Case: 20-71433, 11/30/2020, ID: 11908568, DktEntry: 37, Page 1 of 77
`No. 20-71433
`__________________________________
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`__________________________________
`
`SUSAN SISLEY, et al.,
`Petitioners,
`v.
`U.S. DRUG ENFORCEMENT ADMINISTRATION, et al.,
`Respondents.
`__________________________________
`On Petition for Review From An Order of the U.S. Drug Enforcement
`Administration
`__________________________________
`
`ANSWERING BRIEF FOR THE FEDERAL RESPONDENTS
`__________________________________
`
`JEFFREY BOSSERT CLARK
` Acting Assistant Attorney General
`MARK B. STERN
`DANIEL AGUILAR
`Attorneys, Appellate Staff
`Civil Division, Room 7266
`U.S. Department of Justice
`950 Pennsylvania Avenue, NW
`Washington, DC 20530-0001
`(202) 514-5432
`
`

`

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`
`
`TABLE OF CONTENTS
`
`Page
`STATEMENT OF JURISDICTION ................................................................................. 1
`
`INTRODUCTION................................................................................................................ 1
`
`STATEMENT OF THE ISSUES ....................................................................................... 2
`
`PERTINENT STATUTES AND REGULATIONS ....................................................... 2
`
`STATEMENT OF THE CASE .......................................................................................... 3
`
`I. STATUTORY AND REGULATORY FRAMEWORK .......................................................... 3
`
`II. FACTUAL AND PROCEDURAL BACKGROUND ............................................................ 5
`
`
`
`
`
`
`
`A. The Zyszkiewicz Petition For DEA Rulemaking ............................................ 5
`
`B. Zyszkiewicz’s Attempts To Seek Judicial Review .......................................... 11
`
`C. This Petition For Judicial Review .................................................................... 12
`
`SUMMARY OF ARGUMENT ......................................................................................... 12
`
`STANDARD OF REVIEW ............................................................................................... 14
`
`ARGUMENT ....................................................................................................................... 15
`
`I. THE COURT SHOULD DISMISS THE PETITION FOR REVIEW ................................. 15
`
`
`
`
`
`A. Petitioners Lack Standing Because Their Claims Rest On
`A Generalized Grievance And the Rights Of Third Parties ......................... 15
`
`B. Petitioners Have Not Exhausted Their Administrative
`Remedies, And May Not Challenge The Denial Of
`Another Person’s Petition For Rulemaking .................................................... 22
`
`

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`II. DEA APPROPRIATELY DENIED THE ZYSZKIEWICZ PETITION
`FOR RULEMAKING ....................................................................................................... 28
`
`
`
`
`
`A. DEA’s Denial Was Reasonable And Appropriate ......................................... 28
`
`B. Petitioners’ Nondelegation Argument Is Insubstantial ................................. 39
`
`CONCLUSION ................................................................................................................... 45
`
`STATEMENT OF RELATED CASES
`
`CERTIFICATE OF COMPLIANCE
`
`ADDENDUM
`
`
`
`
`
`ii
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`

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`TABLE OF AUTHORITIES
`
`Cases:
`Agua Caliente Tribe of Cupeño Indians of Pala Reservation v. Sweeney,
`932 F.3d 1207 (9th Cir. 2019) .................................................................................... 22, 23
`
`Page(s)
`
`Alliance for Cannabis Therapeutics v. DEA,
`930 F.2d 936 (D.C. Cir. 1991) ................................................................................... 14, 34
`
`Alliance for Cannabis Therapeutics v. DEA,
`15 F.3d 1131 (D.C. Cir. 1994) ......................................................................................... 35
`
`Americans for Safe Access v. DEA,
`706 F.3d 438 (D.C. Cir. 2013) ........................................................................... 4, 5, 14, 35
`
`Arakaki v. Lingle,
`477 F.3d 1048 (9th Cir. 2007) .......................................................................................... 14
`
`Barnhart v. Walton,
`535 U.S. 212 (2002) ........................................................................................................... 35
`
`Bonds v. Tandy,
`457 F.3d 409 (5th Cir. 2006) ............................................................................................ 28
`
`Cabaccang v. U.S. Citizenship and Immigration Services,
`627 F.3d 1313 (9th Cir. 2010) .......................................................................................... 23
`
`Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc.¸
