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Fierce debate raging over new cancer test guidelines

By Rob Stein
Washington Post Staff Writer
Sunday, November 22, 2009; A07

President Obama's vision for making health care in America more effective and efficient collided for the first time last week with the realities and peculiarities of the nation's health-care system.

As the Senate moved toward its first floor vote on the health-care reform bill, two independent expert groups coincidentally released new guidelines for mammograms and Pap tests aimed at improving treatment for two forms of cancer in women.

Although neither set of recommendations was aimed at cutting costs, both were based on the kind of objective analysis of scientific research that the Obama administration has embraced in its bid to make care better and more economical.

But after the recommendations unleashed fierce criticism, controversy and debate, the administration appeared to quickly distance itself from the mammography guidelines to try to prevent the uproar from endangering a domestic priority.

"This tells us an awful lot more about where we are as a country in terms of our relationship to the health-care system and health-care reform than they do provide new information about how often women should get screened," said John Abramson, a clinical instructor at Harvard Medical School and a leading proponent of eliminating unnecessary care. "It's like a Rorschach test of where we are when it comes to the health-care system and health-care reform."

Nancy-Ann DeParle, director of the White House Office for Health Reform, said Saturday that the debate over the guidelines goes to the heart of "the unique doctor-patient relationship in the American health-care system and the desire to preserve that."

"Today many of these decisions are being made by insurance companies and bureaucrats, and we want to make sure those decisions are made by doctors," DeParle said.

'Evidence-based' care

The recommendations about mammograms and Pap tests are the latest in a series of guidelines that have been emerging as part of "evidence-based" medicine. The seemingly obvious idea behind the movement is to base medical decisions on the best available scientific evidence, including "comparative effectiveness" studies, instead of relying on tradition, intuition or personal experience.

"One of the things I think you're seeing is the maturation of the concept of evidence-based medicine," said Ned Calonge, chairman of the U.S. Preventive Services Task Force, the federally appointed panel that issued the new mammography guidelines.

That task force and others had begun backing off recommendations that men routinely undergo PSA testing for prostate cancer. That rethinking was based on a similar argument: that although the tests may save lives, they often produce false alarms that cause unnecessary anxiety and find tumors that may never require treatment but nonetheless prompt men to get surgery, chemotherapy or radiation, which can leave them impotent and incontinent.

Those recommendations, although somewhat less controversial than the new mammography guidelines, remain the subject of debate. One large study released in March estimated that to prevent one prostate cancer death, more than 1,400 men would need to get PSA tests and 48 would need to be treated. Proponents, however, say the evidence questioning the test's power to prevent deaths is flawed.

In the case of mammography, which costs the nation about $5 billion annually, the task force concluded that although screening reduces the number of women who die from breast cancer, annual screening starting at age 40 rather than 50 comes with a huge downside: For every woman whose life is saved, many more suffer through the erroneous fear that they have cancer, get exposed to radiation from more tests, undergo biopsies, and often endure surgery, radiation and chemotherapy for tumors that may never be life-threatening.

According to one estimate, out of every 1,000 women who begin receiving annual mammograms in their 40s, about 470 extra women will get false alarms and about 33 will get unnecessary biopsies to save 0.7 lives. Another estimate says that about half of all women who have annual mammograms for 10 years will get an unnecessary biopsy.

The task force was not recommending that women be denied mammograms, just that doctors discuss the benefits and the risks with each patient so that women can decide for themselves. Those at high risk because of a family history of the disease or those who are just worried about breast cancer could still opt for more frequent exams.

The same goes for Pap smears, which the American College of Obstetricians and Gynecologists concluded were leaving too many women with scars that led to problems having babies. About 50 million Pap tests are done each year in the United States, at a cost of about $85 per exam.

Benefits vs. risks

The conclusions are part of a recognition that there is an inherent disadvantage to casting the broadest net to catch as many cancers as early as possible.

"We've come to realize that screening is a very nuanced issue that requires a delicate balance between benefits and harms. Everyone originally came to the screening issue thinking it only produced benefits," said H. Gilbert Welch, a professor of medicine at the Dartmouth College Institute for Health Policy and Clinical Practice. "But now it's more broadly recognized that it also brings harms. We need to weigh those."

At the same time, researchers realized that many of the abnormalities caught early would never become life-threatening.

Some experts liken the changes to the decision to stop giving chest X-rays during routine physicals and, more recently, to the growing recognition that annual physicals are probably unnecessary for many healthy people. Similarly, there is an ongoing debate about the value of spiral CT scans for lung cancer screening, testing the elderly for early signs of osteoporosis and doing full-body scans as part of "wellness programs."

"The idea that the best way to stay healthy is to look as hard as you can for everything you can is actually a recipe for doing a lot of harm," Welch said. "Screening is about looking for something in the well. It's really hard to make a well person better. But it's really easy to make them worse."

Studies have also found that many tests are done more to protect doctors against malpractice charges than for patients' benefit.

Not everyone agrees with the new recommendations. The American Cancer Society has stopped recommending routine PSA testing and does not oppose the Pap rules. But, along with the American College of Radiologists and others, the group has condemned the new mammography guidelines. Critics argue that the task force analysis was flawed and minimized the benefits by ignoring important data.

"There's an appearance that these findings are above criticism," said Robert Smith, the cancer society's director of screening. "They're certainly not. Their methodology minimizes the benefits of mammography. We have very good data that mammography saves lives."

Many doctors and patients remain skeptical about the mammography, cervical cancer and prostate cancer guidelines, finding it difficult to accept that early diagnosis and treatment do not save lives.

"I don't know how to stress my anger on this issue," wrote Christine T. Gonzales, who works at a gynecologic oncologist's office in San Antonio, in an e-mail to The Washington Post. "Every day, every minute women are dying of cervical cancer."

But the key to cancer screening, many experts say, is to find better ways to identify the tumors that pose life-threatening risks so benefits can be maximized and harms minimized.

"We have some ability to do that now, but for the most part we're still in the Dark Ages when it comes to the biology of tumors," said Donald Berry, a professor of biostatistics at the M.D. Anderson Cancer Center in Houston.

The mammography debate is unlikely to end anytime soon, and similar clashes are likely to ensue, regardless of what Congress does.

"This will not be the last case of this," said Laura J. Esserman, a professor of surgery and radiology at the University of California at San Francisco. "We don't want people to get less than they need, but we also don't want people to get more. We need to tailor the treatment so they get what they need."

Staff writer Scott Wilson and researcher Madonna Lebling contributed to this report.

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