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Magazine
End of an era
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The recently discovered adverse effects of hormone replacement therapy (HRT) have doctors the world over in a panic. DR. UMA KRISHNASWAMY discusses the implications of the decline of this therapy and questions its success in the first place.
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HRT became a magic pill to stave off the effects of aging.
SPRING 2002 has been a distressing season for many menopausal women and their health care providers around the world, but nowhere more so than in the United States. On May 31, a federally funded study, a component of the Women's Health Initiative (WHI), was stopped prematurely. This was a rigorous study to assess the benefits of combined estrogen and progestin administered long-term to healthy menopausal women.
The WHI is sponsored by the National Heart, Lung and Blood Institute in collaboration with other components of the National Institutes of Health (U.S.): the National Cancer Institute, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Ageing and the Office of Research on Women's Health. The key players, one can see, have unimpeachable credentials.
Between 1993 and 1998, the WHI recruited 16,608 healthy, menopausal women with an intact uterus between the ages of 50-79 to participate in a double blind-controlled trial (the most precise of research trials). Located in 40 clinical centres in the U.S., 8,506 women were given Prempro (conjugated estrogens + medroxy progesterone acetate) provided by Wyeth Ayerst Research and 8,102 women, a placebo.
The patients were stringently monitored and 5.2 years later, a small but definite increase in the incidence of breast cancer, stroke, coronary heart disease and blood clots in the women taking Prempro set alarm bells ringing loudly enough for the study to be stopped by the Data Safety and Monitoring Board of the WHI.
In effect, researchers found that if 10,000 women used the estrogen-progestin combination in question for one year, it would result in: Eight more instances of breast cancer, eight more strokes, seven more instances of heart attacks, eight more instances of pulmonary emboli.
Paradoxically, the drug would reduce the incidence of hip fractures and colorectal cancer to roughly the same degree. But the risks of the drug far outweighed the benefits thus transgressing a cardinal rule of medical ethics: "Primum non nocere" i.e. "First, do not harm (the patient)".
A week later, the media started carrying the press announcement of the National Institute of Health, U.S., released on July 9. A fortnight later, the stories are still running in print, electronic and visual media, so great has the global impact been.
There are nearly 17 million women in the U.S. taking some form of Hormone Replacement Therapy (HRT) with a reported six million women who are on a combination of estrogen and progesterone. Many are on Prempro, manufactured by the pharmaceutical giant Wyeth Ayerst.
Prempro is one of the most popular HRT prescriptions written by U.S. doctors with 22.3 million prescriptions issued last year alone. Contrast this to the United Kingdom where there was an estimated six million prescriptions for HRT issued last year. Prempro is second only to Premarin (a conjugated estrogen derived from the urine of pregnant mares) also manufactured by the same company.
There were 46 million prescriptions last year of Premarin in the U.S. and sales reportedly amounted to more than one billion dollars. The latter drug, too, is involved in a controversy with animal rights activists claiming that the mares in question are farmed with an unacceptable degree of cruelty.
Though Prempro is not readily available in Europe or Asia, similar combinations of estrogen and progestin are. Thus the repercussions of the WHI study are causing consternation well beyond the Atlantic and Pacific.
Phones are ringing in doctor's offices around the world, with patients wanting to understand the implications of the press release. Doctors are consulting their peers to evolve a strategy of damage control and lawyers in the U.S., rightly or wrongly, are calling for and have initiated class action against Wyeth.
It is said that Wyeth had to recently set aside $13.2 billion to settle lawsuits. . And in the New York Stock Exchange, Wyeth shares fell 39 per cent within a week of the announcement.
How did HRT, which was and still is one of the best therapeutic drugs to combat the usually short-lived symptoms of menopause undergo a metamorphosis into a long-term preventive medication ostensibly to prevent chronic conditions such as heart disease and osteoporosis?
We need to look at the story of HRT, which began nearly four decades ago in the 1960s. The pharmaceutical giants Searle, Upjohn and Wyeth Ayerst, so the story goes, supported a New York physician, Robert. A. Wilson, to write a book called Feminine Forever, which was intensely promoted around the U.S..
Dr. Wilson's contention was that menopause was "a state of decay" with women reduced to a "cow-like passivity," leading to their taking refuge in alcohol, sleeping pills and suicide. He advocated the use of estrogen to reverse these physical and mental changes. The stage was thus set in the U.S. and later in Western Europe to view menopause as a disease affecting the mind, body and spirit to be treated by HRT, rather than as a natural phase of life.
The sales of HRT soared, pushed along by aggressive marketing and sales promotions by pharmaceutical companies. The offensive sexism and ageism of that era has been gradually replaced by scientific jargon on how HRT prevents osteoporosis and coronary heart disease.
The pharmaceutical companies adopted a strategy of selling direct to women through the vivid imagery of glossy advertisements in women's magazines and television. How can a 40-something woman resist the sweet voice of singer Patti La Belle saying, "I'm glad I said yes to Prempro?"
Mundane HRT became a magic pill to stave off the effects of ageing. Will HRT make me as young and attractive as Patti? "Feminine Forever" indeed, but with the backing of science in the form of research data!
Was the medical profession unaware of the potential risks in the long-term use of HRT? There has been a steadily growing body of medical literature, though mainly observational studies (which are not as statistically valid as double blind control studies) as also some well publicised research trials such as the Heart and Estrogen/Progestin Research Study (HERS), which have alerted doctors to the increased risk of coronary heart disease. Similarly, there have been studies alerting one to the potential risk of breast cancer with estrogen and progesterone.
Indeed, professional bodies have laid down prescribing and monitoring guidelines for HRT for everyday use in clinical practice. Textbooks of gynaecology, endocrinology and surgery carry specific chapters on the topic. Are these practice guidelines being flouted by doctors?
The latest issue of Time carries a story of a 60-year-old Miami journalist who was put on HRT, for ostensibly no reason, at menopause. What is alarming is that HRT was started despite the woman having a strong family history of breast cancer!
Such stories give credence to the view held by some that the HRT debacle arose from a "triumph of marketing and advertising over science". Yet others accuse the medical profession of gullibility while others hint darkly of the influence wielded by the pharmaceutical industry over medical education, research and clinical practice.
The fact is this is no time to point fingers or find scapegoats. This is a time to praise the National Institutes of Health, for having put ethics and safety ahead of academics; a time for the medical profession to look at the unresolved issues of HRT use; most of all, the time to extend our gratitude to a group of women who participated in this landmark trial at personal jeopardy, thus triggering a paradigm shift in perception and ensuring the safety of millions of women around the world.
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