by Chris Conrad
Both inpatient studies conducted under well-controlled, experimental conditions and outpatient studies conducted under “real world” conditions are needed to evaluate the safety and efficacy of cannabis. Dr. Donald Abrams, of the University of California at San Francisco, designed a study that combines the two approaches, and has been trying for four years to get permission to conduct clinical research comparing the medical use of smoked cannabis and dronabinol in patients with the AIDS wasting syndrome. Dr. Abrams’s proposal was approved by the FDA and all appropriate regulatory authorities. However, the study cannot go forward because NIDA has a monopoly on the supply of cannabis that can legally be used in research and refuses to provide any. NIDA Director Dr. Alan Leshner said he would reconsider the protocol evaluation if it was rewritten as a grant application to the National Institutes of Health (NIH), was reviewed favorably by its evaluation committee, and was awarded government money for the study. This was scant hope, since only 10–15 percent of NIH grants are funded.
Nonetheless, the Multidisciplinary Association for Psychedelic Studies (MAPS) and the Drug Policy Foundation raised $5,000 to pay for staff to prepare the grant application. It proposed two related, sequential studies: first, a randomized, double-blind, placebo-controlled, inpatient evaluation of smoked cannabis at the General Clinical Research Center at San Francisco General Hospital, followed by a randomized, open-label, outpatient study of smoked cannabis versus dronabinol. The inpatient study would provide data on the effects of approximately 4 percent THC-content cannabis on appetite and food intake, as well as safety data on immunological function, HIV viral load, pulmonary function, endocrine function, and neuropsychological function. Based on the results of the inpatient study, Dr. Abrams planned to conduct an outpatient study to develop comparative data on the effects of smoked cannabis versus the licensed, synthetic THC pill. The outpatient study would also provide safety data on immunological function, HIV viral load, pulmonary function, and endocrine function, while treating patients with HIV-associated weight loss over several months.35
In late 1996, Dr. Leshner told Dr. Abrams that the NIH had turned him down because the government could not justify the cost of providing cannabis for such a study. The street value of the cannabis needed was only a few hundred dollars—less than the cost of preparing the grant proposal. Even with private funds to provide and evaluate the cannabis, handling it requires DEA authorization, and the FDA can arbitrarily refuse to recognize the study when it is done. So the fox is still in charge of the chickens.
Not to be stymied, Dr. Abrams’s research team is submitting a revised protocol which incorporates the NIH critique of its 1996 application to meet the May 1, 1997, NIH cycle deadline. Another research option which has not been pursued in recent years is that of the N=1 trial (pronounced “N of 1”), which is a series of controlled, individual patient studies, rather than studies of large-scale control groups. An effective design criterion was described in the Journal of the American Medical Association to produce randomized, double-blind, multiple crossover trial results. “[Single patient trial] costs compare favorably with other conventional services, and clinicians appear to gain confidence and precision from SPTs. When patients or clinicians are uncertain about the value (including the possibility of side effects) of treatment for symptomatic chronic diseases, we believe an SPT can be offered to a patient and will likely yield results that will effect subsequent treatment.”36 The FDA has used these in the past, such as when it approved the use of danazol (a drug used to treat endometriosis) based on a NIH trial involving forty patients, switching between drug and placebo after one month or with an attack. This approach is particularly useful for trials involving chronic, stable conditions or rare diseases, when the treatment offers undetermined benefits but is known to work promptly to provide temporary relief. N=1 trials offer advantages for cannabis research because they are patient-specific in terms of dosage and duration. Outcome measurements, both subjective and objective, are also tailored to the patient. To maintain the double-blind control for a study of THC compared to cannabis, three randomized groups would be given a supply of either A, B, or C. Group A receives 2.5 mg THC for half the test and placebo joints for the second half. Group B receives placebo pills for half and marijuana joints for half. Group C receives placebo pills and placebo joints.37 Neither researchers nor patients know to which group they belong until the end of the study. Possible objective outcome measures of effectiveness can include patient global assessment, physician global assessment, use of rescue medication, and disease-specific response measurements.
