A.T.F. Volume XI #4 Fall 2002
Clinical Concepts
- MMT as a Platform for Treating Infectious Disease
Counseling Issues -
Social Workers' Roles in MMT
Events to Note
From the Editor: Dose
Feedback Needed
Research Update - Metabolism & Higher
Dose Methadone
Current Comments - Accountability
in Addiction Research
Survey Results - HCV
Support
Current Concepts
- MMT as a Platform for Treating Infectious Disease
Substance-dependent persons, especially
injection-drug users (IDUs), exhibit high risks of contracting
infectious disease and are notably noncompliant with anti-infective
treatment regimens. Tuberculosis, hepatitis C, and HIV have
been epidemic in some populations of IDUs and, consequently,
among persons entering methadone maintenance treatment (MMT)
programs.
Can the MMT clinic environment serve as a platform for effectively
treating those infectious diseases?
Directly Observed Therapy (DOT)
Most medications for treating infectious disease must be taken in sufficient
quantity, on a regular schedule, for a specific period of time to be
effective. Self-administration of medication has been problematic in
individuals unlikely to adhere to the prescribed regimen, including:
alcohol or drug abusers, indigent/ homeless persons, or those with
a history of nonadherence with following instructions.
Monitoring of patient adherence with properly taking medications by
a dispensing healthcare professional – called "directly observed
therapy" (DOT) – has been recommended as a strategy for increasing
treatment effectiveness. MMT clinics, staffed with nurses and requiring
regular attendance by patients to receive methadone, would seem to
present optimal settings for DOT.
Application to TB
Tuberculosis (TB) continues to be a serious problem among IDUs, with
those having latent infection at greater risk for progression to active
TB. Preventive therapy for latent infection is essential to control
TB; however, previous research indicates that substance abusers are
more likely to miss doses of the anti-TB medication isoniazid (INH).
Furthermore, direct observation of INH therapy at traditional TB clinics
has been less effective in this population than in other tuberculin-positive
individuals.
A 6-month, randomized controlled trial, conducted at San Francisco
General Hospital during 1995-96, tested whether an MMT clinic could
serve as an effective setting for delivering INH therapy delivery to
IDUs.[1] The study enrolled 111 opioid-dependent patients who were
HIV-negative and had latent TB infection. They were randomly assigned
to one of three groups: 1) standard methadone treatment (n = 37) – including
substance abuse counseling and directly-observed daily INH; 2) minimal
methadone treatment (n = 35) – directly-observed daily INH but
with no counseling; 3) routine care (n = 39) – referral to a TB-treatment
clinic for monthly visits to receive 30-day supplies of INH, without
direct observation of medication ingestion or methadone treatment.
MMT Beneficial
In an intention-to-treat analysis (which includes those who dropped
out of the study), an average 77.1% of patients receiving minimal MMT
and 59.5% of those receiving standard MMT completed their INH therapy;
whereas, only 13.1% of those receiving routine care did so. See Figure
1. Completion, or adherence to
the study medication protocol, required taking at least 80% or more
of INH doses during the 6 months, which was considered necessary for
effective preventive therapy.
 The
two MMT groups had significantly better completion rates (p < .0001).
The minimal MMT group had a 17.6% greater absolute completion
rate than the standard MMT group, although this was not statistically
significant (confidence intervals overlapped, see figure 1).
Figure 1: Percent of each group completing at
least 80% of study medication. Vertical bars represent means; lines
represent 95% confidence intervals.
 In
terms of study retention, most patients participating in both forms
of MMT stayed in INH therapy 5 or more months on average. Conversely,
the vast majority of those in the routine care group remained in
treatment less than 2 months. See figure 2.
Figure 2: Proportion of patients retained in INH
therapy as a function of months retained in treatment.[1]
As with medication adherence, the minimal MMT group appeared to fare
much better in terms of retention in the study than those in the standard
MMT condition, although the difference was not statistically significant
(p = 0.1924). Of clinical significance, 87% of the routine care
group patients did not complete the study and 47% of those failed to
even show up for their initial supply of INH; another 23.5% of routine
care non-completers did not return for subsequent monthly medication
supplies.
