "It's the fact that the credibility of the institution is and the name is being used to sell the drug, as well."

Healy came face-to-face with ghostwriting when one of the drug companies offered to ghostwrite his articles, he said. Since then, he has researched the ghostwriting process to assess how common it is.

The assessment found that "at least half, maybe more, of the articles that appear in major journals under the names of the best known people in the field, are ghostwritten when they have to do with pharmaceutical drugs," he told the jury.

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Evelyn Pringle is an investigative journalist and researcher focused on exposing corruption in government and corporate America.

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