Health - The Women’s Health Initiative and the Body Politic

The Women’s Health Initiative and the Body Politic

Posted: 10 Apr 2011 12:28 PM PDT

In 1898, German doctors fed fresh cow ovaries to a young woman suffering from severe hot flashes after having her ovaries removed. It was a milestone of sorts in women’s medicine, leading to crude hormone treatments and eventually commercially prepared drugs to relieve the symptoms of menopause.

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Bryan Christie

Landmarks From Two Decades of Study (April 10, 2011)

It was also the beginning of a seemingly endless controversy about the safety and necessity of drug treatments for women at the end of their reproductive years.

By the 1960s, pharmaceutical companies and doctors were promoting hormones as a way for women to stay “feminine forever,” even as scientists and women’s health activists argued that more study was needed to assess the risks of the drugs, including cancer. They also warned that menopause should not be “medicalized” or treated like a disease.

All that debate was supposed to end in 1991, when Dr. Bernadine Healy, the first woman to run the National Institutes of Health, decided to embark on a major research effort focusing on women’s health issues at midlife.

The Women’s Health Initiative, a $625 million study, would examine the risks and benefits of menopause hormones, calcium and vitamin D supplements and low-fat diets. All told, the landmark study recruited more than 160,000 women, including 26,000 for the hormone research.

Scientists fully expected the results to be predictable, including that hormones could prevent chronic illness in women, including heart disease.

But the findings have consistently surprised, debunking conventional wisdom time and again — about hormones and health, calcium to protect bones and the importance of a low-fat diet. The results, while invaluable, have also had a negative effect, leaving some women feeling frustrated, betrayed and whipsawed by what often seem to be contradictory headlines. And they have fueled cynicism about the medical establishment’s treatment of women.

The Women’s Health Initiative first shocked the world in 2002, when it stopped its largest hormone study because it showed that a common combination of estrogen and progestin was harmful, increasing a woman’s risk for heart problems and breast cancer.

The news prompted women to abandon the treatment in droves. Later, other data suggested that the news wasn’t all bad, and that the risk of menopause hormones might vary depending on a woman’s age. Still more reports from the research initiative suggested that estrogen increased the risk for stroke, and that the cancers associated with a combination of estrogen and progestin drugs were the most deadly.

Then, last week, the study’s latest finding surprised again. The Journal of the American Medical Association reported that certain woman who used only estrogen during the study had markedly reduced risk for breast cancer and heart attacks.

Confused?

“I have lost all confidence in the studies dealing with female hormone replacement,” wrote one reader on The New York Times’s Well blog.

Investigators with the research project, many of whom have been with it since it began, say that after years of bad news about hormones, the latest twist suggesting a benefit of estrogen for certain women just proves the value of scientific study.

“I think it’s the nature of doing large randomized trials,” said Andrea Z. LaCroix, the lead author on the Journal of the American Medical Association study and professor of epidemiology at the Fred Hutchinson Cancer Research Center in Seattle. “You may get answers you didn’t expect.”

There is no question that scientists now have a far greater understanding of women’s health at midlife than they did before the study. It is, without question, risky for an older woman long past menopause to start hormone treatment to prevent chronic disease. Doing so dramatically increases the risk for heart attack, stroke, breast cancer and other complications. While that may seem obvious today, back in the 1980s and early 1990s, doctors prescribed hormones to women of all ages.

“The W.H.I. has saved many lives,” said Dr. Susan Love, a longtime women’s health advocate and breast cancer researcher. “I think we should be celebrating the fact that we finally have research on women’s issues, an issue we fought hard for. The fact that the research results are not always clear is because our understanding of the biology and the science is not always clear. But the research is what gets us closer to the truth.”

Newly Born, and Withdrawing From Painkillers

Posted: 10 Apr 2011 08:34 AM PDT

BANGOR, Me. — The mother got the call in the middle of the night: her 3-day-old baby was going through opiate withdrawal in a hospital here and had to start taking methadone, a drug best known for treating heroin addiction, to ease his suffering.

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Damon Winter/The New York Times

Liriel, 1 year old, playing with her mother, Kate, in their bedroom at a transitional home where they have lived while waiting for permanent housingin Maine. Liriel experienced withdrawal from opiate dependency at birth and was treated with methadone. Her mother is still receiving treatment.

The mother had abused prescription painkillers like OxyContin for the first 12 weeks of her pregnancy, buying them on the street in rural northern Maine, and then tried to quit cold turkey — a dangerous course, doctors say, that could have ended in miscarriage. The baby had seizures in utero as a result, and his mother, Tonya, turned to methadone treatment, with daily doses to keep her cravings and withdrawal symptoms at bay.

As prescription drug abuse ravages communities across the country, doctors are confronting an emerging challenge: newborns dependent on painkillers. While methadone may have saved Tonya’s pregnancy, her son, Matthew, needed to be painstakingly weaned from it.

