THURSDAY, Aug. 11, 2005 (HealthDay News) -- The world should not have been blindsided by the results of the Women's Health Initiative, the study that cast doubt on the safety of long term hormone replacement therapy (HRT), a new report contends.
Inklings, and perhaps more than mere inklings, of the dangers of HRT had been known to experts for decades, contend the authors of a paper appearing in the August issue of the Journal of Epidemiology and Community Health.
A conspiracy against women users kept this information out of the spotlight, the authors suggest.
"Together, the pharmaceutical companies, physicians and researchers effectively colluded to promote the view that menopause is a 'deficiency disease,' and that women needed long-term treatment with HRT to prevent illness, loss of sexuality and ugly aging," the Harvard researchers wrote.
Other experts, however, fault the tone of the article, saying scientists can't view the events of four decades ago with knowledge and experience only recently acquired.
"You cannot look back at the 1960s with the vision we now have, a 2005 microscope. It's inappropriate," said Dr. Steven R. Goldstein, a professor of obstetrics and gynecology at New York University School of Medicine in New York City. "When hormone replacement therapy came out, people weren't doing placebo-controlled, double-blind, randomized trials. We have progressed a lot. Lots of people would say the HRT bandwagon was a good example of why we need these randomized clinical trials going forward. It underscores the fact that HRT is a very complex issue, with huge pros and cons, and it has to be individualized."
"They're looking at a situation that developed 40 years ago with today's perspective," added Dr. Jay Brooks, chairman of hematology/oncology at the Ochsner Clinic Foundation in New Orleans. "It's important to try to view it from when it started."
Lead author Nancy Krieger, a professor of society, human development and health at the Harvard School of Public Health, did not feel this was a case of "hindsight is 20/20."
"Concerns were raised about the hormones used in HRT back to the 1930s," she said. "Why did that get overlooked? What were the enthusiasms that led to some pretty serious questions being raised?"
HRT had been used for decades as preventive therapy until the results of the Women's Health Initiative in 2002 found an increased risk of both cancer and cardiovascular problems. This trial was a randomized, double-blind, placebo-controlled study, the gold standard for clinical research.
This perspective piece, only the latest installment in a lengthy and confusing saga, evolved from a June 2004 interdisciplinary symposium on hormones, women and cancer risk, held at Radcliffe Institute for Advanced Studies in Cambridge, Mass.
The authors pinned their paper around this question: "Why, for four decades, since the mid-1960s, were millions of women prescribed powerful pharmacological agents already shown, three decades earlier, to be carcinogenic?"
The complicated answer, as the authors see it, includes an industry that is not tightly regulated; the ascendancy of individual as opposed to collective risk; and the "gendering" of hormones involving longstanding beliefs that sex hormones explain women's and men's behavior and biology.
Socially responsible research, they conclude, needs to include greater transparency of funding; a public registry for all drug trials; and a re-weighing of current prevention vs. future risk.
"This is true for much more than just hormone replacement therapy. It's true for any pharmaceutical," Krieger said. "There needs to be much greater transparency regarding how funding is done for research and medical training. We need to be aware that when you administer pharmaceuticals, it's very plausible that many have effects other than those intended, and even intended effects can be very complicated. The idea of giving powerful drugs to healthy people who are not sick and in need of a cure needs to be looked at very critically."
Many experts maintain, however, that HRT still has a place in women's pharmaceutical pantheon.
"The concept that something is carcinogenic from an epidemiological point of view is very different from the risk-benefit ratio we tend to look at. Tamoxifen is considered a carcinogen, yet it's the number one prescribed anti-cancer drug in the world," Goldstein said. "I have had intelligent, articulate women come to me and say, 'I don't care if I get breast cancer in 10 years because if you don't get me through today, tomorrow and next week, I won't be here in 10 years.'"
More information
Visit the National Institutes of Health for more on the Women's Health Initiative and hormone replacement therapy.
