Miracle growth drug brought death to some

Hormone to combat dwarfism used despite contamination warning


In 1958, an American scientist managed to do what nature had failed to. He made a dwarf grow. For the first time, mankind had harnessed human growth hormone.

By 1963, while technically still an experimental drug, the hormone was being supplied free of charge by the National Institutes of Health to pediatricians across the United States. For the next 22 years, the drug was administered to more than 8,000 stunted children.

It worked. The children grew.

But then, decades after taking the hormone, a small but steady succession of recipients began to develop strange symptoms.

First they lost their balance. In the case of a 32-year-old foot surgeon from Brooklyn, N.Y., Dr. Stacey Crair, she started toppling over. As a child, Crair had received growth hormone treatment for 12 years.

Nearby on Long Island, a water safety engineer named Mike Nofi remembers that his 30-year-old wife, Wendy, started feeling as if "she was on a boat." She had received growth hormone for six years.

Soon they began to stagger and drool. Their personalities changed. Within months they were in comas. Their brains were turning to sponge.

They had Creutzfeldt-Jakob disease, or CJD, a human variant of the so-called mad cow disease. CJD is incurable. Its cause is unknown. How they got it, was clear. They had been infected by contaminated hormone. Twenty other hormone recipients in the United States also have died from CJD, and the toll continues to rise.

But the NIH has not apologized, or helped with the care of victims. Having investigated the deaths, the NIH has insisted for the past 15 years that they were unforeseeable."It was an experimental treatment, and people signed informed consents," NIH spokeswoman Jane Demouy said recently.

NIH lab was warned

But the Los Angeles Times has unearthed British court documents showing that the deaths not only were foreseeable, they were foreseen. The NIH lab called in to investigate the deaths in 1985 had been warned of the danger of contamination seven years earlier.

Moreover, a body of research shows that a safer method for processing the drug had been available from the inception of the program. But scientists under contract to NIH chose a cheaper, less labor-intensive method.

Shown the documents, Demouy said the NIH involvement was limited to funding the program.

"Physicians around the country administered the hormone. Decisions regarding the program were made more than 35 years ago, and the people involved are deceased or retired. In 1985, when it was learned that three patients who had received human growth hormone had contracted CJD, distribution of human growth hormone [from cadavers] was ended."

Today, human growth hormone is synthetic and safe. So it is easy to forget how crude its early forms were - or that it was an important medicine. In 1958, a Boston-based researcher named Maurice Raben at Tufts University School of Medicine produced a first. A 17-year-old boy, whom Raben had injected experimentally with human growth hormone, grew 2.1 inches in 10 months.

For parents of stunted children, this offered precious hope: Their children might be spared lives as dwarfs.

But then they were asked to wait. Dwarfism wasn't diabetes. It wasn't life-threatening. Unlike insulin for diabetics, human growth hormone was not seen by drug companies as commercially viable.

Almost immediately, the most enterprising parents enrolled their children in small trials, very like the first Raben experiment. Even then, not enough pituitaries were harvested from cadavers for steady production of the growth hormone. Some parents turned organ scavengers, petitioning hospitals and morgues for pituitary glands from cadavers.

By 1963, pressure from parents, pediatricians and endocrinologists had become so intense that the NIH stepped in. It formed the National Pituitary Agency out of the Johns Hopkins University to organize collection and redistribution of the glands to three universities for processing into growth hormone: Emory in Atlanta, Tufts in Boston and Cornell in Ithaca, N.Y.

Soon, the NIH was guardian of a sweeping experimental drug trial. From 1963 to 1985, it supplied the hormone to 8,157 children nationwide.

Safety questions arise

By 1973, Emory University researcher Alfred E. Wilhelmi and researcher Anne Stockell Hartree from Cambridge University in England were facing questions about the purity of the hormone they extracted without benefit of gel filtration. A member of the British hormone program's steering committee raised concerns about the safety of the drug.

Wilhelmi replied: "We have been preparing hGH since 1958 in increasing quantities, and in all that time there has never been a complaint of that kind of contamination. ... We are presently going to modify our procedure to include a step of filtration on Sephadex G-100, and this, I think, will provide further assurance of removing virus from the system."

The Times could find no record that Wilhelmi or Hartree used the Swedish-style Sephadex gel filtering.

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