Challenging Unproven Medicine and Saving Lives

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The Women's Health Activist
July/August 2012

By Amy Allina

When the U.S. government invests more than $600 million in the largest study of older women ever conducted…

And, the study yields such definitive results that the scientists providing ethical oversight for the research decide that it should be halted years early because the questions it was designed to answer have been clearly and solidly answered…

And, as a result of people taking action based on the research results, the United States experiences the first significant drop in breast cancer rates – 16,000 fewer women diagnosed in the first year alone…

You would think that the medical establishment would rejoice and celebrate this   historic public health achievement: science giving women and their health care providers information that we can use to guide our behavior in a way that dramatically improves our health and saves lives.

But, in the case of the Women’s Health Initiative (WHI), you’d be wrong. More than 10 years after the WHI announced the results of this unprecedented research effort — after a decade of lower breast cancer rates — the WHI’s findings are still being questioned by hormone therapy (HT) defenders who continue to promote unproven     theories about how taking hormones benefits women’s health.  And, they continue to urge women to look to hormone therapy for protection against age-related diseases and health concerns, despite the weight of evidence against these claims.

Money, money, money

Many factors contribute to this persistent commitment to counterfactual beliefs about hormone therapy, but the root cause is money from drug makers. It created the problem in the first place and shaped the conditions that encourage resistance to evidence-based health care practices. The pervasive influence of drug industry money over medical research and practice can be seen at every stage of the hormone therapy story.

A drug company paid for the earliest educational efforts to doctors, providing undisclosed grants and paying travel expenses for a doctor, Robert Wilson, who traveled the country in the 1960s lecturing about the glorious benefits of hormone therapy. In 1966, Wilson also published a book, Feminine Forever, touting his claims that HT would allow women to avoid the physical and emotional consequences of menopause, which he equated with the death of femininity. Comparing the effects of aging on men to that on women, he wrote:

A man remains male as long as he lives.  Age does not rob him of his sexual appetite nor of the means of satisfying it. Throughout life he retains his appreciation of a charming girl or a handsome woman and along with it, a certain live-liness of outlook and level of motivation in other areas that make him function fully and respon-sibly as a human being. […] How different is the fate of woman.  Though modern diets, cosmetics and fashions make her outwardly look even younger than her husband, her body ultimately betrays her.  […] At the very moment when she is most able and eager to enjoy her achievements, her    femininity – the very basis of her selfhood – crumbles in ruin.  But now, at last, medicine offers a practical escape from this fateful dilemma.

Wilson’s loose relationship to facts and the fundamental sexism that this passage reveals are evident throughout the book and in much of the HT promotion of that era. 

Over the following decades, the pharmaceutical industry continued to invest millions of dollars in corporate-sponsored medical education to promote HT to providers. It sponsored professional conferences and paid health care providers to attend lectures on HT’s supposed benefits held at luxury resorts and gourmet restaurants.  All with the goal of ensuring that generation after generation of prescribers would be indoctrinated in the gospel of hormone therapy.

For more than three decades, these prescribers routinely advised their female patients who were turning 50 that using hormone therapy, starting at menopause, would protect them from every age-related concern a woman might have. Worried about heart disease? Take hormones to protect your heart. Having trouble sleeping or remembering things?  Hormones will help. Want to prevent hip fracture, wrinkles, dementia, and depression?  Hormone therapy is the answer.  Need the energy to keep up with your vigorous spouse?  Here’s your prescription.

Drug companies also paid for advertising campaigns aimed directly at women in order to drive home these messages. They produced educational materials touting claims about the benefits of HT that hospitals and medical practices could distribute to patients. And, they used their checkbooks to influence the production of clinical practice guidelines and standards used to evaluate quality of care for women at menopause, ensuring that routine prescription of hormone therapy to women at menopause was one of the key measures of whether older women’s health care needs were being met.

Challenging deeply held beliefs

By the early 1990s, routine prescription of hormone therapy for women at menopause was firmly established in medical practice. Even women who never experienced a single hot flash — one reason for taking HT that was well-established prior the WHI — were advised to start taking hormones when they reached menopause. By 1999, there were more than 90 million annual prescriptions written for these drugs1 — a substantial revenue-producer for drug companies like Wyeth, which manufactured Premarin, the market leader in hormone therapy.

But some were concerned about troubling indications that HT drugs might not be as safe, or offer as many benefits, as their promoters claimed. Throughout this time, the National Women’s Health Network produced independent information about HT for our members; asked tough questions about the unproven claims being made for the drugs; warned about research showing there might be risks that women weren’t being informed about; and advocated for research to provide women with reliable answers to these important questions.

In 1990, when Wyeth asked the Food and Drug Administration (FDA) to add a heart disease prevention indication to the HT drug label, giving it approval to legally advertise the use of hormone therapy for that purpose, only two groups opposed the request: the National Women’s Health Network and the Health Research Group at Public Citizen. Thankfully, the FDA held firm to its standards, rejecting Wyeth’s application because it lacked adequate research evidence to back up the claim. This brave stand thwarted the company’s promotion plans, but it didn’t shake the medical community’s belief in HT’s preventive health benefits. 

