BILL ANALYSIS SENATE COMMITTEE ON PUBLIC SAFETY Senator Mark Leno, Chair A 2009-2010 Regular Session B 7 4 8 AB 748 (Gilmore) As Introduced February 26, 2009 Hearing date: June 9, 2009 Health & Safety Code JM:mc MDMA AS A CONTROLLED SUBSTANCE: INCLUSION ON SCHEDULE II HISTORY Source: Attorney General Prior Legislation: AB 57 (Bates) - 2004, failed passage in Senate Public Safety AB 2300 (Bates) - 2002, failed passage in Senate Public Safety AB 258 (La Suer) - Ch. 841, Stats. 2001 SB 1103 (Margett) - 2002, failed in Senate Public Safety AB 1416 (Leach) - 2002, failed Assembly Appropriations Support: California District Attorneys Association; Los Angeles County District Attorney; Kings County Board of Supervisors; City of Corcoran Police Chief; California Narcotics Officers Association; California Police Chiefs; California Peace Officers' Association Opposition:None known (More) AB 748 (Gilmore) PageB Assembly Floor Vote: Ayes 68 - Noes 3 KEY ISSUE SHOULD MDMA<1> BE PLACED ON SCHEDULE II OF THE CONTROLLED SUBSTANCE SCHEDULES? PURPOSE The purpose of this bill is to place MDMA (3,4-methylenedioxymethamphetamine) on Schedule II of the controlled substance schedules. Existing law classifies controlled substances in five schedules according to their danger and potential for abuse. Schedule I controlled substances are deemed by law to have no accepted medical use and may not be prescribed by a physician in the regular course of practice. (Health and Saf. Code 11054-11058.) Existing law provides that an analog of a scheduled controlled substance shall be treated the same as the scheduled substance for purposes of prosecution and punishment for specified acts (other than merely being under the influence of the analog). An analog is defined as a substance with similar chemical properties or effects to another substance. (Health and Saf. Code 11400-11401.) Existing law , as set out in the decision of the court in People v. Silver (1991) 230 Cal.App.3d 389, provides that MDMA is an analog of methamphetamine. Thus, possession of or commercial activity in MDMA can be punished as if the substance were methamphetamine.<2> Existing law places methamphetamine in Schedule II as a ---------------------------- <1> 3,4-Methylenedioxymethamphetamine <2> Committee staff could find few reported California appellate cases concerning MDMA or MDA prosecutions. (More) AB 748 (Gilmore) PageC stimulant. (Health and Saf. Code 11055, subd. (d).) Existing law provides that possession of any one of specified controlled substances, including 3,4-methylenedioxy amphetamine or methamphetamine, is an alternate felony-misdemeanor, punishable by imprisonment in the county jail for up to one year, or in state prison for 16 months, 2 years or 3 years. (Health and Saf. Code 11377, subd. (a).) Existing law provides that the possession for sale of any one of specified controlled substances, including either 3,4-methylenedioxy amphetamine or methamphetamine, is a felony, punishable by imprisonment in the state prison for 16 months, 2 years or 3 years. (Health and Saf. Code 11378.) Existing law provides that the sale of any one of specified controlled substances, including either 3,4 methylenedioxy amphetamine or methamphetamine, is a felony, punishable by 2, 3, or 4 years in state prison. (Health and Saf. Code 11379, subd. (a).) Punishment for the transport for sale from one county to another within California of either substance is punishable by 3, 6, or 9 years in state prison. (Health and Saf. Code 11379, subd. (b).) Existing law provides that a person who manufactures, produces, etc., any controlled substance is guilty of a felony and is punishable by imprisonment in the state prison for 3, 5, or 7 years and a fine of up to $50,000. (Health and Saf. Code 11379.6.) Existing law , as enacted in Proposition 36 of the November 2000 election, requires non-violent drug possession offenders and parolees to receive drug treatment, with no initial incarceration. A probationer who successfully completes his or her prescribed treatment program may have his or her arrest and conviction expunged. A parolee who successfully completes treatment would not be returned to prison. (Pen. Code 1210, 1210.1 and 3063.1.) (More) AB 748 (Gilmore) PageD This bill includes MDMA (3,4-Methylenedioxymethamphetamine) on Schedule II of the controlled substance schedules. This bill specifically defines MDMA as a Schedule II stimulant, the same classification as methamphetamine, an analog of MDMA. RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION California continues to face a severe prison overcrowding crisis. The Department of Corrections and Rehabilitation (CDCR) currently has about 170,000 inmates under its jurisdiction. Due to a lack of traditional housing space available, the department houses roughly 15,000 inmates in gyms and dayrooms. California's prison population has increased by 125% (an average of 4% annually) over the past 20 years, growing from 76,000 inmates to 171,000 inmates, far outpacing the state's population growth rate for the age cohort with the highest risk of incarceration.