UNITED STATES DISTRICT COURT
I, Dr. Arnold S. Leff, declare as follows:
1. I am a physician licensed to practice in the State of California and have been practicing medicine for 19 years in Santa Cruz, California.
2. I received a B.S. in zoology from the University of Cincinnati in 1963. I received an M.D. from the University of Cincinnati Medical School in 1967. I completed an Internship in internal medicine at the University of Cincinnati Medical Center Hospitals in 1968. In 1969, I completed an internal medicine Fellowship in clinical pharmacology, also at the Medical Center Hospitals.
3. From 1972-1973 I was Deputy Associate Director for the White House Drug Abuse Office under President Richard Nixon. In that position, I worked on a number of different areas of drug policy including: developing drug abuse programs for the Department of Defense and State Department; establishing drug treatment programs in foreign countries; implementing drug testing and treatment programs for U.S. military troops; and consulting with local law enforcement officials on implementing drug treatment programs. From 1973-1975 I was a consultant to the White House Drug Abuse Office on these and other issues. During the late 1970s, I advised President Jimmy Carter’s Administration on national drug policy.
4. I have had experience in drug control policy and public health in other positions as well, including as Director of Health Services for Contra Costa County, California from 1979-1983.
5. Throughout those years, I also held teaching positions on medical school faculties. I was an Assistant Clinical Professor at the University of Cincinnati College of Medicine from 1971-1979, and an Associate Clinical Professor at the University of California from 1979-1984.
6. I am currently a family practitioner with an emphasis on caring for geriatric and AIDS patients. My practice includes approximately 2,000 patients overall. I have been an AIDS specialist since 1985, and currently treat approximately 70 patients for AIDS and AIDS-related conditions.
7. In 1997, largely in response to the passage of California’s Compassionate Use Act, the White House Office of National Drug Control Policy commissioned the National Institute of Medicine of the National Academy of Sciences ("IOM") to undertake an extensive review of the scientific evidence of the therapeutic applications of cannabis. As a former Deputy Associate Director of the White House’s Drug Abuse Office, I took keen interest in the IOM’s charge and its findings. The IOM was tasked with assessing the current scientific findings concerning medical marijuana. In accomplishing its task, the IOM reviewed the scientific bases identifying the active ingredients of marijuana, how those ingredients act on human and animal physiology, and clinical experiments evaluating the efficacy of marijuana and several of its active agents.
8. After an exhaustive year-long study that included scientific workshops, analysis of relevant scientific literature, and extensive consultation with biomedical and social scientists, the IOM published a 250-plus-page report entitled Marijuana and Medicine: Assessing the Science Base, (Janet E. Joy, et al., eds., National Academy Press 1999) (hereafter "IOM Report"). The IOM Report concluded that "[s]cientific data indicate the potential therapeutic value of cannabinoid drugs, primarily THC, for pain relief, control of nausea and vomiting, and appetite stimulation." IOM Report at 15, 179. (The complete IOM report is available at http://www.nap.edu/books/0309071550/html.)
9. The IOM acknowledged that marijuana currently provides the only alternative for certain people for whom approved medicines are ineffective and emphasized the desirability of further research into the effects of cannabinoids and the development of delivery systems by which the active ingredients of marijuana can be delivered to patients in a dose-controlled, smoke-free manner. IOM Report at 10-11, 179. As a result, it is not surprising that the IOM’s endorsement of medical marijuana was conditional.
10. Specifically, the IOM Report suggested that:
Short-term use of smoked marijuana (less than six months) for patients with debilitating symptoms . . . must meet the following conditions: failure of all approved medications to provide relief has been documented, the symptoms can reasonably be expected to be relieved by rapid-onset cannabinoid drugs, such treatment is administered under medical supervision in a manner that allows for assessment of treatment effectiveness, and involves an oversight strategy comparable to an institutional review board process that could provide guidance within 24 hours of a submission by a physician to provide marijuana to a patient for a specified use.
IOM Report at 179. Although the IOM’s statement ostensibly would limit the use of marijuana to six months’ duration, in the context of the full report, it is apparent that the IOM does not urge the automatic termination of treatment at an arbitrary date, but rather recommends that patients’ marijuana use be reevaluated on at least a semiannual basis. The authors’ reluctance to approve the longer-term use of cannabis was based primarily on their concern about the possible pulmonary risks posed by smoking marijuana.
