We love to publish the work of as many as is possible. This submission by Carl Olsen from IA is exceedingly excellent. Carl has been working on cannabis legalization for many decades and has insight that many don’t see or understand.
Is the DEA wrong about marijuana’s medical value?
by Carl Olsen
The Question Presented
I’ve been asked to explain the U.S. Drug Enforcement Administration (DEA) decision on July 19, 2016, not to accept the Marijuana Rescheduling Petition filed by the states of Washington and Rhode Island on November 30, 2011. See Page 53688 of the Federal Register, Vol. 81, No. 156, Friday, August 12, 2016.
I have special expertise because I was one of the petitioners in the Marijuana Rescheduling Petition filed by the National Organization for the Reform of Marijuana Laws (NORML) in 1972 (I joined that case in 1985 and my name is on the cover of the Administrative Law Judge’s Ruling on September 6, 1988), and finally resolved in the U.S. Court of Appeals in 1994 (I did not participate in that appeal). Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991); Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994). I was also one of the original petitioners in the Marijuana Rescheduling Petition filed by the Coalition for Cannabis Rescheduling in 2002, and finally resolved in the U.S Court of Appeals in 2013 (I did participate in that appeal, and I filed my own Petition for Writ of Certiorari in the U.S. Supreme Court). Americans for Safe Access v. DEA, 706 F.3d 438 (D.C. Cir. 2013). The five part test that was developed in the first petition and applied in the second is the same test that was just recently applied again by the DEA in the most recent petition filed by the states of Washington and Rhode Island.
Dividing the Question
So, there are two questions we need to ask. First, the question most people are asking, did the DEA apply the five part test correctly? The second question is one you won’t hear from anyone but me, and that is whether the five part test is even valid. I’m not going to address the first question, because I don’t think its relevant whether DEA applied the five part test correctly. I’m going to divide the second question further and ask whether the five part test was ever valid at all, and then, if it was valid, I’m going to ask if the five part test is still valid today.
The Five-Part Test
On Page 938, Alliance for Cannabis Therapeutics, 930 F.2d 936 (D.C. Cir. 1991), the court explains the difference between schedule 1 and schedule 2, “is whether a drug has ‘no currently accepted medical use in treatment in the United States.’ This case turns on the appropriate definition and application of that phrase.”
On Page 938, the court goes on to explain, “In a prior proceeding, the Administrator had employed an additional eight factor test to further elaborate the characteristics of a drug that he thought had a ‘currently accepted medical use’:”
- Scientifically determined and accepted knowledge of its chemistry;
- The toxicology and pharmacology of the substance in animals;
- Establishment of its effectiveness in humans through scientifically designed clinical trials;
- General availability of the substance and information regarding the substance and its use;
- Recognition of its clinical use in generally accepted pharmacopeia, medical references, journals or textbooks;
- Specific indications for the treatment of recognized disorders;
- Recognition of the use of the substance by organizations or associations of physicians; and
- Recognition and use of the substance by a substantial segment of the medical practitioners in the United States.
53 Fed. Reg. 5,156 (1988).
On Page 939, Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991), explains why the DEA is creating tests for determining “currently accepted medical use.” “The difficulty we find in petitioners’ argument is that neither the statute nor its legislative history precisely defines the term ‘currently accepted medical use’; therefore, we are obliged to defer to the Administrator’s interpretation of that phrase if reasonable.” So, the DEA is trying to define a term used in the statute that Congress did not define.
What is important to note is the the eight-part test was the result of a previous test that was found invalid. In Grinspoon v. DEA, 828 F.2d 881, 891 (1st Cir. 1987), the court found that the Administrator applied an incorrect standard in determining the meaning of the phrase “currently accepted medical use in treatment in the United States.” 53 Fed. Reg. 5,156 (1988). The DEA has had a difficult time creating a valid interpretation of the language used in the statute.
In Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994), the DEA’s “Final Order discards the earlier formulation and applies a new five-part test for determining whether a drug is in ‘currently accepted medical use’:”
- The drug’s chemistry must be known and reproducible;
- there must be adequate safety studies;
- there must be adequate and well-controlled studies proving efficacy;
- the drug must be accepted by qualified experts; and
- the scientific evidence must be widely available.
57 Fed. Reg. 10,506 (1992).
So, the five-part test is the third time the DEA has tried to define a term that Congress did not define in the statute, “currently accepted medical use in treatment in the United States.” We should be asking ourselves if the DEA got it right on the third try.
