[This article expands upon remarks originally presented to the 4th annual National Clinical Conference on Cannabis Therapeutics, April 8, 2006 in Santa Barbara, California.]

The medical use of cannabis presents many interesting public policy problems in both the United States and Canada, interesting unless one happens to be a patient in which case the problems are more likely described as being frustrating, often physically and emotionally painful, and most certainly urgent. How, then, can the public policy process be utilized to alleviate the suffering of patients in a timely manner?

These remarks focus on medical cannabis use in the United States, but the general issues raised in this discussion may provide useful perspectives for Canadians by providing an approach that frames the issue in a useful and productive fashion. There are five key questions that must be considered. 1) How many people are affected? 2) What problems do they face? 3) What solutions have been tried? 4) Why must we address this problem? 5) Where do we look for remedies? In my estimation these questions have simple answers.

The National Survey on Drug Use and Health estimates that there are over 25 million annual users of marijuana in the United States. It is my general estimate that there are 2.5 million medical cannabis users in the United States, and the basis for this estimate will be provided below.

The primary problem these people face is criminal prosecution. While possession of small amounts of marijuana are decriminalized or otherwise subject to minor penalties medical cannabis patients often possess and/or grow larger quantities of marijuana than occasional recreational users. Consequently medical cannabis patients face prosecution for possession of marijuana with an intent to distribute or sell; the average maximum state penalty is a felony conviction and a 5.5 year prison sentence.

In the United States at best 25% of medical cannabis patients receive protection under state and local laws. The various solutions to this problem have been inadequate, often because they do not affect enough individuals to be significant or take too long to benefit existing patients in a timely manner.

The question of public ethics is frequently ignored when this matter is debated. We must address this problem because we have an ethical obligation to address the needs of individuals suffering from disease and debilitating conditions. The US Supreme Court ruled in 1962 in the case of Robinson v. California that it was cruel and unusual punishment to make addiction a criminal offense. Similarly it is against the moral convictions of most North Americans to send the police out to arrest and imprison people whose only intent is to seek therapeutic relief. The issue is not whether cannabis is or is not an approved medicine, the issue is the intent of the individual whose behavior is being subjected to the law. An amputee who smokes cannabis to relieve pain should not be subjected to laws that were passed solely to express public intent to punish or deter people for the drug's casual recreational use.

However both public ethics and the need for comprehensive, national, and timely legislation are frequently ignored in favor of political expediency by both supporters and determined by the opponents of medical cannabis reform. Where we look for remedies is determined by the people affected and the nature of the problems they face, not the path of least resistance that advances the careers of political activists.

To estimate the number of medical cannabis users in the United States it is necessary to revisit the National Survey on Drug Use and Health (NSDUH), sponsored the Substance Abuse and Mental Health Services Administration (SAMHSA) of the US Department of Health and Human Services (HHS). This extensive survey provides the official benchmarks for evaluating marijuana use and related public policies in the US. In the late 1990s NSDUH estimated that approximately 19 to 20 million people used marijuana on an annual basis in the US. After paying people to complete the survey, improving the accuracy of estimates, the estimate of annual marijuana use in the US increased to nearly 26 million in 2002. It's not that the number of annual users increased suddenly by 25%, it's just that the improved survey process provided more accurate measurements of marijuana use.

NSDUH provides the best data with which to estimate the number of medical cannabis users in the United States. NSDUH is a very sophisticated and extensive survey, and while it does not ask people about medical cannabis use it does provide minimal data that supports a broad estimate. This estimate will be produced by a modeling approach derived from known limits and a few basic assumptions. It is reasonable, for example, to assume that medical cannabis users are a subset of the 26 million annual users of marijuana.

