X-Message-Number: 1506
Date: 24 Dec 92 05:13:39 EST
From: "Steven B. Harris" <>
Subject: CRYONICS FDA Erratum

   I seem to be doing a fair amount of erratum posting lately. 
After a bit of checking of my sources, let me add the following
error corrections and amplifications to my posting on the FDA:

1) Francis O. Kelsey, M.D. was not the FDA commissioner, but
rather just the doctor in charge of the New Drug Application for
thalidomide at the New Drug Branch of the FDA.  Her husband was a
pharmacist, but he was a physician as well.

2) Application by Merrell for thalidomide (Kevadon") to be sold
in the U.S. was made Nov. 29, 1960.  It was turned down by Kelsey
in late December of that year not only because of the pharmaco-
logic data problems, but also because Kelsey thought that Merrell
might be glossing over some reports of neuropathy from the drug
which had appeared in the medical literature in late 1960. 
Neither had anything to do with birth defects.

3) The FDA held up the thalidomide application for one reason or
another for a year or so, and that was enough.  Merrell withdrew
thalidomide in Europe in November, 1960 when physicians there
drew the connection between thalidomide use and human birth
defects.  Merrell never did any preliminary screening of thal-
idomide for birth defects, and the FDA never asked for any. 
Later, there was much confusion caused by the fact that thal-
idomide does not cause birth defects in rats or mice (still
later, it was found to cause them in rabbits and primates).  

4) Francis Kelsey in hindsight made much of her concerns over the
possible teratogenicity (birth-defect-causing ability) of
thalidomide, but these are (again) hindsight remarks.  Such
concerns are *not* to be found in any contemporary (1960) FDA
record.

5) President John F. Kennedy awarded Dr. Kelsey the Distinguished
Federal Civil Service Award on Aug 7, 1962. 

   The above does not significantly affect my judgement about the
FDA.  The FDA gets no credit for thalidomide, in my humble
opinion, except in its role as obstructionist.  A bill mandating
an automatic delay in the introduction of *every* new drug in the
U.S. until Europeans (or Africans, maybe) field-test it for us,
would be cheaper than paying for the FDA, if that kind of thing
is *really* what the public wants (of course, we'd have to admit
it to ourselves if we did that....).  Note that the Keefauver
amendment granting the FDA power over drug efficacy, long stalled
in congress before anyone ever heard of thalidomide, was pushed
into law by the thalidomide case, which ironically was a *safety*
issue, and had nothing to do with efficacy.  Go figure.



                                          Steve




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