BLOGGER HTML TEMPLATE AS OF 4/15/16 BEFORE REDIRECTION TO WORDPRESS New Amsterdam Psychedelic Law Blog: Madmen Rule You

Thursday, October 25, 2012

Madmen Rule You

Madmen Rule You: the DEA and the legal logic of permanent cannabis prohibition

(© Noah Potter, 2012. Originally published at psychedeliclaw.com on April 19, 2012)
The author gratefully acknowledges the conceptual clarity provided by Buford Terrell, who, by identifying Grinspoon v DEA and Gonzales v Oregon, made this article possible.  
I. Summary
Part II. - Introduction
Part III. - The latest attempt to take cannabis out of Schedule I
Part IV. - The DEA Ruling
Part V. - Adding a requirement to show medical use, notwithstanding the statute
Part VI. - A federal appellate court rejects the DEA's reliance on FDA approval
Part VII. - The DEA proposes an alternative to the FDA-approval standard 
Part VIII. - The DEA defines its efficacy studies standard to mean the functional equivalent of FDA approval
Part IX. - The DEA's test for "currently accepted medical use in treatment" cannot pass the holding of Grinspoon
Part X. - Whether the DEA's interpretation of the CSA can survive Gonzales v Oregon
Part XI. - Bringing together Oregon and ASA
Part XII. - Conclusion

Dear reader, perhaps in your travels you have encountered the argument that cannabis has no medical use because the Food and Drug Administration has not approved it. Perhaps you wonder how it is that the Drug Enforcement Administration can plausibly assert that cannabis has no medicinal value notwithstanding the existence of state medical cannabis laws in sixteen states and the District of Columbia and the cascade of articles asserting that yet another study has reported another therapeutic use of cannabis. You read articles in the popular press that report on medical cannabis advocacy and then duly and docilely report that the federal government maintains that there is no medical use of cannabis - and you wonder how the feds could be so obtuse.

They are not being obtuse. They have interpreted the law so that cannabis will always fail their tests and they can then claim legal justification to keep cannabis prohibited forever.

I intend to deconstruct this issue and explain the legal reasoning of the DEA. When you finish this article you should be able to challenge the official government position, recited incessantly by prohibitionists in federal, state and local governments as well as the prohibitionist lobby outside of government. At a minimum you should be able to challenge members of the press to demand plausible explanations of the prohibitionist position. 

I. Summary

1. In its public statements, the DEA denies that there is any medical use for cannabis by defining “medical use” as “FDA approval.”

2. In 1987, a federal appellate court, the Court of Appeals for the First Circuit (Massachusetts and the other New England states aside from Connecticut) ruled in the decision of Grinspoon v. DEA that this definition is incorrect: the FDA’s approval of the right to market a drug (which requires a showing to the FDA’s satisfaction through extensive and expensive clinical trials that a drug is “safe” and “effective” for some specific use) is not the same showing that the drug has  “a currently accepted medical use in treatment” under the Controlled Substances Act. Therefore, the absence of FDA approval does not require a conclusion that the drug has no medical use.

No matter – in 1988 the DEA came up with a new definition that means practically the same thing: now it requires that anyone proposing a medical use of cannabis (or any other substance in the same legal category, such as MDMA, LSD, psilocybin, ayahuasca and ibogaine) must show that there have been clinical trials of the type which the FDA requires in order to approve a drug for marketing.  Obviously, requiring that someone seeking to demonstrate a medical use for a psychedelic show the results of the extremely expensive and demanding Phase III clinical trials that meet the FDA’s criteria to obtain approval have taken place is functionally the same as requiring FDA approval. Further, there is no basis whatsoever for this standard in federal law: the DEA made it up out of thin air. We will examine this matter more fully later and consider that the DEA is requiring a form of efficacy evaluation that does not exist in US law.

3. It gets worse: the DEA has refused even to hold hearings at which evidence of medical use can be presented. Even though there is no requirement in federal law that someone seeking to show that there is a medical use for cannabis prove the existence of that use before a hearing, that is exactly what the DEA requires – again, in the form of the equivalent of FDA approval.

4.  There is another minor additional complication in this picture: (a) not only is there no basis for the DEA’s requirement that a proponent of a medical use for cannabis demonstrate the existence of that medical use before there can be a hearing as to the existence of a medical use and (b) not only does the DEA’s definition of medical use as FDA-compliant Phase III clinical trials defy the First Circuit’s 1987 decision but (c) the DEA’s position (I argue) violates Constitutional principles of federalism as established by the US Supreme Court in the decision of Gonzales v Oregon.

Before passing to the full discussion of what I summarized above, it is worth noting briefly an aspect of the DEA's legal reasoning that I believe simply and clearly explains how the DEA works. The DEA recently pulled a switcheroo in order to deny the most recent petition to reschedule cannabis: it changed its requirement that “the drug be accepted by qualified experts” to a requirement that there be a “consensus of qualified experts,” i.e. that there be no “material conflict of opinion among experts." In other words, as state medical cannabis laws spread, the DEA makes its definitions more restrictive in order to continue denying that there is any medical use - notwithstanding the conclusions of the states - and thereby continue to insist that cannabis remain completely prohibited. As the rate of change increases and the threat that cannabis could be legalized increases the DEA moves the target to keep legalization out of range. A more elaborate mechanism is described below.

Part II. Introduction

Everyone knows that beginning in 1996 a wave of state medical cannabis laws broke over America, drenching a society parched and cracked by sixty (minus one) years of federal cannabis prohibition. Everyone knows that cannabis is still prohibited for all purposes (except stringently-regulated research) under federal law.

