[Memorandum to Acting Deputy Director for Intramural Research, NIH from F. William Dommel, Jr.]

The letter published in Lancet.

- shows that certain patients were receiving AZT, which is
contrary to the recommendations of the National Ethics Committee.
- does not mention the two deaths which occurred after
necrosis--between the eight-month follow-up study and the date of
publication--among the patients under immunotherapy, in the
"pitiful" group.. The three deaths which occurred after necrosis resulting from
injection of immunotherapy were not reported to the National
Ethics Committee.. Mr.R. (first death resulting from necrosis) would have
received injections of live virus. This assertion is supported
by a form entitled "Therapeutic Protocol," typewritten, not
dated, not signed, drafted in English, where the name of Mr. R...
is handwritten in the upper right hand corner.
A fourth case of necrosis resulting from immunotherapy appears
possible to him according to the documents in his possession.
Mr. CREWDSON has a list of about a dozen names beginning with
the letter A. This list--whose origin he would not reveal to us-corresponded, accor4ing to him, to names of patients who died
under immunotherapy.
Finally, an article will soon appear in the Chicago Tribune.
Mr. CREWDSON is going to send us a copy.
The responses which we are able to give are as follows:
The letter in Lancet:
- AZT was actually continued, often at a weak dose, in
certain patients. This medicine was ineffective, but was
not always withdrawn in view of humanitarian considerations
(the only treatment recognized at that time).
- the deaths of the "pitiful" patients, as we have said in
our memorandum of April 4, 1991, would have been better
handled by being mentioned in the letter in Lancet, even
though they occurred after the eight-month follow-up.study.
This is a problem of communication of the scientific
results, which is not within our province, but within that
of the scientific experts.
The three deaths as a result of necrosis were reported to the
local ethics committee; of course it would have been desirable
that the national committee be informed.. The administration of live virus to Mr. R. seems more than
improbable; this assertion rests on no solid foundation at all.
The physicians of the Saint Antoine Hospital are indignant at