The Truth about HRTThe shocking truth on HRT May 28 2003 New research shows HRT doubles a woman's chances of developing dementia. This drug is a global disaster, writes Ray Moynihan. Hormone replacement therapy is one of the biggest-selling drugs of all time. For its United States manufacturer, Wyeth, HRT has delivered revenues of $3 billion a year. But for the women taking HRT, long-term use has delivered increased risks of breast cancer, blood clots, heart attacks and strokes. And according to new research published this morning, HRT also damages the brain, doubling a woman's chances of developing dementia. The Pan Pharmaceuticals scandal highlighted important problems in one company and shortcomings in surveillance standards. HRT is a global disaster revealing a profound sickness in the heart of the medical establishment and a gross failure of public health regulation.
Self-interested specialists, misguided GPs and clever drug company promoters have collectively misled generations of women, while health authorities approved the on-going marketing of a medicine doing more harm than good. Wyeth is already fighting 16 class actions in America over HRT, and today's revelations about dementia will inevitably bring more.
If you don't know what HRT is, it's likely your sister, mother, grandmother or aunt will. It has been prescribed for more than a decade for the relief of menopausal symptoms such as hot flushes and vaginal dryness, with the added promise that long-term use will keep women younger and healthier, preventing heart disease, hip fractures and Alzheimer's. Millions of women around the world have taken HRT, either as estrogen alone or combined with progestin. It is the combined version, best known in Australia as Wyeth's Premia, that has been the subject of the latest wave of three extraordinary findings.
In July last year the Journal of the American Medical Association reported the results from a top-quality trial involving 16,000 healthy women aged 50 and over. The study, almost entirely funded by the US Government, was scheduled to run for eight years but was stopped after five because HRT was found to be causing an increase in heart attacks, strokes and breast cancer.
In absolute terms, a woman's chances of suffering one of these serious events due to HRT was small - one in 100 - but given that millions were taking the drug, the total numbers being hurt quickly starts to add up. The researchers argued the risks outweighed the benefits - which came in the form of very slight reductions in hip fractures and colorectal cancers.
Yet despite such strong evidence of harm, its promoters insisted HRT was still invaluable for the relief of menopausal symptoms. Three weeks ago, that myth also crashed into the reality of good scientific evidence. On May 8, The New England Journal of Medicine reported that HRT "had no clinically meaningful benefits on health- related quality of life" when compared with a placebo, or dummy pill. Using data from the same big study, the authors concluded: "There were no significant effects on . . . vitality, social functioning, mental health, depressive symptoms or sexual satisfaction." An accompanying editorial acknowledged that women with severe symptoms may still choose to take HRT short term, but advised: "All women . . . should consider alternative therapies." Now comes this morning's shocking revelations. A Wyeth-funded study published in the Journal of the American Medical Association finds that taking HRT doubles an older woman's risk of dementia, including the well-known form, Alzheimer's disease. Again, in absolute terms, the chances of developing dementia were not high - taking HRT for four years doubled a women's chances from about 1 per cent to 2 per cent. But the researchers pointed out that the dementia problem began to appear in the first year of the study, and concluded: "The risks . . . outweigh the benefits."
Just a few years ago medical specialists considered HRT such a wonder drug that they would gladly have put it in the drinking water. A 2000 Australasian Menopause Society booklet suggested HRT could prevent heart disease, Alzheimer's and ageing skin, yet it failed to mention the well-established side effect of blood clots or the accumulating evidence that the drugs were causing heart disease, not preventing it. It is not surprising the booklet was favourably disposed towards HRT: early drafts came from Wyeth and its PR firm, Hill and Knowlton. Similarly, Wyeth funded an Australia-wide series of seminars for women, yet newspaper advertisements only carried the logo of the menopause society. Last year the company was caught out again, secretly orchestrating a "grass roots" campaign in support of another of its products, arthritis drug Enbrel, angering some consumer advocates who felt used in the process.
With the release of today's dementia findings, there is more concern about Wyeth's behind-the-scenes activities. Scientists who conducted the dementia study are concerned that the company secretly briefed selected medical societies long before today's JAMA paper was out, to allow those societies time to prepare positions for the PR battle that is certain to erupt. Senior Wyeth officials conceded to me last week that the confidential briefings had taken place and described them as "balanced", though they refused to reveal whether the chosen medical societies are sponsored by the company.
The belief that HRT held great benefits wasn't fabricated, it was based on evidence from "observational" studies that found women taking HRT were healthier. But as any decent medical scientist knows, this evidence is often weak, and in this case it was grossly misleading: the women in those "observational" studies who took HRT were healthier anyway, it wasn't the HRT making them healthier. Top-quality randomised controlled trials testing HRT against a placebo or other alternative are a much better way of getting to the truth about risks and benefits, as has finally happened.
Wyeth is vigorously defending 70 court cases in the US over HRT, including the 16 class actions. Hopefully that legal process will deliver the truth about how these drugs were promoted by the company and its "product champions" among the medical specialists. And perhaps with the truth may come some accountability.
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