<3> In December of 2006 plaintiffs in two federal lawsuits against CDCR sought a court-ordered limit on the prison population pursuant to the federal Prison Litigation Reform Act. On February 9, 2009, the three-judge federal court panel issued a tentative ruling that included the following conclusions with respect to overcrowding: No party contests that California's prisons are overcrowded, however measured, and whether considered in comparison to prisons in other states or jails within this state. There are simply too many prisoners for the existing capacity. The Governor, ---------------------- <3> "Between 1987 and 2007, California's population of ages 15 through 44 - the age cohort with the highest risk for incarceration - grew by an average of less than 1% annually, which is a pace much slower than the growth in prison admissions." (2009-2010 Budget Analysis Series, Judicial and Criminal Justice, Legislative Analyst's Office (January 30, 2009).) (More) AB 748 (Gilmore) PageE the principal defendant, declared a state of emergency in 2006 because of the "severe overcrowding" in California's prisons, which has caused "substantial risk to the health and safety of the men and women who work inside these prisons and the inmates housed in them." . . . A state appellate court upheld the Governor's proclamation, holding that the evidence supported the existence of conditions of "extreme peril to the safety of persons and property." (Citation omitted) The Governor's declaration of the state of emergency remains in effect to this day. . . . the evidence is compelling that there is no relief other than a prisoner release order that will remedy the unconstitutional prison conditions. . . . Although the evidence may be less than perfectly clear, it appears to the Court that in order to alleviate the constitutional violations California's inmate population must be reduced to at most 120% to 145% of design capacity, with some institutions or clinical programs at or below 100%. We caution the parties, however, that these are not firm figures and that the Court reserves the right - until its final ruling - to determine that a higher or lower figure is appropriate in general or in particular types of facilities. . . . Under the PLRA, any prisoner release order that we issue will be narrowly drawn, extend no further than necessary to correct the violation of constitutional rights, and be the least intrusive means necessary to correct the violation of those rights. For this reason, it is our present intention to adopt an order requiring the State to develop a plan to reduce the prison population to 120% or 145% of the prison's (More) AB 748 (Gilmore) PageF design capacity (or somewhere in between) within a period of two or three years.<4> The final outcome of the panel's tentative decision, as well as any appeal that may be in response to the panel's final decision, is unknown at the time of this writing. This bill does not appear to aggravate the prison overcrowding crisis outlined above. COMMENTS 1. Need for This Bill According to the author: AB 748 will classify MDMA, more popularly known as Ecstasy, as a Schedule II drug in the Health and Safety Code. Under current law, controlled substances are classified into five scheduled phases, with the greatest penalties and restrictions placed on Schedules I and II. The federal government classifies MDMA as Schedule I controlled substance, but California does not schedule it at all. MDMA has gained significant popularity as a social drug, but these substances are some of the most dangerous and destructive, leading to incidents of date rape and other violent crimes. When it comes to prosecuting those who want to bring these drugs into our community, there must be no wiggle room in the law. Adopting AB 748 will ensure that prosecutors are not spending time and resources arguing in court the ---------------------- <4> Three Judge Court Tentative Ruling, Coleman v. Schwarzenegger, Plata v. Schwarzenegger, in the United States District Courts for the Eastern District of California and the Northern District of California United States District Court composed of three judges pursuant to Section 2284, Title 28 United States Code (Feb. 9, 2009). (More) AB 748 (Gilmore) PageG demerits of MDMA, instead of the merits of the case. 2. Under Existing Law, Prosecutions Can be Brought Under Laws Covering