HRT cops more BAD PRESS

September 2003 – FDA launches hormone therapy campaign

WASHINGTON (Reuters) – The U.S. Food and Drug Administration launched an education campaign about hormone replacement therapy this month, saying women are confused about recent warnings showing it should only be used in the lowest possible doses for the shortest possible time.

The therapy, once prescribed to millions of women to ease the immediate symptoms of menopause and to prevent osteoporosis and heart disease, has been found to increase the risk of heart disease, cancer and blood clots.

“Menopausal hormone therapy is a major personal decision for women and they need to be armed with the latest facts,” FDA Commissioner Dr. Mark McClellan said at a news conference.

It is very important that women realize that this beneficial therapy also carries significant risks. Our recommendation is that if you choose to use hormone therapy for hot flashes or vaginal dryness, or if you prefer it to other treatments to prevent thin bones, take the lowest dose for the least duration required to provide relief,” McClellan added.

Researchers stopped a large study of HRT in July 2002 when it became clear the therapy increased the risk of heart disease, cancer and blood clots. A number of studies since then have supported those results.

“In January 2003, based on the findings of the … study, FDA advised women and health care professionals that menopausal hormone therapy — estrogen and estrogen with progestin — is associated with an increased risk of heart disease, heart attacks, strokes, and breast cancer,” the FDA said in a statement.

“The warning emphasized that these products are not approved for heart disease prevention.”

But the specific risks vary from woman to woman and hormones are the only drugs that can relieve symptoms such as hot flashes and vaginal dryness and irritation. So the FDA has advised that HRT can still be used — but at the lowest dose that works and for the shortest possible length of time.

The FDA devised the education campaign after a request from a House Appropriations subcommittee.

Many women became confused when they learned about the dangers of HRT, said one subcommittee member, Connecticut Democratic Rep. Rosa DeLauro.

“Suddenly, millions of women didn’t know what to do about hormone therapy,” she said. Many, including DeLauro, immediately stopped taking HRT, she said.

The FDA has set up a Web site www.4woman.gov to provide information and the agency has planned a broadcast campaign to educate women, McClellan said.

August 2003 – HRT and breast cancer: results of the Million Women Study

Doctors and women on hormone replacement therapies are being advised to review the use of treatments following powerful new evidence that they increase the risk of breast cancer.

An unprecedented study of the medical histories of nearly 1.1m British women who were cancer-free as they entered the national screening programme revealed that those on some types of HRT were twice as likely to develop breast cancer as those who had not used it.

The so-called Million Women Study, of whom about half used or had used HRT, also indicated for the first time that the increased risk started between one and two years of HRT use, dashing any suggestion that increased cancer risk only developed after long-term use. But the risks grew larger the longer the HRT treatment continued.

Researchers, medicine watchdogs and HRT companies last night sought to dispel any sense of panic at the latest findings, which arose from the biggest single study of women’s HRT use and breast cancer. But the results dealt another huge blow to the reputation of the drugs, used by an estimated 1.5m women in the UK and responsible for 6m prescriptions annually in England alone.

These were once extolled for their power not only to treat the symptoms of the menopause, such as hot flushes and night sweats, but to make “new women” of those entering their 50s and 60s.

But in the past two years researchers worldwide have questioned how effective HRT has been in preventing many illnesses, and whether the long-term benefits outweighed risks.

The biggest blow dealt by the Million Women study, the results of which are published in the Lancet medical journal today, was to combination oestrogen and progestogen therapies, taken by about half of all those on HRT in the study. These doubled the breast cancer risk. They are widely used, because oestrogen-only therapies are known to increase cancer of the womb-lining.

But oestrogen-only therapies, taken by four in 10 HRT users in the study, only increased breast cancer risk by 30%, leaving a difficult dilemma for women and their GP advisers about what to do now. Breast cancer is far more common than cancer of the womb. However, more reassuringly, the extra risk disappeared within five years of giving up treatments.

Other emerging evidence from the study suggests that women still using HRT have a 22% extra risk of dying from breast cancer, for which survival rates have greatly improved in recent years. But so far, according to researchers, this result is of “borderline” statistical significance, and it is too early to estimate extra cancer deaths due to HRT.

However the researchers, funded by Cancer Research UK, the NHS breast screening programme, and the Medical Research Council, calculate that during the past decade HRT use has resulted in an extra 20,000 breast cancers in women aged 50-64, combination therapy accounting for three-quarters of these. In this age group, 15,000 new breast cancers are diagnosed yearly.

Lead author Valerie Beral, director of the Cancer Research UK epidemiology unit at Oxford, said: “Since our results show a substantially greater increase in breast cancer with combined HRT, women need to weigh the increased risk of breast cancer caused by the addition of progestogen against the risk of uterine cancer. Comparing the risk is by no means simple, and women may well want to discuss options with their doctor.”

Australian Consumers? Association said that it was understandable that many women would be extremely worried by recent research findings that HRT can increase the risk of heart disease and breast cancer.

?Many women are feeling like they have been treated like guinea pigs. HRT has been widely promoted as a safe panacea to the uncomfortable symptoms of menopause, now we are finding that sometimes it is not safe at all? Nicola Ballenden, a Senior Health Policy Officer with the Australian Consumers? Association said today.

Ms Ballenden said that the revelations had the potential to undermine consumers? trust in their doctors? advice, which could be very damaging.

This story highlights the fact that pharmaceutical companies are the main source of information for many doctors. Pharmaceutical companies have an interest in selling their products and they do this by heavily promoting drugs, including HRT to doctors. The question is whether doctors are getting balanced information or just promotional material from the pharmaceutical companies.

Also muddying the waters are the mixed ?expert medical opinions? that abound. ?What consumers, and often doctors, don?t understand is that frequently medical experts have a financial relationship with pharmaceutical companies, so their expert opinion might be influenced by this arrangement? Ms Ballenden said.

Consumers are right to wonder why they weren?t given the full picture earlier. As long ago as 1997 British Medical Journal review of 22 studies concluded that there was no evidence that post-menopausal HRT prevents heart and blood vessel problems. Until recently women weren?t given this information, but were told that HRT could protect them from heart disease.

Consumers are right to ask ?Why weren?t these products tested more thoroughly before they were prescribed so broadly and why weren?t we told of the possible risks earlier??