Like most large prospective clinical trials, the National Institutes of Health's arm of the Women's Health Initiative (WHI) raised more questions than it answered. In an effort to bring clarity to the "hormone debate," investigators evaluated the long-term effects of combined estrogen and progestin hormone therapy on menopausal women primarily in regard to heart disease, but also in regard to osteoporosis and breast and colon cancer.
The 16,608-subject study confirmed what most physicians already knew-that long-term use of combination hormone replacement therapy (HRT) increases the risk of breast cancer. But the study does quantify that risk.
Nathan Kase, MD, professor in the department of obstetrics, gynecology, and reproductive science and interim dean for New York's Mount Sinai School of Medicine, says periodic media scares regarding HRT have surfaced during the past decade, but this one is the most significant. He attributes that to the unbalanced information disseminated through the consumer press, which didn't clarify that the results applied only to the therapy used in the study, Wyeth's Prempro (conjugated estrogens/med-roxyprogesterone). Also, the reports often failed to acknowledge that the study provides the first solid evidence that HRT therapy reduces the risk of fracture, osteoporosis, and colorectal cancer.Fueling the hype, the Journal of the American Medical Association publicly accused Detroit Free Press veteran reporter Patricia Anstett of breaking the story's embargo. Although Anstett claims that she tracked the story independently of JAMA, her release of the news before NIH's press conference on the subject shows how large an impact she expected the story to have.
Donnica Moore, MD, former weekly medical contributor for NBC's Later Today and medical editor of the soon-to-launch physician news magazine Women in Medicine, says the massive media attention generated by the trial is warranted. "Of course this is big news; six million women [in the United States] take HRT, 5,000 women per day enter into menopause, and NIH cancelled an arm of the largest clinical trial ever to be conducted on women mid-way because of increased risk of breast cancer.
"But the coffin is by no means nailed shut on Prempro. The fact that Wyeth's stock went down 30 percent in one day was a hyperreaction to the news. That said, women are terrified, and I don't think doctors are yanking patients off HRT nearly as much as patients are stopping it themselves."
A.G. Edwards analyst Kenneth Nover agrees that the financial community overreacted, attributing its response to the prevailing negative mood toward pharma and the market.
A Wyeth spokesperson said the company is reviewing all marketing strategies for Prempro in light of the recent news, including DTC and physician advertising, but she stressed that the study's findings are in accordance with the product's labeling.
Company press releases also emphasized that trial participants were not typical Prempro patients. They claim the average woman starts Prempro therapy at age 51-not 63, as in the study-and uses it short-term to prevent menopausal symptoms, not long-term to prevent heart disease. However, Wyeth has sent letters to doctors to educate them about the findings.
Now, other pharma companies that market HRT combination products must also find ways to demonstrate their safety. For companies that produce alternatives to HRT, as well as man- ufacturers of osteoporosis and heart disease treatments, the news is an opportunity to expand market share. Already, Eli Lilly has distributed a press release explaining the distinction between its selective estrogen receptor modulator product Evista (raloxifene) and HRT. WomenFirst Healthcare conducted a web-cast conference to clear up misunderstandings surrounding the WHI study and WFH's estrogen-only product Esclim (estradiol).