Scheduled for Oral Arguments March 19, 2002
Case # 01-1182
In the United States Court of Appeals
for the District of Columbia Circuit
Jon Gettman and High Times Magazine, Petitioners
against
Drug Enforcement Administration, Respondent
Petition for Review of an Order of the Drug Enforcement Administration,
Dated March 20, 2001
Reply Brief for Petitioners
Law Office of Michael Kennedy
Attorneys for Petitioners
425 Park Avenue, 26th Floor
New York, New York 10022
212-935-4500
Argument from Reply Brief for Petitioners
Note:
Table of Authorities has been omitted from this text version, which also does not include the appendix. References to the Appendix are in the form (A###). Appendix documents are contained at www.drugscience.org, but without the pagination referred to in the brief. Footnotes are contained at the end of this text version and are also noted in the text in the form (##).
THIS CASE HAS BEEN SCHEDULED FOR ORAL ARGUMENT ON MARCH 19, 2002
SUMMARY OF ARGUMENT
Determined to perpetuate its war on marijuana, the DEA claims that marijuana is as harmful as cocaine and heroin and even more harmful than opium and amphetamines. See 21 U.S.C. § 812. To evade judicial review of these incredible findings the DEA urges this Court to afford it extreme deference. Deference to agency decision-making, however, extends only so far. It does not give the DEA a license to apply different criteria to marijuana than for other drugs, ignore critical scientific data, misrepresent social science research or rely upon unsubstantiated assumptions, as the DEA has done in this case. The CSA and APA, as well as fundamental fairness, require the DEA to analyze the scientific data in an evenhanded manner. Its failure to do so here is arbitrary and capricious, requiring a remand to the DEA for a hearing and findings based on the scientific record.
ARGUMENT
- THE DEA’S ATTEMPT TO INSULATE ITS ERRORS FROM JUDICIAL REVIEW BY URGING AN INCORRECT STANDARD OF DEFERENCE SHOULD BE REJECTED
In an attempt to insulate its actions from judicial review, the DEA contends that its denial of the petition to initiate rulemaking proceedings for the rescheduling of marijuana is “evaluated with a deference so broad as to make the process akin to nonreviewability.” DEA Br. at 11 (quoting Cellnet Communication, Inc. v. Federal Communications Commission, 965 F.2d 1106, 1111 (D.C.Cir. 1992). This Court, however, has explained that such extreme deference does not extend to every refusal to initiate rulemaking proceedings. Instead, as this Court explained in Professional Pilots Federation v. FAA, 118 F.3d 758, 763-64 (D.C. Cir. 1997):
“That more deferential standard of review is indicated, however, only when the agency has clearly shown that “pragmatic considerations” would render the usual and somewhat more searching inquiry problematic because “the agency has chosen not to regulate for reasons ill-suited to judicial resolution, e.g., because of internal management considerations as to budget and personnel or for reasons made after a weighing of competing policies.” See Bargmann v. Helms, 715 F.2d 638, 640 (D.C. Cir. 1983) (reviewing FAA decision not to institute rulemaking to require first-aid kits on commercial aircraft). In the case now before us the decision not to initiate a rulemaking . . . was purportedly based upon the merits of the existing Rule. We see no need, therefore, to afford the agency more than the usual–and considerable–deference we show an agency when it adopts a rule implementing a statute it is charged with administering. We shall therefore apply the arbitrary and capricious standard of the APA.”
Id. (emphasis added). Here, as in Professional Pilots, the DEA’s decision not to initiate rulemaking proceedings was based on the merits of the existing rule and the DEA has not shown any “pragmatic considerations” that would impede review by this Court. Furthermore, this case involves a matter of great social and medical significance which has been memorialized in a lengthy record with written findings. This “provides a focal point for judicial review–quite unlike the internal agency decision-making that precedes decisions not to seek enforcement.” National Treasury Employees Union v. Horner, 854 F.2d 490, 496 (D.C. Cir. 1988). Accordingly, the DEA’s refusal to act is not immune from the scrutiny of this Court. See American Horse Protection Ass’n v. Lyng, 812 F.2d 1 (D.C. Cir. 1987) (reversing Department of Agriculture’s refusal to initiate rulemaking proceedings to amend soaring regulations); Geller v. FCC, 610 F.2d 973 (D.C. Cir.1979) (reversing denial of a petition and ordering the Federal Communications Commission to reexamine whether regulations previously promulgated continued to serve the public interest).