The United States government implements federal drug prohibition through the Controlled Substances Act (the “CSA”), which appears in the United States Code at Title 21, Sections 801 through 904. The CSA does not actually prohibit all drugs for all purposes: it establishes criminal penalties for all actions in connection with certain “drugs or other substances” other than in compliance with the CSA’s provisions. The CSA creates five “schedules” of drugs, Schedules I through V; when Congress drafted the CSA in 1970 it made the initial placement of substances into the Schedules. It is most important to us here at Psychedelic Law that Congress placed cannabis, LSD, psilocybin, mescaline and ibogaine (among other psychedelics) in Schedule I. (Although the DEA likes to say that Congress made all the decisions about what drugs belong in what Schedules, ever since 1970 it has been the DEA that “schedules” drugs which it deems have potential for abuse and fights ferociously to keep cannabis permanently prohibited in Schedule I.) The DEA put MDMA in Schedule I in the 1980s. Substances in Schedules II through V can be prescribed by “practitioners” (which, for current purposes, I will describe as physicians); Schedule I substances are never available, even by prescription. 

The criteria for Schedule I placement are as follows: (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 and (c) there is a lack of accepted safety for use of the drug or other substance under medical supervision. 21 U.S.C. 812(b).

Of those three scheduling criteria, number two – no currently accepted medical use in treatment - is the most critical, the reason being that it is unique among all the Schedules. As I have said before at various times, drug prohibition can be defined as follows: the criminal prohibition of the manufacture, sale, purchase, possession and use of a drug except for medical purposes which are defined as narrowly as possible by police. In other words, medical use is an exception to prohibition, but with Schedule I there is no exception to prohibition – because the federal government says there is no medical use. Prohibition of a Schedule I substance is absolute, even when a patient claims that use of the substance is necessary to save her life or relieve excruciating pain.

Now, placement in Schedule I is not the only manifestation of prohibition. Cocaine is in Schedule II meaning that it can be prescribed; it is sale of cocaine without a prescription that is criminal and manufacture or import without the proper DEA licenses is also illegal. Ritalin, Oxycontin, and morphine, for example, are also in Schedule II. When the DEA attacks physicians for their prescribing practices as to opiates in Schedules lower than Schedule I, you are actually witnessing another manifestation of prohibition – but concerning substances that are not completely prohibited for all purposes. It is more proper then to say that the subject of prohibition is the use of a particular drug, not the drug itself. It just so happens that in the case of Schedule I drugs, NO uses are permitted.

It is important to note that even if a drug or other substance is in Schedules II through V but is not approved for marketing by the FDA it still cannot be legally prescribed. So what good is it to move cannabis or any other psychedelic (or any other drug) out of Schedule I? Frankly, I don’t know – you perhaps avoid certain criminal liability but you do not achieve legal status under federal law and you certainly do not achieve the general right for adults to use cannabis in a manner analogous to alcohol, i.e. as part of a lifestyle choice. I understand that moving substances out of Schedule I makes research easier; that is a matter that requires further examination.

Still, I am focusing on the issue of the DEA’s refusal to allow cannabis out of Schedule I because it is the frontline of combat in the American drug war, if only as a matter of government rhetoric. The federal government has committed itself to the extreme position that there is no medical use of cannabis; it has staked its credibility on this impossible and incredible argument.

The DEA’s legal reasoning demonstrates that it is ideologically committed to maintaining complete prohibition of cannabis by any means necessary: when the federal government will not acknowledge any medical use of cannabis, as if it were committed to exterminating heresy, obviously no rational dialogue is possible.

When arguing with the DEA, you are arguing with madmen who, like their prohibitionist constituency, are maniacally obsessed with preventing any legal use of cannabis for any reason, even to save a life. These madmen rule you and your ability to attain physical and mental states which they deem wrong and, therefore, by extension they control the most intimate aspects of human existence – sensation and cognition, individually and collectively. It is necessary to deconstruct the DEA’s arguments and demonstrate how their legal reasoning works in order to demonstrate that they are mad. Perhaps then it will be possible for society to disarm the madmen.

Part III. The latest attempt to take cannabis out of Schedule I

Right now there is a very important lawsuit pending in the United States Court of Appeals for the D.C. Circuit. It seeks to lay the foundation for a challenge to the placement of cannabis in Schedule I.  That lawsuit is Americans for Safe Access, et al., v. Drug Enforcement Administration, No. 11-1265.

The Controlled Substances Act is a complete statutory scheme governing psychoactive substances. (Forget tobacco and alcohol; they are not included.) Among other things, it provides the mechanism by which the DEA can put drugs and other substances into the Schedules, and thus impose criminal penalties for their manufacture, distribution, possession, etc. It also provides the mechanism by which a drug or other substance can be moved into another Schedule – or moved out of the Schedules entirely. Most importantly, for our purposes, the CSA provides that “any interested party” may petition the DEA to move a controlled substance around the Schedules. The provisions of the CSA that govern how a controlled substance may be moved into, out of, or around the Schedules appear in the U.S. Code at 21 U.S.C. 811.

In technical terms, a request that the DEA reschedule cannabis, i.e. move it out of Schedule I into another Schedule, is a “petition” for the DEA to commence “rulemaking on the record,” i.e. to conduct evidentiary hearings as to how a drug should be scheduled. 

In 1972, the National Organization for the Reform of Marijuana Laws (NORML) petitioned the predecessor agency to the DEA to move cannabis out of Schedule I. That proceeding lasted twenty-two years, ending in 1994 after the D.C. Circuit Court of Appeals killed it. In that proceeding, the DEA was forced to hold an evidentiary hearing, as described above, which resulted in the famous statement by the DEA administrative law judge, Francis Young, that cannabis is the safest therapeutic substance known to man and the conclusion that it should be moved out of Schedule I. It also resulted in an order by the DEA Administration rejecting this conclusion.

A second petition followed in 1995 but was rejected on procedural grounds.

In 2002 a coalition called the Coalition to Reschedule Cannabis brought another petition to reschedule cannabis. Between 1995 and 2002, of course, the state medical cannabis movement had broken out following the passage of Proposition 215 in California, the Institute of Medicine had issued a report indicating that there were therapeutic uses of cannabinoids (although it indicated that it believed that the cannabis plant material will never be considered a medicine) and encouraging more research, and it seemed appropriate to revisit the issue with the DEA. The DEA accepted the petition, obtained an opinion from the FDA that cannabis should stay in Schedule I in 2006 and sat on the petition for another five years without ruling until CRC brought an action in federal court in April 2011 to compel the DEA to act.

