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Dr. Stephen Follansbee: Declarations in Conant v. McCaffrey

I, Dr. Stephen E. Follansbee, declare as follows:

  1. I am a physician licensed to practice in the State of California. I graduated cum laude from Pomona College in 1970, and earned a Master's degree from Harvard University in 1972. In 1977, I was awarded a doctorate magna cum laude from the University of Colorado School of Medicine. I subsequently completed an Internship at San Francisco General Hospital (1977-1978), a Residency at the University of California-San Francisco ["UCSF"] (1978-1980), and a Fellowship at UCSF's Division of Infectious Diseases (1980-1982). I am board- certified in both Internal Medicine and Infectious Diseases by the American College of Physicians.
  2. I am currently Chief of Staff at Davies Medical Center in San Francisco. I am also Medical Director of the Institute for HIV Treatment and Research at Davies Medical Center, a position I have held for the past nine years. In 1982 I entered the private practice of infectious diseases in San Francisco. That practice has become Infectious Diseases Associates Medical Group, Inc., and I am a full-time employee of that medical corporation at this time. One year later, in 1983, I became an Attending Physician on Ward 86 (Division of AIDS) at San Francisco General Hospital and in that capacity, a part-time (hourly) employee of the University of California, San Francisco. I am currently on staff at Davies Medical Center, California Pacific Medical Center, St. Luke's Hospital, and San Francisco General Hospital Medical Center. I am also an Associate Clinical Professor of Medicine at UCSF's School of Medicine.
  3. My work as both a researcher and a physician extends into the larger community, as well. Since 1990, I have been the Assistant Director of the Bay Area Community Consortium, whose primary purpose has been to promote AIDS-education and research. For more than 10 years, I have served as Medical Adviser to FOCUS: A Guide to AIDS Research and Counseling, a publication of the AIDS Health Project in San Francisco. I am currently a member of the Institutional Review Board of Project Inform.
  4. I am a member of several professional societies, including the Infectious Diseases Society of America, the Bay Area Infectious Diseases Society, and Bay Area Physicians for Human Rights. I am the author, principle author or co-author of approximately 40 articles and research studies on the subjects of respiratory illnesses, opportunistic infections, epidemiology, and the study and treatment of AIDS-related conditions with a range of clinical therapies. These studies have been published in scholarly and professional peer review journals, including the New England Journal of Medicine, Annals of Internal Medicine, Journal of Infectious Diseases, Clinical Infectious Diseases, Annals of Neurology, Annals of Plastic Surgery, Journal of Experimental Medicine, Western Journal of Medicine, Virology, and the Journal of Reconstructive Microsurgery. My colleagues and I have also authored book chapters, research reports, and educational publications. Several additional manuscripts are currently in print.
  5. For a long time, I resisted going to medical school, largely because I naively regarded doctors as glorified auto-mechanics. I assumed that the practice of medicine involved the rote following of established procedures to fix broken or ailing parts, and that creativity and nuance were neither valued nor necessary. I could not have been more wrong. Medicine, particularly the treatment of the seriously ill, is an art that places a premium on the physician's ability to recognize and respond to each patient as a unique individual. It requires the application of general scientific knowledge to the specific needs and conditions presented in an individual with a unique and complex medical history. I cannot know in advance what will constitute the best treatment for any patient. Rather, I must make educated guesses about what may work best, then observe the patient closely and, when necessary or appropriate, refine and modify the treatment plan in order to strike or maintain optimal conditions for improvement. Certain treatment options work well in some patients but not others; or the treatment works well, but only for a limited period, after which it loses it efficacy. Some patients tolerate various options equally well, in which case I must assess (and likely re-assess) which among them will provide the greatest benefits to my patient.
