An academic analysis of 1,500 unsealed documents
revealed that pharmaceutical company Wyeth used ghostwriters to insert
marketing messages into medical journal articles promoting menopausal
conjugated equine estrogens.
The documents were recently unsealed during litigation
against Wyeth. The company is facing a class action suit on behalf of 14,000
plaintiffs who claim to have developed breast cancer while taking the
conjugated equine estrogens (Prempro).
Adriane Fugh-Berman, MD, of Georgetown University
Medical Center, studied dozens of the ghostwritten articles and commentaries
written by DesignWrite, a medical communication company hired by Wyeth. The
articles, which were published in medical journals and disseminated to
physicians and pharmaceutical representatives, downplayed the risks for breast
cancer associated with HT, defended unsupported cardiovascular benefits of HT
and promoted unproven off-label uses of HT, including the prevention of
Parkinsons disease, dementia, wrinkles and vision loss, according to a
press release. Fugh-Bermans analysis was published Tuesday in PLoS
Specifically, the articles questioned whether HT-induced
changes in breast density were linked to increased breast cancer risk, implied
that estrogen use after breast cancer was safe and suggested that HT-linked
breast cancers were less aggressive.
Fugh-Bermans analysis found that DesignWrite was
paid $25,000 to produce articles reporting clinical trial results
including four summaries of the Womens Health, Osteoporosis, Progestin,
Estrogen (HOPE) study of low-dose Prempo and received $20,000 per
article to write 20 review articles about Prempo.
Given the growing evidence that ghostwriting has
been used to promote HT and other highly promoted drugs, the medical profession
must take steps to ensure that prescribers renounce participation in
ghostwriting, and to ensure that unscrupulous relationships between industry
and academia are avoided rather than courted, Fugh-Berman wrote in the
This appears to be a classic case of the pot calling the kettle
black. That is, much of this material has been taken directly from the
litigation documents prepared by the lead plaintiff attorney, James Szaller.
Thus, Dr. Fugh-Berman appears to have published a semi-ghost written article
herself! The substance of her paper is riddled with errors and misassumptions. I
can speak to the HOPE papers, which she calls ghost written, but, as lead
author of the first HOPE paper, I spent about 1 hour during a 9-hour deposition
as a fact witness, explaining how the paper was developed over a period of
years, and most certainly was not ghost written. In summary, this is an article written by someone trying to justify her
own role as a well-paid expert plaintiffs witness, and falling into the
trap of apparently using ghost written material without attribution. The paper
is riddled with scientific misinterpretations and personal assumptions. The
truth, as always, lies somewhere in the middle.
Wulf H. Utian, MD, PhD, DSc
Independent Consultant, Gynecology and Womens
Health, Cleveland Clinic