Now the Truth Is Known

By Amy Allina and Cindy Pearson

Editor's note: On July 9, 16,000 participants in the Women's Health Initiative (WHI) were told to stop taking hormone replacement therapy. The bombshell announcement, made because women had elevated chances of breast cancer, heart attack, stroke and blood clots after five years of using HRT, vindicated the Network's long effort to draw attention to the dangers of HRT and of aggressive pharmaceutical marketing. The following is excerpted from an article that appeared in the San Jose Mercury News within days of the WHl announcement.

In 1966, Feminine Forever was published and quickly became a bestseller. The book, by Dr. Robert Wilson, promoted estrogen as a wonder drug that could counter the changes of menopause and keep women young, attractive, sexually vital and happy. Wilson set up a foundation and traveled around the country, preaching the gospel of estrogen and describing the experience of menopause in frightening, Gothic terms: warning that "no woman can be sure of escaping the horror of this living decay." Menopausal women, whom Wilson called an "intersex" because they supposedly are no longer totally female, could, however, save themselves by taking estrogen.

It would make them "more pleasant to live with" and prevent them from becoming "dull and unattractive." Estrogen had been in use since the 1930s to treat hot flashes and other menopause symptoms. But Wilson's claims were grander, playing on aging women's desire for longevity and on
their fear of losing beauty and health. By 1975, Ayerst-manufactured Premarin, the leading estrogen pill, was one of the top five most-prescribed drugs in the United States. It was only years later that the public became aware that Wilson's book and his foundation were financed secretly by Ayerst, which merged with, and is now known as, Wyeth. Now, more than 35 years later, drug companies are still selling hormones to menopausal and post-menopausal women who fear loss of their youth and the onset of age-related illnesses. The marketing is more sophisticated today, but the underlying message is the same: There's a pill that will make you healthy, happy and beautiful— never mind whether it has been scientifically proved.

A Larger Problem
The WHl news highlights a story that affects us all. It is a cautionary tale about our desire to believe that pills can keep us healthy and youthful, and the lengths to which drug companies exploit our desire for that silver bullet. The first big scare about taking estrogen came in December 1975, when two studies linked estrogen to endometrial cancer, in the lining of the uterus. Estrogen prescriptions dropped off until the 1980s, when research showed that the risk of uterine cancer was reduced when estrogen was combined with a second hormone, progestin. The popularity of hormone therapy exploded as doctors and many women embraced it enthusiastically. Although the drugs are now available together in one pill, many women still take estrogen and progestin in separate dosages. Estrogen pill sales rose from 13.6 million prescriptions in 1982 to 31.7 million in 1992. In 1995, Premarin estrogen pills were the top-selling brand-name pharmaceutical in America. Sales of progestin pills rose fivefold in the same period, to 11.3 million. But there were some women who remained skeptical and, in 1990, they found justification in the results of a new study.

The Nurses Health Study, then the largest U.S. women's health study, found that women with breast cancer had a moderately greater chance of having used estrogen than women without breast cancer. It didn't prove that estrogen caused breast cancer, but it was a strong association. Hormone proponents responded byassuring women the combination HRT drug was not associated with increased risk of breast cancer, and by asserting that hormones offered benefits that far offset the small increased risk of breast cancer. Both of these arguments have now been proved false. Drug-company ad campaigns have played paradoxically to feminist sensibilities even as they promoted the idea that it's important for aging women to look young. Well-meaning doctors also e misled by sales pitches crafted to look like scientific information.

It was, effectively, the marketing of theory as fact. Manufacturers of HRT drugs also paid for favorable research about the drug and to disseminate the results to doctors. They footed the bill for medical- journal supplements that resembled peer-reviewed studies. The drug makers and their defenders were taking legitimate scientific hypotheses and presenting them as proven conclusions—without doing the time-consuming work of clinical trials. In day-to-day life, it is normal to take leaps of faith to act on a hypothesis without proof. But in health care, the stakes are higher. Drugs are powerful and carry the possibility of harm. To prescribe them based on faith instead of science is a big risk. In this case, the leap of faith has exposed millions of women to increased risk of breast cancer, heart attack and stroke—all of which can kill.

Alternatives Available
There are alternatives to HRT that have been found by the Food and Drug Administration to safely prevent bone loss and fractures. Bisphosphonate drugs and raloxifene prevent fractures, although they are new and no long-term safety data is yet possible. Moreover, the National Institutes of Health has found strong evidence that calcium and vitamin D help preserve strong bones and that regular exercise contributes to developing bone mass and reducing the risk of falls in the elderly. The mere fact that the government was willing to pay for an expensive medical study of HRT should have been enough to let everyone know that HRT was unproven for long-term use and disease prevention. But women's hopes for a bulwark against aging, combined with decades of drug-company marketing, had done their work.

Most women and most doctors prescribing hormones to their patients believed they were safe and prevented everything from heart disease to wrinkles. Now the truth is known. But the ways Americans view medicine, and the marketing methods of the drug industry, have not changed. Who knows what is coming next? It is not hard to imagine that one of the new drugs people are taking today, believing that it makes them healthier, will be the HRT bombshell of tomorrow.

Amy Allina, the Network's program and policy director, and Cindy Pearson, the Network's executive director, helped write The Truth About Hormone Replacement Therapy: How to Break Free From the Medical Myths of Menopause (member price of $10.95 through the Network).