Hormone Therapy: A Prescription for Replacement by Penni Mitchell
In 1966,an American doctor named Robert Wilson wrote Feminine Forever, a book that promoted estrogen replacement as a miracle cure for women 's aging woes. "Breasts and genital organs will not shrivel," the good doctor promised. "Such women will be much more pleasant to live with and will not become dull and unattractive."
According to Dr.Wilson's son, Weth-Ayerst, he manufacturer of Premarin, aid he expenses of writing the book and financed his fther's lectures throughout the U.S. Later, when it was discovered in 1975 that taking estrogen increased women 's risk of uterine cancer, a formula of estrogen with progestin became the standard hormone replacement therapy (HRT). Officially, HRT was approved as a temporary measure to provide relief for women experiencing debilitating hot flashes and night sweats -a target market that includes not more than 10 and 15 percent of women in menopause.
Yet prescriptions for HRT were hand- ed out like candy to millions of symptomless women on the basis of endorsements and claims that were not adequately tested. The Society of Obstetricians and Gynecologists of Canada recommended in 1994 that all menopausal women take HRT for at least 10 years -regardless of whether they experienced any disruptive symptoms. Feminist doctors were outraged. B.C. endocrinologist Dr.Jerilynn Prior was one of them.
Yes, she said, estrogen decreases at menopause and yes, the risk of heart disease increases at menopause. However, to say that heart attacks are brought on by a deficiency of estrogen is "like calling a headache an aspirin-deficiency disease," according to Dr..Prior. More significantly, no double-blinded randomized clinical trials -the gold standard of drug testing -had confirmed that HRT prevented heart disease. Much of the belief that HRT prevented heart disease stemmed from the Nurses 'Health Study, an ongoing observational investigation of more than 121,000 women who are surveyed about their lifestyle and medical conditions every two years. It observed that women who took estrogen for 10 or fewer years reported a lower rate of coronary heart disease. However, since it wasn't a double-blinded study with a placebo group, no one could say for certain whether the correlation was due to taking estrogen or to other factors.
There was little doubt, however, that the medical profession 's endorsement helped HRT become the top-selling drug in Canada by 1998. Premarin sales had reached $1 billion in North America and in Canada the number of prescriptions topped four million, according to pharmaceutical sales tracker IMS Health. Drug manufacturers helped get the message out by sponsoring brochures and advertising to physicians supporting the lower heart risk idea. The reaction of millions of healthy North American women was, 'Well, why not?'.
The answer came last July. A 16,000-woman study on HRT and heart disease sponsored by the U.S. Women 's Health Initiative (WHI) was called off early in order to protect the participants' health. It found that healthy menopausal women who took combined estrogen and progestin hormone therapy for more than four years had a higher relative risk of invasive breast cancer (26 percent), strokes (41 percent) and coronary heart disease (29 percent) compared to women who were not given HRT. Dr.Marcia Stefanick, the principal investigator of the WHI study, concluded that, "They linked up a very beneficial product for treating menopausal symptoms to be the answer for treating all of a woman's aging problems." A bigger problem than the natural aging process, according to Kathleen O 'Grady, communications director for the Canadian Women 's Health Network is "the approach that says you prescribe first and test after."
In The New York Times, Cynthia Pearson of the National Women 's Health Network in the U.S. echoed O 'Grady 's concern, fuming, "Hello? You couldn't approve a drug for healthy men without a randomized clinical trial." So gaga were most physicians about HRT that when women first learned that long-term use of the drug appeared to be linked with an increased risk of breast cancer, they were tut-tutted and reminded that since heart disease is a bigger killer than breast cancer, HRT was worth the risk. For another group of women, the risk of breast cancer was behind a study to see whether tamoxifen could reduce breast cancer for women categorized as 'high risk.' The Breast Cancer Prevention Trial involved over 13,000 Canadian and American women and ended in 1998. "Fewer women taking tamoxifen developed breast cancer within a four-year period," confirms author and breast cancer survivor Sharon Batt. That study was halted early, too. In this case, the researchers claimed that the results were so clearly in favour of tamoxifen as a preventive treatment that they wanted more women to be able benefit from taking it. Critics have pointed out that the tamoxifen study was less a case of disease prevention than one of disease substitution, since participants taking tamoxifen developed higher rates of endometrial cancer, blood clots and other illnesses.
