A U S T R A L I A -------------------------------------------------------------------------------- Menopause drug scare hits women Jul 10 Ray Moynihan and Lisa Allen
Millions of women taking one of the world's biggest-selling drugs are facing increased risks of blood clots, strokes, heart attacks and breast cancer.
A major study of hormone replacement therapy released last night found women taking HRT increased their risk of stroke by 40 per cent, blood clots by 100 per cent, breast cancer by 26 per cent and heart disease by 22 per cent.
HRT is a multibillion-dollar market globally, dominated by Wyeth's popular oestrogen pill Premarin.
The drug generates sales of about $2billion in the United States annually, and is usually taken in combination with a second progestin-based pill.
In Australia, an estimated 500,000 women take combined HRT to ease the symptoms of menopause, and to prevent heart disease and fractures.
Wyeth's locally marketed Premia and Menoprem are used by almost half of those women.
The dramatic findings have emerged from a long-term study of the therapy, involving 16,000 women, which was stopped two months ago when researchers found people taking the drugs were being harmed. Full results of the study by the giant National Institutes of Health in the US will be published in next week's Journal of the American Medical Association, and is expected to spark reaction worldwide.
Despite them being widely used for close to 15 years, the trial is the first time the drugs' long-term risks and benefits for women have been properly assessed.
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Alongside the increased risks of heart disease and breast cancer, the study found HRT reduced a woman's risk of hip fracture and colorectal cancer by a third.
An accompanying editorial in JAMA co-written by Harvard professor Graham Colditz concluded the harms outweighed the benefits, and it strongly advises women to stop taking the drugs for long-term use.
"The impact will be phenomenal. There are going to be millions of women all over the world stopping this therapy. This is turning an established medical treatment on its head," Professor Colditz told The Australian Financial Review.
Despite the clear dangers of the long-term use of combination therapy, Wyeth's director of corporate affairs in Australia, Rachel David, said last night the products would not be taken off the market.
"We still believe combination HRT is therapy proven to relieve menopausal symptoms including hot flushes, night sweats and vaginal dryness.
"Women should talk to their doctors about the risks and benefits in their case," she said.
Deborah Saltman, Wyeth's medical director in Australia, added that combination HRT was the only therapy which was proven to relieve menopausal symptoms.
The United States-based company, which has a market capitalisation of more than $120 billion, yesterday informed Australian doctors of the negative results of the five-year study, called the Women's Health Initiative.
While the company had contributed the medication for the study, the ground-breaking trial was run by the publicly funded NIH.
Even without good evidence of its long-term benefits, almost 40 per cent of older women in the United States are using HRT, and 46 million prescriptions were written for Wyeth's Premarin in 2000. The drug is made from the urine of horses, and is one of the most prescribed products of all time.
While the increases in chances of heart disease and breast cancer from HRT are large in relative terms, the absolute risk for an individual woman is still low. For every hundred women in the trial, only one experienced a major side effect.
Yet according to the accompanying JAMA editorial, "For hormone replacement therapy, which is used by millions of patients, even rare adverse effects can harm substantial numbers of women".
In another section of the same study, oestrogen was used without combination to treat women who have had a hysterectomy. But the same dangers did not exist and use of this drug will continue.
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