New Amsterdam Psychedelic Law Blog

California state court rules that federal law preempts a local licensing ordinance - bad news for the rest of us?

2012-01-24T13:36:00.002-05:00

Pack v City of Long Beach is one of four medical cannabis cases that is going to the California Supreme Court. I believe that the holding and reasoning are not good for the type of system for licensing dispensaries that appears in the RI, NY, and NJ laws, i.e. people apply to the state for licenses to open dispensaries.

The plaintiffs in the Pack case were patients whose dispensaries were closed down under an ordinance which the city passed in order to create a lottery for dispensary applicants. The plaintiffs apparently didn't like the ordinance because they considered it too restrictive so they sued - get this - for a declaration that federal law preempts the ordnance, i.e. it conflicts with federal law and therefore cannot be enforced. That federal law is the Controlled Substances Act, which is the bane of existence of everyone who seeks to liberalize laws governing cannabis, so this position is completely counter-intuitive.

The judge agreed and ruled that the ordinance conflicts with the Controlled Substances Act and is therefore preempted. The reasoning was that California law only exempts patients, caregivers and cooperatives (the legal fiction is that the dispensaries are patient cooperatives or collectives - I believe that is how it works) from criminal prosecution, but the city ordnance affirmatively provided a mechanism for licensing dispensaries, i.e. it authorized them to operate.

I see some problems with the court's reasoning but that is the holding. The problem is that all of the state regulatory schemes coming out now, unlike the system in California, provide that the STATE license the dispensaries - exactly what the California state court said is preempted by the CSA. In the final calculation the judge is probably right, say I without having read the CSA all the way through and researched the case law.

Comments by AZ attorney Ryan Hurley concerning the status of medical cannabis in AZ

2012-01-24T12:05:00.003-05:00

NORML: US attorneys are preparing to attack Colorado medical cannabis industry

2011-12-22T17:10:00.000-05:00

The Next State In The Federal Government’s Crosshairs Is Colorado

NJ township bans medical marijuana dispensaries

2011-12-19T15:37:00.001-05:00

I posted previously about an interesting variation in the federalism problem which state medical cannabis laws create. State medical cannabis laws are an end-run around federal drug control policy, A/K/A prohibition. However, even when the states legalize therapeutic uses of cannabis, the localities can use their powers to ban cannabis distribution systems. Upper Freehold NJ has now banned medical cannabis dispensaries.

Would the localities also ban home cultivation by individuals and caregivers? The New Jersey and New York statutes do not permit individual cultivation; I believe that is why there is a bottle-neck in NJ, i.e. there is a medical cannabis law on the books but patients cannot get legal access since only corporate entities can cultivate it - and the state thwarted licensing any entities as long as it could. The lack of permission for patients to grow their own meant - no legal access to cannabis at all.

One of the common arguments against medical cannabis cultivation is that they create crime. If the objection is that a large grow-and-sale operation known to the public will be a magnet for crime as miscreants try to break in and steal the crop/merchandise, then perhaps private, undisclosed cultivation by patients or their caregivers would be a solution, except that private cultivation in a home - presumably without security guards and serious security systems - would present an even more tempting target, e.g. for potentially violent home invasion.

Cannabis as an herb, literally and legally.

2011-12-18T22:41:00.001-05:00

In my latest post I cited to the section of Gonzales v. Raich in which the decision indicated that moving cannabis to one of Schedule II through V would still subject cannabis to [I paraphrase] the heavy regulatory burdens of the Controlled Substances Act. The opinion goes on to say "Furthermore, the dispensing of new drugs, even when approved by doctors, must await federal approval," citing to United States v Rutherford, 442 U.S. 544 (1979).

I see two significant points in that statement, which I discuss in reverse chronological order.

First, the reference to "federal approval" obviously means approval of a substance by the FDA as "safe" and "effective" since the decision cites to Rutherford, a decision holding that there is no exemption from the requirement that a new drug be approved by the FDA as safe and effective before it goes into commerce - even to terminally ill cancer patients. It is most interesting, then, that the Supreme Court distinguished between (a) approval by doctors of the use of a new drug and (b) approval of a drug by the FDA. This distinction tends to support Buford Terrell's theory that "currently accepted medical use in treatment in the United States" does not mean FDA approval.

Second, this passage suggests that moving cannabis to Schedule II through V will not help because in the absence of FDA approval doctors still could not prescribe it nor could it be marketed.

Buford recently proposed a different approach to deal with problem: reclassify cannabis as an "herb," i.e. a dietary supplement.

Federal regulation of medicine and Gonzales v Raich

2011-12-14T16:45:00.008-05:00

For about two weeks I have intended to respond to Eapen's comment on my last post in which s/he (?) asked about the relationship between (a) Buford Terrell's proposed interpretation of the "currently accepted medical use in treatment" scheduling criterion and (b) the US Supreme Court's decision in Gonzales v Raich, 545 US 1 (2005).

I decided to do a full post instead of trying to put my response into a comment.

This post is an initial treatment of the topic, not a full treatment, because I am still in the process of re-reading the key decision of Gonzales v Oregon, 546 US 243 (2006), which came after the Raich decision and discussed the Controlled Substances Act in depth, specifically the limits of federal authority over the practice of medicine. I am not going to discuss Raich or Oregon in depth here. I hope to do so before too much more time passes.

However, the short version is that I don't see that Raich is more than marginally relevant to Buford's proposed interpretation of the "medical use" prong of Schedule I.

To recap, Buford proposes that the "currently accepted medical use in treatment" clause should be interpreted to mean that the DEA can only determine whether cannabis is used medically at the state level and then must react accordingly; the DEA proposes that medical use means FDA approval. I am going to call Buford's interpretatiYon the "Reality Check" model, since it requires that the DEA check the reality of what is actually happening out and about in the real world. I am going to call the DEA's interpretation the "Permanent Prohibition" model, since as a practical matter it means that the federal government will not recognize a medical use in the absence of Congressional action to reschedule cannabis - who is going to pay the $800 million to take cannabis through Phase III clinical trials? (Anyone? Anyone?)

The Supreme Court in Raich held that the interstate Commerce Clause of the Constitution supports federal jurisdiction over cannabis which two individuals grew within the State of California for their own use. Plaintiffs Angel Raich and Diane Monson argued that the federal government has no right to interfere with activity that occurs entirely within state lines - without overt connection with commercial activity crossing state lines. This argument relates to two principles: (1) in theory, the federal government may exercise only powers which the Constitution grants to it and (2) the enormous growth of federal regulation and control over all aspects of life rests on the constitutional authorization of Congress to regulate "commerce ... among the several states." Article I, section 8. This clause is the "interstate commerce clause." The plaintiffs argued that their activities did not implicate interstate commerce and they sought an injunction and judicial declaration ("declaratory judgment") that the DEA had no legal basis for interfering with their cultivation and use of cannabis - activities that were legal under state law. They did not challenge the Controlled Substances Act as a whole, nor did they challenge the validity of the Schedule I classification of cannabis - so there was no overt discussion of whether the DEA validly determined that there is no currently accepted medical use in treatment.

This argument was a long shot since it ran directly counter to an early Supreme Court decision called Wickard v Filburn. I'm not going to discuss the rationale here; suffice it to say that the majority opinion in Raich rejected the lower court's decision that the Wickard decision did not apply to the entirely intrastate cultivation and use of cannabis for medical purposes. The consequence was a holding by the Court that Raich and Monson's activities did affect interstate commerce and therefore agencies of the federal government had a solid constitutional basis for interfering with those activities.

Logic chains

During law school I read that all of law is a syllogism. If a = b and b = c, then a= c. For example: 1. Tom is a cat. 2. Cats chase mice. 3. Therefore, Tom chases mice. (This is the same as my explanation in the sidebar as to why cannabis is a psychedelic for purposes of legal analysis.) I am going to call this reasoning a "logic chain."

The relevant underlying premise of the Raich decision is that Congress can regulate all activity concerning controlled substances, even activity that takes place entirely wihin state lines ("intrastate activity") because, in the hallucinatory world of legal reasoning, such activity is presumed to affect interstate commerce. If the substance is a Schedule I substance then that regulation takes the form of prohibition.

The disconnect between Raich and the Reality Check theory should now be apparent. The Reality Check v. Permanent Prohibition discussion takes place at an earlier stage of the logic chain than does the interstate commerce question. The Reality Check theory discusses what substances should be in what schedule. In particular, it proposes that the federal government's position as to whether there is a currently accepted medical use in treatment is a CONCLUSION based on state law, since regulating the practice of medicine is a matter which the Supreme Court has already held is reserved to the states. In other words, the choice between Reality Check and Permanent Prohibition - i.e. where the DEA should put a particular substance - takes place at an earlier stage of the logic chain, separate and apart from the question of whether the federal government can validly interfere with Angel Raich's cultivation of her own cannabis. Under the Raich holding, the DEA can regulate Angel Raich's cannabis garden no matter whether cannabis is in Schedule II, III, IV or V. (In fact, precisely this reasoning appears in Raich in Section IV: "Thus, even if respondents are correct that marijuana does have accepted medical uses and thus should be redesignated as a lesser schedule drug, the CSA would still impose controls beyond what is required by California law.")

There is one place in the Raich decision that is plausibly relevant to the medical use question. The Court of Appeals for the Ninth Circuit had distinguished the personal use of cannabis from the facts of the Wickard case by saying that "intrastate, non-commercial cultivation, possession and use of cannabis for personal medical purposes on the advice of a physician and in accordance with state law" is somehow distinct from the drug trafficking which the Controlled Substances Act was intended to reach. In the course of rejecting this distinction, the Supreme Court noted that Congress expressly found that the drug has no acceptable medical uses. That statement is remarkably inaccurate. The Congress cannot find that cannabis has no acceptable medical uses; it may have found at the time that there were no CURRENTLY accepted medical uses in treatment - but that is not the same as determining that there can never be a use for cannabis in medicine. (In fairness to the majority opinionholders, I don't believe that is actually what the justices meant to express. In the beginning of the decision, at length in footnote 37, and in the concluding paragraph, Justice Stevens indicated his sympathy for the plaintiffs and his skepticism about Schedule I classification. Footnote 37 begins: "We acknowledge that evidence proffered by respondents in this case regarding the effective medical uses of marijuana, if found credible after trial, would cast serious doubt on the accuracy of the findings that require marijuana to be in Schedule I.") One element of the Controlled Substances Act is the ability to move substances in the schedules based on evolving knowledge. If a quarter of the states pass laws allowing for medical use of cannabis, then it is plausible that the states are currently accepting a medical use of cannabis in treatment. It is no longer the US Congress that is keeping cannabis in Schedule I; it is the DEA. It is only that the Congress has so far failed to act to rationalize drug control.

The next step is to review the decision in Gonzales v Oregon, which discusses at length the limitations on the federal government's authority to regulate the practice of medicine.

"Currently accepted medical use in treatment," A/K/A the end game

2011-12-02T09:10:00.013-05:00

That which stands between the current human condition and an alternative mode of existence is 21 U.S.C. Section 812(b)(1)(B).

That statutory citation, in plain English, is the "medical use" prong of Schedule I of the Controlled Substances Act, the knot at the heart of drug prohibition.

Section 812 of the CSA states the elements of the Schedules into which first the Congress in 1970 placed and in which the DEA continues to maintain (some) psychoactive substances.

The criteria for classification in Schedule I are as follow:

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has no currently accepted medical use in treatment in the United States.

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

That is the legal home, or should I say the "House of Detention" (to quote The Doors, "When the Music's Over") in which reside cannabis, LSD, MDMA, psilocybin, ibogaine, ayahuasca and mescaline, among other psychedelics.

Psychoactive substances can pass legally in interstate commerce only in accordance with the CSA. The CSA provides no mechanism by which Schedule I substances can move in interstate commerce, i.e. at all. The CSA prohibits the cultivation, manufacture, sale and purchase of Schedule I psychedelics except as the statute permits. Take a look at Section 829 of the CSA, the section governing prescriptions for controlled substances. This section is the statutory basis for physicians to prescribe drugs such as opiates and amphetamines. What does not appear at Section 829? Schedule I substances. Since the federal government does not recognize any medical use of Schedule I substances, no physician may prescribe them. Not even a physician may prescribe them...so surely none of the rest of us may self-administer, administer to others, or participate in facilitating administration.

There you have it. That is how psychedelic prohibition works.

It is the medical use prong that sets Schedule I apart from all the other schedules. Each of the schedules looks to the same criteria: abuse potential, medical use, and safety. In each of the four lower schedules - each of which corresponds to a progressively less-restrictive distribution scheme - at item (B) the statute states that there is a currently accepted medical use in treatment. Again, the distinguishing characteristic of Schedule I is NO medical use. I have said before that the essence of "drug prohibition" (a highly non-technical term which I dislike but I will use for the sake of convenience) is the criminal prohibition of all use of psychoactive substances except for medical use - construed as narrowly as possible. Under this analysis, in the case of Schedule I there is no medical exception, as a matter of law.

When DEA representatives and publications say that marijuana is not a medicine, they are referencing the "currently accepted medicine use in treatment" scheduling criterion.

So what does it mean?

Buford Terrell, a retired law professor in Houston, and one of my regular correspondents, has offered an an analysis of the phrase which I find totally totally totally fascinating. To my eye it is THE essence - the "missing link" - of the debate over drug control and, frankly, I consider insufficient any argument that does not address the issues he discusses. I am not aware of any analysis that addresses these issues and I believe that the arguments about federal control are insufficient without this argument.

I am very pleased that he has posted an analysis of two possible constructions of that phrase, the one which he says the DEA favors, one that imprisons humanity in its current condition, i.e. an existence in which psychedelics are not integrated into society as legitimate tools of therapy and personal growth, and the one that opens the door to an alternative existence.

His post appears here.

I have said in the past in other places that there is an obvious problem with the phrase "currently accepted medical use in treatment." Aside from the questions what does "medical use" mean, what does "in treatment" mean and what does "medical use in treatment" mean, I want to know who does the "accepting"? (We could also ask what does "currently" mean in this context.) This element is phrased in the passive voice. Accepted by .... a doctor? a patient? the American Medical Association? the World Health Organization? Medicaid? the DEA Administrator? It's the zillion dollar question (or perhaps I should say, the question should be valued at the cost over the last forty years of prohibiting any use of cannabis).

Buford addresses this topic head on. He posits that there are two ways of construing phrase: (a) the DEA checks to see whether the FDA has approved the substance or (b) the DEA checks to see how doctors as a matter of fact treat the substance. (I paraphrase.) He argues for the second, addressing the crucial question of whether the US Constitution permits the federal government to regulate the practice of medicine. He says no. If he's right, then the game is over. If the DEA may only ascertain whether doctors ... and we may also argue for patients, their families/caregivers, nurses and other allied health professionals, hospital administrators, public health officials...ACTUALLY consider the substance to be useful "medically" (we can revisit what THAT means), then the DEA must reschedule the substance.

