--Gloria Steinem, founding editor of Ms.
In his book Adverse Reactions, Thomas Maeder recalls the philosophy of Harry Loynd, an old-time president of Parke-Davis who was legendarily blunt. Loynd’s oft-repeated motto was “Pills are to sell, not to take.” He regarded physicians as extremely gullible, and lectured his staff, “If we put horse manure in a capsule we could sell it to 95 percent of these doctors.”
Were he still among us, Loynd might have a great giggle over the fact that Wyeth-Ayerst’s 50-year-old Premarin, boldly named for its featured ingredient, PREgnant MAre’s uRINe, finally rose, in the 1990s, to become the number one best-selling prescription drug in the United States. Indeed, despite some volatility and setbacks (including, most recently, boycotts by animal rights proponents on behalf of the horses), the estrogen-replacement drug has remained in the top 50 since l966--one of only two products to do so.
The Estrogen Spectrum
In the 1960s, ’70s and ’80s, most discussions of menopause permitted several points of view. At one extreme were the evangelistic proponents, such as Dr. Robert Wilson, author of Feminine Forever, who maintained that every woman should take estrogen and once said to me:
In the middle were those who believed estrogen might be beneficial for many or most women, but that some conditions precluded it: cancer, blood clots, high blood pressure, and perhaps fibroids or gallbladder disease.
Lastly, in the conservative corner, were believers that hormones should be prescribed only for the relief of significant symptoms, and with rare exceptions should be reserved for relatively short-term use of less than five years. Some of these conservatives observed that estrogen therapy signaled a daring, potentially dangerous departure in “prevention,” an example of what Dr. Adriane Fugh-Berman of the National Women’s Health Network dubbed “disease substitution,” i.e. trading off possibly lower risks of one disease for higher risks of another. Fugh-Berman minces no words when she laments, “Once consisting of such benign advice as ‘eat well’ and ‘don’t smoke,’ preventive medicine has become a repository of preposterous ideas.”
Feminists were further offended at the image of mature women conveyed in such constructs as “estrogen deficiency disease” or “outliving our ovaries,” but fear of hormone toxicity was hardly limited to feminists. One need only scan the current edition of an esteemed reference work, Goodman and Gilman’s Pharmacological Basis of Therapeutics, to discern that (thus far) estrogen’s benefits to the heart and bones remain unproven or unimpressive, while its role in cancer promotion is thoroughly established. Goodman and Gilman conclude, “The routine, prophylactic use of estrogen is difficult to justify.... When used, estrogens should be administered in the lowest effective dose for the shortest possible time.” These last two sentences express the essence of the conservative view. The long-term preventive benefits of hormonal treatments remain unproven; the short-term use, for symptoms, should be handled cautiously.
Ironically, those who would be cautious include some of the self-same researchers whose work is most widely cited in defense of prophylactic estrogen use. For example, in 1990, when Wyeth-Ayerst asked the FDA to approve Premarin for heart disease prevention, Dr. Meir Stampfer of the prestigious Harvard Nurses Health Study (NHS) testified, “If we applied current knowledge [of good health practices], I believe we could reduce heart disease by 90 percent without estrogen.” Another colleague from NHS, Dr. Graham Colditz, wrote the foreword to Carol Ann Rinzler’s cautionary book on Estrogens and Breast Cancer.
From Scrutiny to Ballyhoo
Why doesn’t the public know this--that FDA has so far refused to approve estrogen as a heart disease preventive, or that principal scientists in NHS hold themselves well aside from the great estrogen stampede? Some blame for the confusion must be placed on media coverage, which--since the end of the ban on advertising prescription drugs direct to the public--has shifted toward less scrutiny and more ballyhoo of such products.
Consider the New York Times, which publicized hopeful news from NHS about estrogens and the heart on page 1 (9/12/91), and frightening news about estrogens and breast cancer-from the same source-on page 18 (11/28/90). Other important negative findings from NHS--such as that the risk of asthma doubles in long-term estrogen users--did not make the paper at all, nor did the Times include the reports in the Lancet last October (10/12/96) that women on lower-dose estrogen replacement continue to face an increased risk of blood clots in the legs and lungs. (Both asthma and blood clots are potentially life-threatening.)
