BALANCING BABIES AND THE MARKETPLACE
Alex Langmuir often said that time imperatives sometimes required throwing EIS officers into the water. If they were unable to swim, they needed to know that there was a rescue team behind them.
The EIS training program always started as early as possible in July. By the end of the month, the fresh officers were dispatched to their new assignments.
One day short of the new assignments, on July 26, 1979, the Birth Defects Branch of the CDC received a report from a pediatric nephrologist in Memphis, Tennessee, of three cases of Bartter syndrome. This rare condition is caused by an autosomal recessive genetic condition that causes children to lose large amounts of sodium and potassium through their kidneys. This leads to a clinical syndrome known as metabolic alkalosis.
Only nine cases of Bartter syndrome had been reported in the world; therefore, the average pediatrician had never seen a child with the condition. Indeed, most pediatricians would never even hear the syndrome mentioned during training.
Normally, you simply cannot divert the short time available in a residency program to discuss issues that will never be seen. But surprisingly, Dr. Jose Cordero, an incoming EIS officer who would report for duty the next day, had actually treated one of those nine patients during his training at Boston City Hospital.
Cordero would have been an outstanding EIS officer even in the absence of this outbreak. Bright and hardworking, he threw himself into his work. However, this report immediately launched his EIS career. In Memphis, he found that all three children were less than 1 year old, had low potassium, low chloride, and metabolic alkalosis. Was this consistent with a diagnosis of Bartter syndrome?
As he looked closer, he found that, while all the children’s mothers seemed to have had normal pregnancies and deliveries, all three infants had milk allergies and had therefore been placed on a soy-based formula.
Dr. Cordero soon discovered that there were five brands of soy-based formula on the market. All three of these children had consumed the same brand, Neo Mull Soy, manufactured by Syntex Corporation. He quickly learned that soy-based formulas represented only 3 percent of the formula market and that Neo Mull Soy was only 10–12 percent of the soy market. So Neo Mull Soy accounted for 0.3 percent of the formula market.
It would be surprising if all three infants, by chance alone, were using the same brand, but it could happen. So Dr. Cordero now took additional steps. He contacted the directors of the accredited pediatric nephrology training programs in the United States and asked whether they had seen cases of metabolic alkalosis in the previous year; if so, how many had they seen and had the affected children consumed infant formula? If they had, what brands were they using?
While anyone could conduct such a study, it is often difficult for a single scientist to focus beyond the immediate problem or to have the resources and the ability to enlarge the inquiry. A national program, such as at the CDC, has the opportunity to ask if this is part of a larger problem—national or even global—and the ability to then investigate beyond the local experience. Dr. Cordero, in a short period, was able to identify nineteen additional cases of recent metabolic alkalosis. Some programs would not identify the formula used, but when information was shared, it was consistent. They had used Neo Mull Soy.
A review of possible mechanisms led to the obvious question: Could these children have low consumption of chloride and potassium? If so, it made no logical sense that an infant formula would be deficient in essential electrolytes.
Cordero talked to the medical director of Syntex. The production of Neo Mull Soy seemed straightforward, and the company had even purchased the soy protein from the same source as other soy manufacturers. But there was one troubling point. Because of several episodes of bacterial contamination, Syntex had been delivering its product with a highly acidic pH to prevent additional bacterial contamination.
Even this finding was not a matter of early concern because the company indicated that it routinely measured electrolyte levels in its product and would have identified a problem in the product if the acidic pH had caused an electrolyte imbalance. In addition, Syntex had a repository of formula for each batch manufactured in the previous year so the company could retest and recheck the results if that seemed to be needed.
On July 31, 1979, Dr. Cordero received a call from the Neo Mull Soy medical staff asking whether he could meet with them the next morning. They now related a problem previously unknown to them. Because of staffing problems that had occurred earlier, the company discovered a problem that had eluded all safeguards. The company review, which resulted from Dr. Cordero’s inquiries, found that the company had been measuring sodium and potassium levels but not chloride levels. This had somehow been missed by everyone in the chain of command. In testing saved batches, they had found low or undetectable levels of chloride. They realized that they had made a mistake and would announce that they were recalling all formula nationwide.
Two Errors Provide Legal Protection
Fact is often stranger than fiction. Children clearly need adequate intake of chloride. If their diet is based on a purchased formula, that formula must contain chloride, or they will be in trouble, as this outbreak indicated. The company, by error, had not included chloride in the formula. But apparently, also by error, they had forgotten to list chloride in the ingredients. Therefore, according to the US Food and Drug Administration, they were not legally accountable. Two errors had occurred, but one of the errors resulted in legal protection.
Two of the mothers involved, Carol Laskin and Lynn Pilot, became active in a legislative solution so this could not happen again. The efforts resulted in Public Law 96-359, signed by President Carter on September 26, 1980.
Two points to close this chapter. The first is the absolute speed with which this investigation proceeded. The original problem was reported to the CDC on July 26, 1979. Within one week, the problem had been characterized, a national survey had been conducted, the biological explanation of low chloride intake was determined, a manufacturing error was discovered, and the product was removed from the market with an explanation of the findings distributed to the medical profession. A mere fourteen months after the first report, the president had signed a public law to prevent a similar event. This represented the CDC, the EIS, the Public Health Service, and the government at their best. It was a demonstration of why we need a strong government to do the things we cannot do ourselves. The usual answers to a strong government involve such matters as defense, regulations, roads, and rescue operations. In this case, it came down to vulnerable babies unprotected by the marketplace.
Some public health solutions require labor-intensive efforts, such as reducing smoking rates or reducing obesity. Others involve a combination of government decisions and behavioral changes, such as immunization programs. Other solutions are very efficient in requiring only government action, as in this case.