`467 U.S. 837 (1984) .................................................................................. 14, 34, 35, 37, 38
`
`Darby v. Cisneros,
`509 U.S. 137 (1993) ..................................................................................................... 26, 27
`
`Elgin v. Department of Treasury,
`567 U.S. 1 (2012) ............................................................................................................... 26
`
`Ex parte Levitt,
`302 U.S. 633 (1937) ........................................................................................................... 17
`
`Fairchild v. Hughes,
`258 U.S. 126 (1922) ........................................................................................................... 17
`
`iii
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`Garfias-Rodriguez v. Holder,
`702 F.3d 504 (9th Cir. 2012) (en banc) .......................................................................... 37
`
`Getty Oil Co. v. Andrus,
`607 F.2d 253 (9th Cir. 1979) ............................................................................................ 30
`
`Gill v. Whitford,
`138 S. Ct. 1916 (2018) ................................................................................................ 13, 19
`
`Grinspoon v. DEA,
`828 F.2d 881 (1st Cir. 1987) ................................................................................ 14, 33, 34
`
`Hemp Indus. Ass’n v. DEA,
`357 F.3d 1012 (9th Cir. 2004) .................................................................................... 35, 38
`
`Hollingsworth v. Perry,
`570 U.S. 693 (2013) ........................................................................................................... 21
`
`Lance v. Coffman,
`549 U.S. 437 (2007) ........................................................................................................... 18
`
`John Doe, Inc. v. DEA,
`484 F.3d 561 (D.C. Cir. 2007) ......................................................................................... 24
`
`Krumm v. DEA,
`739 F. App’x 655 (D.C. Cir. 2018) (per curiam) ........................................................... 35
`
`Leorna v. U.S. Department of State,
`105 F.3d 548 (9th Cir. 1997) ............................................................................................ 14
`
`Lexmark Int’l, Inc. v. Static Control Components, Inc.,
`572 U.S. 118 (2014) ........................................................................................................... 16
`
`Lujan v. Defenders of Wildlife,
`504 U.S. 555 (1992) ........................................................................................ 15, 16, 17, 18
`
`Massachusetts v. EPA,
`549 U.S. 497 (2007) ........................................................................................................... 29
`
`Mills v. United States,
`742 F.3d 400 (9th Cir. 2014) ............................................................................................ 20
`
`Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,
`463 U.S. 29 (1983) ............................................................................................................. 29
`
`iv
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`Gonzales v. Oregon,
`546 U.S. 243 (2006) ........................................................................................................... 36
`
`Pacific Maritime Ass’n v. NLRB,
`827 F.3d 1203 (9th Cir. 2016) .......................................................................................... 27
`
`PDK Laboratories Inc. v. DEA,
`362 F.3d 786 (D.C. Cir. 2004) ......................................................................................... 28
`
`Schlesinger v. Reservists Comm. to Stop the War,
`418 U.S. 208 (1974) ........................................................................................................... 17
`
`Smelt v. County of Orange,
`447 F.3d 673 (9th Cir. 2006) ...................................................................................... 19, 20
`
`Steve G. v. Monterey Peninsula Unified School Dist.,
`933 F.3d 1096 (9th Cir. 2019) .......................................................................................... 24
`
`Thunder Basin Coal Co. v. Reich,
`510 U.S. 200 (1994) ........................................................................................................... 25
`
`Touby v. United States,
`500 U.S. 160 (1991) ..................................................................................................... 40, 41
`
`United Sates v. L.A. Tucker Truck Lines, Inc.,
`344 U.S. 33 (1952) ............................................................................................................. 23
`
`United States v. Kelly,
`874 F.3d 1037 (9th Cir. 2017) ................................................................. 14, 35, 38, 41, 44
`
`United States v. Richardson,
`418 U.S. 166 (1974) ........................................................................................................... 17
