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
Unervisity 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.

Sincerely,
[signed]
Alan I. Leshner, Ph.D.
Director