In October 1998, Mr. McWilliams first learned that his T-cell count had dropped and his viral load had risen substantially. 

[Footnote 1: T-cells are primary immunity agents produced by the human body.  They generally attack and destroy infectious bacteria, viruses, molds and fungi.  The immune system also plays a critical role in preventing cancer.  The AIDS virus attacks and debilitates the immune system leaving the body open to opportunistic illness, including cancer.  The T-cell count is a standard means of measuring the progress of the AIDS virus in the body.  The viral load, a newer and more accurate assessment, measures the amount of live AIDS virus detected per milliliter of blood and is considered the most precise way to gauge the severity of the condition.]

Mr. McWilliams went in for subsequent testing in early November 1998. On November 20, 1998, Mr. McWilliams was notified by his doctor that his viral load had increased by a factor of more than five thousand since August 1998. AIDS doctors generally become concerned when the viral load exceeds 10,000 copies per milliliter of blood. Mr. McWilliams' viral load had climbed from "Not Detectable" (below 20 copies/ml) to 254,600 copies/ml.

On November 25, 1998, Mr. McWilliams filed an emergency motion for review of the order setting his conditions of release before United States Magistrate Judge Wistrich. The parties argued the motion on December 1, 1998, and December 3, 1998. On December 7, 1998, the Magistrate Judge issued an order denying Mr. McWilliams' request.

Mr. McWilliams applied for review in the U.S. District Court. After briefing and oral argument the court denied Mr. McWilliams’ application to modify in a written order dated March 4, 1999 that instructed Mr. McWilliams to attempt to identify a legal alternative and encouraged Mr. McWilliams and the government to work together to develop an "appropriate accommodation."

Two weeks after the district court’s ruling, the National Academy of Science Institute of Medicine issued its report, Marijuana and Medicine: Assessing the Science Base (the "IOM Report").

Prior to petitioning the magistrate, Mr. McWilliams and his physicians had already exhausted the legally available anti-nausea medications without result, nothing changed with the district court’s order. On August 30, 1999, after months of dialog, the government informed counsel for Mr. McWilliams that an agreement regarding his use of medical marijuana was impossible.

On September 15, 1999, Mr. McWilliams again petitioned the district court based on the changed circumstances presented by the IOM Report, the failure to negotiate an "appropriate accommodation" with the government and his continued failing health. The court denied his application without hearing on September 22, 1999.

This appeal is brought pursuant to 18 U.S.C § 3145 and Rule 9(a) of the Federal Rules of Appellate Procedure.

In March, 1996, best-selling author and publisher Peter McWilliams was diagnosed with both the Acquired Immuno-Deficiency Syndrome ("AIDS") and AIDS-related Non-Hodgkin’s Lymphoma, the second most common form of AIDS-related cancer. At that time, Mr. McWilliams’ viral load—the measurement of copies of live virus per milliliter of blood—was 12,500 copies/ml. AIDS doctors typically become concerned when the viral load exceeds 10,000. Upon the advice of a specialist in the field of AIDS treatment, an oncologist and a radiation oncologist, Mr. McWilliams embarked on an intensive treatment regimen that included chemotherapy and radiation for the cancer and the newly approved pharmaceutical AIDS treatment known as "combination therapy." Combination therapy entails a mixture of chemically-derived protease inhibitors and anti-viral medications and is designed to prevent the spread of the AIDS virus. Combination therapy does not cure AIDS, in that it does not remove the virus from the body. However, combination therapy does represent a breakthrough in AIDS treatment as it is able to prevent the production of additional copies of the AIDS virus and eliminates a large number of the copies already present.

The combination therapy was able control the spread of AIDS in Mr. McWilliams’ body, so that his viral load was, for the most part, "undetectable" (a medical term of art indicating less than 20 copies/ml) from April 1996 until August 1998. Likewise chemotherapy and radiation treatments sent his cancer into complete remission. The chemotherapy and radiation treatment ended in October 1996. The AIDS combination therapy continues to this day.

Mr. McWilliams’ survival through this time period depended on his ability to use the chemotherapy, radiation and combination therapy medications. However, his use of those medications would have been unsuccessful but not for his discovery of the pallative effects of medical marijuana.

When Mr. McWilliams first began to take his chemotherapy and combination therapy medications, he experienced violent nausea from the moment the chemicals reached his stomach. His body rejected the medications before they could be absorbed, thus preventing Mr. McWilliams from benefiting from their life-saving action in his body. Mr. McWilliams’ physicians prescribed and, he dutifully took, every state-of-the-art anti-nausea medication available by prescription to help retain his chemotherapy and combination therapy medication. None of the prescription antiemetics were able to prevent him from vomiting his chemical therapies. Although he had not taken illegal drugs in over two decades (Mr. McWilliams considers even caffeine to be too harsh a drug for his compromised immune system), after consultation with his physicians, and his own personal research, Mr. McWilliams tried smoking medical marijuana to control the nausea that was preventing his pharmaceutical therapy regimen from being retained in his body long enough for him to absorb it.

As discussed above, Mr. McWilliams successfully lived with his AIDS for two years as "little more than an inconvenience," due to his use of "cutting-edge modern medical science and one ancient herb." Mr. McWilliams’ conduct and alleged conduct related to his attempt to share his experience with other patients forms the substance of the First Superceding Indictment ("the Indictment") underlying this action.

After he was arrested pursuant to the Indictment in July 1998, Mr. McWilliams spent four weeks in confinement at the Metropolitan Detention Center in Los Angeles while his mother and brother attempted to raise the $250,000 bail. He was released on bond on August 19, 1998 subject to certain conditions of release. During his time in jail, Mr. McWilliams did not receive his combination therapy for the first nine days. Once treatment began again, he was not given an anit-nausea medication that effectively controlled the violent nausea that returned when the combination therapy resumed. Upon his release from jail, Mr. McWilliams immediately reported to his physician for an examination.