One proxy variable for medical marijuana use is the presence of a disability on the part of a marijuana user. The survey asks ""Did any physical, mental, or emotional problem limit you in the kind or amount of work you could do during most of the past 12 months?" One subset of annual marijuana users which likely includes medical cannabis users are individual who use marijuana and have had their ability to work limited or prevented by a physical, mental, or emotional disability. One million people have been kept from work from some disability and have also used marijuana in the last year. When considering people who have had their work limited by a disability and had used marijuana in the last month, an estimate of 1.24 million is produced. Also, there is a subset of annual marijuana users who also spent six or more nights in a hospital; this group numbers 220,000. An important assumption in this estimation is that for every one with limited work that is not a medical cannabis user there is a medical cannabis user whose work was not limited. On this basis a low estimate of medical cannabis users in the United States is 1.4 million.

A higher estimate of medical cannabis users is based on the number of people whose work has been limited by a disability and have used marijuana in the last year. There are 2.4 million annual marijuana users who also report that their ability to work has been limited by a physical, mental, or emotional problem. Add to them the 220,000 who have spent several days in the hospital, utilize the same general assumption as with the low estimate, and the result is a high estimate of 2.6 million medical cannabis users in the United States.

When compared to the estimate of 26 million total annual users, these estimates suggest that medical cannabis users account for 5% to 10% of use in the United States. This is important for several reasons. NSDUH is also used by the US government to generate estimates of annual marijuana use on a state by state basis. If 5% to 10% of annual marijuana users are medical cannabis users, then it is reasonable to apply that estimate on a state by state basis producing estimates, for example, of a total of 168,000 and 338,000 in California, 51,000 to 102,000 in Pennsylvania, 19,000 to 38,000 in Tennessee, and 6,400 and 12,800 in Nebraska.

One of the benefits of a modeling approach is that it invites disagreement. Obviously, if one were to adjust the assumptions of this model it would change the results. Critics and analysts are encouraged to refine this model and/or challenge the assumptions upon which it is based. However, while necessary in many respects, such a debate is irrelevant to the overall need for remedies. Ethically, it doesn't matter if the number of medical cannabis users represents 1%, 5%, 10% or even 25% of all annual marijuana users. The magnitude of the estimate doesn't change the ethical dilemma for the public. A significant portion of marijuana users use the drug for therapeutic relief rather than merely as a hedonistic pursuit - and it conflicts with the public's ethics to subject them to criminal prosecution and prison sentences of any length.

In Arkansas the maximum penalty for the sale of 4 ounces of marijuana is 10 years, according to the National Organization for the Reform of Marijuana Laws (NORML). In Florida it is 5 years, Michigan has a 4 year penalty, New Hampshire has a 7 year penalty and in Oklahoma the penalty is 25 years. Individuals who are arrested with 4 ounces or more of marijuana are often charged with an intent to distribute. Anyone who is arrested with enough marijuana for a year's consumption or growing enough marijuana to produce a year's supply is likely to be charged with a sales or manufacturing offense, often justified by the opinion of law enforcement that the amount of marijuana involved was more than an individual would consume in a year.

It can and has been argued that law enforcement has little interest in targeting medical cannabis users and that the courts have little interests in subjecting them, or anyone for that matter, to the maximum penalties available in this sort of case. However, even in this generous light, it is hard to justify granting the police and the courts with the discretion to impose such a sentence should the circumstances justify it. There simply is no justification to subjecting an individual who grows marijuana for personal medical use to relieve the symptoms of a medical condition to prosecution for felony crimes requiring multiple year prison sentences. There are no circumstances that justify subjecting a cancer patient to a five year prison term for seeking relief from the nausea associated with chemotherapy by using cannabis. It simply does not matter that other medications are available — making a personal choice about medical treatment should not be a criminal offense.

There have been a number of proposed solutions for these problems, including experimental research programs, state-level reforms, and recognition of medical use as a defense against prosecution for felony possession and/or manufacture. One can take a detour into their actual provisions; it is an interesting exercise in the study of the public policy process that obscures what is otherwise an obvious problem. The problem with these approaches, as with the development of pharmaceutical products, is that they don't offer protections for all patients in a timely manner. Patients need access to medical cannabis now, in the short term.