In 1991, the desire to provide the FDA with the evidence it demanded on HT’s benefits — combined with political pressure from the newly expanded caucus of Congresswomen who sought to increase the nation’s investment in women’s health research — created the will to launch an HT clinical trial as part of the new Women’s Health Initiative. As a whole, the WHI examined cardio-vascular disease, cancer, and osteoporosis, which are the leading causes of death, disability, and impaired quality of life, among post-menopausal women. The HT trial, involving more than 27,000 post-menopausal women at 45 clinical centers across the nation, was the most significant component of the multiple research studies that made up the WHI.

Still the drug-money fostered belief in HT had not flagged one bit, and the medical community fully expected the WHI to confirm its assumptions about the great benefits and safety of hormone use.  So, in July 2002, when the National Institutes of Health halted part of the HT trial early and announced that using hormone ther-apy increased a woman’s risk of getting breast cancer and her chance of experiencing a blood clot or stroke, the news was greeted with shock and disbelief in the medical community.

Hormone defenders scrambled to explain these results without accepting the obvious conclusion that HT wasn’t all that it had been cracked up to be.  They said that the women enrolled in the trial were too old, or had a pre-existing disease that kept them from gaining hormones’ protective effect.  But, none of that was true.  (Read the Women’s Health Activist article from May/June 2003, debunking those claims: “The Backlash Against the WHI: Myths and Facts About Menopause Hormone Therapy,” available at: http://nwhn.org/backlash-against- whi-myths-and-facts-about-menopause-hormone-therapy.)

And women weren’t persuaded. They heard about the WHI results and voted with their feet. The number of HT prescriptions that were filled dropped precipitously by about a third in the first year1 and continued a slow decline after that.2 The effect was dramatic: in the first year after the WHI results were released, U.S. breast cancer rates dropped by 16,000. This was the most significant reduction in breast cancer levels ever achieved in the United States.

Still, the argument continues. In May 2012, the U.S. Preventive Services Task Force (USPSTF) published an analysis affirming that the risks of hormone therapy for preventive health outweigh the benefits. Almost a decade after the announcement of the WHI findings this should hardly be a controversial claim. Yet, only a couple of weeks earlier, the journal Climacteric (a publication of the International Menopause Society, which receives substantial financial support from industry3) published an issue including several articles arguing that if women start taking HT at the “right age,” its benefits would outweigh the risks.

This is known as the “window of opportunity” theory and, just like the previous theories about how all aging women could improve their health by taking hormones, it is not supported by reliable evidence. (Read the NWHN’s analysis of the “window of opportunity” theory in our Fact Sheet, Menopause Hormone Therapy and Cardiovascular Protection, available at: http://nwhn.org/ menopause-hormone-therapy-and-cardiovascular-protection.)

Both the USPSTF analysis and the Climacteric articles were covered by health journalists in the mainstream media, leaving readers to puzzle through the contradictions between the two. Many people understandably, although incorrectly, concluded that questions about whether or not hormone therapy prevents heart disease remain unanswered.

Learning from our mistakes

The National Women’s Health Network views the WHI as an unprecedented and extraordinarily valuable public health victory. It not only provided women with essential answers to important questions about our health and led to changes that have already saved more than 150,000 women from breast cancer, but also demonstrated that independent advocacy can have a real and important impact on medicine.

At this 10-year anniversary of the WHI, we continue our independent advocacy for changes in policies and practices to better meet the health care needs of older women, and to prevent the repetition of past mistakes. These changes include:

  • Stronger protections from misleading promotion of unproven and unsafe drugs, including better regulation of drug ads;
  • Increased investment in research to develop safer alternatives to treat hot flashes;
  • Inclusion of more women in heart disease prevention research; and
  • An end to drug company funding for medical education.

Ten years later, the backlash against the WHI continues, to the detriment of women and our health. Prolonging the controversy risks depriving women of the important benefits of our public investment in that important research and potentially puts women who take HT for unproven reasons at unnecessary risk for disease. 

But the positive legacy of the study lives on as well, growing every year that another 16,000 women are saved from breast cancer, and the legacy defines itself anew whenever another advocate, inspired by the example of the WHI, takes up a new campaign to challenge a dangerous or unproven medical practice.


References

1. Hersh AL, Stefanick ML, Stafford RS, “National Use of Postmenopausal Hormone Therapy; Annual Trends and Response to Recent Evidence,” JAMA 2004; 291(1):47-53.

2. North American Menopause Society (NAMS), “Hormone Therapy Statistics,” June 2011. Mayfield Heights, OH: NAMS. Avail-able online at:  http://www.menopause.org/

hormonetherapystats.aspx.

3. Website of the International Menopause Society, Ethical Codes of Conduct, accessed June 3, 2012.  http://www.imsociety.org/ethical_ codes_of_conduct.php.

Amy Allina is the Network’s Program & Policy Director