The Department of Health and Human Services could have prevented the distribution of half a million cans of dangerously defective infant formula if it had not delayed implementing for a year new regulations advocated by HHS Secretary Richard S. Schweiker just months before he took office, according to congressional sources.
House subcommittee on oversight and investigations staff members said 571,000 cans of Nursoy infant formula were recalled last week by its manufacturer, Wyeth Laboratories, because it lacks vitamin B6, which is essential to life.
Vitamin B6 manufactures a number of chemicals in the nervous system. In an earlier case, about 2,000 infants who took Wyeth formula that did not contain B6 had convulsive seizures, and some suffered permanent brain damage such as cerebral palsy, according to Dr. John H. Menkes, professor of pediatrics and neurology at UCLA.
It is not known how many infants have been fed the current defective formula, but some batches may have gotten into stores early enough for infants taking no other food to suffer brain damage. The company managed to call back about 480,000 cans before distribution, but 90,000 cans went to stores and have not yet been located.
The administration admits that it could have prevented the danger if it could have put into effect regulations that would have required Wyeth to test the formula before selling it, according to Wayne Pines, public affairs officer for the Food and Drug Administration.
The regulations were delayed by the adminstration's heralded executive order requiring a "cost-benefit analysis" on proposed regulations, Rep. Albert Gore Jr. (D-Tenn.) said.
President Carter signed the regulations into law in September, 1980, but they have not been issued because "it just takes that long to issue regulations of this dimension," Pines said.
As a U.S. senator, Schweiker was one of the strongest critics of the Carter administration for its delay in putting the rules into effect. In a hearing on June 12, 1980, Schweiker told FDA officials that a delay of even six months was unacceptable.
"There has to be some shortcut procedure when children's lives are at stake. Surely we can come up with something within the bureaucracy to solve a problem like this," Schweiker said.
A Wyeth spokesman said it is not company policy to test infant formula because "it is not required" by law.