Once subjected to review, the DEA’s decision cannot withstand scrutiny. “A long line of precedent has established that an agency action is arbitrary when the agency offer[s] insufficient reasons for treating similar situations differently.” Transactive Corp. v. United States, 91 F.3d 232, 237 (D.C.Cir.1996); see also Airmark Corp. v. FAA, 758 F.2d 685, 691 (D.C. Cir. 1985) (“Deference to agency authority or expertise . . . ‘is not a license to . . . treat like cases differently.’”). The DEA violated this basic requirement of evenhandedness by failing to perform an adequate comparison of the abuse potential of marijuana with other scheduled drugs, as required by the CSA. The DEA also acted arbitrarily by: giving short shrift to its own findings regarding marijuana’s low toxicity and dependence, conflating marijuana use with a high potential for abuse, asserting inconsistent interpretations of the CSA, failing to consider the current medical and scientific record of marijuana’s medical usefulness and denying a hearing even while admitting the complexity of the data and facts. See A300; DEA Br. at 5. The DEA has grossly exceeded the bounds of its discretion. This Court should reverse its arbitrary inaction.
- THE ADMINISTRATOR’S DETERMINATION THAT MARIJUANA HAS A HIGH POTENTIAL FOR ABUSE WAS NOT MADE IN ACCORDANCE WITH THE CSA OR THE DEA’S USUAL CRITERIA NOR WAS IT SUPPORTED BY SUBSTANTIAL EVIDENCE
Rather than dispute that the CSA requires it to compare marijuana to other scheduled substances to determine whether it has a “high” potential for abuse, the DEA claims that it performed such an inquiry but that petitioners misunderstood it. DEA Br. at 19. The DEA’s data does not live up to its rhetoric. Consider first, the DEA’s claim that “HHS’s scientific and medical evaluation contains substantial data regarding the prevalence of marijuana use and side-by-side comparisons of marijuana abuse data with that of heroin and cocaine.” DEA Br. at 19 (citing A307-308, A322-A328). These side-by-side comparisons are nothing more than social survey data indicating that (1) more people use marijuana than heroin or cocaine; (2) marijuana was mentioned as frequently as heroin (and half as much as cocaine) in emergency room visits; and (3) nearly as many people were admitted to drug treatment centers for marijuana as for heroin or cocaine. See A324-26. Putting aside for the moment that widespread use is not tantamount to abuse, see infra at 10, the data collected by HHS and DEA undermines its conclusions. Although a similar number of emergency room visitors mention marijuana as heroin, a far smaller proportion of marijuana users visit emergency rooms at all – cocaine users are more than ten times as likely to make such visits; heroin users more than seventy times as likely to do so. See HHS Report (citing “Drug Abuse Warning Network” study) at A322, A324-25. (n1) Moreover, the studies relied upon by HHS and DEA caution that “since marijuana/hashish is frequently present in combination with other drugs, the reason for the [emergency department] contact may be more relevant to the other drug(s) involved in the episode.” A324. Thus, even when the patient mentions marijuana, the true source of the problem is frequently some other drug, such as cocaine or heroin. (n2) Precious little can be drawn from emergency rooms references.
The same is true with respect to the survey data regarding drug treatment. A3226-27. The DEA’s own data shows that the proportion of admissions for marijuana use increased substantially in the mid- to late 1990s and that, in the last year of the survey, “[m]ore than half of marijuana treatment admissions were referred through the criminal justice system.” A326. This strongly suggests that the rise in admissions to drug treatment for marijuana merely reflects the trend towards treatment, rather than incarceration. Statistics reflecting involuntary drug treatment does not support a finding of a high potential for abuse.