As a result of the vested interests pharmaceutical advertising supports, the conservative view on hormone therapy is no longer seen or heard on many talk shows, is rarely found in magazines that seek advertising, and is muted in prestigious newspapers. Instead of recognizing the spectrum of positions, only extreme and middle-of-the-road proponents of estrogen therapy are acknowledged. That long-term hormone treatment is still controversial, still experimental, still considered dangerous by more than a few authorities, is concealed from general viewers and readers.
Having reported on estrogen products for more than 30 years, I still lean towards the conservative position--and as a result, in the 1990s, I have given interviews to scores of magazine writers, only to have my comments removed from the final copy. I have been called by and booked on all three network morning programs, only to be canceled out with some lame excuse.
I Could Have Been Jane Brody
In 1975, Abe Rosenthal, then executive editor at the New York Times, offered me a job writing about consumer affairs and health, starting at scale. I was aware that he had just hired Mimi Sheraton to write about food for twice that amount. So, as a veteran author of several magazine columns and two books, I asked him to justify the discrepancy, pointing out: “Her job is fun; mine would be hard work.” He replied, “Yes, but she would bring in ads, and you will lose them.” Back in that era, before the invasion of mass media by prescription drug ads, Rosenthal was probably referring not to the paper itself, but to medical specialty publications owned by the Times Media Division.
That was then. On January 19, 1997, Wyeth-Ayerst took a nearly full-page ad for its prescription antidepressant Effexor, prominently placed on the back page of section two of the Sunday New York Times. The ad depicts a joyous little girl ascending a staircase ahead of her mother and announcing, “‘I got my mommy back.’... Depression,” it warns, “affects not only the lives of its victims but also the lives of those closest to them.”
This appeal to maternal and familial guilt is eerily reminiscent of the ads for Premarin in the medical publications of the '70s, including those, owned by the Times Media, which could have lost revenue even then, had I accepted the job. One of my favorites stated, unblushingly, “for the menopause symptoms that bother HIM most.”
In another pitch for Premarin, a distraught woman has just done something awful, possibly hit her teenage son in the mouth, for his hand covers the lower part of his face and he appears rather in pain. He, his younger sister and his father are standing aside and staring at this harpy with fear and loathing. Father is comforting sister who is about to cry. Here the copy states, “Almost any tranquilizer might calm her down...but at her age, estrogen may be what she really needs.... Patients taking Premarin alone often report relief of emotional symptoms due to estrogen deficiency.”
Of course, no drug company has ever proved this to the satisfaction of FDA or any scientific body. Such advertising was therefore terminated. How convenient for Wyeth-Ayerst that they now own an anti-depressant for which they can recycle their same old sales techniques....
Articles That Echo Ads
Whatever advertiser pressures may have lurked in the wings of Abe Rosenthal and the New York Times’ Media Division back in 1975, today the paper itself is looking more like the traditional women’s magazines (where, for example, the beauty columns exhorting readers to use skin moisturizer echo the language of the cosmetics ads) or like the very ad-packed medical publications that Times Media eventually divested.
On January 22, Wyeth-Ayerst’s “I got my Mommy back” ran again in the same spot on the back page of the B Section, while on the health page, in section C, there ran a supportive article by Susan Gilbert, entitled “Lag Seen in Aid for Depression.” The message conveyed is that anti-depressants are “safe, effective, and underused,” and that, moreover, a whopping 24 percent of women “suffer from clinical depression at some point in their lives.” However, to the credit of Gilbert and her editor, her article does note that the “lodging and expenses” at the meeting of the National Depressive and Manic Depressive Association, from which these conclusions issued, “were paid for by Bristol-Myers Squibb, the manufacturer of Serzone, an anti-depressant.”
(On Monday, January 27, the Effexor ad campaign returned to its place at the back of the B Section with a new installment. Now it’s Mommy’s turn to celebrate: “I got my marriage back,” and here she is hugging her husband. I am hooked. I can hardly wait to learn what further good fortune Effexor may bring this nice family.)