Results of his blood test in August 1998, determined that the AIDS virus was again multiplying and that it had reached 400 copies/ml. Due to the discretionary condition of release "No marijuana use" imposed on Mr. McWilliams, he and his physician renewed their efforts in an attempt to find an effective anti-nausea medication. Again, all attempts failed. Mr. McWilliams was unable to retain his combination therapy medication. His doctor explains, "Since Mr. McWilliams stopped using marijuana at the end of last August, his nausea has been uncontrolled . . . increased dosages of Marinol ® and numerous other anti-nausea prescriptions . . . have failed to stop the vomiting." McWilliams’ App. for Modification of Conditions of Release Exhibit B: Letter from Dr. Daniel Bowers, M.D.

Unable to use medical marijuana as a pallative to moderate the uncontrollable vomiting attendant to his combination therapy, Mr. McWilliams could no longer check the multiplication of the AIDS virus in his body. As the viral load increases, the body’s immune system becomes correspondingly weaker. The risk of fatal opportunistic illness, such as pneumocystis pneumonia or cancer, presents itself when the viral load exceeds 10,000 copies/ml. As previously stated, when Mr. McWilliams’ viral load reached 12,500 in March 1996, he had already developed AIDS-related Non-Hodgkin’s Lymphoma. In October 1998, Mr. McWilliams’ physician discovered that due to his inability to retain and absorb his combination therapy, his viral load had increased almost tenfold to 3,789 copies/ml. By November 1998, Mr. McWilliams’ viral load had skyrocketed by a magnitude of sixty, reaching 254,000 copies/ml.

Since the first hearing before the magistrate in December 1998, Mr. McWilliams’ has been unable to retain more than one out of every three doses of combination therapy that he swallows. This partial retention is due to massive doses of synthetic THC, available in prescriptive form as Marinol,® but does not begin to approach the near-perfect retention that Mr. McWilliams was able to achieve with the use of smoked medical marijuana for the two years prior to his arrest. The result is that he is still not receiving the benefits of the combination therapy, as such treatment requires the retention of five doses per day. In the subsequent months, Mr. McWilliams’ health has deteriorated dramatically. Presently, he sleeps eighteen to twenty hours per day, he is unable to do any productive writing or publishing and is facing both personal and professional bankruptcy. He is sometimes not even able to participate in the preparation of his defense, due to his illness. Mr. McWilliams never leaves the house except for medical and court appointments. He is confined to a wheel chair if he must travel distances greater than half a block and he suffers from severe depression and extreme anxiety over his worsening condition.

For five months, counsel for Mr. McWilliams negotiated with the government in an attempt to reach "some appropriate accommodation," as suggested by the district court. On August 30, 1999, the government closed the door on any negotiated accommodation. Necessitating further court action if Mr. McWilliams is to survive until trial.

On September 15, 1999, Mr. McWilliams presented these new circumstances and this additional evidence before the District Court and requested an order from the court removing the discretionary condition of release, "No Marijuana Usage," and that it further direct that his use of smoked marijuana, in the privacy of his home, to keep down his nausea producing pharmaceutical AIDS medication and his personal possession of up to one ounce of marijuana in his home not be grounds for revocation of his release or forfeiture of his bond when such use and possession is pursuant to his doctor’s orders. That request was denied and is the subject of this appeal.

In United States v. Oakland Cannabis Buyers’ Cooperative, _ F.3d _ , 1999 WL 705099 (9th Cir. 1999), decided only weeks ago, a unanimous panel of this court considered the arguments of the Oakland Cannabis Buyers’ Cooperative (OCBC), a large-scale medical marijuana manufacturing, purchasing and distribution enterprise that caters to:

a class of people with serious medical conditions for whom the use of cannabis is necessary in order to treat or alleviate those conditions or their symptoms; who will suffer serious harm if they are denied cannabis; and for whom there is no legal alternative to cannabis for the effective treatment of their medical conditions because they have tried other alternatives and have found that they are ineffective, or that they result in intolerable side effects.

Id. at *6. This court found, in overturning the district court’s injunction, that the district court had ignored "a legally cognizable defense that likely would pertain in the circumstances." Id. at *4. In that case, the government sought unusual relief in the form of an injunction to close the OCBC. Had the government "proceeded in the usual way, by arresting and prosecuting those it believed had committed a crime . . . . [T]he defendants would have been able to litigate their necessity defense under Aguilar in due course." Id. at *4. This court remanded the case back to the district court under orders to,

[R]econsider the appellants’ request for a modification that would exempt from the injunction distribution to seriously ill individuals who need cannabis for medical purposes. In particular, the district court is instructed to consider in light of our decision in United States v. Aguilar, the criteria for a medical necessity exemption, and, should it modify the injunction, to set forth those criteria in the modification order.

Id. at *6 (internal citations omitted).

Given this court’s recognition of the aforementioned class of persons, Mr. McWilliams submits that he is a member of the class of persons described, though not a member of the OCBC. Mr. McWilliams needs medical marijuana to control the nausea that accompanies the life-saving pharmaceutical treatment regimen for his AIDS. He simply cannot effectively control his vomiting with any other medication. Unable to quiet his stomach, he cannot keep the combination therapy dose down long enough to allow his body to assimilate the life-saving medication contained therein. In the fifteen months since his arrest and release on conditions so onerous 

[Footnote 3:  If Mr. McWilliams is found to have violated a condition of his release he faces incarceration in a highly contagious federal facility until trial and his elderly, disabled mother and his brother will each have their homes forfeited.]

that he dare not use medical marijuana despite his lack of alternatives, Mr. McWilliams has gone from a relatively healthy, fully-functioning member of society with a productive publishing company and a viral load that was below detectable levels (less than 20 copies of AIDS virus/ml of blood), to a wheelchair-bound patient, unable to work, who sleeps up to twenty hours per day and rarely leaves the house.