Nor does the DEA fare any better with the additional data it considered comparing marijuana to THC. A338-352. Both are cannabinoid substances with THC serving as marijuana’s active ingredient. See 64 Fed. Reg. 35,928 (July 2, 1999) (“THC is believed to be the major psychoactive component of [marijuana]”);A342 & 348. They are, by definition under the CSA, the same. See United States v. Walton, 514 F.2d 201, 203 (D.C. Cir. 1975) (“the definition of marijuana [contained in the CSA] was intended to include those parts of marijuana which contain THC and to exclude those parts which do not”). By comparing marijuana to THC, the DEA engages in circular reasoning which demonstrates nothing about the abuse potential of marijuana relative to other drugs. It is precisely because THC and marijuana are so similar that the petitioners requested that the DEA reschedule them in one proceeding, along with the cannabinoids dronabinol (Marinol) and nabilone. A4. Aside from marijuana, however, the DEA has failed to act on the rescheduling requests, refusing even to disclose its findings regarding THC. Only by comparing marijuana to non-cannabinoid substances can the DEA properly determine whether it has a “high” potential for abuse required for placement in schedule I. (n3)
Absent the minimally necessary comparisons, the DEA’s comparative inquiry is woefully inadequate under Grinspoon and represents a radical departure from its treatment of other drugs. See Grinspoon v. DEA, 828 F.2d 881 (1st Cir. 1987). In Grinspoon, the DEA compared MDMA to scheduled substances MDA, amphetamines and methamphetamine, and made 46 detailed findings regarding their similar chemical structures and pharmacological and neurotoxic effects. Grinspoon, 828 F.2d at 895. Similarly, when considering butorphanol, the DEA made detailed comparisons with the scheduled substances morphine, codeine, fentanyl and pentazocine in terms of their physical and psychological dependence and pharmacological effects and concluded that the abuse potential of butorphanol falls somewhere between morphine and pentazocine. 62 Fed. Reg. 37004 (July 10, 1997).
Here, by sharp contrast, the DEA eschewed such scientific comparisons in favor of a more impressionistic approach. Rather than consider chemical structures, relative toxicity, physical dependence or pharmacological or neurotoxic effects, the DEA relies, instead, upon social survey data regarding the relative number of users, emergency room visits and drug treatment admissions for marijuana versus cocaine and heroin. Such crude measures of abuse cannot substitute for the scientific evaluations required by the CSA and performed by the DEA for MDMA, butorphanol and other controlled substances. The DEA acted arbitrarily by applying different decisional criteria to marijuana than for other scheduled drugs. See Airmark Corp., 758 F.2d at 692 (vacating exemption rulings as arbitrary due to failure of agency to provide consistent criteria to all petitioners; “At the very least, ‘an agency . . . must supply a reasoned analysis indicating that prior policies and standards are being deliberately changed, not casually ignored’”) (quotation omitted); United States v. Diapulse Corporation of America, 748 F.2d 56, 62 (D.C. Cir. 1984) (“we must insist that the FDA apply its scientific conclusions evenhandedly”); cf. D&F Afonso Realty Trust v. Garvey, 216 F.3d 1191, 1195 (D.C. Cir. 2000) (“we conclude that the FAA acted arbitrarily by issuing a hazard determination inconsistent with established standards”); Transactive Corp., 91 F.3d at 237 (“A long line of precedent has established that an agency action is arbitrary when the agency offer[s] insufficient reasons for treating similar situations differently”). Such arbitrary action must be reversed.
To distract this Court from the fatal shortcomings in its comparative analysis, the DEA points to several “flaws” in petitioners’ arguments. First, the DEA argues that petitioners attach too much weight to HHS’s statement that “marijuana has relatively low levels of toxicity and physical dependence as compared to other illicit drugs.” DEA Br. at 18. Toxicity and physical dependence, however, are two of the most critical indicators of a drug’s potential for abuse, as indicated by the CSA’s express requirement that the Attorney General consider a substance’s level of physical and psychological dependence in determining the appropriate schedule of a controlled substance. (n4) See also 21 U.S.C. §811(c) (listing “psychic or physiological dependence liability” as one of eight factors that must be considered by the Attorney General in making any finding under §812(b), including abuse potential). Petitioners do not rely on these two factors alone, as the DEA misleadingly contends. DEA Br. at 18. The petition also describes pharmacology and characteristic effects of marijuana. See A9, A13. The DEA, however, considered none of this and still has not explained why it gave short shrift to these crucial scientific comparisons in favor of inconclusive social surveys. Petitioners simply expect the DEA to implement its usual criteria.
