ALUMNI PROFILE
Gordon Klein ’67 Wins 18-Year Crusade to Help
Children
By Shira J. Boss '93
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![Jerome Charyn '59](images/klein.jpg)
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 |
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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.
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