Introduction - Uppsala Monitoring Centre

must be due to some recently introduced substance, and they wrote
around to a number of other hospitals in Germany. Most of them
reported the same thing, that they had had an increase in this very
unusual adverse effect. They then thought they would find out the
experience of other countries where thalidomide had been used.
Most of them had indeed seen this increase. They were thrown off,
ironically, because they were under the impression that the drug was
released in the United States. The promotional material said it was
widely used in North America, and it had of course been marketed in
Canada. They wrote to three centres in the U.S. where statistics
were kept on birth defects. There wasn’t really any indication of an
increase. This is, sadly enough, what put them off the scent. It wasn’t
until November of 1961 that Lenz discovered the association. Now,
the first report of phocomelia was announced at the end of
November of 1961. The company immediately phoned us, and told
us the news, and said they didn’t really believe it, but as a precaution
they would put a halt to clinical studies going on in this country. But
they did want to continue some that they had just started on its
possible usefulness in cancer. That seemed no great problem to us,
the benefit/risk ratio being entirely different. In March, early March of
1962, they told us they were withdrawing the application
immediately, as they believed there may be some truth to this
association. There were some weird differences in wording of their
two communications that led us to think it might have been more
widely used in this country than we had gathered from the new drug
application, so we asked for a complete list of the doctors they had
sent the drug to, and were very surprised to find that actually over
1,000 doctors had been given the drug. Most of these were recruited
after the application had been submitted in September, in the
expectation that it would be rapidly approved. They were told, in
essence, “Don’t really worry about recording the results. We just
want you to try it out, and see if you want to use it in your patients.”
We then visited, or had the company visit, every one of these
doctors, and pick up what remaining stocks they had -- and there
were indeed quite a lot -- and find out if they had had any phocomelic
or abnormal births amongst the patients they had given the drug to.
In all, we found about 10 or 11 cases that we thought might be due to
the trials in this country. There were an additional seven patients or
subjects where it was clear that the drug had been gotten from a
foreign source. Now, the thalidomide tragedy in Europe actually
didn’t cause a great stir at the time in this country because there