After nine years of waiting, the petitioners started a federal lawsuit to compel the DEA to issue a decision on the petition, and the DEA promptly issued an order in June 2011 that was published in the Federal Register on July 8, 2011, at 76 FR 40552. The decision, which I will call the “DEA Ruling,” reviewed the petition to hold hearings about whether to move cannabis out of Schedule I, concluded that there was no basis even to hold hearings, and denied the petition.

Once there was a DEA decision, the petitioners could challenge it in court, which is what is happening now in the D.C. Circuit Court of Appeals. The petitioners filed their legal brief in January of 2012. The DEA filed its legal brief in response on March 23.

Part IV. The DEA Ruling

The DEA Ruling of July 8, 2011, consists of two parts, a 2006 report and recommendation by the FDA and then the DEA’s own opinion.

Let's look at how a rescheduling petition works.

As discussed above, the CSA provides for a somewhat elaborate procedure for a petition to move a controlled substance from one Schedule to another, which is described at 21 USC 811.

Any “interested party” can petition the DEA to begin a proceeding to move a drug into another Schedule. (The DEA is arguing in the ASA case that the petitioners are not “interested parties” who can petition the DEA. I am not addressing this argument.)

The DEA is supposed to gather “necessary data” and then request a “scientific and medical evaluation” by the Department of Health and Human Services (“DHHS”) and a recommendation as to whether the drug should be moved to another Schedule. DHHS is the federal health and welfare department, a massive entity containing numerous subagencies, such as the Medicaid and Medicare agencies, the National Institutes of Health, the Centers for Disease Control and the FDA. It is the FDA that does the evaluation and makes the scheduling recommendation on behalf of DHHS, which is the term used in the CSA.

The CSA says that there are eight factors which the DEA and DHHS – which here means the FDA – must consider in evaluating whether to grant a petition for rescheduling which, agains, means an evidentiary hearing to determine whether to move the drug to another Schedule. Those factors are:

(1) the drug’s actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

21 USC 811(c)(emphasis added).

The CSA is a little convoluted, of course, being a federal statute. Although the DEA must consider these eight factors, first the FDA must consider factors (2) [scientific evidence of its pharmacological effect], (3) [the state of current scientific knowledge regarding the drug or other substance], (6) [what, if any, risk there is to the public health], (7) its psychic or physiological dependence liability, (8) [whether the substance is an immediate precursor of a substance already controlled under this subchapter],  and any scientific or medical considerations involved in factors (1) [its actual or relative potential for abuse], (4) [its history and current pattern of abuse and (5) [the scope, duration, and significance of abuse]. The FDA is supposed to give its report on these factors to the DEA and give its recommendations as to the Schedule under which the drug should be listed. The FDA’s recommendations about the “scientific and medical matters” shall be binding on the DEA.

What is missing from the eight-factor test? Any evaluation of “currently accepted medical use in treatment” or “efficacy.” But that doesn’t stop the feds from sneaking it in.

Part V. Adding a requirement to show medical use, notwithstanding the statute

As is obvious from the plain text of 21 USC 811(b), there is no place for an examination of medical use when the DEA is presented with a petition to reschedule a controlled substance. So how does the DEA position itself to place an insurmountable obstacle in front of rescheduling cannabis? It construes the third factor in the eight factor test, “the state of current scientific knowledge regarding the drug or other substance” to mean that it is required to see whether the drug already has a “currently accepted medical use in treatment in the United States.” Is it apparent to you that “the state of current knowledge regarding the drug or other substance” means a “currently accepted medical use in treatment in the United States? It doesn’t to me.

To the contrary, it is blindingly obvious that in construing its obligation to evaluate “the state of scientific knowledge” to mean to check to see whether is a “currently accepted medical use in treatment in the United States,” the DEA has completely reversed the rulemaking process as set forth in the CSA – because whether there is a “currently accepted medical use in treatment in the United States” should be determined in the rulemaking hearings - not as a condition to initiating the hearings. Otherwise there will never be any basis to conduct the hearing in which the existence or non-existence of “currently accepted medical use in treatment” should be determined.

In fact, it is obvious from the text of the CSA that checking whether there is a “currently accepted medical use in treatment” is only done during the course of the evidentiary hearing to be conducted by the DEA, not when the DEA decides whether or not to allow the evidentiary hearing. I’ll prove it to you.

The CSA requires that the FDA and the DEA conduct the evaluation required by the eight-factor test, none of which includes, on a most basic and obvious level, any evaluation of  “medical use” or “efficacy” as a treatment. However, the CSA does require that the DEA make a finding concerning “medical use in treatment” – but after the evidentiary hearing, as is stated in Section 811(a):

(a) Rules and regulations of Attorney General; hearing
The Attorney General shall apply the provisions of this subchapter to the controlled substances listed in the schedules established by section 812 of this title and to any other drug or other substance added to such schedules under this subchapter. Except as provided in subsections (d) and (e) of this section, the Attorney General may by rule -
(1) add to such a schedule or transfer between such schedules any drug or other substance if he--
(A) finds that such drug or other substance has a potential for abuse, and
(B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed; ….
Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by [the federal Administrative Procedures Act].

It is clear from the language of the statute that one of the objects of the rulemaking to be conducted after the opportunity for a hearing – i.e. an evidentiary hearing – is to make the findings required by the CSA at Section 812(b). What appears in Section 812(b) of the CSA? The criteria for scheduling a substance: (a) potential for abuse, (b) accepted medical use in treatment and (c) safety. That’s right – accepted medical use in treatment shows up as one of the elements which the DEA must determine after an evidentiary hearing, not before at the stage when someone petitions for the DEA to conduct that hearing.

