On Christmas Day, 1956, a baby girl was born without ears in Stolberg, West Germany, the home base of an aggressive new pharmaceutical company called Chemie Grünenthal. Her birth was only the first of what historian Rock Brynner calls the “relendess ironies” of the story of thalidomide, one of the most powerful drugs—for good or ill—ever developed. That little girl, the first known surviving thalidomide baby, was born 10 months before the drug went to market; her father, a Grünenthal employee, had brought home
samples to relieve his pregnant wife’s morning sickness.
As Brynner makes clear in Dark Remedy (HarperCollins,
$39.50), his searing account of the drug’s early days, if Grünenthal had exercised even moderate diligence with its many human guinea pigs, history’s greatest medical disaster would have been prevented. Instead, after five years, as many as 12,000 infants in 46 countries, including about 200 in Canada, were born horrifically damaged—their limbs, eyes, ears, genitals or internal organs missing or malformed. Half didn’t survive childhood. And in what may be the greatest irony of all, the revulsion sparked by the birth defects meant that it would be decades before millions would benefit from thalidomide’s other, life-saving, side.
Thalidomide was born in a pill-happy postwar world, where tranquillizers were in high demand. As Brynner— the son of actors Yul Brynner and Virginia Gilmore— points out, most of the drugs in use were dangerous barbiturates that had brought rising death tolls from accidental and
deliberate overdoses. Pharmaceutical companies knew there would be enormous profits in a non-toxic sedative, and when a Grünen thaï researcher stumbled upon thalidomide in 1954 while trying to create a new antibiotic, the company immediately tested its tranquillizing effect on animals. It had none. But thalidomide did seem to have one thing going for it—even at extremely high doses, it simply did not kill test animals. The remarkable non-toxicity meant that Grünenthal refused to give up on thalidomide as a sedative for humans.
To test it, Grünenthal simply sent out free samples to physicians. When many of those doctors reported that thalidomide
FORTY YEARS AFTER CAUSING AN EPIDEMIC OF BIRTH DEFECTS, THALIDOMIDE IS BACK
did give a deep, almost hypnotic, sleep to their patients, as well as alleviating morning sickness, Grünenthal received government permission to begin selling it without prescription on Oct. 1, 1957. The company’s massive marketing campaign emphasized the drug’s safety so successfully that thalidomide was sometimes called “the babysitter” in Germany, in reference to those parents who used it to quiet their children in movie theatres.
The drug became hugely popular across Europe. But in the spring of 1961, a lawyer named Karl Schulte-Hillen went to visit
his sister, who had just delivered a baby with phocomelia (“seal limbs”). Six weeks later, his own daughter was born with the same condition. Stunned, Schulte-Hillen visited pediatric expert Widukind Lenz. Over the next few months, despite a scorchedearth campaign of denial and withering personal attacks by Grünenthal—the company implied, among other things, that the physician was a Nazi obsessed with eugenics—Lenz established the phocomelia-thalidomide connection, and by December, 1961, the drug was banned in most of its markets.
But not from North America. In Canada, thalidomide had become available in April, 1961. Although the federal government knew that December what was occurring in Europe, officials contented themselves with warning doctors of the risk. Not until March 2 of the next year, after damaged Canadian babies were born, did Ottawa demand its removal from stores. Even so, a Macleans investigation that April found thalidomide still widely available. The delay remains unforgivable for Randy Warren, executive director of the 115-member Thalidomide Victims Association of Canada. At least a third of the Canadian victims were conceived after December, 1961. That wasn’t the case with Warren himself; the son of a Canadian officer stationed in Germany, he was born there on June 27,1961, with slightly shortened arms, four-fingered hands and feet attached to his hips.
Only in the United States was the terrible pattern not repeated. In September, I960, Griinenthal’s American partner, RichardsonMerrell, submitted a licensing request to the federal Food and Drug Administration. The FDA gave the file to its newest approval officer, Dr. Frances Kelsey, a week after she reported for work. Kelsey, a native of Cobble Hill on Vancouver Island, proved to have a skeptical mind and a will of steel. For more than a year, she simply refused to sign off while frustrated company executives harassed her personally
‘For three months, I hoped thalidomide would save my life,’ Brynner says, ‘and I guess it did’
and complained to her superiors. The tide finally turned in November, 1961, when Lenz published his discoveries. Seventeen thalidomide babies, victims of the company’s trial runs, were eventually born in the United States, but with 10 million pills set to flood the American market upon FDA approval, what Brynner calls “the singular obduracy” of Kelsey had prevented thousands more.
The epidemic of birth defects, however, is only half the astonishing story of thalidomide. In 1964, a patient critically ill with advanced ENL—an inflammatory complication of leprosy—arrived at a hospital in Marseille. Because of the severity of the man’s pain and resultant insomnia, and because the hospital still had 20 thalidomide pills it hadn’t yet thrown out, doctors gave him two as a last resort. The patient slept soundly for 20 hours; after two more pills his sores began to heal. Further tests on other ENL patients had similar effects. Eventually, thalidomide shut down 90 per cent of the world’s leprosy hospitals. Like the biblical leper Lazarus himself,
Brynner writes, thalidomide was back from the dead. Many scientists, however, still recoiled from the drug.
It seemed almost obscene to use it for any purpose, Brynner notes, “like planning to make good use out of Mengele’s statistics.” But its potential drew some researchers, who kept finding more applications for a drug that had a powerful effect on autoimmune diseases. That proved fortunate for thousands, including, in his own personal irony, Rock Brynner. He had held a variety of jobs in his youth, including a stint as road manager for the Band during their
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famous Last Waltz farewell tour of 1976. In 1993, when he was 46 and a newly minted PhD in history, Brynner developed a sore that would not heal. He was diagnosed with pyoderma gangrenosum, a rare inflammatory disorder of the immune system. At times, he had up to 30 open wounds and was frequently bedridden. Finally, in 1998, Brynner’s doctors turned to the drug for hopeless cases. “For three months, I hoped that thalidomide would save my life,” he recalls, “and I guess it did.”
In September, 1997, growing evidence of the drug’s benefits prompted an FDA licensing hearing. Gathered in one Washington room were many key figures, including Frances Kelsey, still an FDA officerat 83, andThalidomide Victims Association ofCanadahead Randy Warren. “TVAC is the closest thing the Americans have to a victims’ group,” he grimly notes. Thalidomide’s return to respectability was already a sure thing before the hearing, Brynner believes, but the scientists present worried that a passionate denunciation by the victims could inflame public opinion. Passion they got
from Warren, but also a generous offer of co-operation. “We thalidomiders will never accept a world with thalidomide in it,” he told the hearing. “But we who know suffering cannot deny quality of life or longer life to others who suffer.” Warren demanded, and received, a voice for TVAC in designing the antipregnancy warnings given new users. (In Canada, the drug is available through Health Canada’s Special Access Program.)
Human nature being what it is, almost everyone involved with thalidomide thinks that despite the mandatory pregnancy testing and the graphic warnings, a new thalidomide baby will someday be born. Warren used to have a dream in which he looked on helplessly while an anguished mother asked how he could have allowed it. “I’m over that a bit,” he says. “I know we’re doing the right thing.” Thalidomiders’ true hope, Warren says, is for an early success from the scientists seeking a safe analogue—a drug with all of thalidomide’s benefits and none of its evils. “We’re just hanging in there, waiting for a world without thalidomide.” 03
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