As a compromise, the patient registry model could advance the goals of all sides in this dispute.
There is growing public interest to make marijuana available for extremely needy patients. Questions surrounding its use can never be answered unless an effort is made to answer them. Would medical marijuana relieve intractable pain or suffering? Would it be safe to use, when all other treatments have failed a small but sizable number of patients? Can its distribution and use be controlled? A patient registry clinical research study could be the compromise needed to provide marijuana to desperately ill patients while providing the experience necessary to evaluate the risks and benefits of doing so.
The Mayo Clinic, the University of Minnesota or another major research center would organize and perform such a study, involving patients, physicians and medical clinics from across our state. Here’s how it could work from the patient’s perspective and that of the medical research community, law enforcement and government’s need to protect its citizens.
Hundreds of patients would be allowed to use medical marijuana to relieve severe pain, nausea and other types of debilitating conditions if their physicians were to attest that it was truly a treatment of “last resort.” Such patients (or their caregivers) would have to agree to report all benefits and complications relating to its use during a one-year period. Given their plight, patients should be more than willing to agree.
Participating physicians and clinics would have to agree to control the distribution and inventory of marijuana provided to them for this medical research. Participating physicians would be responsible for acquiring all required data from reporting patients. These are very common requirements imposed on physicians who participate in drug and medical-device research studies. They do quite well responding to these requirements.
The major state research center would be authorized to enroll participating patients, physicians and medical clinics into this study. It would be responsible for distributing marijuana to the participating clinics, monitoring for compliance, collecting the required data and analyzing it. Medical research centers have proven experience complying with these types of requirements.
Can this medical marijuana research address the concerns of those who question its safety or its helpfulness to relieve debilitating symptoms? It could be argued that a patient registry study is the only type of medical research that could answer both questions.
Normally, the “gold standard” to answer both questions would be to perform a randomized controlled clinical study of patients who seek this treatment of last resort. In such a study, some patients would have access to marijuana and other patients would not, instead receiving the very best standard of medical care and treatment. But the very best standard of care and treatment has already failed to help. Thus, a conventional approach to scientifically evaluating both questions simply doesn’t apply, since there is no scientific merit to comparing the effects of medical marijuana use against the known failure of not doing so. More important, how ethical would it be to deny marijuana to control patients for the sake of research?
So the question becomes: “Is a patient registry study scientifically valid?” A patient registry study allows acquiring consistent, quality data from large numbers of patients, including those at decentralized locations, for instance, 18 from St. Paul, three from Hibbing, two from Marshall, one from Red Wing, two from Detroit Lakes and so forth. If consistent-quality data were acquired during a one-year patient registry study, the analyzed results would provide valuable prescribing information for physicians who treat future patients. They would know which symptoms of specific medical conditions (terminal cancer, Parkinson’s disease, etc.) could be relieved, how much relief could be expected and what harm marijuana use could create.
Patient registry studies have and will continue to be conducted to provide the most relevant clinical experience possible, when physicians consider whether (or not) to offer a treatment of last resort. A Pulmonary Embolism Patient Registry was established to acquire such experience for patients who have a massive blood clot in their lungs, one that could kill them within one hour of being diagnosed. Such patients would be extremely lucky to be at an emergency room staffed with a doctor experienced enough to suspect this condition and immediately provide lifesaving treatment of last-resort therapy.
Law enforcement authorities also have an important perspective about medical marijuana. They want to know if its use can be controlled and limited solely to needy patients. The U.S. Food and Drug Administration’s regional office could inspect the major research center’s control and release of marijuana to all participating medical clinics statewide. Compliance officers from this agency could inspect representative clinics to make sure that the marijuana inventory and distribution were properly controlled. State, county and local law enforcement agencies would have an opportunity to determine if such controls are practical and could prevent illegal distribution. Based upon this experience, they could even help plan for marijuana pharmacy distribution in the future.
Medical marijuana use presents a complex picture of possibilities and concerns. The many questions surrounding and restricting its use are, by analogy, merely pieces of a puzzle that we are asked to solve without any clear picture to guide us. But we will never really know what the picture can show unless we take the necessary steps. Nothing new has to be created to gain this experience except state approval to do so. For the sake of these patients and the urgency of their conditions, I trust that Minnesota will allow creation of a patient registry study or some other appropriate means to solve this puzzle.
Frank B. Freedman is an adjunct professor at the University of St. Thomas with a focus on medical-device clinical studies.
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