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Wo/Men's Alliance for Medical Marijuana (WAMM)
The facts about: the County of Santa Cruz et. al. vs. Gonzales et. al

 

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Important Documents
 
The Complaint
  WAMM Order (.pdf)
  Motion for Preliminary Injunction

  Judicial Notice Request
  WAMM Protocols and Guidelines

Meet the Plaintiffs

  More about the Plaintiffs

  Their Declarations

  1.   Valerie Corral

  2.   RIP Eladio V. Acosta (of cancer)

  3.   Jennifer Lee Hentz

  4.   Harold F. Margolin

  5.   Levi Castro - Quadriplegic &  business
      owner More soon...

  6.   RIP Dorothy Gibbs
      (of Post-polio complications)

  7.   RIP James Daniel Baehr

  8.   RIP Michael Cheslosky
      (of AIDS/Bone Cancer)

     

Supportive Pleadings

  Arnold S. Leff M.D.

  Earnest H. Rosenbaum M.D.

  Harvey L. Rose, M.D.

  Neil Flynn, M.D.

  Robert Brody, M.D.

 

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BINGHAM McCUTCHEN LLP

Frank Kennamer (SBN 157844)

neha S. nissen (SBN 190848)

LAURI SCHUMACHER (SBN 217506)

TROY SAURO (SBN 224097)

Three Embarcadero Center

San Francisco, California  94111-4067

Telephone:  415.393.2000

Facsimile:  415.393.2286

 

Attorneys for WAMM Plaintiffs

 

Gerald Uelmen (SBN 39909)

Santa Clara University School of Law

500 El Camino Real
Santa Clara, California 95053

Telephone:  408.554.5729

Facsimile:  408.554.4426

 

Attorney for County of Santa Cruz
and WAMM Plaintiffs

 

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA

SAN JOSE DIVISION

 

county of santa cruz, California; City of santa cruz, california; Valerie Corral; Eladio V. acosta; james daniel baehr; Michael cheslosky; jennifer LEE hentz; dorothy gibbs; harold F. margolin; and Wo/men’s alliance for medical marijuana,

Plaintiffs,

v.

Alberto Gonzales, Attorney General of the United States; JOHN B. BROWN, III, Acting Administrator of the Drug Enforcement Administration; John P. Walters, Director of the Office of National Drug Control Policy; and 30 UNKNOWN Drug Enforcement Administration AGENTS,

Defendants.

Case No.:_________________

Declaration OF ROBERT V. BRODY, M.D. IN SUPPORT OF PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION

Date:            
Time:            
Place:           
Judge:           

 

 


 

I, Robert V. Brody, M.D., declare and state as follows:

1.         I am a physician licensed to practice in the State of California.  I am currently Chief of the Pain Consultation Clinic and Attending Physician, Pain Management Service at San Francisco General Hospital (SFGH), where I am also Chair of the Ethics Committee and Director of the Ethics Consultation Service.  I am a Clinical Professor of Medicine and Family and Community Medicine at the University of California, San Francisco (UCSF).  I am a former Medical Director of the Hospice and AIDS Programs of Visiting Nurses and Hospice of San Francisco.

2.         I received my B.A. from Cornell University in 1966 and my M.D. from the Chicago Medical School in 1970.  I subsequently completed an Internship at Los Angeles County-Harbor General Hospital in Torrance, California (1970-1971), after which I served as a Captain in the United States Army at Brooke Army Hospital in San Antonio, Texas (1971).  I practiced for two years at the Charles R. Drew Neighborhood Health Center in East Palo Alto (1973-1975), after which I completed a Residency in Internal Medicine at the University of Cincinnati Medical Center in Cincinnati, Ohio (1975-1977).  In 1977, I received specialty certification by the American Board of Internal Medicine.

3.         Since 1978, I have been a primary care physician at SFGH’s General Medical Clinic.  During my 19 years with SFGH, I have held numerous posts and positions on boards, committees and task forces affiliated or associated with the hospital, including Assistant Chief of the Medical Outpatient Department (1978-1996); Chief of the Hypertension Clinic (1984-1995); member of the Pain Management Committee (1988-present); Chair of the Ad Hoc Hospice Committee (1981-1988); member of the Health Care Evaluation Committee (1980-present); member of the Drug Use Evaluation/Adverse Drug Reaction Subcommittee (1989-present), of which I was Chair in 1989; and member of the Pharmacy and Therapeutics Committee (1984-present).  I have also been active in boards and committees within UCSF, including the UCSF Task Force on AIDS (1983); the Ambulatory Care Coordinating Committee (1992-present); its Department of Medicine Clinical Faculty Review Committee (1996-present); Chair of the Curriculum Committee of the UCSF/SFGH Primary Care Residency Committee (1990-1995); and numerous faculty search committees for UCSF’s Departments of Medicine, Family and Community Medicine, and Psychiatry.

