Science and defiance

When a drug study ends due to risks, PR plays a pivotal role.

When a drug study ends due to risks, PR plays a pivotal role.

In July 2002, with great fanfare from the press, the National Institutes of Health (NIH) ended a major trial of combined hormone replacement therapy (HRT) before completion because it was felt that its risks outweighed its benefits. The study, part of the Women's Health Initiative (WHI), involved almost 17,000 women aged 50-79 taking Prempro, a form of standard-dose dual HRT manufactured by Wyeth Pharmaceuticals. This study arm was designed to last until 2005, but in July of this year, investigators sent letters to participants telling them to stop taking their medication because they noted increases in coronary heart disease, stroke, and pulmonary embolism in study participants on estrogen plus progestin, compared to women taking placebos. Despite noteworthy benefits, including fewer cases of hip fractures and colon cancer, the harm was deemed greater than the benefit. The study's suspension sent shock waves through the lay, medical, and pharmaceutical communities. Hot flashes quickly became news flashes. Women and doctors panicked, and the standard recommendations for HRT usage changed drastically. "The big news was that the study had stopped, but that didn't leave a lot of room for what individual women should do," says Sherri Jaffe, SVP and group director, healthcare, at Cohn & Wolfe in New York. "Initially, we saw the news of the study being stopped lead to some harsh and severe stories. Now we are seeing reporters moving toward helping women reach an individual decision about HRT," she says. Of course, manufacturers of HRT drugs found themselves in something of a crisis. Shares in Wyeth plunged 11% after news of the study's cessation reached the market. At one point, Wyeth's stock reached a five-year low of $29.93, and though it has rebounded to about $35 now, it is still a far cry from its 52-week high of $66. On July 24, Wyeth president and CEO Robert Essner told The Washington Post that inaccurate and sensationalized media coverage had "played a big role" in the company's stock performance, with some media reports "overstating" the risks of breast cancer for Prempro users. The Viagra controversy revisited? Some PR pros liken the hullabaloo to the uproar that occurred when Viagra was linked to heart attacks and chest pain in some men. "Both products are rooted in science, comfort, quality of life, and mass appeal," explains Gil Bashe, president and CEO of NJ-based Catalyst Communications, and co-editor of Branding Health Services. "So naturally, whatever happens to these products will have significant media attention." Both products presented challenges for healthcare professionals and patients in appreciating and interpreting clinical data, he adds. "We need to understand that the data is the data, and be prepared to work with clinical investigators to best understand and interpret that data for the patient - and be able to state where the physician and patient need to interact," he says. Sheryl Williams, senior director of product communications at Cephalon in West Chester, PA, agrees. "The public doesn't understand the scientific process," she says. "They see a study that says take Vitamin B, and another one says, 'If you take too much, this horrible thing can happen to you.' Data is data, and it takes a lot of data to determine a fact, and people don't understand that." While there are some striking similarities between Viagra and Prempro, the sheer numbers of affected consumers - nearly 1.5 million women a year become menopausal in the US and Canada - make the Prempro situation unchartered terrain. "The Prempro situation is part of a larger trend in our society," Bashe explains. "It's not brand-new data, but our connection to it is brand new. In the Post-9/11 and post-Enron era, our individual antennae are up and have high alert for attack, deceit, and disclosure. The consumer has a hunger to read the fine print." When the news broke, Wyeth's first concern was getting information to doctors: It sent out 550,000 "Dear Doctor" letters outlining the study findings. "At the time the data came out, we ceased advertising to make sure it was consistent with new data. We felt that physicians and patients needed time to absorb what's out there," says Natalie DeVane, a Wyeth spokesperson. Bashe says that Wyeth is taking charge responsibly. "They are very assertive and quick to bring the clinical data to the attention of the customer, and they proactively put in new prescribing information, so it is very clear to the physician and prescriber just how the product should be used," he says. Prempro's ripple effect While the WHI findings do not necessarily apply to other HRT products or modes of delivery such as patches and creams, other pharmaceutical companies have been drawn into the Prempro saga. They are doing their best to communicate the WHI findings to the media, physicians, and patients. Pfizer, for example, manufactures a combined HRT product called Femhrt. With the help of C&W, Pfizer transmitted a special issue of Menofax, a fax newsletter on menopause that explained the facts behind the WHI, along with some expert commentary. "The position we take is to communicate the facts of the WHI," says C&W's Jaffe, "and to ensure that as many physicians as possible have all the data and information available to make appropriate choices for their patients." But some admit that part of the game is wait and see. In early October, the North American Menopause Society released a consensus statement on how to prescribe hormones, and to whom. By and large, the expert panel stated that all women considering taking HRT must review their individual risk factors with a doctor before making a decision, and that treating the symptoms of menopause remains the number-one use for HRT. The new recommendations also state that combined HRT should not be used to prevent heart disease. The NIH will convene in late October, and early next year an advisory panel of the FDA will address the issue. William Archer, senior MD of healthcare policy at Hill & Knowlton in Washington, DC, describes what lies ahead as "a huge overhaul." "I have not seen something so widely used and accepted by doctors and patients that has been affected in this way," he says. "Physicians feel boxed in because they have a lot of patients using these medications, and they fear legal action. PR has to engage the dialogue at a deeper level with the manufacturers, medical community, and specialty groups, and determine what the science really means." "There is a lot of fear that has to be overcome," agrees Penny Mitchell, SVP and partner at Fleishman-Hillard in New York. "The important role of a PR agency and big pharma is to flush cogent dialogue between patient and doctor," she says. "There are plenty of women who will be suffering and be beside themselves, and have to know what their choices are," she says. What's good for the goose is good for the gander, Bashe says. "The consumer has a hunger to read the fine print, and PR is uniquely suited to supply them with this information." ---------- How the media reported the story In the first couple of weeks after the story broke, media reports paid a lot of attention to the risks (costs) of taking HRT, and much less the benefits. Despite the fact that all associated diseases were cited side-by-side in the Journal of the American Medical Association report, some media only picked and chose a few of them to cite. Comparatively little coverage addressed the implications to users of the results. Very few articles or broadcasts discussed alternatives (a healthy lifestyle or natural remedies, instead of taking HRT). The consensus was that each user must decide for herself, but it was recommended that all users check in with their doctors before making this decision. The overall message of the WHI study - that HRT wasn't effective against diseases, but OK for short-term relief from menopause symptoms - seemed to have been lost amid all the reporting on the various ways HRT was harmful to you. While the WHI's central message may have been carried in almost two-thirds of the coverage, it wasn't conveyed prominently. Even fewer reports clarified that the estrogen-only side of the study was ongoing, and that it was only the estrogen-progestin combination drug study that had been stopped early.
  • Evaluation and analysis by CARMA International (www.carma.com). ---------- The facts In a component of the Women's Health Initiative (WHI), 16,608 participants - women aged 50-79 with an intact uterus - were given progestin in combination with estrogen, a practice known to prevent endometrial cancer. Researchers found that when compared with 10,000 women not taking combined HRT, the same number of women who are taking the hormones will develop:
  • 7 more heart attacks
  • 8 more strokes
  • 8 more cases of breast cancer
  • 18 more blood clots
  • 6 fewer colorectal cancers
  • 5 fewer hip fractures
  • 44 fewer fractures in other bones
  • No difference in total mortality (of all causes)

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