Saturday, December 13, 2008

Grassley continues inquiry into medical ghost-writing

Duff Wilson in the 12 Dec 08 issue of the New York Times reports on an inquiry of Senator Charles Grassley to Wyeth about possible ghost written articles appearing in medical journals:

letters, sent electronically Friday [Dec. 12] by Senator Charles E. Grassley, ask Wyeth and DesignWrite, a medical writing company [based in Princeton, NJ], to disclose payments related to the preparation of journal articles and the activities of doctors who were recruited to put their names on them for publication.

The letters explicity raise the issue of manipulation of the scientific literature:

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth’s chairman and chief executive, Bernard J. Poussot.

[One wonders if such ghost-written science articles have ever been used to support a patent application? That would be inequitable conduct.]

Articles surrounding the drug Prempro are at issue:

One article was published as an “Editors’ Choice” feature in May 2003 in The American Journal of Obstetrics and Gynecology, more than a year after a big federal study called the Women’s Health Initiative linked Wyeth’s Prempro, a combination of estrogen and progestin, to breast cancer. The May 2003 article said there was “no definitive evidence” that progestin caused breast cancer and added that hormone users had a better chance of surviving cancer.

The failure to disclose conflicts of interest is an issue:

The documents show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.

There was reference to an article in Trial by James F. Szaller.

A New York University professor was also implicated:

In another case, documents show, Dr. Lila E. Nachtigall, a New York University professor and director of its Women’s Wellness Center, was recruited by Wyeth as author of a 1999 journal article extolling hormone treatment after the manuscript had already been drafted.

However, Nactigall invoked a defense worthy of Alan Dershowitz of Harvard Law:

“If they came up with the idea or gave me an outline or something, I don’t remember that at all.” Dr. Nachtigall added: “It kind of makes me laugh that with what goes on in the Senate, the senator’s worried that something’s ghostwritten. I mean, give me a break.”

[In the context of defending Laurence Tribe from charges of plagiarism (and possibly ghostwriting), Dershowitz spoke of a culture of plagiarism in legal writing. ]

The Wall Street Journal had the text:

"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."

***See also

JAMA duped by ghostwritten paper about VIOXX

On conflicts and giving a lecture at the Ritz Carlton Golf Resort in Naples, Fla.

***CNNMoney covered the Times reporting on Grassley

***The Newark Star Ledger briefly covered the Grassley/Wyeth interchange on Dec. 13 in a piece which separately noted that the owner of the Bridgewater Commons Mall, General Growth Properties , is in financial difficulty.

***DesignWrite's website includes the text:

DesignWrite was founded in November 1993 in Princeton,
New Jersey by principals Mitchell A. Leon, President, and
Linda B. Sullivan, Executive Vice President. A privately held
corporation, DesignWrite has grown from 5 members in 1993
to over 100 employees currently.


Strategic Publication Planning

Primary Papers
Derivative Papers
Case Reports
Continuing Education Programs
Journal Supplements
Symposium Reports
Independent Proceedings
In-house Publications

**One notes a 1992 paper, titled Five versus Three Days of Ofloxacin Therapy for Traveler's
Diarrhea: a Placebo-Controlled Study in ANTIMICROBIAL AGENTS CHEMOTHERAPY, Jan. 1992, 87-91 , which includes
the text:

Mitchell A. Leon and Hans Tester made valuable contributions to the development of the manuscript


Elsevier officials on Dec. 19 announced plans to investigate recent allegations by Sen. Chuck Grassley (R-Iowa) that one of the medical journals published by the company included an article improperly ghostwritten by Wyeth to promote the hormone replacement therapy Prempro, the New York Times reports. [from]

In a statement, Glen Campbell, senior vice president for the U.S. Health Sciences Journals division of Elsevier, said, "The charges made by Senator Grassley's office with regard to the article published in 2003 by Dr. Eden are a significant concern" to the journal and Elsevier. He added, "As with any charge of misconduct or inappropriate publishing acts," the journal has "launched its own investigation into the claims of ghostwriting and undisclosed financial support."

Wyeth officials in a statement said that the company did not pay the academic authors of the articles [what about the ghostwriters??] and that the authors had "substantive editorial control" of the articles.[not exactly denying the use of ghostwriters]


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