The difference between the minimal and standard MMT retention rates
was close to statistical significance, suggesting that less comprehensive
approaches to MMT, such as interim methadone treatment, may be of benefit.
(If more subjects had been enrolled in this study, a significant advantage
of minimal MMT might have been demonstrated. A further limitation was
not having a fourth treatment group in which patients received daily
observed INH without participating in MMT.)
Health Benefits Supported
Steven Batki, MD, lead author of the study, told A.T. Forum that
the study demonstrated "proof of concept" that MMT can offer
significant public health benefits when used as a platform for delivering
medical services to IDUs. Batki is currently Professor and Director
of Research, Department of Psychiatry at SUNY Upstate Medical University
in Syracuse, NY.
However, a temporary approach to MMT, such as only 6-months of treatment
in this study, would not be expected to achieve illicit-drug abstinence
objectives. Urinalysis results were not fully reported, but Batki observed
that, in terms of continued drug abuse, "Essentially, neither
of the two methadone treatment groups did very well in a program that
limited MMT to 6 months."
One reason for continued drug use in the MMT patients might be that
they did not have the usual incentives for good behavior, such as take-home
methadone privileges and a long-term commitment to recovery. Also,
the researchers enrolled out-of-treatment drug users who were largely
indigent (homeless or with unstable housing), did not specifically
apply for MMT, and were newly entering the addiction treatment environment.
How might this approach work in a more stable MMT clinic population?
Batki believes that patients typically found in most MMT clinics would
respond much better; therefore, the research study is an underestimate
of the potential outcomes. Furthermore, current INH therapy does not
require daily dosing, so DOT can be done less frequently.
DOT for HIV in MMT
Might the DOT-in-MMT approach work for other infectious diseases?
In their study, Batki et al. excluded patients with concurrent TB and
HIV disease. However, there have been other promising investigations
in MMT patients with HIV.
A recent pilot study conducted at Albert Einstein College of Medicine,
Bronx, NY, reported on a simplified HAART (highly active, multi-drug,
antiretroviral therapy) regimen administered to HIV-positive patients
under direct observation in an MMT clinic. After only 8 weeks, 4 of
the 5 patients had undetectable HIV viral loads.[2]
A larger study, conducted in Ireland, enrolled 39 patients administered
HAART as a component of the MMT regimen.[3] At 48 weeks, 51% of antiretroviral-experienced
patients and 65% of antiretroviral-naïve patients had achieved
maximum viral suppression. The authors termed this approach "DAART" (directly
administered antiretroviral therapy), which was an attractive individualized-care
solution for patients in whom HAART was previously inaccessible or
ineffective
.
Further Research Warranted
Batki's latest interest is evaluating benefits of DOT for treating
hepatitis C (HCV) in MMT clinics. Controlled clinical trials of this
approach have yet to be done and he has a research proposal pending
with NIDA. He believes there would not be any obstacles to the delivery
of anti-HCV medications by MMT medical staff, as long as there are
sufficient staff to provide such services.
Batki is proposing a randomized trial in which half of the patients
will receive anti-HCV therapy during MMT clinic visits and a second
group will be treated for HCV at a separate medical facility.He also
is considering ways of reducing ongoing substance abuse during HCV
treatment via a voucher incentive approach, to determine if this might
affect antiviral-treatment success.
Another area for future investigation might be a cost-efficiency, economic
analysis of DOT in MMT.
For example, in the Batki et al. TB study,[1] there were only 2 cases
of active TB (1.8% of all enrolled subjects) found at an average 4-years
of followup; both were subjects who did not complete therapy, one each
in the minimal MMT and routine care groups. None of the patients in
the standard MMT group converted to active TB, whether or not they
completed the study.
Any case of active TB might be considered important from a public health
perspective. However, it would be helpful to demonstrate that the risk/benefit
balance justifies costs of preventive TB therapy – or, HCV or
HIV treatments – within the MMT setting.
1. Batki SL, Gruber VA, Bradley JM, Bradley
M, Delucchi K. A controlled trial of methadone treatment combined
with directly observed isoniazid for tuberculosis prevention
in injection drug users. Drug Alcohol Dependence. 2002;66:283-293.