Here is a (large) excerpt from his post:

The second possible meaning is that the issue is strictly one of demographics. Under this theory, the DEA has no competency to examine the scientific and medical questions, but must limit itself to determining what, in fact, doctors do in the course of treating patients. In other words, the question becomes one of whether a substantial number of doctors treat marijuana or MDMA is a therapeutic agent when dealing with their patients and whether other doctors approve or disapprove of that use.

An examination of the development of the regulation of both legal and illegal drugs indicates that the second reading, limiting the DEA to the question of what doctors do in practice, is more consistent with current constitutional law. That story began soon after the enactment of the Harrison Narcotic Tax Act in 1914.

That act criminalized a doctor’s dispensing or prescribing an opiate to a patient outside of the normal course of medical practice. The government began prosecuting doctors who furnished morphine or heroin for the purpose of maintaining their habits (much like methadone is used today), claiming that maintaining addicts in a stable, functioning life was not part of the normal practice of medicine.

The Supreme Court considered that question three times before deciding that Congress had no constitutional authority to say what was “the practice of medicine”. In Linder (1925) the Court held that medical practice was not part of interstate commerce and, consequentially, the power to regulate medicine, including determination of what is or is not medicine, is reserved solely to the states.

While the Supreme Court has discussed medical marijuana in over twenty opinions, it has not directly dealt with this problem of interpretation of the CSA. However, in Conant v. Walters (2002), the Ninth Circuit applied this reasoning in holding that the federal government, acting under the CSA, could not prevent a state-licensed doctor from recommending the use of marijuana to a patient. So far the DEA has not presented the issue to another circuit.

Congress was faced with this exclusion of the federal government from the regulation of medicine when it created the Food and Drug Administration through the Food, Drug, and Cosmetics Act in the 1930s. The purpose of the act was to insure food and drug safety, but since Congress could not regulate drugs directly, indirect action was called for.

Consequently, the FDA was not given power to approve drugs, but instead, it was empowered to prevent drugs from being sold in a deceptive or misleading manner. A drug sale would be misleading and deceptive unless that drug bore a label approved by the FDA. That label would be approved only if it were substantiated by valid scientific tests that the drug was safe for the intended use.

That method of regulating drugs by controlling their marketing was continued as the FDCA was amended, first in the1950s to separate prescription and over-the-counter drugs and then in the 1960s to require scientific proof of efficacy for at least one medical use before a label could be approved. The Supreme Court has approved this distinction in cases involving the rights of doctors to prescribe drugs for “off label” uses, treatment of conditions not included on the label, although manufacturers have been punished for publicizing or advertising those uses. Doctors distributing drugs which they themselves had produced and furnished to their own patients as part of a broader therapy and not using the instrumentalities of interstate commerce have also been held to be outside the jurisdiction of the FDA. The most recent case, Gonzales v. Oregon (2006), prevented the DEA from taking action against doctors acting under Oregon’s assisted suicide law.

...

This constitutional derivation strongly favors the interpretation that the DEA is limited to asking only what doctors are, in fact, doing and is barred from inquiring into the medical or scientific value of the drug. The statutory language itself reinforces this interpretation. The statute specifies “currently accepted medical use”; Congress could have easily used “medically effective” or “substantial medical value” if the intent had been to empower the DEA to conduct independent scientific investigations. Congress did, in fact, empower the FAA, FCC, and NTSB with those kinds of direct powers in regulating airplanes, broadcast stations, and trucks and buses: all direct instrumentalities of interstate commerce.

The DEA’s own Administrative Law Judge applied a “medical use” standard in the first two contested scheduling proceedings under the CSA: the first marijuana petition and the proceeding for the emergency scheduling of MDMA. The politically appointed Administrator reversed his recommendations in both cases. In the MDMA proceeding, the Administrator rejected the ALJ’s findings, equating “medical use” with “approved by the FDA”. The Court of Appeals (Grinspoon, First Circuit, 1987) rejected this interpretation and remanded the case for further consideration.

If the courts were to require the DEA to use a medical use standard instead of a medical value standard, rescheduling of marijuana and MDMA would necessarily follow, allowing them to be sold through normal medical channels; and the rescheduling of psilocybin, LSD, mescaline, and possibly heroin and ibogaine would be likely. These drugs, while having no, or little, current medical use, could be covered by a “but for…” argument. Each of them had thriving medical use and widespread favorable medical reporting before they were classified as Schedule I drugs. But for that classification, their medical use would probably be common today. Heroin, for instance, is routinely used in many countries with developed, sophisticated medical systems. This information would be probative in a rescheduling action. If coupled with expert opinions about the scope of its use by American physicians and pharmacologists, it should be persuasive.

Translation: the DEA says that the law says that there is no medical use of cannabis (or MDMA or LSD or ibogaine) because the FDA has not said that there is a medical use and therefore there is no medical use. However, the FDA does not say that whether or not there is a medical use of a substance. It permits marketing and distribution of a drug if it passes the FDA's tests for efficacy.

Any comments?

Irony in federalism - New Jersey

2011-11-27T02:02:00.003-05:00

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.

Clinical trials of cannabis in California? What?

2011-11-22T22:34:00.000-05:00

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.

The City Council hearing

2011-11-21T13:27:00.000-05:00

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 said 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.

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

2011-11-16T23:47:00.000-05:00

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.

Global Cannabis March

2011-05-05T14:09:00.000-04:00

The annual global cannabis policy protest day is scheduled for this coming Saturday. See the Global Cannabis March website for a list of participating cities.
I for one find it very impressive that this event, which grew out of the annual May Day Marijuana Parade in New York City, has gone viral so to speak and solidarity events now take place in cities across the globe. (Some cities conduct their events on days close to but not quite on the first Saturday in May.)

I find even more interesting that there is apparently a strong protest presence in Mexico. Is this not amazing news? A Mexican cannabis law reform movement? In Mexico - the failed narco-state constantly in the news because of the 30,000 people killed after Calderon declared war on the cartels? The state whose past president said that the US should end prohibition? How is that no one has paid any attention to the Mexican cannabis law reform movement. Fascinating. I don't speak Spanish but maybe someone will be my translator....

Assembly for the NYC event will begin at Washington Square Park at 12:00 and continue with a march down to Foley Square. Foley Square is interesting because it is located between the federal and state court buildings. It's a perfect place to speak about drug policies and the laws that embody them. It's not much for aesthetics. The event is co-sponsored by Celebstoner, NYC NORML, Empire State NORML, and Law Enforcement Against Prohibition.

There's lots of other news, most of which is likely known to readers of this blog. The Montana legislature's attempt to repeal the state's 'medical marijuana' law got a lot of press. However, I believe that the most interesting news item is the federal government's new statement of position that it will re-prioritize prosecution of dispensaries operating in compliance with state law. Although I have not yet read the actual communications by US Attorneys to state officials stating the new policy I understand that it is a reversal of the policy in the October 2009 memo from the Attorney General to the US Attorneys stating that action against dispensaries operating in compliance with state law is not a priority for the Department of Justice. It was this memo that was construed as the Obama Administration's tolerance for state 'medical marijuana' laws.

The memo was phrased as nothing more than a suggestion that the US Attorneys focus on other things, not a statement that the US government would irrevocably refuse to enforce the Controlled Substances Act against the 'medical marijuana' industry. One veteran cannabis law practitioner, David Holland, Esq., argued extensively in a criminal case in the US District Court for the Northern District of New York that the memo, which he referenced as "the Ogden Memo," actually required the rescheduling of cannabis, the argument being that since the federal government directed its personnel to defer to state law stating that dispensaries could operate legally, cannabis could no longer logically remain in Schedule I. I think it's an excellent argument but I understand from Dave that the judge didn't go for it. (Maybe Dave's argument scared DOJ and prompted a policy reversal....) Again, the only way I see to make a real change in drug policy starts with real changes in the Controlled Substances Act - e.g. abolishing Schedule I or throwing out the scheduling criteria.

Psychedelic sacraments

2010-12-14T00:01:00.001-05:00

I read with great interest the material at freetaitajuan.org concerning a Colombian ayahuasca healer who was arrested in Houston for possession of the substance. It got me thinking about one of the alternative paradigms of psychedelics. (Thanks to Ben for bringing it to my attention.)

We are all familiar with the model of psychedelics use as a form of substance abuse.

One alternative model is the medical/therapeutic use of psychedelics, which basically tracks the medical model that governs psychoactive substance use: if the criteria for socially-condoned use is "medical" utility, then show there's a medical use. That's basically the MAPS model.

Another model, however, is the sacramental model, which we see in the context of ayahuasca, peyote, psilocybin, and iboga, among others. (Of course there is also a contingent of cannabis users who have argued for sacramental status; my understanding is that argument has not fared well in the courts.)

One potentially interesting point of contact is the question of whether there is necessarily a conflict between the idea of a sacrament and the idea of a therapeutic agent. Perhaps there could be a sacramental aspect to a therapeutic agent.

It seems to me that this inquiry comes back to the question of supply-side regulation. I believe that the critical conceptual inquiry - in general - is the nature of the supply side: who can participate, what are the barriers to entry, who determines that someone else may no longer participate in the market (e.g. by losing a license), and so on.

Regulating a medicine is a fairly straightforward matter for post-Enlightenment society.
The only question in the context of psychedelics is whether the psychedelic can be a medicine.

However regulating a sacrament may be a little more tricky.

What would happen if psychedelics were to be redesignated as sacraments?
Who is qualified to determine whether use of a psychedelic is sacramental or abusive?
Only the congregation? Only the "Church Elders"?
Someone else?

Just wondering.

Further musings

2010-11-30T02:01:00.000-05:00

The November 16 conference at the Bar Association went off well. The presentations were top-notch.

I found especially interesting Steve Rolles and Mark Haden's discussions of classifying psychoactive substances. One point which Steve made in After the War on Drugs and repeated in his presentation is the limited utility of saying that one drug is more dangerous than another - without regard to dosage: in other words, is one drug safer than another at all doses?

What about using a different standard for toxicity, such as the lethal dose level? There were comments at the panel - I think also from Steve but maybe from Mark - differentiating between substances that are toxic in the near term versus substances that are toxic over the long term. Tobacco is not toxic in the near term but it is toxic over the long term. Possibly then it is necessary to create a nuanced standard for toxicity - one which recognizes that there are substances that can damage the users immediately and some that cause damage only over the long term.

I come back to the question of "medical utility" as a basis for drug classification. Everyone knows by know that the existing drug control system rests on the ban of non-medical use. Therefore, the question of medical use is the threshold question: if there is no medical use, then no use is permissible. I have seen floated the idea that the essential step going forward is to eliminate entirely a medical use requirement from the drug classification scheme; that change is probably what would equalize the majority of psychoactive substances with alcohol, tobacco, and caffeine. What makes the latter three psychoactive consumer products? They do not require medical justification for their use.

October 2010: current events and musings about The Big Picture

2010-10-24T14:33:00.000-04:00

Hello all.

Various personal and professional issues have separated me from my true love - you, my readers - but I am back for a brief and discreet rendezvous.

There is a vast stream of news and information regarding 'drugs' rushing through the media arteries. Most of it relates Proposition 19 in California, the "legalization." There is also a steady stream of articles about the county-by-county litigation in Colorado regarding dispensaries.

There are also a few stories closer to home regarding cannabis.

New York
I am delighted to announce that I will be moderating a panel on legal issues on the second day of the exciting conference on the cannabis industry to be held on October 25 and October 26 here in New York City AKA The Capital of Everything (including capital). The speakers will be Justin Alpert, a New York- and New Jersey-licensed attorney who advises start-ups, and Brian Vicente, a cannabis industry lawyer from Sensible Colorado.

Rhode Island
As of June 12, 2010, there were 15 applicants for registry as "Compassion Centers," the term which the Rhode Island medical marijuana statute," uses to describe dispensaries.

On September 10, 2010, the Rhode Island Health Department rejected all 15 applicants for registry as Compassion Centers, citing alleged defects in all 15 applications.

Now, unlike the situation in New Jersey, this act by the state appears not to be fatal to the medical marijuana program since the statute allows for cultivation of cannabis by patients and designated caregivers.

On October 1, the Health Department subsquently put out a call for new applications using amended application forms.

Petition for declaratory ruling by the Rhode Island Department of Health
There is one particularly interesting development in this mix, which is a petition dated September 27 requesting a ruling by the Health Department as to whether there will be a violation of Rhode Island health regulations when a physician, nurse practitioner, or physician owns an interest in a Compassion Center.
The petition, in the form of a letter from David C. Hughes on behalf of Community Care Health and Wellness, Inc., suggests a regulation of the Rhode Island Board of Medical Licensure and Discipline and an opinion of the American Medical Association which such ownership might violate.

The petition suggests that such ownership would be equivalent to a violation of the antikickback statute since a physician's advocacy of a particular drug or device should not be influenced by the physician's own financial interest, i.e. ownership of an interest in a business whose revenue could increase as a result of advocacy. (Here, of course, the physician would not "prescribe" cannabis, since no one can prescribe cannabis until Congess moves it out of Schedule I or, when the lion lies down with the lamb, the DEA moves it out on its own accord.)

The petition asserts that there is "an urgent need" for such a declaration since, it alleges, six applicants for registry as Compassion Centers are associated (my paraphrase) with physicians and one physician assistant.

Without casting aspersions, I note that, according to the Providence Journal, the author of the petition, Community Care Health and Wellness, Inc., was one of the fifteen applicants for registry. From afar, the petition could be construed as a crass attempt to eliminate competition or it could be seen as a straightforward observation that a healthcare practitioner should not be allowed to obtain compensation from sale of a product when a practitioner is the sole gatekeeper to the legal acquisition of that product.

Of course, this whole paradigm goes to one of the fundamental questions on which I have dwelt in the past, which is the medical/non-medical dichotomy. Yes, it is standard that a health care practitioner not profit from his own prescription (in this case "recommendation") practices - but why is a physician the gatekeeper to cannabis?

Anyway, Community Care Health and Wellness seems to have scored a hit since the Department of Health website says regarding the petition: "The Department does not expect to issue a ruling before the Compassion Center registration application period ends. Applicants are advised that the ruling may impact the eligibility of their applications. Applicants and others should check this web page for updated information about the Declaratory Ruling process." (Emphasis added.)

New Jersey

New Jersey finally issued draft regulations for operation of its medical marijuana program. Advocates decry these regulations as intolerably restrictive. Some of them explicitly contravene the medical marijuana statute, like limiting the alternative treatment centers to four, even though the statute states that six is the minimum. Audacious.