4.         I have written and lectured widely in the areas of pain management, treatment of the terminally ill, palliative care, and quality of care in providing treatment services to chronically and/or terminally ill patients.  I am the author and co-author of numerous chapters, articles and abstracts published in medical texts, as well as in scholarly and professional journals, including the Western Journal of Medicine, Journal of Pain and Symptom Management, and Archives of Internal Medicine.  I am co-author of a chapter entitled “Care at the End of Life” in Current Medical Diagnosis and Treatment, currently in press.  I also serve as a reviewer of scholarly and research studies submitted for publication to the Western Journal of Medicine, Journal of General Internal Medicine, Annals of Internal Medicine, and the Journal of Law, Medicine and Ethics

5.         I have been a member in good standing of the Academy of Hospice Physicians, Society for General Internal Medicine, and the American Society for Law, Medicine and Ethics.  As part of my commitment to community service, I have served on the Boards of Directors of the San Francisco Home Health Agency, Visiting Nurses Association of San Francisco, Hospice of San Francisco, Shanti Project, and several subcommittees of the California Pacific Medical Center Board.  I am a frequent consultant to the San Francisco Department of Public Health and other public and private health care providers.

6.         I am a frequent participant, presenter and speaker at training seminars, conferences, and university courses on issues of pain management, multiple and adjunct therapies in the treatment of chronic pain, palliative care, and medical ethics.  Examples of recent lecture topics include “Teaching Pain Management” (to the San Francisco Chapter of the American Cancer Society); “Pain In AIDS” (to the Western Pain Society); “Care Of the Terminally Ill” (annual meeting of the Society of General Internal Medicine); and the keynote address to the Florida State Bioethics Network.

7.         Persistent and disabling pain can have numerous, and sometimes multiple, causes.  Illnesses, injuries and/or medical conditions that commonly give rise to chronic and/or acute pain include: cancer (particularly those affecting the stomach and gastrointestinal tract, as well as lung, breast, bone and prostate); AIDS; sickle cell anemia; interstitial cystitis; reflex sympathetic dystrophy, post-herpetic neuralgia, scoliosis and other defects or injuries to the back, neck and spinal cord; arthritis, spondylitis, and other rheumatic and degenerative hip, joint and connective tissue disorders; and severe burns.  The goal of pain management is to enable patients to function as fully as possible by reducing their pain to the greatest extent possible, while minimizing the often debilitating adverse effects of the various primary pain therapies.  By definition, pain is a subjective phenomenon.  It varies in frequency, duration, and severity according to the individual’s condition, co-existing conditions or vulnerabilities, age, prior medical history, previous therapies, chemical sensitivities, and the individual’s threshold for pain.  Even factors such as ethnic background and cultural norms can affect the degree to which pain affects one’s ability to function on a daily basis.  Moreover, most of the traditional analgesics themselves vary markedly in their effectiveness.  Discussing the opioid analgesics in particular, a published overview report noted, “(B)ecause of tremendous variation in drug absorption, metabolism, and the individual nature of the pain experience, there is no standard opioid dose.”  Joranson, D.E., et al., “Opioids for Chronic Cancer and Non-Cancer Pain: A Survey of State Medical Board Members,” (1997) (hereinafter “Joranson Pain Report”).  The underlying condition -- be it sickle cell, rheumatoid arthritis, or cancer -- determines the appropriate curative approach, but does not determine the proper symptom management.  In other words, pain per se is not the primary condition or injury, but is rather a severe, and often intolerable, symptom.  It is the character, severity, location and duration of the pain that determines the range of appropriate therapies.

8.         In discussing severe pain, clinicians and lay persons often refer to (or distinguish between) “acute” pain (sometimes referred to as “episodic” pain) and “chronic” pain.  In simple terms, acute pain is generally of shorter duration and carries with it some expectation that it will abate within a given period of time.  Examples would include post-operative pain, certain types of physical injuries (e.g., broken limbs), gunshot wounds, and kidney stones.  Another type of “acute” pain is associated with episodic flare-ups of underlying chronic conditions.  Examples include acute lumbar and cervical strains, as well as periods of acute pain associated with sickle cell anemia.  In some cases, these acute episodes overlap with underlying chronic pain, exacerbating the severity of the pain and markedly increasing its disabling effects for periods of days, weeks, or even months.

