BILL ANALYSIS                                                                                                                                                                                                    







                      SENATE COMMITTEE ON PUBLIC SAFETY
                             Senator Mark Leno, Chair                A
                             2009-2010 Regular Session               B

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          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





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                                                           AB 748 (Gilmore)
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          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.



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          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.)




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                                                           AB 748 (Gilmore)
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           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).)



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               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  




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               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).



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               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  




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          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.



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          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  




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          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  




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          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  





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          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.













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          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.





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          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.


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