Reporters for Full Disclosure
Unlike Gilbert’s example, too many articles in the Times, and indeed in most media, omit the conflict-of-interest full-disclosure information on healthcare and pharmaceuticals that has lately become far more available from professional sources than it ever used to be. Evolving since the mid-1980s, the most widely read and influential medical journals, including the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine, now require that contributors disclose all potential conflicts of interest, such as financial support from industry or assistance in writing articles from staffers at medical PR firms. This information is, in turn, now printed with the published articles, and also flagged in the press releases sent to science and medical reporters. Alas, certain researchers, now well known to enjoy mutually beneficial relations with industry, also seem to enjoy a kind of immunity from exposure in the press.
A notorious example, Dr. Trudy Bush, epidemiologist at Johns Hopkins, chairs the PEPI Trial Writing Group at the National Institutes of Health. In PEPI, which stands for Post-menopausal Estrogen/Progestin Interventions, only three years of exposure to “unopposed” estrogen (i.e. not combined with another hormone, progestin) caused abnormal endometrial changes in 34 percent of the women with intact uteruses, leading in some cases to hysterectomies. Bush’s positive claims for hormone treatments have been reported on the front page of the Times, but neither the harm that her study did to some participants, nor her extensive and complex web of industry support, have had much media attention. Yet her latest article and accompanying press release, published in JAMA November 5, 1996, include the following editor’s note:
Scientists and physicians, including some who freely seek and accept corporate backing for their own research projects, privately express wonderment that a woman linked to so many hormone manufacturers was ever selected to play a principal role in a government study. In time, it may discredit the study altogether, they speculate, but such concerns have also not been aired in the mainstream press. To be fair, Bush does write more skillfully and gracefully than many other epidemiologists.
On October 12, 1996, shortly before JAMA’s recent airing of Bush’s corporate ties, the leading British medical journal, Lancet, published three reports which should have provoked immediate widespread re-evaluation of the risk/benefit ratios of replacement hormones. They did not, as few U.S. women or their doctors ever learned of them. These new findings were: Among women aged 45-64 with no apparent risk factors other than hormone use, at the low doses currently recommended, potentially fatal blood clots in the feet, legs and lungs increase twofold to fourfold-both on estrogen alone and on regimens which include progestins.
Based on information from the 1970s, the risk of blood clots is still (as required by FDA) enunciated in the patient warnings on estrogen. However, many doctors have been telling their patients--on the strength of wishful thinking--that the risk of blood-clotting has diminished with the lower doses of estrogen (as is actually the case with the lowest-dose brands of oral contraceptives). Some doctors have gone so far as to resume prescribing estrogens to women who already have a medical history of blood clots; so with an estimated 9 million U.S. women taking replacement hormones, it would seem urgent for the Lancet findings’ to circulate widely to the public.
Lancet is well perused by medical and science journalists in the United States, yet while its blood clot studies were picked up immediately in some consumer newsletters, including MaryAnn Napoli’s influential Health Facts, a Nexis search by Extra! confirmed this reporter’s “eyeball” estimate that coverage in advertising-supported print media was sparse: Only six U.S. papers in the Nexis computer database carried any notice of the Lancet articles, these being the Houston Chronicle (11/6/96), the Bergen County (N.J.) Record (10/28/96), the Albany (N.Y.) Times Union (10/22/96), the Atlanta Journal and Constitution (10/21/96), the Chicago Tribune (10/11/96) and the Orange County Register (10/11/96). All of these were brief filler items, 100 words or less, included in round-up health news columns compiled from wire services.
“Cumbersome and Boring”
But if publishers are hustled to “praise the product,” journalists experience a different pressure--to get the big story. When I question young medical reporters on their reluctance to convey the conflict-of-interest information--once so scarce and precious, and now so available and overlooked, some of them tell me, frankly, that it:
“makes the story less exciting.”
“makes it less credible.”
“gets too wordy.”
“gets too cumbersome and boring.”
“The average reader doesn’t care.”
“My readers don’t know it’s important and I’m not sure my editor does either.”
Victor Cohn, retired science editor of the Washington Post, and author of a popular journalism textbook, News and Numbers: A Guide to Reporting Statistical Claims and Controversies in Health and Other Fields, addressed these issues in a recent JAMA editorial (12/18/96):
There is a wise saying: “If you would have public confidence, confide in the public.” Any other course may work temporarily, then backfire disastrously.
Barbara Seaman is author of The Doctor’s Case Against the Pill, recently reissued by Hunter. She is a contributing editor of Ms. magazine and co-founder of the National Women’s Health Network.