Lyle E. Craker, Ph.D.
Lyle Craker is a professor of Plant and Soil Sciences at the University of Massachusetts, Amherst. Since 1967 when Professor Craker earned his Doctorate degree in Agronomy & Plant Genetics from the University of Minnesota, his research has centered on crop physiology, principally on the physiology of medicinal and aromatic plants.
Professor Craker has written more than 100 articles on a range of topics from the effects of heavy metals in soil on plant growth to the development of essential oils in everyday herbs like rosemary and sage. In addition to his teaching and research responsibilities at the University, Professor Craker is currently editor of The Journal of Herbs, Spices and Medicinal Plants and Chairman of the Medicinal and Aromatic Plant Section of the International Society for Horticultural Science. Professor Craker’s research interest in medical marijuana developed from his work with other medicinal plants.
Professor Craker is currently appealing the U.S. Drug Enforcement Administration’s (DEA’s) denial of his application to grow marijuana at the University of Massachusetts for medical research. Professor Craker’s battle to break the federal government’s monopoly on medical marijuana available for research began in 2001 when a non-profit organization seeking to develop marijuana into a prescription medicine approached him about growing research-grade marijuana of the quality needed to meet FDA approval. At that time, he applied to the DEA for a permit to grow medical marijuana, a controlled substance, for use in medical research. The DEA took no action on the application for almost three years until a federal court ordered DEA to respond to the application. In December 2004, the DEA finally denied Professor Craker’s application to grow medical marijuana for medical research.
The American Civil Liberties Union represents Professor Craker in the appeal before the DEA’s Administrative Law Judge. The Judge could recommend that the DEA approve the application on the basis that doing so would benefit the general public’s interest.
Statement of Lyle Craker, Ph.D., respondent in DEA administrative law judge hearing
Since being approached by MAPS with an interest in funding the growth of quality plant material with balanced, consistent constituent levels for use in testing the possible health benefits of medical marijuana, I have considered this case important to me as a scientist. In this role, I have viewed marijuana the same as any other medicinal botanical in which possible health benefits are unknown or unproven. That is, the plant and plant extracts should be investigated by qualified medical professionals to determine whether the plant material has any potential for treating human afflictions, separating the anecdotal from the tested.
From the beginning, I have recognized that this plant is somewhat different from other medicinal plants, long suppressed because of misuse as a recreational drug. Yet, I also recognized that with proper security any misuse of plant material grown for medical trials could be prevented. Indeed, the danger from growing this plant seems no more hazardous than other illicit drugs to which the government limits access through appropriate security arrangements.
As a faculty member at a great public, land-grant University, I have the responsibility of serving the people by participating in scientific studies that supply evidence through experimental trials. In this effort, I have spent the last 20 years as an agronomist investigating the growth and development of various medicinal and aromatic plants and providing leadership in the study of these plant materials at the local, national, and international level. These investigations, I trust, have been helpful to a number of medicinal and aromatic plant growers and ultimately to the people interested in using these products for health purposes.
Overall, the proposed research effort with medical marijuana involves several people with different specialties and different roles. My job would be to produce a selection of plant material that could be used in clinical trials trials established so that medical doctors can determine if use of this plant material could improve patient health or provide symptom relief. If we do not seek the answer to this question, I believe that we all lose, our fear of scientific investigation blinding us to patients’ continued suffering.
Allen Hopper is a senior staff attorney at the American Civil Liberties Union’s Drug Law Reform Project. He represents Professor Lyle Craker in his appeal of the U.S. Drug Enforcement Administration’s denial of his application to grow research-grade marijuana for use in studies that aim to develop it into a legal, prescription medicine.
Immediately prior to joining the ACLU, Mr. Hopper was a post-conviction death penalty defense attorney with the California Appellate Project (CAP) in San Francisco. CAP was established by the California Supreme Court and the State Bar to act as liaison to the Court, overseeing and providing case assistance to the lawyers appointed by the Court to represent death row defendants in their state and federal post-conviction proceedings.
At the ACLU, Mr. Hopper focuses on marijuana policy-related litigation. He wrote a legal analysis of the continued validity of state medical marijuana laws in the aftermath of the U.S. Supreme Court’s recent decision in Gonzales v. Raich and has been quoted extensively in the national news media on the topic. Mr. Hopper wrote letters to the attorneys general and head officials in four states demanding that they reinstate medical marijuana laws that were improperly suspended after the Raich decision in June 2005. All states complied. In addition to litigating cases, Mr. Hopper works with ACLU staff to conceptualize public education campaigns that aim to shift our nation’s punitive drug policies away from over-incarceration and towards a public health approach.
Mr. Hopper earned his J.D. from the University of California, Davis, School of Law in 1992. While in law school, he worked with a Washington D.C. public interest law firm engaged in litigation seeking to expose the relationship between the war on drugs and American foreign policy in Central and South America. Mr. Hopper worked in the Immigration Law Clinic at the U.C. Davis School of Law and did anti-apartheid impact litigation with the Legal Resources Centre in Durban, South Africa. After graduating from law school and before joining CAP, he worked in private practice focusing on criminal defense, prisoners’ rights and police misconduct litigation.