`
`Warth v. Seldin,
`422 U.S. 490 (1975) ..................................................................................................... 16, 21
`
`Washington v. Barr,
`925 F.3d 109 (2d Cir. 2019) .......................................................................... 13, 24, 25, 28
`cert. denied, --- S. Ct. ---, 2020 WL 6037234 (Oct. 13, 2020) ................................... 13, 24
`
`Whitman v. American Trucking Ass’ns,
`531 U.S. 457 (2001) ............................................................................................... 39, 40, 43
`
`v
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`

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`Whitmore v. Arkansas,
`495 U.S. 149 (1990) ........................................................................................................... 16
`
`Woodford v. Ngo,
`548 U.S. 81 (2006) ....................................................................................................... 22, 23
`
`Yakus v. United States,
`321 U.S. 414 (1944) ..................................................................................................... 40, 43
`
`Zyszkiewicz v. Barr,
`2020 WL 3572908 (D.D.C. June 30, 2020) .............................................................. 11, 21
`
`Constitution, Treaties, and Statutes:
`U.S. Const. art. I, § 1 ............................................................................................................ 39
`
`Single Convention on Narcotic Drugs, 18 U.S.T. 1407 (1967) ...................................... 43
`
`Pub. L. No. 91-513, title II, § 202(c) (schedule I(c)(10)),
`84 Stat. 1242 (1970) ...................................................................................................... 3, 40
`
`Pub. L. No. 89-329,
`98 Stat. 280 (1984) ............................................................................................................ 33
`
`5 U.S.C. § 706(2)(A) ............................................................................................................. 15
`
`16 U.S.C. § 1540(g) ............................................................................................................... 17
`
`21 U.S.C. § 355(b)(1) ............................................................................................................ 33
`
`21 U.S.C. §§ 801-971 .............................................................................................................. 3
`
`21 U.S.C. § 811.................................................................................................................. 5, 24
`
`21 U.S.C. § 811(a) ............................................................................ 1, 3, 4, 13, 22, 28, 30, 42
`
`21 U.S.C. § 811(d) ........................................................................................................... 41, 44
`
`21 U.S.C. § 811(d)(1) ...................................................................................................... 42, 43
`
`21 U.S.C. § 811(d)(2) ............................................................................................................ 42
`
`21 U.S.C. § 811(h) ................................................................................................................. 41
`
`21 U.S.C. § 812........................................................................................................................ 5
`
`vi
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`21 U.S.C. § 812(a)-(b) ............................................................................................................. 3
`
`21 U.S.C. § 812(b) ........................................................................................ 14, 41, 42, 43, 44
`
`21 U.S.C. § 812(b)(1) ..................................................................................... 3, 34, 37, 41, 44
`
`21 U.S.C. § 812(b)(1)(B)........................................................................................... 14, 29, 35
`
`21 U.S.C. § 812(b)(1)(B)-(C) ................................................................................................ 34
`
`21 U.S.C. § 812(c) .................................................................................................................. 3,
`
`21 U.S.C. § 812(c), schedule I(b)(10) ................................................................................. 33
`
`21 U.S.C. § 812(c), schedule I(c)(10) ...................................................................... 37, 38, 40
`
`21 U.S.C. § 823(a) ................................................................................................................. 20
`
`21 U.S.C. §§ 823-824 ............................................................................................................ 36
`
`21 U.S.C. § 877................................................................................................. 1, 5, 11, 20, 25