Big picture

I am going to take one more moment. In it I will address what I consider the big picture consideration. Much of my extracurricular activity has gone into working on the event at the NYC Bar Association discussed in the previous post, and its subject matter dominates my current thinking, if not that of the last 17 years, since it revolves around the Controlled Substances Act.

The big picture is the concept of the "regulated market." The basic concept, if I may try to summarize it, is that there are numerous potentially dangerous products in the marketplace, e.g. alcohol, tobacco, pharmaceuticals, firearms, explosives, automobiles, airplanes, even pornography. (Have you ever considered that any nut job can walk into a housewares store and buy a steak knife?) All of these products are "legal" under limited circumstances. The question at hand is whether substances subject to the Controlled Substances Act can be allowed into the consumer market under any circumstances - and, if so, what those circumstances should be.

The "medical marijuana" debate is really a subchapter of this question, which encompasses all psychoactive substances. I believe that this inquiry - what is the appropriate form of market regulation for each substance considered on its own terms after a completely new evaluation from the ground up - is the name of the game. Should cannabis be available in a smoke shop alongside tobacco? (Hmm, of course that presupposes that tobacco is not on its way to being banned.) Should it be allowed for onsite consumption, like a tavern, or only takeout, like a package store? Should it be allowed only pursuant to a physician's prescription, which would be the result if it moves into Schedule II of the Controlled Substances Act?
How about MDMA? Should its use be allowed only under the supervision of a physician? How about under the supervision of a psychologist? How about heroin? Should it be available for onsight consumption - e.g. in a supervised injection facility under the supervision of social workers and peer counselors with a physician on staff?

I have always assumed that a real critical reassessment of drug control will require revising or retiring outright the three statutory criteria for scheduling Controlled Substances, appearing at 21 U.S.C. 812:
(A) potential for abuse
(B) currently accepted medical use in treatment in the United States
(C) safety for use of the drug or other substance (under medical supervision)
Under these criteria, cannabis, heroin, and LSD all appear in Schedule I.
I know I am not being original here, but perhaps the first step would be to eliminate (B), "medical use," as a scheduling criteria.

Anyway, I nominate the regulated market inquiry, i.e. "what is the appropriate legal mechanism of regulating each particular substance" as the big picture question of which all other questions, even the speculation as to whether Proposition 19 will cause the tax revenues of California to increase, are derivatives.

Upcoming program at the New York City Bar Association

2010-10-03T13:13:00.000-04:00

Following is the notice for an upcoming event to be held at the New York City Bar Association, 42 West 44th Street, New York (between Fifth Avenue and Sixth Avenue) on Tuesday, November 16, beginning at 5:30 pm:

CONFRONTING AN OXYMORON: TAKING CONTROL OF CONTROLLED SUBSTANCES

The federal Controlled Substances Act of 1970 defines U.S. drug control. For forty years it has affected crime, public health, and the justice system, with little success: the societal harm relating to drugs continues to escalate. On this fortieth anniversary of the Controlled Substances Act, the Committee on Drugs and the Law will present an international group of experts to address key questions:

• What can health and law enforcement officials do differently to control the supply of and demand for psychoactive substances?

• What economic, regulatory, and social tools to control the drug markets are we not using?

• Which currently-regulated markets for potentially harmful substances or products might be adapted to control the sale and use of illicit drugs?

• Which controls best protect young people?

MODERATOR:
Ellis Cose, Author and Newsweek Contributing Editor

SPEAKERS:
Hon. Roger Goodman, J.D., Vice Chair, House Judiciary Committee, Washington State Legislature, Kirkland, WA.
Topic: Current legislative struggles to reform drug regulation at the state level: legal, practical and ideological obstacles.

Mark Haden, M.S.W., Addiction Clinical Supervisor, Vancouver Coastal Health Authority, Vancouver, B.C., Canada.
Topic: Options for regulation of drugs based on public health and human rights.

Nathan Riley, Legislative Assistant, N.Y. State Senator Joseph Galiber (1990-1993), New York, NY.
Topic: An early attempt to create a regulated market for drugs in New York State and public health crises as the primary impetus for drug law reform to date.

Steven Rolles, Senior Policy Analyst, Transform Drug Policy Foundation, author of “After the War on Drugs: Blueprint for Regulation,” Bristol, England.
Topic: Existing models around the world for regulating products such as caffeine, tobacco, alcohol, pharmaceuticals, as well as prohibited psychoactive substances.

Marc Sorini, Esq., Head of the Alcohol Regulatory and Distribution Group, McDermott Will & Emery, Washington, D.C.
Topic: The legal mechanism of alcohol regulation. (This presentation will focus exclusively on alcohol control and will take no position regarding drug law.)

Eric E. Sterling, President, Criminal Justice Policy Foundation, Assistant Counsel, U.S. House Judiciary Committee (1979-1989), Silver Spring, MD.
Topic: History of federal drug laws from 1914, focusing on the Controlled Substances Act and Reagan-era criminal statutes.

It's no longer a "war." What is it? What it has always been.

2010-09-05T00:06:00.001-04:00

I am allowing myself a short and strictly conceptual post (as opposed to an attempt to analyze a statute or policy statement).

In studying other aspects of drug control I have come to the conclusion that there is a missing change in terminology.

Once upon a time there was a "War on Drugs."
Actually twice: there was a Nixon War on Drugs and then there was a Reagan/Bush War on Drugs.

However, references to a "drug war" are few and far between these days.
There are some real wars that have people's attention. Iraq. Afghanistan. Al-Qaeeda. That ongoing thing with Iran.

Essentially the "War on Drugs" or "drug war" got downgraded to a police action.
There is a military aspect of drug control to the extent that the opium trade finances the Taliban - and it is therefore necessary for the military to conduct actions against the opium fields as part of an actual war.
Otherwise, it is a matter of criminals violating drug laws with police assigned to stop them.

If that is the case, what are we to call the existing policy?

Is it accurate to call it a "War on Drugs" - if that language is no longer current?

Should we call it "Prohibition"?

Is it really Prohibition, i.e. the classic Prohibition of alcohol? I don't think so because it does not employ an amendment to the U.S. Constitution; alcohol prohibition was simply the outright grant of a Constitutional basis for a federal ban on alcohol. Once that Constitutional basis went away, control went back to the states and there is legal manufacture, sale, and possession of alcohol.

The current policy of federal prohibition has a different constitutional basis; it is the interstate commerce clause. Federal "narcotics" prohibition, which is the ancestor of all "drug" prohibition, was never based on its own constitutional amendment. Instead it has been expressed in statutes that relied, in the first generation, on the federal tax authority and now on the federal authority to regulate interstate commerce generally.

The current statute, the Controlled Substances Act, regulates commerce in certain psychoactive substances.
Those substances include heroin, cocaine, cannabis, methamphetamine, LSD, PCP - all the biggies.
It imposes criminal penalties for violations of its provisions.
It IS the policy.

I have said consistently that it's a form of market control in which the only permitted use is "medical" and any misuse is criminal.

Perhaps the task at hand is to limit the acts that qualify for criminal sanction.
Perhaps the task at hand is to redefine the criteria for use.

I don't know. I presume that the task at hand fundamentally is to devise a new set of terminology, one that characterizes substances in terms of their functions, such as sedative, stimulant, dysphoric, euphoric, etc. That distinction appears in a very simple and immaterial way in the Controlled Substances Act, but the statute does not use those classifications to make practical distinctions between the substances.

For the moment, I would explain the current drug policy as "the federal criminal prohibition on the non-medical use of some drugs" - the drugs that are within the jurisdiction of the Controlled Substances Act.

Then take your pick of issues. I would focus on what is "medical."

Summer vacation

2010-09-03T12:52:00.000-04:00

Hello all. I have been out on personal and professional matters for the month of August, and September likely will be full as well. However, I hope to be back soon with more postings on legal developments and announcements concerning upcoming events.

"Rutgers University delivers strong uppercut to Governor Christie," or "The New York Times' Newspeak"

2010-07-24T22:49:00.000-04:00

Saturday's New York Times ran a story that crystallizes into a little pill-size dose large volumes of the conceptual chaos called "drug control policy."

The title of the article is "New Jersey’s Medical Marijuana Law Loses Planned Grower and Dispensers." That is utter nonsense.
It is the famed Newspeak of Orwell's "1984." The headline is a complete mischaracterization of the story which the article tells.

Question: Why did I title this post with the aggressive and dramatic imagery of the chief executive of the State of New Jersey sustaining a very dangerous blow to the head - in contrast to NYT's bland characterization?

Answer: I recognize that it is really a war - a "Drug War" - in the sense of absolute war. It is a war in which everyone is a combatant, because it is an economic war - a war over whether cannabis may enter the free market in which we are all consumers. It is a war over whether cannabis may compete simultaneously with both (a) "medicines" and (b) mood-altering psychoactive substances such as alcohol and, more subtly, tobacco and caffeine. It is a war over whether a new legal industry may come into being - a legal cannabis industry. It is a form of anticompetitive restraint of trade created and maintained by the United States Government.

Prohibition of psychedelic therapeutics, including "medical marijuana," is a war, and Christie was doing his duty as a dedicated drug warrior faced with an unpleasant reality: he had just become governor of a state that had legalized the sale and purchase [note the free market concept] of cannabis under very narrow circumstances. The New Jersey statute contemplates that nonprofit dispensaries may grow cannabis and sell it to patients. Those are the "alternative treatment centers" to which I referred in my last post.

Private enterprise. Outrageous.

Christie decided to destroy the incipient medical marijuana program by announcing that he wanted a drastic revision to the statute - a statute which the legislature had already passed and which the previous governor had already signed into law.

First, of course, he declined to comply with the statutory requirement that his branch of government, i.e. the executive branch as represented by the Department of Health and Senior Services, draft regulations that would allow the program to come into being. Then, when the activists and patient advocates knocked on his door to ask him to explain his malfeasance, he announced that he really just intended to kill the program. How did he do that? He announced his intent to create a government monopoly on the supply of cannabis, and not only would he take supply out of the hands of the private sector but he would put it in the hands of bureaucracies that cannot in practice implement the program because of federal law.

Under Christie's plan, Rutgers University would be the sole entity that could cultivate cannabis and only hospitals could dispense it. I said, as did Chris Goldstein of Philadelphia NORML, that this plan was dead on arrival because in no way, shape. or form could universities or hospitals, as creatures hopelessly dependent on federal funding, engage in such brazen defiance of federal law and survive financially.

And thus today's NYT article reports: "But on Thursday, Rutgers announced that it would not participate for fear of losing grants from the federal government. State officials said the hospitals had the same concern." And again: Robert Goodman, the executive dean of agriculture and natural resources at Rutgers said "'it just puts too much at risk,' jeopardizing research grants, contracts, student aid or other funds from Washington." And again: "The New Jersey Council of Teaching Hospitals declined to comment, but several people briefed on the discussions said the hospitals wanted some kind of guarantee that they would not be jeopardizing federal money."

Of course they want a guarantee. And of course Christie cannot make that guarantee. And that's why the proposal was a plan to abort the medical marijuana program. Along the lines of what I have argued previously, anyone who makes that kind of proposal without reaching an informed conclusion that it is viable under federal law is either grossly incompetent and should not be allowed to remain in a position of authority or understands the consequences and seeks them.

When Rutgers University came forward and said to the media that it cannot do what the Governor wants out of a healthy fear and sense of self-preservation, it shouted that the Governor Wears No Clothes - because it was a no-brainer that the proposal was a bad joke. I assume that Rutgers needed to come forward and make the statement because no one in the Governor's Office had the common decency to come forward and admit the obvious.

NYT reports that the governor is angry about the university's decision - and of course he should be: they didn't continue to run interference for him.

Now, the more interesting comment is the report that one of the sponsors of the bill, Assemblyman Reed Gusciora, thinks that Rutgers is "'chickening out'" by not testing federal authorities' willingness to grant a waiver. That is an interesting idea - the university should enlist in the medical marijuana movement, jeopardizing its financial well-being in the name of ending federal cannabis Prohibition. That would be very valorous and self-destructive, but I sense from the article that Gusciora may not be up on the issue: the university would be violating the Controlled Substances Act by manufacturing a federally-controlled substance without being first licensed by the Drug Enforcement Administration. See 21 U.S.C. 823(a). What Gusciora seems to say is that the DEA should allow Rutgers to manufacture cannabis without going through the licensing process.

Again, I doubt that anyone has really thought the issue that much, because if they had done so they would have run across the administrative proceeding in which the Multidisciplinary Association for Psychedelic Studies has attempted to obtain DEA's permission for Dr. Lyle Craker at the University of Massachusetts to manufacture cannabis - so that MAPS can conduct the clinical trial of cannabis which the DEA says is lacking. The short version is that MAPS wanted to obtain a legal source of cannabis for use in a clinical trial. The only way for MAPS to obtain cannabis under federal law is to deal with a manufacturer of cannabis licensed by the DEA. There is only one such manufacturer, the National Institute on Drug Abuse (NIDA), a federal administrative agency in the Department of Health and Human Services; NIDA has contracted with the University of Mississippi to grow its cannabis since the 70s. NIDA won't let MAPS have any cannabis to do a clinical trial. Also, MAPS has explained that it is ultimately pointless to conduct FDA-compliant clinical trials of cannabis: MAPS cannot demonstrate that the final product brought to market will correspond to the substance tested - because the supply is in the hands of a government monopoly. The DEA administrator rejected the determination by the agency's Administrative Law Judge in 2007 that the agency should license Dr. Craker to manufacture cannabis. The government monopoly remains protected. A government monopoly on the supply of the substance. Sound familiar? Sound like Christie's plan?

That's a large part of why I think the NYT article is so disingenuous. It says "The Obama administration has stopped the practice of raiding medical marijuana dispensaries in [states that have 'medical marijuana' laws] but the Drug Enforcement Administration remains reluctant to grant permission to grow the plants, even for medical research." "Reluctant"? The DEA refuses to break the government monopoly on the supply of cannabis. That's not reluctance. That is a blockade - an act of war.

I come back to my point from earlier posts. The state medical marijuana laws are a populist uprising against federal Prohibition as embodied in the Controlled Substances Act. It is absolutely essential to avoid the federal government at all costs - you should definitely not designate only entities that depend on federal funding as the sole suppliers to the market. Someone who is going to violate the Controlled Substances Act by growing cannabis without a DEA license should at least be someone willing to assume the risk. Maybe the DEA would not want the bad press of arresting private citizens who create a corporation and get licensed by their state to grow cannabis: presumably those people are militant activists who are in the struggle because it is just, they hate tyranny, and they are ready for the fight. However, it should be much, much easier to intimidate a large institution that has depends on federal funding and has other business besides overthrowing the criminal ban on psychedelic therapy.