Finally, the DEA seizes on the current illegality of marijuana to equate use with abuse, arguing that petitioners’ argument “rests on the false premise that the use of marijuana for its hallucinogenic effects (and in violation of federal law) is anything other than ‘abuse’ within the meaning of the CSA”). DEA Br. at 21. Not surprisingly, the DEA is unable to cite any relevant authority for the proposition that all use of an illegal substance equals abuse, much less a high potential for abuse. (n5) Congress implicitly rejected this position when it exempted the most popular drugs, alcohol and tobacco, from the proscriptions of the CSA. See 21 U.S.C. § 802(6). If use, alone, could justify schedule I treatment, extremely popular substances, such as caffeine and aspirin, which are not statutorily exempt, would have to join marijuana in schedule I. (n6) Of course, the CSA does not compel such a result. Rather than indicate a high potential for abuse, widespread use reflects individual decisions which in many cases are made with knowledge of marijuana’s relatively low dependence liability. No matter how widespread, subversion of DEA authority is not the same as drug abuse.
III. CHEVRON DOES NOT ALLOW THE DEA TO DISPENSE WITH THE REQUIREMENT THAT A SCHEDULE I SUBSTANCE MUST HAVE A HIGH POTENTIAL OF ABUSE, EVEN IF IT DOES NOT HAVE A CURRENTLY ACCEPTED MEDICAL USE
Contrary to the plain language of §812, the DEA insists that a high potential for abuse is not required for schedule I status because marijuana’s lack of currently accepted medical use is a sufficient basis to maintain it in schedule I. See DEA Br. at 27-35. The DEA, then, seeks to avoid judicial review of this interpretation by contending that Chevron mandates that deference be given to its “reasonable interpretation of the substantive terms of the statute.” Id. at 30-31. The DEA’s Chief Counsel, however, gave a conflicting interpretation of §812 when he testified in the administrative proceedings for an earlier rescheduling petition. See NORML v. DEA, 559 F.2d 735, 748 (D.C. Cir.1977). Such an unexplained departure from established DEA precedent deprives the conflicting agency interpretations of the deference ordinarily afforded agency decisions. See, e.g., Donovan v. Adams Steel Erection, Inc., 766 F.2d 804, 807 n.3 (3d Cir. 1985). “Indeed, where an agency departs from established precedent without a reasoned explanation, its decision will be vacated as arbitrary and capricious.” ANR Pipeline Co. v. FERC, 71 F.3d 897, 901 (D.C.Cir.1995); accord Northern California Power Agency v. F.E.R.C., 37 F.3d 1517, 1522 (D.C. Cir. 1994); see Pontchartrain Broadcasting Co. v. FCC, 15 F.3d 183, 185 (D.C. Cir. 1994).
Thus, in NORML v. DEA, 559 F.2d 735 (D.C. Cir.1977), this Court explicitly rejected the very same argument as the DEA urges today. See Pet. Br. at 26-28. In NORML, this Court noted that such rigid interpretation of the CSA is irreconcilable with the DEA’s treatment of substances like poppy straw, which were placed in schedule II despite lacking a currently accepted medical use. The DEA tries to distinguish the poppy straw example by contending that its placement in schedule II was due to an exception for immediate precursors of other controlled substances, rather than DEA policy. DEA Br. at 32 (citing §811(e)) (Congress expressly provided that substances that are immediate precursors of other controlled substances are exempt from the scheduling criteria). This attempt to harmonize its inconsistent positions ignores the DEA Chief Counsel’s admission wherein he “ acknowledged that marihuana could be rescheduled to Schedule II without a currently accepted medical use.” 559 F.2d at 748 (emphasis added). The DEA is bound by this interpretation. See Donovan v. Adams Steel Erection, Inc., 766 F.2d 804, 807 n.3 (3d Cir. 1985).
The DEA also offers several other distinctions. First, it contends that NORML is not dispositive because the question therein was whether marijuana had any potential for abuse, not whether it had a “high” potential for abuse. DEA Br. at 33-34. In NORML, this Court explicitly stated that Congress intended “a finely tuned balancing process involving several medical and scientific considerations” “including potential for abuse and danger of dependence.” 559 F.2d at 748. This Court discussed the rescheduling of marijuana as an example supporting its formulated approach. Id. This removes any doubt that this Court intended the fluid balancing approach to apply to the scheduling determinations as well as the initial determination regarding potential for abuse.
Finally, the DEA cites this Court’s alternative holding regarding the insufficiency of the DEA’s medical use findings and its consideration of treaty issues as reasons this Court should depart from its holding in NORML. DEA Br. at 34-35. It hardly bears stating that neither dicta nor inapplicable treaty considerations can alter this Court’s holding that lack of currently accepted medical use does not ipso facto require a drug’s placement in schedule I. NORML requires that the DEA not end its inquiry merely by finding a lack of a currently accepted medical use. Under §812, a high potential for abuse must also be established for schedule I classification.