Drug Analogs; this Bill Would Simplify MDMA Prosecution California law provides that a person can be prosecuted for possession, trafficking or manufacturing a drug if the drug involved in the charged act is an "analog" of a scheduled controlled substance, regardless that the actual substance is not specifically scheduled. (Health and Saf. Code 11401.) The court in People v. Silver (1991) 230 Cal.App.3d 389, held that a defendant could be successfully prosecuted for sale of MDMA as an analog of methamphetamine. Thus, there appears to be no bar to California prosecution of MDMA related conduct pursuant to the scheduling of methamphetamine (or another drug such as MDA). The Los Angeles County District Attorney has argued that requiring the prosecution to prove that MDMA is an analog of a controlled substance is burdensome. The District Attorney argues that jurors may be confused by the complex scientific testimony needed to establish that MDMA is an analog of methamphetamine. SHOULD MDMA BE INCLUDED IN SCHEDULE II OF THE CONTROLLED SUBSTANCE SCHEDULES? 3. MDMA - History - Original Federal Scheduling Hearing Recommending Schedule III MDMA was patented by Merck in Germany in 1912. Although it has been previously reported that the drug was developed as an appetite suppressant, Merck recently stated that MDMA was the by-product of efforts to develop nasal congestion medicines. During the 1950's, MDMA was included in some research by the U.S. Army into psychoactive drugs. However, MDMA remained largely unknown except for a few university and industry biochemists. In the late 1970s, researchers and clinicians (More) AB 748 (Gilmore) PageH explored the use of MDMA in therapy. Researchers were particularly impressed that MDMA induced profound empathy, an important component of psychological recovery. MDMA was used to treat post-traumatic stress, depression and other maladies. Although therapists sought to limit MDMA publicity, extensive Federal Drug Enforcement Administration hearings in the 1980s brought MDMA to wide public attention including sensationalized media reports. Despite the recommendation of the presiding judge that the drug be placed in Schedule III, MDMA was finally placed in Schedule I in 1988.<5> (21 CFR, Part 1308.) Placement in Schedule III would have allowed physician prescription. It appears that the sensational media reports helped create a growing market for non-therapeutic use of the drug. Drug dealers supplied the market. Government prohibitions increased publicity. Additional publicity created even more use. Despite federal prohibitions, some unauthorized therapeutic use has continued in the U.S. There have been anecdotal reports of use by terminal cancer patients who have become withdrawn, depressed and anxious. MDMA reportedly relieved overwhelming anxiety, facilitated emotional intimacy and gave very effective pain relief without the dulling of the mind that accompanies narcotic painkillers. AS RECOMMENDED BY THE JUDGE WHO PRESIDED OVER THE ORIGINAL FEDERAL SCHEDULING HEARINGS, SHOULD MDMA BE PLACED IN SCHEDULE III? 4. Limited MDMA Clinical Trials for Treatment of Post Traumatic Stress Disorder Began in the United States April 2004; Clinical Trials in other Countries. With little media notice, protocols for clinical trials in South Carolina for therapeutic use of MDMA to treat post-traumatic --------------------------- <5> MDMA had briefly been removed from Schedule I pursuant to a court challenge. (More) AB 748 (Gilmore) PageI stress disorder (PTSD) were approved by the FDA between 2001 and 2004. The trial is sponsored and funded by MAPS - the Multidisciplinary Association for Psychedelic Studies. The double-blind, controlled study began on April 16, 2004, and involved 21 patients who suffered from treatment-resistant PTSD. Each patient had failed to respond to prior treatment with a medication such as Prozac. The study was completed in September 2008. Data analysis and a report are being completed. Clinical studies have been conducted in Spain on women who suffered from treatment-resistant PTSD as a result of sexual assault. Initial positive reports about the research drew strong criticism from anti-drug activists and the study was halted by the hospital where the study took place. The Spanish government has not withdrawn approval for the trial. Clinical studies for treatment of post-traumatic stress patients are proceeding in Israel. Subjects in the trial suffer from treatment resistant PTSD occasioned by war or terrorism. The protocol from the study in Israel has been submitted to the (U.S.) FDA in connection with trials and proposed trials in the United States. A MAPS sponsored clinical trial for subjects suffering from treatment resistant PTSD is ongoing in Switzerland. About one-half of the 12 subjects have been treated. This protocol has also been submitted to the FDA. A clinical trial has been approved in Canada and will begin this year. A clinical trial is also being developed in Jordan, and will likely involve Iraqi refugees. 