  6. When a patient suffers from nausea, retching, or persistent weight loss ("wasting syndrome"), I do not consider medical marijuana as my first treatment option. It has always been my practice to first attempt to identify the cause of the problem, and prescribe the necessary therapy for treatable causes. If there are no directly treatable causes, symptomatic therapy may be necessary. For nausea or retching, I start with anti-nausea medications, of which there are several available by the oral, rectal, or on occasion the intravenous route. For wasting syndrome due to poor appetite, after altering the medications that may be contributing to this problem, I have prescribed Marinol since it was USA-FDA approved for this indication. I begin with Marinol because it is legally available and it is often an effective treatment in relieving these symptoms. However, in my clinical experience, a significant number of patients find that Marinol is not as effective as marijuana; it does not provide the same relief. Because the Marinol capsule is not as quickly or efficiently absorbed, it can be less effective than marijuana. My patients frequently report that Marinol can create a dysphoria that they dislike. As a practical matter, the very symptoms which Marinol is intended to address (e.g., nausea and retching) often make oral ingestion of any medication intolerable or ineffective. Marinol is currently available in capsule form only. Marijuana, on the other hand, can be ingested by inhaling it, eating it in baked goods, or drinking marijuana tincture in a tea.
  7. The federal government's threats against physicians who discuss or recommend medical marijuana can have, and are indeed having, several negative repercussions on the quality of care that physicians can provide their seriously ill patients.
  8. Medical students are taught that proper diagnosis and treatment require a detailed and accurate patient history. That chart will follow the patient wherever he or she goes. If properly maintained, it provides critical information to all future health providers. Each treating physician necessarily relies on the information contained in that chart in diagnosing and devising a safe course of treatment for that patient.
  9. The government's gag on physicians discourages doctors from maintaining a comprehensive written record of the patient and the care she or he receives. I am personally very nervous about creating a detailed record of my patient histories with respect to the use of marijuana, medically or otherwise, for fear of government reprisal against me, my medical practice, or the hospital of which I am Chief of Staff. The government's threats expose me to criminal and civil sanctions, including the loss of my DEA license to prescribe schedule II drugs, without which I could not practice infectious disease medicine. I fear the loss of government research grants, both to myself and to my colleagues and the facilities I am associated with. I also fear that, on the basis of my record- keeping, my patients might be denied coverage under Medicare or MediCal, which is so often the only means for them to receive continued medical treatment for any illness or ailment.
  10. Information about a patient's drug use -- licit and illicit -- is an important part of that patient's history (medical, psychiatric and social) that a physician must consider to provide safe, appropriate and effective medical care. It is common practice to learn about a patient's use of tobacco and alcohol, as well his/her history of substance abuse or dependence. That information, which may be embarrassing or shameful or involve illegal behavior, can only be fully disclosed in an atmosphere of trust and safety. That is one very important reason that I spend a great deal of time making my office a safe and confidential place for my patients. I make sure they understand that our discussions are confidential and their files are secure.
  11. There are many instances in which a conversation about medical marijuana with a seriously ill patient is medically warranted. First, there are possible health risks of ingesting marijuana. The physician must be able to provide that information to a seriously ill patient; s/he must also advise that patient on how s/he might reduce or eliminate those risks. For example, patients with HIV or AIDS may suffer from respiratory problems that may be exacerbated by smoking any substance, whether tobacco or marijuana. I have these concerns with patients suffering from pulmonary aspergillosis, an infection of the lungs seen often among AIDS patients. In such circumstances, the physician might wish to dissuade the patient from smoking marijuana, encouraging the patient to try alternative treatments, including ingesting marijuana as a tincture or in baked form. Providing that advice is part of my duty to treat and prevent unnecessary illness and suffering.
  12. There may be other risks associated with marijuana. Marijuana sold on the street may contain fungaspores and other impurities that pose little danger to healthy users but can compromise the health of a seriously ill patient, particularly a patient whose immune system is weakened. A physician might wish (quite properly) to dissuade the patient from using marijuana and encourage the patient to try alternative treatments. Failing that, the doctor might encourage the patient to avoid marijuana from unknown street sources; or to bake the marijuana to kill fungaspores before ingesting; or to smoke the marijuana through a water pipe to decrease exposure to impurities.
  13. Finally, a patient who is not accustomed to marijuana, or a patient who habitually ingests more than is medically indicated, may experience adverse effects from THC. The obvious concern is that the over-medicated patient may forget to take his or her other medications. This is true with every drug which causes drowsiness, including many medications used to relieve pain or to treat anxiety, trauma, seizure disorders, allergies, and a range of psychiatric conditions. To assess the risks to a particular patient, the atmosphere of candor and confidentiality must be unquestioned by either doctor or patient. Only then can a physician feel free to ask, and the patient feel comfortable in answering, questions regarding marijuana use. As with any medication, the physician must consider that information in her/his individualized assessment regarding that medication, its dosage, the route of administration, and the possible interactions with other medications. Ultimately, my decision must be explained to the patient -- that, too, is a necessary part of the doctor-patient relationship.
