Introduction - Uppsala Monitoring Centre

eally were, except for those few, no victims. The one person who
was concerned was Dr. Helen Taussig, who was the professor of
cardiology at the Johns Hopkins Hospital. She had heard about the
outbreak from an ex-resident of hers who was now in Germany, and
he had urged her to come across and see some of the victims, many
of whom had cardiac defects. Before going, she had contacted
another ex-resident who was working at the Food and Drug
Administration, and when she got back she invited both him, Dr.
John Nestor, and myself to hear the results. They were essentially
published later in the JAMA after she gave a talk to the American
Academy of Physicians. It caused a great increase in the science of
teratology, or means of testing drugs for adverse effects in
pregnancy. So those were some of the immediate good effects. I
would say, however, that thalidomide never faded away. I mentioned
that we permitted certain trials in cancer to proceed. Some years
later, when an application was submitted for leprosy, we felt that was
a reasonable use, since there was great need for such a drug in this
distressing disease, and the patients would be under pretty good
control.’
She also spoke before the House committee, but it really wasn’t
until mid-July when the article in the Post came out, authored by
Morton Mintz, that the country realized the enormity of the problem.
Almost immediately, the long-awaited Kefauver-Harris bill was
passed in October 1962. This not only required proof of safety, but
also proof of efficacy. It also included a last-minute addition that
patient consent must be obtained from all subjects in the clinical trials
in the future. Meanwhile, FDA had hastened to strengthen the
investigational drug requirements, and essentially published early in
July, what was finalized in early March, with the addition of this
efficacy and consent requirements. So these were the two immediate
effects of thalidomide, the strengthening of the law and the
regulations, both offering greater protection both to subjects of trials
and to the public getting drugs later.
It also stimulated other countries to bring new laws. Many of them
had laws such as we did back in 1930, before 1930, when a
manufacturer could simply put a drug on the market if he felt it was
safe when used as labelled. The onus was on the government to
remove them. But many of them introduced laws similar to our 1962
ones, and one of the great forward steps has been the
harmonization, the efforts being made to bring the requirements of
Japan, the European countries, and the United States into harmony.