Last Friday, November 18, I attended a hearing conducted by the New York City Council’s Committee on Mental Health, Mental Retardation, Alcoholism, Drug Abuse, and Disability Services. As discussed in my previous post, the subject of the hearing was a proposed resolution by the Council calling upon the New York State legislature to enact a “medical marijuana” law, specifically A.7347/S.2774 introduced in the Assembly by Richard Gottfried and in the Senate by Tom Duane (the “Bill”). (I described this bill in its earlier incarnations in posts in this blog in May and July 2010.)

Five council members heard testimony: Gail Brewer, Daniel Dromm (the author of the resolution), David Greenfield, G. Oliver Koppell, and Reuben Wills. (I note that Koppell is a former NYS Attorney General.) For all intents and purposes the members other than Greenfield asked the witnesses to give them a good reason why they should not approve the resolution. They were clearly sympathetic to the idea that cannabis should be available to sick people and people in pain. Indeed, Dromm and Brewer referred to their own personal acquaintance with people who had benefited from the use of cannabis, including deceased Council Member Philip Reed. Wills, the chair of the Drug Abuse Subcommittee, seemed very well-versed in the issues concerning medical marijuana – when presented with the standard counterargument that “medical marijuana” already exists in the form of Marinol, he focused on the degree to which insurers will reimburse for Marinol and the cost of a Marinol prescription versus the cost of an ounce of cannabis from a dispensary. In response to the objection that marijuana is dangerous because the smoke contains tar, Koppell put this danger in context by observing that there are other dangers in society that are not criminalized.

In contrast, the sole voice of opposition among the Council Members was that of Greenfield who presented the standard objections: there is no evidence of medical utility, marijuana is a “crude plant” product and cannot be standardized, there are multiple types of marijuana, Marinol is a good alternative, and so on.

The position of the NYC Department of Health and Mental Hygiene

The first witness and the only witness for the City was Dr. Adam Karpati, Executive Deputy Commissioner for the Division of Mental Hygiene in the NYC Department of Health and Mental Hygiene. It was a sad and unenviable job that befell Dr. Karpati – coming up with some coherent basis for the Mayor’s opposition to the resolution. According to Dr. Karpati, DHMH opposes the resolution because of “the lack of clear, scientifically validated medical benefits of smoked marijuana and the known harmful components of marijuana smoke.” Dr. Karpati’s testimony referred to recommendations by the Institute of Medicine, the National Institutes of Health, the WHO and the American Public Health Association to the effect that “therapeutic uses of cannabinoids warrant further basic pharmacological and experimental investigation and clinical research into their effectiveness.” His prepared statement continued: “They agree that more research is needed on the basic neuropharmacology of THC and other cannabinoids and related methods of administration so that better therapeutic agents can be found.” (Emphasis added. This statement seems to express the classic position that use of the cannabis plant should be avoided at all costs – i.e. the plant form cannot be a medicine.)

His prepared statement recites that “the potential negative health effects of smoking marijuana are serious. Smoking marijuana damages the lungs. Marijuana smoke contains cancer-causing chemicals and it deposits four times as much tar in lungs as cigarettes.”

Koppell and Wills put a series of questions to Dr. Karpati. Dr. Karpati was not aware of any studies in “medical marijuana” states evaluating the effects of marijuana on patients. Council Member Koppell asked if he was aware of any studies evaluating the degree, duration and amount of marijuana ingestion necessary to achieve therapeutic effect, i.e. how many marijuana cigarettes are needed; in response Dr. Karpati essentially ducked the question and said that it raised the issue of the lack of clear information on clinical conditions and the patient population. Koppell commented that DHMH’s position is inconsistent: if the Department really believes that marijuana smoke is so bad he would expect to see DHMH targeting healthy marijuana smokers (presumably in the form of an advertising campaign targeting cannabis users with negative imagery in the subway similar to the campaign against tobacco.)

Wills commented that every drug on the market has adverse health effects. Dr. Karpati responded that the benefits of smoked marijuana are not clear and that the clinical trials show no benefit. (Emphasis added. I wonder what are the clinical trials to which he refers.) He cited to comments by the Institute of Medicine to the effect that smoked marijuana is a “crude delivery system” that delivers tar. Wills asked Dr. Karpati if he knew how accessible Marinol is, especially whether health insurance will cover it; Dr. Karpati said he was not aware of any obstacles to Marinol. Wills asked if he was familiar with the monthly cost of Marinol and if he was aware that a patient could obtain an amount of marijuana sufficient for a month at the cost of $50; Dr. Karpati responded by saying that the issue of access to health care is important in general and the health care system is not perfect. Wills asked if Dr. Karpati is familiar with vaporizers as a delivery system; he responded that there are some interesting alternative delivery mechanisms.

