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  Sunday Times Review Section
Sunday 18TH April 2004

Is HRT Safe?

I remember it well. Women would turn up to their GP and explain that they were not feeling well. They were, they explained sadly, going through their menopause and suffering from hot flushes. Not only that, their libido had disappeared, they could not sleep and they were exhausted. The doctor would look the patient in the eye and explain that he or she was terribly sorry but there was nothing that could be done. And off the woman would go, to suffer at home in silence.

That was in 1968. Since then HRT has brought relief to millions of women. But recently, the treatment has been facing crisis. In the last 15 months, the number of British women using HRT has dropped by 30%. In the United States, the fall has been even steeper - HRT use is down by 50%. These figures are the result of two studies which apparently showed links between HRT and breast cancer, heart attacks and strokes.

Yet last week another report was published. This one, in the Journal of the American Medical Association, suggested that HRT is not linked with an increase in breast cancer or heart attacks; indeed these illnesses were less common!

Not surprisingly, women everywhere are confused. So what is the truth about the safety of HRT?

I became interested in the treatment when one of its pioneers, Robert Greenblatt, an American gynaecologist, invited me to go to his clinic in Augusta, Georgia to observe his patients. For three days I sat and watched scores of healthy women who were all enthusiastic takers of HRT. They took oestrogen and some testosterone, and they all said that their lives became transformed. I returned to England and wrote to all the heads of departments of gynaecology in medical schools asking the advice given on HRT. Only one of them taught that HRT was a useful treatment. So I opened -in Birmingham - the first menopause clinic in Europe.

Swiftly, the clinic became a great success. But six months on, the British Medical Association protested that HRT was unethical and dangerous, and closed my clinic down. I was furious. Eventually, the BMA was won round and six months later we reopened. Today the Clinic is still hugely successful. These first women said we had helped them not by just helping their hot flushes and sweats, but something more fundamental. They said they felt happy, confident and wanted - all the important things in life. They also reported a domino effect; the HRT cured their insomnia and exhaustion; which, in turn, helped cure their loss of libido; which, in turn, helped their marriages. There is also evidence that HRT prevents osteoporosis. All but one of 30 papers on HRT show that oestrogen therapy is associated with fewer heart attacks, possibly fewer strokes and fewer incidences of Alzheimers' Disease.

For years women enjoyed the benefits of HRT. Then, 18 months ago, the World Health Initiative (WHI) published a study of 19,000 women which erased 30 years of careful practise and research. Probably the most expensive and ill-conceived study that I have come across warned that HRT increased the risk of breast cancer, heart attacks and stroke.

The study understandably scared women - which explains why so many have stopped taking HRT. It ought not to have done so as it was fundamentally flawed.

There were several problems with the research. For a start, the women in the study were too old. In real life, women on HRT usually begin taking it in their early 50's; and their dose varies with age. In the WHI study, the average age of the participants was 63, and a quarter of them were over 70. Furthermore, each was given a standard dose of HRT whether she was aged 50 or 79, whether they had bone problems or depression or simply flushes and sweats. In the WHI study many of the women were also overweight, or had high blood pressure. Eight percent of them had even had had previous heart attacks before starting on the HRT.

But the most extraordinary thing is that the women in this study did not have any menopausal symptoms. Indeed, the researchers specifically searched for women who were not showing symptoms. This may sound bizarre, but it is true. In other words, they were being given a treatment that they did not need. The women did not feel any better - which was hardly surprising, given that you would not expect aspirin to cure a non-headache.

What is truly disgraceful is that these sensational findings - that HRT causes heart attacks and increases the risk of breast cancer - was announced at a press conference days before publication.. It was only later, after the story had hit the newspaper headlines, and the report was published, that the details I have just outlined emerged. But then it was too late.

I do not think one can blame the press; journalists had published the information in good faith. The problem was that the scientific community had not been given the opportunity to analyse the study before it was publicised.

Then came another report - perhaps even worse. The Million Women Study (MWS), which was published two months ago, was even more disastrous. Full of errors and discrepancies, it claimed, for example, that there was a huge increase of breast cancer for many women in their first year of HRT. Yet, we all know that breast cancer takes four, five, seven years before it's diagnosed. So these women whose breast cancers had been "caused" by HRT had in fact already been carrying the cancer - which may have been missed by their previous mammogram - when they signed up for the trial. There were many other objections to this study - which was also first presented at a press conference days before publication.

Menopausologists around the world think that these papers are appalling. Many GP's are refusing to give HRT, and actually, I understand why - even though I believe the research on which they have based their decision is entirely wrong.

I have absolutely no doubt people will change their minds when the truth emerges.

I draw an important conclusion from the mess we find ourselves in. Academic studies should not be presented to journalists with the razzmatazz of a press conference before fellow scientists have had a chance to evaluate it. It is unusual to have a paper of such importance published without it being discussed at workshops and meetings.

Andrew Wakefield, the doctor who attempted to draw a link, rightly or wrongly, between the MMR vaccine and autism also held a press conference before he published his work. I cannot help wondering if there are scientists who are using unquestioning journalists at press conferences to beef up their message.

I have just finished a snapshot survey of nearly 100 patients who have had HRT for ten years asking them if they wish to come off HRT. Only three out of a 100 agreed. The reason is simple: woman on HRT feel better, and have more energy and self confidence. I say to women: if you are confused by the various reports, be reassured that the HRT is effective and safe - if properly used and can transform your life for the better.

Professor of Gynaecology
Chelsea & Westminster Hospital

April 2004

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