By HENRY I. MILLER
Published: June 17, 2007
In Stanford, California
MANY states nationwide are considering legislation to legalize the medical use of marijuana. Last week, one such bill cleared both houses in Connecticut (but at press time had not yet been signed by the governor), New York appears likely to follow suit and New Jersey has two bills with bipartisan support. Indeed, a number of states have had similar measures in play over the last year, in addition to the 12 that have already passed such laws.
The picture is very different at the federal level, where marijuana is branded as an illegal drug. An amendment to a recent drug safety bill would require all purveyors of state-authorized medical marijuana to be subject to Food and Drug Administration regulation. The senator who introduced this amendment said that making any drug available without F.D.A. review or proof of safety and effectiveness would set a dangerous precedent that would threaten patient safety. Marijuana advocates have opposed the bill, because it would close medical marijuana cooperatives and create barriers to the use of the drug.
Should state laws permit marijuana dispensaries — which charge high prices for marijuana products, including tinctures, baked goods and candies, and offer medical advice — to flourish without any kind of federal supervision or other assurance of quality? After all, marijuana is not a uniform, well-defined material. Different plant strains vary radically in their cannabinoid composition and in the contaminants — fungi, bacteria, pesticides, heavy metals and other substances — they contain. Products made without any proof of quality control may be ineffective or harmful.
If marijuana has therapeutic potential, it should be required to pass muster with the F.D.A. like any other medicine. We have considerable experience with making drugs from plant material, including the opium poppy. We don’t authorize patients to smoke (or vaporize) opium for medical purposes; rather, we require that opiate products, including morphine for pain relief and paregoric for diarrhea, be standardized, controlled for quality, fully tested, delivered in an appropriate manner and shown to be safe and effective. Why should marijuana be any different?
That question is often ignored by marijuana advocates as they tout recent research findings. For example, they note that researchers like Dr. Donald Abrams of the University of California, San Francisco, have demonstrated that marijuana has a modest ability to relieve pain, but play down its significant side effects, not to mention the risks of smoking.
It is difficult to see how inhaled herbal cannabis can ever become a federally approved medication. Indeed, the California Medical Association recently questioned the appropriateness of continued research into crude herbal marijuana plant material. So why does controversy continue?
Medical marijuana proponents claim that it is only for political reasons that the F.D.A. and the Drug Enforcement Agency will never license a marijuana-based product or even permit legitimate research. But they are being disingenuous at best and deceptive at worst. These marijuana advocates fail to acknowledge that although smoking is an imprecise way to deliver any substance to the bloodstream (and from there to the brain), there is substantial evidence that herbal marijuana material can be extracted, formulated, standardized and delivered by means of an appropriate delivery system, and that such research is at an advanced stage in the United States and elsewhere. When presented with a cannabinoid development program that comports with modern scientific principles, both the F.D.A. and the D.E.A. have demonstrated their willingness to allow it to proceed.
Last year, the F.D.A. approved advanced clinical trials of a marijuana-derived drug called Sativex, formulated as a mouth spray. Sativex has been approved in Canada for the treatment of neuropathic pain associated with multiple sclerosis, and it is available by prescription (though not yet fully licensed) in Spain and Britain. The scientific community has shown interest in the future of cannabinoid products, and this year, two major organizations of pain specialists held a symposium that presented data on Sativex. Numerous cancer pain researchers have agreed to join the study, which is scheduled to begin soon.
Sativex contains an equal ratio of two cannabinoids: tetrahydrocannabinol, which is psychoactive, and cannabidiol, which is not. Its spray dispenser delivers a precise dose of the drug, which is absorbed through the mucous membranes of the mouth. The composition of the drug and the manner in which it is delivered together allow its active ingredients to be medically effective without causing the kind of “high” that many patients view as an undesirable side effect. Like other products ranging from the cancer drug taxol (derived from the bark of the yew tree) to codeine (from the opium poppy), Sativex offers a model for making a genuine pharmaceutical out of crude plant material.
Drugs like Sativex should — but won’t — end the rancorous debate over medical marijuana in a way that would both benefit patients and satisfy the legal requirement that marketed medicines must be proven safe and effective. Even if it did, the issue of whether marijuana should be legalized as a recreational drug would remain. In fact, one cannot escape the suspicion that the real agenda of many medical marijuana enthusiasts is legalization, and that they are using state legislative initiatives as a way to circumvent rigorous testing and federal oversight.
Patients who are genuinely in need deserve safe and effective medicines, and rigorous testing and oversight are the best ways to provide them.
Henry I. Miller, a doctor and fellow at the Hoover Institution, headed the Food and Drug Administration’s Office of Biotechnology from 1989 to 1993. He is the co-author, most recently, of “The Frankenfood Myth.”
After the New York State Assembly passed a medical marijuana bill (it still needs to pass the State Senate and be signed by the Governor to become law), the New York Times Metro section published an op-ed by Henry I. Miller, “Crackpot Legislation.” Unfortunately, while Miller makes the important point that marijuana should be evaluated by FDA-approved research, he fails to make any mention of the federal government’s systematic obstruction of such research.