New data suggest that physicians with ties to the pharmaceutical
industry may be more likely to write opinion pieces supporting the use of
menopausal hormone therapy, despite study results linking the treatment to
adverse events.
In 2002, results of the Women’s Health Initiative (WHI) linked
treatment with combination
estrogen and progestin and estrogen alone with elevated risk
for stroke, deep vein thrombosis, dementia and incontinence. In 2004, the study
also linked estrogen-only treatment with increased rates of breast cancer. Yet,
several surveys indicated that many gynecologists continued prescribing
menopausal HT. These results prompted researchers to explore articles published
in medical journals with promotional tones that may influence physicians’
prescribing practices.
The researchers combed the Medline database for authors who had written
at least four reviews, editorials, comments or letters on HT between 2002 and
2006. They identified 50 articles written by 10 authors and, after blinding,
reviewed them for scientific accuracy and tone. Scientific accuracy was defined
as recognizing HT’s potential link to breast cancer diagnosis and lack of
cardiovascular benefits.
Trends in promotional articles
Reviewers deemed 86% of the 50 articles as scientifically accurate, and
they characterized 64% as promotional. They noted that the following themes
were common among those supporting HT use:
- The WHI study was flawed.
- The WHI study was controversial.
- The WHI study examined an inappropriate population or one that was
not representative of the general population of menopausal women.
- Clinical trials should not guide treatment.
- Animal studies can guide clinical decision-making.
- Risks associated with HT are exaggerated.
- Benefits of HT have been or will be proved.
To identify conflicts of interest, the researchers considered those
declared in the articles, disclosures from the Council on Hormone Education and
Google searches for the authors’ names combined with the term
“conflict of interest.” Of the 10 authors included in the study,
eight had received payment for research, speaking or consulting from menopause
hormone manufacturers.
Thirty of 32 promotional articles were written by authors with conflicts
of interest vs. 11 of 18 written by those without conflicts of interest
(P=.0025), the researchers said. According to the data, promotional
articles were 2.41 times more likely to have been written by those with
conflicts of interest (95% CI, 1.49-4.93).
In addition, the researchers identified three authors with conflicts of
interest whose text from one article appeared word-for-word in a subsequent
article in which they were listed as an author. No articles written by the two
authors without conflicts of interest contained repeated text, according to the
researchers.
Implications
The researchers said articles written by authors with conflicts of
interest conveyed more “enthusiasm” about HT’s use than those
written by authors with none.
“There may be a connection between industry funding for research,
speaking, or consulting and the publication of promotional pieces on menopausal
HT,” they wrote. “Health care providers should exercise caution if
they choose to read such articles.”
For more information:
Disclosure: Dr. Fugh-Berman directs PharmedOut
(www.pharmedout.org), a Georgetown University Medical Center project that
educates physicians about inappropriate pharmaceutical practices and is also a
paid expert witness on behalf of women who developed breast cancer while taking
menopausal hormone therapy. Alicia M. Bell was the paid project manager of
PharmedOut during part of the time this study was conducted.
The pernicious effects of pharma funds in medicine are well-recognized. While drug companies continue to separate promotional and educational activities, physicians are generally dismissive of the influence of the former on their practice (even while believing that their colleagues are so influenced). The article by Fugh-Berman et al extends studies of the effects of industry monies on medical practice to focus on the tone of review articles (and commentaries) as it relates to pharma connections of the primary authors. The article finds that authors with a drug company connection are more likely to endorse the use of that company's drug, here for menopausal HT, medical evidence notwithstanding. Since review articles are important resources for the busy practitioner, it reasonably follows that they will be influenced by such reviews. Although such influence was not established here, the continued use of menopausal HT, despite many adverse risk-benefit analyses, supports this viewpoint. Authors' mere disclosure, often perfunctory, may not be enough to overcome such a conflict of interest.
– L.J. Deftos, MD, JD, LLM
Endocrine Today Editorial Board member
Disclosure: Dr. Deftos reports no relevant financial disclosures.