Pubdate: 17 Mar 1997
Source: Chris Clay
Author: Robert Randall
Note: MAP is archiving each of the affidavits filed in the Chris Clay 
Constitutional Challenge to preserve these important documents.
Bookmark: (Clay, Chris)

(Southwest Region)






I, ROBERT RANDALL, of the City of Sarasota, in the State of Florida, MAKE 

1. I received my B.A. degree from the University of South Florida (Tampa) 
in 1969. I obtained my M.A. degree in Rhetoric and the Oral Interpretation 
of Literature in 1971. Currently, I am President of the Alliance for 
Cannabis Therapeutics (ACT), an organization which seeks to make marijuana 
legally available for legitimate medical uses. Attached hereto as Exhibit 
"A" is a copy of my curriculum vitae.

2. Attached hereto as Exhibit "B" is a copy of my testimony before the U.S. 
Drug Enforcement Administration in 1987, which sets out my efforts, at both 
the state and federal level, to have laws enacted which would make 
marijuana legally available for legitimate medical uses.

3. I suffer from glaucoma. In 1976, I was successful in raising a defence 
of "medical necessity" in a legal proceeding regarding my use of marijuana; 
I secured licit access to marijuana for use in a supervised routine of 
medical therapy for this condition. By producing reports from my physician 
which indicated that marijuana had, and continues to have, a critically 
important contribution to the treatment of my glaucoma (by prolonging my 
sight), I was able to prove to the Food and Drug Administration (FDA) that 
access to marijuana was a medical necessity.

4. In 1978, federal agencies terminated my access to marijuana. I sued 
them. We settled the dispute out of court so that I again had licit access 
to marijuana. I was the first person in the United States to secure such 
legal access. As a result of having access to marijuana for therapeutic 
purposes, I have gained prolonged sight without any apparent medical or 
physiological injury.

5. In 1980, I co-founded ACT. This is a non-membership organization. We do, 
however, have an advisory board of approximately 50 people comprised of 
patients, physicians, medical researchers, FDA approved investigators and 
elected representatives from a number of states. ACT does not support any 
non-medical uses for marijuana.

6. In 1982, I received the Galen Award of Rho Pi Phi from the Philadelphia 
College of Pharmacy "For Superior Achievement in Expanding the Capacity of 
Health Care Professionals by Introducing New Therapeutic Methods".

7. Over the past 15 years I have given informal talks and formal addresses 
on marijuana's medical uses before many legal, medical, political, and 
professional organizations including the American Bar Association, the 
National Conference of Drug Abuse and the First International Conference 
for Cannabis Reform (Amsterdam, 1980).

8. I have been qualified as an expert witness on the legal classification 
and medical utility of marijuana and synthetic THC in the courts of 
Pennsylvania, North Carolina, Florida, Wisconsin, Alabama, West Virginia, 
Virginia, Arkansas and Indiana.

9. I have testified regarding marijuana's medical uses before the U.S. 
House of Representatives as well as many state committees.

10. I have edited six books, the first five of which are on the ACT 
booklist which is attached hereto as Exhibit "C": Muscle Spasm, Pain & 
Marijuana Therapy; Cancer Treatment & Marijuana Therapy Manjuana, Medicine 
& the Law Vol. I and II, Marijuana & AIDS: Pot, Politics &  PWAs in America 
and Marijuana as Medicine: Initial Steps. The first four books are excerpts 
from the hearings that took place between 1986 and 1988 before the U.S. 
Drug Enforcement Administration regarding the medical uses of marijuana and 
its proper legal classification.

11. Muscle Spasm, Pain and Marijuana Therapy provides a comprehensive 
review of scientific studies, state laws, methods and the results of 
marijuana use in the treatment of MS, paralysis and pain, spinal cord 
injuries and arthritis for patients, physicians and other interested 
parties. The text in the book is taken from testimony in two cases 
concerning the issue of marijuana's therapeutic utility in the treatment of 
muscle spasm and chronic pain.

12. Cancer Treatment & Marijuana Therapy contains testimony from several 
witnesses as well as the results of a recently published survey conducted 
by Harvard University which indicates that 70% of American oncologists 
favor prescriptive access to marijuana for reducing nausea, muscle spasm 
and chronic pain.

13. Marijuana, Medicine & the Law Vol. I and II reviews the testimony of 
those who are both for and against marijuana's use in medical treatment. 
Volume I The Direct Testimony includes detailed affidavits from more than 
fifty-five witnesses, including many of the world's leading medical experts 
on marijuana's therapeutic uses, patients, scientists, researchers, 
attorneys and health administrators. Volume II: The Legal Argument includes 
legal briefs from the Drug Enforcement Administration (DEA) and the 
petitioning parties as well as selected portions of the oral arguments. The 
full text of the Chief DEA Administrative Law Judge's ruling, which 
concluded that marijuana  has significant therapeutic benefits, is also 
included. Attached hereto and marked as Exhibit "D" is a true copy of the 
decision of Chief DEA Administrative Law Judge Young.

