Congressional investigators are probing drug maker Wyeth's practices concerning scientific-paper writing and whether its marketing employees help shape manuscripts for medical journals.In separate letters to Wyeth and DesignWrite Inc., a medical-writing and -education company hired by Wyeth, Sen. Charles Grassley asked the companies to disclose payments he said were made to prepare certain articles and for information about how doctors were recruited to place their names on those articles. The articles, published in peer-reviewed medical journals, involved Prempro and other female-hormone-replacement therapies made by Wyeth. What Wyeth might fear on this issue is Qui Tam or a Whistleblower Lawyer.
The inquiries come as part of the Senate Finance Committee's examination of "medical ghostwriting," part of a broader probe into the influence of drug companies on the health-care industry. The committee collected internal Wyeth documents obtained during civil legal actions involving Prempro.
In his letters, Sen. Grassley, the committee's senior Republican, described ghostwritten manuscripts as those written or heavily developed by others -- including marketing or medical-education companies -- beyond the scientists named as primary authors on the manuscripts.
"The ghostwriting issue is important because it concerns the integrity of the scientific views expressed in medical journals," said Sen. Grassley in a statement. "Shedding light on the relationships between drug companies and authors helps establish accountability and safeguard the credibility of influential medical journals."
Wyeth, based in Madison, N.J., said it approaches scientists with ideas for articles and offers them the assistance of a professional medical writer. But the scientists retain complete editorial control, it said.
In a separate statement, Wyeth added that "this inquiry appears to represent an effort by plaintiffs' product liability attorneys to recycle arguments that have been rejected by judges and juries alike," It said it would comment further later. DesignWrite, of Princeton, N.J., couldn't be reached to comment.
Sen. Grassley is looking into possible ghostwriting practices of other major pharmaceutical companies, as well. Medical journals also have been scrutinized for several years for their role in maintaining scientific integrity for the papers they publish.
In the letter to Wyeth Chairman and Chief Executive Bernard J. Poussot, Sen. Grassley asks the company for information involving payment to study authors and to DesignWrite. Sen. Grassley also requests information concerning each author's involvement in the drafting of the manuscripts for all papers involving DesignWrite since 1995.
He also asks Wyeth to provide the same information about all other third-party-written manuscripts involving human drugs since 2000. Further, the Iowa Republican asks about how Wyeth's marketing employees are involved in the manuscript-drafting process.
