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Drug Maker Should Take Chill Pill

Wednesday, August 21, 2002

In the first of our monthly columns on media, Sheila Gibbons dissects coverage of the government's recent decision to end its study of the possible benefits of hormone replacement therapy. She finds that the media did its job well.

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In the first of our monthly columns on media, Sheila Gibbons dissects coverage of the government's recent decision to end its study of the possible benefits of hormone replacement therapy. She finds that the media did its job well.
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Sheila Gibbons

(WOMENSENEWS)--The head of Wyeth Pharmaceuticals is angry at the media. This president and chief executive officer, Robert Essner, complains that sensationalized and inaccurate reporting about the government's decision to halt its huge study of Wyeth's Prempro hormone replacement drug has contributed to his company's financial woes.

Some media reports, he told The Washington Post's Bill Brubaker in an article published July 24, exaggerated the risk of breast cancer for Prempro users.

Between the July 9 announcement by the National Heart, Lung and Blood Institute of the National Institutes of Health that it was ending the study and Essner's conference call with Wall Street analysts and follow-up interview with Brubaker on July 23, Wyeth's stock price dropped by more than a third. Presumably a good deal of Essner's personal wealth went south with it.

Essner, of course, is not the only person in a bad mood about the news that Prempro's side effects may outweigh its benefits. Just ask some of the 6 million women taking it, and the millions more taking other types of hormone replacement.

But was the coverage of the study's cancellation sensational? Inaccurate? Overblown? The news media with the clout to influence investor perceptions about Wyeth don't appear to have mishandled the facts. Over the years, the press has duly reported conflicting study results about the hormone replacement-breast cancer connection that would make any intelligent woman wonder if, indeed, there wasn't a reason to be concerned. However, the announcement that the largest study of hormone use by menopausal women had been abruptly stopped did not lead to a rash of articles with data-bending conclusions.

Big Five Major U.S. Dailies Relied Heavily on Official Statements

I read reports of the study's cessation in five of the largest U. S. daily newspapers on the first day and for a week after. The newspapers I monitored were the Wall Street Journal, the Washington Post, the Chicago Tribune, USA Today and The New York Times.

The newspapers' reporting of history, issues and facts closely followed the National Institutes of Health news release, quoting much of it word for word. I didn't see anything that would confirm Essner’s complaint of distortion. There was little hyperbole or hysteria in the comments of those quoted, or in supporting material reporters developed to help tell the story. If anything, there was a clinical detachment. Considering the impact on the huge numbers of women taking or planning to take hormones, it would have been legitimate if the articles had had a little more heat.

Prempro, which combines estrogen and progestin along with the estrogen-replacement drug Premarin, accounted for nearly 15 percent of Wyeth's 2001 revenue. The blow was delivered not by the press but by government itself. Topped by the headline, "NHLBI Stops Trial of Estrogen Plus Progestin Due to Increased Breast Cancer Risk, Lack of Overall Benefit," the first paragraph of the news release also said the study "found increases in coronary heart disease, stroke and pulmonary embolism in study participants on estrogen plus progestin compared to women taking placebo pills."

"There were noteworthy benefits of estrogen plus progestin," the release continued, "including fewer cases of hip fractures and colon cancer, but on average the harm was greater than the benefits. The study, which was scheduled to run until 2005, was stopped after an average follow-up of 5.2 years."

Drug Company Chief Thought News Should Be "Comforting"

Four of the newspapers reported these details in prominent Page One articles. The Wall Street Journal gave the announcement only eight lines in its Page One "What's News" roundup, leading instead with stories on health care for minority groups in Pittsburgh, the troubles of Deutsche Telekom's chief executive officer and President Bush’s crackdown on corporate crime.

But the Journal gave extensive treatment of the story beginning on Page One of its second section, including a sidebar on alternatives to hormone replacement therapy and, of course, an interview with Essner. He was quoted as saying the study results were "somewhat disappointing" and expressing hope that physicians dispensing Prempro would find the newly documented risks "to be in the realm of their expectations, and that may be comforting."

The 16,000 study participants who received letters telling them to stop taking Prempro could hardly have found the news "comforting," nor could the millions of women who had been assured that Prempro would support their health, not jeopardize it. If Essner believes anyone could be comforted by the study results, it's easy to see why he thinks media coverage of those results was sensationalized.

The organization of news accounts in the five newspapers was similar: descriptions of the findings, accompanied by charts showing the documented risks and benefits of Prempro, fleshed out by interviews with doctors, women’s health activists, university researchers, scientists and women who take or have taken Prempro or another form of estrogen replacement. The New York Times coverage was particularly detailed. USA Today and The Wall Street Journal ran Q&A’s for women readers with decisions to make. USA Today, The Times and the Chicago Tribune published editorials the same day they reported the announcement, with USA Today and the Tribune saying women "deserve better," and the Times blaming "aggressive marketing" by pharmaceutical manufacturers and wishes for "medical miracles" by doctors and patients for pushing drugs beyond the uses that good science can justify.

Editorials Not Particularly Tough on Wyeth

The editorials called for more and better science to support women's health and were not particularly tough on Wyeth. What readers should look for now is follow-up coverage that clarifies health choices for women, looks more closely at doctor-manufacturer and doctor-patient relationships and tracks Wyeth's efforts to salvage its investment in hormone replacement products.

It could be an uphill battle for Wyeth: Last week, the Food and Drug Administration, along with the National Institutes of Health and the Agency for Healthcare Research and Quality, announced a comprehensive reassessment of the risks and benefits of all combination hormone products. The Food and Drug Administration is also insisting on immediate changes in the label and package insert that accompanies Prempro--including eliminating the phrase "hormone replacement therapy."

Appropriately, it was columnists and op-ed writers who captured the emotional essence of the dilemma into which women using or considering these drugs have been thrust. "Now it turns out that HRT was less like money under the mattress than money invested in 21st Century tech stocks," wrote Mary Schmich in the Chicago Tribune. "Hope that was here yesterday is gone today." On the other hand, she wrote, "the promise of medically protracted youth comes with stress attached. Men worry about getting old, too," she said, "but women live with a particularly female version of the tiresome internal duel between getting old the natural way or fighting it through medicine."

Dr. Susan M. Love, a professor of medicine at the University of California at Los Angeles and author of several books on breast health, says doctors got carried away: "What happened is that medical practice, as it so often does, got ahead of medical science," she wrote in The New York Times. "We made observations and developed hypotheses--and then forgot to prove them." Her point: It wasn't clear whether hormones made women healthy or whether healthy women were more likely to take hormones. For a long time, women who took hormone replacement therapy, and their physicians, believed the former was true.

Not any more. And that's because many scientists, not reckless or careless journalists, said so.

Sheila Gibbons is editor of Media Report to Women, a quarterly newsletter of news, research and commentary about women and media. She is also co-author of Taking Their Place: A Documentary History of Women and Journalism (Second Edition), published this summer by Strata Publishing, Inc.

For more information:

Press release: NHLBI Stops Trial of Estrogen Plus Progestin Due to Increased Breast Cancer Risk, Lack of Overall Benefit:
http://www.nhlbi.nih.gov/new/press/02-07-09.htm

Wyeth informs physicians of WHI findings – Company reaffirms role of combination HRT in menopausal treatment – Estrogen-only arm to continue:
http://www.wyeth.com/news/Pressed_and_Released/pr07_09_2002.asp

Susan Love MD Breast Cancer Foundation:
http://www.susanlovemd.com

Media Report to Women:
http://www.mediareporttowomen.com/aboutcra.htm