Monday, January 28, 2013

The meaning of the DEA's recent victory in ASA v DEA

Following, after a brief introduction, are two comments on the D. C. Circuit Court of Appeals ruling last week in the proceeding captioned Americans for Safe Access v. Drug Enforcement Administration. In its decision the DC Circuit denied a petition by a coalition of drug law reform activists seeking to overturn the DEA's July 2011 decision not to conduct an evidentiary hearing as to whether cannabis should be moved out of the most restrictive category in US drug control, Schedule I of the Controlled Substances Act.


After those two points is a short colloquial summary of what I explained at length in my post of October 25, Madmen Rule You 

I. Brief introduction

In Madmen Rule You I explained the legal theory which the DEA uses to supports its public statements that marijuana is not a medicine. Those statements are extremely deceptive. In technical terms, the actual legal position is that there is no "currently medical use in treatment in the United States," which I abbreviate for convenience as "CAMUIT" (pronounced "commute," as in "commute the sentences of all non-violent drug offenders").


I explained that there is a split of opinion between the DC Circuit in the Alliance for Cannabis Therapeutics v. Drug Enforcement Administration decision in 1994 and the 1st Circuit decision in the Grinspoon v Drug Enforcement Administration decision in 1987 - and the ASA v DEA case should go to the Supreme Court so that it can resolve the split.


I also explained that the DEA has perverted the procedure set forth in the Controlled Substances Act for evaluating whether cannabis should be moved out of the most restrictive category in federal drug control.


I also explained that the DEA's construction of the Controlled Substances Act is unconstitutional.


What happened last week - the two issues which the Court considered


In last week's decision the Court focused entirely on two points, disregarding almost the entirety of the petitioners' argument, which focused on evidence of the health benefits and safety of cannabis.


The first point concerned whether the petitioners had "standing" to sue the DEA, i.e. as a matter of the judiciary's self-generated housekeeping rules whether any of the petitioners were sufficiently damaged by the DEA's action that they had the right to sue. I am not going to discuss that issue.


The second point. Sigh. The Court disposed of the petition without reaching any other substantive point except whether the petitioners had shown the existence of "adequate and well-controlled studies proving efficacy of cannabis" because that is the test which the DEA claims to apply in determining whether there is a CAMUIT. I'm going to abbreviate "adequate and well-controlled studies standard" as "AWCS" (pronounced "awacs," as in one of the first scandals of the Reagan administration).


I discussed this test for several pages in Madmen Rule You because of my longstanding belief that this test is the key. It is the essential tool which the DEA uses to maintain permanent cannabis prohibition. It is the one issue that separates Schedule I (the legal prison for psychedelics) from all the other Schedules, i.e. the categories that allow as how there may be a therapeutic use.


I was right about the significance of this issue. The Court basically held that if you do not prove that there is a CAMUIT then just give up. There is no reason to proceed any farther in the analysis.


II. Two comments

1. The court decided only that the DEA need not conduct an evidentiary hearing

Notwithstanding careless reporting in the popular media, the decision and order from the DC Circuit did not rule that there is actually no medical use for cannabis. The Court ruled on the narrow question of whether the petitioners had shown that the DEA acted arbitrarily and capriciously in refusing even to hold a hearing on the scheduling - i.e. to call witnesses and present evidence of the safety, abuse potential ("addictiveness") and efficacy of cannabis - such that the Court should second-guess the administrative agency's decision. 

2. The petitioners did not challenge the DEA's thought-construct

In its decision, the Court set forth very quickly the fundamental defect in the petitioners' approach: they did not challenge the DEA's legal standard - they accepted the legal standard and tried to show that they met the standard. The Court said at page 24-25 of the decision:
Petitioners do not seriously dispute  the propriety of the five-part test approved in Alliance for Cannabis TherapeuticsThus, they are left with the difficult task of showing that the DEA has misapplied its own regulations. Petitioners challenge the agency’s reasoning on each of the five factors. However, “[a] drug will be deemed to have a currently accepted medical use for CSA purposes only if all five of the foregoing elements are demonstrated.” Denial, 76 Fed. Reg.  at 40,579. In this case, we need only look at one factor, the existence of “adequate and well-controlled studies proving efficacy,” to resolve Petitioners’ claim.
Once you reach that text which I bolded and in particular the text which I italicized it's a pretty good guess that the case is over. The Court told the petitioners what went wrong: their job was to explain why the DEA's regulatory framework was wrong, not to show that the petitioners had met the DEA's requirements.