Readers who use marijuana medicinally are urged to participate in the Cannabis Patient Registry (Appendix D). As the possibilities to conduct research evolve, participants may be eligible for inclusion in an N=1 trial.
LEGISLATIVE OPTIONS
The beauty of Proposition 215 is that it does not conflict with federal law because it does not legalize cannabis; it simply creates a medical exception to enforcement. The question of states’ rights versus federal domination often comes down to political expediency. For example, when the federal government decided to fight the 1996 anti-affirmative action initiative, Proposition 209, California officials, including Governor Wilson, denounced it as a violation of the Tenth Amendment. However, the governor expressed no such concerns when General McCaffrey threatened to prosecute doctors who recommend cannabis to their patients under Proposition 215 or when the DEA threatened to pull doctors’ licenses to prescribe medicine. Dan Lungren went to Washington, D.C., to meet with federal officials to discuss how to get around the new law, and said he was “heartened” by the federal Department of Transportation plan to use urine testing to keep drivers from using medical marijuana.38 When the U.S. Senate held hearings to discuss the matter, Arizona’s Senator Jon Kyl asked the DEA to step up their antidrug efforts in states where voters support medical marijuana.39 General McCaffrey has repeatedly threatened to use surveillance, entrapment, and secret police to infiltrate and destroy the physicians and clubs that provide cannabis. The intimidation of doctors is extremely problematic because the bill requires a physician’s recommendation for cannabis to be used legally. The CMA advised doctors against recommending cannabis, and at least one doctor rescinded his previous recommendation to a patient since the general began his threats.
A special meeting of law enforcement officials, the general, and other opponents of the initiative was convened at taxpayers’ expense in Washington, D.C., to thwart the will of the voters. Now there is talk of federalizing the nation’s police force by deputizing state and local police to override the will of the voters and defy the Tenth Amendment, an unfunded mandate that borders on treason. And who would pay the salaries of police mercenaries diverted away from enforcing state law to enforce federal law? Taxation without representation is one thing, but being taxed to pay for your own suppression is sadistic.
The Brady Bill provision to control handgun sales by requiring local police to run a background check on buyers was argued before the U.S. Supreme Court in 1996. Justice Anthony Kennedy attacked the plan, asking, “Isn’t the point not to have one government interfere with another?” Justice Sandra O’Connor challenged “the notion that the federal government can just commandeer” state officials to enforce federal law. The federal attorney agreed that the government probably could not require states to administer a federal program without offering them money and a chance to opt out. Those arguments should hold for cannabis, also.
In 1996 in Arizona, voters passed Proposition 200, an even more sweeping bill, by a nearly 2–1 margin. It legalizes prescription and medical use of cannabis and other controlled substances, and replaces prison sentences for nonviolent drug possession with probation. An estimated 1,000 prisoners will be released when it is fully implemented. Proposition 200 was backed by numerous physicians and by prominent Arizona conservatives, including retired Republican Senators Barry Goldwater and Dennis DeConcini, and several former Reagan administration officials. G
overnor Symington claimed he could veto any proposition that does not receive a majority of the state’s total number of registered voters, not only those who voted. “If the governor presumes he has more authority than the people of this state, then he has lived one day too long on the political landscape,” House Minority Leader Art Hamilton retorted. He warned that if Symington did attempt to veto the measure, “The first thing I would do in January would be to introduce articles of impeachment.”40 The governor backed down, but the attack moved to the federal level.