5. MDMA Research - General Summary Substantial MDMA research has been conducted on animals. Numerous studies on human users of MDMA - typically long-term or heavy users - have also been done. This research would be difficult to fully describe in this analysis. Some of the research has been quite controversial. Arguably, the results have not been clear or consistent. (Some of the most notable or (More) AB 748 (Gilmore) PageJ controversial research is noted below.) MAPS researchers have tracked the research over the past 23 years. Lisa Jerome, Ph.D. summarized the state of the evidence concerning MDMA use: Many studies in nonhuman animals suggest that frequent or high doses of MDMA can damage serotonin neurons, and some studies in ecstasy using humans suggest that repeated use, especially when heavy, can affect serotonergic function and specific domains of cognitive function. Ecstasy users exhibit impairment in specific areas of cognitive function, particularly verbal memory. However, when apparent, most long-term effects seem to be more strongly associated with heavy and not moderate use. The risk of impaired serotonin function or verbal memory after exposure to one to there doses of MDMA in the course of a controlled study remains possible, but evidence from retrospective and prospective studies of ecstasy users suggest that this risk is minimal after a low number of exposures. While there may also be risks related to psychological well-being such as increased symptoms of anxiety or depression, support for these long-term effects are even less strong than for the previously listed changes. (Jerome, Investigators Brochure - MDMA - Dec. 2007/) 6. Few Controlled Studies have Examined the Use of MDMA by First-Time Users - Recent Dutch Studies - Most Studies have Involved Subject with Extensive Self Reported Use Subjects with Extensive Prior Illicit MDMA Use in Unsupervised Settings Subjects in most MDMA studies were chosen because of self-reported past use - often hundreds of doses - of the drug. These subjects often took MDMA in "rave" settings where they may have become dehydrated and overheated, factors that increase any MDMA dangers. These subjects had also typically used many other (More) AB 748 (Gilmore) PageK drugs. In many cases, research subjects were recruited at raves. Researchers could not determine the strength of MDMA used, or whether the subjects had actually taken MDMA, rather than other drugs such as MDA or LSD, which are commonly sold as MDMA in rave settings. Recent Controlled Studies Considering Novice MDMA Users Few supervised, controlled studies have been done as to the immediate and long-term effects of standardized doses of MDMA on na?ve (first-time) users. This is particularly true in the United States. Dutch researchers have relatively recently (circa 2005) conducted MDMA studies with subjects who had not previously used MDMA. In one study, subjects took an average of two to six doses. The maximum use was 10 doses. The brains of the subjects were imaged before use and about seven weeks after use. Researchers failed to find any chemical markers of neuronal injury. They found very few changes in cerebral blood flow. Another study involved 25 subjects (with 24 control subjects) who had taken an average of two tablets each. (One person in the study had reported cumulative MDMA use of 30 tablets.) Researchers found no significant differences in brain activity (as measured by an MRI) or in working memory and attention. Still another study with approximately 60 subjects who took an average of about 3 MDMA tablets found some association between MDMA use and verbal memory, but none between attention or working memory. All results were in the normal range. These recent Dutch studies, of course, do not conclusively establish whether or not there could be long-term effects from relatively few uses of MDMA. The researchers, however, did not find the types of changes seen in MDMA users. 