After only four months of not having access to medical marijuana, Mr. McWilliams’ viral load rose to over 250,000 copies of virus/ml of blood. When the viral load exceeds 10,000 copies/ml the risk of opportunistic infection is pronounced. When Mr. McWilliams’ viral load was 12,000 copies/ml in March 1996, he had already developed the AIDS-related cancer known as Non-Hodgkin's Lymphoma. Without medical marijuana, Mr. McWilliams cannot retain and assimilate his pharmaceutical AIDS medication and without that medication he will die. This fact has not been disputed in the lower court. Mr. McWilliams and his physician have submitted uncontested evidence that Mr. McWilliams will suffer serious harm if he is denied cannabis and that there is no legal alternative to cannabis for the effective treatment of his medical condition. Mr. McWilliams has tried a panalopy of available alternatives and has found them all ineffective. Only medical marijuana works where the pharmaceutical remedies have failed.

In OCBC, this court took great pains to protect "the strong public interest in the availability of a doctor-prescribed treatment that would help . . . relieve the pain and suffering of a large group of persons with serious or fatal illnesses." Id. at *4. Mr. McWilliams is a member of this identified group and as such, urges this court to order that he be exempt from the conditions of his release that prevent his use of medical marijuana as a matter of medical necessity.

This court, in United States v. Aguilar, outlined four factors to invoke the necessity defense: 1) the defendant was faced with a choice of evils and chose the lesser evil, 2) the defendant acted to prevent imminent harm, 3) the defendant reasonably anticipated a direct causal relationship between his conduct and the harm to be averted, and 4) the defendant had no legal alternative to violating the law. United States v. Aguilar, 883 F.2d 662, 693 (9th Cir. 1989), see also United States v. Dorrell, 758 F.2d 427, 430 (9th Cir. 1985), United States v. Contento-Pachon, 723 F.2d 691 (9th Cir. 1984). The medical necessity defense is a subset of the defense of necessity and has been considered as a defense in both state and federal cases involving medical marijuana. See United States v. Cannabis Cultivators’ Club, 5 F.Supp.2d 1086 (N.D. Cal 1998), United States v. Burton, 894 F.2d 188 (6th Cir. 1990), United States v. Randall, 104 Daily Wash. L. Rep. 2249 (Sup. Ct. D.C. 1976), People v. Trippet, 56 Cal.App.4th 1532 (1997), Jenks v. Florida, 582 So.2d 676, 678 (Fla. App. 1 Dist. 1991), State v. Hastings, 801 P.2d 563 (Idaho 1990), Florida v. Mussika, 14 F.L.W. 1 (Fla. 17th Cir. Ct, 1988), State v. Bachman, 595 P.2d 287, 288 (Hawaii 1979), State v. Diana, 604 P.2d 1312 (Wash.App. 1979); see also Robin Isenberg, "Medical Necessity as a Defense to Criminal Liability: United States v. Randall, Geo. Wash. L.Rev. Vol. 46, No. 2, p 273 (1978). Under the Aguilar test, Mr. McWilliams’s meets all the factors sufficient to establish the defense of necessity at trial, which he intends to do. However, the conditions of Mr. McWilliams’ release that prevent him from using medical marijuana have placed him in such a dire physical condition that he may not survive to offer his defense at trial.

Mr. McWilliams has pursued other legal remedies to solve his current dilemma. He is a named plaintiff in a pending class action lawsuit against the federal government by patients seeking access to medical marijuana. See Kuromiya v. United States, 1999 WL 130613 (E.D.Pa.). In addition, Mr. McWilliams has submitted a petition to reschedule marijuana to DEA. That petition was rejected by Donnie Marshall, DEA Acting Administrator, after he determined that it was substantially identical to the petition of Jon Gettman that has been awaiting DEA action since 1995.

The very act of waiting for federal action threatens the life and severely impacts the health of Mr. McWilliams. He is disconcerted by the rescheduling odyssey experienced by the National Organization for the Reform of Marijuana Laws ("NORML"). In 1972 NORML filed a petition to reschedule marijuana. It did not receive a final ruling from DEA until 1992, and a final decision on appeal until 1994, a total of 22 years. Alliance for Cannabis Therapeutics v. DEA 15 F.3d 1131 (D.C. Cir. 1994). Further, the petitioners had to go to the U.S. Court of Appeals for the District of Columbia Circuit on four occasions to compel the DEA to take the appropriate action mandated by the Controlled Substances Act ("CSA"). See, National Org. for the Reform of Marijuana Laws v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974); National Org. for the Reform of Marijuana Laws v. Drug Enforcement Admin., 559 F.2d 735 (D.C. Cir. 1977); National Org. for the Reform of Marijuana Laws v. Drug Enforcement Admin. & Dep’t of Health Education & Welfare, No. 79-1660 (D.C. Cir. Oct. 16, 1980); and Alliance for Cannabis Therapeutics v. Drug Enforcement Admin., 930 F.2d 936 (D.C. Cir. 1991). U.S. District Court Judge Breyer noted in May 1998, while passing on this issue that,

The Court doubts whether a rescheduling petition is a reasonable alternative for all seriously ill patients whose physicians have recommended marijuana for therapeutic purposes . . . . Needless to say, it hardly seems reasonable to require an AIDS, glaucoma, or cancer patient to wait twenty years if the patent requires marijuana to alleviate a current medical problem.

5 F. Supp.2d 1086, 1104 (N.D. Cal 1998).

For two years Mr. McWilliams was able to retain his pharmaceutical AIDS medication as a direct result of medical marijuana’s anti-nausea properties. He has always been a law-abiding person and only sought to violate the letter of the federal statutory law when his very survival depended on it. As detailed above, Mr. McWilliams is not presented with any legal alternative. While he is confident that he will be vindicated at trial, he is deeply concerned that he may not survive that long and implores this court to allow him to resume the only means of therapeutic relief available to prolong his life. Mr. McWilliams must he be exempted from the conditions of his release that prevent his use of medical marijuana. His very life depends on it.

Mr. McWilliams expects the government to argue that Mr. McWilliams is in an inferior position to Congress when it comes to determining the appropriate scheduling of controlled substances. Further the government is also likely to argue that Mr. McWilliams had alternatives to breaking federal statutory law, such as petitioning the DEA or Congress for a reclassification of marijuana. In addition to the arguments presented above, Congress has failed to remove marijuana from Schedule I for a simple yet disturbing reason—those federal agencies specifically bound by law to update Congress regarding medical and scientific advances about controlled substances listed in the various schedules have repeatedly failed to do so with regards to marijuana.