The NYT article closes with the statement "the plan to use Rutgers and the teaching hospitals would have given the state far more direct control over the program than the Legislature intended." Well, that's really the issue, isn't it? The statute expressly provides for the operation of not for profit corporations as growers and sellers of cannabis; the officers and directors of those corporations will assume the risk of growing cannabis without a DEA license - a risk which we can assume no sane hospital administrator or university president will take. Those corporations will be the prototype of retail sale to customers. Christie has attempted to prevent those corporations from coming into existence - first by ignoring the deadline for the state to promulgate regulations for the program and then by attempting to chain the program to the federal government, as described above. Now that Rutgers has exposed his proposal for what it is - ludicrous - the question is whether he will continue trying to impair the program or whether he will allow cannabis to be integrated into a legal market in New Jersey.

Cannabis as alternative medicine

2010-07-18T22:41:00.000-04:00

I have been turning over in my head recently the whole phenomenon of the "medical marijuana" movement and I conclude that it is time to discard a pernicious dichotomy.

I believe that the irony of the struggle in New Jersey resides in the statutory name of the not-for-profit corporate dispensaries which the medical marijuana statute creates and which Governor Christie seeks to destroy. The funny thing is that the statute refers to the dispensaries as "Alternate Treatment Centers." Note the language with its clear reference to the field of complementary and alternative medicine (CAM).

Those Alternative Treatment Centers are what Christie seeks to destroy through his proposal to undo the enacted statute and place all control over supply in the hands of entities that cannot possibly participate in this market for fear of losing their federal funding. It is just so funny: the legislature devised a scheme to let cannabis slip through federal prohibition by making into an alternate treatment and, in order to thwart this plan, Christie is trying to stick it back into the federal regulatory scheme that effectively governs the practice of medicine.

The tension in cannabis control is the dichotomy between "medical use" and non-medical use. Opponents of the concept of "medical marijuana" state that it is simply a front for non-medical use. However, they don't say "non-medical use." They say "recreational use." Or they say "abuse."

The inner meaning of this language is the dichotomy between medicine and intoxication. The medical/non-medical dichotomy posits what I will call an "alcohol" model of drugs - or an "intoxication" model. The image of use other than for utilitarian purposes, i.e. use that is not intended to solve an acute health problem, is visualized as a form of illicit sensation - a potentially dangerous foray into hedonism. It is a model of unjustified euphoria - a sensation not sanctioned by the authorities. But then, why should non-medical euphoria be justified when society has experienced so much of the intoxicant model, whether as exemplified by alcohol or through unsafe use of other drugs. The intoxicant model is one in which the user seeks oblivion - by consuming to excess, by consuming with the desire for stimulation or impairment to the extent of endangering self and others. The intoxicant model of use is difficult to justify to anyone entrusted with protecting the safety, health and welfare of society.

Enter the model of "alternative treatment." Instead of being a "medicine," which cannabis can't be legally because (a) it is in Schedule I of the Control Substances Act and (b) the FDA has not approved its sale in interstate commerce, or a recreational intoxicant, it is a form of alternative medicine.

This formulation opens the door to the re-characterization of cannabis as something that simply makes a person feel better. Like a painkiller. It relieves pain. Maybe it relieves stress. It could be characterized not as a medicine nor as an intoxicant but as a therapeutic agent if used under the right circumstances i.e a conducive societal context.

The therapeutic use model must contend with two dueling models: the medical model, which is the premise for drug prohibition (since any use other than medical use is criminal), and the intoxicant model, which remains the dominant model of drugs in popular culture - and remains the nightmare image of self-impairment and destruction that justifies drug prohibition. The task at hand then may be to retire the intoxicant model. This approach may be unpopular with the population that projects the model of cannabis 'inebriation,' e.g stoner culture, as a viable option, but it may be the necessary compromise with the surrounding bureaucratic culture of accounting that is charged with assessing risk and figuring out who pays for the mess caused by intoxicated people.

I would like to think that this analysis discloses a deeper stream in the Christie administration's attempt to subvert New Jersey's medical marijuana statute. It is ironic that the Governor of New Jersey has launched an attack on a statute that explicitly describes cannabis as an alternative medicine, a term that implicates an alternative paradigm of psychoactive substance use - a "third way" out of the intoxicant-prohibition impasse. This model of "therapeutic use" as an alternative to both drug prohibition and to intoxication is the real, if perhaps unintended, target of the Christie administration.

How to kill a medical marijuana system, Part II

2010-07-18T22:17:00.001-04:00

It's a little late, I know, but the following article, published July 13, continues to illustrate the point I made earlier. New Jersey Governor Christie's proposal to revise the medical marijuana system devised by the legislature is in essence a plan to kill the system through federalism.

According to this article, the association of teaching hospitals in New Jersey has expressed a strong desire that its members should be the sole dispensers of cannabis to patients - as Christie proposed. Leaving aside the question of whether or not that characterization is true, the most fascinating aspect of this article is the assertion, about three quarters of the way down the article, that the statement by the association in favor of this arrangement admits that the association has not fully analyzed the potential problems with the federal government that the arrangement could cause.

What? No analysis as to the problems this arrangement could cause with federal regulators? Like - the DEA? Like - the Department of Health and Human Services? How could the association possibly make a statement that it would like to participate in this program without conducting such a legal analysis? Is that - what? - gross dereliction of duty by the legal counsel, officers, and directors of the association?

If this statement is true, it tells us that the State of New Jersey has no real concern with creating a functional medical marijuana program - it is proceeding without having conducted the most fundamental consideration in marijuana law: what can the federal government do to you? It instead contemplates allowing the creation of a program that could very well be inoperable from the outset - a program that cannot function since the state government has run its program right back into the grip of the federal government, a sovereign that tolerates no medical use of cannabis. Christie's plan negates the entire logic of a state medical marijuana system, which is that medical marijuana can only function when pried loose from federal control - due to the refusal of the federal government to allow it out of Schedule I of the Controlled Substances Act.

Am I missing something?

Associated Press reports cannabis shortages in New Mexico's program

2010-07-18T01:03:00.000-04:00

My news source does not run many news stories about the situation in New Mexico, but the Associated Press just ran a story quoting a licensed cannabis producer and a patient as saying that New Mexico's licensing system is too cautious and is not adequately supplying the market. This article states that New Mexico is a national model for the state-licensed dispensary system - e.g the model for the Rhode Island, New Jersey, and New York laws; indeed, one of the first stories that ran after the first showdown with NJ Governor Chris Christie stated that the NM Department of Health confirmed that the NJ Department of Health and Senior Services had contacted it regarding NM's program. Accordingly, if there is a problem with the operation of the state that is the model for the other second-generation states, the viability of that state's model requires contemplation.

I have been saying that the trend seems to be onerous over-regulation as a means of preventing medical marijuana systems from functioning. This tactic is, at best, unfortunate since it negates what would have been a workable compromise. If the situation in California and Colorado frightens the states and localities, then the alternative is to require that suppliers get licensed before they open for business. However, if states adopt medical marijuana systems that do permit them to license suppliers, and ostensibly manage an orderly medical marijuana market, and then utilize this licensing power to prevent the effective functioning of the market, they effectively discredit further government regulation and demonstrate again why the citizenry first rose up in California against the drug war.

The next option may be to return medical marijuana entirely to the local, i.e. county, level, such that sympathetic localities permit the de facto operation of medical marijuana cultivation and dispensing. Perhaps the next step is for the citizenry of towns and counties to push their representatives to make declarations in support of workable medical marijuana supply programs.

More New York prosecutors grossly mischaracterize the proposed law

2010-07-13T00:31:00.000-04:00

A new piece on ynn reports that upstate prosecutors have come out against the medical marijuana law.

There is nothing new in their arguments; indeed the recurrence of the identical arguments in every statement of opposition to the therapeutic use of cannabis [or any use, of course] ever more strongly suggests that the opposition derives its position statements, that is to say its lines, from one source. (I can only speculate it is the DEA.) There is the nonsense about the cannabis, grown in dispensaries licensed by the Department of Health, being laced with pesticides or PCP - why do we think that the cannabis grown in such facilities will be laced? Is that, like, the top shelf version of the product - the one that costs the dispensary its license and sends the operators to jail? Then there is the nonsense about more research is necessary before anyone should be allowed to use the drug because... well maybe it's so dangerous that terminal patients should not be allowed to use it... not until someone wants to come forward and put out $800 million for a clinical trial of cannabis. Perhaps there is an intrepid reporter who would like to ask why anyone would attempt to test the therapeutic uses of cannabis when the DEA has refused to license a new legal cannabis cultivator (which would break the federal government's monopoly on the legal cultivation of cannabis) that could supply cannabis for use in the clinical trial of cannabis which the Multidisciplinary Association for Psychedelic Studies attempted to conduct until it was forced to sue the DEA.

Again, when they say that more research is needed, they mean more research into the risks in allowing anyone to use cannabis ever for any purpose, not that the federal government should do the honorable thing and affirmatively FUND clinical trials of cannabis to evaluate its therapeutic utility.

The prosecutors have pumped up strongly this time the completely vacuous, nay - specious, nay - simply untrue argument that the bill will create an unregulated system. From where could they possibly have gone that idea? I addressed the essential logic of this article in an earlier post,("Save us from the doctors.") It's criminal drug prohibition at its atomic, bureaucratic level, so fascinating for us political science students: it is domination of the drug control bureaucracy, budget, and thought process by law enforcement. Don't let the doctors have control of drugs; societal collapse lurks.

You can see that position exemplified in the remarks of Mr. Fitzpatrick of Onondoga County (AKA Syracuse) when he says that the legislature failed to consult the DA's association about the bill - "the people most knowledgeable about the pros and cons of such a move." Fascinating. Why are the PROSECUTORS the people most knowledgeable about the medical utility of cannabis? Why are they the ones most knowledgeable about how to determine whether a patient is using cannabis responsibly or irresponsibly? Perhaps he means that the prosecutors are the ones most familiar with the problem of diversion. Fair enough, so on to my next question: how do licensed dispensaries, whose premises and records are open to inspection and which, under the bill, must document all their sales and report on them to the Department of Health, pose a threat to the public order by allowing seepage of legal marijuana into the illegal drug markets that is anything more than negligible?

Ultimately, all of the criticisms of the bill are just boring. It's the same set of vacuous arguments over and over. We know them all by heart now. They bear no relationship to the proposed law.

Changes to the proposed New York law

2010-07-05T23:20:00.000-04:00

The medical marijuana bill which I described in my first post has changed as the legislative year draws to a close.

As I read the revised bill, I reach one paramount conclusion: someone in Albany is taking seriously what is happening with medical marijuana in other states.

Why do I say that? I detect in the amendments references to the statutory transformation of Colorado and to the recent controversy in New Jersey.

Fundamentally the bill is tracking the evolution of the system in Colorado (by statute) into a revenue-raising measure. In addition I believe that one of the changes may enable the state to preclude the emergence of any private sector in the supply-side of the market, as we see the Governor has attempted (will still attempt to do?) in New Jersey.

Assessment

The really big thing that stands out in the amended bill is the revenue-raising function that appears in new Section 3368. This section provides that a supplier (other than a governmental entity) pays 7.5% of gross sales to the Department of Health (DOH).

This new provision suggests to me a reference to the new Colorado statute which, in addition to placing application requirements on Colorado dispensaries and allowing local governments to ban them, provides for payments by Colorado dispensaries to the state department of revenue, which itself looks to me like a hybrid revenue-raising/medical-use bill.

Special status for entity that contracts to supply cannabis to the Department of Health

Section 3364(1-A) provides that DOH can contract with another "entity" through a "request for proposals process" to manufacture medical marijuana to sell to DOH in connection with DOH's operation as a marijuana supplier. (DOH, an administrative agency in the state government, is one of the six types of corporate entities that can operate in the supply side of the market.) It says that "an entity contracting with the department ... shall be deemed to be a registered producer when acting under that contract."

Why does this section catch my attention? Right away it contemplates that the DOH could actually function as a participant in the supply side. In my May post I opined (subtly and in other words) that that scenario was practically impossible due to the low likelihood that the state government would itself cultivate and distribute a Schedule I substance. (I actually wondered internally why that provision would be in the statute given the unlikelihood that the executive branch of the state government would secede from federal cannabis prohibition so extremely.) However, the fact that someone cared enough to add this provision suggests that someone is considering the possibility.

Next and even more interesting is the language that allows everyone and his brother to avoid the standard application process and enter the supply side of the market - they just need to apply to supply DOH with cannabis. You see, this section says that an "entity" can submit proposals to DOH for the terms on which it will manufacture for DOH. I am thinking very much of the scenario which New Jersey Governor Chris Christie proposed for his state: whereas there the governor proposed changing the regulatory scheme to make a university the sole authorized producer of cannabis and allow only hospitals to distribute, here I see the potential for the executive branch to allow only a single large corporate entity, e.g. a university, to operate as a producer and to allow only DOH to dispense to patients.

Under the standard application process as contemplated in the bill, you apply to DOH for a license to participate in the supply side of the market, i.e. manufacturing or otherwise acquiring cannabis and distributing it to the public. The process is somewhat burdensome in that you need to demonstrate a lot of things to DOH, for example that your directors are all of good moral character and not, e.g., convicted drug felons and that you have the actual capacity to keep people from stealing the cannabis and selling on the black market. (There are others; see the May article for a fuller treatment.)

However, this scheme now allows anyone to propose directly to DOH to supply cannabis to DOH - and that person will be deemed retroactively to be a registered producer (one of the six types of supply-side participants). Why does the amended bill allow an express lane to registration for an entity that contracts to supply DOH with cannabis - except to move DOH to the head of the line for dispensing? NJ Governor Christie called for the elimination of the centerpiece of that state's law: the creation of the six "Alternative Treatment Centers" i.e. corporate entities that will function analogously to retail (i.e. direct-to-consumer) distributors. Instead Christie wanted (wants?) to give the job of supplying the market exclusively to hospitals. To date, legislative sponsors of the NJ law have rebuffed Christie's efforts. I see in the proposed change to the NY bill the potential for DOH to monopolize the supply side - simply by determining that it is no longer in the public interest to register retail dispensaries when DOH can dispense and instead operate as the sole source.

Of course, that scenario was always potentially feasible under the old bill. However, the fact that someone took the trouble to spell it out in an amendment catches my attention, especially in light of what Christie tried to do to the NJ statute.

