After that, Prempro got additional FDA-mandated black-box warnings (the most severe warnings a drug label can contain) emphasizing the newly reported risk of breast cancer — a risk that increases with each year of use — as well as a warning that HRT should not be used to prevent heart disease. Wyeth sent out 500,000 “Dear Doctor” letters. Prescriptions dropped precipitously. Meanwhile, WHI researchers planned a follow-up study: In 2006 and again this year, they reported that U.S. breast cancers decreased directly in step with the decline of hormone therapy.
But the Prempro saga is incomplete without the story of medicinal marketing at its finest (or its worst).
Mona Lisa smile on her lips, supermodel Lauren Hutton sits, leaning forward, hands folded. “I take an active interest in my health,” say the words floating above her head in the magazine. “That’s why I asked my doctor about the consequences of estrogen loss at menopause.”
In the 2000 ad, Hutton — stunning at 57 — is surrounded by advertising copy reporting everything any study had looked at with respect to menopause: “Brain: For the past 10 years, research has explored the questions surrounding the consequences of menopause and cognitive functioning, memory, and Alzheimer’s disease.” “Teeth: Research continues to explore the association between tooth loss and menopause.” And so forth. “Talk to your doctor,” the ad urges the reader.
There were other spokeswomen, like Patti LaBelle, and other advertising channels, too, throughout the years. There was Seasons, Wyeth’s free magazine sent primarily to Premarin users (circulation: 1 million). There were the brochures in doctors’ lobbies, declaring “Menopause isn’t gone in a flash — its debilitating consequences can affect the rest of your life.” Welcome to prong 1 of HRT marketing: Direct to Consumer.
It’s been effective. A draft of a 1998 internal marketing presentation tracking “the success of changing the HRT paradigm” showed just how drastically Wyeth thought the public’s perception of the drugs changed in a decade. A drawing of a scale represents the public perception in the 1980s. “Perceived risks” are on its left side, weighing it down heavily: breast cancer, endometrial cancer. On the right are the “perceived benefits”: relief of vasomotor symptoms (hot flashes). The risks outweighed the benefits. But in the Prempro 1990s, the lone perceived risk — breast cancer — appears to carry little weight compared to the benefits side of the scale, heavy with the many perceived uses for HRT: vasomotor symptoms, osteoporosis, cardiovascular disease, Alzheimer’s, colon cancer, macular degeneration, osteoarthritis.
That only the first two conditions shown were scientifically accepted and FDA-approved uses of HRT? Well, in advertising, as they say, perception is reality.
And the really smart stuff — the kind of marketing that Nike and Coca-Cola wish they dreamed up — is marketing that doesn’t look like marketing at all. Prong 2.
Some years after Premarin had been linked to endometrial cancer, research found that the drug helped to reduce postmenopausal bone loss. Estrogen helped prevent osteoporosis! It was good news. Wyeth promptly launched a public-awareness campaign regarding osteoporosis and its treatment — neither of which were, at the time, hot topics in women’s health. (Mission accomplished.) Then came the formation of the National Osteoporosis Foundation, to which Wyeth was a contributor. In 1988, Premarin was granted FDA approval to put “prevention of osteoporosis” on its label. By the early ’90s, Premarin — which, even before Prempro, was often being used in tandem with progestin to protect against endometrial cancer — was back on top.
When Prempro was launched, CEO Bob Essner spoke to a roomful of Wyeth-Ayerst sales associates. “We can make real the full promise of HRT to create in the near future a world where the majority of women will start HRT at menopause and continue on it for the rest of their lives,” he said.