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Introduction - Uppsala Monitoring Centre

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Germany, particularly for use in children. When the British company<br />

thought they would market a similar one, their pharmacologist was<br />

horrified to find out how very toxic this compound was. I can still<br />

remember his anguish when he described experiments he had done.<br />

It was a micronized preparation in a sweet solution. Despite his<br />

findings, however, it was marketed for a while in Britain. As I<br />

understand it, the preparation was taken off the market because of<br />

some toxicity in humans, but we didn’t know this. The application<br />

was resubmitted again on January the 17th, which meant that by<br />

mid-March we would have to give them another opinion. We were<br />

continually concerned about the lack of data on metabolism,<br />

excretion, absorption, and this curious lack of toxicity. Then, at the<br />

end of February – the 23rd, I think it was, actually – we picked up a<br />

number – it was actually the December 30th number – of the British<br />

Medical Journal, which contained Florence’s article posing the<br />

question, did thalidomide cause peripheral neuritis? This was a little<br />

late in getting to us, because the mail was on strike. It was actually a<br />

shipping strike, I think, and we did not get our British and other<br />

foreign publications by airmail in those days. However, this did come<br />

in time. When we questioned the company about it, they said they<br />

had just seen that, too. They were sort of surprised, and were going<br />

over to Europe to find out more, and would let us know when they<br />

came back. Now, what we didn’t know, again, was the German<br />

company had been questioned about peripheral neuritis as early as<br />

the winter of December of 1959, before our application was even<br />

submitted. The same person that asked them about it this time gave<br />

a paper – I believe it was in May of 1960 – describing a number of<br />

cases of peripheral neuritis, some of which seemed pretty severe.<br />

The British actually answered the first report by saying that they were<br />

aware of it, and had put some reference to it in the material that they<br />

distributed with the drug. Our company was not obliged to submit<br />

foreign supporting material or material of that type at that time, so we<br />

were not aware of this side effect. They had independently<br />

discovered it about May of 1960, and there is good evidence that the<br />

German and the British company had a sort of gentleman’s<br />

agreement to keep the matter rather quiet until the American<br />

company had a chance to get the drug on the market. So we were<br />

inclined to believe that the American company had not heard of this<br />

earlier. The company did report to us on their trip to Europe. They<br />

said that indeed there did seem to be some cases that neither in<br />

Germany nor in England were it considered of great moment, and

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