2. McCance-Katz EF, Gourevitch MN, Arnsten J, Sarlo J, Rainey P, Jatlow
P. Modified directly observed therapy (MDOT) for injection drug users
with HIV disease. Am J Addict. 2002, in press.
3. Clarke S, Keenan E, Ryan M, et al. Directly observed antiretroviral
therapy for injection drug users with HIV infection. AIDS Read. 2002;12[7]:305-316.
Research
Update - Metabolism & Higher Dose Methadone
Do some MMT patients require higher daily
methadone doses because they naturally digest the drug more
rapidly or extensively?
Methadone is metabolized by several enzymes of the Cytochrome
P450 system, primarily in the liver by CYP3A4. A new study*
examined the relationship between patients requiring different
levels of daily methadone for stabilization and the intrinsic
activity of this enzyme.
Subjects at the Center for Addictive Problems, Chicago, were
selected representing 3 methadone-dosing levels (approx. 10/group): "low" (up
to 99 mg/day); "high" (100-199 mg/d); "very
high" (200 mg/d and above). All were long-term patients,
stabilized on methadone, and abstinent from illicit drugs.
Prior to daily methadone dosing, patients were administered
midazolam. (The metabolism of this short-acting benzodiazepine
serves as a marker for CYP3A4 enzyme activity.) CYP3A4 activity
and methadone serum levels were assessed via blood samples
sent to specially equipped laboratories in Switzerland.
Compared with the "low" dose group, patients requiring "very
high" methadone doses for stabilization had significantly
76% greater CYP3A4 enzyme activity. There also was a significant
difference between the "high" and "very high" dose
groups.
In a broader analysis, all patients were divided into those
receiving either less than the median 110 mg/d methadone dose
(mean 74 mg/d; range 20-100 mg/d) and those receiving more
than 110 mg/d (mean 283 mg/d; range 120-1000 mg/d). Those in
the higher-dose group had approximately 50% greater CYP3A4
activity.
This study demonstrated that there is a significant correlation
between the optimal daily methadone dose required for stabilization
in MMT and the metabolic activity of CYP3A4. That is, as the
authors concluded, many patients may require higher methadone
doses than commonly administered due to a greater intrinsic
activity of key enzymes that metabolize the drug.
*See: Shinderman M, Maxwell S, Brawand-Arney M, Golay KP, Baumann
P, Eap CB. Cytochrome P4503A4 metabolic activity, methadone
blood concentrations, and methadone doses. Drug Alcohol
Dependence. In press 2002.
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Counseling
Issues - Social Workers' Roles in MMT
Social workers in the United States have a long
history of helping substance-dependent individuals and their families.
Initially, they focused on alcoholics.
As early as 1917, social worker Mary Richmond, a major force in professionalizing
the field, rejected the prevalent moralistic view of alcoholism,
portraying inebriates as "sinners," and embraced an "inebriety
as disease" model. She stressed the importance of both physical
and mental elements in diagnosing the illness.[1]
Richmond viewed social workers as playing important roles in gathering
social data about clients and offering necessary assistance to supplement
medical treatments.[1] Through the years, social workers have contributed
a unique biopsychosocial perspective to treating addiction,
based on their knowledge of emotional, cultural, and socioeconomic
factors influencing addictive behaviors.[1,2]
Obstacles and Frustrations
According to S. Lala Ashenberg Straussner, DSW, CAS, as polydrug
abuse became more prevalent in persons also diagnosed with mental
illness, social workers expanded the scope of their activities from
helping alcoholics to working with all substance-dependent persons.
She is Professor and Coordinator of the Post-Master's Program in
the Treatment of Alcohol and Drug Abusing Clients at New York University
Ehrenkranz School of Social Work, New York City. In 2001, Straussner
was instrumental in founding the Journal of Social Work Practice
in the Addictions (see box), for which she still serves as editor.
Straussner believes that more social workers are being hired nationwide
by methadone maintenance treatment (MMT) programs, but she is concerned
about just how they fit in. Many of these professionals do not stay
in the MMT setting very long because they feel they are not being
used effectively.