To summarize: it is clear from the text of the CSA that the DEA has no business testing for the existence of a currently medical use of cannabis before it conducts an evidentiary hearing. The only matters for the DEA to consider relate to safety and abuse potential. The only time at which the CSA requires that the DEA evaluate whether there is a currently accepted medical use in treatment is after the DEA grants the rulemaking petition and conducts the evidentiary hearing. 

It gets better in terms of perversity, that is to say worse in terms of rational conduct by public servants.

Part VI. A federal appellate court rejects the DEA’s reliance on FDA approval

When you travel around the world of medical cannabis advocacy, you will invariably encounter the argument that because the FDA has not “approved cannabis as a medicine” it is not a medicine. This is the colloquial way of saying that there is no “currently accepted medical use in treatment in the United States,” which is the precise statutory language, and therefore the states should not permit the use of cannabis for medical purposes (or, of course, cultivation and distribution of cannabis incidental to supplying the market).

What could be the source of this argument? The DEA’s persistent misstatement of the law.

In 1987, the Court of Appeals for the First Circuit ruled in Grinspoon v. Drug Enforcement Administration, 828 F.2d 887 (1st Cir. 1987) that in order to show the existence of a “currently accepted medical use in treatment” it is not necessary to show that the FDA has approved a drug for marketing and sale in interstate commerce, i.e. approved a New Drug Application (“NDA”). In that case, Dr. Lester Grinspoon sought a hearing to challenge the DEA’s placement of MDMA in Schedule I. Although the DEA administrative law judge concluded after the hearing that MDMA did not belong in Schedule I, in part because there was a “currently accepted medical use in treatment,” in a now-familiar course of conduct, the DEA rejected the judge’s conclusion. The DEA Administrator stated in his decision that because the FDA had not approved an NDA to market MDMA in interstate commerce, MDMA had no “currently accepted medical use in treatment” and there was a lack of accepted safety or use of the drug or other substance under medical supervision (the latter corresponding to the third criteria for scheduling a drug - “safety”). In other words, the test for whether a drug belongs in Schedule I would be whether the FDA has approved it for sale, which would require a showing satisfactory to the FDA, based on exhaustive and extremely expensive clinical trials, that it is “safe” and “effective” in treating some specific disease condition according to the standards promulgated by the FDA under the federal Food Drug & Cosmetic Act.

The Court of Appeals for the First Circuit rejected numerous arguments by the DEA in support of that standard, holding that a finding of “currently accepted medical use in treatment” does not require FDA approval. Fundamentally, the Court explained that FDA approval is not the same standard as “currently accepted medical use in treatment”: for example, a drug could have an acceptable safety standard and a currently accepted medical use in treatment even though it is not approved for marketing in interstate commerce (i.e. there is no “FDA approval”). 

Most importantly, in its final section, the opinion focuses on what it considered the DEA’s attempt to define the CSA in a way that would make evidentiary hearings under 21 USC 811(a) irrelevant:

It is plain, therefore, that while Congress intended the recommendation of HHS [i.e. the FDA] to have significant weight in the decisionmaking process, it also intended that there be an opportunity for a meaningful hearing after receipt of the HHS report. It would surely be anomalous if the FDA's recommendation, based solely on the absence of approval for interstate marketing, sufficed to determine the ultimate conclusion prior to the hearing.
If we were to accept the Administrator's construction of section 812(b)(1) in this case, the opportunity for a meaningful hearing would be lost, and satisfaction of the "accepted medical use" and "accepted safety" criteria would turn solely on the existence of FDA approval for interstate marketing. A hearing on issues of the sort required by the statute -- Does the substance have an accepted medical use in treatment in the United States? Is the substance safe for use under medical supervision? -- would be reduced to an empty formality and, for participants like Dr. Grinspoon, would amount to an exercise in futility. We hesitate to interpret the CSA in a manner that would cause its important provision requiring a administrative hearing to be meaningless as to two of the three requirements for scheduling a substance in Schedule I. We believe instead that, for the hearing opportunity to be a significant one on these issues, the agency must remain flexible enough to weigh and consider claims raised at the administrative hearing to the effect that a substance has an accepted use and is accepted as safe even though it is not approved for distribution in interstate commerce.

(Emphasis added.)

The language of the opinion is strong. The DEA doesn’t care. I guarantee that the next time you hear the DEA and its minions and prohibitionist sympathizers among state officials and anti-drug activists object to the medical use of cannabis, they will say that cannabis has no medical use because the FDA has not approved it – as if no federal appellate court has rejected that position.

However, even though the DEA publicly uses the argument, rejected by a federal appeals court, that FDA approval is what is necessary to show medical use, in its legal arguments it uses another standard which it devised after the Grinspoon decision.

Part VII. The DEA proposes an alternative to the FDA-approval standard

As I stated previously, the current petition to reschedule cannabis is the latest in a series of petitions. The first petition, commenced by the National Organization for the Reform of Marijuana Laws began in 1972. It ended in 1994 with the opinion issued by the Court of Appeals for the Federal Circuit in Alliance for Cannabis Therapeutics v.  Drug Enforcement Administration, 15 F.3d 1131 (D.C. Cir. 1994).
 
This 20-year plus process actually did result in hearings at which physicians testified concerning the medical benefits of cannabis and resulted in the DEA Administrative Law Judge, Francis Young, holding that there is a “currently accepted medical use in treatment” for cannabis and it should not be in Schedule I. As was the case with MDMA, per the Grinspoon decision, the DEA Administrator rejected that conclusion.

After the Grinspoon decision, which was issued while NORML’s cannabis rescheduling was pending, it was necessary for the DEA to formulate a new legal standard to define “currently accepted medical use in treatment” that did not rely on FDA approval. Accordingly, the DEA formulated a new eight-factor test to define what is a “currently accepted medical use in treatment.” 

