Food News Blues

From the beginning, the WHI was controversial. Scientists especially questioned the diet trial, which enrolled 48,835 women. Psychologist Kelly Brownell, director of Yale's Rudd Center for Food Policy and Obesity, was on a committee convened at the request of Congress in 1993 to review the WHI. He says committee members were concerned about the design. Cancer and heart disease can take decades to develop. Would an eight-year trial be long enough? Would the women in the test group fully report their eating habits? Self-reports of dietary intake are notoriously inaccurate. On average, the participants weighed 170 pounds at the outset and reported that they ate 1,700 calories a day. By the end, they reported eating 1,400 to 1,500 calories daily. "They should have lost loads of weight," says Brownell. "Yet the women in the test group only lost three or four pounds. The control group actually gained about a pound. A scale is a scale. It won't lie. That screams out to me that the dietary records were inaccurate." It could mean that the difference in fat intake between the test and control groups wasn't large enough to show a distinct effect.

The calcium and vitamin D study also had its critics. When it was designed, calcium was considered so important that researchers thought it would be unethical to tell women in the control group to stop taking supplements. In the end, the test subjects and the placebo group were both taking in roughly the same amount of calcium. So when the final results showed little difference in the fracture rate between the two groups, some scientists blamed the study design. And there was a second problem. The amount of vitamin D they were given is considered inadequate today. Most doctors still recommend calcium supplements if women can't get enough in their diets. "It was a disappointment that it was not better designed," says Joan Lappe, professor of medicine at the Osteoporosis Research Center at Creighton University. She and her colleagues are worried that the public is getting the message that calcium and vitamin D don't matter.

WHI investigators fired off their first bombshell in 2002, when they stopped the hormone study early after a safety-monitoring board concluded that the risks outweighed the benefits. Gynecologists' phones rang off the hook as millions of patients demanded to know if they'd been duped. That study continues to be a source of fierce debate. Although the results showed an increased risk of breast cancer, stroke, blood clots and heart disease in women who took estrogen and progestin, some scientists say the reaction was too strong. Many doctors believe younger women who take hormones for a short time to relieve menopausal symptoms like hot flashes are generally at low risk. There's also some evidence that estrogen might protect younger women against heart disease. Researchers are only beginning to study that issue.

Years ago this debate would have been confined to scientific circles. Medical journals would have filtered new research and doctors would have read the journals, discussed studies with colleagues and then figured out how to translate data into clinical practice. All this was hidden to patients. Now even the most respected journals have had to adapt to the growing demand for health information. When The Journal of the American Medical Association (JAMA) and The New England Journal of Medicine were launched in the 19th century, they would have had no conception of a "publicity" department. But today, JAMA, which has published several WHI studies, spends $1 million annually on its media and communications program, says Dr. Catherine DeAngelis, the editor. Half goes to packaging video interviews, which TV reporters use in their stories. DeAngelis says the JAMA footage hits an average of 20 million viewers a week through local, national and international outlets. The other half of the money is used to run the communications office, hold press conferences and prepare press releases about upcoming studies, which reporters receive before the studies are published--if they tacitly agree not to print anything before the journal's publication date. If they agree to these "embargo" terms, they can question the scientists involved in the study and others who might have a more objective view of the research.

All that was in place last month when the WHI released its diet study. The headline in the main JAMA article, published on Feb. 8, gave no hint that some readers might be tempted to head for Krispy Kreme: low-fat dietary pattern and risk of invasive breast cancer. Two other articles in the same issue discussed the impact of the diet on heart disease and colorectal cancer. Like any journal report, all three were laden with details, including the number of women in the trial (48,835) and the goals (to reduce fat to 20 percent of calories and to increase consumption of vegetables, fruit and grains). The conclusion of the breast-cancer study--that a low-fat diet did not lower risk--was fairly nuanced. It suggested that if the women were observed for a longer time, there might be more of an effect. At a conference last week at the National Institutes of Health, which sponsors the WHI, researchers were even more direct, saying that they hoped women would not start eating fat because of this study, but that message got lost in the headlines.

The diet study was a victim of its time. Fifteen years later, we know a lot more and understand that some fatty foods, like olive oil and avocados, may actually be beneficial. And some food labeled fat-free is full of calories, which might have accounted for some of the participants' weight issues. "These studies are more complicated than a simple headline or sound bite can convey, and that's an important lesson for all of us," says Dr. Elizabeth Nabel, director of the National Heart, Lung, and Blood Institute, which administers the WHI.