July 27

US Federal Judge Orders Wyeth Documents Unsealed

Wyeth flooded medical journals with some 40 favorable ghostwritten articles penned by prominent physicians who sold their name for cash, in an all-out effort to offset the scientific evidence linking its female hormone replacement drug, Prempro, to breast cancer.

According to a New York Times report, Sen. Charles Grassley obtained these documents as part of a congressional investigation into drug industry influence on doctors.

Public Library of Science (PLoS) and The New York times asked the court to unseal the documents in Dec. 2008.

Little Rock attorney Gerry Schulze, who represented the Times stated: "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."

District Court order at:

Read Public Justice’s brief in support of PLoS Medicine’s motion for access to the documents.

Learn more about Public Justice and its Access to Justice Campaign.

Posted by Vera Hassner Sharav

Associated Press
Judge orders Wyeth papers unsealed
July 25, 2009

LITTLE ROCK, Ark. – 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.

Arkansas Democrat-Gazette
Successful intervention by PLoS Medicine and New York Times in Federal court grants public access to evidence that drug company ‘ghostwrote’ medical articles about hormone therapy drug, Prempro
by Ginny Barbour
July 25, 2009

Today  an Arkansas federal judge granted public access today to evidence that Wyeth Pharmaceuticals “ghostwrote” medical articles regarding its hormone therapy drug Prempro.  Along with the New York Times,  PLoS Medicine, represented by the law firm Public Justice, had sought to intervene in a court case of women bringing an action in relation to Prempro and other hormone therapy drugs, in order to unseal papers that allegedly show that Wyeth failed to disclose its role in preparing medical journal articles promoting Prempro and in recruiting academic authors to put their names on the articles for publication—that is that they practised ghost  writing.

The judge’s decision does not take effect until July 31, 2009 ie  Wyeth has until next Friday to decide whether to appeal his order.

Public Justice Press Release
July 24, 2009
Contact:  Deborah Mathis at (202) 679-2652 or dmathis@publicjustice.net
Evidence of Wyeth Pharmaceuticals’ Ghostwriting Campaign for Prempro Unsealed

An Arkansas federal judge granted public access today to evidence that Wyeth Pharmaceuticals “ghostwrote” medical articles regarding its hormone therapy drug Prempro, which a national study has shown increase a woman’s risk of stroke, heart attack, blood clots, cardiovascular disease, and cancer.

The evidence has been under seal in an ongoing federal lawsuit filed on behalf of victims of Prempro.  Public Justice, a national public interest law firm headquartered in Washington D.C., sought access to the evidence on behalf of PLoS Medicine, a medical journal published by the non-profit Public Library of Science (PLOS).  Along with the New York Times, PLOS had moved to interevene in the case to unseal the ghostwriting documents because the public has powerful interest in knowing the truth about the drug companies’ conduct and the safety of its drugs.

“We are thrilled by the Court’s decision to stop Wyeth’s attempt to hide evidence of its ghostwriting,” said Amy Radon, Public Justice’s lead attorney for PLoS Medicine. “Public health and safety is put at serious risk when a drug company fails to reveal its role in authoring a medical journal article touting its own product.”

The ghostwriting evidence in the Prempro litigation, which is ongoing, was under seal due to a confidentiality order that permitted Wyeth to shield from public inspection any material that Wyeth itself deemed to be “confidential.”

In his July 24 ruling, U.S. District Court Judge Bill Wilson, Jr., held that there was no good cause for secrecy and ordered that the documents be made publicly available as of 5:00 p.m. on Friday, July 31.  The New York Times reported last December that the secret documents include evidence of a “mammoth” ghostwriting campaign involving Prempro.  U.S. Sen. Charles Grassley, R-Iowa, has this material as part of a congressional investigation into drug industry influence on doctors, accordingto the Times story.

“Wyeth did not even attempt to show good cause for keeping these documents secret,” said Morgan “Chip” Welch of Arkansas’ Welch and Kitchens, LLC.  “Judge Wilson’s decision will undoubtedly save lives.

Public Justice is America’s public interest law firm, supported by – and calling on — a nationwide network of  more than 3,000 of the nation’s top lawyers to pursue precedent-setting and socially significant litigation. It has a wide-ranging litigation docket in the areas of consumer rights, worker safety, civil rights and liberties, toxic torts, environmental protection, and access to the courts. Public Justice is the principal project of the Public Justice Foundation, a not-for-profit membership organization headquartered in Washington, DC, with a West Coast office in Oakland, California. The Public Justice web site address is www.publicjustice.net.

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