I, Dr. Debasish Tripathy, declare as follows:

1. I am a physician licensed to practice in the State of California. I received a B.S. degree in chemical engineering from the Massachusetts Institute of Technology in Cambridge, Massachusetts in 1981, and earned my medical degree at Duke University School of Medicine in Durham, North Carolina in 1985. I subsequently completed an internship and residency in internal medical at Duke University Medical Center, followed by a clinical fellowship in hematology and oncology, and then a post-doctoral fellowship in cancer research, both at the University of California-San Francisco ["UCSF"].
2. I have been a member of the UCSF faculty since 1991, first as a Clinical Instructor, and then (since 1993) as Assistant Clinical Professor of Medicine. I am certified by the American Board of Internal Medicine in the areas of Internal Medicine, Clinical Hematology, and Medical Oncology. I am an active member in good standing of the American Society of Clinical Oncology. I serve on the Board of Directors of Cancer Support Community, a nonprofit agency which has provided free support and advice to cancer patients and their families for the past 20 years. I am a Contributing Editor of Breast Diseases: A Year Book Quarterly.
3. My clinical research and publications have focused on the diagnosis and treatment of breast cancer. I am currently involved in several major research studies assessing the efficacy of specific therapies in several patient groups, including those with metastatic breast cancer. I am the Principle Investigator on fifteen of those studies. I am the author and co-author of several chapters appearing in standard medical texts. I have also published widely in scholarly and professional journals, including Annals of Internal Medicine, Journal of Clinical Oncology, Breast Cancer Research Treatment, Journal of Clinical Outcomes Management, and Clinical Research.
4. Since 1993, I have been a physician at the UCSF Mount Zion Breast Care Center in San Francisco. My practice is devoted exclusively to breast cancer patients. I treat more than 1,000 patients. Approximately 100 of these patients are currently undergoing chemotherapy, a treatment utilizing various combinations of powerful medications. In some cases, the therapeutic dose of the medication we use is not far from the potentially lethal dose. Although chemotherapy is a widely used treatment in the treatment of many cancers, it can also cause severe adverse affects which some patients are simply unable to tolerate. The most common adverse effects of chemotherapy are nausea and retching.
5. The nausea and retching associated with chemotherapy are often disabling and intractable. The severity of the symptoms and their medical consequences vary from patient to patient. In many cases, the immediate results are weight loss, fatigue, and chronic discomfort. The consequences can be far graver in patients whose health and functioning is already compromised. For example, the dangers associated with weight loss and malnutrition are greater in patients whose cancer has metastasized and attacked other parts of the body.
6. For most chemotherapy patients, relief from nausea is obtained through one of several medications, including Compazine or Ondansetron, a recently developed medication specifically used for relieving chemotherapy-induced nausea. In my practice, I often rely on these medications as first-line treatment for my chemotherapy patients. They are legally available and clinically effective in many patients. For those who cannot tolerate them in pill form (e.g., certain patients with cancer of the colon, stomach, throat or esophagus), these and some of the other anti-nauseants are available in other forms. Compazine, for example, can be administered intravenously, intramuscularly or in suppository form. Nonetheless, these FDA-approved medications are not effective in some patients. There is no singular formula for treating illness -- I. e., no "best medicine" which is appropriate or advisable for all patients. Indeed, the phrase "best medicine" belies the concept of individualized treatment.
7. Another medication often used to combat nausea is Marinol, a synthetic form of THC, which is one of the key active ingredients in marijuana. In my opinion, Marinol is often the third or fourth line treatment for chemotherapy-induced nausea. I generally prescribe Marinol only after Compazine or Ondansetron have proven unsuccessful in "refractory" patients -- i.e., those who are resistant to traditional treatments. It is often in that patient group (those who do not respond to commonly effective treatments) that clinicians see the greatest variation. Individual responses to medication may be idiosyncratic, unexpected or otherwise unique. In those patients, cautious trial and error is essential to effective treatment. Therapies must be modified or "customized' to the unique needs and responses on the individual. Some degree of experimentation, closely monitored, is clinically appropriate.
8. Marinol is FDA-approved as an appetite stimulant and for relief from nausea associated with chemotherapy. I have prescribed Marinol to some of my patients and it has proven effective in some cases. However, scientific and anecdotal reports consistently indicate that smoking marijuana is a therapeutically preferable means of ingestion. Marinol is available in pill form only. Moreover, Marinol contains only one of the many ingredients found in marijuana (THC). It may be that the beneficial effects of THC are increased by the cumulative effect of additional substances found in cannabis. That is an area for future research. For whatever reason, smoking appears to result in faster, more effective relief, and dosage levels are more easily titrated and controlled in some patients.