- THE ADMINISTRATOR’S DETERMINATION THAT MARIJUANA HAS NO CURRENTLY ACCEPTED MEDICAL USE IN TREATMENT IN THE UNITED STATES IS NOT SUPPORTED BY SUBSTANTIAL EVIDENCE
With respect to petitioners’ arguments concerning marijuana’s medical use, the DEA’s initial complaint is that the petition “did not assert as a basis for the proposed rescheduling that marijuana has a currently accepted medical use in treatment in the United States.” DEA Br. at 23. Accordingly, DEA argues that the issue “was not the primary focus of HHS or DEA in evaluating the petition.” Id. DEA’s position ignores the statutory requirement that HHS must conduct a scientific and medical evaluation in determining whether a drug should be controlled or removed as a controlled substance. See §811(b). Indeed, HHS assured counsel for petitioners that it was “not bound to consider only the evidence contained in the petition, but rather considers all relevant evidence in its medical and scientific evaluation” and that it was “taking into account studies, reports, and data that have become available since Mr. Gettman filed his petition with the DEA.” Letter from HHS to Michael Kennedy, Esq., 12-22-00 at A301.
Apparently aware of its statutory duty to consider all relevant evidence in establishing the three criteria of §812, the DEA responds to petitioners arguments by claiming that it did not rely on lack of FDA approval to the exclusion of current scientific evidence in concluding that marijuana lacks medical utility and safety. See DEA Br. at 23-27. According to DEA, HHS expressly considered the five factors established by DEA for determining whether a drug has a currently accepted medical use and advised DEA that “there have been no studies that have scientifically assessed the efficacy of marijuana for any medical condition.” DEA Br. at 23-24 (citing A332).
In fact, HHS chose to select only portions of the record in reaching this conclusion, while ignoring contradictory findings. For example, it failed to mention that the Institute of Medicine Report, a study on which it relied, also recognized that marijuana does in fact have medical use and is necessary to treat certain conditions. See Institute of Medicine, Marijuana and Medicine: Assessing The Science Base at 179, 180 (Janet E. Joy et al. eds., National Academy Press 1999) (“we acknowledge that there is no clear alternative for people for people suffering from chronic conditions that might be relieved by smoking marijuana, such as pain or AIDS wasting). Rather than fully acknowledge the IOM Report and other parts of the current scientific record, DEA placed undue reliance on the lack of FDA approval and outdated studies concerning marijuana’s medical efficacy. See Pet. Br. at 28-29. (n7)
Finally, the DEA criticizes petitioners’ reliance on state medical marijuana laws claiming that “these laws were enacted based on popular will, rather than the scientific criteria mandated by Congress under the CSA scheduling provisions.” See DEA Br. at 25-26. The DEA is wrong. The State of Hawaii implemented its medical marijuana law through legislative action, rather than referendum, thus presuming legitimacy with respect to consideration of scientific and medical evidence. Even those states that acted through referendum have developed protocols based on scientific and medical considerations, thus demonstrating marijuana’s accepted medical use and safety for use under medical supervision in those states. (n8) Clearly, many states recognize the medical uses of marijuana even if the DEA cannot.
- THE OPPORTUNITY FOR A HEARING IS NOT LIMITED TO ACTUAL RULEMAKING PROCEEDINGS AND MAY BE GRANTED IN RESPONSE TO A PETITION TO INITIATE RULEMAKING PROCEEDINGS
In opposition to petitioners’ request for a hearing, the DEA incorrectly suggests that hearings are limited to actual rulemaking proceedings. See DEA Br. at 37. Not only did NORML flatly contradict this position, see Pet. Br. at 34, but the legislative history makes clear that hearings are appropriate at this stage of the proceedings. In its report on the APA, the Senate Judiciary Committee noted that the mere filing of a petition does not require an agency to grant it, or to hold a hearing, or engage in any other public rulemaking proceedings. The refusal of an agency to grant the petition or to hold rulemaking proceedings, therefore would not per se be subject to judicial reversal. However, the facts or considerations brought to the attention of an agency by such a petition might be such as to require the agency to act or prevent the rule from continuing or becoming vulnerable upon judicial review. . .