A provision allowing cannabis smokers to claim chronic illness or pain as a legal defense was included in the 1996 Ohio state crime bill. When a patient with a Dutch prescription for cannabis was arrested in the state, the new law was invoked in court and discussed in national and international news reports of the case. Charges were dropped due to an illegal search, but after General McCaffrey began threatening to impose federal law, Ohio state legislators claimed that they had no idea what they were voting for. The governor, attorney general, and even the bill’s sponsor all denied knowing what was in the law they had adopted. Deputy Attorney General Mark Weaver said, “it’s impossible to know what’s on every page of every bill passed by the legislature,” and promised to have a new bill reversing the law before lawmakers in January, 1997. Ohio voters now wonder what other laws their politicians have unwittingly approved.
Despite these dishonorable political sideshows, the issue is ripe for further development, given the large base of voter support for medical marijuana—about 75 percent, according to a national survey conducted for the American Civil Liberties Union in early 1996. Twenty states now have bills that allow patients to argue medical necessity if charged with cannabis possession. An excellent listing of legal and political options has been compiled by the Marijuana Policy Project foundation into a packet entitled How Can a State Legislature Enable Patients to Use Medicinal Marijuana Despite Federal Prohibition.41 The report is a comprehensive analysis of state medicinal cannabis laws, past and present, as well as recent state legislative proposals. It includes specific suggestions for how activists can approach their officials to enact necessary changes at the state level, and is an excellent starting point for planning such a strategy.
THE FINANCIAL FACTOR
If you judge a plant by the power of its enemies, then cannabis is very important, indeed. How many other garden-variety herbs are listed in national emergency plans, have their own federal eradication program costing taxpayers about $8 billion per year, and generate at least $36 billion in the underground economy each year? Given the broad popular support for medical marijuana and industrial hemp, who, one might wonder, would be opposed to letting sick and dying people use their traditional medicines? Who would forbid farmers to grow a traditional crop that could produce more jobs and clean up the environment? Who benefits from causing so much pain and destruction? Follow the money.
Not only are there multimillion dollar contracts to build and supply our nation’s courts, jails, and prisons, now there is domestic prison labor to sweeten the pot for the Drug War profiteers. Federal prisoners in the United States were paid 37½¢ per hour in 1996 to work for the Unicor company; not quite slave labor. That’s the same wage paid in 1825 to immigrants working on the Erie Canal. Now there are prisons privately run for profit. In California the prison guard union sleeps snugly with both Governor Wilson, who received almost a million dollars in political donations from the group, and Attorney General Lungren, who’s never seen a prison he didn’t like. The union was also a major funder of the opposition to Proposition 215.
Alcohol and tobacco companies get big tax write-offs to pay advertising companies to slam their competition, marijuana—as a public service, of course. Pharmaceutical companies sell expensive drugs to replace cannabis, since no one can buy the herb legally. That needlessly drives up medical costs and insurance rates. The drug testing industry has no natural markets, so the federal government passed the Drug Free Workplace bill as a subsidy for this disgusting program, forcing businesses to seize hair and urine samples from innocent, hardworking people without probable cause.
The pork barrel of prohibition is not limited to civilians. The principle of posse comitatus, adopted after the Civil War, forbids the military to enforce domestic law, yet the Pentagon has received more than $7 billion for counter-drug operations since the Bush administration overrode that provision in 1989. Rich contracts for exotic equipment are awarded to the same contractors who brought us Vietnam.42 The military now employs more than 8,000 active duty and reserve personnel as professional drug warriors, and these troops participated in 754 domestic operations in 1995. In a de facto form of martial law, the Defense Department project Joint Task Force Six links the nation’s domestic law enforcement forces with soldiers, members of the Air Force, Green Berets, Navy SEALs, and Marine reconnaissance patrols. Along with that, police departments and federal agencies get billions of tax dollars from the government each year to creep around forests, look into backyards, fly overhead in planes and helicopters, and even use satellite surveillance to spy on citizens to see if any hempseed may have sprouted.
If these police happen to catch somebody, the forfeiture laws kick in and allow the agencies to keep a substantial part of any property they seize. The accused don’t even have to be found guilty, according to the U.S. Supreme Court.