Tamoxifen's preventive effects also appeared to wear off after year four, around the same time the study was halted. "Three women taking tamoxifen died from blood clots in their lungs and an update on the trial shows continued increase in endometrial cancers including four cases of uterine sarcoma, a rare, aggressive form of cancer," according to Batt, who is the Elizabeth May Chair in Women 's Health and the Environment at Dalhousie University. Since then, tamoxifen 's manufacturer, AstraZeneca, has changed the product insert to contain a warning about the risk of potentially fatal strokes, pulmonary embolism and uterine malignancies. Despite the warning, Batt is still worried. She believes that the strategy of prescribing drugs to healthy people -primarily women -"threatens to overtake and even displace the traditional public health strategy of identifying and removing the causes of disease." A case in point is that breast cancer rates have steadily increased over the last century.
However, in spite of evidence that environmental toxins such as pesticides mimic the effects of estrogen in the body and increase the risk of breast and other cancers, the chemical/pharmaceutical industry has successfully kept public attention focussed on the notion of 'a cure.' It 's an approach that 's lost its charm with politicized breast cancer survivors. "As long as the federal government and the cancer industry encourage women to believe that prevention of breast cancer comes in pills, we will never get to the end of this," according to Barbara Brenner, executive director of Breast Cancer Action in San Francisco. Healthy women are once again being recruited for the Study of Tamoxifen Against Raloxifene, a study comparing the effectiveness of raloxifene and tamoxifen to prevent breast cancer among healthy women identified as 'high risk.' Tamoxifen is currently prescribed to some breast cancer patients to reduce the recurrence of the disease. Health Canada hasn't approved the drug -as the U.S. Food and Drug Administration has -as a preventive treatment for breast cancer. However, Batt and other health activists want to make sure that this new form of chemotherapy does not become widespread in Canada.
"The precautionary principle states that when there are reasonable scientific grounds that a product may be unsafe, we should take precautionary measures," Batt explains. The precautionary principle would place responsibility for demonstrating safety on the manufacturer. Batt belongs to The Working Group on Women and Health Protection, a coalition of health activists calling for a host of reforms, including consumer input into the country 's drug regulation process. And environmental groups from Greenpeace to the Sierra Club of Canada are also demanding that Health Canada and Environment Canada follow the precautionary principle.
"The first rule of disease prevention is to put safety first, and that means before trade and profits," says Batt.
There are some positive signs. In 2002, the federal Health Products and Food Branch announced a public advisory committee, however it has yet to be formed. Bringing doctors on side is another part of the challenge. As ethicist Susan Sherwin points out in The Politics of Women's Health: Exploring Agency and Autonomy, "Few physicians demand examination of the potential contributory role played by the use of pesticides or chlorine, or the practice of feeding artificial hormones to agricultural animals." And few inform their patients that alternatives to HRT exist. Black cohosh, for example, has been found in a new clinical trial to be as effective as standard estrogen therapy in reducing hot flashes. However, the Society of Obstetricians and Gynecologists' new guidelines on HRT state that "alternative therapies are limited in their effectiveness."
The guidelines also say that combined HRT "should not be initiated or continued for the sole purpose of preventing future cardiovascular events." An increasingly vigilant consumer health movement is demanding not only a change in the power imbalance between individual women and their physicians, but between the gatekeepers of health and the pharmaceutical industry. Reducing the health risks to healthy individuals from drugs prescribed for preventive campaigns is now part of that effort. As Barbara Brenner of Breast Cancer Action puts it, "Women have been guinea pigs for too long."
Check out the report "Preventing Disease: Are Pills the Answer?" on the web site of the Working Group on Women and Health Protection, (www.whp-apsf.ca).