`
`Regulations:
`21 C.F.R. § 1308.11(e)(3) ..................................................................................................... 33
`
`21 C.F.R. § 1308.12(f)(2) ..................................................................................................... 38
`
`21 C.F.R. § 1308.13(g)(1) ..................................................................................................... 38
`
`28 C.F.R. § 0.100 .................................................................................................................... 3
`
`57 Fed. Reg. 10499 (Mar. 26, 1992) ......................................................................... 4, 30, 35
`
`84 Fed. Reg. 44920 (Aug. 27, 2019) ................................................................................... 20
`
`84 Fed. Reg. 54926 (Oct. 11, 2019) .................................................................................... 20
`
`Other Authorities:
`Pet. for Declaratory Judgment, Writ of Mandamus, and Review,
`Zyszkiewicz v. Barr, No. 20-1599 (D.D.C. May 29, 2020) .............................................. 11
`
`Mot. to Dismiss, Zyszkiewicz v. DEA,
`No. 20-1308 (D.C. Cir. Oct. 5, 2020) ............................................................................. 11
`
`vii
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`Opp.,
`Zyszkiewicz v. DEA, No. 20-1308 (D.C. Cir. Oct. 25, 2020) .................................. 12, 21
`
`Zyszkiewicz v. Barr, No. 20-1599 (D.D.C.) .......................................................................... 11
`
`Zyszkiewicz v. Barr, No. 20-5213 (D.C. Cir.) ................................................................. 11, 21
`
`Zyszkiewicz v. DEA, No. 20-1308 (D.C. Cir.) .............................................................. 11, 21
`
`
`
`
`
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`
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`STATEMENT OF JURISDICTION
`
`On April 22, 2020, the U.S. Drug Enforcement Administration (DEA) denied a
`
`request by two individuals to initiate a rulemaking under 21 U.S.C. § 811(a). ER2-5.
`
`Petitioners in this case did not participate in that request for rulemaking and have not
`
`asked DEA to initiate rulemaking. Instead, petitioners ask this Court to review
`
`DEA’s denial of a rulemaking petition filed by other people, citing 21 U.S.C. § 877.
`
`For the reasons explained infra, pp. 15-21, this Court lacks jurisdiction over the
`
`petition.
`
`INTRODUCTION
`
`This case concerns marijuana’s status as a schedule I substance under the
`
`Controlled Substance Act. Under the Act, any citizen may petition DEA to move a
`
`schedule I substance to a different schedule, or to remove it from the schedules of
`
`controlled substances entirely. If DEA denies that petition, or issues an adverse
`
`order, the petitioner may seek judicial review.
`
`In January 2020, two individuals—Stephen Zyszkiewicz and Jeramy Bowers—
`
`petitioned DEA to reschedule marijuana in a one-page petition. DEA denied that
`
`request. Zyszkiewicz has filed two separate lawsuits in the federal courts for the
`
`District of Columbia seeking review of DEA’s decision. Neither those lawsuits are
`
`before this Court.
`
`Petitioners here seek review of the denial of the Zyszkiewicz petition even
`
`though they were not involved in that request and have not asked DEA to reschedule
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`

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`marijuana. Instead, petitioners ask this Court to reverse DEA’s decision based on
`
`arguments that were never presented to the agency. If petitioners think marijuana
`
`should be rescheduled, they may petition DEA to do so and present their contentions
`
`to the agency. And if their petition is denied, they can then pursue those arguments in
`
`this Court. They may not, however, present an array of arguments in this Court that
`
`formed no part of a request for rulemaking filed by other people, not parties here.
`
`Assuming that the petition is properly before the Court, its arguments fail on
`
`the merits. Petitioners contend that DEA’s decision to retain marijuana on schedule I
`
`is arbitrary and capricious and that Congress has unconstitutionally granted DEA
`
`legislative authority. Those arguments are contrary to settled precedent and should be
`
`rejected if the Court were to reach them.
`
`STATEMENT OF THE ISSUES
`
`1. Whether petitioners have standing to challenge DEA’s denial of another
`
`person’s petition to reschedule a controlled substance.
`
`2. Whether petitioners have failed to exhaust their administrative remedies
`
`because they have not asked DEA to reschedule marijuana.
`
`3. On the merits, whether DEA’s denial of the rescheduling petition violated
`
`the nondelegation principle or was arbitrary and capricious.
`
`PERTINENT STATUTES AND REGULATIONS
`
`
`
`Pertinent statutes and regulations appear in the addendum to this brief.