As detailed in Section III, Congress only tentatively listed marijuana in Schedule I of the CSA, pending the development of further information and knowledge about its physiological, pharmacological, psychological and societal effects. Congress delegated to the Attorney General, the duty to add, remove or transfer substances among the five schedules of the CSA. 21 U.S.C. § 811(a). The Attorney General in turn delegated that responsibility to DEA pursuant to 21 U.S.C. § 871(a). In the twenty-nine years since marijuana was first listed in Schedule I of the CSA, the understanding of the plant has increased dramatically.

The IOM Report, detailed below, is only the latest installment in a series of government studies providing evidence that marijuana is improperly listed in Schedule I of the CSA. See National Research Council, An Analysis of Marijuana Policy, Washington, D.C.: National Academy Press (1982) ("1982 IOM Report") ("Over the past 40 years, marijuana has been accused of causing an array of anti-social effects including . . . provoking crime and violence, . . . leading to heroin addition, . . . and destroying the American work ethic in young people. [These] beliefs . . . have not been substantiated by scientific evidence."); Marijuana: A Signal of Misunderstanding; First Report of the National Commission on Marijuana and Drug Abuse, 145-146 (1972) ("Shafer Commission Report") ("There is little proven danger of physical or psychological harm from the experimental or intermittent use of natural preparations of cannabis . . . . Existing social and legal policy is out of proportion to the individual and social harm engendered by the drug."); Mayor’s Committee on Marihuana, The Marihuana Problem in the City of New York: Sociological, Medical, Psychological, and Pharmacological Studies, Lancaster, PA: Jacques Cattel Press (1944) ("LaGuardia Commission Report") ("There [is] no direct relationship between the commission of crimes of violence and marihuana . . . and marihuana itself has no specific stimulant effect in regard to sexual desires. The use of marihuana does not lead to morphine or cocaine or heroin addiction."); Canal Zone Committee, The Panama Canal Zone Military Investigations, (1925) ("Canal Zone Report") ("The influence of [marihuana] . . . has apparently been greatly exaggerated . . . . There is no evidence . . . that it has any appreciably deleterious influence on the individual using it."). Still, Congress and DEA have failed to take action to adjust the federal law to keep pace with changing information and understanding. This failure to act has led to the present situation confronting Mr. McWilliams—if he obeys the federal statutory law, as written, he dies. If he acts to preserve his life and health with the only effective remedy available, he risks the forfeiture of his elderly disabled mother’s home, the forfeiture of his brother’s home where he currently resides and his pretrial incarceration in a facility with a high risk of infection to his already compromised immune system. Mr. McWilliams is being deprived of his most fundamental right, the right to life, because the law has failed to respond to "evidence-based medicine" and "rigorous scientific analysis." McCaffrey Testimony (June 16, 1999), supra.

The restoration and preservation of Mr. McWilliams's rights guaranteed by the U.S. Constitution requires judicial intervention. This court offers its own guidance as to the appropriate balance of power in the federal system. "Though the reviewing court should not ignore the conclusions of Congress about issues of constitutional law, it is the ultimate responsibility of the courts to decide whether Congress has violated the Constitution." Information Providers Coalition for Defense of the First Amendment v. Federal Communications Commission, 928 F.2d 866, 869 (9th Cir. 1996).

Mr. McWilliams is confident that Congress would have amended the federal statutory scheme regarding marijuana had it been provided with accurate, objective, scientific and medical evidence. Unfortunately, the facts about marijuana are all too often obscured amidst an atmosphere of drug war rhetoric. The misinformation campaign before Congress began with the very first federal law regarding marijuana.

Urging Congress to pass the Marijuana Tax Act of 1937, Federal Bureau of Narcotics Commissioner Harry Anslinger read various letters and press clippings into the record among them a letter from a Colorado newspaper editor stating that,

I wish I could show you what a small marijuana cigaret (sic) can do to one of our degenerate Spanish-speaking residents. That’s why our problem is so great; the greatest percentage of our population is composed of Spanish speaking persons, most of whom are low mentally, because of . . . racial conditions.

Hearings on H.R. 6385 Before the House Comm. on Ways and Means, 75th Cong., 1st Sess. 32 (1937). Anslinger continued,

We find then that Colorado reports that the Mexican population there cultivates on an average of 2 to 3 tons of the weed annually. This the Mexicans make into cigarettes, which they sell at two for 25 cents, mostly to white school students.

Id. at 32-33. Explaining further that,

There are 100,000 total marijuana smokers in the U.S., and most are Negroes, Hispanics, Filipinos and entertainers. Their Satanic music, jazz and swing, result from marijuana usage. This marijuana causes white women to seek sexual relations with Negroes, entertainers and any others.

Id.. See Richard J. Bonnie and Charles Whitebread II, "The Forbidden Fruit and the Tree of Knowledge: An Inquiry into the Legal History of American Marijuana Prohibition," Virginia Law Review Vol. 56, No. 6 (Oct. 1970); John C. McWilliams, The Protectors: Harry J. Anslinger and the Federal Bureau of Narcotics, 1930-1962, Newark: University of Deleware Press, 1990. The American Medical Association ("AMA") sent its legislative counsel, Dr. William Woodward to oppose the Marihuana Tax Act, at hearings before the Congressional committee that considered the issue. Woodward opposed the bill for a number of reasons, noting particularly that the bill was not grounded in objective medical fact and that, "In the first place, it is not a medical addiction that is involved." Testimony of William C. Woodward, Taxation of Marihuana, U.S. House of Representatives, Comm. on Ways and Means, Hearings, May 4, 1937. Dr. Woodwards’ testimony was received by the hostile chairman of the committee who angrily dismissed him saying,

If you want to advise us on legislation, you ought to come here with some constructive proposals, rather than criticism, rather than trying to throw obstacles in the way of something that the Federal Government is trying to do.