9.         In some instances, it is difficult (and sometimes even unproductive) to distinguish between acute and chronic pain.  For example, many patients suffering from acute episodes of sickle cell anemia present more like chronic pain patients, often requiring daily high dosages of opiate-based medications (“opioid analgesics”) in order to function.  One of my patients with sickle cell disease had approximately 50 long, drawn-out hospitalizations over three years for unbearable pain before being referred to SFGH’s pain clinic.  We treated that person much the same as we would treat a patient with “chronic” cancer pain, with a long-term regimen of opiates.  That patient experienced a marked reduction in pain, and notable improvements in daily functioning and general quality of life.  During nearly 10 years of pain treatment, the patient has been admitted only three times for fewer than 10 days, and held a job, working five days a week installing televisions.

10.       The medical profession has been increasingly successful at providing pain sufferers with the tools necessary to manage their pain, obtain substantial relief, and lead productive and meaningful lives.  Achieving this requires that physicians design and frequently adjust treatment plans that are highly individualized, a process which sometimes takes weeks or even months.  To provide relief, medical professionals must consider and have available to them the full range of medications and therapies, including not only traditionally recognized analgesics, but also less traditional and/or adjunct (or adjuvant) therapies. 

11.       Adjunct or adjuvant therapies are an essential and central part of pain management.  The Joranson Pain Report defines adjuvant therapies as “(a) number of other drugs (other than opioids), some of which are non-opioid controlled substances, (which) may be used to augment pain relief and symptom management . . . .”  The report goes on to describe the nature and purpose of adjuvant drugs thus:


 

There are a number of other drugs, many of which are controlled substances, that are essential in the treatment of cancer related pain.  These substances may be used together or in combination in order to improve overall pain and symptom management . . . .  The addition of adjuvant drugs to control opioid side effects, as coanalgesics or to manage other symptoms, may be necessary to provide optimal patient care.  Concerns about opioid toxicity, tolerance, physical dependence, and addiction are largely unwarranted.

Joranson Pain Report.

12.       Failure to adequately treat severe and/or chronic pain can have tragic consequences.  Not infrequently, people in unrelieved pain want to die.  This is especially true among those in chronic pain for whom the prospects for relief are dismal.  Because their quality of life is often so poor, a level of despair is almost inevitable, such that they will often discontinue potentially life-saving procedures (e.g., chemotherapy or surgery), which themselves cause severe (though generally temporary) suffering.  In such dire cases, anything that helps to alleviate the pain will prolong these patients’ lives.

13.       Patient autonomy and full information and communication are integral parts of palliative care.  “Palliative care” refers to treatment intended to relieve suffering caused by specific symptoms -- of either the disease or injury, or caused by treatment itself -- but not to cure the underlying condition.  When seeking appropriate and effective palliative care, the trust and communication inherent in an effective physician-patient relationship become even more critical than in other aspects of medical treatment.  This is due in part to the nature of pain, which varies greatly from patient to patient.  The effectiveness of any one pain treatment not only varies widely, but the reasons for these variances are largely unknown and therefore unpredictable.  The other factor which makes the patient-physician relationship so essential is also related to the nature of chronic pain.  It is, by definition, unique and subjective -- i.e., it cannot be identified on an x-ray or in a blood test, such that the treating doctor must rely, in large part, on the experience and reporting of the patients themselves.  Unless a patient trusts his or her doctor, and the doctor listens to that patient and is familiar with the individual patient’s pain history, the likelihood of obtaining maximum relief is greatly reduced.

14.       The very fact that chronic pain patients have lived with this disability for months, perhaps years, means that they are often as informed as many clinicians regarding the available treatment modalities, the risks and benefits inherent among them, and their own experiences in that regard.  If I do not provide full and accurate information to a patient regarding any aspect of his/her condition or treatment, the patient will very likely learn it on his or her own and the trust which is critical to our treatment relationship will be shattered.  This is especially likely (and potentially even more destructive) if I were to withhold information which I believed, in my professional opinion, might provide substantial relief to my patient, thereby dramatically improving his or her quality of life.

15.       Opioid therapy is often the most effective treatment for severe acute and chronic pain.  Indeed, opioid analgesics are often the only medications that can control a patient’s pain.  The opioid analgesics commonly used to combat pain include codeine, hydrocodone, oxycodone, propoxyphene, pentazocine, meperidine, morphine, hydromorphone, levodromoran, fentanyl, and methadone.  Although these medications, either alone or in combination, often provide significant relief, they are powerful drugs with their own risks and adverse effects.  All opiates have the potential to induce nausea (often very severe nausea), as well as vomiting or retching.  The intensity and duration of this nausea (sometimes lasting for days at a time) can cause enormous discomfort and additional suffering.