THE NEXT PHASE
With this book and others, the person who chooses to intelligently self-medicate with cannabis has a chance to make informed decisions. Just as people do not call a doctor to catch a thief, we cannot look to prosecutors, police, prison lobbyists, and criminal lawmakers to dictate appropriate health care for people. Criminal penalties will never successfully suppress cannabis for four key reasons. First, many patients have no choice but to break the law as a matter of medical necessity. Second, cannabis users are recalcitrant offenders because they do not feel like they have committed any crime; in fact, they generally feel proud of their decision to use cannabis and punishment simply makes them lose their respect for government. Third, a policy that is based on obvious lies and conflicts of interest is doomed because the truth cannot be suppressed forever. And fourth, the ecological and economic benefits of industrial hemp are so compelling that the crop will ultimately have to be restored as a matter of planetary survival.
Fully implementing the policy advocated by General McCaffrey after the election entails arresting one out of two cancer doctors, who feel they should in good conscience recommend cannabis to at least one patient, and one out of every three high school seniors, since 38 percent say they smoke cannabis. Whose children are we talking about? Our own. What does that say about his proposal? That it isn’t good for our kids.
Parents must not allow the War on Drugs to become a war on young people. We all want to protect our children; the question is how best to do that. Eventually you are going to have to discuss cannabis with your children, and I urge you to be honest and reasonable. Don’t live in denial about the real world your children face. If you demand total abstinence from teenagers, you can’t talk to them about not driving under the influence, or any of the other gray areas that make up the adult world. Don’t underestimate their intelligence. Parents should lead by example to teach their children how to make good choices and control their appetites. That means taking responsibility for the condition of the world you are preparing for them.
Young people will encounter lots of wrong messages about cannabis, many put out by people with good intentions. Marijuana does not kill people, lead to hard drugs, or cause problems in the lives of adults who use it responsibly. Neither is it a toy; it is an important and powerful medicine. It should only be used with parental consent by anyone who is less than eighteen years of age. Certain things require adult judgment, such as voting, driving a car, signing a contract, and drinking alcohol. Cannabis fits into this category, too. There are too many other changes going on in adolescent lives to add to the confusion.
CONCLUSION<
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Since anyone can develop a health condition that is helped by resinous cannabis, everyone has an interest in creating a safe and affordable distribution system. Political leaders are out of touch with the people on this issue, but they do know how to count votes. We who favor medical marijuana are now an empowered constituency. Each of us can make a personal difference, and together we are a solid majority. The power still belongs to the people, and Americans don’t like having their elections stolen.
Now that California and Arizona voters have brought medical cannabis back within the scope of law, we can again hold our public officials accountable for their actions. Civil suits and class actions are appropriate vehicles for this. In January 1997 a group of physicians and patients backed by Americans for Medical Rights filed suit against General McCaffrey and other administration officials for using intimidation to violate their rights regarding cannabis. The nature of the attack on the 1996 elections is just one matter that could eventually lead to grand jury investigations of official misconduct.
When and if patients and doctors are prosecuted in the future, the freedom to self-medicate is likely to be reinforced and expanded by jurors who understand another person’s back pain, stress, or religious beliefs. And what will happen when a patient discovers that THC doesn’t help, and he needs to grow an acre or two of industrial hemp to get enough herbal matter to extract CBD for his medical need? Sell the stalks for profit, and medical marijuana could well be the stepping stone to industrial hemp!
Many California voters intended Proposition 215 to allow buyers clubs to legally provide affordable cannabis to patients in a safe location. As of this writing, a judicial decision has lifted the injunction against the San Francisco club, allowing it to serve patients again, and numerous new clubs are sprouting across the state. Although dispensaries have their role, it is important that not all clubs become sterile clinics. Cannabis heals the patient’s body and mind best in an environment that stimulates health and happiness. Part of what makes cannabis special is that it promotes congeniality and community among its users. Clubs allow patients to share information about their own experiences, as well as socialize in a pleasant, casual atmosphere that lifts their spirits and enhances their recovery.