The new test which the DEA issued to determined whether there existed a “currently accepted medical use in treatment” of a substance required:

(1) Scientifically determined and accepted knowledge of its chemistry;
(2) The toxicology and pharmacology of the substance in animals;
(3) Establishment of its effectiveness in humans through scientifically designed clinical trials;
(4) General availability of the substance and information regarding the substance and its use;
(5) Recognition of its clinical use in generally accepted pharmacopeia, medical references, journals or textbooks;
(6) Specific indications for the treatment of recognized disorders;
(7) Recognition of the use of the substance by organizations or associations of physicians; and
(8) Recognition and use of the substance by a substantial segment of the medical practitioners in the United States.

In Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991), the petitioners cited to Grinspoon and argued that the new eight-factor test invoked the same standard of FDA approval which the First Circuit had rejected. (Apparently the petitioners argued that the first three factors duplicate the elements of FDA approval and thus conflict with the Grinspoon holding; to my eye only the third factor duplicates dead-on the standard of FDA approval.)

In response, the Circuit Court misstated the holding of Grinspoon. Then it allowed the DEA to keep efficacy studies as a test for the existence of a “currently accepted medical use in treatment.”

The Court said:

The present criteria, it is argued, duplicate a number of those original criteria. But the criteria challenged in Grinspoon included several elements, such as the availability of patent information or FDA-required labelling, which were necessary only to market the drug in interstate commerce. These criteria are clearly relevant to the FDA's mission, but not to the DEA's, see Grinspoon, 828 F.2d at 887. The First Circuit never suggested the DEA Administrator was foreclosed from incorporating and relying on those standards employed by the FDA that are relevant to the pharmaceutical qualities of the drug. The court merely held that while FDA approval is sufficient to establish the existence of an accepted medical use, the converse is not true — that absent FDA approval, commonly accepted medical use cannot be proven. Nor can we conceive of a reason the Administrator should be barred from employing notions developed by a sister agency insofar as those notions serve the missions of both agencies.

(Emphasis added.)

In other words, although the DC Circuit Court acknowledged Grinspoon’s holding that FDA approval of a drug for marketing is not the way to establish the existence of a currently accepted medical use in treatment, it held that the DEA could require elements of what the FDA would require in order to approve a drug for interstate marketing, specifically efficacy studies.  (It also apparently held that FDA approval can establish the existence of a currently accepted medical use in treatment, but is not the only way to do so.)

For reasons that are not important here, the next thing that happened was that the DEA replaced the eight-factor test for the existence of a “currently accepted medical use in treatment” with a new five-factor test, which is the one which the DEA currently uses. Although it discarded numerous elements from the eight-factor test, it retained efficacy and safety studies as its required elements. This standard appeared in Alliance for Cannabis Therapeutics v.  Drug Enforcement Administration, 15 F.3d 1131 (D.C. Cir. 1994).

The five-factor standard that the court allowed to stand is as follows:

i. The drug’s chemistry must be known and reproducible
ii. There must be adequate safety studies
iii. There must be adequate and well-controlled studies proving efficacy
iv. The drug must be accepted by qualified experts
v. The scientific evidence must be widely available

There is one simple problem with the DEA’s requirement of efficacy studies as an element of a “currently accepted medical use in treatment”: what are they? The standards for proving efficacy and safety in order to obtain FDA approval of a New Drug Application are relatively well-known. They are discussed at length in FDA regulations and guidance documents and constitute a significant element of the huge costs that go into bringing a drug to market. What, however, are these mysterious efficacy studies which the DEA seeks to use as a test for “currently accepted medical use in treatment?” Who designs them? Who evaluates the results – the DEA? The FDA? Someone else? Under what rule? Apparently the D.C. Court of Appeals was not troubled by these questions.

Apparently the petitioners did not continue to object to the Court’s apparent approval of the DEA’s inclusion of “adequate and well-controlled studies proving efficacy” or, for that mater, “adequate safety studies.”

The five-factor test that appeared in the ACT decision is the present test for “currently accepted medical use in treatment.” It is the one which the DEA used to reject the current rescheduling petition.

Part VIII. The DEA defines its efficacy studies standard to mean the functional equivalent of FDA approval

The Court of Appeals for the First Circuit held in the Grinspoon decision that it is not necessary to show FDA approval of a drug for marketing in interstate commerce in order to show that there is a “currently accepted medical use in treatment,” which is one of the criteria for moving the drug out of Schedule I. This opinion rejected the DEA’s test.

In response the DEA created a new five-factor test that included, as relevant here, a requirement that there be “adequate and well-controlled studies proving efficacy.” What does that term mean? We can see from the DEA Ruling denying Americans for Safe Access’s petition to hold an evidentiary hearing as to whether cannabis should be moved out of Schedule I that the DEA interprets it to mean Phase III clinical trials, i.e. the type of hugely expensive clinical trials involving thousand of patients that are necessary…. to obtain FDA approval of a drug for marketing in interstate commerce.
Coincidence? I think not.

Examination of the FDA report and recommendations and the DEA’s own reasoning in the DEA Ruling show beyond doubt that the DEA is treating its own five-factor test as a requirement of the full scope of clinical trials that are required to be included in a New Drug Application to the FDA for permission to market a drug.

Let us start with the DEA’s analysis.

At page 40579 of the DEA Ruling, the DEA discusses in full its reasoning as to why the petitioner has not shown the existence of a “currently accepted medical use in treatment for cannabis,” reviewing the elements of the five-factor test. It states as follows with regard to the third element of the five-factor test: “adequate and well-controlled studies proving efficacy”:

DHHS states that no studies have been conducted with marijuana showing efficacy for any indication in controlled, large scale, clinical trials.
To establish accepted medical use, the effectiveness of a drug must be established in well-controlled, well-designed, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients (57 FR 10499, 1992). To date, such studies have not been performed. The small clinical trial studies with limited patients and short duration are not sufficient to establish medical utility. Studies of longer duration are needed to fully characterize the drug's efficacy and safety profile. Scientific reliability must be established in multiple clinical studies. Furthermore, anecdotal reports and isolated case reports are not adequate evidence to support an accepted medical use of marijuana (57 FR 10499, 1992). The evidence from clinical research and reviews of earlier clinical research does not meet this standard.