16.       Medication-induced nausea has ramifications far beyond the immediate discomfort of the patient.  Persistent, uncontrolled nausea can lead to malnourishment, anorexia, wasting, and a severe decline in a patient’s strength and general health.  Some patients find this degree of nausea so intolerable that they are inclined to discontinue the primary pain treatment, rather than endure the nausea.  Thus, relieving the opiate-induced nausea of these pain patients is a critical component of their overall pain management.

17.       The treatment modalities used to combat the adverse effects of primary therapies (including the nausea and retching discussed above) are sometimes referred to as “adjuvant therapies.”  Although they are not first-line analgesic medications per se, they are nonetheless a critical aspect of pain management for victims of both acute and chronic pain.  Among these adjuvant therapies are medications intended to stem nausea, known as “antiemetics.”  There are a variety of antiemetic drugs currently available, including Zofran, Reglan, Dramamine, and Compazine.  These medications have varying degrees of success in alleviating my patients’ nausea.  Some of my patients do not respond to any of these prescriptions.  For those who do, the relief obtained may be partial or inadequate.

18.       For patients whose nausea is not relieved by the antiemetics listed above, I often prescribe Marinol, a pill containing one of the many cannabinoids found in marijuana.  A good number of these patients obtain some noticeable relief from Marinol, but not without experiencing some adverse effects.  Most of my patients who try Marinol either find that it does not work effectively, or they report that the relief it provides is too unpredictable or the side effects are too unpleasant or long-lasting.  In their words, Marinol makes them feel overly “drugged” and unable to function normally.

19.       In cases where both traditional antiemetics and Marinol are ineffective or inadequate, I sometimes discuss the subject of smoked marijuana.  According to numerous patients who have turned to marijuana after suffering overwhelming opiate-related nausea, smoked marijuana provides almost immediate relief with significantly fewer adverse effects.  There are several possible medical factors that might explain this difference.  One is the speed and efficiency with which the active compounds in marijuana are absorbed into the blood stream.  It is for this reason that inhalation is an increasingly common, and often preferable, route of administration for many medications.  Another reason for the increased effectiveness of smoked marijuana may be that other cannabinoids (in addition to THC) are present in marijuana, but not in Marinol.  These additional cannabinoids may well have additional and complementary antiemetic qualities.

20.       A study commissioned by the White House Office of National Drug Control and Policy and conducted by the Institute of Medicine entitled Marijuana and Medicine: Assessing the Science Base (hereinafter “IOM Report”) recognizes the role that marijuana can play in treating chronic pain.  “After nausea and vomiting, chronic pain was the condition cited most often to the IOM study team as a medicinal use for marijuana.”  IOM Report, 2.27.  The study found that “basic biology indicates a role for cannabinoids [a group of compounds found in marijuana] in pain and control of movement, which is consistent with a possible therapeutic role in these areas.  The evidence is relatively strong for the treatment of pain and intriguingly, although less well established, for movement disorder.”  Id. at 2.44.  According to the Report, a number of brain areas that have an established role in sensing and processing pain respond to the analgesic effect of marijuana, id. at 2.29, such that cannabinoids have been used successfully to treat cancer pain, which is often resistant to treatment with opiates.  Id. at 4.6.  The Report further notes that cannabinoids serve as an anti-inflammatory agent, and so have therapeutic potential in preventing and reducing pain caused by the swelling of body tissues.  Id. at 2.42.  In addition to marijuana’s analgesic properties, the Report indicates that marijuana, like its synthetic cousin Marinol, can help treat the nausea often induced by opiate therapy, especially when other antiemetics prove ineffective.  Id. at 2.29; 4.5; 4.16-4.17.  In short, the IOM Report recognizes the potential benefits of medical marijuana for certain patients, including

Patients on chemotherapy, especially for the treatment of mucositis, nausea and anorexia.  Postoperative pain patients as an opiod adjunct [to help reduce] nausea and vomiting from opioids.  Patients with spinal cord injury, peripheral neuropathic pain, or central post-stroke pain.  Patients with chronic pain and insomnia.  AIDS patients with cachexia, AIDS neuropathy, or any significant pain problem.

Id. at 4.8. 

