Chief Cushie ~MaryO~ Posted August 14, 2002 Chief Cushie Report Share Posted August 14, 2002 http://www.washingtonpost.com/wp-dyn/artic...-2002Aug13.html Hormone Replacement Gets New Scrutiny Finding of Increased Risks Prompts Federal Effort By Marc Kaufman Washington Post Staff Writer Wednesday, August 14, 2002; Page A01 Federal officials announced yesterday that they have begun a major reassessment of the risks and benefits of all combination hormone products containing estrogen used by post-menopausal women, one month after a large government study found potentially serious side effects from hormone replacement therapy. The federal effort could change how popular drugs such as Prempro are advertised, prescribed and used, with new recommendations about who should take them, at what dosages and for how long. The initiative, which will include several public forums this fall sponsored by the National Institutes of Health, the Food and Drug Administration and the Agency for Healthcare Research and Quality, will also try to guide future research on the suddenly more complex and controversial subject. The move marks the first significant action by the federal government in response to the latest findings about hormone therapy. It is designed to address the widespread confusion that has caused anxious women to inundate doctors with questions about whether they should continue taking the powerful hormones. "Somebody needed to take a leadership role, because there is chaos in the medical societies," said Wulf H. Utian, executive director of the North American Menopause Society, who has been invited to participate in the meetings. "It's time to clear the air and address the issues." The brief announcement of the initiative came as the FDA separately pushed for immediate changes in the label and the package insert for the hormone combination sold as Prempro to reflect the risks confirmed by the Women's Health Initiative (WHI). Part of that federally funded study was stopped three years early because of small but statistically significant increases in heart disease, breast cancer, stroke and blood clots among women taking Prempro, a combined estrogen-progestin drug. While the study used only Prempro, agency officials said they have new questions about other estrogen-progestin products on the market, as well. In response to the immediate FDA concerns, officials at Wyeth Pharmaceuticals, maker of Prempro, said the company expects to submit new safety precaution information as early as this week that will take into account the WHI findings. The WHI study was testing the widely held hypothesis that hormone therapy reduced the risk for heart disease in particular and, so, was especially surprising. "The FDA says it is our responsibility to get new information out there, and we agree," said Bruce Burlington, Wyeth's vice president for regulatory compliance. He said that many of the WHI findings on increased risks to women were already known and incorporated into the Prempro label but that "the risks were better quantified in WHI." These initial steps can be taken without formal FDA approval. But officials said that they are aggressively reviewing hormone replacement therapy generally -- now used by 14 million menopausal and post-menopausal American women -- and that more wide-ranging changes can be expected. As part of the effort, federal officials want to explore whether hormone therapies and their producers have encouraged women to believe menopause is a condition to be treated, rather than an inevitable and natural set of changes to be managed. The hormone therapy issue is being actively debated within medical societies, too, with the American College of Obstetricians and Gynecologists, the North American Menopause Society and others forming task forces on hormone replacement in response to the WHI findings. Reflecting the FDA's discomfort with the way that hormone treatments have been widely presented as an antidote to menopause, the agency has told Wyeth to remove all references to "hormone replacement therapy" from its Prempro label. The "replacement" model, officials said, has never been accepted by the agency, which approved Prempro for specific symptoms of menopause and to prevent osteoporosis, a reduction in bone mass. "The impact of the WHI findings [is] very far-reaching, and that fact is not lost on the FDA," said Florence Houn, a director at the FDA's Center for Drug Evaluation and Research. "As a public health agency, we need to step to the plate and reassess the risk-benefit conditions for labeling and risk management for patients." Estrogen products have been used for decades and have helped millions of women handle the sometimes-severe symptoms of menopause, including hot flashes, night sweats, sexual discomfort and the increased risk of bone fractures. For years, studies on heart disease, Alzheimer's, colon cancer and bone fractures also showed potential benefits to women taking hormone replacement long-term, and those findings were widely embraced by doctors and advertised by the drugmakers. The earlier positive findings on estrogen and heart disease, for instance, were considered strong enough by the American Heart Association to be included in its literature for women as recently as 1997. But studies in the past several years began to raise doubts about the benefits and risks from long-term hormone therapy, and the large WHI study concluded that hormone therapy actually increased the risk of heart disease. That finding has required a quick pivot by medical authorities, individual doctors and, now, federal officials. Further complicating the picture, the WHI study found that hormone therapy did help protect women against colon cancer and hip fractures. In addition, another arm of the WHI study did not find cardiovascular and cancer dangers with estrogen treatment alone (as opposed to the estrogen-progestin combination) when it was used by women who have had hysterectomies. That part of the study was allowed to continue. The FDA expects to hold an expert advisory meeting this fall or winter to make recommendations about how hormone therapies should be used. Among the issues to be addressed are whether hormone treatment should be limited to several years, whether all hormone combinations containing estrogen carry the same risks, and whether estrogen-combination products require the kind of more prominent black box warnings that are used for drugs with potentially fatal side effects. Although the WHI study did not find an increase in deaths from breast cancer, heart disease or stroke before it was stopped, the study did conclude that Prempro was associated with a greater risk of those diseases. "Ultimately, the label that does get full FDA approval may well look quite different from what the company feels is needed for immediate strengthening," Houn said. The FDA-approved label for a drug is key to how it is advertised, prescribed and used by patients. While doctors can write prescriptions off-label, companies can advertise to consumers and doctors only the uses approved by the FDA, and they must convey the side effects deemed serious by the agency. Wyeth officials said that since the WHI study was discontinued, they have stopped direct-to-consumer advertising about hormone replacement but increased visits to doctors to explain the results. ? 2002 The Washington Post Company Quote Link to comment Share on other sites More sharing options...
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