My concern is that the proposal, explicit in New Jersey and implicit in New York, that the supply side of the market be reserved to a university, a hospital, or a government agency ("Institutional suppliers" for the purposes of this post) will effectively negate the bill for as many months or years as it takes to determine whether that arrangement actually works. If only Instutions are allowed to function, and relatively nimble private sector not-for-profit corporations and for-profit wholesalers are not permitted to begin operating as soon as their applications can be improved, the market will be subject to the vagaries of the Institutions, whether intentional lethargy or timidity if they are subjected to threat from the federal government. At that point, it will be necessary to renew the debate about the proper operation of the statute and propose and negotiate statutory or regulatory revisions.
It appears to be a delay tactic to forestall the appearance of the not-for-profit corporate suppliers described in Section 3364(1)(C) of the proposed statute. I think it obvious that these "retail dispensaries" are the key element in the proposed system: they will the actors in the supply-side most likely to facilitate a viable market - and the actors that are most threatening to the people who see a threat in a legal, above-ground medical marijuana market. (See, e.g., the uninformed warnings issued by Bloomberg and Brennan forecasting the uncontrolled spread of dispensaries throughout New York City.)

I could be wrong. I just see a potential problem.

No requirement that DOH act timely on application for registration by supplier

I had not noted previously that the bill does not set any time limit within which DOH must act on an application for registration by a supplier but it requires that DOH act on an application for registration by a patient within thirty days from DOH's receipt of a complete application. See Section 3363(6). I find this provision more interesting in light of the new section discussing DOH's prospective operation as a medical marijuana distributor to patients.

Further, I don't see any date by which DOH must promulgate regulations and application forms for the patients and suppliers. Hmmm.

Circumscribing the "public interest" factor

I commented previously on the far-reaching potential of allowing DOH to consider the completely undefined "public interest" in deciding whether to deny an application for registration by a not-for-profit dispensary. New Section 3365(2)((V) specifically states that in evaluating whether granting an application would be in the "public interest," DOH may "consider whether the number of registered organizations in an area will be adequate or excessive to reasonably serve the area...." That seems to me a potentially useful clarification or, at a minimum, suggestion.

Save us from the doctors

2010-07-01T23:43:00.000-04:00

A recent op-ed in the Times Union (Albany) demonstrates the essential logic of the camp arrayed against therapeutic uses of psychedelics: society must be protected from the doctors. Keep control over psychedelics in the hands of the police.

The op-ed calls for all reasonable men to oppose the proposed medical marijuana law because of the clear and present dangers which it poses to society. Again, as stated in previous posts, a minimal familiarity with the law reveals that the arguments presented are utterly irrelevant to the proposed regulatory scheme.

The op-ed recites the standard litany of reasons to make sure that no one ever uses cannabis for any reason under any circumstances - it is simply too dangerous for society to withstand. Witness Los Angeles - everyone knows that Los Angeles has descended into chaos due to the onslaught of medical marijuana dispensaries. The Los Angeles city government is finally taking action to protect the citizenry. New York should avoid that horrific experience entirely.

The op-ed is most perplexing in its disregard for the actual mechanism of the proposed law because the author, Mr. Turetzky wrote as a representative of the Respect for Law Alliance, which is composed of extremely distinguished personages, including some very distinguished members of the judiciary. I would be extremely disappointed to believe that they, as accomplished jurists, could in good conscience have approved the legal reasoning which the Alliance has taken publicly.

There are the standard arguments that appear everywhere: marijuana is a gateway drug, it is dangerous to the lungs and brain, it is more potent than in the past, and it needs to be studied more before anyone should be allowed to use it. [Incidentally, the 'needs more study' position does not necessarily mean 'assess whether it has therapeutic potential and, if so, what kind' - if the federal government had wanted to do such studies, it would have appropriated money to conduct them long ago; the studies in question presumably focus on addictive potential and toxicity.]

However, there are some truly fascinating and revealing arguments that appear in the context of the op-ed's total ignorance of the actual elements of the proposed law. This author believes that the most telling complaint is that:
"Contrary to the allure of a potential huge new source of tax revenue from the legal sale of cannabis, legalizing medical marijuana will shift the burden of monitoring its safe manufacture and distribution to the state Health Department."

Shift the burden to the state Health Department? YES! EUREKA! THAT'S THE WHOLE POINT OF THESE LAWS. The fundamental point of the state medical marijuana laws is to shift oversight away from the police - or at least to distribute the wealth of regulatory authority and its attendant funding.

I would re-characterize what is colloquially called "Drug Prohibition" as an expression of a fundamental distrust for the healing professions. Students of drug control history know that federal drug prohibition in 1914 commenced a war against physicians over their prescription practices with regard to opiates. The federal Controlled Substances Act vests authority over psychoactive substances in the Department of Justice, i.e. the federal police, not the federal doctors in the Department of Health and Human Services. Marijuana resides in the police part of The State.

The op-ed in its totality, as did NYC Special Narcotics Prosecutor Bridget Brennan's recent statement, reduces to the implicit claim that the New York State Department of Health is incompetent and cannot administer a medical marijuana program.
It states explicitly that the bill will shift the "burden" (i.e. budget and authority) of regulation to the Department of Health; since there is no expressly-stated reason why this shift would be bad we must assume that there is some inherent evil in this shift in authority. (The immediately following statement that "The federal Food and Drug Administration will not participate in testing and monitoring the safety of an illegal drug" deserves its own extended treatment, but suffice it to say for the moment that obviously if the law passes then cannabis will not be an "illegal" drug for purposes of state law, and the federal government has always been free to move cannabis out of Schedule I of the Controlled Substances Act, at which point, when and if the US government will allow someone to sponsor randomized double-blind clinical trials of cannabis, the FDA will be able to regulate away to its heart's content.)

i get a certain thrill in seeing the recurrence of complete mischaracterizations of the mechanism of the law and inappropriate comparisons with the laws of a different state - and understanding that the Emperor Wears No Clothes: there really is no substantive argument on the other side. Complete and presumably knowing mischaracterization is the sole weapon of the opposition.

Perhaps the most interesting aspect of the op-ed is the multifaceted complaint about the practice of medicine: (a) cannabis will not be dispensed pursuant to a valid prescription, (b) there will not be any examinations of patients by physicians in good standing, and (c) there will be no guidance as to what constitutes a valid medical condition.

(1) Obviously there will be no dispensing of cannabis with a valid prescription - that's the whole point of Schedule I: no physician may write a prescription for a Schedule I substance and no pharmacist could fill such a prescription. That's why there are STATE medical marijuana laws, folks. Federal law prohibits prescriptions for cannabis, so the states need to sneak around the federal prohibition.

(2) The assertion that there will be no examination of patients by physicians in good standing must rely on some sort of prophecy. Why will there be no examination of patients by physicians in good standing? Even if many or all of the physician examinations of patients [not preparatory to writing a prescription, of course, but only to "certify" the physician's professional option as to the utility of cannabis for that patient] do not comport with the standards for the legitimate practice of medicine, why is the Department of Health incompetent to intervene and take appropriate disciplinary action, as it does in any other case of physician misconduct? Because the health care bureaucracy is fundamentally incompetent and cannot be entrusted with managing this threat to the public safety and welfare? Maybe the Department will just need more funding in order to administer the program.

(3) The best, the absolute best one of them all, is the complaint that there is no guidance as to what is a valid medical condition - i.e. one which cannabis can legitimately treat. Let us leave aside the clear implication of this position that there is in fact some medical condition for which cannabis is a valid treatment. Let us turn to the bigger question: is this not why we have doctors? Do we not trust doctors to assess what would be an appropriate therapeutic intervention for a given condition?

No, we don't. That's the root of the "War on Drugs," AKA "Drug Prohibition," AKA zero tolerance for illegal drug use - what makes drug use "illegal" is a decision by the police as to what constitutes a valid medical use of a drug.

The op-ed continues to misconstrue the proposed law entirely, by claiming that dispensaries will spring up out of control, like in Los Angeles - when actually the law is a conservative approach that requires licensing of distributors before they open for business, like a pharmacy or a liquor store. The Department of Health will be the gatekeeper that grants or denies an application for a license. This regulatory scheme is the exact opposite of the scheme that exists in California. As with the comments by Bloomberg and Brennan, this position expresses either complete ignorance of the terms of the proposed law or a willful mischaracterization - but there is one other possibility. It may be that this position does not express ignorance. Instead it expresses an opinion - the Department of Health will issue licenses inappropriately. The obvious implication is that the Department of Health is incompetent to administer the statute and control over cannabis must remain exclusively in the hands of the police.

It is a sad situation if the directors of and advisors to the Respect for Law Alliance have indeed endorsed a position that operates by completely misrepresenting the operation of the proposed law. It is an even sadder situation if these distinguished persons, including state and federal judges, are saying that the medical profession cannot properly assess and regulate the medical use of drugs and so drug control should be in the hands of police so that they can save the populace from the doctors.

NY Times article on Colorado market

2010-06-27T12:58:00.001-04:00

In case you have not seen it, here is the New York Times feature article on the medical marijuana market in Colorado.

I have just started reading the new Colorado statute, since I have been focusing on events here in the Northeast, but from what I have seen so far it is a fascinating mix of approaches. It's a four-way split: (a) it divides authority over the market between the taxing authority and the health department and (b) it splits jurisdiction between the state and local governments.

First, the statute creates a "state licensing authority" within the Colorado Department of Revenue, not the health department. This tax authority body regulates the dispensaries, i.e. the supply side. (Anyone with a long-enough memory will remember that federal drug control was originally based on the Constitutional taxing authority before the Controlled Substances Act hung it on the Interstate Commerce Clause.) The health department retains authority over patients and caregivers, i.e. the demand side.

It also splits authority between the state and local government.
Further comments to follow, time permitting.

NJ legislature allows only a limited amendment to the state's medical marijuana law

2010-06-24T14:29:00.000-04:00

Chris Goldstein of Philadelphia NORML reported that the NJ legislature has granted only a minor amendment to the NJ medical marijuana law.

If so, then the legislature did not acquiesce in Governor Christie's proposal to eviscerate the law by allowing only Rutgers University to cultivate cannabis and allowing only hospitals to dispense to patients.

Instead the Legislature simply extended the effective date of the law from July 1, 2010, to October 1, 2010 - presumably to give the Department of Health and Senior Services more time in which to promulgate the overdue regulations that are necessary to enable patients, manufacturers, and distributors to become licensed.

Open question #1: how will legislative proponents and advocates ensure that the executive branch meets this new, adjourned deadline, which was necessitated by the executive branch's initial failure to comply with the law?

Open question #2: what will advocates do in New York now that the City of New York and the Governor have come out against medical marijuana?

Bloomberg and Brennan come out against NY medical marijuana law

2010-06-22T18:35:00.000-04:00

As discussed in my post from this past Saturday, New York City Special Narcotics Prosecutor, Bridget Brennan, has publicly stated opposition to the proposed medical marijuana bill now pending in the New York State legislature.

I wondered if Brennan's position represents an authentic statement of New York City's position on the bill. Apparently it does: as I read it, Mayor Michael Bloomberg's denunciation of the medical marijuana bill on Friday announced an open campaign against the bill by the massive government apparatus called The City of New York - and opened the door to Brennan's statement.

Bloomberg's statements on Friday, June 18 categorically denounced the idea of medical marijuana. Like Brennan, Bloomberg completely misconstrued the proposed law to a degree indicating either actual ignorance or willful ignorance of the law's provisions and proposed operation.

Elements of the City's Argument
Let's call them the "City ." The City has opposed the bill on the following grounds, according to news reports [I hope to obtain official versions of the alleged statements]:

A. Brennan:
1. Dispensaries cause crime [public safety concerns: crime, quality of life, nuisance]
2. The marijuana could be laced [public health argument: product purity]
3. There should be a requirement that physicians actually examine the patients [delegitimization of the healthcare sector: impugning the integrity of health care practitioners]

B. Bloomberg
4. California's experience has not been good [suggests a quantitative/qualitative analysis of data available for review and challenge]
5. Medical marijuana is a fraud: it is simply a decoy - the Trojan Horse, if you will - for legalization [overt adoption of ideological position]
6. If you want to debate legalization, then debate legalization [the only socially productive statement by the City, but disingenuous in context]
7. This is not really about medicine [see number 5 above]
8. Marijuana is more potent these days [another public health argument: suggesting deference to healthcare professionals but actually adopting federal police reasoning for continuing cannabis prohibition; in context, deference to federal rationale implies wholesale, uncritical acceptance of the entire federal position - needs investigation]
9. It may lead to use of harder drugs [gateway/addiction theory - see number 8, above]
10. "I think it's a terrible idea" [overt adoption of IDEOLOGICAL OPPOSITION to THE IDEA that there could be a therapeutic use of cannabis in its entirety]

There is one fundamental flaw in the City's analysis: it has no idea what the bill provides. Since it has no idea what the bill provides, it cannot assess the utility of referring to the experience of California, another state with another law and another history, to the possible consequences of the proposed New York law.

The bill, essentially, requires state licensing of the supply-side of the marijuana market prior to anyone entering that market.
The bill assigns authority to the State Department of Health to administer the statute. The Department of Health. Not the Attorney General. Not a police commissioner. Not a municipal prosecutor of major drug trafficking crimes. Not the mayor of a city, no matter how large or influential. What the City is saying, without saying it, in bureaucratic language, is that the City considers the State Department of Health to be incompetent and unable to administer the statute properly.

Fundamentally, the task at hand is to assign regulatory authority over psychoactive substances to administrative agencies other than the police. That's what this bill would do with regard to certain uses of marijuana. The Department of Health will have discretion to register an applicant for patient status (i.e. by issuing a registry identification care - basically a license to buy, possess, and use cannabis) or deny the application. The Department of State will grant or deny applications for registration by prospective suppliers. Everyone must be registered by the state before entering the market. Is this part of the scheme what's bothering Mike Bloomberg? Excessive market regulation?

The New York statute differs qualitatively from the California model

The proposed New York bill is part of a major evolution in the history of state medical marijuana laws. I call the regulatory systems that have emerged in this evolution "second generation" laws. First generation laws, the type of law that appeared in California in 1996 and in Colorado in 2000 (and in most of the other "medical marijuana" states), protect patients, more or less. The first generation model does not even purport to govern the supply side. In California and Colorado, dispensaries just sprout like mushrooms after a rain: they open up for business at will, since they are unregulated, leaving the cities to chase after them and try to shut them down one by one or ban them categorically within the city limits.

The second generation laws channel all power through the state executive branch - the medical bureaucracy. This branch of the bureaucracy licenses the participants in the supply side and the demand side of the market.

Neither Brennan nor Bloomberg indicated any familiarity with the principles which I describe above. They didn't even offer a shred of evidence to support their positions, to the extent that any of them are factual. While Brennan stayed objective in her posture, Bloomberg simply stated his personal, uninformed belief that the entire concept of medical marijuana is a bad idea.
He did suggest that we debate legalization. If he wants that debate he should first acquire a fundamental understanding of how drug control works.

