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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 cheslovsky; 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; ASA HUTCHINSON, 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 NEIL M. FLYNN, M.D. IN SUPPORT OF PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION

Date:            
Time:            
Place:           
Judge:           

 

 

 

I, Dr. Neil M. Flynn, declare as follows:

1.         I am a Professor of Clinical Medicine in the Division of Infectious Diseases of the Department of Internal Medicine at the University of California at Davis School of Medicine.  I also serve as attending physician in the University Medical Center's Infectious Diseases Clinic and at the Center for AIDS Research, Education and Services, Sacramento (CARES).  I received my B.A. in bacteriology from the University of California at Los Angeles in 1970, graduated from the Ohio State University Medical School in 1973, and did my internship and residency in internal medicine at Loma Linda University Hospital from 1973‑76.  I completed a fellowship in infectious diseases at the University of California at Davis from 1976‑78 and was awarded my Master of Public Health from the University of California, Berkeley, in 1994.  I am licensed to practice medicine in the State of California.

2.         I am a member in good standing of several professional societies including the American Public Health Association; Infectious Diseases Society of America; American College of Physicians; and the American Society for Microbiology.  I am board certified in Internal Medicine and in Infectious Diseases.

3.         In addition, I have served on numerous hospital and medical school committees at the University of California, Davis (UCD).  Currently, I am a member of the Chancellor’s Committee on AIDS.  Previously, I have served as a member of the Department of Internal Medicine Quality Assurance Committee, the Medical Director of the AIDS & Related Disorders Clinic, and Chair of the Infection Control Committee, and Chair, Institutional Review Board (IRB) at UC Davis (Office of Human Subjects Research Protection).

4.         Among the awards I have received are the ACP Humanitarian Award (1995), Sacramento Regional Pride Award (1991), Lambda Community Award (1988), Kaiser Foundation Hospitals Award for Excellence in Teaching Clinical Sciences (1986), Outstanding Staff Award at UCD Medical Center (1982-83), and the Roessler Foundation Research Scholarship Award (1972-73).  I have successfully sought hundreds of thousands of dollars in grant money to pursue research on HIV and AIDS since establishing the UCD AIDS and Related Disorders Clinic in 1983.  The continuation of this research depends upon my ability to obtain future grants from both private and public sources.

5.         I am the principal author or co-author of numerous articles and book chapters in the area of infectious diseases.  My writings have appeared in such journals as The New England Journal of Medicine, JAMA, Western Journal of Medicine, Life Sciences, Annals of the New York Academy of Sciences, and Journal of Acquired Immune Deficiency Syndromes.  I have also delivered numerous lectures at professional symposia, in this and other countries, including the Third through Tenth International Conferences on AIDS.

6.         Through the University’s AIDS Clinic and the Center for AIDS Research, Education and Services (CARES), a private, non-profit clinic for treatment of HIV infection and disease, I participate in the care of approximately 1,500 HIV and AIDS patients.  I am the primary physician for 200 HIV/AIDS patients.

7.         Intractable nausea and wasting syndrome are frequent symptoms associated with HIV/AIDS and the treatment of HIV/AIDS.  The nausea, which can last for days, weeks or months, is one of the most severe forms of discomfort or pain that a human being can experience.  It destroys the quality of life of the patient, whose sole objective is to make it through the next hour, the next day.  Racked by intense vomiting and queasiness, time for the patient seems to stand still. 

8.         Wasting can take a similar psychological and physical toll as nausea.  Protease inhibitors, the newest and perhaps most effective drugs in the battle against AIDS, are beginning to lose their efficacy in some HIV/AIDS patients.  When this happens, wasting syndrome, a potentially deadly process, begins.  Body mass lost to wasting is difficult to regain. Therefore, it is preferable to stop wasting as early in the process as possible. 

9.         For patients suffering intractable nausea and/or wasting, my first concern is to help relieve these painful symptoms.  If I fail to do so, the patient is increasingly likely to decide that life is simply intolerable.  I have had patients whose nausea and/or wasting were so disabling that they preferred death.  As a physician, I try my utmost to avoid this end result.

10.       In addition to the agony of nausea and/or wasting, it is not uncommon for HIV/AIDS patients to experience severe neuropathic pain.  Neuropathic pain is a symptom commonly associated with a variety of illnesses or conditions, including HIV/AIDS, metastic cancer, multiple sclerosis (MS), and diabetes.  Neuropathic pain can also be a side effect of the recommended treatments for various conditions.  For example, many of the reverse transcriptase and protease inhibitors commonly prescribed as part of the "AIDS Cocktail" cause side effects including peripheral neuropathy, as well as nausea, and vomiting.  See, e.g., Physician's Desk Reference 889 (Didanosine), 895 (Stavudine) (54th ed. 2000).

