BLOGGER HTML TEMPLATE AS OF 4/15/16 BEFORE REDIRECTION TO WORDPRESS New Amsterdam Psychedelic Law Blog: November 2011

Sunday, November 27, 2011

Irony in federalism - New Jersey

Let us revisit New Jersey for a moment, with specific regard to a fascinating comment in a recent story in the Philadelphia Inquirer (Nov 26, 2011) about local opposition to Alternative Treatment Centers ("ATCs")0.

First, back in March, the state approved the six entities described as ATCs, i.e. the suppliers to the medical cannabis market. They are as follow:
(The following information comes from a story in the Inquirer from March 21, 2011.)

NORTHERN REGION

Foundation Harmony, Cliffside Park.
Board of Directors: Maria Karavas, Ida Umanskaya, Margarita Ivanova and Dmitri Bajanov.
Proposed location: Secaucus, Hudson County.

Greenleaf Compassion Center, Montclair.
Board of Trustees: Joseph Stevens, president, CEO; Jordan A. Matthews, Robert J. Guarino.
Proposed location: Montclair, Essex County.

CENTRAL REGION

Breakwater Alternative Treatment Center, Corp., Ocean.
Board of Trustees/Officers: Richard Lefkowitz, CEO; H. Alexander Zaleski, COO.
Proposed location: Manalapan, Monmouth County.

Compassionate Care Centers of America Foundation Inc. (CCCAF), Jersey City.
Board of Directors: David Weisser, Michael Weisser and Anastasia Burlyuk.
Proposed location: New Brunswick, Middlesex County.

SOUTHERN REGION

Compassionate Care Foundation Inc., West Trenton.
Board of Trustees: William J. Thomas, David Knowlton, James C. Herrmann, Ann Marie Hill, Jeffrey Warren, JoAnn Lange, Mark Dumoff.
Proposed location: Bellmawr, Camden County

Compassionate Sciences, Inc. Sea Cliff, NY.
Board of Trustees, CEO Richard Taney, Dr. Steven Paterno, CFO Jack Burkolder; Webster Todd.
Proposed location: either Burlington or Camden County

According to the Inquirer coverage, the applicants had to show that the proposed center's location is not in a drug-free school zone, and conforms to local zoning or the applicants have applied for a variance to permit the operation.

I find this interesting because the Inquirer just ran article about how some of the ATCs are facing opposition from the local communities in which they wish to set up. The article focuses on (a) a public hearing in Upper Freehold on an application by Breakwater Alternative Treatment Center (Central Region) to create a grow facility on a local farm and (b) a decision by a zoning board in Maple Shade, Burlington County (Southern Region) that a proposed site for Compassionate Sciences Alternative Treatment Center's grow operation and dispensary was not appropriate.

On the other hand, the article goes on to say that Ilan Zaken, a local businessman in Camden, would like to rent commercial space to an ATC. I see only Compassionate Sciences and Compassionate Care Foundation as ATC's in the Southern Region, so I assume that Mr. Zaken will be dealing with one of those two.

Now, the really fascinating aspect of this story is the statement that members of the township council in Upper Freehold who oppose the ATC setting up a grow facility in their town said that they would try to pass an ordinance "that would bar the town from allowing anything contrary to federal law."

The irony here is great: state medical marijuana laws came into being because federal law will not permit any medical use of cannabis, but here a local government is attempting to prevent licensure of one of the supply-side entities legalized under state law by alluding to federal law. I see this argument as similar to the classic argument which the DEA uses to oppose all domestic reform: the US has no choice but to maintain the status quo because we are bound to international treaties which prohibit any change in US law. In the NJ situation, the locality is essentially rejecting the determination by the state government that legalized the medical use of cannabis and instead reaches up to the federal government in an attempt to declare its solidarity with federal opposition to 'medical marijuana.'

What an interesting approach. The place to oppose the law was in the NJ legislature at the time of enactment; I would expect to see an attempt to repeal the law in the state legislature. I might also expect to see federal intervention. I might expect the localities to reject an application by ATCs on a case-by-case basis. However, this approach is something entirely: it functionally cancels the state law by resetting federal law as the applicable standard. It is not "state" action, i.e. it is not Governor Christie preventing implementation of the law: instead it is local level opposition to a business enterprise licensed by the state.

Tuesday, November 22, 2011

Clinical trials of cannabis in California? What?

Doug drew my attention to the following article about the Center for Medical Cannabis Research at the University of California: The Gaps in Medical Marijuana Knowledge - voiceofsandiego.org: Q & As.

