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

Thursday, December 22, 2011

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

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

Monday, December 19, 2011

NJ township bans medical marijuana dispensaries

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.

Sunday, December 18, 2011

Cannabis as an herb, literally and legally.

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.

Wednesday, December 14, 2011

Federal regulation of medicine and Gonzales v Raich

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.

Friday, December 2, 2011

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

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?