As noted, DHHS states that a limited number of Phase I investigations have been conducted as approved by the FDA. Clinical trials, however, generally proceed in three phases. See 21 C.F.R. 312.21 (2010). Phase I trials encompass initial testing in human subjects, generally involving 20 to 80 patients. Id. They are designed primarily to assess initial safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary studies of potential therapeutic benefit. (62 FR 66113, 1997). Phase II and Phase III studies involve successively larger groups of patients: usually no more than several hundred subjects in Phase II and usually from several hundred to several thousand in Phase III. 21 C.F.R. 312.21. These studies are designed primarily to explore (Phase II) and to demonstrate or confirm (Phase III) therapeutic efficacy and benefit in patients. (62 FR 66113, 1997). No Phase II or Phase III studies of marijuana have been conducted. Even in 2001, DHHS acknowledged that there is “suggestive evidence that marijuana may have beneficial therapeutic effects in relieving spasticity associated with multiple sclerosis, as an analgesic, as an antiemetic, as an appetite stimulant and as a bronchodilator.” (66 FR 20038, 2001). But there is still no data from adequate and well-controlled clinical trials that meets the requisite standard to warrant rescheduling.

(Emphasis added.)

In the concluding section, the DEA Ruling again states:

To establish accepted medical use, among other criteria, the effectiveness of a drug must be established in well-controlled scientific studies performed in a large number of patients. To date, such studies have not been performed for cannabis. Small clinical studies with limited patients and short duration such as those cited by the petitioner are not sufficient to establish medical utility. Larger studies of longer duration are needed to fully characterize the drug’s efficacy and safety profile. Anecdotal reports, patients’ self-reported effects, and isolated case reports are not adequate evidence to support an accepted medical use of cannabis.

(Emphasis added.)

The section of the DEA Ruling containing the FDA’s report and recommendation states in relevant part:

In addition to demonstrating efficacy, adequate safety studies must be performed to show that the drug is safe for treating the targeted disease. DHHS stated that safety studies for acute or subchronic administration of cannabis have been carried out through a limited number of Phase I clinical investigations approved by the FDA, but there have been no NDA-quality studies that have scientifically assessed the efficacy and full safety profile of cannabis for any medical condition.

It is beyond doubt that the DEA is requiring the completion of Phase III clinical trials, including from “several hundred to several thousand” subjects, as evidence that there are “adequate and well-controlled studies proving efficacy.” In citing to Title 21, Section 312.21 of the Code of Federal Regulations, the DEA quite clearly is demanding clinical trials, the results of which are sufficiently thorough that they could be submitted to the FDA as part of a New Drug Application. We can conclude so because that section appears in the part of the Code of Federal Regulations governing the FDA drug approval process and sets forth the elements of those clinical trials. I do not claim to be an expert on FDA clinical trials, but I understand that the clinical trials must be randomized, double-blind trials in which there are patients receiving the active substance being tested and a placebo and that neither the investigators nor the subjects know who is in the “control” (placebo) group.

This standard is entirely unreasonable since as shown above, there is absolutely no requirement in the CSA that there be any showing of efficacy before the DEA begins rulemaking about the correct classification of a Schedule I drug. 

Part IX. The DEA’s test for “currently accepted medical use in treatment” cannot pass the holding of Grinspoon

It is obvious that the DEA has defined the efficacy element of the five-factor test to mean the completion of Phase III clinical trials compliant with the FDA’s requirements for the tests that must be included in a New Drug Application (i.e. application for approval to market a drug).

There is one simple problem about the DEA’s requirement of such efficacy studies: what are they? What are these mysterious efficacy studies which the DEA seeks to use as a test for “currently accepted medical use in treatment?” Who designs them? Who evaluates the results – the DEA? The FDA? Someone else? Under what rule? If someone does sponsor Phase I through Phase III clinical trials of cannabis and somehow determines which agency will evaluate the results – what results from these clinical trials constitute evidence of a “currently accepted medical use of cannabis”? As a practical matter, who is going to sponsor these clinical trials but not do so in the course of applying for a New Drug Application as to cannabis (since that is a requirement which Grinspoon rejected)? What kind of procedure exists for evaluating the results of Phase III clinical trials outside the scope of a New Drug Application? Does the FDA customarily do so under some arrangement with the DEA?

Would it help to explain the insanity of drug law if the DEA requires that cannabis pass a set of tests that do not exist before it will recognize a medical use?

As the proponent of the efficacy test requirement, it is incumbent upon the DEA to provide answers to the preceding questions.

The ultimate challenge to this element of the DEA’s test for a “currently accepted medical use in treatment” is in the last stage of the reasoning in the Grinspoon opinion.

As discussed above, the Court of Appeals for the First Appeal focused on the need for a meaningful hearing to evaluate whether there is a currently accepted medical use.

Here is the Court’s language (which I put in bold text in a previous section of this post):

It is plain, therefore, that while Congress intended the recommendation of HHS to have significant weight in the decisionmaking process, it also intended that there be an opportunity for a meaningful hearing after receipt of the HHS report. It would surely be anomalous if the FDA's recommendation, based solely on the absence of approval for interstate marketing, sufficed to determine the ultimate conclusion prior to the hearing.

If we were to accept the Administrator's construction of section 812(b)(1) in this case, the opportunity for a meaningful hearing would be lost, and satisfaction of the "accepted medical use" and "accepted safety" criteria would turn solely on the existence of FDA approval for interstate marketing. A hearing on issues of the sort required by the statute -- Does the substance have an accepted medical use in treatment in the United States? Is the substance safe for use under medical supervision? -- would be reduced to an empty formality…

In other words, the Grinspoon decision’s final reasoning was that whether there is a currently accepted medical use in treatment should be determined at a hearing, not before the hearing on the basis of the existence of or non-existence of FDA approval of a New Drug Application.