I had heard of the Center but never really focused on it.
The article says that the Center has been conducting what are the equivalent of Phase II clinical trials on the therapeutic uses of cannabis, specifically pain relief.

What?

So maybe I need to educate myself further on the question as to whether there have been clinical trials of cannabis. If there have in fact been clinical trials, and Dr. Grant indicates that he thinks that what the CMCR has been doing, then where are the clinical trials showing NO benefit which Dr. Karpati alleged at the hearing on Friday?

There are many, many interesting things about this story, but the one that jumps out is the idea that this is a state-funded research program. In other words, it is a publicly-funded whose focus seems to be researching therapeutic uses of cannabis - not doing studies trying to show how dangerous it is.

Dr. Grant says that his funding will run out next year so the studies will stop. He says "I don't see where the funding will come from."

How about - taxes on the dispensaries? Federal funding diverted from raids on dispensaries or eradication efforts? In other words, divert a little rivulet of the drug control budget into evaluating the claim that cannabis has no therapeutic benefit.

Monday, November 21, 2011

The City Council hearing

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.

Wednesday, November 16, 2011

New York City Council to hold hearing on proposed resolution calling on the NYS legislature to enact a medical marijuana law

The New York City Council Committee on Mental Health, Mental Retardation, Alcoholism, Drug Abuse and Disability Services, jointly with the Subcommittee on Drug Abuse will hold a hearing on Friday, November 18, 2011 at 10:00 a.m. in the 16th Floor Committee Room, 250 Broadway, New York, NY to consider Proposed Res. No. 94-A, a resolution calling upon the New York State Legislature to pass A.7347/S.2774, legislation that would legalize the medicinal use of marijuana.


Here is the text of the resolution:

Proposed Res. No. 94-A

Resolution calling upon the New York State Legislature to pass A.7347/S.2774, legislation that would legalize the medicinal use of marijuana.

By Council Members Dromm, James, Vann, Brewer, Comrie, Jackson, Koppell, Koslowitz, Mark-Viverito, Nelson, Williams, Mealy, Mendez, Rodriguez, Lander, Rivera, Crowley, Sanders Jr., Reyna and Koo.

Whereas, Marijuana refers to all parts of the plant Cannabis sativa L.; and

Whereas, The primary active ingredient in marijuana is THC (delta-9-tetrahydrocannabinol), which reacts to nerve cells in the brain and leads to a euphoric high that users generally experience when smoking marijuana; and

Whereas, Proponents of medical marijuana point to a large body of reports and journal articles that support the therapeutic value of marijuana; and

Whereas, These written works address the ability of marijuana in the treatment of a variety of disease-related problems, including relieving nausea, increasing appetite, reducing muscle spasms and spasticity, relieving chronic pain, reducing intraocular pressure, and relieving anxiety; and

Whereas, Nationally, 16 states, Alaska, Arizona, California, Colorado, Delaware, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont, Washington, and the District of Columbia, have enacted laws or passed ballot measures which have authorized the use of medical marijuana; and

Whereas, On October 19, 2009, the United States Department of Justice issued formal guidelines for federal prosecutors in states that have enacted medical marijuana laws; and

Whereas, The guidelines contain in pertinent part that, "[p]riorities should not focus federal resources in your States on individuals whose actions are in clear and unambiguous compliance with existing state laws providing for the medical use of marijuana;" and

Whereas, Marijuana remains a Schedule I substance under the Controlled Substances Act and the United States Drug Enforcement Association asserts that this classification means that marijuana has a high potential for abuse, currently has no accepted medical use in treatment, and lacks accepted safety for use of the drug or other substance under medical supervision; and

Whereas, Yet, advocates of medical marijuana laws view the Department of Justice's policy as an important acknowledgement that patients and medical professionals should not fear prosecution as a result of adhering to state law; and

Whereas, However, some advocates are concerned that recent action taken by the Department of Justice against medical marijuana dispensaries in California will threaten individuals engaging in the medicinal use of marijuana throughout the country; and

Whereas, In New York State, Assembly Member Richard Gottfried and Senator Thomas Duane introduced A.7347/S.2774, legislation that would legalize the medicinal use of marijuana; and

Whereas, This legislation would accomplish this task by legalizing the possession, manufacture, use, delivery, transfer, transport or administration of marijuana by a certified patient or designated caregiver for certified use; and

Whereas, The bills also create procedures for allowing practitioner's to certify that their patients' serious medical condition should be treated by the medical use of marijuana; and

Whereas, Pursuant to the legislation, the New York State Department of Health is required to monitor the use of medical marijuana, promulgate rules and regulations for registry identification cards and provide reports to the Governor and the Legislature on the medical use of marijuana; and

Whereas, Multiple public health and advocacy organizations support this legislation including the Medical Society of the State of New York, the New York State Nurses Association, the Hospice and Palliative Care Association of New York, the New York Statewide Senior Action Council and the Gay Men’s Health Crisis; now, therefore, be it

Resolved, That the Council of the City of New York calls upon the New York State Legislature to pass A.7347/S.2774, legislation that would legalize the medicinal use of marijuana.