Similarly, Ellen Friedman, ACSW, CASAC, observes that many
become frustrated due to a lack of emphasis on resolving psychosocial
problems contributing to substance abuse. She notes that in New York
City the number of social workers employed by MMT programs ranges
from none to many, since their presence is not required by regulation.
Friedman has been in the methadone treatment field since 1975, when
she joined the Beth Israel Medical Center, New York, MMT staff. Currently,
she is Director of Chemical Dependency and AIDS Mental Health at
Greenwich House, a multifaceted addiction services provider in New
York City.
Friedman believes that funding to hire social workers is a major
obstacle. Although, she says, "Hospital-based MMTs tend to have
more social workers, and there has been grant money available to
have social workers assist HIV-positive drug-addicted persons."
Treating the Whole Person
Until recently, Straussner notes, the biological aspect of the biopsychosocial
approach to social work was not emphasized. However, neurobiology
is becoming more important, largely due to scientific advances during
the past decade in understanding brain function in addiction and
mental illness (see box at end).
However, Friedman observes that many MMT programs tend to focus on
the biology of opioid dependence, considering methadone as the major
solution, without treating the whole person or viewing recovery in
multi-dimensional terms. The biopsychosocial approach also looks
at a person's inner strength and how the individual interacts with
their environment. The goal is to identify potential areas and local
supports for necessary life changes.
Straussner agrees that, from a social worker's perspective, methadone
is not a holistic approach to the problem of opioid addiction. "In
some settings, methadone is dispensed without attempts to deal with
multiple, psychosocial problems clients may have," she suggests. "There
also has been concern that many clients are denied therapeutic doses
of methadone because of stigma surrounding the medication."
Friedman adds, MMT programs that conceive of themselves as "addiction
treatment" rather than merely "methadone medicating" facilities
tend to offer more psychosocial services. Also, programs believing
that clients are responsible themselves for finding community resources
to meet their needs would not hire social workers; whereas, social
workers in MMT clinics can play important roles in assisting clients
to access community agencies and services.
(Social workers respectfully use the term "client" for
persons in therapy for addiction, Straussner notes. Although,
hospital or medical staff more commonly use "patient.")
Attending to Special Needs
Friedman says, "Social workers tend to have broader perspectives
in overall assessment of client needs than counselors. They view
the client's problems in psychosocial and socioeconomic terms, rather
than just behavioral terms, and also can assess concomitant mental
illness. If needed, social workers are well-versed in the referral
process for accessing other services."
Both Friedman and Straussner note that social workers are capable
of serving as clinical administrators, supervisors, and advocates
for better client care. Few become accredited in addiction counseling;
although, as certified social workers they are trained in that capacity.
Plus, they have specialized knowledge of group dynamics that might
offer new approaches for more traditional therapy groups in dealing
with addiction.
Furthermore, Straussner stresses that family dynamics in addiction
recovery are very important, even if the family is entirely in the
background. Cultural, ethnic, and gender issues – such as, the
particular needs of women, lesbians, gays, etc. – need attention
for addressing individual client's concerns and are all part of the
social worker's purview. These aspects of recovery have been largely
ignored by MMT programs, and social workers receive special training
in such matters.
Evidence of Efficacy?
As in other healthcare disciplines, evidence-based practices are
of interest in social work. However, Straussner observes, "Efficacy
trials of specific social work interventions have been noticeably
scarce." Currently, there is little evidence to rely upon for
recommending specific social work practices in the addiction treatment
field.
She believes this is changing and there is a growing emphasis on
research in the field. For example, NIDA is providing more funding
for studies in the social sciences.
Action Steps
Very little of current social worker training involves methadone,
Friedman concedes. Recruiting social workers into MMT programs largely
depends on the willingness to adequately compensate these skilled
professionals and then us-ing them effectively. MMT programs represent
the largest treater of addiction; however, the way things are today,
the work environment can be stressful and unproductive due to heavy
case loads and administrative paperwork.
Straussner recommends that, besides hiring more staff social workers,
MMT clinics should involve social work student interns. "They
question existing norms of treatment and, in so doing, may provide
new insights for improving client care." Students must be supervised
by practicing social workers, she notes. Although, in some cases,
teachers at local universities may be able to act as off-site supervisors.
