The legacy of WHI? Confusion and apprehension, possibly

“Afraid of hormones”

In the years since early WHI findings were published, Anita L. Nelson, MD, has not noticed confusion so much as fear among her patients. Dr. Nelson is professor of obstetrics and gynecology at the David Geffen School of Medicine at UCLA in Los Angeles.

“I think the things that are concerning to patients by and large are breast cancer and, in women who have done more reading on it, some of them are concerned about dementia,” Dr. Nelson says. “But by and large, other than those focused issues, it is hormones that patients are afraid of, and they sort of wave their hands in this global aura of ‘badness’ that they’re afraid of.”

One reason is the WHI. “Obviously that contributed to it,” she says. But a bigger cause of fear among her patients, a large percentage of whom are referred, is the fact that “their physicians have been taking them off of therapy. They’re not offering it,” she says, “or they are putting up a sort of barrier by saying, ‘You have to go see Dr. Nelson before you can start taking those medications.’”

The problem doesn’t end there, she adds. “The sad thing is that they are by and large not offering them alternative medications while they’re waiting for the transition—or if they are, sometimes they are actually giving them hazardous drugs. One of my favorite things is when patients who have high blood pressure are denied estrogen but are given Bellergal [ergotamine, belladonna alkaloids, and phenobarbital], which has a vasoconstrictive medication in it.”

“We do want folks to review the data,” she says, noting that ObGyns are “true believers” and unlikely to quit prescribing hormone therapy (HT). It is the internists and the family medicine physicians “who still have significant misgivings about the safety of these therapies in recently menopausal women.”

Joanna Shulman, MD, agrees. She is associate professor and director of the medical student clerkship in obstetrics and gynecology at Mount Sinai School of Medicine in New York City.

“The internists I work with or that my patients see tend to be terrified of hormone therapy. So I think they tend to discourage their patients.”

Mea culpa, anyone?

Confusion over the WHI is an issue for another prominent ObGyn—Wulf H. Utian, MD, PhD, editor-in-chief of Menopause Management and executive director of NAMS. In an editorial in the September/October issue of Menopause Management, Dr. Utian faults the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) for starting a “firestorm in women’s health” by publicizing the abrupt termination of the estrogen–progestin arm of the WHI study.⁴

Utian notes that he pointed out his dismay over the WHI way back in 2002, when he wrote, again in Menopause Management: “The manner in which the study was terminated was poorly planned, abrupt, and inhumane. Predictably, the media response was enormous, ranging from thoughtful to sensational. Panic was caused, numerous women discontinued therapy, and women and their health providers alike have been thrown into a state of confusion, distrust, and quandary of what to do next.”⁴

Bruce Wineman, DO, concurs. Although he retired from practice as a reproductive endocrinologist at the Marshfield Clinic in Marshfield, Wisconsin, shortly before the WHI findings were first published, he maintains his license and stays active in the ASRM. “The worst part of the WHI is that they got so much press with it,” he says, “and that the group of women that they chose was exactly the group of women that was going to have the maximum amount of negative effect.”

Utian believes a mea culpa is in order. “There are reams of important and pertinent data coming out of all the substudies of the WHI,” he writes. “For these to be accepted with confidence, it is well time for the NIH to bring all their WHI investigators together to develop a transparent and comprehensive summary of their results. It is also time for the WHI investigators to cease their stubborn defense and misrepresentation of their 2002 data, and to return to scientific integrity.”³

Same view in the trenches

Mohamed Mitwally, MD, spends 90% of his day in clinical practice at the Reproductive Medicine and Fertility Center in Colorado Springs, Colorado. He estimates that roughly half of his perimenopausal and menopausal patients troubled by vasomotor and other symptoms are currently on HT. Since the WHI’s initial findings were published, Dr. Mitwally has “absolutely” had to spend considerably more time educating his patients—“and educating physicians,” he says. His patients are reluctant to take HT because of press attention to the WHI. And other physicians are reluctant to give HT because they understand that the WHI is a randomized trial “and so don’t question it.”