21.       Smoking is not the only means of obtaining the medical benefits of marijuana.  In my hospice practice, I have encountered several patients suffering from severe pain and nausea for whom prescription antiemetics were not effective.  Some of these patients were put off by the stigma (and legal complications) of marijuana; others simply preferred not to smoke.  Such patients have the option of ingesting the marijuana as a tincture brewed in tea or baked in a brownie, although absorption and titration through these modalities are somewhat less efficient.

22.       I am careful to advise my patients regarding all potential risks of using medical marijuana.  This is a standard part of informed consent, as required both legally and ethically in providing any medical advice or information.  The risks include possible health effects from smoking cannabis, including the potential to aggravate pre-existing medical conditions such as asthma, bronchitis, or pulmonary diseases.  The possible psychoactive effects of marijuana must also be considered and discussed.  Perhaps the greatest known risks to my patients, however, are the threats of arrest and civil or criminal prosecution for possessing and using the very medication which allows them to function.

23.       Although I am careful to discuss them with patients, the psychoactive effects of marijuana are not my greatest concern.  Initially, I did have reservations in this regard, but many years of experience has proven to me that patients generally curtail or cease their intake of marijuana as soon as they find that the psychoactive effects are unpleasant or debilitating.  It is important to note that these are patients whose minds and lives have been clouded by powerful psychoactive pain medications for long periods of time.  With very few exceptions, their goal is to think clearly and function productively, with as little medication as possible.

24.       A far greater concern to me is that patients who need marijuana have access to marijuana that is untainted with herbicides and/or other chemicals (licit or illicit), and that they can be treated with marijuana that is of a known, or at least consistent, potency.  Absent those assurances, the quality and consistency of my patients’ treatment is extremely difficult to monitor.  This is a concern quite similar to that which is often voiced regarding over-the-counter vitamins, minerals, and other dietary supplements which are currently in high demand.

25.       As a physician responsible for the care and treatment of those who live in horrible pain, I believe that these patients need, above all else, the broadest possible range of therapeutic options and as full and accurate information as possible regarding those options as they relate to the individual patient.  In recent years, I have noted that the public and the government have become increasingly aware of these needs, and one hopes that measures have been taken to promote adequate pain care for the seriously ill and injured.  Several states, including California, have adopted laws and/or guidelines for the prescribing of controlled substances, which seem to permit physicians to treat pain patients without fear of sanction or interference from state authorities.  Insofar as The Compassionate Use Act passed in 1996 expressly provides that “chronic pain” is a condition for which physicians are authorized to recommend marijuana without threat or fear of punishment, the Act appears to be an additional assurance for physicians like myself that we can rely upon a full range of treatment modalities to care for patients in pain.  The IOM Report provides still further support for doctors insofar as it recognizes the potential medical benefits of marijuana mentioned above.  Nonetheless, it appears that most physicians still err on the conservative side in developing pain management plans: “It has...been suggested that physicians may prescribe conservatively due to concern about scrutiny by regulatory agencies.”  Joranson Pain Report.[1]

26.       Marijuana has a place in any pain physician’s armamentarium.  It represents an important therapeutic option that allows physicians to uphold their commitment (and indeed duty) -- under state law and standards of medical practice -- to provide patients with safe, effective and compassionate palliative care. 

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 ____ day of April, 2003 in San Francisco, California.

 

 

_____________________________

Robert v. Brody, M.D.


 

[1]           In support of this premise, the authors cite numerous published studies, including Angarola, R.T. & Wray, S.D. (1989) “Legal impediments to cancer pain treatment,” in Advances in Pain Research and Therapy, Volume II, eds. C.S. Hill Jr. & W.S. Fields, pp. 213-231 (New York:  Raven Press, Ltd.); Foley, K.M. (1989) “The ‘decriminalization’ of cancer pain,” in Hill & Fields (eds.), supra, pp. 5-18; Hill, C.S. (1989) “The negative effect of regulatory agencies on adequate pain control,” Primary Care and Cancer, November 47-53; Max, M.B. (1990) “Improving outcomes of analgesic treatment:  Is education enough?” Annals of Internal Medicine 113:885-889; McIntosh, H. (1991) “Regulatory barriers take some blame for pain undertreatment,” Journal of the National Cancer Institute 83(17)12021204; Portenoy, R.K. (1990) “Chronic opioid therapy in nonmalignant pain,” Journal of Pain and Symptom Management 5(1):S46-S62; and Weissman, D.E., Joranson, D.E. & Hopwood, M.B. (1991) “Wisconsin physicians’ knowledge and attitudes about opioid analgesic regulations,” Wisconsin Medical Journal, December 1991.

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