Once you accept the standard designed by the DEA to keep cannabis and other psychedelics prohibited forever, just give up. Such an approach is a disaster, as the Court's holding demonstrates. The DEA operates in a parallel universe of legal sophistry, a labyrinth of obfuscation and denial, the purpose of which is to maintain cannabis prohibition as an expression of an ideological position as to the nature of "mental health" and "mental illness." (An initial treatment of this topic appears in my post "Toxin and therapy in the mind of the bureaucracy.")

In fact, I believe that the DC Circuit actually looked quite favorably on the petitioners' position. I believe that the two judges in the majority understood that the DEA's test is defective but they held that the petitioners failed to attack the test and thereby could not prevail. 

Here's why. Petitioners relied primarily on the huge growth in 'peer-reviewed' studies to demonstrate that adequate and well-controlled studies demonstrated cannabis' medical uses. At page 26, the opinion says "Contrary to what Petitioners suggest, something more than “peer-reviewed” studies is required to satisfy DEA’s standard, and for good reason."   As I said in Madmen Rule You, the AWCS standard actually requires the equivalent of FDA-compliant Phase III clinical trials even though the DEA regulation does not explicitly say so (since it must avoid the Grinspoon holding, as discussed below). The DC Circuit agreed. ("The DEA interprets 'adequate and well-controlled studies' to mean studies similar to what the Food and Drug Administration (“FDA”) requires for a New Drug Application (“NDA”)." Page 26 of the DC Circuit's decision.) Now look at the Court's language: "something more than 'peer-reviewed studies' is required..." I believe that this statement is a joke -  because the Court recognizes that the DEA never explained what that "something more" is. In other words, the DEA has created a standard that is inherently arbitrary and capricious because it is completely subjective. The DC Circuit, located in DC, handles appeals from administrative agency decisions all the time - and a "something more" standard is obviously preposterous as an administrative standard. However, the petitioners never went after the integrity of that standard and the Court wasn't feeling charitable, especially not on the contentious issue of cannabis classification. It essentially punted this issue to the Supreme Court.


I believe that the Court actually focused on this standard in order to isolate it and focus attention on it. The Court could have sua sponte looked to the Grinspoon decision (which the petitioners cited in passing) and adopted that decision's reasoning but it did not, presumably because the petitioners never made the argument. 


III. Short colloquial summary of Madmen Rule You


- Perversion of the procedure for a petition to reschedule.

The DEA promulgated a regulation requiring that a petition to reschedule cannabis show that there is a CAMUIT. There is no basis whatsoever for that standard anywhere in the Controlled Substances Act. The DEA created it out of thin air. It is actually directly contrary to the CSA. The CSA does not require proof of medical use before conducting a hearing. It's an obvious matter of logic: whether there is a medical use is determined at the hearing on the petition and therefore it cannot be the threshold issue in the petition for initiating the hearing. It is the conclusion to be reached through consideration of evidence.

- There is no support in federal law for the "adequate and well-controlled studies" standard which the DEA invented in 1992: it is an attempt to avoid the holding of the 1st Circuit Court of Appeals in Grinspoon v. DEA, but a careful examination demonstrates that this new standard also cannot survive the reasoning in Grinspoon.

The DEA's AWCS standard is a completely baseless attempt to require that anyone attempting to break cannabis out of Schedule I conduct the equivalent of FDA Phase III clinical trials. The DEA's prior position was that CAMUIT was the same as the showing necessary to get FDA approval to market a drug in interstate commerce - a showing based on extremely long and expensive tests that a drug is "safe" and "effective" for a specific use. The 1st Circuit Court of Appeals explicitly rejected that position in Grinspoon. In response, the DEA formulated the AWCS standard. The problem with that standard is that it is the functional equivalent of FDA approval and fails the 1st Circuit's reasoning.



The essence of the 1st Circuit's reasoning was that Congress cannot have meant that the DEA need only check to see whether there is FDA approval when presented with a rescheduling petition - BECAUSE THEN THERE WOULD NEVER BE A NEED FOR AN EVIDENTIARY HEARING, rendering the petition process meaningless. (Every court tries to interpret a statute that gives effect to every part of a statute - and avoid the conclusion that a part of the statute is meaningless.) The DC Circuit itself in its prior decision NORML v DEA used exactly the same logic when adjudicating the first scheduling petition - the Court said that the agency must be flexible enough to consider various forms of evidence of medical use (which, remember, need not even be shown at the petitioning stage, i.e. BEFORE the evidentiary hearing).

