Global Insight Perspective | |
Significance | Findings from the study reiterate heart disease risks for older women, but are positive for hormone replacement therapy (HRT) usage for women during early menopause. |
Implications | Wyeth continues to tout its Premarin franchise, but issues a cautious note in the overall risk/benefit ratio, specifying other factors such as age, type of therapy, and the number of years since menopause. |
Outlook | Although the study has not absolved Prempro and Premarin from its present woes, it points to a selective use of hormonal therapy that could bring some cheer to Wyeth. |
Study Findings
The Women’s Health Initiative (WHI) carried forward its hormone therapy studies, re-examining the combined data from two hormone replacement therapy (HRT) trials held earlier in 2002, which examined oestrogen and progestin effects, and in 2004, which studied the effects of oestrogen treatments only. The objective this time was to identify the effects of the therapies several years post-menopause, taking into account dietary modification such as calcium and vitamin D as preventive therapies for menopausal women. Two of Wyeth's products were once again under the scanner, namely Premarin (conjugated oestrogens; 0.625 mg) and Prempro (conjugated oestrogens /medroxyprogesterone acetate; 0.625 mg). The trials involved women in three age categories: 50s, 60s and 70s. The results of the analysis, posted on the WHI website, suggested the following:
- The risk of heart attack from hormones may not be increased in women who start HRTs within 10 years ”after menopause”, but risks in women who are more distant from menopause remain.
- The risk of stroke resulting from hormones does not depend on the timing of the initiation of the therapy, as the likelihood of suffering a stroke increases with age, regardless of menopause.
- The risk of death from any cause appeared to be reduced in women between 50-59 years at the time of HRT initiation.
Wyeth's Response
Wyeth has responded to the new published findings with a note of caution. The company has focused on the positive element emerging from the study—that there is no apparent increase in coronary heart disease in women who initiate HRT close to menopause. Senior Vice-President Joseph Camardo stated in the company's press communiqué that the overall findings of the pooled analysis are consistent with other studies on the therapy, and touted the company's franchise as “remaining a good healthcare choice for ‘appropriate’ women seeking to relieve moderate to severe menopausal symptoms”. Despite reiterating that the therapies should not be used for cardiovascular diseases, clearly pursuant to the WHI’s standing firm on its 2002 report findings, Camardo added that the risk/benefit ratio of HRT may depend on other factors such as age, type of therapy, and timing of treatment initiation.
Outlook and Implications
The scars of its plummeting Premarin and Prempro sales immediately after the release of the WHI's 2002 studies have clearly been weighing on Wyeth and hence, the company has reacted tentatively and carefully in accepting the risks and highlighting the positive aspects of the study. It is significant to note here that the WHI has stated that the new analysis does not change the current recommendation that HRT should not be used for prevention of heart attacks, which was echoed by Wyeth too. The 2002 study outlined several setbacks for the therapy, including increased risk of breast cancer that has resulted in litigations. Wyeth is currently facing around 5,000 product liability lawsuits over claims that it misled patients and physicians over the potential risks of hormone-dependent breast cancer associated with the use of Prempro and Premarin. The current study findings may play only a limited role in the ongoing litigations. However, it points to a potential rise in the selective use of hormone therapies, while quashing earlier myths that hormonal treatments assist in thwarting cardiovascular diseases. The Premarin franchise has managed to recover from its earlier setbacks and has registered a strong 16% annual growth rate in sales for 2006, topping figures of US$1.05 billion.
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