Id. When the bill came to the floor of the House, there was only ninety seconds of debate. The only question raised was whether the AMA had issued an opinion. Rep. Vinson answered on behalf of the Ways and Means Committee, "Yes, their Dr. Wentworth (sic) came down here. They support this bill 100 percent." Whitebread, "The Forbidden Fruit and the Tree of Knowledge," supra. It is upon this type of misrepresentation before Congress that all future misinformation is based.

The arguments for marijuana prohibition have changed little since the 1930s. On April 1, 1999, Mr. McWilliams wrote a letter to ONDCP Director Gen. (Ret.) Barry McCaffrey pointing out several statements made to Congress by McCaffrey that were pointedly contradicted and proved erroneous by the IOM Report. Exhibit A: Letter from Peter McWilliams to Gen. Barry McCaffrey, dated April 1, 1999. He asked Gen. McCaffrey to correct these statements so that Congress could remove marijuana from Schedule I—where it clearly no longer belongs. Gen. McCaffrey ignored Mr. McWilliams request. Indeed, at his next major appearance before Congress he again failed to inform it of the complete findings in the IOM Report. During the June 16, 1999 hearing before the House Government Reform and Oversight Committee Subcommittee on Criminal Justice, Drug Policy and Human Resources Gen. McCaffrey characterized the IOM Report in his written 28-page report as follows,

[T]he most comprehensive summary and analysis of what is known about the medical use of marijuana. The report emphasizes evidence-based medicine (derived from knowledge and experience informed by rigorous scientific analysis), as opposed to belief-based medicine (derived from judgment, intuition, and beliefs untested by rigorous science). ONDCP is delighted that the discussion of medical efficacy and safety of cannabinoids can now take place within the context of science.

The IOM report concludes that there is little future in smoked marijuana as a medically approved medication. Although marijuana smoke delivers THC and other cannabinoids to the body, it also delivers harmful substances, including most of those found in tobacco smoke. The long-term harms from smoking make it a poor drug delivery system, particularly for patients with chronic diseases. In addition, cannabis plants contain a variable mixture of biologically active compounds, therefore they cannot be expected to provide a precisely defined drug effect. Medicines today are expected to be of known composition and quality. Even in cases where marijuana can provide relief of symptoms, the crude plant mixture does not meet this modern expectation. If there is any future in cannabinoid drugs, it lies with agents of more certain, not less certain composition. The future of medical marijuana lies on classical pharmacological drug development.

The study also provides a detailed analysis of marijuana’s addictiveness. It concludes that marijuana is indisputably reinforcing for many people. It states that a distinctive marijuana and THC withdrawal syndrome has been identified, but it is mild and subtle compared to the profound physical syndrome of heroin withdrawal. The study notes that few marijuana users become dependent but those who do encounter problems similar to those associated with dependence on other drugs. Slightly more than four percent of the general population were dependent on marijuana at one time in their life. After alcohol and nicotine, marijuana was the substance most frequently associated with a diagnosis of substance dependence.

"The Drug Legalization Movement in America," Testimony of Barry R. McCaffrey, Director, Office of National Drug Control Policy, Before the House Government Reform and Oversight Comm. Subcomm. on Criminal Justice, Drug Policy and Human Resources, June 16, 1999. This represents every bit of information that Gen. (Ret.) McCaffrey has provided Congress regarding the 260-page report on the results of the IOM’s eighteen-month study since its release in March 1999. While he acknowledges that marijuana is less addictive than heroin, a Schedule I drug, Gen. McCaffrey failed to inform Congress that the IOM Report also found marijuana less addictive than Valium® a drug listed in Schedule IV of the CSA and less addictive than nicotine, a completely unscheduled drug. More significantly, Gen. McCaffrey completely failed to mention the points from the IOM Report detailed below that would lead Congress to the inevitable conclusion that marijuana is improperly listed in Schedule I of the CSA, specifically that marijuana does not have a high potential for abuse, that it has a currently accepted medical use in treatment and that it may be used within an acceptable safety range under medical supervision. 

[Footnote 4:  The IOM Report concludes in its Executive Summary: a) that marijuana is medicine, b) marijuana is not a gateway drug, c) there is currently no alternative to smoked marijuana for some patients, d) patients who need medical marijuana should be able to obtain approval within 24 hours, e) if marijuana is addictive at all it is only mildly so and any withdrawal symptoms are minimal, and f) there is no reason to believe that medical marijuana will increase recreational marijuana use.  IOM Report, ES.4 - ES.9. see infra.]

As Gen. McCaffrey’s testimony was given under oath, Congress reasonably expected to be provided with the truth, the whole truth and nothing but the truth.

Faced with such misinformation regarding marijuana Congress has been, and continues to be led to legislate based on inaccurate or missing data. In October 1998, six months before release of the IOM Report that was supposed to answer the question of marijuana’s effectiveness as medicine, Congress declared in a Sense of Congress resolution that marijuana has no redeeming medicinal value. Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999, Pub. L. No. 105-277, 112 Stat. 2681 (October 21, 1998). Such a conclusion simply cannot stand in the face of objective, empirical, scientific and medical evidence. However the polarity regarding reclassification of marijuana under the federal drug control scheme continues to distort the facts. During the same June 16, 1999, hearing entitled, "The Pros and Cons of Drug Legalization, Decriminalization and Harm Reduction" 

[Footnote 5: Rep. Mark Souder took exception to the very concept of a hearing on the pros and cons of legalization saying, “We don’t hold hearings on the pros and cons of rape, or the pros and cons of child abuse, or the pros and cons of racism.  The advocates of legalization are responsible for blood in my community, and they are as responsible for this as rapists.”]

before the House of Representative Committee on Government Reform’s Subcommittee on Criminal Justice, Representative Barr asked Donnie Marshall, Acting Administrator of the DEA, whether Marshall saw any real difference between someone advocating drug legalization and someone advocating pedophilia. Marshall said that he saw "no real difference." Christopher Wren, "Opposing Camps Square Off at Congressional Hearing about Drug Legalization," New York Times June 20, 1999. Regrettably, this is the same federal official tasked with the ultimate responsibility of evaluating requests to reschedule marijuana and the person who summarily rejected Mr. McWillliams’ Petition for Rulemaking.

