Healthy Skepticism Library item: 16101

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Judge orders Wyeth papers unsealed
Newsday.com 2009 Jul 25
http://www.nj.com/news/index.ssf/2009/07/morris_county_pharmaceutical_o.html

Full text:

A federal judge has ordered the unsealing of thousands of pages of documents pertaining to the ghostwriting practices of Wyeth Pharmaceuticals, which is being sued over hormone replacement drugs.

U.S. District Judge Bill Wilson ordered the papers unsealed Friday at the request of a medical journal and The New York Times. Plaintiffs attorneys presented the papers earlier at trial to show Wyeth routinely hired medical-writing firms to ghostwrite articles that appeared in seemingly objective medical journals but included only the name of a scientific researcher as the author.

The ruling came in a case that involves about 8,000 lawsuits that have been combined before Wilson. The lawsuits focus on whether Wyeth hormone therapy drugs Prempro and Premarin, used to treat symptoms of menopause, have caused breast cancer in some women.

The New Jersey drugmaker already had turned over the documents, which it says concern about 40 articles in medical journals and other publications, to Sen. Charles Grassley, R-Iowa. Grassley sought them last year without a subpoena as part of a congressional investigation into drug-industry influence on doctors.

On June 11, a biomedical journal, PLoS, published by the Public Library of Science, filed a motion to intervene in the Prempro litigation. PLoS, represented by a public-interest law firm, Public Justice, wanted to set aside the confidential designation that had been placed on the documents before a series of trials began in 2006. The documents were shown to jurors at trial but were otherwise unavailable publicly.

Plaintiffs say ghostwriting is when a drug company conjures up the concept for an article that will counteract criticism of a drug or embellish its benefits, hires a professional writing company to draft a manuscript conveying the company’s message, retains a physician to sign off as the author and finds a publisher to unwittingly publish the work.

Drug companies disseminate their ghostwritten articles to their sales representatives, who present the articles to physicians as independent proof that the companies’ drugs are safe and effective.

The Times wrote about the ghostwriting issue and Grassley’s efforts in December. On June 17, it joined PLOS in its quest to intervene to ask that the documents be unsealed.

“These documents will educate the public and allow them to better understand materials they use every day in making their often life-depending health care decisions,” said Little Rock attorney Gerry Schulze, who represented the Times.

“Why don’t they want to turn loose of them?” plaintiffs attorney Erik Walker asked during the hearing. Then he answered his own question: “Because it makes them look bad.”

Wyeth attorney Stephen Urbanczyk acknowledged the articles are part of a marketing effort. But he said they are also fair, balanced and scientific and that no one has ever shown that they are inaccurate.