The same reasoning applies fully to the DEA’s requirement that there be “adequate and well-controlled studies proving efficacy.” DEA’s interpretation would turn on whether anyone has conducted Phase I-IIII clinical trials – and, presumably, submitted the results to the FDA or the DEA – but, inexplicably, without the intention of obtaining an NDA. In the same way the Grinspoon said that under the DEA’s interpretation, “the opportunity for a meaningful hearing would be lost, and satisfaction of the "accepted medical use" and "accepted safety" criteria would turn solely on FDA’s approval of the drug for interstate marketing,” such an opportunity would be lost if the existence of an accepted medical use were to depend on the completion of Phase III clinical trials. The DEA’s current standard creates the same problem that was at issue in Grinspoon: instead of examining evidence of medical use, the DEA ends the examination without a hearing by determining whether another part of the federal bureaucracy has taken some action or by determining that some set of tests had ended. In either case, the DEA makes its decision based on the status of some stage in the FDA drug approval process, not evidence presented in the hearing before an administrative law judge which the CSA requires.

What we have is a split between the First Circuit Court of Appeals and the D.C. Circuit Court of Appeals that should be resolved by the Supreme Court.

Part X. Whether the DEA’s interpretation of the CSA can survive Gonzales v Oregon

The last issue I will address is the question of whether the DEA – or, for that matter, the FDA - has Constitutional authority to determine what constitutes a “currently accepted medical use in treatment” without deferring to state laws following the United States Supreme Court’s decision in the case of Gonzales v Oregon, 546 U.S. 243 (2006). I consider it highly likely that the answer is no, and that the DEA’s position that state medical cannabis laws are irrelevant violates the Constitution as recently interpreted by the highest court.

In Oregon the Supreme Court rejected the Attorney General’s claim that he was permitted under the Constitution to define the “legitimate practice of medicine” to exclude physician-assisted suicide. In that case, the state of Oregon had passed a law allowing physicians, under relatively strict requirements, to prescribe Schedule II drugs in lethal amounts for the purposes of enabling terminally ill individuals to commit suicide. In response the Attorney General issued an Interpretative Rule stating that assisting suicide (i.e. by prescribing a lethal amount of a Schedule II controlled substance) is not the legitimate practice of medicine. Many years earlier the DEA had issued a rule saying that every prescription of a controlled substance must be for a “legitimate medical purpose”; by stating that assisting suicide via a prescription was not a prescription for a legitimate medical purpose, the Attorney General laid the foundation for revoking the registration under the CSA of physicians who wrote such prescriptions. (Did you know that every physician who wishes to be able to write a prescription for a controlled substance, e.g. a painkiller, must register with the DEA? In practice that means …all of them.) 

The Supreme Court ruled that the Attorney General’s action violated the Constitutional principle of federalism, i.e. the principle that whatever powers the Constitution does not assign to Congress are reserved to the states. In doing so, the Court repeatedly referred to the traditional authority of states to regulate the practice of medicine. The Court stated:

In deciding whether the CSA can be read as prohibiting physician-assisted suicide, we look to the statute’s text and design. The statute and our case law amply support the conclusion that Congress regulates medical practice insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood. Beyond this however, the statute manifests no intent to regulate the practice of medicine generally. The silence is understandable given the structure and limits of federalism, which allow the States great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons.
The structure and operation of the CSA presume and rely upon a functioning medical profession regulated under the States’ police powers.

Further cautioning against the conclusion that the CSA effectively displaces the States’ general regulation of medical practice is the Act’s preemption provision, which indicates that, absent a positive conflict, none of the Act’s provisions should be construed as indicating an intent on the part of Congress to occupy the field in which that provision operates…to the exclusion of any State law on the same subject which would otherwise be within the authority of the State.

The Court assembled numerous other arguments to the effect that the Attorney General is not authorized to define what is the legitimate practice of medicine, but the specific discussion tended to focus on the particulars of that case, which concerned the Attorney General’s ability to regulate prescription rather than, as here, the DEA’s authority to determine whether there is a “currently accepted medical use in treatment” of a given drug such that it cannot remain in Schedule I. However, the issue should be clear by now: if (a) the practice of medicine is a matter traditionally reserved to the states, doesn’t this principle mean that (b) the determination by a state that cannabis can be used for medical purposes necessarily requires the conclusion that (c) cannabis has a “currently accepted medical use in treatment” for purposes of the CSA? This interpretation takes out of the federal government’s hands all power except to determine whether states have recognized a medical use for cannabis. When I say the “federal government,” I include the FDA. Even though the Supreme Court made reference in Oregon to a delegation of authority to DHHS to make “medical judgments” at the federal level, that language does not require a conclusion that the FDA can decide that there is no currently accepted medical use in treatment of a drug when states have decided to the contrary, especially in light of the federalist principles stated in Oregon – and the fact that nothing in the CSA expressly delegates that particular decision to any federal agency.

Part XI. Bringing together Oregon and ASA

In the ASA litigation, the petitioners argued that the DEA erred in failing to consider all available evidence of a currently accepted use for cannabis in treatment when it disregarded the medical judgment of sixteen states plus the District of Columbia, that cannabis has medical use, i.e. as demonstrated by their laws permitting the use of cannabis for medical purposes. The petitioners cited to the Supreme Court’s decision in Oregon, for the holding that “states have the authority to define general standards of medical practice.” They reasoned that the Government’s argument in that case to the effect that the fact that forty-nine states had not legalized physician-assisted suicide showed that that practice is not the legitimate practice of medicine contradicts the DEA’s argument that state medical cannabis laws are irrelevant to determining there is a medical use for cannabis. In conclusion, they argued that “given the traditional and well-recognized constitutional authority of states and medical practitioners to define the legitimate practice of medicine,” the DEA acted arbitrarily and capriciously in disregarding views of states and physicians and concluding that cannabis has no medical use.

