Introduction - Uppsala Monitoring Centre

that both companies felt a little note on the labelling would suffice.
There were even questions early on whether the drug should
continue on an over-the-counter status, as it was in some parts of
Germany, and other parts of the world. It was a little time later that
the over-the-counter drug status was changed, and the drug became
prescription-only. But it’s difficult to exaggerate how popular this drug
was at this time. I think it was the third largest-selling drug in Europe.
As I mentioned, it was considered so safe that it was over-thecounter
in many areas. We were concerned about the peripheral
neuritis, even if the companies did not seem to be. We sought some
outside consultations with neurologists, Dr. John Tower at NIH and
Dr. Webb Haymaker in the Army Walter Reed Hospital. They both
felt the same. They felt that peripheral neuritis could be serious,
painful, and often irreversible. The risk of developing this would not
be justified in a drug that was used simply as a hypnotic and
sedative, since there were other drugs on the market for this
purpose. We continued to feel it might be a serious matter. One of
the questions we raised at this time was what would happen if the
mother took it through pregnancy, and this drug was taken for quite
long periods of time, what would be the effect of the drug on the
child? This was not a shot in the dark, because at that time the Food
and Drug Administration and the American Academy of Paediatrics
had been concerned about the effects of drugs when taken during
pregnancy, and were in the midst of preparing guidelines for the
testing of such drugs. There had been a number on the market that
had been shown to have disastrous effects – aminopyrine,
chloramphenicol, to name a few. I’d had a little experience some
years previously when I worked on the anti-malarial drug project
during World War II. We were given a little time for research, and we
were interested in the metabolism of the effective anti-malarials,
quinine and Atabrine. We established that the quinine was very
rapidly metabolised by the liver of the rabbit, but we found that the
foetal liver had no such activity, and it did not appear till shortly after
birth. This, of course, was the same situation that causes the
chloramphenicol problems. The baby simply doesn’t have the
enzymes to protect itself against the chloramphenicol as the adult
did. The answer always was, if it had had an ill effect, surely it would
have been known by now. That, of course, is a common excuse
about any adverse effect. But, interestingly enough, it had. A German
in Bonn, Germany, a paediatrician and a geneticist, had been struck
by the increase of phocomelia cases in their hospital. They felt it