The recent news about the harmful effects of hormone replacement was played in the media as a health story, but it is much more than that. In fact, it may be the hot-flashiest corporate scandal to date: Let's call it Estron.
If other corporate scandals have been about fudging figures, this one is about fudging science--something that seems to have been surprisingly easy to do. And such is the corporate culture that we have apparently preferred to believe the drug companies rather than the women's health advocates who have been lobbying for decades simply to get the scientific evidence to back the companies' claims. The director of the North American Menopause Society (NAMS), Dr. Wulf Utian, called the bad news about hormones a bombshell, but it really isn't. Information has been slowly accumulating about hormone replacement therapy's risks, even as Wyeth and other manufacturers have been pushing their product as an elixir for a widening group of symptoms. In recent years, this potentially carcinogenic drug has been marketed with the nonchalance of a vitamin pill: HRT advertising suggests that almost no woman over 50 couldn't benefit from it somehow.
Estron is the latest in a long line of scandals pitting women's health against the interests of Big Pharma--scandals like the sale of faulty Dalkon Shield contraceptives, which caused infertility, and medications like DES, which caused severe illnesses in users and their children. What all these cases have in common is that--like the manufacturers of menopausal hormones--the drug companies, in their rush for profits, insufficiently tested their wares before selling them to millions. What these scandals suggest is that somewhere in the swampy landscape of medical research funding, unhealthy relationships incubate between medical practitioners and the drug-company reps who manage to dazzle them with quasi science and quasi truths. The industry spends around $15 billion a year to promote its products--more than it spends to develop them. Clearly, even those doctors who resisted the luxury-cruise-lectures approach to sales found themselves suckered in.
The manipulation of HRT's scientific credentials began back in the mid-1960s, when Wyeth paid gynecologist Dr. Robert Wilson to extol its new wonder drug, estrogen replacement. In an evocatively named book, Feminine Forever, Wilson declared that by replacing the estrogen lost at menopause, women would remain attractive and easier to live with. Over the decades since, Wyeth and other hormone manufacturers have revised dosages and combinations to fit new medical revelations and poured billions into sophisticated propaganda to get their message out. The message is that menopause is not a natural life stage but a disease--estrogen deficiency--and it will make you old. HRT is the cure, and it will keep you young.
In recent years the manufacturers have claimed protective qualities for HRT way beyond its original ambitions. First, it promised (and delivered) relief from menopausal symptoms. Next came claims for protection against heart disease in women already affected, and then in healthy women. Then came its role as a treatment against osteoporosis, which, manufacturers warned (falsely), becomes an instant risk at the moment of menopause (it's a gradual risk over many years).
The truth is that the manufacturers didn't exactly know what HRT did or didn't do, because they never ran a big, randomized national study stringent enough to meet medical standards. For more than twenty years, the companies used observational studies showing that women who took hormones were healthier, but they didn't look at why: Was it that the hormones themselves made women healthier, or that health-conscious women were more likely to take hormones to begin with? There were many other uncertainties. Yet calls to answer these questions, from women's health groups and even from prominent politicians like Pat Schroeder and Olympia Snowe, went unheeded.
For all the hype, there has been plenty of evidence, both scientific and epidemiological, that estrogen, named a carcinogen by the FDA two years ago, is not a wonder drug for everyone. Thirty percent of prescriptions for estrogen remain unfilled, and the growing search for alternative menopause products shows that increasing numbers of women are uncomfortable with the prospect of a lifetime of swallowing synthesized horse urine. And for all the spin, there has also been accumulating evidence of serious side effects. As early as 1975 the FDA identified links between estrogen and higher rates of uterine cancer. (Wyeth responded by adding another product, progestin, to offset the risk.) In 1990 the Nurses Health Study reported that women on estrogen faced a 36 percent greater risk of breast cancer. That same year the FDA refused to approve Premarin as a treatment to prevent heart disease, because the company's evidence didn't convince them. The 2000 HERS study, actually funded by Wyeth, found that hormone therapy increased risks in heart disease patients in the first few years. (Wyeth countered that long-term, it works.)
And people have been trying to warn us. As far back as the mid-1990s, The Menopause Industry, by Australian reporter Sandra Coney, presented heavily researched evidence of uterine bleeding, gallbladder disease and increased cancer rates in hormone takers. In 1997 breast cancer specialist Dr. Susan Love's Hormone Book returned to the link between HRT and increased breast cancer risk and came under attack for raising an alarm. Earlier this year Cindy Pearson, executive director of the National Women's Health Network, published The Truth About Hormone Replacement Therapy, outlining many other discrepancies between hormone hype and science. The medical establishment barely paid attention.
Finally, the scientific evidence that we have now, based on two large randomized trials, is definitive, according to one of the study's leaders, Dr. Deborah Grady. The trials have shown that not only does HRT do more harm than good for women with existing heart disease, but it doesn't protect healthy women either; in fact, during the trial it increased incidence of heart attacks, breast cancer, strokes and blood clots--enough to have caused the study to be abandoned three years early. And yet belief in the hormone was so strong that researchers feared it would be unethical to put women on placebos.
How is this possible? Dr. Utian of NAMS has admitted that many different parties--from the drug companies to their paid researchers and spokespeople to the prescribing gynecologists--have had a vested interest in the success of hormone replacement, and for them, he told the New York Times, the issue is about more than data. For them, Utian said, truth is opinion. But that seems a risky precept for physicians to work with. It sounds like something Arthur Andersen would say.