Friedman concludes, "I think persons in methadone treatment
need social workers, just as anybody with a chronic illness really
could use a social worker."
1. Straussner SLA. The role of social workers
in the treatment of addictions: a brief history. J Soc
Work Addict. 2001;1(1):3-9.
2. Friedman EG. Methadone maintenance in the treatment of addiction.
In: Straussner SLA. Clinical Work With Substance-Abusing Clients.
New York: Guilford Press;1993:135-152.
The Journal of Social Work Practice is
available from The Haworth Social Work Practice Press.
Of special interest, Vol. 1, No. 3 of the Journal also
was published as a book: Neurobiology of Addictions, Implications
for Clinical Practice (Editors: Spense RT, DiNitto
DM, Straussner SLA), ISBN 0-7890-1667-2. This text, bridging
the gap between science and practice, is recommended for
all professionals in the addiction field. For information
and ordering: Tel: 1-800-HAWORTH (outside U.S./Canada call
1-607-722-5857);
Web: http://www.HaworthPressInc.com;
E-mail: getinfo@haworthpressinc.com. A.T.
Forum readers are eligible for a special 38% discount
on Haworth publications by mentioning Code BCSO when
ordering.
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Events
to Note
For additional postings & information,
see: www.atforum.com
JANUARY 2003
AAAP Review Course in Addiction Psychiatry
January 18-19, 2003
Denver, CO
Contact: 913-262-6161; info@aaap.org
24th Ann. Institute on Addictions, Inst.
for Integral Development
January 22-25, 2003
Clearwater Beach, Florida
Contact: 800-544-9562
29th Ann. Advanced International
Winter Symposium,
"Addictive Disorders & Behavioral Health"
January 28 - February 1, 2002
Colorado Springs, Colorado
Contact: 719-594-9304; addicteduc@aol.com
- FEBRUARY 2003
NCAD/COSA Intl. Conf.
on Addiction
February 1-2, 2002
Montgomery, Alabama
Contact: 334-262-1629; csancadd@bellsouth.net
American Group Psychotherapy Assoc. Annual Meeting
February 18-23, 2003
New Orleans, Louisiana
Contact: 877-668-2372
UPCOMING 2003…
American Counseling Assn. Ann. Conf.
March 20-24, 2003
Anaheim, California
Contact: 800-347-6647 ext. 222
AATOD (Amer. Assn. for
the Treatment of Opioid Dependence) 2003 Conference
April 13-16, 2003
Washington, DC
Contact: 856-423-7222 x360; aatod@talley.com
ASAM 34th Annual Conference
May 1-4, 2003
Toronto, Ontario, Canada
Contact: 301-656-3920; www.asam.org
NAATP (Natl. Assn. of
Addict. Treatment Providers) 2003 Annual Conference
May 17-20, 2003
Indian Wells, California
Contact: 717-392-8480
From the Editor:
Your Feedback Needed - Today!
Graying of Methadone Revisited
At one time, opioid-dependent persons did not survive into old age;
they either died or were incarcerated. Methadone maintenance treatment
(MMT) appears to have reversed that trend.
Today, just as there is a new class of younger addicts entering treatment – in
part related to lower-priced, purer heroin, and oxycodone and other
opioid analgesic abuse – there also are increasing numbers of
older persons who have been in MMT for many years. When we last reported
on the "Graying of Methadone" 7 years ago (Fall 1995; Vol.
4, No. 3), more than half of the patients at one of the largest MMT
programs worldwide were older than age 40; 16% were more than 50 years
of age.
By now, the 50+ population in MMT programs has increased further, bringing
with them a set of particular needs. The healthcare, psychological,
and socioeconomic concerns of older persons naturally differ from those
of youngsters. Also, for the most part, these "seniors" have
longer tenures in MMT, which might qualify them for special privileges.
A general question is: Have MMT programs effectively adapted to meeting
the needs of older patients? More specifically, we wonder…
- Have MMT clinic accreditation processes and
new regulations made life easier for older patients?
