The art and science of women’s health

The Women's Health Initiative, a series of randomized controlled trials begun in 1991, was supposed to be definitive in terms of the role hormone-replacement theory would play in managing the health of post-menopausal women. However, the WHI has yielded unexpected and sometimes apparently inconsistent results.

The medical establishment expected the WHI to show that HRT, which had been popular for years, helped prevent cancer, heart disease and osteoporosis in older women.

L'Arlesienne / Vincent van Gogh
"Sheesh"

Instead, in 2002 researchers announced in the Journal of the American Medical Association that they had stopped the trials, which involved more than 160,000 women, because participants receiving estrogen combined with progesterone were developing invasive breast cancer at substantially higher rates than were women receiving a placebo, and their rates of heart disease were also high.

HRT, which to that point had been prescribed liberally for post-menopausal women, virtually disappeared as a therapy, in spite of the fact that it did seem to be helping women avoid hip fractures and colon cancer.

Just last week, though, again in JAMA, a group of WHI researchers reported that a smaller study of women who have had a hysterectomy, who were treated with estrogen alone for a median of 10.7 years, showed a decreased breast cancer risk with the treatment, with no significant increase in heart disease.

Well, that's disconcerting. Should post-menopausal women be asking their doctors about HRT after all? Probably not most of them.

“Women are different — it’s relevant to almost every medication and almost every intervention,” Joann E. Manson MD told Tara Parker-Pope in a story in last Sunday's New York Times.

“With this study, in many ways, science worked the way it’s supposed to work. It’s a little like watching sausage being made. It may seem on the surface that the study was a real problem and had many, many flaws, but in reality, it ended up giving invaluable information,” said Dr. Manson, a WHI investigator who is also chief of preventive medicine at Brigham and Women’s Hospital in Boston.

Adds Pope, "The most compelling lesson of the research should be that science is always worth the wait. Consumers should insist that doctors make recommendations based on scientific evidence, say investigators, rather than allowing drug companies or marketing hype to dictate patients’ health care choices."

That's true for middle-aged women, pregnant women, men and parents as well.

Image: Vincent Van Gogh's "L'Arlesienne"

Medicine is only as good as its evidence.

People talk about "evidence-based medicine" in obstetrics, and in the holistic birthing community as well, as if it's a sleek, shiny package tied up with a bow and ready for Christmas morning.

But evidence-based medicine is a shambling, messy thing, always on the move, only as reliable as the researchers who conduct it -- and as the research that has gone before and serves as its foundation.

The Lancet's retraction earlier this month of a 1998 study that appeared to establish a link between the development of autism in young children and the vaccine for measles, mumps and rubella is a good demonstration of the fallibility of evidence-based medicine.

One reason the original Lancet study collapsed was that other researchers could not duplicate lead author Andrew Wakefield MD et al.'s results. But even while 10 of the 13 original co-authors withdrew their support for the study, the public absorbed the idea that a cause-effect relationship exists between vaccination and autism.  That idea has not been eradicated by the Lancet's retraction.

And while such a retraction is unusual, it is unfortunately not unheard of.

Last July, anesthesiology researcher Scott S. Reuben MD of Baystate Medical Center in Springfield, Mass., was revealed to have falsified results in at least 21 studies that appeared in several peer-reviewed journals. Anesthesia and Analgesia alone retracted 10 of Dr. Reuben's articles.

Dr. Reuben specialized in multimodal analgesia, a drug-delivery system designed to control the pain of surgery.

In January, Dr. Reuben pleaded guilty to fraud for such audacious creations as a 2005 trial of Pfizer's drug Celebrex as an agent in a multimodal analgesia model. Dr. Reuben accepted $74,000 from Pfizer to conduct the study, simply did not do the work, and then published fabricated results in Anesthesia and Analgesia.

Unfortunately, other researchers based their own work on those phony results.

The collapse of Reuben's data has left multimodal analgesia “in shambles....The big chunk of what people have based their protocol on is gone,” said Jacques Chelly,  an anesthesiologist at the University of Pittsburgh Medical Center, in Anesthesiology News last March.