`
`2
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`

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`STATEMENT OF THE CASE
`
`I.
`
`STATUTORY AND REGULATORY FRAMEWORK
`
`The Controlled Substances Act, 21 U.S.C. §§ 801-971, establishes a
`
`comprehensive federal scheme to regulate the manufacture and distribution of
`
`controlled substances. The Act divides controlled substances into five schedules,
`
`based on their potential for abuse, medical uses, and risk of physical or psychological
`
`dependence. Id. § 812(a)-(b). Generally speaking, a schedule I substance has no
`
`accepted medical use and a high risk for abuse, while schedule II-V substances have
`
`accepted medical uses and decreasing risk of abuse and dependence. Id. Congress
`
`initially designated scores of substances under the schedules, id. § 812(c), and
`
`authorized the Attorney General to add, remove, or reschedule substances through
`
`rulemaking, id. § 811(a). The Attorney General, in turn, delegated this authority to the
`
`DEA Administrator. 28 C.F.R. § 0.100.1
`
`Congress initially designated marijuana as a schedule I substance. See Pub. L.
`
`No. 91-513, title II, § 202(c) (schedule I(c)(10)), 84 Stat. 1242, 1249 (1970). Schedule
`
`I substances have “a high potential for abuse,” have “no currently accepted medical
`
`use in treatment in the United States,” and lack “accepted safety for use * * * under
`
`medical supervision.” 21 U.S.C. § 812(b)(1). In a 1992 rulemaking, DEA set forth
`
`
`1 For simplicity, this brief refers to authority exercised by DEA whenever the
`Controlled Substances Act grants authority to the Attorney General and the Attorney
`General has in turn delegated that authority to the DEA Administrator.
`
`3
`
`

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`five factors to consider in determining whether a substance has a currently accepted
`
`medical use:
`
`1. Whether the substance’s chemistry is known and reproducible;
`2. Whether there are adequate safety studies;
`3. Whether there are adequate and well-controlled studies proving efficacy;
`4. Whether the substance is accepted by qualified experts; and
`5. Whether the scientific evidence is widely available.
`
`57 Fed. Reg. 10499, 10506 (Mar. 26, 1992). Under that rulemaking, DEA has
`
`required all five factors to be satisfied in order for a substance to “be deemed to have
`
`a currently accepted medical use.” Americans for Safe Access v. DEA, 706 F.3d 438, 450
`
`(D.C. Cir. 2013).
`
`DEA can, if the evidence warrants, transfer a substance from one schedule to
`
`another by rulemaking. 21 U.S.C. § 811(a)(1). Such rulemaking proceedings “may be
`
`initiated” by the DEA Administrator “(1) on his own motion, (2) at the request of the
`
`Secretary [of Health and Human Services], or (3) on the petition of any interested
`
`party.” Id. § 811(a). “[B]efore initiating [rulemaking] proceedings,” DEA gathers all
`
`“necessary data” and obtains a written “scientific and medical evaluation” and a
`
`recommendation from the Secretary of Health and Human Services (HHS) as to
`
`whether a substance should be rescheduled. Id. § 811(b). The Secretary’s
`
`recommendations on scientific and medical matters “shall be binding.” Id. If DEA
`
`determines that substantial evidence supports moving the substance to a different
`
`schedule, then it “shall initiate proceedings for control or removal, as the case may
`
`be.” Id.
`
`4
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`

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`“[A]ny person aggrieved by a final decision” regarding rescheduling may seek
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`judicial review in the D.C. Circuit or the circuit in which their principal place of
`
`business is located. 21 U.S.C. § 877. Thus, a person who petitions DEA to
`
`reschedule a substance may seek judicial review if the Administrator denies that
`
`petition. Americans for Safe Access, 706 F.3d at 442.
`
`II.
`
`FACTUAL AND PROCEDURAL BACKGROUND
`
`A.
