The founder of the North American Menopause Society (NAMS) has called for an independent review of all major publications from the Women's Health Initiative (WHI), citing a dissonance between some of the data and conclusions resulting in harm to women's health.
When the NIH's National Heart, Lung and Blood Institute halted the estrogen-progestogen arm of the WHI in 2002, the increased risks of breast cancer, coronary heart disease, stroke, and pulmonary embolism in the active treatment arm were overstated, according to Wulf Utian, MBBCh, PhD, a consultant in women's health, founder, and executive director emeritus at NAMS.
In response to Utian's comments, NAMS issued a statement clarifying its position.
Utian's views, NAMS said, "do not represent the official position of the Society. NAMS has recently updated its position statement on hormone therapy, affirming that hormone therapy continues to have a clinical role in the short-term management of menopausal symptoms but should NOT be used long-term for the purpose of trying to prevent chronic diseases. Although the benefits of hormone therapy are likely to outweigh the risks in many newly menopausal women who have moderate-to-severe symptoms, risks may exceed benefits when hormone therapy is used long term for disease prevention purposes."
A focus on relative risks instead of absolute risks colored the negative perception of the data and dramatically dampened menopausal hormone therapy use, he wrote in Climacteric, the journal of the International Menopause Society, which supports Utian's call for an independent review of the WHI's findings.
Quoting from an earlier commentary he had written on the subject, Utian said that "the manner in which the study was terminated was poorly planned, abrupt, and inhumane."
The main problem, he argued, is that the conclusions of various studies from the WHI that the risks of menopausal hormone therapy outweigh the potential benefits are not supported by the evidence.
And he questioned the methods used to evaluate the evidence, noting that the WHI investigators developed a method of assessing the risks and benefits -- called the global health index -- that combines all outcome data together without stratifying by age or time since menopause. That technique has not been validated and was not part of the original study design, Utian said.
"The entire science of ranking clinical outcomes with proven and validated tools such as cost-effectiveness analysis using quality-adjusted life years (QALY), measuring a trade-off between longevity and quality of life, had been completely ignored by the WHI investigators," he wrote.
"So, while the WHI data in relation to the early menopausal woman are in complete alignment with the observational studies, clearly demonstrating that benefits outweigh risks, most definitely in women treated on estrogen only, the women themselves remain in fear of postmenopausal hormone therapy and continue to be influenced by the early misrepresentations of the data by the WHI," he continued. "Enormous damage has already been inflicted on the last generation of early postmenopausal women."
The claim that the WHI has done more harm than good "is clearly a harsh indictment," Utian acknowledged, "and it therefore becomes urgent for an appropriate independent evaluation of the key publications out of the WHI to be taken to confirm whether there was irresponsibility that needs to be identified and admitted."
He said that evaluation should be completed by a commission consisting of representatives from women's health organizations, experts in related health specialties, statisticians, key individuals from the WHI, and representatives from leading medical journals.
Without the latter two groups, he wrote, the conclusions of the independent panel likely wouldn't be taken seriously.
"Women progressing through and beyond menopause in the next decade need to be spared the unnecessary harm inflicted on their sisters of the previous decade, as resulted from the rush to publication of incomplete and poorly analyzed data by the Women's Health Initiative spokespeople in July 2002," Utian argued.
A request for comment from the WHI was not immediately returned.
Disclosures
Utian reported that he is not consulting or on any pharma speaker panels on estrogen therapy/estrogen-progestogen therapy/hormone therapy. He is consulting on nonhormonal products for the following companies: Hygeia, Bionovo, Cleveland Clinic Foundation Innovations Center, Pharmavite, Merck, Sharp & Dohme, Novogyne, Bayer FSD, Teva Women's Health, and Pfizer.
Primary Source
Climacteric
Utian W. "A decade post WHI, menopausal hormone therapy comes full circle -- need for independent commission" Climacteric 2012; 15: 320-325.