11. While the IOM was conducting its evaluation, Great Britain’s House of Lords was conducting hearings and taking testimony from leading researchers, clinicians and patients regarding the medical benefits and drawbacks of cannabis. The findings and recommendations of the Lords Report parallel those of the IOM. The House of Lords concluded that "cannabis almost certainly does have genuine medical applications, especially in treating the painful muscular spasms and other symptoms of MS and in the control of other forms of pain." Select Committee on Science and Technology, House of Lords, Sess. 1997-98, 9th Report, Cannabis: The Scientific and Medical Evidence: Report (Nov. 4, 1998), available at http://www.publications.parliament.uk/pa/ld199798/ldselect/ldsctech/151/15101.htm (“Lords Report”).
12. On July, 30, 2001, Canada's "Marihuana Medical Access Regulations" came into force. Marihuana Medical Access Regulations, SOR 2001-227, § 2 et seq. (June 14, 2001) (Can.), available at http://www.hc-sc.gc.ca/hecs-sesc/ocma/index.htm. These regulations permit the possession and production of marijuana for medical purposes and were developed by Health Canada after it had reviewed the scientific evidence regarding the therapeutic value of smoked marijuana and conducted its own survey in 2000-2001 to gather and analyze data regarding the medical uses of marijuana. Health Canada developed regulations to allow certain persons the ability to possess and cultivate marijuana for medical use. Consistent with the IOM, the House of Lords, and the weight of scientific evidence and personal experiences attesting to marijuana's efficacy, Canada's new law permits doctors to recommend and prescribe medical marijuana to certain persons who are suffering from severe pain, muscle spasms, anorexia, weight loss, and nausea, and who have not found relief from conventional therapies. Office of Cannabis Medical Access, Medical Access to Marijuana – How the Regulations Work, available at http://www.hc-sc.gc.ca/hecs-sesc/ocma/bckdr_1-0601.htm.
13. The experiences of Great Britain and Canada with respect to medical marijuana cannot be ignored by clinicians in the U.S. Sound medical research transcends national boundaries and political divides, and has potential relevance for health professionals regardless of their country of practice.
14. For many of my AIDS patients and some of my patients who suffer acute or chronic pain, I prescribe Marinol to combat severe nausea, to stimulate appetite, and alleviate pain. Marinol is the brand name of dronabinol and a synthetic isomer of THC, a primary active ingredient of marijuana. A significant number of patients, however, have difficulty tolerating Marinol. In my clinical experience, many patients who do not tolerate Marinol well obtain better, faster, and more reliable relief from their debilitating symptoms by smoking marijuana. I believe that for certain patients, marijuana can be preferable to Marinol for alleviating debilitating symptoms for at least four reasons.
15. First, although Marinol is approved by the Food and Drug Administration to treat nausea and vomiting associated with chemotherapy and anorexia associated with weight loss, it paradoxically is often vomited before it can counteract the vomiting. 64 Fed. Reg. 35,928 (1999). Moreover, many patients suffering from the symptoms for which Marinol is approved are unable to swallow the drug, much less keep it down. Consequently, patients are often unable to ingest a sufficient quantity of the drug to benefit from its effects. Marijuana, particularly when smoked, appears to pose no such problem.
16. Second, Marinol delays relief to patients. Marinol is ingested while the active ingredients in smoked marijuana are inhaled. As a result, patients in need of immediate relief must often suffer for an extended period of time before Marinol takes effect. By contrast, inhaling marijuana into the lungs is a more efficient delivery mechanism as it provides the blood stream with the therapeutic properties of marijuana almost instantaneously. As a result, patients tend to experience prompt relief. As the IOM report notes:
smoking . . . delivers a rapid drug effect, whereas the THC capsule takes effect slowly, and its results are variable. There are many symptoms for which a quick-acting drug is ideal, such as pain, nausea, and vomiting.
Opening Statement of Stanley J. Watson, Jr., Institute Of Medicine News Conference Marijuana and Medicine: Assessing the Science Base (Mar. 17, 1999) (The complete text is available at http://www4.nationalacademies.org.)
17. Third, Marinol tends to produce more debilitating psychoactive side effects than marijuana, particularly smoked marijuana. After ingestion, Marinol is delivered first to the stomach and then to the liver where it is metabolized into 11-hydroxy-delta 9-THC. This metabolite is three times more psychoactive than THC that is delivered to the lungs by smoked cannabis. IOM Report at 36 (Citing Razdan, R., Structure-activity relationships in cannabinoids, 38 Pharmacology Rev. 75-149 (1986)). Therefore, not only do patients who take Marinol experience a delayed onset of relief, but they also often hit with harsh psychoactive side effects from ingesting a full-dose of THC that they cannot mitigate except with the passage of time. By contrast, patients who smoke marijuana, because of its fast-acting effect, can regulate their dose of THC with relative precision, achieving the desired therapeutic effect without experiencing the same intensity of psychoactive side effects.