My comments:

I am happy to see this initiative on the part of the City Council and I am greatly looking forward to attending the hearing.

However.
I note with ... curiosity ... the jump, without further analysis, in the resolution from (a) the reference to the "Ogden Memo" from October 2009 that deprioritized enforcement of marijuana laws against individuals whose actions are in compliance with medical marijuana laws to (b) the oblique reference to "recent action taken by the Department of Justice against medical marijuana dispensaries in California."

The situation, according to all reports I have seen, is that the federal government has begun an all-out assault on the California medical marijuana movement. One aspect is the tactic by the IRS to deny medical marijuana businesses, especially Harborside Consulting, the ability to deduct expenses incurred in the course of their operations. [I have read about this issue only in passing and have not studied it in any depth, so my comment does not purport to be overly authoritative.] Another is the increase in DEA raids in California. The key issue for our purposes is the series of threats by US Attorneys that state officers who participate in medical marijuana programs will be in violation of federal law and subject to criminal penalties.

That latter one is the bigger issue and should be the focus of the City Council.

I must revisit the situation in NJ which I described in early posts. I would lay this whole situation at the feet of Chris Christie, since, I believe, he was the one who triggered this backlash by the feds - by trying to kill the NJ medical marijuana program in various ways - including the proposal that Rutgers University cultivate all of the cannabis to be supplied, thus completely undermining the supply side which the statute provided, that being a set of dispensaries. Of course Rutgers publicly stated that it could not do so because it would jeopardize its federal funding. Obviously. What we have, then, is the public recognition that the feds have numerous mechanisms for stopping medical cannabis, including threats to state officials. What else? The feds will deny funding of highway construction to any state that implements a medical marijuana program?

I always, always thought that the Ogden Memo of October 2009 was thin ice and wildly overestimated - because it never went to the roots of federal prohibition. It is the mildest of mild: it is a suggestion about what prosecutors should prioritize. In fact, it is loaded with disclaimers that it creates no rights or defenses.

Now, I do note a fascinating argument which Dave Holland made to the effect that the Ogden Memo implicitly upended Schedule I classification - because it deferred to state law recognizing a medical use of cannabis. Brilliant argument, Dave, keying right off of the "currently accepted medical use in treatment" prong of Schedule I classification, which has been the source of most if not all human suffering since 1970. It is genius because it connects directly to the theory which Buford Terrell discusses to the effect that since the practice of medicine is a matter reserved to the states the feds have no authority to reject determinations by the states as to what constitutes a valid medical treatment; see also Carl Olsen's petition in Iowa. Last I heard, however, the District Court Judge presiding in Dave's case denied his motion to dismiss the indictment without comment.

I would propose something different: a resolution by the City Council directed to the President of the United States and the US Attorney General calling upon them (a) to direct the DEA Administrator to stop raiding medical marijuana dispensaries, (b) to direct the US Attorneys in the states with medical marijuana programs not to threaten action against state officers implementing medical marijuana programs and (c) to clarify the meaning of the "medical use" prong of Schedule I classification. Then the resolution can call upon the NYS legislature to make a similar demand - and enact a medical marijuana law. The Council could also call upon the DEA to license Dr. Lyle Craker of the University of Massachusetts as a "bulk manufacturer" of cannabis for use in a clinical trial of cannabis to be conducted by Dr. Donald Abrams - i.e. breaking the monopoly held by the National Institute of Drug Abuse as the sole legal supplier of cannabis in the US.

I might even demand that the United States government cease attempting to determine what constitutes medical treatment. (I intend to post more on this issue, which I consider the key to ... everything.)

Hmm. I guess what I am saying is that if the City Council is going so far as to endorse the enactment of a NYS state medical marijuana law - which is a stupendous and highly commendable development - the Council should also reference the broader context of federal intransigence and hostility that forced the creation of populist state-based medical cannabis movements - and demand an end to that conduct.

I may say as much at the hearing.