Furthermore, everyone knows that in reality NO ONE IS GOING TO SPEND $800 MILLION ON A CLINICAL TRIAL OF A RAW BOTANICAL PRODUCT THAT HAS BEEN USED MEDICINALLY FOR A COUPLE THOUSAND YEARS AND CANNOT BE PATENTED. That clinical trial will NEVER HAPPEN as a practical matter. Most critically in connection with the AWCS standard, no one in his/her right mind unless s/he had $800M to blow, would pay for FDA-complaint clinical trials except in the course of an application for an NDA - the standard which the reasoning of the Grinspoon decision vaporized. 

The DEA then is doing exactly the thing that the 1st Circuit said was not valid - instead of the invalid test of checking only to see if the FDA has approved an NDA for cannabis, it simply uses the invalid test of checking to see if there have been unspecified results of some amorphous clinical trials not expressly defined anywhere in federal; if not, no hearing for you, sunshine, and the DEA will not consider evidence of any other  kind. But ... that approach directly contravenes the Grinspoon ruling: just checking to see the existence/non-existence of any particular fact, to the exclusion of all others, renders the evidentiary hearing part of the statute meaningless, a result every court seeks to avoid.

These AWCS are amorphous and undefined and no taxpayer-funded public servant should be allowed to get away with proposing an amorphous, undefined and entirely subjective standard as the test for whether there is a medical use. It is beyond ludicrous to propose that someone seeking to reschedule cannabis show the "results" of a clinical trial which the administrative agency never defines. What is this fabled clinical trial? Where does it exist in federal law? (Nowhere - the DEA cannot come out and say that it is an FDA Phase III trial.) What is it? Administrative agencies are not allowed to apply amorphous, undefined totally standards that are ripe for abuse. Furthermore, the DEA requires only "results" from the trials. What results - negative? positive? How positive? What success rate? What is the efficacy standard? 

Who reviews the results of these trials? The DEA? Really? Where does it get that authority? Well, it doesn't have that authority. The FDA? Well, maybe - except that there is no basis for that conclusion in federal law - and the Grinspoon holding precludes that conclusion.

There you have it, folks.

The DEA requires cannabis to pass a test that does not exist in federal law.
The only way the citizens can move cannabis out of Schedule I is to get an evidentiary hearing - so the DEA designed a test that will never permit an evidentiary hearing.
That is arbitrary and capricious.

Postscript:
If you want to read why the DEA's entire construction of the CAMUIT provision in the Controlled Substances Act is unconstitutional just go ahead and read Madmen Rule You already.


4 comments:

  1. Your analysis suffers from the same fallacy as the DEA's. Truncating "currently accepted medical use in treatment in the United States" to "currently accepted medical use in treatment (CAMUIT)" is reading the states (federalism) completely out of the statute. I don't know why all you want to disregard states' rights, but the position you are taking is unconstitutional. If you want an acronym, it should be CAMUITITUS, not CAMUIT.

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  2. Hi Carl. Thanks for your comment.

    As I see it, the federalism issue does not appear on the surface of that clause and so it needs to be discussed/drawn out in a separate discussion in any event, so I don't think that the truncation in the acronym makes a practical difference. Even if you include the initials of the last four words (including "in the United States") in the acronym, you still need to walk through the 10th Amendment issue; so I don't see a great loss in leaving out those last 4 letters, which just makes the acronym more cumbersome.

    The only issue that appears in the text of the clause is the implication that medical use in treatment outside the US makes no difference on the federal government's position - which we could assume anyway.

    I discussed the federalism issue in Madmen Rule You.
    I just don't think that the appearance/non-appearance of "ITUS" in the acronym is critical since it needs to be explained anyway.

    Everyone doing the analysis is free to focus on and explain the issue.

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  3. Noah, I've read much on this subject, but this is by far the best explanation and analysis I've seen.

    Thanks

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    Replies
    1. Thanks for the kind word.
      There is far more to be analyzed and written on the subject.
      I hope I helped open a door.

      Delete