ALUMNI PROFILE
Gordon Klein ’67 Wins 18-Year Crusade to Help Children
By Shira J. Boss '93

It took 18 years, but pediatrician Gordon Klein '67 has finally gotten the FDA to ban potentially harmful aluminum from feeding solutions. PHOTO: JOHN GLOWCZWSKI, UTM/GALVESTON

Pediatrician Gordon Klein ’67 waged a one-man battle against government bureaucracy for 18 years to remove a harmful ingredient, aluminum, from feeding solutions. His campaign, started in 1982, succeeded in 2000 when the Food and Drug Administration finally acknowledged his constant pressure and made a ruling outlawing the offending substance.

“I felt an obligation to do it because nobody else was doing it,” Klein says. “I attribute a lot of this to the social conscience that I developed at Columbia.”

Klein received his medical training at Albert Einstein College of Medicine, Cambridge University and Stanford, then served in the Navy Medical Corps for two years during the Vietnam War. He completed fellowships at Johns Hopkins and UCLA, focusing on pediatric nutrition and digestive diseases.

“I felt that other disciplines took themselves a wee bit too seriously,” Klein says. “I felt more at ease taking care of children.”

Even though Klein was a government major at the College, nothing had prepared him for the travails of taking on the FDA. After Klein and his colleagues discovered the harmful effects of aluminum when it was present in intravenous feeding solutions such as those given to premature babies, Klein contacted the regulatory agency about requiring manufacturers to remove aluminum. Studies showed that aluminum, when introduced to the bloodstream for an extended period of two weeks to two months, is responsible for a painful bone disease and neurological damage.

It took four years for the FDA to draft the Intent to Propose Changes to Regulation and Request for Information. The actual proposal to make changes took another eight years. “These proposals spend an endless amount of time in legal offices,” says Klein, whose calm, steady manner and soothing voice belie the relentlessness he displayed in taking on the FDA. Year after year, he wrote letters, made phone calls and sent e-mails.

“Those were the toughest eight years,” he says of the waiting period for the proposal. “Fortunately, other things were going on to prevent me from going crazy and developing an ulcer.” In 1986, Klein was appointed an associate professor of pediatrics and preventive medicine at the University of Texas Medical Branch, where his work included the care of children with digestive diseases and research in nutrition and bone metabolism in addition to teaching. He was promoted to professor in 1995.

Every couple of months, Klein would again turn to his campaign and try to make headway in Washington. In addition to pressuring government officials, he contacted reporters at The New York Times and The Washington Post, but nothing was written. “At one point, I got so frustrated,” he says, “that I wrote an article for the American Journal of Clinical Nutrition called ‘Aluminum in Parenteral Solutions Revisited — Again.’”

Colleagues encouraged him to keep up the pressure. “I had to figure out how I could do it politely,” Klein says. “I found out that the only thing I could do is give [the FDA] new data and send copies of papers I thought were relevant, including abstracts of presentations I would make at a meeting, and then add, ‘And by the way, where is [the proposal] now, and who can tell me when it will come out?’”
Klein eventually contacted the offices of California Congressman Henry Waxman (D) and Texas Senator Phil Gramm (R). Both wrote to the FDA, urging it to follow the recommendations of the professionals.

Klein thinks it may have been his personal plea in 1999 to the new FDA commissioner, Jane Henney, that moved the process toward final action. “I wrote a synopsis of the problem and said, ‘Please remember that every day that passes, more and more infants are being loaded with this potentially toxic substance,’” Klein says. Shortly thereafter, the proposal was published and circulated. In January 2000, the final rule was published; it went into effect a year later.

“I think the process takes as long as the noise level will allow it to take,” Klein says of his understaffed struggle. By the time the new rule was made, children born when Klein and his colleagues discovered the problem had reached high school. “If there had been lawsuits, press coverage, a big hue and cry, things would have moved faster. This really got put on the back burner and nobody could tell me when it was going to be moved along, although the FDA never disagreed with the necessity to move it along.”

In addition to premature babies and infants in intensive care, at-risk patients include those who have intestinal disease, kidney problems or are on dialysis, and those who receive intravenous feeding because of severe fluid loss. “Nobody thought it was going to affect as many people as it did,” Klein says.

Manufacturers have until next year to comply with the new standards, and Klein is keeping his eye on them. “It’s easy to relax and say, ‘I’ve done my part, and now whatever happens, happens,’” he says. “But you can’t do that.”

In the meantime, the FDA has retained Klein as a consultant to review cases of aluminum contamination in other products.