FDA Scientists Dispute Soy Health Claim

NEW YORK--On June 9, the primetime newsmagazine 20/20 reported that soy may not be a panacea for good health. The newsmagazine's report was based on the findings of Daniel Doerge and Daniel Sheehan, research scientists for the Food and Drug Administration (FDA). According to Doerge and Sheehan, soy may increase the risk of breast cancer in women, affect brain function in men and affect the sexual development of infants. They believe the new soy health claim is being misinterpreted by the public as a much broader endorsement for soy protein as a universal remedy.

In a letter to the FDA, Doerge and Sheehan argue that the health claim was issued without enough research into soy's adverse effects on health. They even ask the FDA to rescind the claim, citing research that demonstrates soy's role in causing fertility problems in animals. According to Doerge and Sheehan, those reports are compelling evidence that soy can be harmful as well as helpful.

"The animal data is a clear indication for adverse effects, [and] the potential for adverse effects in humans," Doerge said in his 20/20 interview.

The 20/20 report focused on the debate over soy in infant formulas. It reported that according to Doerge and Sheehan's research, soy isoflavones, which have an estrogen-like effect, may alter a baby's sexual development. The newsmagazine quoted Sheehan as saying that the use of soy baby formulas is a "large uncontrolled and unmonitored experiment on human infants."

The soy and infant formula industries had other opinions. "Mother's milk is the best nutrition for babies," said Dr. Susan Baker, chair of the American Academy of Pediatrics Committee on Nutrition. "[However, our] policy is that soy formulas are safe and effective for babies who are not being breast-fed and cannot tolerate cow's milk."

Mardi Mountford, executive director of the International Formula Council, expressed concern about how people may now view soy. "One of the things which is so frustrating about [this] story is that they said the safety of soy formula hasn't been tested." According to Mountford, researchers did not consider the thousands of children who were fed soy formula and developed normally.

[Currently, a study in its last stages is testing the safety and benefits of soy formulas. Those results will be published in the near future. For more information, call Mardi Mountford at (404) 252-3663 or contact Michelle Babb at the United Soybean Board at (206) 270-4635.]

Other health concerns raised in Doerge and Sheehan's report included soy's effects on breast cancer and brain aging. According to Dr. Claude Hughes, director of the Women's Health Center at Cedars-Sinai Medical Center in Los Angeles, there are certain types of breast cancer that actually "feed" on estrogen, and soy's isoflavones may enhance, rather than inhibit, their activities.

"It can speed up divisions of those cells that are already cancer cells that depend on estrogen for their growth," Hughes said to 20/20.

The other concern focused on brain deterioration caused by aging. One study in particular focused on a group of Japanese men living in Hawaii who ate more than two servings of tofu each week. According to the study, those men showed a marked increase in the deterioration of brain function associated with aging.

Though unusual, Doerge and Sheehan's letter to the FDA has not, as yet, solicited a response from the agency.