[S]moking . . . is actually a very good route of administration, in some ways; it is very effective, there is a very rapid absorption, and the patients have a great deal of control over how much they take. They learn to titrate.
Select Committee on Science and Technology, House of Lords, Sess. 1997-98, Cannabis: The Scientific and Medical Evidence: Evidence (Nov. 4, 1998) ("Lords Evidence").
18. It should also be noted that for persons who have compromised pulmonary systems for whom smoking poses an unacceptable risk, the therapeutic components of the cannabis plant can be inhaled using vaporizer devices. Vaporizers heat cannabis to 150-200 degrees Centigrade, evaporating the cannabinoids and other volatile oils. This temperature is below the burning point of combustible plant material, so smoke is not generated. This technology has been available for over 20 years. John M. McPartland & Patty L. Pruitt, Medical Marijuana and Its Use by the Immunocompromised, 3 Alternative Therapies 39, 43 (1997).
19. Fourth, Marinol is often less effective than marijuana in treating debilitating symptoms such as pain, nausea, and vomiting because it lacks other active ingredients contained in marijuana. Marinol is composed of a single compound, THC. By contrast, marijuana is a complex botanical substance, containing over 400 constituents and approximately 66 cannabinoids, which fall into 10 groups of closely related cannabinoids. IOM Report at 24. The main cannabinoids include delta9-THC, delta8-THC, cannabidiol ("CBD"), cannabinol, cannabichromene, and cannabigerol. IOM Report at 24-25.
20. Several of the cannabinoids found in marijuana — not just THC — have therapeutic applications, either alone or in combination with others.
Herbal cannabis contains a mixture of active compounds. It is too early to be certain if the therapeutic action [of cannabis] is limited to one compound. . . . Cannabis may contain a synergistic mixture of active compounds. This is particularly likely now that we know there are at least two receptor specified loci of action.
Lords Evidence at 32. See also John M. McPartland & Patty L. Pruitt, Side Effects of Pharmaceuticals Not Elicited by Comparable Herbal Medicines: The Case of Tetrahydrocannabinol and Marijuana, 5 Alternative Therapies 57, 60 (1999). For example, CBD, which is not psychoactive, has been shown to have potential neuroprotective and anti-inflammatory uses. See A.J. Hampson et al., Cannabidiol and (-)delta-9-tetrahydrocannabinol are neuroprotective antioxidants, 95 Proceedings of the National Academy of Sciences 8268 (July 1998) (addressing neuroprotection use); A.M. Malfait, et al., The Nonpsychoactive Cannabis Constituent Cannabidiol is an Oral Anti-arthritic Therapeutic in Murine Collagen-Induced Arthritis, 97 Proceedings of the National Academy of Science 9561 (Aug. 2000) (addressing anti-inflammatory/anti-arthritic uses). These articles are available at http://www.pnas.org/all.shtml.
21. I currently treat at least 20 patients for whom I believe marijuana is medically appropriate in responding to treatment-induced nausea or for appetite stimulation. In my medical judgment, in some cases medical marijuana may be the only effective medicine.
22. People diagnosed with debilitating and/or terminal illnesses and their families face many challenges that may leave them feeling overwhelmed, afraid, and alone. It can be difficult to cope with these challenges or to talk to even the most supportive family members and friends. Often, support groups can help people feel less alone and can improve their ability to deal with the uncertainties and challenges that these conditions bring. In fact, attention to the emotional burden of the illness is sometimes part of a patient’s treatment plan.
23. An increasing body of research shows that support groups help patients and loved ones accept their circumstances, develop necessary coping skills, enhance the physician-patient relationship, and discover ways to maintain self-esteem and a sense of purpose amidst the complications imposed by serious, often chronic illness. In support groups patients can discuss in a confidential atmosphere the challenges that accompany their illnesses with others who may have experienced the same challenges. They can exchange information about their disease — including practical problems such as managing side effects, returning to work after treatment, or how to prepare for death. They can also share their feelings. See, e.g., http://cis.nci.nih.gov/fact/8_8.htm (National Institutes of Health’s National Cancer Institute web page discussing the importance of support groups).
