Methadone Maintenance: Some Treatment Programs Are Not Effective; Greater Federal Oversight Needed

Published by the Government Accountability Office on 1990-03-23.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                 United States General Accounting   OfIke

on Delivery      Some Treatment    PrograqAre
Expected at      Not Effective;    Greater
9:30 a-m, EST    Federal Oversight     Needed
March 23, 1990

                 Statement of
                 Mark V. ETadel, Associate       Director
                 for National  and Public       Health
                 Human Resources Division
                 Before the
                 Select Committee on Narcotics
                   Abuse and Control
Heroin addiction   is widespread  in the United States.      The
National Institute   on Drug Abuse (NIDA) estimates     that there                                                  are
500,000 heroin addicts    in this country.
Methadone maintenance    is the most commonly used treatment       for
heroin addiction.     rn 1988,   about 100,000 heroin addicts    received
methadone maintenance    treatment    at over 650 programs nationwide.
These programs try to help addicts       by combining methadone
maintenance   with counseling    and other services.
Using        the   results    of federally  sponsored                            research   and its own
review        of   the activities     of 24 methadone                            maintenance   treatment
programs,          GAO found the following:
Program        policies,            goals,       and practices                differed.         These program
characteristics                  are set        by the programs                themselves        and vary
Many programs              are      not      effectively           treating         heroin      addiction.
A substantial  percentage    of patients                               continued             to use heroin
after  6 months of treatment.
None of    the 24 programs  evaluate their  effectiveness.    With one
exception,     the programs did not know the extent to which their
treatment     goals were met or the overall  level of continued   drug
use in the programs.
Federal  oversight                  of methadone           treatment
                                                             maintenance programs                                    has
been very limited                   since    There are no federal
                                           1983,                       treatment
effectiveness          standards    for these programs.       Instead,     federal
regulations          have primarily     established   administrative
Interim        maintenance,               without          other    supportive            services,      is   not
effective.   GAO concluded that interim    maintenance--the                                             provision
of methadone without    any counseling  or rehabilitative                                             services--
would not significantly    reduce heroin use.

GAO recommends that the Secretary         of Health and Human Services
 (1) develop performance     standards    for programs,    (2) give guidance
to programs regarding     data collection     so that NIDA can assess
program performance,     and (3) increase     program oversight.       GAO
also recommends that the proposed interim          maintenance    regulations
be withdrawn.
Mr.     Chairman        and Members of the                     Committee:

         Mr.     Chairman,        I am pleased                 to be here             today      to discuss            our
report         on methadone            maintenance             programs.              The report         resulted
from your         request        concerning              the       extent      of treatment            services          made
available         to methadone                patients,            and whether           treatment        programs
have been successful                    in     reducing            heroin      and other          drug    use among
their      patients.           You also           expressed               concern      over      a recently
proposed         regulation            that     would       allow          methadone          to be dispensed
without         the    supportive             services         that        are considered             important
components            of effective             treatment            for     heroin       addiction.             This
proposed         treatment         is commonly referred                        to     as "interim

          In response          to your           request,           we reviewed           the     activities            of 24
methadone         maintenance             treatment            programs.              These programs             were
located         in eight        states:          California,               Florida,       Illinois,            Maryland,
New Jersey,            New York,          Texas,         and Washington.

         Using        the    results          of federally                sponsored       research        as well            as
our review            of the     24 programs,               we also          assessed          the    potential
effectiveness               of the proposed               interim           maintenance           program.

          In summary,          we found:
          --    Many programs             were not          effectively               treating        heroin

                addiction.             A substantial                percentage           of their        patients

     continued        to use heroin                after        6 months         of treatment.
     Patients       also      used other               drugs,       primarily        cocaine.

--   Treatme-nt       programs            set    their       own goals,           policies,           and
     practices,         which       varied         greatly.            However,          programs           did
     not     evaluate       the effectiveness                    of their         treatment           and,
     therefore,         did     not       know the         extent       to which          their       goals
     were met or the             overall           level        of continued             drug      use      in
     their       programs.