Since 1984, the Secretary of Health and Human Services (the "Secretary") has been required by law to submit a report to Congress every three years, "describing current research findings made with respect to drug abuse, including current findings on the health effects of marihuana." 42 U.S.C. § 290aa-4. The first report was filed in 1984. The second, covering research from 1983 to 1986, was submitted in 1987 and the third, summarizing research from 1986 to 1989, was filed in 1991. The Secretary has not filed a report since 1991. This is particularly significant for two reasons.

First, beginning in 1990, several important discoveries and research developments led to a greatly enhanced understanding of the physiological mechanism of cannabinoids in the brain. A THC receptor has been identified in the body. The receptor is only stimulated by THC or an analogous chemical known as Anandamine that is naturally produced by the body to modulate pain, regulate immune system functioning, enhance balance and a variety of other functions that are still being studied. This indicates the natural manner in which THC produces its healing effects in the body. See Herkenham, M et. als., "Cannabinoid receptor localization in the brain," Proceedings of the National Academy of Sciences of the United States of America, 87: 1932-1936 (1990); Devane, WA et. als., "Isolation and structure of a brain constituent that binds to the cannabinoid receptor," Science 258: 1946-1949 (1992). These discoveries and developments have answered many of the perennial questions regarding the physiological and pharmacological effects of medical marijuana. The results of this research alone, if reported to Congress, are significant enough to warrant an adjustment in marijuana’s classification under the CSA.

However, these important discoveries become more pronounced in light of the relevant recent history. Since marijuana was first targeted by federal legislation, lawmakers have inquired about the way it effects the body and the mechanisms that produce the observable results. These questions left unanswered led DEA Administrator Jack Lawn to overturn the rescheduling recommendation of DEA Administrative Law Judge Francis Young—who after conducting lengthy hearings found that, "In strict medical terms marijuana is far safer than many foods we commonly consume." In the Matter of Marijuana Rescheduling Petition, Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge, U.S. DEA Docket No. 86-22 at 58 (Sept. 6, 1988). In recommending that marijuana be removed from Schedule I, ALJ Young found that, "Marijuana, in its natural form, is one of the safest therapeutically active substances known to man." Id. at 58-59. He concluded that,

The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence in this record.

Id. at 68. Administrator Lawn rejected ALJ Young’s recommendation that marijuana be rescheduled because, "the chemistry, toxicology, and pharmacology of marijuana is not established." 54 Fed. Reg. 53,767, 53,783 (1989). Lawn’s decision was upheld in A.C.T. v. DEA, 930 F.2d 936 (D.C. Cir. 1991). These questions raised by Administrator Lawn have now all been answered by detailed research—in favor of marijuana’s medical effectiveness, mild addictive potential, and relative safety for use under medical supervision—yet the Secretary has failed to provide Congress with this significant and relevant information in direct violation of her statutorily mandated duty.

Unlike the above mentioned litigation that revolved around a petition to reschedule marijuana first filed in 1972, Mr. McWilliams maintains that had ONDCP, DEA and HHS complied with their statutorily mandated duties and had provided accurate objective information, Congress would have concluded that marijuana is improperly listed in Schedule I of the CSA. Indeed the IOM Report is only a comprehensive summary of relevant scientific and medical evidence that should have been made available to Congress by these agencies years ago. It is the responsibility of the appropriate agencies, in this case ONDCP, DEA and HHS, and not patients like Mr. McWilliams, to keep pace with changes in the law and circumstances. This act of waiting for administrative action is a life-threatening experience for Mr. McWilliams and absolutely unnecessary given the longstanding scientific knowledge about the health and medical effects of marijuana and the current state laws.

Mr. McWilliams has little doubt that were Congress routinely provided with accurate, objective, scientific and medical information regarding the medical properties of marijuana, it would have acted to remove marijuana from Schedule I some time ago. However, the current politicized climate of rhetoric, misinformation and failed responsibility that has stymied any credible evaluation of marijuana’s therapeutic potential by Congress is rapidly hastening the death of Mr. McWilliams and doubtless thousands of others.

While Mr. McWilliams could provide this court with mountains of evidence regarding marijuana’s medical effectiveness. However he need only refer to one comprehensive document the—IOM Report—to conclusively prove that had Congress been giving accurate information concerning the scientific understanding of marijuana, it would no longer be listed in Schedule I of the CSA. This court, which was fortunately provided with more information that Congress, has already ruled as much.

This court’s ruling in OCBC, discussed above, recognizes that marijuana has an actual accepted medical use and that it is needed by a class of persons with serious or fatal illnesses. OCBC, supra. Still, marijuana is listed in Schedule I of the CSA. 21 U.S.C. § 812 (c). "Schedule I drugs are subject to the most severe controls . . . they are deemed to be the most dangerous substances, possessing no redeeming value as medicines." Alliance for Cannabis Therapeutics v. Drug Enforcement Administration, 930 F.2d 936 (D.C. Cir. 1991). Three findings are required to list a drug or substance in Schedule I of the CSA. "[A] drug or substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance." 21 U.S.C. § 812(b). The findings required to list a substance in Schedule I are:

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has no currently accepted medical use in treatment in the United States.

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Id. at § 812(b)(1). Unless all three pillars are present, a substance cannot legally be listed in Schedule I of the CSA. In the case of marijuana, none of the three requirements is met.

The legislative history surrounding passage of the CSA suggests that Congress did not consider the medicinal utility of cannabis in drafting that act in 1970. Congress was advised by Roger Egeberg, the Assistant Secretary for Health and Scientific Affairs, that, "Some question has been raised whether the use of [marijuana] produces ‘severe psychological or physical dependence’ as required by a schedule I or even a schedule II criterion." U.S. Code Cong. & Admin. News (1970) 4630. Egeberg recommended that, "Since there is still a considerable void in our knowledge of the plant and effects of the active drug contained in it, our recommendation is that marijuana be retained within schedule I at least until the completion of certain studies now underway." Id.