`
`The Zyszkiewicz Petition For DEA Rulemaking
`
`In January 2020, Stephen Zyszkiewicz and Jeramy Bowers filed a one-page,
`
`handwritten petition “to remove or reschedule cannabis (marijuana) in all its forms”
`
`under “21 USCS 811, 812.” ER1. Zyszkiewicz and Bowers stated that “the current
`
`situation of cannabis in Schedule I [is] completely untenable” because “[h]alf the
`
`states allow for medical use and the FDA allows CBD and THC pharmaceuticals as
`
`well as IND compassionate use.” ER1. Zyszkiewicz and Bowers offered no other
`
`argument for rescheduling marijuana, and provided no medical evidence regarding its
`
`use.
`
`DEA responded in an April 2020 letter. ER2-5. DEA denied the petition for
`
`rulemaking, explaining that DEA had conducted an extensive analysis of the medical
`
`and scientific literature related to marijuana potential use in treatment in response to a
`
`different petition for rulemaking in 2016. ER2, ER7. As part of that 2016 analysis,
`
`the DEA Administrator had referred a petition to reschedule marijuana to the
`
`Secretary of HHS to obtain her findings and opinions on scientific and medical
`
`5
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`

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`matters, in accordance with 21 U.S.C. § 811(b). ER8. The Secretary, in turn, referred
`
`the petition to the Food and Drug Administration (FDA) to evaluate the scientific
`
`and medical data, assess whether marijuana has a currently accepted medical use, and
`
`provide a scheduling recommendation for marijuana. ER31-32. FDA conducted its
`
`scientific review, ER31-57, and referred the petition back to the Secretary, who issued
`
`a series of factual findings concerning marijuana’s chemistry, its physiological effects,
`
`its potential medical use, and its potential for abuse, ER8-31. The Secretary
`
`concluded that “[m]arijuana does not meet any of the elements for having a ‘currently
`
`accepted medical use.’” ER26. The Secretary then referred the petition back to DEA,
`
`which issued additional findings, ER58-85, and the DEA Administrator ultimately
`
`concluded that marijuana should remain a schedule I substance, ER7. For ease of
`
`reference, this brief generally refers to the findings and conclusions of this
`
`collaborative process as being DEA’s.
`
`In concluding that marijuana does not have a currently accepted medical use,
`
`DEA applied the five-factor test set out in the governing regulations, and concluded
`
`that none of the factors were met. ER26, 75-76.
`
`1. The substance’s chemistry must be well known and reproducible. DEA explained that
`
`marijuana samples come from a variety of cultivated strains, which can have “very
`
`different chemical constituents.” ER11. In particular, each marijuana plant will
`
`possess approximately 100 cannabinoid chemical compounds, but the concentration
`
`of these compounds will vary across different strains. ER11, 17. This variation in
`
`6
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`marijuana’s chemical profile “complicate[s] the interpretation of clinical data using
`
`marijuana.” ER17. For example, a 1-gram marijuana cigarette might have as little as 3
`
`milligrams of THC (tetrahydrocannabinol, marijuana’s principal psychoactive
`
`chemical) or as much as 150 milligrams of THC, thus making it difficult to evaluate
`
`studies that test the efficacy of smoking marijuana. ER17-18. In considering whether
`
`to reschedule marijuana, DEA concluded that it was not possible to reproduce a
`
`consistent, standardized dose for all of marijuana’s potential strains. ER19 (noting
`
`that this might be possible for a particular marijuana strain if it was consistently
`
`cultivated under strict conditions).
`
`2. There must be adequate and well-controlled studies proving efficacy. DEA reviewed
`
`the abstracts of 566 scientific articles, which contained terms indicating that they
`
`might be an adequate and well-controlled study of marijuana’s efficacy. ER34 & n.30.
`
`Of these, only 11 studies were determined to be “randomized, double-blind, placebo-
`
`controlled clinical studies conducted with marijuana to assess marijuana’s efficacy in
`
`any therapeutic indication.” ER34; see also ER35 (explaining why other studies did not
`
`meet this criteria). DEA concluded that these 11 studies did not demonstrate efficacy,
`
`but were best understood as “[p]roof of concept studies” that can “provide
`
`preliminary evidence on a proposed hypothesis involving a drug’s effect.” ER20.
