A hot flush for Big Pharma
Authors: J. Clark
Journal: BMJ (2003)

So the headlines have dealt another blow to the image of hormone replacement therapy (HRT). Will the drug companies be able to revive the fortunes of one of their most lucrative products? Will the big guns of the pharmaceutical industry be blazing, eager to counteract the latest volley of bad publicity? Or will the industry construct its defences more subtly?

Certainly, if the history of HRT promotion is anything to go by, the pharmaceutical public relations machine will be doing all it can to limit the fallout from studies published last week in the New England Journal of Medicine (2003;349: 523-34) [PubMed] and the Lancet (2003;362: 419-27) [PubMed], just as it has been since the first damning results from long term HRT studies were released last year. After all, billions in global sales are at stake. The two latest studies confirm that postmenopausal women taking combined HRT have an increased risk of heart disease and a twofold greater chance of developing breast cancer. These support the negative findings released in July 2002 after the huge US Women's Health Initiative (WHI) study was prematurely halted by its safety monitoring board.

But what exactly can the PR machine do in the face of evidence that now says long term HRT use increases women's risk of blood clots, strokes, heart attacks, breast cancer, and dementia, and has no quality of life benefits? Probably what it has always been doing—promoting the idea of HRT both as a cure for a medicalised menopause and an elixir even in the absence of scientific data.

HRT has been touted for decades as a panacea not just for the symptoms of menopause (hot flushes, vaginal dryness) but also for heart disease, dementia, osteoporosis, sexual function, mood, and overall vitality. Its tireless promotion by manufacturers is often held up as the ultimate case study in pharmaceutical marketing. Not content to mass market its benefits for the short term relief of menopausal symptoms, the industry set its sights on a bigger goal: the widespread acceptance of HRT as a long term preventive medicine for the massive (and growing) number of postmenopausal women. So far it seems that that strategy has worked. Science journalist Barbara Seaman, who has written extensively about the medicalisation of the menopause, says that American pharmaceuticals giant Wyeth's HRT products have been in the top 50 selling drugs in the US for almost four decades.

More than 100 million women worldwide—1.5 million in Britain—took HRT in 2001 and global sales amounted to $3.8bn (£2.4bn; €3.4bn). But after the first wave of publications from the WHI study, Wyeth, which accounts for more than 70% of the global market, saw its share price plummet. The stock, which traded as high as $58.48 (£36.48; €51.66) in May 2002, fell by almost half to a low of $28.25 in July.​July.




Figure 1




HRT promotion has depended heavily, although covertly, on industry involvement with scientists. In the 1960s American physician Robert Wilson wrote the influential Forever Feminine, extolling the virtues of HRT as a virtual fountain of youth for the “dull and unattractive” ageing woman. In an article in the New York Times last year (10 July 2002), Wilson's son conceded that Wyeth paid for his father's book and promotion of HRT.

In 2002 the powerful New York based Society for Women's Health Research, whose “sole mission is to improve the health of women through research,” held a celebrity gala ostensibly celebrating women's “coming of age.” It was entirely underwritten by Wyeth. In a Washington Monthly article entitled “Hot Flash, Cold Cash,” journalist Alicia Mundy reported that only a few days after the Wyeth themed gala the company donated a quarter of a million dollars to the society.

Several weeks later, the WHI study results were made public. Wyeth was in a tailspin. They found support from the society, whose high profile chief executive, Phyllis Greenberger, and her staff went on national radio and television talk shows attacking the findings of the WHI study and its authors. “Instead of taking the side of its constituents,” Mundy observed, “the society seemingly took the side of its donors—and of Wyeth in particular.” As they fervently downplayed the negative findings of the WHI study and urged women not to abandon their HRT, the society's staff failed to disclose their substantial links to Wyeth and other drug companies. Similar activities and non disclosures are under investigation in Australia, after a complaint about the involvement of a well known doctor, Susan Davis, in HRT promotion.

HRT industry tactics play out not only in the ivory tower, but also in the corridors of big public relations firms. A group called HRT Aware hired London based PR firm the RED Consultancy to create an initiative that would “secure positive news coverage about HRT, target 45+ women with positive HRT messages, and link HRT to an aspirational life style” (www.pmlive.com/awards). The Choices Campaign, as it was called, launched in February 2000 to wide media coverage. It reached masses of “ordinary” women by touring bingo halls with local celebrities, using a former soap star and female doctor as spokeswomen, and forging relationships with charities such as the Menopause Amarant Trust. What is not so well known is that HRT Aware was an industry group comprised of oestrogen product manufacturers Janssen-Cilag, Wyeth, Solvay, Servier, Organon, and Novo Nordisk.​Nordisk.




Figure 2



What will the drug companies do now?




HRT Aware also commissioned the Social Issues Research Centre to produce a Jubilee Report (named to coincide with the Queen's Jubilee celebrations), which last month won a Communique award from the magazine Pharmaceutical Marketing in the public relations and medical education category. SIRC's research linked the improved lives of modern day postmenopausal women to HRT. It introduced a new elite group of 50+ women, dubbed the “HRHs” (hormone-rich and happy), who were said to have better careers, relationships, health, wellbeing, and sex lives than those not taking HRT. The Jubilee Report received widespread—and supportive—media coverage in the UK, virtually none of which mentioned that the pharmaceutical industry fashioned the campaign.

This year Novo Nordisk hired German PR firm Haas & Health Partner, which sent out to doctors letters downplaying the WHI results. The letters emphasised that the “absolute risk for women is quite minimal” and were signed by Dr Irene Haas (a historian, according to her company's website). A subsequent letter from Dr Haas states “amazingly, a glass of wine per day and obesity have higher breast cancer risks.”

That pharmaceutical companies devise clever ways to market their products is hardly surprising. But let us hope that any counter attack that they make to the latest damaging research is subjected to the same kind of scrutiny that HRT itself is now under.