[Footnote 7: The results of this eighteen-month study, known as the Shafer Commission—named for Raymond Shafer, the former Republican Governor of Pennsylvania who was hand-picked by President Nixon to chair the commission—concluded that marijuana was unjustly demonized because it symbolized the “counterculture” not because it had any harmful physiological effects.  It found that existing social and legal policy is out of proportion to the individual and social harm engendered by marijuana.  The Commission unanimously concluded that marijuana use is not so grave a problem that individuals who smoke marijuana or possess it for that purpose, should be subject to criminal procedures.  Marijuana:  A Signal of Misunderstanding; First Report of the National Commission on Marijuana and Drug Abuse, 145-146 (1972).]

The recent release of the National Academy of Science IOM Report, as well as the legislative action in California and in five other states in the Ninth Circuit, combined with this court’s ruling in OCBC based on empirical medical and scientific evidence conclusively demonstrates that whatever the reasonableness of the tentative determination made by Congress in 1970 to list marijuana in Schedule I, the requisite findings no longer accurately describe marijuana.

In the wake of the passage of Proposition 215 in California and Proposition 200 in Arizona, Office of National Drug Control Policy Director Gen. (Ret.) Barry McCaffrey commissioned the National Academy of Science Institute of Medicine to study the medical effectiveness of marijuana. 

[Footnote 8: The need for the IOM Report was made more pronounced by the failure of the Secretary of Health and Human Services to provide any of the statutorily-mandated triennial reports “describing current . . . findings on the health effects of marijuana” since 1991.  42 U.S.C. § 506(b).  See discussion infra.]

The eighteen-month study culminated in the release of the IOM Report in March 1999. During a recent Congressional hearing, Gen. (Ret.) McCaffrey praised the IOM Report as quoted above.

The IOM’s thorough treatment of the medical evidence led to conclusions in the IOM Report demonstrating that marijuana is improperly listed in Schedule I of the CSA based on the failure of all three listing criteria. The IOM Report discounts the actual abuse potential presented by marijuana.

The IOM Report found that, "Although few marijuana users develop dependence, some do. . . . A distinctive marijuana withdrawal syndrome has been identified, but it is mild and short-lived." IOM Report at ES.7. This withdrawal syndrome "is observed under a narrower range of conditions than with benzodiazepines, opiates, cocaine or nicotine" and the symptoms "appear to be mild compared to opiates or benzodiazepines, such as diazepam (Valium®)." Id. at ES.3. That is, marijuana is mildly addictive in some persons, but the dependence and withdrawal is less severe than that observed for the opiates, Valium® or even nicotine.

The IOM Report also laid to rest any concerns that marijuana is a "gateway" drug, leading users on to harder drugs such as heroin or cocaine. "There is no conclusive evidence that the drug effects of marijuana are causally linked to the subsequent abuse of other illicit drugs." Id. at ES.7. Not surprisingly, the IOM Report found that, "In fact, most drug users begin with alcohol and nicotine before marijuana—usually before they are of legal age." Id.

These results answer the question posed to Congress in 1970 whether marijuana "produces ‘severe psychological or physical dependence’ as required by a schedule I or even a schedule II criterion." Supra U.S. Code Cong. & Admin. News (1970) 4630. Clearly and unequivocally it does not, as evidenced by the independent assessment of the well-respected National Academy of Science Institute of Medicine, in its report commissioned, financed and subsequently praised by the ONDCP.

Despite being listed in Schedule I of the CSA, there is a large body of evidence demonstrating that marijuana has an accepted medical use. This is all the more remarkable considering marijuana’s prohibited status.

After reviewing all the available data, conducting interviews and holding public hearings, the IOM researchers reached the undeniable conclusion that, "Scientific 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 ES.5. The IOM Report, while cautioning against the potentially harmful effects of inhaling smoke, acknowledged that, "Until a non-smoked, rapid-onset cannabinoid drug delivery system becomes available . . . there is no clear alternative for people suffering from chronic conditions that might be relieved by smoking marijuana, such as pain or AIDS wasting." Id. at ES.9.

Mr. McWilliams is precisely the type of patient the IOM Report discusses in these conclusions. He is suffering from a chronic, life-threatening, yet treatable condition. The unbearable paradox is that the only palliative medication that makes Mr. McWilliams’ retention of his life-saving medication possible is medical marijuana—a substance that the federal government erroneously maintains has no redeeming medical properties.

Mr. McWilliams’ experience alone is sufficient to demonstrate that, at the very least, marijuana has a definite, predictable and consistent therapeutic effect. Medical marijuana controls the nausea and subsequent vomiting that otherwise precludes Mr. McWilliams from treating his AIDS with the state-of-the-art pharmaceutical treatment regimen. This fact alone would be sufficient to call marijuana’s scheduling into question. However, Mr. McWilliams’ experience is far from unique.

This court in OCBC, recognized the class of persons with a demonstrable "need for cannabis in order to treat . . . debilitating and life threatening conditions." OCBC, 1999 W.L 705099, at *4. OCBC members and their doctors submitted declarations regarding this need and this court found it noteworthy that such persons and professionals came forward, "despite their very real fears of criminal prosecution." Id. There are doubtless thousands, if not millions, of others who could be helped by the medical use of marijuana, but instead suffer untreated because of their "very real fears." Forcing patients like Mr. McWilliams—who are already suffering and quite likely fighting for their lives—to break federal statutory law and risk prosecution with only the chance for a successful medical necessity defense to protect them from federal prison is cruel, unjust and counter to the principles embodied in the U.S. Constitution and the CSA.

In November 1996, California, the most populous state in the nation, enacted Proposition 215 by popular initiative. The initiative, codified as California Health & Safety Code § 11362.5 ("Cal. H&S § 11362.5") declares its purpose to ensure that "seriously ill Californians have the right to obtain and use marijuana for medical purposes where that medical use is deemed appropriate and has been recommended by a physician." Cal. H&S § 11362.5(a). Five other states in the Ninth Circuit passed similar legislation by popular initiative in November 1998.

[Footnote 9: Alaska (A.S. § 17.37.010), Arizona (A.R.S. § 13-3412.01), Oregon (Measure 67), Washington (R.C.W. § 69.51.010) and Nevada (Question 9—In accordance with state law, the question must be passed again in 2000 before the law takes effect).]