WWHT, Inc. v. F.C.C., 656 F.2d 807 (1981) (quoting S.Rep.No.752, 79th Cong., 1st Sess. (1945), reprinted in Legislative History, at 185, 201 (1946) (emphasis added). That petitioners seeking to initiate rulemaking proceedings may be entitled to a hearing was confirmed by this Court during the NORML litigation. See Hearing on Petition to Reschedule Marijuana and Its Components, 51 Fed. Reg. 22946 (June 24, 1986) (codified at 21 C.F.R. pt. 1308).
While acknowledging the NORML proceedings, DEA attempts to distinguish that case by summarily asserting that the remedy (i.e. hearings) in NORML “was directed by this Court in light of the particular and complex nature of that litigation.” DEA Br. at 37-38. Not surprisingly, DEA does not explain how the “particular and complex nature” of the NORML litigation made that case more deserving of a hearing. Instead, DEA once again hides behind what it views to be unbridled Chevron deference. See DEA Br. at 38. As in NORML, petitioners are entitled to a hearing.
Indeed, there are even more compelling reasons than in the NORML petition to order hearings in this case. First, HHS and DEA’s unreasonable delay in deciding the petition has precluded petitioners from presenting current medical and scientific evidence relevant to marijuana’s proper scheduling under the CSA. Such obstruction has been exacerbated by HHS’ and DEA’s failures to engage in the required comparative analysis of marijuana’s abuse potential, see Argument III above, and its refusal to consider currently available evidence concerning marijuana’s medical efficacy and safety, see Argument V above, thus depriving petitioners of a reliable determination of their petition. Moreover, contrary to DEA’s assertion, the record contains factual contradictions that can only be resolved through hearings. (n9)
The obvious reason the DEA is unwilling to subject its scheduling decision to a hearing is that it remembers the result of the court ordered hearings in NORML. After the court directed the DEA to hold such hearings, the DEA’s own ALJ recommended that marijuana should be reclassified to schedule II. See Pet. Br. at 19. With little explanation, the DEA disregarded the recommendation of its ALJ. It, quite understandably, wishes to avoid the same embarrassment again.
VII. CONCLUSION
Wherefore the reasons stated, petitioners respectfully request that the petition be remanded for an evaluation of marijuana’s relative abuse potential as compared to other scheduled substances, and for meaningful consideration of all factors under section §811(c) in determining whether marijuana meets the three criteria of §812(b). Following a proper evaluation by HHS, petitioners request a public notice and comment period and hearings before an administrative law judge.
DATED: January , 2002 Respectfully Submitted,
New York, NY
Michael Kennedy
Michael Kennedy, P.C.
425 Park Avenue, 26th Floor
NY, NY 10022
(212) 935-4500
n1 The number of annual users is not in the record provided by HHS or DEA, but the statistics are derived from reconciling the NHSDA and DAWN data, both of which are contained in the record. According to the 1998 National Household Survey, there were 18.7 million annual marijuana users, 3.8 million annual cocaine users, and 253,000 annual heroin users. According to 1998 DAWN data there were 76,870 emergency room mentions for marijuana, 172,014 mentions of cocaine, and 77,645 mentions of heroin/morphine. Incorporating both sets of data indicates that rates of emergency room mentions per 100,000 users is 411 for marijuana, 4,514 for cocaine, and 30,690 for heroin.
n2 Where an emergency room patient mentions only one drug, more than twice as many mention either cocaine or heroin than marijuana. See A325.
n3 That the DEA chose to compare marijuana only to schedule I cannibinoids and not to schedule III Marinol or to schedule II nabilone, despite recognizing that these cannabinoid substances are structurally related to marijuana, A309, underscores its commitment to maintain marijuana in schedule I (without making the proper comparisons).
n4 Schedule II requires a finding that “abuse of the drug or other substances may lead to psychological or physical dependence”; Schedule III requires a finding that “abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence; Schedule IV requires a finding that “abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule III; Schedule V requires a finding that “abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule IV.
n5 Indeed, the DEA’s sole “authority” for this unprecedented proposition is Oakland Cannabis Buyers’ Cooperative, 121 S.Ct. 1711, 1718 (2001), in which the Court held that manufactures and distributors of marijuana are not entitled to a medical necessity defense under federal law. As part if its inquiry, the Court noted that marijuana is a schedule I substance under Controlled Substances Act, therefore lacks a currently accepted medical use under federal law. Contrary to the DEA’s interpretation, however, the case is irrelevant to the issue of abuse potential.