Statement of Allen Hopper, Attorney with the ACLU Drug Law Reform Project
The American Civil Liberties Union welcomes the opportunity to represent Professor Craker. We believe that scientists and doctors should be free to pursue the truth about all drugs and to conduct legitimate research without government obstruction or censorship rooted in the politics of the drug war. We believe that the public has a right to know the truth about the drugs and medicines they consume. And we believe that sick people have a right to safely access the medicines their doctors say they need to save their lives or alleviate pain; they should not have to buy these drugs off the street. Patients throughout America are already benefiting from medical marijuana, but further research is needed to develop a safe, affordable, predictable and reasonably attainable treatment.
The U.S. Supreme Court recently held in Gonzales v. Raich that the federal government maintains authority under the commerce clause of the Constitution to enforce federal marijuana laws, even in states that have made the medical use of marijuana legal. During the Raich oral arguments, however, Justice Breyer signaled the way forward, telling one of Angel Raich’s attorneys that his clients should ask the Food and Drug Administration to reclassify marijuana as appropriate for medical use. Justice Breyer noted, medicine by regulation is better than medicine by referendum.
We’d like to take Justice Breyer up on his suggestion on behalf of the nearly 80 percent of Americans who support medical marijuana. Unfortunately, the federal government has set up a classic Catch-22: They say we need more research to establish the safety and efficacy of marijuana as a medicine, yet at the same time obstruct that very research. One of the primary ways the federal government has kept medical marijuana research from moving forward is through the monopoly the National Institute of Drug Abuse (NIDA) has on marijuana that can legally be used for research. No other controlled substance including LSD, MDMA (ecstasy), heroin, and cocaine is subject to this absurd NIDA monopoly. All other controlled substances can be procured by scientists from any number of DEA-licensed laboratories once their research protocol has been approved by the FDA. Yet with marijuana, even after the FDA approves a research protocol and grants permission for a study to go forward, NIDA maintains virtually sole discretion over the provision of material required for research. And NIDA has refused, time and again, to provide marijuana for legitimate, FDA-approved research, bowing, instead, to the politics of the government’s war on drugs.
Under the current regulatory scheme, the only realistic way that scientists will be able to conduct the research necessary to evaluate marijuana’s safety and efficacy as a medicine is to develop an alternative source to NIDA. That is what Professor Craker seeks to do, barred only by the DEA’s refusal to grant him a license a license the DEA is legally obligated to issue if so doing would be in the public interest. We intend to prove through the testimony of scientists, doctors and patients that it is, without question, in the public interest to grant Professor Craker’s application.
The government is afraid of the truth: Marijuana may be a safe and effective medicine. The government is forsaking science and putting politics before the public good. We hope that Professor Craker’s legal challenge will expose and begin to redress this reprehensible situation.
Rick Doblin, Ph.D.
Rick Doblin is the founder and director of the non-profit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS). One of the primary missions of MAPS is to sponsor scientific research designed to develop marijuana into a Food and Drug Administration- -approved prescription medicine and to educate the public honestly about the risks and benefits of this drug.
MAPS holds the only Orphan Drug designation granted by the FDA for the medical use of marijuana, specifically for AIDS Wasting Syndrome. The Orphan Drug program was created by Congress to facilitate development of drugs for rare diseases diseases affecting less than 200,000 people in a year. Drugs for such rare diseases are not considered sufficiently profitable for pharmaceutical companies, and their research has therefore been minimal, leaving such drugs as orphans. Orphan Drug designation provides a package of incentives for research and development, including seven years of patent protection (exclusive right to market) should convincing data about the drug’s safety and efficacy ever be submitted to the FDA, and the drug subsequently approved. Marinol, the oral pill containing the active ingredient in marijuana, THC, was approved for AIDS Wasting under the Orphan Drug program.
MAPS is the sponsor of a research project at a Drug Enforcement Administration -licensed laboratory into the safety and efficacy of the marijuana vaporizer, an alternative non-smoking delivery system for medical cannabis. This laboratory applied over two years ago to purchase 10 grams of marijuana for research from the National Institute on Drug Abuse (NIDA) currently, the sole supplier of marijuana for medical research. Because NIDA and relevant federal agencies have failed to review the simple research protocol to date, this study has been effectively blocked. NIDA has also refused to supply marijuana to two other FDA-approved human studies sponsored by MAPS, preventing them from taking place. The government’s monopoly on marijuana fundamentally obstructs MAPS’ effort to develop marijuana into an FDA-approved prescription medicine. Furthermore, NIDA’s marijuana, even if made available to MAPS-sponsored researchers, is not necessarily of sufficient quality to meet FDA approval standards.
Beginning in 2000, MAPS has sponsored University of Massachusetts Professor Lyle Craker’s efforts to establish a marijuana growing facility to produce marijuana of the quality required to legitimately pursue FDA approval. Rick Doblin is presenting testimony before a DEA Administrative Law Judge that approval of Professor Craker’s application to grow research-grade marijuana would benefit the public interest by allowing critical, privately funded, MAPS-sponsored research into the potential medicinal effects of marijuana.
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