An article recently published in the open-access journal PLoS Medicine suggests a disturbing explanation for why physicians are often reluctant to change how they advise and treat their patients even when the evidence overwhelming points to the fact that the approaches they’re using may cause harm.
That explanation? Promotional materials disguised as expert opinion.
The article is yet another reminder about how BigPharma effectively uses medical journals as marketing tools.
It’s also a reminder to physicians — and consumers — that reviews and commentaries in medical journals need to be read with considerable skepticism and caution.
Why the rejection?
Dr. Adriane Fugh-Berman and her colleagues at Georgetown University Medical Center undertook the PLoS Medicine study because they were curious as to why half of U.S. gynecologists continue to distrust and downplay the results of the Women’s Health Initiative (WHI) study of menopausal hormones.
The largest randomized, placebo-controlled trial of menopausal hormone therapy ever performed, WHI was stopped early (a rare occurrence) in 2002 because of its harmful findings, most notably that the hormones increased the risk of stroke, breast cancer, blood clots, dementia and incontinence.
Yet large numbers of gynecologists — who are responsible for more than 70 percent of menopausal hormone prescriptions in the United States — have repeatedly told survey takers that they don’t find the WHI findings convincing.
Many women, though, were convinced by WHI and stopped taking the hormones. Menopausal hormone prescriptions plummeted by 80 percent in the 12 months after the WHI study ended — and the incidence of new breast cancer diagnoses fell as well, by almost 7 percent.
Correlation with conflicts
To find out why so many gynecologists continue to doubt WHI’s findings, Fugh-Berman and her team analyzed opinion pieces on hormone therapy published in medical journals during the four years post-WHI (through June 2006).
They then narrowed their focus to the 10 authors who had published four or more opinion pieces on WHI during that period (some 50 articles in all), and evaluated these authors’ writings for scientific accuracy and tone.
They found that although most of the articles (86 percent) were scientifically accurate, some 64 percent presented (others might say “spun”) the science with pro-hormone promotional language.
They also found that eight of those 10 authors had declared receiving consulting or speaking payments from manufacturers of menopausal hormones. Of the articles the Georgetown University researchers deemed to be promotional, some 90 percent were written by those with financial conflicts of interest.
The spinning often involved downplaying the health risks uncovered by WHI. Writes Fugh-Berman and her colleagues:
For example, most articles conceded that hormone therapy was associated with breast cancer, but promotional articles contained statements such as “The risk of breast cancer with hormonal therapy is put into perspective with the realization that this risk is related to hormonal dose and duration of us, and that the absolute risk remains small,” or “The WHI agreed with convincing evidence in the literature that postmenopausal hormone therapy does not increase the risk of breast cancer beyond that already associated with recognized risk factors, such as a positive family history.”
Articles with a promotional spin were also more likely to stress themes that good researchers (and wise physicians) know to be untrue — that observational studies are as good as or better than randomized clinical trials, for example, or that animal studies can guide clinical decision-making.
Amazingly, the Georgetown researchers found that three of the authors with conflicts of interest recycled sections of text word-for-word (without citation) in different articles. That practice is considered highly questionable and begs the question: Why didn’t the journals catch it?
Fugh-Berman and her colleagues conclude that “narrative review articles on hormone therapy may provide accurate statements about the risks of a therapy while simultaneously providing positive impressions of that therapy for uses unsupported by evidence. There may be a connection between industry funding for research, speaking, or consulting and the publication of promotional pieces on menopausal hormone therapy. Health care providers should exercise caution if they choose to read such articles.”
Consumers should, too.