In response, the DEA attempted to limit the significance of Oregon by treating it as limited to the case in which the Attorney General tried to restrict the ability of a physician to prescribe a drug by defining the scope of the legitimate practice of medicine; by contrast, the DEA said, the CSA explicitly delegates to the Attorney General (which means, in practice, the DEA, since the DEA acts on behalf of the Attorney General with regard to controlled substances) the authority to make scheduling decisions. It distinguished those scheduling decisions from the regulation of medical practice. It argued that the conclusions of states do not substitute for the requirement that the DEA and FDA conduct the state of current scientific knowledge concerning the drug (under the CSA’s eight-factor test) or rebut the FDA’s conclusion that research has not progressed to the point that cannabis can be considered to have a currently accepted medical use in treatment. Among other arguments in the DEA’s memorandum of law, the most noteworthy one is the naked and unsubstantiated assertion that “the federal agencies are not required to defer to the conclusions of the states” and these conclusions do not substitute for the “evidence-based considerations” required by the CSA.

There are two fundamental problems with the DEA’s reasoning. First, the DEA starts with the assumption that it has the authority to determine whether there is a currently accepted medical use in treatment and that it is not required to defer to the contrary conclusions of states – but whether it has that authority at all is exactly the issue in dispute! It starts with its own disputed conclusion and argues backwards from there. It is perfectly reasonable to say – to the contrary - that when sufficient evidence of state laws permitting the medical use of cannabis is presented to a DEA administrative law judge during the evidentiary hearing required by 21 USC 811(a), the judge must acknowledge those laws and rule accordingly that there is a currently accepted medical use in treatment in the United States.

Second, although it’s a clever argument, it is impossible to separate (a) the power to define the scope of the legitimate practice of medicine from (b) the power to determine whether there is a “currently accepted medical use in treatment.” When the DEA states that it need not defer to the opinions of the states, which have the authority to regulate the practice of medicine, it necessarily claims even greater authority to regulate the practice of medicine because it says that it can second-guess the states or even ignore their opinions completely.

Third, when the DEA states that it is bound by the evidence-based standard of 21 USC 811(c), it again (willfully?) confuses two sets of standards. Section 811(c) sets forth the eight-factor test, which, as I have shown above, does not require any determination as to whether there is a currently accepted medical use at the stage of deciding whether to grant a petition and begin the evidentiary hearings. It requires only a consideration of the current state of scientific knowledge concerning the drug; the prerequisite that the FDA and DEA find that there is already a currently accepted medical use prior to granting the petition is the DEA’s own invention.

There is one final matter to consider here. The DEA cited to two decisions in support of its position. It cited to ACT II for the statement that the DEA is not required to abandon the need for “rigorous scientific proof” in favor of anecdotal reports even from doctors. At the time of the evidentiary hearings in that case, there were no medical cannabis laws in a third of the states, so this statement is irrelevant as to the question of whether the state laws prove there is a currently accepted medical use of cannabis in treatment. In addition, the DEA cited to the decision of Krumm v. Holder, No. Civ-08-1056, Lexis 52748 (D.N.M. 2009) by a trial-level federal court in New Mexico for the statement that “the CSA does not contemplate that state legislature’s determinations about the use of a controlled substance can be used to bypass the CSA’s rescheduling process.” However, in Krumm the plaintiff was seeking the far more radical judicial ruling that cannabis should be moved out of Schedule I – not, as in the ASA case, that the DEA should just begin the evidentiary hearings required by the CSA to determine whether cannabis should be rescheduled. That decision did not say that state medical cannabis laws have no bearing on whether there is a medical use: it held that the necessary course for the plaintiff was to petition the DEA – which is exactly what ASA did.

Part XII. CONCLUSION

Dear reader, I hope you now have some sense of the legal reasoning that hides within the statement, unchallenged by anyone in the press, that the federal government does not recognize any medical use of cannabis.

As I said earlier, moving cannabis out of Schedule I may make an incremental difference in US drug policy but more likely it is necessary to move cannabis out of the Schedules entirely and treat it as a product perhaps regulated by the FDA but not the DEA.

I leave you with some final thoughts for consideration: why is there a DEA? Why do police officers have final jurisdiction over psychoactive substances other than alcohol and tobacco? Why is it not sufficient to create a psychoactive substances bureau inside some other regulatory body, such as perhaps the FDA, that will note the potential or actual risks of psychoactive substances, issue warnings and propose standardized labeling and means of distribution, and seize adulterated products - but no more, leaving primary regulatory authority to the states? Police regulation is usually required for firearms, explosives, and other potential weapons, but drugs and other psychoactive substances are not weapons.

Prohibition at the federal level began when regulatory authority over opiates was given to police. I have attempted to deconstruct in this writing the legal reasoning which the police use to justify their ultimate power over drug control forever, no matter what the consequence. Their obsession with this power to state whether a psychoactive is a medicine or a poison is madness, and they will retain this power until you decide to end the rule of madmen. 

3 Comments:

At December 28, 2012 at 9:14 AM , Anonymous Anonymous said...

Great post men ... peace.

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Denial of cannabis by Prohibition ‘law’ premeditatedly inflicts suffering, blindness, and, in many instances, death. Those who maintain any use of life-saving cannabis to be "illegal" should be regarded and treated as perpetrators of the gravest of crimes, and deemed unfit to hold any public office in a democratic society.

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At February 11, 2013 at 5:31 PM , Anonymous Constitutional Cannabis said...

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At January 27, 2014 at 2:28 PM , Blogger MarkTulk said...

An excellent article and great exposition of the DEA's clear agenda to maintain prohibition at all costs. Seeing "madness" in this lights reminds me, in some way, of R.D Laing's "Politics of Experience." Pondering what is "sane" and what is "insane" he asks, who is madder… the man who believes he has a bomb in his stomach, or the man who authorizes the dropping of bombs on people, killing them by the thousands?

With regard to prohibition, the "insane" or "deviant" mother risks her freedom, reputation and future livelihood by breaking the law and growing some plants to help her sick child… the "sane" DEA locks her up and puts her child in custody, in order to "protect" them both…

 

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