This is Chris Loder from Pfizer. We want to thank you for the opportunity to post a comment regarding your article.

This is the second time in six months that the main author of this article and PLoS Medicine have published a piece critical of hormone therapy with a misleading and incomplete disclosure. Dr. Fugh-Berman is a paid expert witness for plaintiffs’ lawyers in ongoing hormone therapy litigation against Wyeth, one of the companies implicitly criticized in this article. In addition, the lawyers that represent plaintiffs in HT litigation also direct the law firm that represents PLoS Medicine. These same lawyers continue to name Dr. Fugh-Berman as one of their litigation experts, and have used her PLoS Medicine articles in legal proceedings. While criticizing Wyeth for old disclosure policies, PLoS Medicine and Dr. Fugh-Berman today continue to fail to fully disclose the legal and financial relationships they enjoy with plaintiffs’ lawyers.

In her article criticizing the tone of HT articles, Dr. Fugh-Berman also departs from scholarly objectivity and exudes a tone unjustly critical of hormone therapy. The authors cite as a reason to conduct this analysis the fact that ‘it is unclear why gynecologists and other physicians continue to prescribe’ hormone therapy medicines. It is preposterous for Dr. Fugh-Berman and others to make such pejorative comments about prescribers’ motives when the FDA, women’s health organizations, and many prescribers continue to believe that science supports hormone therapy as an important treatment option for many women.

Hormone therapy is among the most thoroughly studied medicines, as well as an important treatment option for the appropriate woman seeking relief of moderate to severe menopausal symptoms. The FDA describes hormone therapy as ‘the most effective FDA approved medicine for relief of hot flashes [and] night sweats.’

Again, like other PLoS Medicine articles by Dr. Fugh-Berman, this article completely and conveniently fails to mention that published HT articles are subjected to rigorous peer-review by outside experts on behalf of the medical journals that published them. Dr. Fugh-Berman herself acknowledges that ‘the majority of articles were judged to be scientifically accurate’ in this most recent analysis.

Lastly, Dr. Fugh-Berman and her co-authors - three of which are not physicians - acknowledge the limitations of their methodology, including the fact that it has not been previously validated. More importantly, they acknowledge that they could not determine whether the authors of the medical literature examined received financial support from PhRMA companies before or after they published their work - a limitation that raises doubt about the study’s conclusions regarding the alleged influence of money.

PFIZER’S DISCLOSURE POLICY
As a science-based company, Pfizer places the utmost importance on the integrity of scientific research and authorship of medical literature. Pfizer has a publicly posted policy on authorship, which, among other things, ensures that the named authors of each article, typically the principal investigators, control the preparation of the articles about Pfizer-sponsored trials. Pfizer adheres to the authorship criteria established by the International Committee of Medical Journal Editors (ICMJE) and the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results and trains both clinicians and staff on these guidelines. For articles in which Pfizer is involved, authors are required to acknowledge the contributions of any non-authors assisting in the preparation of articles.

In February 2009, Pfizer, as part of its commitment to increased transparency and public candor, became the first biopharmaceutical company to commit to disclosing publicly its financial relationships with physicians, medical organizations and patient advocacy groups payments, including fees for speaking and consulting and investigators who conduct clinical research.

Thanks again for this opportunity to post a comment.