Greenfield presented a set of questions that, as Koppell’s and Wills’ questions indicated their posture inclined towards approving the resolution, indicated his opposition. He asked if the doctor was aware of any other medicines that are smoked, how many types of marijuana there are and how it could be possible to standardize a dose in light of the more than one hundred types, how many chemicals there are in marijuana smoke, whether heroin should be legalized, and whether medical marijuana is a back door to legalization. Dr. Karpati had very little work to do in response to these questions although I did sense that responding to the question about legalizing heroin (“that’s a longer question”) required some diplomacy. In his followup questions, Koppell encouraged DHMH to look into the question of the safety of ingestion by vaporizer.

Other testimony

There was testimony by other panels. Witnesses for the New York State Nurses Association (Ellen Brickman), the Marijuana Policy Project (Karen Crosson), and Law Enforcement Against Prohibition (Joanne Norton), and a medical marijuana patient (Arlene Williams – the “Ganja Granny”) testified in favor of the Bill, as did (of course) Richard Gottfried and Tom Duane. Three witnesses testified in opposition: an addiction treatment counselor (Max Schwartzberg) who spoke of his ten-year addiction to marijuana and the destruction it caused, an addiction medicine doctor (Dr. Nick Pace), and a psychiatrist (Dr. Greg Bunt). The opponents to the resolution testified consistently that marijuana is not a medicine because the FDA has not approved it and no exception should be made for marijuana that is not made for other medicines.

I found very interesting the fact that no one appeared to testify on behalf of NYPD or any of the District Attorneys or the Special Narcotics Prosecutor (who, as discussed in a previous post, issued a public letter opposing the Bill).

The fundamental issue – federal obstacles to clinical trials

Although the City Council invitation to attend had also invited me to testify, I did not intend to testify because I did not consider myself sufficiently knowledgeable about the federalist questions in other jurisdictions to speak. As I listened to the testimony I realized that we would not reach those issues. I decided that I must speak to the Council Members in order to clarify the many misstatements I was hearing. However, by the time I reached the microphone there was only one issue that required comment.

The medical/non-medical dichotomy in drug control which I have described in previous posts is the fundamental conceptual obstacle to rationalizing drug control. My cursory reading of David Musto’s “The American Disease” indicates that this dichotomy became a practical legal matter at the outset (circa 1915) of the US Treasury Department’s enforcement of the Harrison Narcotics Act because the Treasury Department determined that prescribing opiates to maintain an addict’s habit was not a legitimate treatment.

That issue appears front and center in the medical marijuana debate. The essence of the opposition to the City Council resolution was that marijuana has not been proven to be a medicine. Why? There have not been enough studies. The FDA has not approved marijuana.

I testified (actually I just said my name and started talking – no oath required) to state that this basis for objection is completely disingenuous – for the reasons I stated in my last post, plus one special reason. The basic cause for the current debacle is federal intransigence in placing cannabis in Schedule I and then maintaining it there for forty-one years. Let us aside for the moment the question of what it means to have a “currently accepted medical use in treatment in the United States” – let us assume for the sake of argument that it does mean “FDA-approved.” It is now federal intransigence that is preventing a clinical trial of cannabis – the proposed clinical trial of cannabis in vaporizers, with Dr. Donald Abrams as lead researcher under the auspices of the Multidisciplinary Association for Psychedelic Studies. Dr. Abrams sought cannabis for use in clinical trial. The only legal source of cannabis in the United States (i.e. the only source for use in research) is the National Institute on Drug Abuse, which has licensed Dr. El-Sohly at the University of Mississippi. NIDA refused to provide cannabis to Dr. Abrams. MAPS decided it would be necessary to create its own legal source of cannabis and so applied to the DEA to license Dr. Lyle Craker at the University of Massachusetts as a “bulk manufacturer” of cannabis, meaning that he could cultivate cannabis for use in clinical trials. The DEA refused. MAPS brought an administrative proceeding against the DEA to compel the DEA to license Dr. Craker. The DEA Administrative Law Judge ruled in favor of MAPS. The DEA rejected the ruling. MAPS is now proceeding against the DEA in federal court. See the MAPS page describing its attempts to obtain cannabis for use in the clinical trial which the opponents to medical marijuana laws say is lacking.

No discussion of the movement to legalize the medical use of cannabis under state law is complete and accurate without a discussion of federal intransigence and obstructionism. In the research venue, the clearest example is Dr. Craker’s application. All claims that more research is necessary are disingenuous if they do not take into account the failure of the federal government to facilitate or – at a minimum – permit research intended to evaluate cannabis’ safety and therapeutic efficacy.

That was my message to the Council Members present. (Mr. Greenfield had left by the time I spoke.) Presumably, if the Committee approves the resolution – which I do not doubt – then the matter will go to the City Council as a whole. At that time it will be necessary for proponents of medical marijuana in New York State to be ready to deal with the standard arguments that come out time after time after time. (There really are no new arguments; they seem to come straight out of a DEA briefing manual.) The key issue, as is clear from Friday’s hearing, is whether FDA approval is what qualifies a substance as a “medicine” and – if so – whether marijuana is excused from this standard by reason of the United States Government’s failure to allow clinical research. It correctly restates the statement by opponents of the medical use of cannabis that there should no exception from FDA-compliant clinical trials for cannabis.