A Challenging Prescription

Now, doctors and patients must weigh risks of drups, therapies

August 05, 2007|By Dennnis O'Brien | Dennnis O'Brien,Sun Reporter

When a study published this spring showed that Avandia, a drug that lowers diabetics' blood sugar, also increased their risk of heart complications, Dr. Mary M. Newman, a Lutherville internist, was in a quandary about what to advise her patients taking the medication.

"It was easy for patients to feel the drug was proven to be dangerous and everyone was concerned," Newman said. "But the thing is, there were benefits." In the end, she said, the decision on whether to continue the medication varied with each patient.

Last week, assessing Avandia became even more complicated for Newman and her patients when an FDA advisory committee voted 20-3 in finding that Avandia increases the risk of heart disease in Type 2 diabetes, but at the same time the panel voted 22-1 to leave it on the market.

At a time when more information than ever is broadly available about illnesses and the effects - positive and negative - of the drugs used to treat them, doctors and patients are facing a growing challenge as they attempt to sort out the benefits and risks of medications and therapies.

Every week, professional journals and other sources report the results of new medical studies - a rising tide of information that sometimes seems contradictory. Patients can read the studies on the Internet, or read about them in newspapers, and bombard their doctors with questions that frequently don't have simple answers.

"So many patients go on the Internet now and with what the press bombards them with, they have a lot of information. They need to be able to understand the literature, so they can take it to the doctor and ask informed questions," said Erik Rifkin, a retired environmental consultant and co-author of The Illusion of Certainty, a new book that argues for increased clarity in the reporting of medical research.

Rifkin and his co-author, Edward J. Bouwer, both of whom live in Baltimore, say researchers should state findings in terms that are easier to understand. Statistics used in studies - and repeated in news reports - are often misleading, they say.

William Mohler ran into information overload last year when he turned to the Internet for help in understanding a condition that predisposed him to cancer.

The retired plant engineer had developed Barrett's esophagus with high-grade dysplasia, a condition that experts say carries roughly a 30 percent risk of developing cancer of the esophagus.

Online, Mohler found detailed descriptions of the usual treatments: inserting a laser into his esophagus to burn away the pre-cancerous tissue, a procedure that would make him sensitive to sunlight; and surgery that would have been "the equivalent of a quadruple bypass," he said.

"I got so much information that I had to quit because with the Internet, there was so much out there," said Mohler, 69, of Frederick.

His doctor referred him to a specialist at the University of Maryland Medical Center, where as part of a clinical trial he had an endoscope inserted into his esophagus so the abnormal tissue could be sprayed with ultra-cold liquid nitrogen, destroying it and allowing healthy tissue to grow in its place. "It's been a godsend," Mohler said.

Increasingly, some physicians say, patients come to them with fixed opinions based on what they have heard or read about in the latest medical studies. "They actually tend to believe more what's in the newspaper and what's on the Internet than they believe me," said Dr. Joanna Saba, an Owings Mills internist.

Consumers also may reach incorrect conclusions about studies they read or hear about. Some studies, doctors say, make medications sound attractive to people who don't need them. Others scare away patients from potentially beneficial therapies.

Nearly five years ago, women were alarmed when researchers linked estrogen replacement therapy to an increased risk of heart attack and stroke, Saba noted.

"That study really freaked women out and everyone wanted to dump their hormones," she said, "but the numbers of women actually at risk in that study were actually very small."

Last month, another research team found that the only women at significant risk of heart attack and stroke from hormone therapy were those who delayed taking it for at least 10 years after menopause. One newspaper reported the results with the headline: "Doctors Change Course Again on Estrogen Therapy."

"So a lot of women dumped their hormones and became miserable post-menopausal women and didn't have to," Saba said.

Published research, especially in widely read, peer-reviewed journals, should provide sufficient information to help make informed decisions about courses of treatment, experts say.

"What a doctor needs to know is what the benefit is to patients overall, and to patients in different risk categories," said Dr. Peter C. Wyer, an associate professor of medicine at Columbia College of Physicians and Surgeons. "The results have to be really badly reported for you to not have those numbers."

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