24. The Wo/Men’s Alliance for Medical Marijuana (WAMM) is a support group in Santa Cruz, the community in which I practice, that provides valuable services to its seriously and terminally ill members. By reducing the suffering of its members, WAMM also serves the community at large. On the one hand, WAMM is a traditional support group in that it holds regular meetings that provide its members with important interaction, information, and inspiration. On the other hand, WAMM is perhaps unique in that its members also tend a cooperative garden in which organic vegetables as well as organic medical marijuana is cultivated, harvested and processed for the members’ benefit. All of WAMM’s members suffer from serious medical conditions and have state-licensed physicians who have advised them that they may benefit medically from the use of marijuana, and that the potential health benefits of using marijuana outweigh the risks in their cases.
25. It is necessary to underscore the medical significance of the fact that WAMM’s members grow their own medical marijuana, do so in accordance with strict organic guidelines, track and maintain different genetic strains of the plants, carefully process the marijuana to insure that it is of clinical quality, distribute it equitably and cost-free to one another, and educate one another on how to safely ingest marijuana to achieve optimum medical efficacy. Like with any medicine, marijuana should not be adulterated with potentially harmful toxins, including mold or fungi. Maintaining the marijuana’s purity is particularly important for patients, such as those with HIV/AIDS or those undergoing chemotherapy, whose immune systems may be compromised. Insuring marijuana’s chemical consistency is also important, so that patients can safely rely on their accustomed dosage to provide the needed relief. Disseminating information concerning a range of routes by which medical marijuana can be administered – including tinctures, teas, baked goods, poultices, sprays, suppositories, cigarettes, vaporizers, and inhalers – is also beneficial, as patients’ medical conditions or living circumstances may make certain routes of ingestion impossible or other routes uniquely advantageous. And by cultivating their own marijuana and providing it free of charge to one another, WAMM members, many of whom have incurred substantial medical expenses and who are too ill or disabled to hold regular employment or earn a living-wage, can obtain an efficacious medicine without exacerbating their financial plight.
26. Over the years several of my patients have become WAMM members and I have observed WAMM’s activities under the leadership of Valerie and Michael Corral. WAMM’s members have created a highly compassionate and nurturing environment. Through its horticultural activities, weekly meetings, and on-call emergency support services, I have seen how WAMM promotes healing, builds emotional courage and physical strength, averts premature abandonment of viable therapeutic options, and likely prolongs life. I have also seen, to dramatic effect, how WAMM provides critical end-of-life care to its terminally ill members, many of whom come to WAMM in agony. Through its medical marijuana distribution and supportive services, WAMM has successfully alleviated the pain and suffering of dying patients, so that they could spend their final months in relative peace and comfort. WAMM, and the marijuana it provides, has also helped terminal patients reclaim autonomy and dignity which have allowed them to plan for and control the course of their final days and hours. As a result, these members have been able to die what they and loved ones consider a “good” death. Put simply, as a clinician who has followed WAMM’s efforts and closely monitored several of its members, it is my professional opinion that WAMM has improved the health and/or well-being of many of its members to a remarkable degree, both through the provision of medical marijuana and an array of supportive services.
27. Two of my patients, Hal Margolin and Dorothy Gibbs, have benefited tremendously from their membership in WAMM. Both suffer from chronic pain. Ms. Gibbs, who is 93 years old and who had not previously tried marijuana until joining WAMM, has found marijuana to be a highly effective analgesic for treating acute and chronic pain associated with post-polio syndrome and complications arising there from. Ms. Gibbs turned to marijuana only after trying a wide range of conventional prescription pharmaceuticals and therapies prescribed by me, but to little or no avail. These treatments, including powerful and highly addictive opioid analgesics, either did not work, gradually lost their efficacy, or caused such debilitating side effects(particularly nausea and dizziness) that Ms. Gibbs found intolerable. Ms. Gibbs is a good example of a patient who experiences episodic acute pain for which Marinol is too slow-acting and who, when stricken with acute pain, often requires the faster analgesic and antiemetic effects produced by smoked marijuana. I have been pleasantly surprised at the degree to which marijuana has afforded Ms. Gibbs relief from the agony that she suffered.
28. Mr. Margolin suffers chronic and acute neuropathic pain, as well as numbness and spasticity, as a result of cervical disk disease and perhaps the surgery performed to decompress his spinal cord. As a result of these symptoms, Mr. Margolin is severely disabled.
He has difficulty tolerating conventional analgesics but has found that marijuana offers effective pain relief. Since he began to use medical marijuana on a regular basis to treat his symptoms, Mr. Margolin has regained an important degree of mobility and general well-being.
I declare under penalty of perjury under the laws of the United States and the State of California that the foregoing is true and correct to the best of my knowledge.
Executed at Santa Cruz, California, this Twenty First day of April, 2003.
ARNOLD S. LEFF, M.D.
Copyright Women's Alliance for Medical Marijuana 2007 - 2008