So, this brings us up to 1994 and the final ruling from the courts is that the five part test is a valid interpretation of the language used in the statute. What happens in 1996 is that California becomes the first state to enact a law accepting the medical use of marijuana. We now have a total of twenty-six (26) states that have accepted the medical use of marijuana, and an additional sixteen (16) states that have accepted the medical use of a marijuana extract. Let’s do a little review here. In 1987, the DEA’s interpretation of “currently accepted medical use in treatment in the United States” was found to be invalid. In 1991, the DEA’s interpretation of “currently accepted medical use” was found to be invalid. Notice how the words got truncated to completely ignore “in treatment in the United States.” Then, in 1994, the DEA’s interpretation of “currently accepted medical use” was found to be valid. So, why did the words “in treatment in the United States” get left out? In 1994, there were no states that had accepted the medical use of marijuana.
A couple of graphics illustrate the point.
Did the DEA apply the five-part test correctly?
Yes, under the five-part test, no plant could ever be approved for medical use by the DEA, which makes perfect sense. DEA has never rescheduled a plant. All the plants are in the same schedule Congress originally put them in. Doctors are not writing prescriptions for plants in schedule 2. If opium plants and coca plants had to pass the DEA’s five-part test, they would fail the same way marijuana does. So, the test is being applied correctly, the same way it would be applied to any other plant. Congress did not give the DEA the any directions on what to do if a plant is in the wrong schedule. Because schedule 1 prevents their medical use, these plants will remain without medical use until Congress removes them from schedule 1.
Was the five-part test valid in 1994?
It’s hard to say whether a test for medical use of a plant in schedule 1 could ever be valid, because schedule 1 prevents them from being used for medicine. However, the court did approve this test, so it was valid from that perspective. The five-part test was not contested, so it was valid from that perspective. In 1994, there were no states that had accepted the medical use of marijuana, and there were no states that had accepted the medical use of marijuana in 1970 when the law was written. So, there wasn’t a better interpretation of “currently accepted medical use” in 1994. Apparently, nobody wanted to state the obvious, a test for medical use of a plant in schedule 1 is an oxymoron. Accepted medical use in a state is a state decision, but there were none in 1994 or in 1970.
Is the five-part test valid in August of 2016?
The problem with the petition filed by the states of Washington and Rhode Island is that it cedes state sovereignty to a federal administrative agency by accepting the DEA’s ability to interpret the meaning of “accepted medical use in treatment in the United States” without regard to state laws defining marijuana as medicine If the DEA is going to interpret the meaning of “accepted medical use in treatment in the United States” without considering state laws on the matter then the five-part test is the only approved test for making that determination. Both the states of Washington and Rhode Island classify marijuana as a schedule 1 substance with no accepted medical use in treatment in the United States in their own state drug laws, in clear violation of the Full Faith and Credit Clause of the U.S. Constitution. Revised Code of Washington §§ 69.50.203(a)(2) and 69.50.204(c)(22) (2016); State of Rhode Island General Laws, §§ 21-28-2.03(2) and 21-28-2.08(d)(10) (2016). The states of Washington and Rhode Island will not appeal from the DEA’s denial of their petition, because they have no grounds on which to appeal (they have 30 days from the date of publication in the Federal Register to appeal), thereby proving they knew they had no valid legal argument when they filed their petition.
So, the question is why the DEA is still being asked to interpret the meaning of “accepted medical use in treatment in the United States” when we have forty-two states as of August of 2016 that have accepted it for medical use. One explanation is that the states of Washington and Rhode Island have marijuana classified as having no accepted medical use in the United States in their own state drug laws, despite the fact both states have defined marijuana as medicine in those same state drug laws. How could a state act against its own interests in this way?
Back to Federalism
Notice how the phrase “accepted medical use in treatment in the United States” is interpreted by the court in Grinspoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987):
We add, moreover, that the Administrator’s clever argument conveniently omits any reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads “in the United States,” (emphasis supplied). We find this language to be further evidence that the Congress did not intend “accepted medical use in treatment in the United States” to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance.
And, notice in that case the phrase is not truncated to only say “currently accepted medical use.” Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987):
Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions do not apply to drugs manufactured and marketed wholly intrastate. Compare 21 U.S.C. § 801(5) with 21 U.S.C. § 321 (b), 331, 355(a). Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing.
So, the DEA’s five-part test, just like approval for interstate marketing, does not take into account individual states. The five-part test is for “every state,” just like the approval for interstate marketing, because it would require a finding of recognized medical use in every state. This leaves absolutely no doubt, the five-part test is no longer valid.
This is not the first time state officials in states such as Washington and Rhode Island have acted against the interests of the people who elected them. In New York v. United States, 505 U.S. 144, 181-182 (1992), the U.S. Supreme Court asked, “How can a federal statute be found an unconstitutional infringement of state sovereignty when state officials consented to the statute’s enactment?” The context was different in that case, but the idea is the same as it is here. State officials in the states of Washington and Rhode Island have consented to the DEA interpreting a statute in a manner that infringes on their own state sovereignty.