9. Still, patient preferences between Marinol and marijuana are not uniform. I have had patients who stopped smoking marijuana and returned to Marinol to address their nausea. Some report bothersome side effects, including the grogginess reported by some Marinol users. Still others, whose fellow patients have endorsed marijuana, have been reluctant to try it for legal, social or philosophical reasons. They cite the moral stigma attached to marijuana as an illegal "drug," their concern that others will learn of their "drug" use, and practical concerns about violating the law.
10. Means of ingestion is often critical to the efficacy of specific treatments. For example, insulin is far more effective when injected. Many medications are inhaled, while others are administrated intravenously or intramuscularly. DDAVP, a synthetic pituitary hormone, is administered through a rhinal tube, through which the patient sniffs the substance.
11. Like many substances, the efficacy of Marinol is particularly variable in refractory patients. Clinicians report a range of factors which appear to increase the difficulty of identifying effective treatment. For example, younger cancer patients seem to have more difficulty with the adverse effects of chemotherapy, possibly because they generally have more acute sensory reflexes. Adverse reactions are also more common among patients with co-existing conditions. They may present with more complicated symptom pictures, and their bodies may already be weakened by the effects of pre-existing illness. Emotional and psychiatric disorders, not uncommon in seriously or terminally ill patients, may also render traditional side-effect medications less effective.
12. In my practice, the most common treatment-induced symptom reported is nausea, which is fairly subjective. and therefore difficult to measure. Because there has been relatively little research conducted on this subject, I believe that physicians have a duty to provide their suffering patients with all clinical information available. From a moral and humane point of view, my duty increases when the suffering is caused by treatments which I have recommended and administered. When I consider chemotherapy for my patients, I factor in the possibility of disabling adverse reactions, as well as my ability to reduce or eradicate unwanted effects. In some instances, the balance between the risks and benefits of a proposed treatment is very close. If the information I provide does not include all possible means of reducing adverse effects, my patients must make decisions with incomplete information. In other words, the balance between the pros and cons of chemotherapy (or any treatment) may be thrown off. The patient's decisions regarding treatment may therefore be ill-informed and medically regrettable. When the treatment (e.g., chemotherapy) is intended to prolong life and cure cancer, the choice to forego potentially life-saving treatment can literally be fatal.
13. The balance of risks and benefits is a process which continues throughout treatment. There are patients whose adverse reactions are seemingly intolerable. It is not unusual for those patients to consider terminating therapy; some of them discontinue treatments midway through the therapeutic protocol. For them, the suffering caused by the chemotherapy outweighs the potential long-term benefits of completing the full cycle. In many cases, incomplete therapy is of little use in fighting cancer. The decision to stop treatment can shorten lives. If I believe that marijuana might reduce their suffering and allow them to complete treatment, I must provide that information.
14. I do not generally initiate discussions about marijuana, but I am ethically bound to answer questions posed by my patients. When asked, I advise my patients about the benefits and risks (both scientific and legal) inherent in the use of marijuana for medicinal purposes. Were it clearly legal, I would include marijuana as one of the medical options available in treating persistent treatment-induced nausea. I have not provided written recommendations for marijuana to my patients, but that decision is not based upon independent clinical judgment. It is colored by political and legal implications, as well as threats of criminal sanctions.
15. There is one additional consideration which must be addressed in this discourse. The medical benefits of marijuana are generally limited to its use in treating cancer patients and late-stage AIDS patients suffering from wasting syndrome. I am aware of no clinical or scientific reports indicating short-term risks posed by marijuana when used in small amounts. Any discussion of adverse consequences appears to focus on the effects of long- term use (e.g., adverse effects on the lungs), and even those concerns are speculative. That fact must be a factor in balancing the risks and benefits. In populations with short life expectancies, the risks become less imminent and the benefits more paramount.
16. Many medications administered to combat cancer and other serious (potentially fatal) illnesses are far more toxic than marijuana. That is a consideration which I, as a healer, must acknowledge in caring for every patient in my practice. It defies common sense and sound medical practice to withhold any information which might minimize the effects of those treatments. The recent government threats to prosecute physicians for recommending, or even advising, their patients regarding marijuana place me in an unacceptable and unethical position: to fulfill my duties as a healer, I make myself vulnerable to legal sanctions which are not grounded in science or the healing arts. The government's recently announced policies jeopardize both the integrity of my practice and the quality of care received by the many patients who depend on me.

I declare under penalty of perjury under the laws of the United States of America and the State of California that the foregoing is true and correct and this declaration was executed this 13th day of February, 1997, in San Francisco, California.

Debasish Tripathy, M.D.