VOICES
The Wonder Drug that Wasn't
In January 1997, editors and writers for some of the country’s largest magazines gathered in Washington to attend a ball celebrating President Clinton’s second inauguration. They ate, drank, mingled, and spent the night, all courtesy of the pharmaceutical company Wyeth Ayerst. It was common for the leading manufacturer of hormone replacement therapy (HRT) drugs to court women’s magazines. Let’s hope the party’s over.
Their top-selling drugs — Premarin, Prempro, and Premphrase — which generated more than $2 billion for Wyeth last year, or nearly 15 percent of the company’s revenue, may finally be fading, now that the National Institutes of Health has advised 16,000 women in a nationwide trial to stop using HRT. The pills were shown to raise the risk of heart attack, stroke, blood clots, and breast cancer. Nearly 45 million prescriptions for Premarin alone were filled last year, and experts say that in hindsight, the medical community jumped the gun. For years, doctors — who were also intensively solicited by drug companies — urged women to take hormones to ward off heart disease, despite the fact that the drugs had never been approved for that purpose.
But there’s another reason for the medications’ enormous popularity: in the effort to enlarge the market for these drugs, pharmaceutical companies aggressively promoted off-label uses of estrogen drugs to journalists, not only through wining and dining but by routinely supplying them with information that overstated the benefits and ignored the risks. Worse, these efforts worked.
As former health editors — at McCall’s and American Health for Women — we were provided a steady stream of sources who spoke about HRT’s supposed heart benefit as if it was proven, and who dismissed research showing that the drugs might actually promote heart problems. These experts also played down the breast cancer risk, one of the leading reasons many women have refused to take hormones over the years. The sources’ financial ties to the drug companies were not revealed. “Companies have to get approval before they can market a drug for a particular use, but that doesn’t mean they can’t pay a university professor or group of experts to promote it off-label,” said Dr. Diana B. Petitti, director of research and evaluation at Kaiser Permanente Southern California. Food and Drug Administration rules prevent speakers from touting unapproved drug uses during press conferences, but they are free to do so in other settings.
Written materials distributed over the years trumpeted the same themes. As part of a 1998 American Heart Association campaign sponsored by Wyeth, we received a twenty-two-page pamphlet titled, “Take Charge! A Woman’s Guide to Fighting Heart Disease.” Loss of estrogen was listed first among heart-disease risk factors. A giant blurb stated: “Estrogen replacement helps protect against coronary heart disease risk.” Estrogen’s then-proven risks, like endometrial cancer and blood clots, were never mentioned.
Drug companies also tried to sell journalists on HRT by playing up the fact that heart disease is the number one killer of American women. Few editors and writers for women’s magazines — the vast majority of whom are women — could resist. The problem was that in these stories, journalists repeatedly hyped the medication’s unproven uses and played down the dangers. A story in the October 1997 issue of Ladies Home Journal, for example, stated: “A woman’s chance of dying from heart disease is more than five times greater than dying from breast cancer, and HRT lowers that risk.” An article published the following September in Better Homes and Gardens, the sixth-largest-circulation magazine in the country, advised women to “talk to your doctor about taking estrogen or hormone replacement therapy,” adding, “Research has shown that estrogen and HRT may reduce the risk of heart attack after menopause by as much as 50 percent.”
Over the years, this idea that hormones protect against heart disease — mostly based on a single observational study that is now cast in doubt — became part of the vernacular, and many magazines never even bothered to quote a source or cite statistics. A story in the November 1, 1999 issue of Ladies Home Journal stated in passing, “estrogen replacement therapy, which also protects against cardiovascular disease . . . .”
Even more disturbing, magazines continued to make statements like that after the 1998 Heart and Estrogen/Progestin Replacement Study (HERS) trial, a controlled clinical study that raised a big red flag in finding that women who use hormones have higher rates of heart disease during the first year of use. More risks were found in the Women’s Health Initiative, the national trial that was halted by the NIH in July.
Women’s magazines aren’t the only ones to blame. Newsweek, for example, ran many stories over the years that quoted the same handful of sources who have financial ties to the drug companies, Wyeth in particular, and never mentioned those ties. Several of the stories cited no sources at all and, in fact, read like press releases in touting estrogen’s benefits: Estrogen replacement therapy, according to a May 25, 1992 article, under the empowering title “Every Woman for Herself,” “almost always zaps hot flashes, soothes vaginal dryness, improves bladder problems, evens out mood swings, and clears up short-term memory loss. It also combats the more serious effects of estrogen deficiency: osteoporosis and an elevated risk of heart attacks. The hormone retards bone loss and cuts death from heart attacks in half.”
Then, in an almost absurd turnaround, in Newsweek’s July 22 coverage of the Women’s Health Initiative, a story titled “The End of the Age of Estrogen,” says: “Women had been told for decades that estrogen taken with progestin would not only ease hot flashes and insomnia but help preserve bone strength, mental acuity and most important, heart health.” Nothing like the passive voice.
What we can say about the past is this: the millions of American women who swallowed a hormone pill every day in the hope that it would protect them against heart disease deserved to know, at a bare minimum, that the drug was never approved to prevent or treat heart problems. Had journalists been more skeptical of the information they received, and reported on HRT with greater accuracy, women would have understood the differences between the medications’ proven and unproven benefits and been better informed of the significant and life-threatening risks.
Going forward, it is important to recognize that journalists are confronted with a challenge that’s hardly limited to these particular drugs: pharmaceutical companies aggressively pursue the press, and too often their messages are misleading. What can we do? We can start by securing sources that have no financial ties to the drugs we report on, or being sure to cite them when they do; by accurately reporting statistics and not using the same old stale numbers; by distinguishing between observational studies and controlled trials and other types of studies; by saying when a drug use is off-label; by being aware of nonprofit organizations that sound independent but are funded largely or entirely by drug companies (there are many!); and, for sure, by turning down invitations to those “free” lunches.
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