`
`Five studies showed “positive results” for using marijuana as an analgesic for
`
`chronic neuropathic pain. ER41. But the subjects in these studies continued to use
`
`their preexisting analgesic drugs in addition to marijuana, making it difficult to
`
`7
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`conclude if marijuana had effective analgesic properties on its own. ER36-39. The
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`subjects also suffered from many different kinds of neuropathic pain, “making it
`
`difficult to identify whether a specific set of symptoms might be more responsive to
`
`the effects of marijuana.” ER41. Some subjects also had to withdraw from the
`
`studies based on adverse effects from marijuana. ER37 (one subject “developed an
`
`intractable smoking-related cough” while the only “marijuana-naïve” subject
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`“experienced an incident of acute cannabis-induced psychosis”).
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`Two studies showed “positive results” for using both marijuana and dronabinol
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`(synthetic THC) to increase appetite and weight gain in HIV-positive patients. ER41.
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`However, all of the subjects in these studies were chronic marijuana users, and the
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`doses of THC given to the subjects were several times greater than the typical doses
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`for appetite stimulation. ER41. Thus, the studies did not address whether patients
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`with little prior exposure to marijuana would be able to tolerate the high THC levels
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`used in these studies, or whether marijuana would still show positive results with
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`limited adverse effects for such patients. ER41.
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`One study showed some “positive results” for treating spasticity in multiple
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`sclerosis patients with smoked marijuana. ER42. However, the patients continued to
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`use their preexisting medication regime, and it was difficult to conclude marijuana’s
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`efficacy as a stand-alone treatment. ER42. Moreover, it was “concerning” that five
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`out of thirty subjects withdrew from the study “because they were unable to tolerate
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`the psychiatric [adverse events] induced by marijuana.” ER40, 42.
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`While one study showed “positive results” for treating asthma patients with
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`smoked marijuana, there was an obvious concern about administering “harmful and
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`irritating substances” into the lungs of asthma patients by instructing them to smoke.
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`ER42. Additionally, the patients smoked marijuana while they were at rest and not
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`suffering bronchospasms, leaving it uncertain whether marijuana was effective at
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`treating asthma attacks. ER42.
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`Two studies had shown “positive results” for treating glaucoma with marijuana,
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`but “the effect is short-lasting, requires a high dose, and is associated with many
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`[adverse events]. Thus, the potential harmful effects may outweigh any modest
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`benefit of marijuana for this condition.” ER42.
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`DEA noted a number of other complicating factors in these studies that limited
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`their usefulness in determining marijuana’s efficacy as a medical treatment. The
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`treatment groups in these studies were small (ranging from 10 to 25 subjects) and
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`were “statistically inadequate to support a showing of safety or efficacy.” ER42. No
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`study lasted longer than five days, although the purpose of the studies was to
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`determine to demonstrate marijuana’s efficacy for treating chronic medical conditions
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`that could last a lifetime. ER43. And, as a general matter, it was “not recommended”
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`to prescribe smoking as a medical treatment, because this would necessarily put
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`smoke “into the lungs of individuals with a disease state * * * when their bodies may
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`be physically compromised.” ER43. Finally, all of these studies had an inherent
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`difficulty in ensuring that the subjects were truly “blind,” i.e., that they did not know if
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`Case: 20-71433, 11/30/2020, ID: 11908568, DktEntry: 37, Page 19 of 77
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`they were receiving marijuana or a placebo. ER43. Because marijuana has a “rapid
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`onset of psychoactive effects,” test subjects will likely know if they are receiving
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`marijuana instead of a placebo, which could lead to an expectation bias that changes
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`the subjects’ “perceived responsivity to the therapeutic outcome.” ER43.
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`3. DEA then determined that none of the remaining three factors supported a
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`finding that marijuana had a currently accepted medical use. DEA concluded that
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`there were no adequate safety studies for marijuana, becau