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Hormone Replacement Therapy - Truth at Last

Evidence for serious risks associated with hormone replacement therapy (HRT) has left women struggling to interpret conflicting advice from their doctors and the media. A series of large studies over the past two years has shown that HRT doubles the risks of breast cancer and makes those who suffer from such a cancer less likely to survive. It also significantly increases the risk of blood clots, strokes and heart attacks, and doubles the risk of dementia in women over the age of 65.

Remarkably, international debate over the future of HRT continues, and it is reported that less than half of the 30 million hormone users in the United States have quit. Official guidelines for doctors now state that HRT is no longer recommended long-term for the prevention of heart disease and osteoporosis and should only be used in the lowest dose for the shortest time possible for the control of severe hot flashes and night sweats.

Forty years ago, the Western world thought that medicine had discovered the Holy Grail in the form of supplemental oestrogen - a medicine initially claimed to virtually stop women from ageing. Although justification for long term use came from trials that were observational, poorly designed or lacked controls, by the 1990s, HRT was considered the treatment of choice for the health-conscious menopausal woman - the accepted way to manage the ups and downs of the menopause transition and to prevent heart disease, osteoporosis, even Alzheimers disease. By 2001, HRT was the number one prescription drug in the world. The promise that a single pill could prevent age-related chronic diseases had led vast numbers of healthy women to take medication for diseases they didn’t have, and may never have developed. We now know they also were exposing themselves to serious harm.

Barbara Seaman, author of 'The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth' points out that women were never told that they were part of a huge uncontrolled experiment. "Over the years, hundreds of millions, possibly billions of women, have been lab animals in this unofficial trial. They were not volunteers. They were given no consent forms. And they were put at serious, often devastating risk."

Results of a large study published in The Lancet in August 2003, calculated that HRT had caused 20,000 cases of breast cancer over the past decade in Britain alone. Because the US population is roughly six times that of the UK, it is possible that 120,000 cases of breast cancer in American women have been caused by HRT in the past decade. With the other serious risks taken into account, HRT is now implicated in the deaths and suffering of hundreds of millions of women in more than 80 countries. They have had their lives shortened rather than lengthened after trustingly taking hormones for purposes that had not ever been proven. Professor Bruno Muller-Oerlinghausen, chairman of the German Commission on the Safety of Medicines describes HRT as a ‘national and international tragedy’ more significant but less visible than the thalidomide scandal.

In reality HRT had only been proven to be effective in relieving hot flashes and treating vaginal dryness in postmenopausal women. A recent article by Adriane Fugh-Berman and Cynthia Pearson of the National Women's Health Network asks the obvious question: “Why did the medical and research community ever believe that hormone replacement therapy prevented or treated disease? Not a single controlled trial ever showed that HRT prevented cardiovascular disease, stroke, Alzheimers disease, or wrinkles, nor that it was an effective treatment for depression or incontinence.”

The warning signs were there. Several studies had already linked HRT to breast cancer and British researchers had previously warned that a number of placebo-controlled studies done before 1997 were showing that HRT increased rather than decreased the risk of heart disease. The studies were conducted by drug companies for licensing purposes but most remained unpublished and unavailable. The warnings of the researchers went unheeded, but recent editorial in the British Medical Journal finally questions why this information was never made available by the drug manufacturers.

The definitive Women's Health Initiative trial (WHI), a large long-term randomized controlled trial consisting of 16,608 healthy women aged 50 – 79 was halted prematurely in July 2002 when it was found that risks, particularly for breast cancer, heart attacks and stroke outweighed the small benefit to bone health. The trial advised that within 5 years, 1 in 100 women using HRT would have a serious adverse event. A separate branch of the WHI trial measuring the risk of estrogen only was similarly terminated in 2004 when it was found that estrogen alone also carries an increased risk of stroke, blood clots and dementia. It also increases the risk for cancer of the lining of the uterus.

Unchecked ‘disease-mongering’ has resulted in the treatment of non-existent diseases in well women for half a century - an experiment that has brought gargantuan profit to the companies involved. Whether anyone will be held accountable for the countless tragedies that must have resulted only time will tell.

Million Women Study Collaborators. Breast cancer and hormone replacement therapy in the Million Women Study. Lancet 2003; 362:419-427
HRT 'The New Thalidomide' Jeremy Laurance / The Independent (UK) 4 Oct., 2003
The Overselling of Hormone Replacement Therapy, Pharmacotherapy 10/21/2002 Adriane Fugh-Berman, M.D., and Cynthia Pearson, B.A. http://www.medscape.com/viewarticle/441936
Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321-333.
Stephen B. Hulley, MD, MPH; Deborah Grady, MD, MPH The WHI Estrogen-Alone Trial—Do Things Look Any Better? JAMA. 2004;291:1769-1771.