Medicine: Sleeping Pill Nightmare

What seemed, when first tested a few years ago, to be the ideal sleeping pill has turned into a frightening medical nightmare. The drug is thalidomide; it has been widely used in Western Europe (except France) under the names Contergan and Softenon, in Britain as Distaval, and in Brazil and Japan. In Canada, and (under heavy restrictions) in the U.S., it is distributed as Kevadon. Not a barbiturate, thalidomide quickly induces sleep and seldom leaves a hangover. It appears virtually impossible to commit suicide with it; 188 people are known to have tried and failed. But on a statistical basis, it stands accused of causing many hideous malformations in babies born to mothers who took the drug in the sixth to eighth week of pregnancy.

The nightmare started in the West German town of Stolberg, near Aachen, in 1954, when laboratory chemists synthesized the drug for the firm of Chemie Gruenenthal GmbH. After three years of testing with animals, thalidomide was judged so safe that it was approved for over-the-counter sale, with no prescription needed, throughout West Germany.

Chemie Gruenenthal burbled: “Contergan is especially well suited for calming down anxious, nervous and restless children . . . Excellent for babies.” Obstetricians who found that it tranquilized pregnant women prescribed it to allay morning sickness. Consumption shot up in many countries. Last April, the Canadian subsidiary of Cincinnati’s Wm. S. Merrell Co. put it on prescription sale in Canada.

In the U.S., the cautious Food and Drug Administration confined Kevadon to medical researchers “for investigational use only.” and presumably consumption has been small—though some American women travelers have brought foreign pills home in their pocketbooks.

Seal Limbs. Last fall, doctors in West Germany noticed a mysterious epidemic.

It consisted of assorted internal malformations in newborn babies, plus an upsurge in one hitherto rare condition: phocomelia or “seal limbs.” so called because the hands and feet are like flippers, attached close to the body with little or no arm or leg. Hamburg University’s Pediatrician Widukind Lenz. 43. began to suspect Contergan because he found that in many cases the mothers had taken it late in the second month of pregnancy, when the fetus’ limbs are forming.

As similar reports multiplied, a four-university team was set up to check every malformed birth since January 1959 in West Germany’s most populous state (Nordrhein-Westfalen, 15.5 million people). Chemie Gruenenthal took Contergan. and every compound drug containing thalidomide off the market. And all 18,500 doctors in Canada got a December warning from the Merrell Co.: “Kevadon should not be administered to pregnant women nor to premenopausal women who may become pregnant.” U.S. investigators using the drug got a similar warning.

3,000 Blighted Babies? There is no evidence that a woman’s risk of bearing a malformed child is increased by having taken thalidomide before her pregnancy.

The trouble is that in the apparently crucial second month, many women do not know they are pregnant. At this stage, some doctors think, thalidomide may cause malformations in as many as 20% of cases. Dr. Lenz fears that there have been 2,000 to 3,000 blighted babies in West Germany alone. Many are stillborn or die within a few days, but two out of three survive.

With a drug so widely and often casually used, it is almost impossible to be sure whether a woman was taking thalidomide at the critical time. Last week in the Lancet, a canny Scottish doctor told how he had done it. In Stirlingshire. Dr.

A. L. Speirs questioned ten mothers of malformed babies about drugs they had taken. He got vague or negative answers.

More strikingly, he got the same kind of answers from their doctors. Dr. Speirs refused to give up, had the prescription records searched. He got his evidence: no fewer than eight of the ten mothers had been taking Distaval, and a ninth might have been. Distaval and thalidomide compounds were pulled off the British market in early December. But many women now pregnant may have been taking the drug, and the Lancet raises editorially an ominous question for doctors: whether to terminate pregnancy in such cases.