Introduction - Uppsala Monitoring Centre

November the 10th, although I said the application was received on
the 8th, or some little time before it got logged in. I think the official
date of acknowledgement was September the 15th. So we got our
letter out on the 10th of November. In this, we declared that the
application was incomplete and inadequate, and could not be filed.
Then we gave the reasons for our decision. We all had fairly serious
questions. The pharmacologist felt that the chronic toxicity studies
had not run for a sufficient length of time. He also felt that there were
inadequate absorption and excretion data. The chemist found all
sorts of problems or shortcomings with the manufacturing controls.
She had concerns about the asymmetrical carbon atom, and
wondered what was known about the D 172 and the L forms, and in
what proportion they were present, and so on. She, fortunately, had
been educated in German, and a lot of this application consisted of
German reprints with an English translation. She of course could
read the original German, and did find at least one error in the
translation. I, who know no German, or just enough to pass a Ph.D.
exam in it, was very impressed by this. I had some problems. The
data to submit safety was very sketchy and anecdotal. The claims
were quite fulsome, you might say, almost. It was of course perfectly
non-toxic. It lacked hangover effect. It was non-habituating, or
addicting, and so on. But one by one, these claims sort of were
modified somewhat. I was particularly – and all of us were –
concerned about the fact that you seem to be able to give enormous
amounts, both to animals and humans, without any effect of perhaps
drowsiness or sedation. In fact, one of the claims or one of the
mentions in the brochure included several cases in which persons
had tried to commit suicide, and been unable to do so. You’ve
probably heard a later comment that, had thalidomide been on the
market, Marilyn Monroe would be alive today. Well, pretty soon it
was acknowledged that, like all other drugs of its class, there was
indeed some hangover effect, but we were concerned about this
non-absorption. We felt there might be conditions of the non-toxicity,
which we felt was surely due to non-absorption, and we thought
there might be conditions, illness or another drug or something like
that, that might change this so much more would be absorbed, and
toxic effects might appear. We did not know, for some years later,
that a solution of liquid form of the drug had been marketed in
172 D and L forms = Two substances can have the same chemical formula because of different optical activity.
The dextro (D) form twists polarised light to the right whilst the levo (L) form does so to the left.