Infants like him may cry excessively and have stiff limbs, tremors, diarrhea and other problems that make their first days of life excruciating. Many have to stay in the hospital for weeks while they are weaned off the drugs, taxing neonatal units and driving the cost of their medical care into the tens of thousands of dollars.

Like the cocaine-exposed babies of the 1980s, those born dependent on prescription opiates — narcotics that contain opium or its derivatives — are entering a world in which little is known about the long-term effects on their development. Few doctors are even willing to treat pregnant opiate addicts, and there is no universally accepted standard of care for their babies, partly because of the difficulty of conducting research on pregnant women and newborns.

Those who do treat pregnant addicts face a jarring ethical quandary: they must weigh whether the harm inflicted by exposing a fetus to powerful drugs, albeit under medical supervision, is justifiable.

“I’ve had pharmacies that have just called back and said: ‘This lady’s pregnant. Why do you want me to fill this scrip? I can’t do that,’ ” said Dr. Craig Smith, a family practitioner in Bridgton, Me. “But when you stop and think about what actually happens during withdrawal and how violent it can be, that would certainly be not in the baby’s best interest.”

Still, even doctors who advocate treating pregnant addicts have had moments of doubt.

“At first I was going, ‘Gosh, what am I doing?’ ” said Dr. Thomas Meek, a primary care physician in Auburn, Me. “ ‘Am I really helping these people?’ ”

There are no national figures that document the extent of the problem, but interviews with doctors, researchers, social workers and women who abused painkillers while pregnant suggest that it has grown rapidly, especially in rural regions, where officials say such abuse is most common.

In Maine, which has been especially plagued by prescription drug abuse, the number of newborns treated or watched for opiate withdrawal, known as neonatal abstinence syndrome, at the state’s two largest hospitals climbed to 276 in 2010 from about 70 in 2005. Hospitals in states including Florida and Ohio reported similar increases, and experts said the numbers were probably higher since pregnant women are rarely tested for drug use and many mothers do not admit to abusing opiates.

Tonya, 24, said she was introduced to painkillers like OxyContin, Percocet and Vicodin while working the overnight shift at an industrial bakery an hour from her home. Everyone — including co-workers, the boyfriend she met on the job and their manager — was taking pills, she said.

“It was a lot easier to get through life and have energy,” Tonya said at Eastern Maine Medical Center here in January, holding Matthew a month after his birth. He was still being weaned off methadone.

Before she was pregnant, Tonya said, she quickly became addicted, spending all of her money on pills bought on the street. She and her boyfriend, Josh, needed to stave off withdrawal and get through the day, she said.

Now that she is in treatment, Tonya, who like most mothers interviewed for this article did not want her last name used, said her focus was on Matthew. “We put him in this situation,” she said, “and we have to help him out of it.”

‘How Little We Know’

Rigorous studies on treating infant withdrawal are scarce, and the American Academy of Pediatrics has not published guidelines since 1998.

“It’s really remarkable how little we know about the effect of prescription drugs and even nonprescription drugs on the fetus,” said Dr. Nora D. Volkow, director of the National Institute for Drug Abuse. “There are real roadblocks in terms of helping us advance the field.”

Dr. Mark L. Hudak, a neonatologist in Jacksonville, Fla., is helping to revise the pediatrics academy’s guidelines. “There are commonalities, but it’s not like you can go to a Web site that says, ‘This is what should be used by everyone,’ ” Dr. Hudak said. “No one knows what the best approach is.”

Within states, every hospital that delivers babies exposed to painkillers may have its own approach. Eastern Maine treats affected newborns with tiny doses of methadone, while Maine Medical Center in Portland uses morphine combined with phenobarbital, a barbiturate that prevents seizures. Some hospitals are also experimenting with clonidine, a mild sedative that can relieve withdrawal symptoms.

There is growing debate over treatment for pregnant women addicted to prescription drugs, in light of concerns over the effects on their babies. Many are slowly weaned from their dependence with methadone, the standard of care for decades. Methadone, when taken in prescribed doses, keeps a steady amount of opiate in the body, preventing withdrawal and drug cravings that occur when levels dip. But it, too, can be addictive and cause nagging side effects like drowsiness. And for addiction treatment, it can be obtained only at federally licensed clinics where most users have to report for a daily dose.

A growing number of addicts are instead taking buprenorphine, another drug used to treat addiction that some studies suggest staves off drug cravings as effectively as methadone but is less likely to cause withdrawal in newborns. In rural areas of the nation, where methadone clinics are few, buprenorphine is considered a promising alternative because it can be prescribed by primary care doctors and taken at home.

But buprenorphine also appears not to work for some addicts.

Health

Sunday, April 10, 2011