These initiative measures all passed despite intense negative campaigning and spending by the federal government.

Implicit in each of these measures is a determination by the majority of voters in the various states that marijuana has a medical utility. In litigation regarding a petition to reschedule marijuana in the 1970s and 1980s, the Court of Appeals for the D.C. Circuit wrestled with the question of how to determine "currently accepted medical use in treatment in the United States" for a Schedule I controlled substance. Alliance for Cannabis Therapeutics v. Drug Enforcement Administration, 930 F.2d 936 (D.C. Cir. 1991). Finding no guidance in the legislative history beyond the plain language of the term, the court accepted the DEA Administrator’s interpretation of the phrase. The Administrator, in overruling the findings of a DEA Administrative Law Judge, applied an eight-part test to determine whether a drug or substance has a "currently accepted medical use." Id. at 938. Neither the Administrator, nor the Administrative Law Judge, nor the A.C.T. court contemplated the situation presently before this court, namely the direct unequivocal acceptance of marijuana as medicine by six states. Nor does the legislative history suggest that Congress considered such a situation when it enacted the CSA.

The situation here requires no great imagination or statutory construction on the part of the court. The plain meaning of the term "currently accepted medical use in treatment in the United States" must control. Connecticut National Bank v. Germain, 112 S.Ct. 1146, 1149, (1992) (when words of a statute unambiguous judicial inquiry is complete); Ardestani v. Immigration and Naturalization Service, 112 S.Ct. 515, 520 (1991) (strong presumption that plain language of statute expresses congressional intent); United States v. Behnezhad, 907 F.2d 896, 898 (9th Cir. 1990) (courts should rely on plain meaning when language clear). The simple fact being the position that marijuana has no "currently accepted use in treatment in the United States" is not tenable in light of the recent legislation in California and the other states. A substance cannot simultaneously have an accepted use in treatment—as marijuana does in the six western states—and be properly listed as a Schedule I controlled substance.

The IOM Report identifies marijuana’s actual medical value and demonstrates that a relative margin of safety exists for its use under medical supervision.

While the IOM Report described smoking the marijuana plant as a "crude" delivery system for the beneficial cannabinoids, several of its conclusions provide a new perspective on the tentative Congressional determination in 21 U.S.C. § 812 (b)(1) that, "There is a lack of accepted safety for use of [marijuana] under medical supervision,"

The IOM Report concluded that:

IOM Report ES.6, ES.8. These well-reasoned and thoroughly researched conclusions demonstrate that there is a margin of accepted safety for use of marijuana under medical supervision given the current understanding of marijuana in a medical context.

Additionally the IOM Report countered the argument that the medical use of marijuana would increase its recreational use among the general population. "The existing date are consistent with the idea that this would not be a problem if the medical use of marijuana were as closely regulated as other medications." Id. at ES.7.

According to the plain language of the CSA, marijuana is not properly listed in Schedule I.

States have historically had the power to regulate the practice of medicine as a means to protect the health and safety of their citizens. The United States Supreme Court has long observed that right,

[W]e have consistently recognized the legitimate state pursuit of such interests as compatible with the Commerce Clause, which was never intended to cut the States off from legislating on all subjects relating to the health, life, and safety of their citizens.

General Motors Corp. v. Tracy, 117 S.Ct. 811, 828 (1997); Raymond Motor Transportation, Inc. v. Rice, 434 U.S. 428, 443 (1978) (state regulations enacted to promote public health and safety are accorded particular deference); Linder v. United States, 268 U.S. 5, 18 (1925) ("obviously, direct control of medical practice in the states is beyond the power of the federal government"). This language was echoed just last year by the U.S. Department of Justice in response to an inquiry by U.S. Senator Ron Wyden regarding federal intervention in Oregon after passage of an assisted suicide initiative there. "There is no evidence that Congress, in the CSA, intended to displace the states as the primary regulators of the medical profession, or to override a state’s determination as to what constitutes legitimate medical practice," wrote L. Anthony Sutin, Acting Assistant Attorney General, in denying Sen. Wyden’s request for intervention. Letter from L. Anthony Sutin, Acting Assistant Attorney General, to Senator Ron Wyden, dated June 5, 1998.

[Footnote 12: Despite Congress’ disgust that physicians in Oregon were prescribing lethal doses of controlled substances pursuant to the state Death with Dignity Act, the only federal recourse was to enact the Assisted Suicide Funding Restriction Act, 42 U.S.C.  § 14401 et. seq., that restricts the use of federal funds to pay for items and services which are used to cause or assist suicide or euthanasia.]

California and her five sister states have acted to protect the health and safety needs of patients in their states, through the most responsive form of lawmaking available, the popular initiative. Those actions reflect a value judgment on the part of the voters that the health benefits afforded by the medical use of marijuana outweigh any real or perceived risks to public safety. See United States v. Oakland Cannabis Buyers Cooperative, _ F.3d _ , 1999 WL 705099 (9th Cir. 1999) ("OCBC has identified a strong public interest in the availability of a doctor-prescribed treatment that would help ameliorate the condition and relieve the pain and suffering of a large group of persons with serious or fatal illnesses."). The inquiry ends with the state action, not with a determination by Congress or DEA.

Mr. McWilliams must be allowed to resume his use of medical marijuana as a matter of dire medical necessity. He meets all four of the conditions required for the necessity defense as described by this court in Aguilar. Mr. McWilliams is faced with the choice of breaking federal statutory law or being left unable to assimilate his medication, he wishes to act to avoid an imminent and recurring harm and to ensure his survival through trial. Medical marijuana is proven to alleviate Mr. McWilliams’ condition and he has no legal alternative to violating the law.

For the foregoing reasons, Mr. McWilliams respectfully urges this court to enter an order exempting him from the conditions of his release that prevent him from using medical marijuana.

Dated: October 14, 1999 Respectfully submitted,

_

THOMAS J. BALLANCO

Attorney for Defendant/Appellant

PETER McWILLIAMS