14. Marijuana & AIDS: Pot, Politics & PWAs in America includes: personal 
stories of four people with AIDS who fought for and won the right to 
legally use marijuana as treatment for their respective diseases, 
information on how to legally obtain marijuana from the Food and Drug 
Administration (FDA), answers to frequently asked questions about the 
medical use of marijuana, a discussion on marijuana's effect on the immune 
system, and a comparison between marijuana and Marinol (synthesized 
delta-9-tetrahydrocannabinol (THC), marijuana's psychoactive ingredient).

15. Marijuana as Medicine: Initial Steps includes a review of medical 
conditions, including treatment for life-threatening or sense-threatening 
ailments, for which marijuana is useful. It also makes recommendations for 
a system of research and approval. Further, it discusses the political 
undercurrents involved in the debate over the use of marijuana for medical 
purposes in the U.S., including cases where the defence of medical 
necessity was advanced.

16. With respect to the issue of whether synthetic THC can be employed for 
medical treatment in lieu of relying upon the plant substance, the 
substitution of Marinol for marijuana would be acceptable if it achieved 
those goals which are the objectives of a synthetic medicine; namely, to 
increase its bio-availability to the patient's system, to increase the 
medicine's therapeutic value and to reduce the potential adverse effects 
caused by the use of the medicine. Marinol does not meet any of these 
objectives in the context of treating the nausea, vomiting and/or rapid 
weight loss associated with cancer, chemotherapy and AIDS.

17. In terms of bio-availability to the system, when marijuana is inhaled 
it effectively reduces nausea and vomiting within 5 to 10 minutes, with 
many patients reporting instantaneous benefits. Within 45 minutes to an 
hour of inhalation the desire to eat is stimulated. The oral ingestion of 
Marinol, by comparison, has very erratic bio-availability properties. The 
oil-soluble nature of the medicine makes it difficult for the digestive 
system to access the THC, which means that patients must wait 1 to 4 hours 
before the nausea and/or vomiting are affected. Consequently, patients may 
end up regurgitating the synthetic drug before it has time to act as an 
anti-emetic. Furthermore, it is also less effective in terms of increasing 
the desire to eat. The same pattern of effectiveness is present where the 
patient is being treated for spasticity.

18. In terms of the therapeutic utility of the synthetic medicine, numerous 
studies, including the Chang/National Cancer Institute (1979) study and 
several state studies from New Mexico, New York, Georgia and Michigan, 
report a sharp difference between the therapeutic effect of Marinol and 
marijuana. For example, the New Mexico Department of Health reported to the 
FDA in 1980 that marijuana significantly reduced nausea in 90% of cancer 
patients who had failed to respond to more conventional anti-emetic 
substances. In contrast, Marinol proved to be far less effective, aiding 
less than 60% of similar patients. In nearly all studies where a comparison 
was made between Marinol and marijuana, marijuana proved to be far more 
reliable, predictable and effective.

19. On a personal level, I was tested on marijuana and 
delta-9-tetrahydrocannabinol (now marketed and distributed as Marinol) 
during a controlled medical experiment at UCLA's Jules Stein Eye Institute 
in December 1975. 1n these experiments, I was given 20 to 30 milligram 
doses of orally ingested delta-9-THC. These proved to have no therapeutic 
effect in reducing my ocular pressure. Marijuana, however, relaxed my eye 
pressure by 25% to 50%. As a result, the investigator, Dr. Robert S Hepler, 
concluded that for me smoking marijuana was clearly superior to the oral 
ingestion of delta-9-THC.

20. In terms of reducing the adverse effect of taking the medicine, the 
vast majority of patients who smoke marijuana report that they do not feel 
negative effects due to the marijuana. In fact, many patients seem to enjoy 
the minor euphoric effect of smoking marijuana. Similarly, in state 
sponsored studies of marijuana use, for medical purposes (to offset nausea 
from cancer chemotherapy etc.), by over 1000 patients, no one ever required 
hospitalization or other forms of medical treatment as a result of an 
adverse effect from the marijuana. On the other hand, Marinol appears to 
have a much greater propensity to produce adverse effects. Many patients 
are unable or unwilling to withstand delta-9-THC's more pronounced 
psychoactive effects. In the New Mexico study referred to earlier, patients 
were allowed to switch from marijuana to Marinol, and vice versa, depending 
entirely upon their own preference. Many more patients chose to switch to 
marijuana than to Marinol.

21. In my personal experience, during the UCLA experiment, delta-9-THC 
produced more powerful anxiety provoking effects than I had ever 
experienced on marijuana. In the earliest study of marijuana use for 
medical purposes, Dr. Norman Zinberg from Harvard University administered 
delta-9-THC to reduce the effects of cancer induced nausea in his patients. 
While he noted that delta-9-THC seemed to be effective, approximately 25% 
of his patients left his study in order to use marijuana, which they found 
to be more effective.

22. Based on the three criteria noted above, marijuana provides relief more 
reliably, more rapidly and with fewer adverse effects than Marinol. In 
fact, it should be noted that it is not unusual for a patient on Marinol to 
return the dosage to the doctor who prescribed because it is either so 
ineffective or so difficult to cope with its negative effects. As in my own 
case, many patients find Marinol ineffective while marijuana is repeatedly 
effective. It should be noted that delta-9-THC contains marijuana's most 
psychoactive ingredient, but not necessarily its most therapeutic ingredient.

Sworn before me at the
City of Sarasota in the
State of Florida,
this 26 day of March,

Robert Randall