What the states of Washington and Rhode Island should have done is tell the DEA it has no business interpreting a term Congress has not defined (“medical use”) when the state has a law that defines the “medical use” of marijuana. See, Gonzales v. Oregon, 546 U.S. 243 (2006), for an example of how this works. Gonzales v. Oregon, 546 U.S. 243, 258 (2006):
The Attorney General has rulemaking power to fulfill his duties under the CSA. The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.
DEA is the federal agency that acts for the U.S. Department of Justice in making scheduling decisions. In Gonzales v. Oregon, the Attorney General tried to tell the state of Oregon that the use of controlled substances to assist in suicide was not a lawful “medical use” of controlled substances, but the court disagreed and said the state has the authority to decide what is “accepted for medical use” because Congress did not make those decisions in the federal statute. The court said Congress could make decision on “medical use,” but hasn’t. Gonzales v. Oregon, 546 U.S. 243, 271-272 (2006):
Even though regulation of health and safety is “primarily, and historically, a matter of local concern,” Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 719, 105 S. Ct. 2371, 85 L. Ed. 2d 714 (1985), there is no question that the Federal Government can set uniform national standards in these areas. See Raich, supra, at 9, 125 S. Ct. 2195, 162 L. Ed. 2d 1. In connection to the CSA, however, we find only one area in which Congress set general, uniform standards of medical practice. Title I of the Comprehensive Drug Abuse Prevention and Control Act of 1970, of which the CSA was Title II, provides that
“[The Secretary], after consultation with the Attorney General and with national organizations representative of persons with knowledge and experience in the treatment of narcotic addicts, shall determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts, and shall report thereon from time to time to the Congress.” § 4, 84 Stat. 1241, codified at 42 U.S.C. § 290bb-2a.
This provision strengthens the understanding of the CSA as a statute combating recreational drug abuse, and also indicates that when Congress wants to regulate medical practice in the given scheme, it does so by explicit language in the statute.
It’s clear that Congress never intended to tell states what they can accept for medical use within their own borders. But, we have states telling the DEA it’s a federal decision when it’s not. The DEA simply refuses to budge until someone gives them a valid legal argument for removing marijuana from schedule 1.
There are three ways that could happen: (1) an executive order declaring marijuana has accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1; (2) a ruling from a court declaring marijuana has accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1; and, finally (3) a clarification from Congress explaining that state laws are accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1. There are some bills pending in Congress (S. 683 and H.R. 1538, for example) that would do this, but they are not as clean as simply enforcing the existing law (they would place marijuana into another schedule, which an executive or judicial ruling would not do, for the best example).
Congress has withheld funding for enforcement of federal schedule 1 against medical use of marijuana in states that have accepted it. See United States v. Marin Alliance, 3:98-cv-00086-CRB (N.D. Cal., 12/18/2015); and United States v. Steve McIntosh, No. 15-10117 (9th Cir., 8/16/2016). These cases demonstrate the difficulty imposed on the federal courts, because the court has to determine if the defendant was in compliance with a state medical marijuana law, and then has to determine if the money being appropriated for the prosecution of the case falls within the time period that Congress has forbidden the appropriation of such funds for such purposes. Wow!
Finally, the DEA ruling published in the Federal Register on August 12, 2016, relies on international treaty obligations. If a schedule is required by an international treaty, then the DEA is precluded from applying some or all of the scheduling criteria. 21 U.S.C. § 811(d)(1). The courts have previously determined that international treaty obligations prevent marijuana from being scheduled any lower than schedule 2. NORML v. DEA, 559 F.2d 735, 751 (D.C. Cir. 1977). Because the abuse potential for schedule 1 and schedule 2 is the same, the only relevant question then is whether marijuana has “currently accepted medical use in treatment in the United States.” Abuse potential is not relevant, because the international treaties prevent the DEA from considering it.
Because the states of Washington and Rhode Island ceded the authority to define “medical use” to a federal administrative agency, they also limited the choices to schedule 1 or schedule 2, regardless of whether marijuana actually belongs in either of those classifications.
But, the international treaties themselves provide the answer. Only one of the treaties is specifically mentioned, the Single Convention on Narcotic Drugs, 1961 (As amended by the 1972 Protocol), but all of the treaties use the same language in their enforcement sections:
Article 36(2) “Subject to the constitutional limitations of a Party, its legal system and domestic law, . . .”
The treaty does not apply if there is a domestic law that allows the activity. A domestic law would be intrastate and solely within the borders of a state. State medical marijuana laws are exempt from the international treaties.
The states of Washington and Rhode Island have not only ceded their state sovereignty to a federal administrative agency, but they have also ceded their state sovereignty to an international administrative agency, the United Nations Commission on Narcotic Drugs. This is treachery of the highest magnitude.