Suggesting to patients that one course of action or another will provide limited access at some distant point in the future is not an acceptable answer for many patients and/or their families. Passage of legislation in Illinois, for example, doesn't do anything for medical cannabis patients in Kansas. Neither does passage of congressional legislation that prevents the federal government from enforcing federal law in states with local protections for patients. A national solution is required because the patients requiring assistance are in every part of the nation. A timely solution is required because therapeutic relief is a necessity rather than a luxury that can be deferred. Ethics require that the interests of patients come first. Patients need relief from prosecution throughout the entire country, and they need legal access, as soon as possible, under federal law and regulations.

The most important remedies, thus, are state and local level protections from prosecution. The challenge of creating just, effective laws and regulations addressing the public policy problems caused by medical cannabis use must not used as an excuse to avoid the urgency of the problems faced by individual patients. There are compelling moral, ethical, and practical arguments why therapeutic cannabis users should not be classified as criminals by society and the law. Contemporary marijuana laws persist to express societal disapproval of recreational marijuana use and to deter casual, non-medical use. These laws were enacted for a different purpose than to criminalize individuals seeking relief from chronic pain. That aspect of the law is the biggest problem for medical cannabis users, and it should be the first priority of public policy efforts seeking to respond to the needs of patients. They need to be protected from prosecution.

Medical cannabis patients require immediate relief from prosecution, protections for all patients in all states and territories, followed by short-term federally regulated access (such as in the form of state-managed research programs) and long-term, federally regulated drug and analog development.

More specific steps are: 1) Institute state-level protections from prosecution; 2) Reschedule cannabis under federal Controlled Substances Act; 3) Implement manufacturing and distribution regulations consistent with the new scheduling status; 4) Follow the Institute of Medicine recommendation to provide for n=1 research programs under federal or state auspices; and 5) Design and implement policies designed to make medical cannabis manufacture and distribution consistent with US federal food, drug, and cosmetic laws.

This last point requires some elaboration. The needs of patients require that we tailor our policy recommendations to their benefit. Cannabis is an easily produced substance and relatively safe to use; indeed it is widely produced and used throughout North America. Cannabis need not be approved as "medicine" under federal laws to be available to patients for therapeutic use. Indeed the most efficient set of regulations for both medical cannabis users and the general public would be to have cannabis production and sales regulated for safety, purity, and controlled access and leave the issue of medical effectiveness up to the practice of informed consent. In other words, it will be less expensive for everybody to allow for marijuana's use outside the closed system of medical approval and controlled pharmaceutical manufacture.

The process of drug development is immensely expensive. Rescheduling marijuana in the United States will provide greater certainty about the future regulatory environment, which, in turn, should expedite the flow of capital into cannabinoid drug development. This will eventually produce great benefits for patients, but those benefits will be in the future, they will be expensive to produce, and regardless of criminal laws and public health regulations those benefits will still have to compete with the availability of illicitly grown and sold marijuana. Marijuana is available now and will, regardless of the law, be available in the future. Let's save everybody involved a lot of time and money and recognize the reality of the situation.

What is the ethical justification for extracting huge amounts of capital from the sick, their families, and the general public when there is an efficient and substantially less costly alternative available? Medical cannabis patients are already being exploited by the market. For example, even in California where patients are protected by state law medical cannabis is frequently sold at prices set by the illicit market — several hundred dollars per ounce. What patients need are federal regulations that expedite access, provide consistent supply, reduce costs, and protect them from exploitation. Efficient solutions to these problems exist that address both the needs of patients and the public. The key to reaching them is to stay focused on the actual problems of patients and the ethical challenges these problems present to society.

The public policy process works best when it is confronted with real problems, legitimate interests, and appeals to common values. The way to get the public policy process to address the needs of medical cannabis patients is to sharpen the focus of public debate on the most pressing problems these individuals face — prosecution for exercising their right to choose a course of medical treatment. Honestly addressing this fundamental problem is the key to unlocking the ability of the public policy process to address the needs of medical cannabis users. The key to using the public policy process to resolve the medical cannabis crises in North America is to make sure we elevate the interests of patients over those of the political class that serves them.