Thalidomide on Trial

The drug was never licensed for sale in the U.S., so American victims of thalidomide number fewer than 20. Great Britain, however, has more than 1,000 thalidomide babies. In West Germany, where Chemie Gruenenthal GMBH first introduced thalidomide as a magically potent tranquilizer and sleeping pill, there are at least 3,184 surviving thalidomide-deformed children, while an equal number have died. In addition, some 5,000 adults are believed to have suffered permanent injury, a generalized neuritis that is invariably painful and sometimes disabling.

Now, seven years after the disaster, Gruenenthal's executives have been brought to trial. West German government lawyers collected 70,000 pages of evidence and prepared a 972-page indictment in which company officers are charged with personal negligence leading to the marketing of an unsafe and insufficiently tested drug. The trial promises to last at least two years and will be divided into two main phases: 1) an effort to show that the damage was indeed caused by thalidomide; and 2) an attempt to prove that Gruenenthal's executives were knowingly responsible and negligent. Last week, in a courtroom in Alsdorf, near Aachen, the prosecution moved deep into Phase 1.

While seven defendants watched from the box (two have been excused for health reasons), a detachment of parents who are co-plaintiffs followed the testimony intently from reserved seats, while malformed children played in the corridors. On the witness stand was the man who, by extensive research, first developed the evidence that forced thalidomide's withdrawal from sale. Dr. Widukind Lenz was a pediatrician in Hamburg when he began to study the effects of the drug. Now 49, he has moved to Muenster as director of the Institute of Human Genetics.

Seal Limbs. After three months of frustrating legalities, the people in the crowded courtroom saw for themselves the naked evidence of thalidomide's devastating effects. Dr. Lenz showed color slides of children with no arms, or no legs, or only seal-like flippers where arms and legs should be. Some of the pictures came from post-mortems and showed malformations of the heart and other internal organs.

Relentlessly, Lenz assembled the evidence against thalidomide. Phocomelia (seal limbs) had been one of the rarest of congenital defects until 1960, the year after thalidomide went on the market. Then the incidence of the condition increased exponentially, and Lenz had a damning graph showing that it went up on a curve exactly paralleling that of thalidomide sales--but with an eight-month time lag. Lenz explained that he explored other suggested explanations for the increase in phocomelia, such as X rays, TV radiation, fallout and attempted abortions. As a cautious clinical scientist, he eventually rejected them all. Said Lenz: "There is no doubt that thalidomide caused the malformations."

In crossexamination, defense attorneys hammered away at the theme that causality cannot be proved by statistics. They insisted that so long as no one knows how thalidomide actually works inside the human system, it is impossible to forge a link between the drug and a child's malformation. Lenz answered that thalidomide has been shown to cause phocomelia in rhesus and other monkey species in which the condition does not occur naturally. For doctors to seek comparable proof in man would be at least unethical and in most countries illegal. Said Lenz: "You are demanding a kind of scientific perfectionism that is not applicable to medicine. Despite the statistical methods we are forced to use, one can still conclude that there is a safety borderline, which thalidomide crossed."

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