From USA Today
Formula for bright babies?
By Rita Rubin, USA TODAY
If you've never shopped for baby formula, you might be surprised at the variety. You won't see chocolate or vanilla, but you will find formulas with milk or without, with lactose or without and with rice starch or without, to name a few. For most parents who decide to use formula, the choice of which type basically comes down to whether Junior spits up a lot or not. Beginning this week, though, the choice becomes more complicated.
Mead Johnson Nutritionals of Evansville, Ind., is introducing Enfamil Lipil, a milk-based formula supplemented with two fatty acids found in breast milk that scientists say are associated with brain and vision development. And in April, Ross Products of Columbus, Ohio, plans to bring out a similar formula called Similac Advance.
For parents eager to give their babies a leg up before they can even walk — think "Baby Einstein" videos and interactive toys — the new formulas might seem particularly attractive. But will they make the difference between whether or not little Mikey and Mallory get into the preschool of their parents' dreams?
The U.S. debut of these products comes after years of scientific debate over the value of adding docosahexaenoic acid (DHA) and arachidonic acid (ARA) — two building blocks of the brain and the retina — to infant formulas.
Proponents point to studies in which supplemented formula, compared with conventional formula, appeared to enhance brain and vision development.
"My reading of the literature is there is a clear benefit in neurodevelopment," says Norman Salem of the National Institute on Alcohol Abuse and Alcoholism, who conducted some of the research. "My personal opinion is that it (supplementation) should be mandatory."
But the Food and Drug Administration, the American Academy of Pediatrics and some scientists in the field aren't yet convinced that the supplemented formulas, expected to cost 10% to 15% more than conventional formulas, will make much of a difference in babies who aren't premature.
"There are some who are passionate" about supplementing formulas, says William Heird, a pediatric nutrition expert at the Baylor College of Medicine in Houston, who does not count himself among that group. "I keep looking at the data again and wonder what I'm overlooking."
Nancy Krebs, chair of the American Academy of Pediatrics' nutrition committee, echoes Heird's skepticism. Supplementation "is far from a clear-cut advantage," says Krebs, associate professor of pediatrics at the University of Colorado School of Medicine in Denver.
Last summer, the FDA did deem the DHA- and ARA-rich oils now being used to supplement the new formulas as safe, but the agency is nowhere near ready to say that the supplemented products are better for babies.
"Some science says yes, some science says no. It's not compelling enough," says Christine Taylor, director of the FDA's Office of Nutritional Products, Labeling and Dietary Supplements. "We're spending a great deal of time looking at the science of this."
Breast milk the gold standard
While the companies aren't allowed to come right out and say their new formulas will make babies smarter than conventional formulas would, some doctors and parents were convinced long ago.
Before supplemented formulas became available, they were advocating that women who weren't breast-feeding their babies add purified DHA to conventional formulas.
In the womb, fetuses receive DHA and ARA from their mother. This is especially important during the last trimester, so initial studies of supplemented formulas focused on preemies. After birth, breast-fed babies receive DHA and ARA through their mother's milk, although DHA levels in U.S. women have been dropping for decades because women have been consuming less fatty fish, such as salmon, and eating more prepared foods.
Medical experts agree that breast milk is the gold standard of infant nutrition, but the reality is that only a minority of U.S. women breast-feed beyond the first few months of their baby's life. While two-thirds nurse their babies in the hospital after delivery, half of them stop by the time their children are 6 months old. And many women who do breast-feed also give their babies formula.
"I feel that the best we can hope for (with supplemented formulas) is to narrow the gap between breast- and standard formula-fed infants," says Robert Gibson, an infant nutrition scientist at Flinders Medical Centre in Adelaide, Australia. "Best guess is about three to five IQ points."
But many studies haven't included enough babies to detect such a small difference, Gibson says, so some have found a benefit while others haven't. Still, even before much of the research was published, the World Health Organization in 1994 began recommending that DHA and ARA be added to infant formula.
U.S. formula makers already sell supplemented formula for preemies and full-term babies in dozens of other countries. In many, sales of the supplemented formulas have surpassed those of the unsupplemented formulas, even though the former are pricier.
Why would anyone question whether spending the extra money is worth it? For one, unsupplemented formulas do contain fats that are precursors of DHA and ARA. Full-term babies can make DHA and ARA from those fats, although proponents of supplemented formulas believe that not all infants can make enough DHA and ARA to supply their rapidly growing brains.
And while no research has suggested that adding DHA and ARA to formula can hurt, not every study has found that it helps. "I don't think you can totally discount studies that show a positive difference, but you have to recognize that there are equally good studies that show no difference," Heird says.
All the fatty acids babies need
One such study, led by scientists from Similac maker Ross and funded by the company, appeared in the August issue of Pediatrics. William MacLean Jr., vice president of medical and regulatory affairs at Ross, says the study shows that unsupplemented Similac contains all the fatty acids babies need. Ross has been studying the effects of DHA and ARA since 1987, MacLean says.
Although Ross announced last month that it will introduce a supplemented formula, MacLean says he still isn't convinced of a scientific need to do so.
"We have a long tradition of trying to provide a range of infant formulas for both parents and pediatricians," MacLean says. "It's a nice option to have."
James Hansen, MacLean's counterpart at Mead Johnson, blames the differences in research findings on the design of the studies, not the merit of the fatty acids. Hansen says Ross didn't use enough DHA in its study to show a benefit, and its DHA came from fish oil, not Martek Bioscience's tanks of algae.
Hansen calls supplemented formula "the best opportunity for a (full-)term infant to get a head start." Still, he acknowledges that the benefits found in full-term babies "are rather small," translating perhaps into a few points on the IQ scale.
"That's not a huge performance difference," Hansen says, "but we'd like to get every little bit we can."
Eileen Birch, a senior research scientist at the Retina Foundation of the Southwest in Dallas, co-authored most of the promising studies about DHA- and ARA-supplemented infant formulas.
"We wouldn't be doing studies if there wasn't controversy," Birch says.
So far, full-term babies in Birch's studies received supplemented formulas for only the first four months of life. She has followed the babies up to only 18 months of age.
It's not yet known whether feeding supplemented formula to babies older than four months, when many women switch from breast milk to formula, makes a difference, Birch says.
She and her collaborators hope to answer that question in an ongoing study comparing supplemented and unsupplemented formulas for the entire first year of life.
Their research recruits only new mothers at two Dallas hospitals who have indicated they do not plan to breast-feed, Birch says. "We're really careful to never discourage breast-feeding."
And Birch and her collaborators are now following up 4-year-olds and 9-year-olds from their earlier studies. She acknowledges that the tests of thinking ability they took as babies are not necessarily predictive of future intelligence. For the most part, Birch says, the tests were designed to identify infants who need special attention, not distinguish smart kids from really smart kids.
Although all the answers about supplemented formula are not yet in, Birch says, "I think the fact that it's more like mother's milk, and there's no harm associated with it, will make it an attractive product." |