  14. After candid and thorough discussions with my patients, I have refused to write letters recommending medical marijuana for several patients, generally because I believe that those patients are not proper candidates for this medicine. There are also patients I have counseled not to smoke marijuana when their particular circumstances or conditions pose risks which, in my clinical opinion, outweigh the potential medical benefits. In those situations, I often counsel the patients to try a different means of ingesting the marijuana -- for example, by baking it or using a water pipe.
  15. Since the government's initial threats in December, my conversations have been curtailed. Because of these threats, I have been reluctant to raise the issue of marijuana, or even use the word, with my seriously ill patients. I feel extremely vulnerable to intrusive actions by the government which will undermine my clinical judgment and the integrity of my practice. I am, frankly, fearful that a government agent will masquerade as a patient in an attempt to monitor my practices and, if possible, develop evidence to imply wrongdoing or unethical practice. I am concerned that overzealous officials might seek to prosecute or sanction me as an example to individual physicians and the medical profession. I believe that my concerns are well-founded. Reports of DEA agents appearing in physicians' offices are already spreading through the medical community.
  16. If I discuss marijuana with a patient (upon the patient's initiative or my own), s/he may well report that marijuana has helped reduce nausea or combat wasting syndrome. Having learned that, I am cast between the Scylla of legal sanctions and the Charybdis of medical care. To acknowledge that the patient's report is not uncommon -- supported by medical research and echoed by the New England Journal of Medicine -- may lead the patient to request that I recommend marijuana as a part of treatment. If I respond honestly, based on my medical knowledge and clinical experience, I may be inclined to recommend marijuana. In doing so, though, I risk sanction by the federal government.
  17. If I decline to answer the patient's question, I risk losing that patient's trust and confidence, sending the message that there are issues regarding that patient's health that are off-limits; that, at some level, I hold the patient's well-being subordinate to issues of politics. This result stands at odds with my dedication to the art of healing; it results in my refusal to relieve that patient -- already seriously ill and struggling to remain alive -- from additional, unnecessary pain, suffering, and hopelessness.
  18. It might be suggested that I parrot the views of General Barry McCaffrey and Attorney General Janet Reno, that Asmoke is not medicine,@ and Amarijuana has no known medical use but is a highly dangerous drug.@ To adopt such an obviously ill-informed position would undoubtedly alienate the patient, who through personal experience (and perhaps some background research) knows otherwise. Many of my patients use aerosolized medicines and would be right to question why one form of inhalation is efficacious while another is not. If the patient senses that his/her physician has been dishonest or disingenuous or is withholding critical information, s/he may well terminate the relationship and discontinue treatment. Alternatively, patients may try to read my mind and discern my true opinion. No patient should be forced to read a doctor's mind. Alternatively, patients may simply consider me sorely misinformed, and so, with good reason, may question or reject my medical advice on other serious issues. Either way, sound medicine suffers. More importantly, the patient's health is jeopardized. I cannot practice medicine in an ethical and honest manner if ill-informed government policies mandate that I be dishonest with those who seek my help.
  19. A core tenet of medical practice is to Ado no harm.@ In that spirit, I believe that acts of omission are often as profound (and as potentially damaging) as acts of commission. If a seriously ill patient is suffering severe nausea or chronic loss of appetite as a result of his/her illness or treatment, and such symptoms or side effects compromise his/her ability to tolerate other, traditional therapies, or to withstand a second or third cycle of chemotherapy for lymphoma, or simply to maintain the physical or psychological strength to fight for life, I do significant and inexcusable harm if I fail to counsel and treat that patient in accordance with my best medical judgment.