--   Just      as program        goals          varied,         we found         great      variation
     in the programs               for     the     services          they       provided,          their
     staffing       levels,         and the            aftercare        they      provided.

--   There       are no federal                performance           standards,           and
     federal       oversight             of methadone            programs         has been
     virtually        nonexistent.

--   Recent       federally         sponsored             research          found    that         interim
     maintenance           would         not    significantly               reduce       IV heroin           use
     and the       corresponding                risk      of AIDS.           GAO also         did     not         find
     clear       evidence       of an overall                serious         shortage         of    methadone
     treatment        slots      that          would      justify       interim          maintenance.
         There        is no typical            methadone          maintenance           treatment         program.
Programs         can be found             in rural         and suburban             areas      as well     as the
inner       cities,          and may range          in size         from     less      than     100 patients          to
over     700.         While      most programs             are established              by private         not-
for-profit            organizations,             there      are also         private-for-profit                 and
public       programs.

         Many private-for-profit                      programs           do not      receive      public
funding        and charge             their    patients          a fee for          services.        Publicly
operated         and private             not-for-profit             programs         may receive          public
funds.         These funds             may be in the             form of Medicaid,               block     grants,
or other         state        and local        government           assistance.               In the programs              1
we visited,            monthly         revenue      from all            sources      ranged      from     $145 to
$533 per patient.                     Out-of-pocket             costs     to patients,           which
partially           depend on ability               to pay,         ranged        from no charge           to $280         f
per     month.

         The Food and Drug Administration                                (FDA),      National       Institute         on
Drug Abuse            (NIDA),         and the     Drug Enforcement                 Administration            (DEA)
share       responsibility               for   regulating          methadone          maintenance
treatment           programs.            FDA approves            methadone         maintenance           treatment
programs         and has primary               responsibility              for     ensuring       programs
comply       with      federal         methadone          maintenance            regulations.            NIDA is           f
responsible            for     drug     treatment          evaluation            and research.            DEA              F

authorizes          programs            and is responsible                for     ensuring        that    supplies
of methadone            are      safeguarded          against          illegal       diversion.


         Methadone           maintenance            treatment          programs       established             their
own goals,           policies,           and practices,              which       varied     greatly.            Program
goals      varied        from treating              only      heroin      addiction         to treating           abuses
of all       drugs      with      the eventual              goal     of getting           the patient           free     of
all     drugs,       including           methadone.               A wide variance            also     existed          among
program       policies           with      respect         to methadone           dosage      levels,         urine
testing,         dismissing             patients,          and counselor           staffing         levels.

         An adequate             dose of methadone                  is necessary           to stop       heroin
use.        According          to NIDA,        60 milligrams              (mg) is generally               the
lowest       effective           dose,      and low dose maintenance                       (20 to 40 mg) is
considered           lVinappropriate.Vt               The average               dose of methadone               at 21
of the       24 programs           we visited,              however,       was less         than      60 mg.

         Methadone           maintenance            can be an effective                   treatment       for     heroin
addiction.            But,       judging       from the            continued       use of heroin              among
patients,         in practice,              nearly         half     the programs           we visited           are not
effective         in treating             heroin      addiction.                At 10 of the          24 programs,
more than         20 percent             of the patients               continued          to use heroin           after

6 months         of treatment.                    This      is a higher           percentage              than     experts
believe       should        occur          among patients                 in treatment.

          At the       24 programs                we visited,            urine     testing          to determine                    the
use of       illicit        drugs          ranged          from once a week to 8 times                            a year.                At
five      New York programs,                      urine      testing        occurred         once a week,                   but
only      one of the             five      programs          observed         the collection                of urine                in
order       to prevent            a patient              from tampering            with      the      sample.               A
consequence            of continued                heroin          or other       drug     use could              be
dismissal          from     a program.                   Fifteen        of the programs               dismissed
patients         for      repeated          drug         use while         nine    did     not.

