This week we will consider the rise and fall of hormone replacement therapy. As we learned, publications ethics affect not only individual author’s professional standing and funding, but they can also have a very large impact on public health. As an example, we will examine the paper by Adriane Fugh-Berman “The Haunting of Medical Journals: how ghostwriting sold HRT”.
An author: Adriane Fugh-Berman is an associate professor in the department of pharmacology and physiology, and in the department of family medicine, at Georgetown University Medical Center. She is also the director of PharmedOut, a research center at Georgetown University Medical Center dedicated to researching the effects of pharmaceutical industry marketing on drug prescriptions (wiki).
Background: Menopause occurs when woman’s ovaries cease to produce female hormone estrogen, which usually happens in the fifth or sixth decade of life. Giving that estrogen is essential for maintenance of almost all the organs in female body, not just reproduction, it is hard to overstate the role of this hormone.
Onset of menopause is commonly accompanied by symptoms that can range from mild to very severe. Menopausal symptoms could last for years and be quite disabling. Therefore, in many cases menopause negatively affects women’s quality of live and ability to function. Since every woman will undergo menopause in her life, the demand for the interventions that can alleviate menopausal symptoms is tremendous.
Unfortunately, in the past none of these interventions provided any significant relief. Hormone replacement therapy (HRT), when “missing” estrogen was formulated in a drug form, brought a new era in treating menopausal symptoms and was greeted with enthusiasm by both clinicians and patients. However, unethical writing and publishing practices contributed to over-selling the treatment which lead to serious harm to many women.
When the connection between HRT and increased morbidity and mortality became apparent, thousands lawsuits followed, drug companies paid off, and unethical practices came to light.
Write a short (1-2 pages single space, 11 pts font) assay on what you learned from the paper by Fught-Berman and supplementary material. Specifically, touch the following points:
- a) What kind of health hazards are linked to HRT use?
- b) List and explain ethically questionable practices that are described in the paper. Be specific.
- c) Growth of majority of breast cancers is stimulated by estrogen. Dissect the approach by which drug companies sent the message minimizing the risk of breast cancer in women on HRT.