n6 Whether the severity of the abuse is a problem or not depends upon the extent to which the self-administration of the drug represents a problem to the individual or society. A good example is caffeine. “While most recent studies indicate that caffeine has abuse potential . . . it seems unrealistic and irrational to assume therefore that it is equal to other drugs of abuse in terms of its effects on the individual or society. Ultimately, relative abuse potential and its severity must be considered in terms of the criteria outlined above [compulsive self-administration, preoccupation with drug seeking behavior to the exclusion of all other activities, craving and tendency to relapse upon withdrawal].” See Petition Exhibit C, Section 1 at A53 (citing Cicero, 1992, pg 17. [Cicero, T. (1992) Assessment of Dependence Liability of Psychotropic Substances: Nature of the Problem and the Role of the College on Problems on Drug Dependence. Contractor Document for the Office of Technology Assessment. (Springfield, VA: National Technical Information Service. 1992.) (NTIS Doc. #PB94-175643)]
n7 DEA also relies on the Supreme Court’s decision in Oakland Cannabis Buyers’ Cooperative, 121 S.Ct. 1711 for the proposition that marijuana has no currently accepted medical use. See DEA Br. at 26. Such reliance is misplaced, however, because the Court was not ruling on the scientific and medical evidence of marijuana’s medical use. Rather, the Court simply acknowledged that the CSA presently classifies marijuana as schedule I due in part to a lack of medical use.
n8 See e.g. Cal. Health and Safety Code §11362.5(A) (“to ensure that seriously ill Californians have the right to obtain and use marijuana for medical purposes where that medical use is deemed appropriate and has been recommended by a physician who has determined that the person’s health would benefit from the use of marijuana in the treatment of cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine, or any other illness for which marijuana provides relief”).
n9 Aside from contradictions between the data culled by petitioners and HHS/DEA, the DEA and HHS also contradict one another. For example:
(1) HHS claims there “does not appear to be a ‘hangover’ syndrome following acute administration of marijuana . . . ” (A313), while DEA asserts that marijuana does in fact produce a hangover effect. (A344).
(2) HHS claims that “the majority of early-onset marijuana users do not go on to become heavy users of marijuana,” (A315), while DEA asserts that “findings further suggest that marijuana’s role as a gateway to more serious substance use has become more pronounced over time.” (A382).
(3) HHS claims “reductions in male fertility by marijuana are reversible and only seen in animals at concentrations higher than those found in chronic marijuana users,” (A317), while DEA asserts that “the endocrine system effects include moderate depression of spermatogenesis and sperm motility and decrease in plasma testosterone on males.” (A368).
(4) HHS claims that “the concentrations of THC that are necessary for psychoactivity are lower than those that alter immune system,” (A317), while DEA asserts that “THC and other cannabinoids in marijuana have immunosuppressant properties producing impaired cell-mediated and humoral immunce system responses. THC and other cannabinoids suppress antibody formation, cytokine production, leukocyte migration and killer-cell activity.” (A368). See also (A369) (DEA asserting that “data on the immune system indicates that marijuana does effect the body’s ability to resist microbes including bacteria, viruses and fungi and decrease the body’s antitumor activity . . .In a person with a compromised immune function marijuana could pose a health problem”).
(5) HHS claims that “an experienced marijuana smoker can titrate and regulate the dose to obtain the desired acute psychological effects and to avoid overdose and/or minimize undesired effects,” (A320), while DEA asserts that “[Delta-9] THC intoxication is associated with impairments in memory, motor coordination, cognition, judgment, motivation, sensation, perception, and mood. The consequences produced by [Delta-9]-THC-induced behavioral impairments can greatly impact the individual and society in general.” (A384).
(6) HHS claims that “physical dependence on marijuana is a rare phenomenon compared to other psychoactive drugs and if it develops, it is milder when marijuana is the only drug instead of being used in combination with other drugs,” (A330), while DEA asserts that “the findings from this study [Kouri & Pope, 2000] . . . clearly demonstrate a “marijuana dependence syndrome” in humans . . . These data suggest that dependence to THC may in fact be an important consequence of repeated, daily exposure to cannabinoids. . .” (A346)