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Hormone Therapy is Dead


"Is Hormone Replacement Therapy Dead?" I asked in March this year, pointing to a statement of the World Health Organization where the therapy was described as "a big mistake".

Not that we did not know for years already - Sherrill Sellman had done the research and published it in a two-part article in Nexus Magazine, which now is archived here.

The most recent study, which was described by Dr. Lori Mosca, director of preventive cardiology at New York Presbyterian Hospital as "the final nail in the coffin" of hormone therapy was published last week by the Journal of the American Medical Association.

The Baltimore Sun reports...

Bad news on estrogen true

Studies: Hormone replacement therapy, thought for years to stave off a range of ailments, instead raises risk of diseases, research confirms.

By David Kohn
Sun Staff (The Baltimore Sun)
Originally published April 19, 2004

For older women, estrogen was a wonder drug. The hormone not only relieved menopausal symptoms such as hot flashes and mood swings, but also prevented bone loss, heart disease and memory problems. Better yet, it endowed many of those who took it with youth and vigor.

At least, that's what everybody thought.

Over the past two years, estrogen's reputation has plummeted. Two large-scale clinical studies by the National Institutes of Health were called off early when researchers decided that hormone replacement therapy increased the risk of stroke and heart disease -- the very ailments it was thought to prevent.

An article in last week's Journal of the American Medical Association confirmed the bad news. The study's leader, National Heart, Lung, and Blood Institute director Dr. Barbara Alving, said hormone replacement therapy (HRT) does not prevent chronic disease, and should only be used for menopausal symptoms on a short-term basis and as a second-line drug for bone loss.

The latest study "is the final nail in the coffin," said Dr. Lori Mosca, director of preventive cardiology at New York Presbyterian Hospital.

So what happened? How could so many scientists and doctors have been so wrong?

Those involved say it was human error: Researchers and practitioners relied on believable but flawed evidence, and put too much faith in appealing but unproven theories.

Critics say other human failings -- greed and naivete -- also played a role. They blame drug companies for overselling hormones and doctors for buying into the hype.

Women have been taking estrogen since the 1930s, when scientists first distilled it from the urine of pregnant mares (which remains a key source). Over the decades, researchers uncovered a mountain of evidence that estrogen could stave off a range of ailments in menopausal women.

"Lots of people were looking at the pill as a fountain of youth," said Garnet Anderson, a biostatistician at the Fred Hutchinson Cancer Research Center in Seattle and a lead investigator in the two halted studies.

But much of the support for HRT's preventative properties came from so-called "observational" evidence. In these studies, scientists compared women who were on HRT with others who weren't. Although seemingly balanced, this research contained a huge flaw, scientists say.

The key problem: Women who take estrogen tend to be significantly healthier than those who don't, even before they start the therapy. On average, they are wealthier, take better care of themselves and are more likely to get early care for medical problems. As a result, positive effects that seem to come from estrogen might actually stem from the overall health disparity between the groups.

The NIH study, known as the Women's Health Initiative (WHI), was set up differently. It was a randomized clinical trial, which is less prone to bias than an observational study.

WHI researchers randomly split a pool of similar subjects into equal groups, then gave estrogen therapy to one and a placebo to the other. This approach ensured that both groups started out equally healthy and allowed scientists to accurately gauge the preventative effects of hormone therapy.

The WHI trial, which included more than 16,000 women, came up with very different results than earlier studies.

In 2002, NIH abruptly ended a portion of the study because the therapy increased risk for strokes, heart attacks and possibly dementia.

This study looked at a combination of estrogen and progestin, another hormone. (Estrogen raises uterine cancer rates; progestin offsets this risk.)

Last month, NIH stopped another segment of the study, this one involving estrogen alone, which is taken by women who have had hysterectomies. The findings showed women on estrogen had a slightly higher risk of stroke.

The negative results -- particularly the 2002 announcement -- startled millions of women, many of whom had been taking estrogen to prevent a variety of ailments. Estrogen use in the United States dropped significantly, from about 15 million women in 2000 to 10 million today, according to a recent study.

Among those cutting back was 49-year-old Linda Vinson, a retired sales manager who lives in Stevenson. She had a hysterectomy in 1998 and has been on estrogen ever since. But she has reduced her dosage by two-thirds. "There's no reason to take a medicine if you don't need it," she said.

The negative results also stunned researchers. "Anybody who's honest will say they were surprised," said Mosca. She thinks the mistake will change the way medical science is practiced. "The great lesson we learned from this is the critical importance of randomized trials in humans," she said.

But study design alone didn't trip up the medical community, scientists admit. They were also fooled because the positive results supported an appealing theory that connected a range of phenomena. Because natural estrogen loss came at an age when many women begin to suffer from a variety of ailments, then estrogen replacement, they reasoned, might head off many of these problems.

"We wanted to be led astray, and we were," said Anderson.

Some believe that drug makers are culpable. For decades, critics say, companies aggressively promoted unproven ideas about hormone therapy. "It was just hugely exaggerated," said Cynthia Pearson, executive director of the National Women's Health Network. She was among a minority questioning HRT in the 1980s and 90s.

Wyeth Pharmaceuticals, which controls more than half of the hormone replacement market, disputes her assessment. The company says it advertised estrogen strictly for menopausal symptoms and bone loss -- the only uses the Food and Drug Administration approved.

Pearson and others also criticize physicians for accepting HRT claims without question. Many doctors don't keep up with the latest research in their field and get much of their information from drug company representatives, says Diana Zuckerman, president of the National Center for Policy Research for Women & Families.

"Many doctors were prescribing hormones like they were candy," said Zuckerman.

Others are less critical. Presbyterian's Mosca points out that many knowledgeable hormone researchers made the same misjudgment. "We did the best we could with the information we had," she said.

But hormone replacement might have preventive benefits after all. In the midst of the downbeat news, some scientists are quietly suggesting that data from the WHI and other studies indicate that estrogen may thwart heart disease -- but only for women in their 40s and 50s.

Mosca finds the theory intriguing, but needs a more careful hearing than its predecessor. "We all want to be hopeful that there is a magic bullet," she said. "But we don't want to practice medicine based on hope."

See also:

Is Hormone Replacement Therapy Dead?

How to Achieve positive Results without actually Lying to Overcome the Truth

Pharma profits do not equal health - Berkely Prof advocates alternative

Medical system is leading cause of death and injury in US

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