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                  <text>W?
Hatem Al~Chalabi, M.D.

June 12, 1977

Suffolﬂ Developmental Center
Box 788

Melville,

New York

Dear Dr. Al—Chalabi,

I have read your proposal, to study the effects of lithium
therapy on aggressive, disruptive and self-mutilating behavior in
patients with mental deficiency (severe). In the main, the intent is
clear, the issues well thought out, the misSion important, and the
safety well within the margins ordinarily set by our community. Indeed,
I can find only two questions of merit.
Selecting dosages of lithium that will yield plasma
mBq/l is a goal that is set in the study. While these levels
may be necessary, I think that the conservative approach within a new
setting is to set a lower level as the goal, one within the therapeutic
range, but surely not associated with side effects, such as 1.0 mBq/l.
If there is no therapeutic efficacy or toxicity at these levels in
3 to 6 subjects, then the higher level can be set for the remainder
of the sample. If you already have experience at these lower levels,
then this conservative step may not be necessary.

levels of 1.5

The second issue is that of consent. The protocol does not
discuss this issue; one that is a problem since the population is made
up of minors with mental deficiency. A consent form should be prepared
for the relatives, describing the goal and methods of the study.

These comments are my own. Should you wish to have hhe advice
of the Research Committee of the Department of Psychiatry and the Long
Island Research Institute, I would suggest you send a revised copy of
the protocol, with your curriculum vitae and the consent form to the
Chairman of the Department, Stanley Yolles, M. D., and he may
refer it
to the appropriate committee.
Good

luck in your study.

Sincerely yours,
Fink, M.D.
Professor of Psychiatry
Max

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              <text>Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York).</text>
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