  20. My increased reluctance to discuss medical marijuana with seriously ill patients recently led a patient's wife, who was with him in my office, to raise the issue herself. This placed me in an extremely difficult situation. I felt gagged by the government, yet ethically obligated to act as a physician. The patient and his wife, in turn, expressed terrible guilt at having placed me in a moral dilemma. That should never occur in a proper clinical setting. No simple question about medical treatment should place a physician in a conflict of that sort; and no patient should ever be dissuaded from requesting reasonable (indeed appropriate) medical information. That is the chilling affect of government interference in clinical practice.
  21. Adjusting treatment options to best serve a patient's individual needs is what sound medical practice requires. Government officials evince a stunning disregard for the healing arts when they attack medical marijuana with the assertion that patients deserve Athe best available medicine.@ We all want and deserve the best treatment. But in medicine, the best is always a personal best; it is not determined by a simple formula. The government's contention -- that marijuana can never be the best, or even an appropriate medicine -- is simply wrong. This contention fails to recognize that physicians typically value and depend upon a range of medical treatments, that no one medicine is best for all patients. To speak of the best medicine makes little sense unless viewed in the context of treatment options. For some seriously ill patients suffering extreme nausea, Marinol may be the best treatment available for them. But that does not make Marinol the Abest@ medicine for anyone else. The government's references to the Abest@ medicine are facile and without any clinical or practical meaning. In my experience, Marinol does not work well for all patients. The same applies to virtually any medication, aspirin and penicillin included. For certain seriously ill patients, marijuana may in fact be the best medicine, or the only medicine. The federal government now prohibits me from informing those patients of this fact.
  22. Even if it were true, as the government contends, that marijuana is not the Abest@ medicine, the government itself acknowledges that an important role is served by second-, third-, and even fourth-line drugs. Federal regulations require that manufacturers of certain drugs state that they are considered a secondary or tertiary treatment option for certain conditions. The treatment of pneumocystis pneumonia with Mepron is one such example. Nonetheless, these medications are not proscribed or criminalized because they are not generally (or even usually) the Abest@ medications available. The government instead relies on the informed judgment of physicians to determine whether, when, and how to dispense these drugs.
  23. Marijuana, by history and for clinically sound reasons, is one of these so-called second or third-line medications. To proscribe any potentially-effective treatment, including marijuana, as a treatment option, flies in the face of longstanding government policy and medical practice. It also deprives the healer of the full clinical armamentarium -- i.e., the entire range of treatment options available in the practice of medicine. The federal government has in place detailed procedures for authorizing the use of experimental drugs. Many experimental drugs, including retrovirals and growth hormone, have been licensed by the Food and Drug Administration having had much less information than the medical profession has about marijuana.
  24. A large percentage of my patients are infected by the HIV virus; a significant number suffer from conditions and opportunistic infections which have come to define AIDS. I have provided care for a population that, until very recently, was considered hopeless. They were perceived as suffering from a terminal illness that progressively and painfully destroyed the immune system, rendering them thoroughly disabled -- blind, demented, incontinent, and unable to attend to their most basic needs. The physical agony and mental anguish that often accompanies AIDS results in some patients' desire to die. I know of no physician who relishes the thought of a patient dying. Indeed, as a doctor, I work daily to stave off death and to provide my patients with the means to control their pain and maintain their autonomy and dignity. As our knowledge and treatments become refined and more plentiful, the certain death we saw only a few years ago is no longer an accepted fate for my patients.
  25. Patients who seek my advice regarding the benefits of medical marijuana are evidence that there is hope. They have a very strong desire to survive their illness and to function as normally and productively as possible. Some of the medications that have led to this renewed optimism and have recently been licensed by the USA- FDA produce side effects (nausea and vomiting) that can be alleviated by the medical use of marijuana, and may not respond to other first-line or second-line agents. These patients ask me about marijuana not because they want to get high, but because they are fighting for their lives, which includes an honest search for the best available means to do so. Government threats against the physicians who struggle with these patients will inevitably thwart the patients' efforts. They may, in fact, remove their doctors from the healing process when vulnerable individuals are most in need of their counsel. Denying information and treatment advice to a seriously ill patient, when that medicine could promote and facilitate critical medical treatment, may needlessly hasten the patient's death.

    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 to the best of my knowledge, and that this declaration was executed this 13th day of February, 1997 in San Francisco, California.

    Stephen Eliot Follansbee, M.D.



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