          Comprehensive                 services,           including         counseling            and vocational
training,          'have been found                  to be essential               to     program          effectiveness
and here,          too,     we found              wide variation.                 Counseling              is a key
component          of methadone                  maintenance            treatment.           Many counselors                        and
program        directors            told         us that      it       was difficult          to provide                more
than      minimal         counseling              to patients            when a counselor@s                      caseload
exceeded         35 patients.                    Patient      ratios        at our programs                 ranged
between        1 to 15 and 1 to 96.                          Research         indicates            that     a good
relationship              between          the     counselor            and the      patient,             which        is
developed          over     time,          improves          treatment           outcomes.            The average
length       of employment                 for     counselors            at the      20 programs             that
provided         us data          ranged          from      6 months to over               8 years,          but        less
than      one-half         the      counselors             had been employed                 for     more than                  1


        Most       of the          programs         were lax             in providing          vocational           and
educational           services,             which      are required                 by federal       regulation.
Few programs             had such services                    on their         premises          and those          that
referred       patients             to services              off-site         did     not   track       patient        use
or progress.

        None of          the methadone               maintenance              programs         we visited
evaluated          the      effectiveness              of their            treatment,



        Federal          regulations               reguire         that      in order       to use methadone
in treatment,               programs         meet certain                 conditions        such as requiring
urine      testing          for     continued          drug use.              FDA and NIDA have primary
responsibility               for        regulating          programs,          but     these      agencies
provided       virtually                no oversight            of the programs                between      1982 and
early      1989.         When FDA did               begin       inspecting            programs       for
compliance           with         the    administrative                  requirements          of federal
methadone        maintenance                regulations             it     found      serious       problems.              FDA
inspections           in fiscal             year     1989 found              62 programs         that      failed          to
(1) meet m inimum urine                      testing          requirements,              standards         for
admissions,           and medical.            evaluation                 requirements:           (2) comply with
frequency        of attendance                and take-home                 requirements;            (3) maintain
an adequate           patient            record      system;             (4) or meet m inimum program
standards.            Thirty            of the      62 programs             were in New York.

Current        regulations            are process          rather         than     results      oriented.
There      are no federal               treatment         performance             standards       for     methadone
maintenance           treatment          programs         such as the             overall      level,      if    any,
of continued              drug   use that         is permissible.                  Thus,      oversight         has
been oriented               towards      regulatory            compliance          rather      than     program


          In March 1989,              FDA and NIDA proposed                      revised      methadone
maintenance           regulations              to allow        "interim          maintenance"--the
provision          of methadone            without        any counseling              or rehabilitative
services.           The purpose            is to get           addicts          who are waiting           for
comprehensive               treatment          to reduce        IV heroin          use with       its     attendant
risk      of AIDS infection.                    The proposal             is based       on the        assumption
that      many addicts           are on waiting                lists      for     treatment       and that
interim       maintenance             would      result        in      reduced     IV heroin       use and the
attendant          risk      of AIDS.           Both assumptions,                 however,      are

          First,      we found          that     while     some programs              had waiting          lists,
there      is no clear           evidence         of a serious             shortage          of methadone
treatment          slots.

        Second,          a recent       study    by Department              of Veterans            Affairs           (VA)
and University              of Pennsylvania             researchers          found         that      interim
maintenance         is not       effective         in reducing             IV drug         use.       The VA
researchers         stated       that     @ I. . . methadone               by itself          does not
guarantee        clinical        improvements            or reduced          AIDS risk."               The report
concluded        that       merely      increasing         the    availability              of methadone              in
the    absence      of administrative,                  counseling,          and rehabilitative
services        may not       adequately         protect         the majority              of patients           from
continued        drug       use and the         risk     of AIDS.


        In our report,               we have made a number of recommendations                                    to
the Secretary             of Health       and Human Services.                    These include                 the
development         of performance              standards,         guidance          for      data     collection
on program        performance,            and increased            program        oversight.
Additionally,             we recommend that              the     interim       maintenance             proposal            be
withdrawn        until       there      is sufficient            evidence        to clearly            demonstrate
its    effectiveness            in actually            reducing      intravenous              heroin      use.

This    concludes           our prepared         statement,          Mr.     Chairman,            we would           be
pleased     to answer          any questions             you may ha&.