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

explained that help from N-1.11. scientists for this project, approve~d by the
N.I.H, was str'ictly linlijed to the supplying of recombinant vaccine (which
we could have manufactured as we did for the vaccinia Lister expressing
gp160 protein of projects A, B and C). With the exccption of this product,
the cntirc clinical trial was French, in budgetary, materidl logistical and
medical terniz, As is clearly shown by the results of the enquiry carried ouw
by our government - to whom alone we are responsible - and all our
activities have confor med to French ethical and doontological regulations.
In this context. we wish to menition the following details:
1. T--he number of patient~m treated is not 40 but docs not exceed 2-1. if;
one co.*untq paticnt treated only unct before thoy abaindoned further
UredtrncflL:
2. In fact thc decision of the Ethics Comimittee is not neces-sary foi'oclldcornpusSlinate p JtiIHtS, iuNL USIL ws not necessa,%r for other
puitients in 1 9')7. OL)iatorv authorisation daiv.s ( nly frrom I.1January 199 1
1w liuriet IaW'i and the conditions of our trials respccted the termiis of the
Huriet law? even before it A.a,3 pas.cd.
3%. RlaIoh * eneen fjec tionlandi death: it in jectiuncoud causu a
Cutancous necro-.siqs and lead to the death of thce epatients \vho wcrc at the
termniinal stage of imm IIUne d ificiency (T4 lekss than 10 per m m-1), inl the case
Of at leastto of" them wvho survi%-ed for 1 2 alld 14 TMonths after the