7. Highly Publicized Study Projecting Grave Harm from Single MDMA Dose has been Retracted - Researchers Injected Monkeys with Methamphetamine, not MDMA (More) AB 748 (Gilmore) PageL Specific Problems with the 2000 A study by Johns Hopkins researcher George Ricaurte published in 2000 in Science Magazine (Science, 2002, 297: 2260-63) concluded that a single recreational dose of MDMA could cause Parkinsonism later in life. The report specifically noted allegedly new evidence that MDMA could damage dopaminergic neurons, while prior studies focused on serotonin. The study involved giving a drug - reported to be MDMA - to squirrel monkeys and baboons. Many scientists quickly questioned the results of the study. For example, scientist commentators noted that the primates must have been given extremely high doses because 20% of the animals died in the study and two others suffered heatstroke. Nevertheless, the study received extensive publicity, including cover stories in major newsmagazines. Ricaurte testified before Congress about the results and the study was used to support passage of federal laws to limit "rave" gatherings. In September 2003, Ricaurte retracted the study. He reported that the monkeys had been given methamphetamine, not MDMA. Ricaurte stated this error occurred because the vials containing the drugs had been mislabeled. (The retraction noted that damage to dopaminergic neurons would be expected from methamphetamine use.) After retraction of the study many scientists have called for much more rigorous peer review of studies concerning controversial controlled substances, particularly MDMA. Further, the controversy surrounding Ricaurte's research appears to have affected applications for clinical studies of MDMA. (More) 8. Standard Dose of MDMA in a Supervised Setting Published reports by researchers and clinicians noted that the primary effects of MDMA last about 4 hours. While a person is under the influence of a normal dose of from 100 to 125 milligrams, MDMA rarely interferes with cognitive functioning or perception and usually produces a warm feeling and a reduction of fear and defensiveness. Subjects can usually "negotiate" and handle psychological material and often can move toward or away from certain thoughts or emotions. 9. MDMA and Brain Biochemical Processes MDMA has been described as chemically similar in structure to amphetamine and mescaline, but with unique properties. In simplest terms, MDMA causes substantial release of serotonin from nerve cells in the brain into the synapses (spaces) between the cells. Serotonin is found throughout the body. In brain nerve cells, serotonin acts as a neurotransmitter and plays a critical role in mood regulation and numerous other functions. Drugs such as Prozac (selective serotonin reuptake inhibitors) regulate brain serotonin levels by inhibiting the ability of nerve cells to reabsorb serotonin. It is theorized that depression can result where serotonin levels in the nerve synapses are too low to stimulate adequate nerve activity. This theory has not been conclusively established. Further, there has been some recent criticism of the assumption that SSRIs relieve depression through blocking reuptake of serotonin by brain neurons. Serotonin reuptake is blocked within hours of SSRI ingestion, yet depression is typically not abated for weeks into treatment. The lack of understanding about how SSRIs work and similar questions about how MDMA indicate that research on all drugs regulating the serotonin system could be very important. SSRIs have been approved for numerous medical and psychological conditions. Limiting or impeding research into MDMA may limit our understanding of the brain and the action of widely used drugs. (More) AB 748 (Gilmore) PageN 10. Particular Concerns and Dangers of Use of MDMA with High Ambient and Body Temperatures There have been reports of some heat prostration or heat stroke injuries and deaths related to MDMA use at raves. MDMA side effects may be temperature sensitive. An increase in body temperature combined with fluid depletion from hours of dancing can put some persons at risk for heat related injury. This appears to occur in a very small proportion of persons. Organizations such as DanceSafe have promoted safety measures at raves and similar events 11. Orphan Drugs - FDA Classification for Drugs to Treat Rare Disorders To encourage development of non-patent protected substances for the treatment of rare disorders, federal law grants exclusive rights to an entity that successfully applies for "orphan drug status." Without orphan drug protection, drug makers would generally have little incentive to develop non-patented drugs for rare conditions. The developer of such a drug to treat a rare disorder would have no protection from competition by others who avoided the costs of testing and approval. The standard clinical testing procedures must be followed in addition to the orphan drug process. If clinical trial results are promising, orphan drug status may be sought for MDMA treatment of PTSD. This raises an issue of whether the number of persons suffering from PTSD who would be appropriately treated with MDMA is lower than 200,000, the standard for orphan drug status. ***************