Response to the Announcement that Health Risks Outweigh Benefits for Combined Estrogen plus Progestin, Statement of Cynthia Pearson, Executive Director National Women's Health Network, July 2002
This week early results were announced from the Women's Health Initiative, a clinical trial to assess the effects of hormone replacement therapy (HRT)on healthy women. The HRT part of the trial has been halted because the increased risks of breast cancer, heart attack, stroke and pulmonary embolism were found to exceed the benefits of reducing risk of bone fracture and colorectal cancer.
After years of arguing with drug companies and doctors about the need for randomized controlled trials to discover the real benefits and risks of HRT, the National Women's Health Network considered it a victory in 1993 when the National Institutes of Health finally launched the Women's Health Initiative. The results published this week have proven that we were correct to be skeptical about the claims that have been made for these drugs.
"The Women's Health Initiative has driven a stake into the heart of hormone replacement therapy (HRT). But the real question is: why did we ever believe that HRT prevented disease?
"Pharmaceutical companies have used statistical smoke and mirrors to tout unproven benefits, minimize risks, and mislead physicians into being an unsuspecting marketing force for a regimen that harms healthy women. There was never one single clinical trial that showed that HRT prevented cardiovascular disease or stroke. This is not a story of science moving sedately forward, carefully adding pieces to a puzzle before making recommendations to patients. This is a story of the corruption of the medical and scientific community. The belief that hormones are good preventive medicine has been a triumph of marketing over science.
"Recent news stories have exposed the lavish gift-giving that characterizes the physician-pharmaceutical company relationship. But the hidden influence that drug companies have is an even greater problem. Physicians who eschew the cruises, scorn the dinners, and spurn the drug reps cannot escape the more insidious influence that drug companies have on all educational information that physicians receive. This includes presentations at scientific conferences, articles in eminent medical journals, and continuing medical education (CME) programs. Pharmaceutical companies control what studies get funded, who gets paid for doing them, where (and whether or not) those studies are published, and how the studies are interpreted. Drug companies, who provide beautiful slides along with a prefab perspective, often pay the physicians and researchers invited to give talks at scientific conferences. Professional organizations, such as the North American Menopause Society, often distribute educational materials funded by drug company grants.
"Researchers may be paid $10,000 or more to write review articles listing unlabelled uses of drugs in medical journals. Those articles may be distributed by drug reps or distributed by medical education companies (which subsist almost entirely on laundered drug company money). The physician may even get CME credit for reading a drug company-funded article and answering questions posed by drug company contractors. (Drug company influence on doctors and consumers is documented in the National Women's Health Network's book The Truth About Hormone Replacement Therapy, Prima, 2002.)
"Millions of women took HRT on the advice of their physicians, who honestly believed that the treatment prevented heart disease, the biggest killer of women. HRT doesn't prevent heart disease; it causes it.
"Women, and their physicians, were duped. Women were placed in the way of harm by their physicians, who acted as unsuspecting patsies for pharmaceutical companies. The Women's Health Initiative, the only prospective, randomized controlled trial of the effect of HRT on disease incidence in healthy women, happened only because of the efforts of the National Women's Health Network. (Some physicians opposed it on the grounds that not giving hormones to women was unethical!)
"In scientific meetings, physicians were told that dozens of observational studies showed that women who took hormones were healthier than women who didn't take hormones. The HERS study, which showed no benefit for cardiovascular risk in women with heart disease who took hormones, is often dismissed at medical meetings as an aberration; one RCT against dozens of positive observational studies. The problem with observational studies is that women who chose to take hormones may be healthier than women who chose not to take hormones. Also, observational trials never include dead people, so would not have picked up women who died from hormone use. When the HERS study found no benefit of HRT, hormone promoters scrambled to point out that women with heart disease were different, vastly different, than healthy women (in fact, there is no drug that prevents disease in healthy people that doesn't also help those who already have the disease).
"With egregious hubris, the hormone promoters' positive spin on HERS was that although HRT increased cardiovascular events in the first and second year, the risk became lower in the third and fourth year; it took time to see the benefits of hormones. However, this argument was proved false when longer follow-up showed that there is no benefit from the hormones. When HRT was linked to breast cancer in those observational studies, drug companies reassured doctors that HRT causes "good", easily treated breast cancer. In fact, WHI has shown us that HRT increases the risk of invasive breast cancer.
"Spinning science has to stop. HRT is not the only therapy being over-promoted by drug companies to healthy people. Pharmaceutical companies have bought physicians, have bought scientists, and have bought clinical medicine. Science must be separated from advertising.
"The lesson we need to learn for the future is that we need unbiased research. We need to remove drug company influence from all medical education. And pharmaceutical interventions should not be inflicted on healthy people until these interventions are proven safe and effective in randomized controlled trials."