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Why Are Pfizer's Ghostwritten Hormone Therapy Articles Not Retracted?

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Plagiarism, "unethical research" and unreliable findings from "fabricated data" are grounds for retraction of medical journal articles according to the Committee on Publication Ethics (COPE).

But one look at the US National Library of Medicine database reveals that bogus, ghostwritten papers Wyeth (now Pfizer) planted in medical journals in a scandal which reached the US Congress last year, still stand, unretracted.

"Is there an association between hormone replacement therapy and breast cancer?" asks an unretracted article in the Journal of Women's Health, 1998 Dec;7(10):1231-46-a question a fourth grader could answer in the affirmative.

The "author" William T. Creasman, MD, neither wrote or initiated the article but was suggested by Jeff Solomon of Wyeth, according to documents posted on the University of California, San Francisco's Drug Industry Document Archive (Dida) http://dida.library.ucsf.edu.

ghost

The article which finds-surprise-no "definitive evidence" of a cancer link was written by an operative of DesignWrite, Wyeth's marketing firm, named Karen Mittleman.

How about Wyeth's "The role of hormone replacement therapy in the prevention of postmenopausal heart disease," in the Archives of Internal Medicine, 2000 Aug;14-28;160(15):2263-72-a role medical professionals agree should be none at all since hormone therapy increases cardio risks?

Lori Mosca, MD, PhD agreed to be "author" 11 months after the outline was completed by freelance writer E. Wesselcouch according to posted documents.

How about the unretracted "The role of hormone replacement therapy in the prevention of Alzheimer disease," in the Archives of Internal Medicine, 2002 Sep 23;162(17):1934-42? Is the fact that hormone therapy doubles dementia risk and a freelancer named Stella Elkabes wrote the outline for $2,300 a mere detail?

"Attached is the outline for your review in the hope you will agree to author," wrote Alice Conti, another Wyeth operative, to the published "author" Howard M. Fillit, MD.

Then there's the unretracted "Mild cognitive impairment: potential pharmacological treatment options," in the Journal of the American Geriatrics Society, 2000 Apr;48(4):431-41, by Barbara Sherwin, Ph.D, which also misrepresents dementia risk. Minutes from a Wyeth meeting three months after the article was written by freelance writer F. Karo ask, "Has initial contact been made with Dr. Barbara Sherwin for Memory paper?"

It's no secret journal editors prefer taking an article offline or behind an access barrier to jeopardizing ad sales, article reprint sales and author relations by admitting error. Nor do academic institutions want to admit they harbor pharma compliant doctors like New York University whose Lila Nachtigall, MD collaborated with Wyeth on many ghostwritten papers according to Dida documents.

Eight months after Sen. Charles E. Grassley of Iowa revealed the scientific con, NYU vice president for public affairs Deborah Bohren told the New York Times the university had not investigated because, "we have not received a complaint." Doesn't a probe from the chairman of the Senate Finance Committee qualify as a complaint?

So, even though hormone therapy increases the risk of breast cancer by 26 percent, Dr. Creasman's article, which finds "data fail to provide definitive evidence that the use of postmenopausal HRT is associated with an increased incidence of breast cancer," is part of the literature on which physicians train and practice is based.

Even though hormone therapy increases the risk of heart attack by 29 percent, Dr. Mosca's "cardioprotective" piece stands.

And even though hormone therapy doubles the risk of dementia and actually "decreases brain volumes," according to the Women's Health Initiative Memory Study, Dr. Fillit's Alzheimer paper stands-as does Dr. Sherwin's cognitive impairment paper which has been cited 50 times.

Wyeth and DesignWrite's ghostwriting scheme was not hidden from doctors.

"We are working on a review paper on diabetes and HRT," writes Mittleman to William Cefalu, MD in one memo. Would you "be interested in working with us as the author of this paper?"

Nor was it hidden from journal editors who eagerly correspond with DesignWrite as it "repped" doctor authors, archived documents show.

Hormone therapy represents one of the largest swaths of preventable injuries to healthy citizens in recent history with thousands of women developing cancer and other deadly side effects. Yet Wyeth/Pizer maintains it doesn't know how the idea that hormone therapy could prevent heart disease and dementia and provide other "benefits" ever got started.

One look at Dida archives shows how the "idea" got started. And the scores of unretracted papers in the medical literature show how the ideas persist.

Martha Rosenberg is a columnist and cartoonist, who writes about public health

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