The State of New York endorsed medical marijuana thirty years ago.

The irony is that New York was one of the national pioneers in medical marijuana. New York State enacted a medical marijuana program back in 1980 under the guidance of State Senator Antonio G. Olivieri. Article 33-A of the New York State Public Health Law provides for a medical marijuana program operated by the Department of Health.
Under the program:
1. The Department of Health administers the program as a "research program" through hospitals
2. Participation is limited to cancer patients, glaucoma patients, and "patients afflicted with other diseases as such diseases are approved by the commissioner," i.e., the Health Commissioner has discretion to determine what other medical uses marijuana might have.
3. Patient qualification review boards evaluate patient applications for participation in the program.
4. The statute does not create a mechanism for supplying the marijuana.
5. The statute requires that the Department of Health apply to the federal Food and Drug Administration for approval of the program (i.e., that the Commissioner submit an Investigative New Drug application).

Of course, the Olivieri Medical Marijuana Law that sits in the statute book differs dramatically from the current statutes in place around the United States, including New Jersey, and the one proposed for New York. It was enacted sixteen years prior to Proposition 215, the California voter initiative that constituted a populist uprising against federal marijuana prohibition. (Proposition 215 was the breakthrough that opened the door to medical marijuana statutes everywhere; it created a defense for patients but not for distributors, and that is the model for completely unregulated entry into the market by suppliers in the majority of medical marijuana states).

It is worth noting the Olivieri Medical Marijuana Law's "legislative findings":

"The legislature finds that recent research has shown that the use of marijuana may alleviate the nausea and ill-effects of cancer chemotherapy, may alleviate the ill-effects of glaucoma and may have other therapeutic uses. The legislature further finds that there is a need for further research and experimentation with regard to the use of marijuana for therapeutic purposes under strictly controlled circumstances. It is for such research programs that controlled substances therapeutic research act is hereby enacted."

In other words, the State of New York is on record with the position that marijuana can have therapeutic uses; the practical question is how to make it available.

To repeat, existing New York state law provides for a "research program" in which cancer patients, glaucoma patients, and other patients which the Department approves will receive marijuana from a hospital. That law is a dead letter, and I am willing to venture that it was doomed for failure from conception because (a) it attempted to enlist hospitals as the distribution mechanism and (b) it required an interface with the federal government. Involving the federal government is obviously the kiss of death for any medical marijuana program or initiative since the immense bureaucracy called the "United States Government" does not recognize any use of marijuana whatsoever by anyone for any purpose - upon pain of criminal penalty. The effective state laws therefore disregard the federal government entirely; they do not recognize federal regulation of this field except to try to avoid overt conflicts with federal law where possible.

(Incidentally, I presume that the foregoing inherent problem with operating through hospitals is the reason why New Jersey Governor Chris Christie proposed that NJ's medical marijuana program be operated exclusively through hospitals - that requirement should functionally kill the law or at least delay any implementation of the law any time soon.)

The burden of proof is upon the City of New York to explain its opposition to the proposed medical marijuana law. Possible means of succeeding in its argument are (a) reading the law and/or (b) presenting factual evidence in support of its claims. The burden of proof is particularly heavy since the State of New York endorsed the utility of conducting a medical marijuana distribution ("research") program thirty years ago. Perhaps the City would be most helpful in stating affirmatively what type of medical marijuana market it would prefer to see operate within the city limits.

More on how the executive branch can prevent implementation of a medical marijuana law - NJ Governor wants to dispense only through hospitals

2010-06-20T22:11:00.000-04:00

This article from Friday explains a lot about what is happening in NJ. Basically, according to the article and - as usual - I have not yet seen the text of the actual proposal by the State - Governor Chris Christie wants to eliminate the ability of nonprofit dispensaries to participate in the supply-side of the medical marijuana market. Instead he wants all dispensing through hospitals.

I speculated in my article on the NY medical marijuana bill that no hospital would want to dispense marijuana because marijuana is completely prohibited under federal law so NO ONE, including a hospital, may legally dispense it - under federal law. The state medical marijuana laws provide a defense to criminal prosecution for marijuana cultivation, distribution, purchase, possession, and use. Any collective that is not registered with or otherwise interfacing with the federal government presumably has little worry in terms of retribution by the federal (except perhaps the occasional DEA raid). However, hospitals are generally dependent on medicaid reimbursement and could be penalized for violating federal law. Does anyone know hospital law well? Offhand, what are the other means through which the federal government funds/controls hospitals?
Did the State consider the possibility that it is setting up hospitals for a direct conflict with federal law if they wish to dispense cannabis - and therefore no hospital will choose to participate?

Further as Chris Goldstein noted, the proposal that Rutgers University cultivate all the marijuana for the state program potentially implicates the same part of the Controlled Substances Act that has allowed the University of Mississippi to maintain a monopoly on the legal manufacture and distribution of marijuana in the United States, as evidenced in Dr. Lyle Craker's litigation against the DEA.

Anyway, this move by the Governor clearly demonstrates an intention to limit severely the scope and nature of the market - by effectively institutionalizing it deep within the health care bureaucracy. My question for the Governor is the same question which I pose to Bridget Brennan, the Special Narcotics Prosecutor for the City of New York [who came out against the New York bill suspiciously close to the time of Governor Christie's announcement]:

- What is your basis for concluding that there should be no direct-to-public dispensation of cannabis by corporate entities?
- What is the evidentiary support for the claim that dispensaries create crime?
- What is the reason for stating that only hospitals should be permitted to dispense cannabis - and did you investigate the possibility that the federal government might take action to prevent any dispensing of cannabis by a hospital?

NYC prosecutor criticizes proposed New York medical marijuana law

2010-06-20T00:47:00.000-04:00

Various news sources, including the New York Post and MSNBC, have reported that Bridget Brennan, the Special Narcotics Prosecutor for New York City, has stated her opposition to the proposed medical marijuana law. I have not yet seen the actual text of the letter, but the news reports suggest a willful misreading of the proposed law.

Brennan's opposition appears to particularize to three issues: (a) the threat of uncontrolled spread of dispensaries, (b) the lack of any mechanism of testing the cannabis - which could be laced with other substances, and (c) the lack of any requirement that a prospective patient meet with a physician.

I ask why the matter of a proposed medical marijuana law is relevant to the office of the Special Narcotics Prosecutor the function of which is prosecuting major drug crimes.

Uncontrolled spread of dispensaries
As to (a), which includes the statement that dispensaries have become magnets for crime in other states, this statement appears to be entirely disingenuous, unless Brennan actually intends to say that the state Department of Health is incompetent. The fundamental point of the second generation laws is to require that supply-side market participants obtain licenses from the state before commencing operation. Under the statute, those applications must include the proposed address of the dispensary. Therefore the Department of Health implicitly possesses discretion to determine whether a dispensary is appropriate for the area in which it proposes to operate. This comment by Brennan seems to repeat the classic formula of drug control, which is the claim by law enforcement that it and only it can be trusted to regulate controlled substances - in this case because the Department of Health cannot responsibly process dispensary applications.

At the outset, therefore, it borders on nonsense to compare the proposed regulatory scheme with, e.g. California or the old system in Colorado (which is now in flux), since ALL NY DISPENSARIES MUST OBTAIN STATE APPROVAL PRIOR TO DOING BUSINESS.

Having said that, it may be appropriate to work in to the scheme some kind of local comment or participation in the location of dispensaries. Should there be local public hearings and comments on proposed dispensary applications? Should the dispensaries be treated by like bars or like pharmacies? A provision of the law allowing for local participation in the process would make the New York law more a hybrid between the NJ/RI model, in which regulation occurs at the state level, and the California model, in which local governments regulate dispensaries. However, while this may be a valid question, it is not apparent to me why it is any more an appropriate question for the Special Narcotics Prosecutor than the issuance of a liquor license to a nightclub or licensing of a pharmacy.

Testing of cannabis
As to (b), why is it any business of the Narcotics Prosecutor as to whether the law requires purity testing of the merchandise? Is this not a matter for the Department of Health to consider as a basis for revoking an offending dispensary's registration - or denying a renewal application? Is this not, in the alternative, a matter for the Department of Consumer Affairs? Again, we see the classic pattern of law enforcement claiming a monopoly over the ability to regulate psychoactive substances (other than alcohol, tobacco, and caffeine) to the exclusion of any executive branch administrative agency.

As to (c), again, why does the Narcotics Prosecutor presume to comment on the practice of medicine unless to say that the state Office of Professional Medical Conduct will be incompetent to do its job? Why should the legislature need to write in to the bill that a prospective patient meet with a physician?

I ask:

- What is the evidentiary support for the Special Narcotics Prosecutor's claim that dispensaries create crime?

- The function of the New York City Office of the Special Narcotics Prosecutor is major drug trafficking. Why is the Prosecutor presuming to comment on a proposed medical marijuana law to be administered by the New York State Department of Health?

As stated above, I have not yet seen the actual text of the letter and I will attempt to refine my comments as necessary after I see it.

New Jersey: a new form of struggle

2010-06-15T22:29:00.000-04:00

I think that this article about the spreading legal war in Colorado, city-by-city, over whether to ban cannabis dispensaries demonstrates well the difference between the first generation medical marijuana laws and the second generation that is taking root here on the East Coast.

The California/Colorado model fails to provide explicitly for regulation of the supply side. The Rhode Island/New Jersey/New York model does provide for regulation of the supply side - by requiring that a prospective supplier obtain a license to do business for beginning operations. The upside is that regulation starts with the state, a sovereign superior to the localities; therefore, the localities must regulate the dispensaries around the state laws, which take precedence and guarantee the existence of dispensaries - optimally even approving specifically the location of the dispensaries. The downside of this model appears when the State fails to permit the suppliers to begin operations - such as in New Jersey where the state government (Department of Health and Senior Services - an administrative agency in the executive branch) has simply failed to enact the regulations that would allow prospective suppliers to begin applying for business licenses. Since the law restricts all manufacture and distribution to government-licensed entities - and prohibits individual patient or caregiver - this failure to permit the registration process to begin effectively prevents the creation of a legal medical marijuana market, notwithstanding the will of the legislature.

Medical Marijuana Press Conference in Jersey City on 6/17

2010-06-15T14:51:00.000-04:00

From the website for the Coalition for Medical Marijuana New Jersey:

MEDIA ADVISORY
FOR IMMEDIATE RELEASE
6/14/2010

The Coalition for Medical Marijuana New Jersey (CMMNJ)
www.cmmnj.org

Medical Marijuana Press Conference in Jersey City on 6/17
City officials work on guidelines; patients, professionals seek timely regulations

On Thursday, June 17, 2010 at 1 PM, New Jersey medical marijuana advocacy groups will hold a press conference in front of City Hall in Jersey City.

Local cannabis policy experts are working closely with Jersey City officials to create municipal guidelines for the placement of an Alternative Treatment Center. The second largest city in New Jersey is seeking to welcome local, non-profit medical marijuana providers once they can be licensed for operation.

"Guidelines in Jersey City and other towns will assure a local infrastructure is ready for regulated cannabis facilities to serve patients as quickly as possible," said CMMNJ/NORMLNJ advocate Chris Goldstein

Last month a request was made by Governor Christie for a six to twelve month extension on the issuance of the medical marijuana program regulations. The extension would require additional legislation.

The New Jersey Compassionate Use Medical Marijuana Act was signed into law January, 11 2010. As passed, the Department of Health and Senior Services (DHSS) was to issue draft regulations in July. Patients are anticipating access to a running program by the fall.

CMMNJ and NORML-NJ do not see any need for a delay.

Ken Wolski, a Registered Nurse and Executive Director of CMMNJ said, “If the DHSS cannot write these regulations in 6 months, there is no guarantee they will be able to write them in 18 months. Patients are suffering as they continue to wait for the program.”

Anne M. Davis, Executive Director of NORML-NJ said, “This is a law and there are no exceptions. There are patients with chronic or even terminal illnesses that cannot get an extension on life.”

The 6/17/10 press conference will feature brief statements along with a Q&A.

Speakers will include potential medical marijuana patients, medical professionals and supporters of the new law who will address the proposed delay in implementing the state's therapeutic cannabis program.

Media may contact:
Ken Wolski: ohamkrw@aol.com (609) 394-2137
Anne Davis: law@annemdavis.com (732) 477-4700
Chris Goldstein: media@cmmnj.org

WHAT: Medical marijuana press conference
WHERE: Jersey City, NJ – In front of City Hall – 280 Grove Street, Jersey City, NJ 07302
WHEN: June 17, 2010 at 1:00 PM
WHY: Timely implementation of New Jersey’s medical marijuana law, local ATC guidelines

Litigation coming in NJ over Governor's intention to delay?

2010-06-14T16:45:00.001-04:00

Here is a statement from the press conference by the Coalition for Medical Marijuana - New Jersey indicating that New Jersey medical marijuana advocates will be going to court to force the governor to move forward in implementing the medical marijuana law. The specific issue at hand, apparently, is the State's refusal to allow patients to cultivate their own cannabis during the lag time until the State promulgates regulations governing the dispensaries. Since New York's statute follows New Jersey's in omitting any provision for patient cultivation, this situation looks highly significant in the event that the NY bill passes and is signed into law.

CMMNJ's main page shows the text of the following email from the NJ Department of Health and Senior Services:

From: Medical.Marijuana@doh.state.nj.us

At this time, the Department is not reviewing proposals or receiving documents, nor is the Department meeting with potential vendors, advocacy groups, lobbyists or other interested parties to present business plans, strategies or offers of assistance. Given the large numbers and diverse recommendations, we believe this is the best way to assure an objective, science based strategy.

As you are aware, medical marijuana is not available in the state of New Jersey. The Department must first establish a process to register qualified patients, caregivers and alternate treatment centers. This includes the continuation of coordinated implementation strategies amongst all state agencies to ensure all issues are addressed adequately. Full implementation of the New Jersey Compassionate Use of Marijuana Act awaits completion of this mandated process, which will assure the intent of the Act is accessible to those patients with designated medical conditions, while ensuring that it is implemented in a safe and effective manner.

For additional information regarding this topic, please visit our website at www.nj.gov/health for the most current information about the implementation of the New Jersey Compassionate Use Medical Marijuana Act, including frequently asked questions.

(I haven't actually found it at the State's website but then I didn't search too hard.)

L.A. City Council action to limit dispensaries

2010-06-10T00:53:00.000-04:00

See the recent article on L.A.'s move to shut down dispensaries. Query whether this approach is possible in a jurisdiction in which the state government approves applications to open dispensaries - and those applications specify the address of the dispensary, meaning that the state government has already approved operation of the dispensary at a particular location.

