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food and nutrition
gambling
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gun control
health communications
health impact assessment
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health inequalities
health literacy
human rights
illicit drugs
injuries
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media-related issues
nanny state
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occupational health
physical activity
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A must-read: how ghostwriters helped sell HRT

For those who have been mystified by the resolute defence of HRT by some specialists, for those who are interested in integrity in publishing, medicine and science, and for those who enjoy a shocking yarn – this PLoS Medicine article is a must-read.

It is by Adriane J. Fugh-Berman from the Department of Physiology and Biophysics at Georgetown University Medical Center in Washington, DC, who was an expert witness in recent litigation against Wyeth, in which more than 14,000 plaintiffs brought claims related to developing breast cancer while taking Prempro.

Some 1500 documents revealed in the litigation provide unprecedented insights into how pharmaceutical companies promote drugs, including the placement of ghostwritten manuscripts in medical journals. These documents became public when PLoS Medicine and The New York Times intervened in the litigation.

Fugh-Berman reports that Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HRT, to defend the unsupported cardiovascular “benefits” of HRT, to downplay competing therapies, and to promote off-label, unproven uses of HRT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.

She notes that despite definitive scientific data to the contrary, many gynecologists still believe that HRT’s benefits outweigh the risks in asymptomatic women. “This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature,” she writes.

Her paper ends with a call to arms:

“Medicine, as a profession, must take responsibility for this situation. Naïveté is no longer an excuse. Perhaps physician-investigators should create and uphold a standard where relationships with industry are regarded as unsavory rather than sought after. Academic institutions and medical journals should take a hard line on ghostwriting. Patient care will benefit if physicians draw together as a profession to denormalize relationships with industry and avoid the role of corporate pawns in the future.”

Meanwhile, just to show that the problems go much wider than HRT: here is an example from cardiology, describing  “how marketing studies end up in influential medical journals”.

Comments 3

  1. ron batagol says:

    There are two separate issues here. Firstly, I have no problems with the author’s concerns about Industry ghost writers. On the other hand, I do take issue with her comments that “despite definitive scientific data to the contrary, many gynecologists still believe that HRT’s benefits outweigh the risks in asymptomatic women. “This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature,” In fact, the data with respect to risks of short-term use of HRT is far from definitive. The WHI Study that she seems to heavily rely upon for her “definitive evidence” has been acknowledged to have had major flaws in its design, by a number of authoritative sources, quite apart a from those who have had a commercial or vested interest in promoting the use of HRT ( eg. Klaiber et al. Fertil Steril 2005; 84:1589). Also as noted by clinical Peak Bodies such as the RACOG, the cohort selected by WHI for their Study were an older age group with a higher risk of adverse disease outcomes, and using the drugs for a longer period than the majority of women using HRT. As one who has followed the literature on HRT for some time, as a peripheral issue, I am intrigued that very few people mention that the WHI Study found a DECREASE IN INCIDENCE of bowel cancer and hip fractures!

    In summary, it’s great that she is pursuing the important issue of ghost writing, but a shame that she has taken such leaps of faith in devising various conclusions regarding the risks of HRT

    Ron Batagol, Pharmacy & Drug Information Consultant

  2. Melissa Sweet says:

    The bigger picture is that for years, the pharma industry, working closely with some specialists, promoted a treatment for widespread use in healthy women on the basis that it would prevent disease. This was done on the basis of inadequate and misleading evidence. The lack of a subsequent mea culpa or even a “what can we learn from this history” has been striking.

  3. ron batagol says:

    Yes, it’s true as Melissa notes that, for all the reasons she mentions, HRT was promoted and recommended for years for the prevention of cardiac disease and coronary artery disease for many years. However, it is also true that both RACOG and the NHMRC identify that there is good evidence that HRT does prevent the onset of osteoporosis in otherwise healthy menopausal women. BTW, since I don’t recall them being mentioned, I hope that in the “bigger picture”, deprecating the pharma industry also includes the purveyers and promoters of the ubiquitous use of bioidentical hormones for all and sundry assorted menopausal “diseases”, with unknown adverse effects and without objective high-quality evidence of efficacy.

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