Department of Health & Human Services
Public Health Service
National Institutes of Health
National Institute on Drug Abuse
5600 Fishers Lane
Rockville, Maryland 20857

April 19, 1995

Donald I. Abrams, M.D.
Chairman, Community Consortium
Assistant Director AIDS Program
San Francisco General Hospital
Professor of Clinical Medicine
University of California San Francisco
995 Potrero  Avenue
Building 80, Ward 84
San Francisco, California 94110

Dear Dr. Abrams:

We have reviewed your request that the NIH supply marijuana for a study 
of the effects of smoked marijuana on weight changes in persons with 
HIV-related wasting syndrome.  Unfortunately, we have determined that we 
cannot comply with your request.

As you know, decisions for the commitment of limited NIH resources are 
based upon scientific principles, so as to ensure the most effictive use 
of our research resources.  Our decision here is based upon issues of 
design, scientific merit and rationale.  We believe that your study will 
not adequately answer the question posed.

Although the study propose seeks to make a dose-effect comparison of 
smoked marijuana to delta-9-tetrahydrocannabinol (THC), there is no real 
dosing control.  The marijuana is to be taken home and there is no 
requirement and way to ensure that the subjects smoke all available 
materials on any fixed schedule.  Additionally, that they are given a 
two-week supply of marijuana at one time further confounds the study 
design.  Thus, we believe the dose-effect component is confounded since 
the study cannot correlate variability in weight gain with dosage.

We also believe the study lacks adequate sample size to make any 
inferences regarding the dose-effect relationship.  We base our 
conclusion on an analogous study performed by the National Institute on 
Allergy and Infectious Diseases that compared megestrol and THC in 56 
subject [sic] with AIDS-related wasting syndrome but still lacked 
inferential power.  Another counfounding variable not adequately 
controlled for in your proposed study is diet.  Neither the total daily 
caloric intake nor the percentages of the composition of the foodstuffs 
is assessed.

We sincerely share your hope that new treatments will be found swiftly 
to improve the quality and prolong the lives of patients suffering from 
this terrible disease.  As you know, a great deal of NIH research 
support is directed toward this end.

Alan I. Leshner, Ph.D.