Perspective

Conflicts of interest may prompt physicians to pen articles promoting menopausal HT

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.

PERSPECTIVE

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.

Twitter Follow EndocrineToday.com on Twitter.

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.

PERSPECTIVE

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.

Twitter Follow EndocrineToday.com on Twitter.