I assume that the experiences of L.A. and San Francisco are the most relevant to New York; after all, can you contemplate Manhattan with dispensaries? How about one in Times Square and one on St Mark's Place? I can see the neighborhood associations and City Council going wild. Maybe people in the West Village won't mind location of a dispensary within their neighborhood, but i assume that there will be resistance everywhere else.

Carl Olsen's litigation in Iowa

2010-06-10T00:23:00.000-04:00

Thanks to Buford Terrell for directing my attention to Carl Olsen's litigation in Iowa to compel the Iowa Board of Pharmacy to reclassify cannabis. I have only begun reading the documents at the Iowans for Medical Marijuana website but from what I have seen so far, the essential argument is that "medical use" is defined under STATE law, as opposed to FEDERAL law, and that the enactment of medical marijuana laws throughout the United States demonstrates that there is a currently accepted medical use of cannabis in the United States.

This issue goes to the heart of Schedule I and, therefore, all of U.S. drug control - the legal conclusion that there is no medical use of cannabis or, for that matter, any of the Schedule I psychedelics. The "medical use" issue is the fundamental battleground of the war and Carl is occupying that space.
It is fascinating for numerous reasons, including federalism as well as the assignment to federal police of the authority to determine what is a medicine.

I hope to present a more thorough treatment of the litigation but I invite others to review the material and offer their analyses.

N.J. Advocates threaten legal action if Governor delays issuing regulations

2010-06-07T00:09:00.000-04:00

Another article on the status of medical marijuana in New Jersey. Exciting for litigators.

TRENTON -- Legal and medical marijuana advocates say they are gearing
up for a court fight if the Legislature relents and gives Gov. Chris
Christie the potentially year-long delay he wants before making the
drug legally available to chronically ill patients.

The New Jersey chapter of the National Organization for the Reform of
Marijuana Laws is "ready to fight the state of New Jersey," said Anne
Davis, executive director and attorney from Brick. She spoke to a
gathering of about 40 protesters and journalists outside the
Statehouse today. "We will not accept any delay."

Click on the link above for the full article

Pubdate: Fri, 4 Jun 2010
Source: Star-Ledger (Newark, NJ)
Webpage:
http://www.nj.com/news/index.ssf/2010/06/legal_medical_marijuana_advoca.html
Copyright: 2010 Newark Morning Ledger Co
Contact: eletters@starledger.com
Website: http://www.nj.com/starledger/
Details: http://www.mapinc.org/media/424
Author: Susan K. Livio, Statehouse Bureau
Bookmark: http://www.mapinc.org/find?253 (Cannabis - Medicinal - U.S.)

Anticipating the opening of the New Jersey dispensaries

2010-06-02T12:29:00.000-04:00

A recent article describes the preparations for enactment of regulations that will govern dispensaries in NJ. Following are excerpts from the article describing the supply side under the NJ statute.

The article gives highlights of the statute and indicates how it differs from and resembles the proposed NY law.
First, it prescribes a set list of conditions approved for patients use. This provision differs from New York.
Second, it limits the amount which a patient can possess to 2 oz., similar to New York (maximum 2.5 oz.).
Third, no individual cultivation - like New York.

Note the statement that California operators are looking to get in on the New Jersey action.
Presumably we will see the same thing in New York if the bill is enacted.

Note the reference to zoning laws. As I see it, one immediate question for litigators in New York is going to be whether State approval of a registry application for a dispensary will protect a dispensary from adverse action by local government - since the application will specify the address of the dispensary.

It is also worth noting that the New Jersey statute has a residency requirement for patients. There is no such provision in the New York bill; perhaps the Department of Health will add a regulation to that effect. Does anyone know whether that kind of provision is within the scope of an administrative agency's authority under New York law? If not, I will be researching it myself.

Note also the reference to massage services, accupuncture and yoga classes. These services indicate a "clinic/spa" model as opposed to the pharmacy/package store model or the tavern/cafe model. The clinic/spa model seems to me to offer the greatest scope of opportunity for other occupations to participate in the medical marijuana market - as incidental service providers.

HIGH HOPES FOR BUSINESS FOLK PLANNING NJ POT SALES

...Another of the likely marijuana provider applicants in New Jersey is Anne M. Davis, a lawyer who also consults with several people interested in opening treatment centers.

She says she's hearing from current drug dealers who want to go legit, caregivers who already procure marijuana for the sick, and career changers-especially commercial real estate agents who have fallen on slow times. Some of the dispensaries in California, where medical marijuana laws are less restrictive, are looking into opening branches here, Davis said.

There are people with smart business plans and people experienced with growing the plants-illegally of course.

"They think, 'Hey, I'm going to open this great business and I'm going to make a fortune,'" Davis said. "But that's not what it's going to be. It's going to be very strictly regulated in New Jersey."

Those regulations are not yet written, and Gov. Chris Christie, who says he supports the medical marijuana bill, is trying to win a delay to give his administration extra time to write them.

Still, the state's new law offers a glimpse at how the clinics will operate.

It requires at least six nonprofit groups be given the first licenses. They must be spread around the state. Subsequent clinics could be for-profit.

Unlike other states, New Jersey will not allow patients to grow their own. Instead, that will be handled by the centers that distribute marijuana. Patients will be tracked and allowed to buy only 2 ounces per month.

Only doctors who have ongoing relationships with the patients will be able to approve marijuana use for them. Only people with certain medical conditions will be allowed to use. Cancer, glaucoma and any prognosis that gives the patient less that a year to live are on the list; headaches are not.

Bays and another potential treatment center operator, Joseph Stevens, both say they would have their growing operations located away from the treatment centers for security reasons. Their business plans call for growing indoors so that harvesting can be done year-round.

Stevens said town officials in the place he wants to operate have accepted the idea, but he's not yet ready to say where it would be.

Pretty much the only thing he's made public so far is a logo for his establishment, called The Health Clinic and bearing the not-so-subtle motto: "A HIGHER standard of care."

...

Both Stevens and Bays, who wants to open her center in Asbury Park, envision clinics where patients could get other services-perhaps massage, acupuncture or yoga classes.

In other states, that's one model. But some dispensaries are more like stores; others resemble cafes. It's not clear now whether New Jersey might end up with a full range of types of establishments.

The prospective sellers are now spending time puzzling through possible local zoning requirements, learning what strains of pot might ease pain and other medical symptoms, and registering as nonprofits....

Pubdate: Sun, 30 May 2010
Source: San Jose Mercury News (CA)
Webpage: http://mapinc.org/url/EYAKdSgp
Copyright: 2010 San Jose Mercury News
Contact: letters@mercurynews.com
Website: http://www.mercurynews.com/
Details: http://www.mapinc.org/media/390
Author: Geoff Mulvihill, Associated Press Writer
______________

Growing and selling marijuana in New York under the proposed medical marijuana law

2010-05-27T14:46:00.000-04:00

Executive Summary:[1]

Proposed legislation for New York State, if enacted, will create a process by which various corporate entities can apply to the state Department of Health for registration as marijuana growers and sellers. The law apparently will allow for-profit entities to grow marijuana and sell it to not-for-profit corporations (and certain other highly-regulated entities) that in turn can sell directly to patients who are registered with the Department of Health. This article summarizes the elements of the proposed law relevant to the supply side of the prospective medical marijuana market in New York.

History and context of the proposed New York medical marijuana law

Assembly Member Richard Gottfried (chairman of the Assembly Health Committee) and Senator Tom Duane (chairman of the Senate Health Committee) have sponsored legislation in their respective houses[2] that, if enacted, will permit cultivation, sale, purchase, and use of marijuana for medical purposes. Although Assembly Member Gottfried has sponsored some variation of this legislation every year over the past twelve years, this year is the first one in which an identical bill is pending in the Senate as well.

While the chaotic growth of the medical marijuana dispensary business in California has generated news coverage and extensive litigation, the regulatory scheme which the Gottfried/Duane bill proposes differs significantly from the California approach. The proposed New York medical marijuana law is part of a second generation of medical marijuana bills – similar to the type enacted in New Jersey,[3] New Mexico,[4] and Rhode Island.[5] In this type of regulatory scheme, the state government licenses both the patients and their “designated caregivers” (the demand side) and the cultivators and dispensers of marijuana (the supply side). With one minor exception,[6] the proposed law in New York will permit only corporate entities to be registered as suppliers. In fact, the proposed law does not permit individuals to cultivate marijuana, even for their own use. Unlike the system in Rhode Island,[7] the law does not place any arbitrary limitation on the number of suppliers which the state government can license.[8]

Sidestepping federal prohibition of marijuana through a doctor’s “certification”

Fifteen states and the District of Columbia have approved bills or enacted legislation permitting the medical use of marijuana[9] notwithstanding the fact that federal law does not permit any use of marijuana, whether for “medical” or “non-medical” purposes, other than in research.[10] Under the Controlled Substances Act (“CSA”), as a psychoactive substance classified as “Schedule I,” marijuana may not even be prescribed by a physician.[11] The various state medical marijuana laws attempt to avoid this federal prohibition in the following way: a physician does not “prescribe” marijuana for a patient, but rather certifies that in his professional medical opinion the patient would benefit from the use of marijuana. The patient can then use the physician’s certification as a defense against criminal prosecution for possession and use of marijuana.

The first generation laws, beginning with California, did not provide explicitly for the establishment of the supply-side, i.e. the legal manufacture and sale of marijuana to patients. This lack of definition has led to some of the volatility seen in the California medical marijuana market, in particular police raids on medical marijuana growers and dispensaries and civil litigation in which counties and municipalities try to limit access to or ban marijuana dispensaries altogether.[12]

Cultivating and selling marijuana under New York law

The second generation laws attempt to avoid this disorderly situation by centralizing the process within the state government and requiring pre-registration of both patients and suppliers. Following the lead of states such as New Jersey, New Mexico and Rhode Island, the Gottfried/Duane bill, creates a new Title V-A in Article 33 of the N.Y. Public Health Law [13] which will allow (a) patients to apply to the Department of Health for registration and issuance of a “registry identification card”[14] based on certification by a “practitioner”[15] that, among other things discussed more fully at the end of this article, it is the practitioner’s professional opinion that the patient would benefit from the use of marijuana and (b) six types of entities to apply to the Department of Health to become “registered organizations” with the right to cultivate and sell marijuana to duly-registered patients. In his or her application, a patient may identify another individual whom the patient wishes to act as a “designated caregiver” and who may obtain marijuana for that patient.[16] For simplicity this article will use the terms “supplier” and “consumer” to refer to “registered organization” and “patient and/or designated caregiver,” respectively.

The NY law will permit the following six types of entities to be a supplier: (a) a pharmacy, (b) a hospital, (c) the state Department of Health (the “DOH”), (d) a local department of health, (e) a not-for-profit corporation organized for the purpose of supplying marijuana to consumers, and (f) a person or entity with appropriate expertise in acquiring, cultivating, and distributing marijuana.[17] The proposed law refers to this last type of supplier as a “registered producer.” Under the plain language of the proposed law, two primary characteristics of a registered producer are that (i) it can be any person or entity, which implies a for-profit entity and (ii) it can only distribute marijuana to another supplier.[18] In other words, an individual or for-profit entity can act as a wholesaler and cannot distribute directly to consumers–an arrangement reminiscent of alcohol regulation.

It is an open question whether any pharmacy or hospital will actually attempt to function as a supplier until there is a change in federal law. Pharmacies must register with the federal Drug Enforcement Administration in order to distribute controlled substances[19] and therefore, presumably, are at risk of license suspension if they attempt to cultivate, acquire, possess, or distribute marijuana. Likewise, to the extent a hospital relies on federal funding or reimbursement, its attempt to act as a supplier presumably could jeopardize its function by putting it at risk of sanctions from the federal government. Whether DOH or local health departments will attempt to act as suppliers is a political question the resolution of which may leave the supply side of the market wholly to private sector actors. The practical analysis then is to determine who will create and operate (a) the not-for-profit corporations that may distribute to consumers and (b) the persons or (potentially for-profit) entities that can only distribute to other suppliers, which shall be distinguished from other suppliers as a “wholesaler” consistent with the market lexicon being used in this article.

A supplier may legally acquire, cultivate, sell, transport, and distribute marijuana according to the terms of the proposed law.[20] The law provides that any supplier (other than a wholesaler) may lawfully, in good faith, sell, deliver or distribute marijuana to a consumer upon presentation of a registry identification card issued by DOH.[21] The law limits possession of marijuana by a consumer to no more than two and a half ounces of at any one time[22] and accordingly limits a supplier to distributing a maximum of two and a half ounces to any consumer at one time.[23] When a supplier sells, delivers or distributes marijuana to a consumer, it must also provide (a) a receipt stating the name, address, and registry identification number of the supplier, the registry identification number of the consumer, and the amount of marijuana sold[24] and (b) a safety insert to be developed by DOH which shall state (i) the methods for administering marijuana, (ii) any potential dangers resulting from the use of marijuana, and (iii) recognizable signs of and available treatments for problematic usage of marijuana.[25] The supplier must retain a copy of the registry identification card and the receipt for one year.[26]

Applying for registration as a marijuana supplier[27]

The proposed law authorizes DOH to promulgate regulations that will govern implementation of the law. As relevant here, the law delegates to DOH the exercise of discretion over the initial registration of suppliers and registration renewals.

