Was there a surreptitious link between articles about hormone replacement therapy and industry funding after one arm of the federally funded Women’s Health Initiative ended in 2002? For those who do not recall, the estrogen plus progestin trial was stopped after investigators found patients given the treatment had a greater risk of heart disease and breast cancer.

A new study believes there was a link. Since earlier studies found that many gynecologists continued to prescribe hormone replacement therapies after the WHI results were published and nearly half did not find the outcome convincing, the researchers looked at whether any promotional tone could be identified in what they called narrative review articles - or opinion pieces - about HRT. Among the widely used HRTs was Wyeth’s Prempro, which is now owned by Pfizer and the subject of litigation (see this).

A review of the literature found articles written by authors with industry ties suggested that the WHI was flawed, maintained that treatment should not be determined by trial results, downplayed the associated health risks and posited that benefits would be proven, or already had been. The review, which was published in PLoS Medicine, argues the articles may have encouraged some docs to prescribe the meds unnecessarily. The PLoS study reviewed 340 articles deemed to be relevant and that were published between July 2002 and June 2006, and they focused on 10 authors who published at least four articles during that time. Consequently, 50 articles were evaluated. Of these, 86 percent deemed scientifically accurate, while 32, or 64 percent, were considered promotional.

The researchers cited several statement as examples of promotional language. Here’s one: “‘…the WHI did not study the appropriate population in the appropriate time period to establish that hormone therapy does not exert a primary preventive effect on the risk of” congestive heart disease. Another: ‘‘Are such experts jumping to conclusions, and jeopardizing the health and quality of life of
these peri- and early postmenopausal women, who differ from those in the WHI trial, two-thirds of whom were over 60 years old?” Meanwhile, of the 10 authors studied, eight received payment for speaking or consulting on behalf of drugmaker with HRT treatments and 30 of 32 articles, or 90 percent, were determined to have promoted HRT were written by authors with potential financial conflicts. By comparison, 11 of 18 articles, or 61 percent, had potential conflicts (read the study here).

The upshot? Articles promoting the use of HRT were more than twice as likely to have been written by authors with conflicts as by those without conflicts. Also interesting, the researchers maintain there were articles from three conflicted authors in which certain text was repeated word-for-word in different articles. One example: 84 percent of the text and all seven tables in one article was also found in four other articles. “Our results suggest that authors who have received payments from industry convey more enthusiasm about the industry’s products than do authors who have not declared that they received such payments,” the authors conclude, adding that “health care providers should exercise caution if they choose to read such articles.”

One note: the lead author is Adriane Fugh-Berman, who directs PharmedOut, a project at Georgetown University Medical Center project that focuses on pharmaceutical marketing practices. She is also a paid expert witness on behalf of women who developed breast cancer while taking an HRT.