Pubdate: Sun, 25 Jul 2010 Source: Record, The (Hackensack, NJ) Copyright: 2010 North Jersey Media Group Inc. Contact: http://www.northjersey.com/ Details: http://www.mapinc.org/media/44 Author: Kate Greenwood Note: Kate Greenwood is a research fellow at the Center for Health and Pharmaceutical Law and Policy at Seton Hall University School of Law. Read her blog at HealthReformWatch.com. THE ALTERNATE APPROACH TO MEDICAL MARIJUANA DISTRIBUTION WE FEEL there is no question about it: The careful, legal distribution of medicinal marijuana to those in need is a good thing. The New Jersey Legislature agreed and passed legislation permitting distribution last January. Then-Gov. Jon Corzine signed the measure before leaving office. But Governor Christie has requested a delay in its implementation, and a proposal to modify the system of distribution is cause for concern. More than a year ago, Seton Hall Law's Center for Health and Pharmaceutical Law and Policy distributed a position paper to New Jersey lawmakers urging passage of the marijuana measure, called the "New Jersey Compassionate Use Medical Marijuana Act." The center did so citing the inclusion of "multiple measures designed to reduce the risk of abuse or diversion" and noting that "the medical literature supports the conclusion that smoked marijuana can provide relief to patients suffering from debilitating medical conditions for whom conventional treatments have failed." Implementation Delayed The act was to have taken effect this month, but, in response to a request from Christie, the Legislature pushed back the effective date to October. As passed, the act provides that medical marijuana be grown and distributed by six not-for-profit "alternative treatment centers." But now, the New Jersey Council of Teaching Hospitals has proposed that the act be amended - before it is even implemented - to provide that medical marijuana instead be grown by Rutgers University and distributed by the state's teaching hospitals. While hospitals are, as the Council of Teaching Hospitals points out, experienced dispensers of medicine, the act should not be rewritten to require them to dispense medical marijuana. The passage of the act affects the rights and responsibilities of patients and providers of medical marijuana under New Jersey law; it does not change the fact that distribution and use of marijuana are illegal under federal law. Although Attorney General Eric Holder has pledged not to prosecute patients and providers who comply with applicable state laws, and hospitals could thus dispense medical marijuana without fear of criminal prosecution, they would still be violating federal law. Condition of Participation This is a problem because compliance with federal law is a condition of participation in the Medicaid and Medicare programs. Hospitals depend heavily on Medicaid and Medicare funding; the Compassionate Use Act's alternative treatment centers would not. Hospitals would require assurances beyond Holder's pledge not to prosecute before they could dispense medical marijuana. At a minimum, they would need an assurance from the federal Centers for Medicare and Medicaid Services that dispensing marijuana in accord with New Jersey law would not affect their eligibility to participate in Medicaid and Medicare. Even assuming that such an assurance would be granted, obtaining it would, in all likelihood, lead to further delay. The New Jersey Council of Teaching Hospitals argues in support of its proposal that, in addition to being experienced dispensers of medicine, many hospitals have experience conducting medical research. The council suggests that hospitals could direct some of the proceeds from the sale of marijuana toward research into the drug's medicinal effects. The Necessary Expertise More medical marijuana research is much needed and New Jersey's teaching hospitals have the requisite expertise and experience to conduct it. But if hospitals were to violate federal law by selling marijuana, it is unlikely that they would be able to secure the federal approvals necessary to embark on such research. As the Compassionate Use Act provides, "Modern medical research has discovered a beneficial use for marijuana in treating or alleviating the pain or other symptoms associated with certain debilitating medical conditions." But there is still a lot we do not know about marijuana's full potential as a medicine. For example, a clinical trial sponsored by the Center for Medicinal Cannabis Research at the University of California San Diego suggests that determining the correct dose could be key to how well the drug works. While marijuana cigarettes containing a low dose of the active ingredient THC provided no pain relief to study participants, marijuana cigarettes containing a medium dose of THC had a significant pain killing effect. Meanwhile, marijuana cigarettes containing a high dose of THC actually increased the study participants' pain. New Jersey researchers seeking to study marijuana's medicinal effects would first have to comply with numerous federal laws and regulations. Before any unapproved "new" drug is tested in humans, an investigational new drug application must be filed with the Food and Drug Administration. When the drug in question is marijuana, researchers must clear additional bureaucratic hurdles. A Public Health Service committee has to sign off on the merits of the research protocol and the competency of the researchers, after which the Drug Enforcement Administration must give its approval. Research-Grade Product The National Institute of Drug Abuse then provides the research team with government-authorized "research-grade" marijuana. Only by establishing working relationships with all of these federal regulators was the University of California's Center for Medicinal Cannabis Research able to conduct the first clinical trials of smoked marijuana in the United States in over two decades. It is hard to understand how New Jersey's hospitals could successfully establish similar relationships while simultaneously selling marijuana in contravention of federal law. Beneficial Research Our hospitals do not need to go into the medical marijuana business in order for beneficial research to proceed. Sen. Nicholas Scutari, D-Union, one of the sponsors of the Compassionate Use Act, has proposed that the government tax sales of medical marijuana. Some or all of the proceeds of such a tax could be directed to a dedicated research fund. A rigorous, competitive process, akin to that developed by the Center for Medicinal Cannabis Research, could then be employed to determine which research proposals would be supported. If the Legislature requires New Jersey's teaching hospitals to distribute medical marijuana, it will put them at legal risk and make it near impossible for them to pursue clinical research into the drug's safety and efficacy. The Compassionate Use Act should be implemented as written, with marijuana plant growth and distribution conducted through alternate treatment centers, as quickly as possible. - --- MAP posted-by: Richard Lake