11.       It is estimated that over 30% of patients with HIV/AIDS suffer from excruciating pain in the nerve endings (polyneuropathies), many in response to the antiretroviral therapies that constitute the first line of treatment for HIV/AIDS.  See, e.g., David M. Simpson et al., Selected Neurologic Manifestations of HIV Infection: Dementia and Peripheral Neuropathy, Improving the Management of HIV Disease, Dec. 1999; Nathalie Do Quang-Cantagtrel et al., Neurologic AIDS Research Consortium, Peripheral Neuropathy, available at http://www.neuro.wustl.edu/narc/peri-neuropathy.html (“Treatment of neuropathic pain . . . is notoriously difficult.  Even narcotics may not fully relieve [it].”).

12.       Unfortunately, there is no approved treatment for neuropathic pain that is satisfactory for a majority of patients. Opiod analgesics, the medications most commonly prescribed to treat neuropathy, are often ineffective at successfully treating the pain and are often intolerable to HIV/AIDS patients.  See, e.g., Nathalie Do Quang-Cantagtrel et al., Opioid Substitution to Improve the Effectiveness of Chronic Noncancer Pain Control: A Chart Review, 90 Anesthesia & Analgesia 933 (2000) (reporting opioid analgesics are effective for only 36% of patients, ineffective for 34%, and intolerable for 30% of patients).  As a result, some patients must reduce or discontinue their HIV/AIDS therapies because they can neither tolerate nor eliminate the debilitating side effects of the antiretroviral first-line medications.  To avoid this result, it is incumbent upon me to help alleviate these patients’ neuropathic pain, just as I must find try to find ways to alleviate the pain associated with nausea and wasting.  My failure to do so can have life threatening consequences for my patients.

13.       Fortunately, I am often able to relieve the patient’s acute suffering and, thereby, restore her quality of life to an acceptable level.  My first line of therapy for acute nausea involves the use of Compazine or Reglan.  Sometimes these traditional anti-emetics do not work, either because they fail to reduce the nausea and/or the patient does not tolerate them well.  The drugs themselves have side effects, and can cause impairments in a patient’s fine and gross motor skills.  As a result, patients sometimes move in a slow, stiffened manner.  Their faces may appear frozen.  And they can develop severe muscle contractions.  I also prescribe a newer drug called Ondansetron (Zofran) which was developed specifically for the treatment of chemotherapy-induced nausea.  The success of Ondansetron varies greatly among patients.  Benzodiazepines are an additional anti-emetic treatment available to me.

14.       If I am unable to relieve the patient’s nausea with the above remedies, I next prescribe Marinol, a synthetic version of THC, one of the main active compounds found in marijuana.  Marinol is also helpful in stimulating appetite in patients suffering from AIDS wasting, as are other drugs, Megace, anabolic steroids, and human growth hormone .

15.       If Marinol does not provide adequate relief from nausea, wasting and/or pain, I may suggest that the patient try a related remedy, marijuana.  I firmly believe that medical marijuana is medically appropriate as a drug of last resort for a small number of seriously ill patients.  Nearly thirty years of clinical experience persuade me of this fact.  The anecdotal evidence is overwhelming.  Almost every patient I have known to have tried marijuana to combat nausea and wasting achieved relief from their symptoms with it.  That success rate surpasses that for Compazine.  Many patients have also informed me that marijuana has helped them control their neuropathic pain, and it has done so without the nausea and cognitive changes caused by powerful opioid analgesics.  Accordingly, as with any other medication that I consider potentially beneficial to my patients, I have a duty to discuss the option of medical marijuana in detail when appropriate.  I consider a failure to do so to be medical malpractice. 

16.       For those patients for whom I believe marijuana is an appropriate remedy, I discuss the various ways in which marijuana can be ingested.  Smoking marijuana is the most direct, rapid, and accurate delivery of the drug.  But smoking has the drawback of putting particulate matter in the patient’s lungs.  This is of concern to me because studies show that HIV/AIDS patients who are heavy cigarette smokers shorten their life spans by about 2 years.  It is not unreasonable to surmise that heavy marijuana smoking could lead to similar results.  Nevertheless, inhalation – of which smoking is one means -- may be the most efficient way to deliver a number of drugs, from antihistamines or marijuana.  Indeed, GW pharmaceuticals of Great Britain is currently developing and testing an inhaler device for the delivery of marijuana to treat pain.  Although smoking marijuana may not be advisable over the long-term or for persons with compromised pulmonary systems, there are ways of reducing particulate matter contained in smoke, for example through the use of water pipes which tend to filter the smoke, and consumption of unadulterated marijuana.