The law provides for the following application process. An applicant must submit a description of the activities it intends to conduct, along with any information DOH may reasonably require, and demonstrate that: (a) the applicant and its managing officers are of good moral character,[28] (b) the applicant possesses or has the right to use sufficient land, buildings, and equipment to carry on the activities which it intends to conduct,[29] (c) the applicant is able to maintain effective control against “diversion” of marijuana,[30] (d) the applicant can comply with all applicable state laws and regulations,[31]and (e) the applicant is one of the six types of entities that may be a supplier.[32]

The application must also include the name, residence address, and title of each of the officers and directors of the applicant or the name and residence address of each person or entity that is a member of the applicant.[33] This language strongly suggests that an applicant seeking to be registered as a wholesaler may be a business corporation or a limited liability company; whether the applicant may be a partnership, limited partnership or other entity remains to be seen and will be a matter of interpreting the law. Each person or a representative of each corporate entity must submit an affidavit with the application stating (a) any position of management or ownership of ten percent or more interest in any business that has been engaged in manufacturing or distributing drugs in the past ten years, (b) whether any such person or business has been convicted, fined, censured, or had a registration suspended or revoked relating to the manufacture, distribution, sale, or possession of drugs, and (c) any other information which DOH may reasonably require.[34] In addition to these initial disclosures, a supplier has an ongoing obligation to report to DOH any change in the facts stated in the application or any new fact that would have been required to be disclosed in the application.[35]

DOH is also authorized to set the application fee.[36]

The proposed law states that DOH shall register an applicant (or, as discussed below, approve an amendment to a registration) if it is satisfied that (a) the applicant will be able to prevent diversion, (b) the applicant will be able to comply with all relevant state laws, (c) the applicant and its officers are ready, willing and able to carry on the cultivating or distributing activity described in the application, (d) the applicant has the right to use sufficient land, buildings, and equipment to carry on the activities which it intends to conduct, (e) it is in the public interest that the registration be granted, and (f) the applicant and its officers are of good moral character.[37]

If DOH is not satisfied that the application should be granted, it must notify the applicant of the factors that require further evidence.[38] The applicant may submit additional material in support of its application, request a hearing, or both within thirty days from receiving a notice from DOH.[39]

DOH may deny an application for registration on the basis of failure to demonstrate any one of the six factors listed above. Of these factors, the “public interest” seems to have the farthest-reaching potential for subjective determination. The other five factors relate directly to the applicant itself; in contrast, the public interest factor seems to open the door to consideration of any and all conditions unrelated to the applicant, for example, the number of existing suppliers in a given area, a fact for which other second generation medical marijuana laws explicitly mandate consideration. A viable medical marijuana regime in New York will require interpretation and application of the public interest factor in a manner that does not unreasonably restrict the supply of medical marijuana. It is worth noting that the introductory section of the proposed law recites a legislative finding that “thousands of New Yorkers have serious medical conditions that can be improved by the medically-approved use of marijuana” and that “the law should not stand between them and treatment necessary for life and health”; this introductory section further states the legislative intent that the law “be implemented consistently with these findings and principles, through a reasonable and workable system with appropriate oversight, evaluation, and continuing research.”[40] These statements of legislative intent provide a basis for interpreting “public interest” in favor of a supply limited only by the volume of legitimate demand determined by the market itself, and accordingly registering an applicant unless evaluation of the other five factors demonstrates defects in the applicant.

A registration is effective only for the particular applicant and it shall specify the applicant’s name and address and those activities of a supplier that are permitted under the registration.[41] This provision apparently seeks to prevent the transfer of a registration from one entity to another without DOH’s approval. A supplier’s registration is valid for two years from the date of issue.[42]

The law also permits a supplier to amend its registration in order (a) to relocate from the address specified in its application or (b) to add or delete activities that it may conduct.[43] An amendment requires a separate application to DOH.[44]

Renewal of a registration

As stated above, an initial registration as a supplier is valid for two years from the date on which the registration is granted. The proposed law provides that a supplier may apply for renewal of a registration beginning six months before the expiration date and not less than four months prior to the expiration date.[45]

DOH is authorized to determine what information must be included in a renewal application, but shall require inclusion of information concerning: (a) any significant change in the circumstances or factors required for the supplier’s initial application for registration and (b) every known charge or investigation by any government agency concerning diversion of marijuana or compliance with state laws governing other controlled substances during the prior period of registration.[46] If DOH determines that an application for renewal of a registration should be denied, the applicant has the opportunity to submit additional information, demand a hearing or both.[47] DOH must grant an application to renew unless it finds that the supplier is unlikely to prevent diversion of marijuana or is unlikely to comply with state laws governing the activities permitted under its existing registration.[48]

Reports by a supplier

The proposed law requires each supplier to report all sales of marijuana.[49] DOH is permitted to develop the format of the report and to mandate the frequency of reporting. In the first year after the law takes effect, DOH can require reports only as often as every three months; after the first year DOH can require reports no more often than every six months. Each report must state each sale of marijuana, the date of sale, the quantity of marijuana sold, and the name, address, and registry identification number of the consumer.[50]

Reports by the Department of Health; contracts with the private sector

The proposed law also requires that DOH report to the Governor and legislature one year after the law takes effect and every two years thereafter on the functioning of the medical marijuana system and make appropriate recommendations.[51] DOH may contract with individuals, not-for-profit corporations or other organizations to evaluate the implementation and effectiveness of the law.[52]

Note on the scope of conditions for which marijuana will be available

The proposed law contains a broad scope of conditions for which marijuana will be available. As noted above, when a person applies to be registered by DOH as a medical marijuana patient, the patient does so on the basis of a practitioner’s certification that it is the practitioner’s professional opinion that the patient would benefit from the use of marijuana.[53] Specifically, the practitioner also certifies that the patient has “a serious medical condition” and that the patient is under the practitioner’s care for that serious medical condition.[54] The law defines “serious medical condition” as “a severe debilitating or life-threatening condition, or a condition associated with or a complication of such a condition or its treatment (including but not limited to the inability to tolerate food, nausea, vomiting, dysphoria or pain),”a rather extensive definition.[55] Unlike the laws of other states,[56] the law proposed for New York does not limit the conditions for which marijuana will be available; instead, it grants maximum discretion to a physician or other health care practitioner to facilitate a patient’s access to marijuana for therapeutic purposes.

Penalties for misconduct

The proposed law does not expressly provide any penalties for violation of the law, whether diversion of marijuana or other misconduct. The law states that a person or entity shall not be subject to criminal or civil liability or professional discipline for acting reasonably and in good faith.[57] This statement supports an argument that the law intends to leave untouched existing criminal penalties for marijuana cultivation and sale and will rely on the existing structure for professional medical discipline as the mechanism for ensuring that health care providers do not act as the marijuana equivalent of “pill mills.” In other words, the proposed law can be understood as a medical exception to the existing marijuana prohibition and a defense to prosecution for marijuana-related offenses.

Conclusion

As drafted, the proposed law will allow not-for-profit corporations to apply to DOH for authorization to cultivate and sell marijuana to consumers. It will also authorize individuals and both not-for-profit or for-profit corporate entities to cultivate marijuana and sell it to the entities that in turn sell marijuana directly to consumers. It will grant to physicians and certain other health care providers maximum authority to determine whether a given patient would benefit from the use of marijuana. It will grant DOH exclusive control over the process of legalizing access to marijuana by patients based on a practitioner’s certification and, likewise, over the licensing of entities that can supply marijuana to the market. The law does not propose to permit any use of marijuana for non-medical purposes, although it is arguable that the successful operation of the supply side of the medical marijuana market would be the prototype for a regulated market of marijuana for general purposes.

In the event that the law is enacted, attorneys representing suppliers can reasonably expect to be called upon to address the nature of the regulations which DOH will enact, the narrowness with which DOH will administer the statute, the degree to which law enforcement will defer to the discretion of the medical profession and DOH, and, if the California experience is instructive, attempts by localities and private citizens to restrict the operation of suppliers through administrative action or civil litigation, such as public nuisance laws.

[1] The author acknowledges the assistance of Douglas Greene, Janet Mitrany, Buford Terrell, Zara Watkins, Esq., and Neil Wiesner, Esq. in preparing this article.
[2] A. 9016, 2010 Leg., Reg. Sess. (N.Y. 2009) and S. 4041-B, 2010 Leg., Reg. Sess. (N.Y. 2009).
[3] The New Jersey Compassionate Use Medical Marijuana Act, N. J. Rev. Stat. § 24:6I-1 to 16.
[4] Lynn and Erin Compassionate Use Act, N.M. Stat. Ann. § 26-2B-1 to 7 (2007).
[5] The Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act, R.I. Gen. Laws §§ 21-28.6-1 to 12 (2009).
[6] An individual can apply to be a “registered producer,” a form of supplier that can sell marijuana only to other suppliers, not directly to an end user or the user’s caregiver.
[7] R.I. Gen. Laws § 21-28.6-12(a)(8) (limiting to three the number of registered dispensaries, designated as “compassion centers”).
[8] In comparison, the New Jersey law provides that the state licensing agency, the Department of Health and Senior Services, shall ensure a sufficient availability of suppliers “pursuant to need,” and that there shall be a minimum of two suppliers in each of the north, center, and south of the state. However, the statute does not require that the State determine whether the number of suppliers is adequate to meet the needs of patients until two years after the effective date of the statute. N. J. Rev. Stat. § 24.6I-14(c).
[9] Alaska Stat. §§ 17.37.010 - 17.37.080 (LexisNexis 2010); California Compassionate Use Act of 1996, Cal. Health & Saf. Code, § 11362.5 (LexisNexis 2010) (codifying voter initiative Prop. 215); Cal. Health & Saf. Code, §§ 11362.7 - 11362.83 (LexisNexis 2009-2010) (codifying SB 420); Colo. Const. Art. XVIII, § 14 (LexisNexis 2009); Colo. Rev. Stat. § 18-18-406.3 (LexisNexis 2009) (interpreting and applying the provisions of the constitutional amendment); Colo. Rev. Stat. § 25-1.5-106 (LexisNexis 2009) (codifying the powers and duties of the Colorado Department of Public Health); Haw. Rev. Stat. §§ 329-121 - 329-128 (LexisNexis 2010); Me. Rev. Stat. Ann. tit. 22, § 2383-B (LexisNexis 2009); Maryland Darrell Putman Compassionate Use Act, Md. Crim. Law Code Ann. § 5-601(c)(3)(ii) (LexisNexis 2010); Michigan Medical Marihuana Act, Mich. Comp. Law Serv. §§ 333.26421 - 333.26430 (LexisNexis 2010); Medical Marijuana Act, Mont. Code Anno. §§ 50-46-101 - 50-46-210 (LexisNexis 2010); Nev. Rev. Stat. Ann. §§ 453A.010 - 453A.810 (LexisNexis 2009); New Jersey Compassionate Use Medical Marijuana Act, N. J. Stat. § 24:6I-1 - 16 (effective July 1, 2010) (LexisNexis 2010); Lynn and Erin Compassionate Use Act, N.M. Stat. Ann. § 26-2B-1 - 7 (LexisNexis 2009); Oregon Medical Marijuana Act, Or. Rev. Stat. §§ 475.300 - 475.375 (LexisNexis 2009); The Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act, R.I. Gen. Laws § 21-28.6-1 - 12 (LexisNexis 2010); Vt. Stat. Ann. tit. 18, §§ 4471- 4474d (LexisNexis 2010); Rev. Code Wash. §§ 69.51A.005 - 69.51A.902 (LexisNexis 2010). On April 20, 2010, the District of Columbia Council voted to approve the “Legalization of Marijuana for Medical Treatment Initiative Amendment Act of 2010.” Legislative Information Management System. (Accessed May 24, 2010, at http://www.dccouncil.washington.dc.us/lims/searchbylegislation.aspx)
[10] See Controlled Substances Act, 84 Stat. 1242, 21 U.S.C. § 801 et. seq. (1970); Gonzales v. Raich, 545 U.S. 1, 14 (2005) (“[b]y classifying marijuana as a Schedule I drug, as opposed to listing it on a lower schedule, the manufacture, distribution, or possession of marijuana became a criminal offense, with the sole exception being use of the drug as part of a Food and Drug Administration pre-approved research study”).
[11] 21 U.S.C. § 812(c) (classifying marijuana as a Schedule I drug); 21 U.S.C. § 829 (providing for prescription of substances in Schedules II through V, and omitting any such prescription of substances in Schedule I).
[12] See, e.g. City of Claremont v. Kruse, 177 Cal. App. 4th 1153 (Cal. Ct. App. 2d 2009) (affirming preliminary injunction against operation of medical marijuana dispensary on the grounds that operation of dispensary in violation of local zoning ordinance was nuisance per se notwithstanding state medical marijuana law).
[13] This article will refer to the relevant sections of the N.Y. law as “Section ____.”
[14] The State of California also provides for registration of patients and issuance of cards identifying the holders as medical marijuana patients but registry is voluntary. See Cal. Health & Safety Code § 11362.71. Whereas the proposed New York law keeps all registration functions with the state Department of Health, the California law assigns to counties the task of processing applications for registration and issuing identification cards. See id. at subparagraph (b); see also County of San Diego v. San Diego NORML, 165 Cal. App. 4th 798 (Cal. Ct. App. 4th 2008)(affirming judgment in favor of state in action by counties claiming that the voluntary registration program violates the United States Constitution and therefore counties were not obligated to participate).
[15] Defined in N. Y. Public Health Law 3302(29) as “a physician, dentist, podiatrist, veterinarian, scientific investigator, or other person licensed, or otherwise permitted to dispense, administer or conduct research with respect to a controlled substance in the course of a licensed professional practice or research licensed pursuant to this article.”
[16] Section 3363.2(c).
[17] Section 3364.1(a)-(f).
[18] Section 3364.1(f).
[19] 21 U.S.C. § 823(b), 21 C.F.R. § 1301.3(d).
[20] Section 3364.2.
[21] Section 3364.3.
[22] Section 3362.1.
[23] Section 3364.4.
[24] Section 3364.3.
[25] Section 3364.5.
[26] Section 3364.3.
[27] The application process for a prospective supplier discussed here corresponds generally to the process set forth in N.Y. Public Health Law § 3312-13, by which prospective manufacturers and distributors of other controlled substances apply to DOH for registration.
[28] Section 3365.1.A(I).
[29] Section 3365.1.A(II).
[30] Section 3365.1(A)(III). Diversion is defined in N.Y. Public Health 3302(12) as “the manufacture, possession, delivery, or use of a controlled substance by a person or in a manner not specifically authorized by law.”
[31] Section 3365.1(A)(IV). Unlike N.Y. Public Health Law § 3312.1(d), this section does not require a showing of the ability to comply with federal laws and regulations, presumably due to the complete federal prohibition of all uses of marijuana.
[32] Section 3365.1.B.
[33] Section 3365.1(C).
[34] Id.
[35] Section 3365.1(D).
[36] Section 3365.2(C).
[37] Section 3365.2(A)(I)-(VI).
[38] Section 3365.2(B).
[39] Id.
[40] A. 9016, S. 4041, supra FN 2, at Section 1.
[41] Section 3365.2(D).
[42] Section 3365.3.
[43] Section 3365.2(E).
[44] Id.
[45] Section 3365.4(A).
[46] Section 3365.4(B).
[47] Section 3365.4(E).
[48] Section 3365.5
[49] Section 3366.
[50] Id.
[51] Section 3367.3.
[52] Section 3367.1.
[53] Section 3361.1.
[54] Section Id.
[55] Section 3360(6).
[56] The New Jersey medical marijuana law permits the use of marijuana for treatment of a “debilitating medical condition,” which it defines as eleven enumerated conditions and such other medical conditions as the state may approve by regulation, N. J. Stat. § 24:6I-3. These eleven conditions are subject to additional limitations; for example, “debilitating medical condition” includes cancer only when the cancer or its treatment results in severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome.
[57] Section 3368.3.