DesignWrite, a medical writing company based in Research Park, has received a letter from the United States Senate Committee on Finance requesting detailed information on any medical ghostwriting it may have done in connection with a controversial hormone replacement drug.

The letter, dated December 12, came from Senator Charles Grassley (R-Iowa), who is spearheading an investigation into influence of drug companies on the healthcare industry, and more specifically, on the alleged practice of drug companies hiring medical writers to author journal articles, which are then presented as being the unbiased research of medical experts.

DesignWrite, a 15-year-old, 75-person company, is being questioned on its role in the preparation of journal articles supporting a Wyeth Pharmaceutical product, Prempro, an estrogen replacement drug that is suspected of causing breast cancer. Nearly 9,000 women have filed lawsuits against Wyeth over alleged effects of the drug.

One article was published in the American Journal of Obstetrics and Gynecology in 2003, more than a year after a federal study linked Prempro to breast cancer.

According to published reports, including articles in the New York Times, Wyeth and DesignWrite came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors, and indentified publications to run the articles “all without disclosing the companies’ roles to journal editors or readers.”

Documents released by Senator Grassley track journal articles from conception to publication and find Wyeth and its contractors providing substantial input. He points to 10 articles in which manuscripts were completed by the company before they were sent to the named author for review.

Senator Grassley has asked Wyeth to list all scientific reports prepared for it by DesignWrite since January 1, 1995.

In his letter to DesignWrite, addressed to Mitchell Leon, president of the company, Grassley asked for a detailed information on all manuscripts and reports it has prepared for Wyeth going back to that date. Information requests include the names of authors who participated in the preparation of the reports, payment made to the authors, extent of involvement and participation of the authors, total payment from Wyeth for the completed work, names of any third parties hired by DesignWrite to assist in the work, and copies of contracts between Wyeth and DesignWrite.

DesignWrite is also asked to provide details on any litigation in which the company provided information regarding an article, and to turn over the resumes of five writers with whom it has had a relationship.

DesignWrite sprung up after the demise of a similar company, Symedco. Leon was vice president of Symedco, a Research Way company that was a producer of medical symposia, conferences, and literature. In a 1992 lawsuit eight of Symedco’s employees alleged that the company failed to pay them some $89,000 in overtime wages (U.S. 1, August 19, 1992).

At that time U.S. 1 interviewed a former employee who provided a picture of what it was like to work for Leon. “A lot of this come back to Mitch Leon,” she said of the lawsuits. “His management style was intimidation and humiliation. He had employees working 15 hours a day, 7 days a week.” Then, the employee said, he would call from the road and scream at employees, calling them “idiots.”

Symedco responded that the aggrieved employees were professionals, and therefore exempt from overtime rules. Many of the claims were dismissed by a Plainsboro judge on a technicality. But apparently the damage was done. Symedco soon filed for bankruptcy. One year later Leon founded DesignWrite. The company grew quickly, going from 33 employees in 1997 to 100 employees by 2002. In 2005 it was sold to the Wicks Group of Companies, a New York City concern.

DesignWrite has not responded to requests for comment on the Senate’s request for information.

DesignWrite Inc., 175 Wall Street, Princeton 08540; 609-924-1116. Mitchell Leon, president.

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