17.       I inform my patients that they may try eating marijuana through a variety of baked goods.  But this, too, is not without difficulties similar to those experienced by many patients who try Marinol.  Eating marijuana (or ingesting a Marinol capsule) can cause unpredictable results because the absorption of the THC can either be rapid or delayed, depending on whether the patient ingests the marijuana on a full stomach.  The same is true for drinking marijuana tea.  Nevertheless, eating or drinking marijuana preparations is clearly the preferred route of ingestion for certain patients, particularly those who cannot tolerate smoking or whose lungs are severely compromised. Recently, marijuana is being prepared in gel capsules to be taken much like other oral medications.  Although this is a relatively new development, for some patients the capsules result in an extended half-life and thus a longer-acting medication.  Capsules, however, are often difficult if not impossible to ingest for patients suffering from acute, persistent nausea.

18.       In my experience, the unpleasant side effects that some patients experience from marijuana, regardless of how it is ingested, are far less severe than the side effects experienced from Compazine and Reglan and similar antiemetics, or opioid analgesics. Nor do I have to worry about harmful drug interactions with patients who use therapeutic doses of marijuana: to my knowledge, there are none.  If a patient presents with both nausea and anxiety, I can prescribe Compazine and Valium.  However, marijuana can effectively treat both conditions simultaneously.  It is not at all clear to me that the combination of Compazine and Valium, both of which are toxic (and the latter of which is addictive), is better than marijuana alone.  For that matter, benzodiazapines and barbiturates – medications also used to combat nausea – are more addictive, and far more susceptible to patient misuse than marijuana, particularly with respect to their ability to induce death due to overdose.

19.       As the above approach illustrates, I begin treating my AIDS patients by listening to their complaints and concerns.  For symptoms such as intractable nausea, wasting syndrome, and neuropathic pain, I first prescribe those medications that are legally available (and covered by the patient’s health insurance).  If these medications do not work, or prove intolerable, I then discuss the option of using medical marijuana, which appears near the bottom of my cascade of options. 

20.       While many physicians may discuss medical marijuana with their patients, it is more rare for physicians to document those conversations in the patients’ medical charts.  In my experience, this failure to record medical marijuana-related information in patient charts stems from the desire of physicians to protect their patients and themselves from possible legal recriminations.  As the majority of physicians in California know, in 1996 high ranking federal law enforcement officials threatened physicians with criminal prosecution and the loss of their prescription licenses if they recommended marijuana to patients.  Although those threats were subsequently enjoined by a federal court, the chill of the government’s threats persists.  Indeed, those threats have been the subject of discussion among my colleagues who provide care to AIDS patients in the greater Sacramento area.  As a general policy, a group of physicians who treat approximately 1,200 AIDS patients decided to speak with their seriously ill patients about the benefits and drawbacks of medical marijuana, but not to record this information to protect the patient from federal investigation or prosecution – actions which could cause them far greater harm than the use of the drug itself.  I suspect this practice – don’t chart, just tell – occurs throughout the state, and that the medical records of patients who use marijuana upon the advice and recommendation of their physician(s) often fail to reflect this fact or mention it in a very abbreviated fashion.  

21.       Physicians often consult with one another and discuss our various options of treatment and talk anecdotally about our patients’ therapies, including their use of marijuana.  We try to find the most effective, least toxic medications for our patients.  When faced with a choice of equivalency, we opt for the least toxic treatment.  When one medication is more toxic than another, but is also more effective, we discuss this fact with patients, and they pick the preferred course of action.  The practice of medicine is a constant process of adjustment.  When advising a patient, I do not simply have my next treatment plan in mind, I have my next three or four treatment plans in mind.  I develop a sequence of options, in case my next move doesn’t work.  “If this hasn’t worked in 2-3 days,” I tell the patient, “we’ll try something else.”

22.       In my nearly thirty years of clinical experience caring for the HIV/AIDS patients, many near to or at the end of life, I have found marijuana to be a valuable medication for the alleviation of intense suffering associated with nausea, wasting, and neuropathic pain.  Marijuana has helped patients overcome these potentially life threatening symptoms, and has done so safely and without the debilitating side effects induced by many mainline therapies.  I have seen marijuana restore patients’ will to live by restoring their ability to eat, gain strength, and perform simple, daily activities free from crippling nausea or pain.  There is no doubt in my mind that for some seriously ill patients, marijuana can help make the difference between life and death; and that for other terminally ill patients, marijuana can make the difference between exercising control over their final months and days and passing in relative peace and comfort, or dying in constant and severe agony (or incapacitated in a prolonged sedated haze, unaware of their surroundings). 

23.       Marijuana, in short, can help sick and dying persons achieve autonomy over their lives by alleviating the intense suffering caused by their illnesses or the side effects of their medications.  For some patients (for example those suffering from operable cancer), medical marijuana may allow them to continue their treatments and thus serve as a bridge to eventual cure; for others marijuana may help promote relative well-being and prolong a life free from intolerable pain; and for still other patients, marijuana may help them control the manner and timing of their deaths consistent with their values, beliefs and dignity.

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 ___________________, California, this ____ day of April, 2003.

 

 

_______________________

Neil M. Flynn, M.D.

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