- Are more older patients receiving office-based
methadone treatment from private physicians ("medical maintenance")?
- Are counselors being specially trained in helping
these patients?
- Is the medical community in general more receptive
to older persons on methadone?
- Are methadone doses adjusted to take into account
the metabolism of older persons and/or possible interactions with
other prescribed medications?
These are just a sampling of questions for which we
need answers from MMT patients and staff. Please help
us revisit the "Graying of Methadone" in an upcoming
article by writing to us, today, via letter, fax, or e-mail.
See contact information on page 3, lower left hand column.
The Elusive Optimal Methadone Dose
Trends indicate that methadone doses have slowly edged upward during
the past decade. This is a positive sign, considering that by the late
1980s dose levels had fallen well below initial recommendations during
the 1960s by the originators of MMT – Dole and Nyswander.
Have typical doses finally achieved parity with originally-recommended
levels? It has been several years since our last A.T. Forum methadone
dose survey (Fall 1998, Vol. 6, No. 3), so the time is right for another
one.
We encourage all readers who have the necessary information
to respond to the dose-survey questions below.
How Much Methadone is "Enough"?
During the past 30 years, the optimal methadone dose for treating opioid
dependence has been elusive. Perhaps, this is because the "right" dose
is so variable, depending on many factors in each patient, including:
medical conditions, drug interactions, and concurrent substance abuse,
to name a few.
A mythology of methadone has evolved for determining what is a "necessary" or
safe dose, without any scientific basis. Staff in many MMT clinics,
as well as patients, have come to believe that doses above preset levels
are not only unsuitable but, in a way, "evil."
Yet, very recent research demonstrated that some patients naturally
metabolize methadone more rapidly or completely due to increased action
of liver enzymes (see Research Update on next page). Another study
showed that patients maintained on low doses of methadone had more
psychopathological symptoms – e.g., anxiety, depression, physical
complaints – and stronger cravings for heroin and alcohol (Lubrano,
et al. Heroin Add & Rel Clin Probl, August 2002).
In fact heroin/alcohol craving was inversely related to the amount
of methadone prescribed. This helps explain why, in many patients,
alcohol and illicit drug use can be eliminated only when daily methadone
doses are increased to what many would consider very high amounts.
Failings of Clinical Research
Despite the many observational studies indicating that patients often
need higher methadone doses for success in MMT, to date, randomized
controlled clinical trials focusing on methadone dosing have investigated
quantities that would be grossly inadequate for a significant number
of patients. Consequently, as noted in past editions of A.T. Forum,
we know much about the "science of methadone undermedication," but
very little about truly optimal dose.
It is concerning that there has been no public questioning about the
propriety and validity of randomly assigning research subjects to methadone
doses, or even a placebo(!), that are almost certain to fail. Consequently,
research results have depicted high rates of continued substance abuse
and/or study dropouts, which have unfairly reflected poorly on MMT
overall.
Methadone Dose Survey - Round III
The first two A.T. Forum dose surveys were well-received and
helpful to the field. So, to the extent possible and based on available
information, please respond to the following questions:
- The Highest typical daily methadone dose at
my clinic is ___ mg/d.
- The Lowest typical daily methadone dose is
___ mg/d.
- The Average typical daily methadone dose is
___ mg/d.
- What percent of patients at your clinic are
receiving the following methadone doses: <60 mg/d __%; 61-80
mg/d ___%; 81-100 mg/d ___%; 101-200 mg/d ___%; >200 mg/d ___%.
- We operate on a ___ for profit, ___ nonprofit
basis (check one).
- My clinic is located in the state of: ________________________.
There are several ways to respond: A.
provide your answers on the postage-free feedback card in this issue; B.
write, fax, or e-mail [info below]; or, C. visit our web site
to respond online. As always,
your written comments also are important for helping
us discuss the results.
Stewart B. Leavitt, PhD, Editor
stew202@aol.com
Addiction Treatment Forum
P.O. Box 685; Mundelein, IL 60060
Phone/Fax: 847-392-3937
Internet: http://www.atforum.com
E-mail: feedback@atforum.com
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Current
Comments - Accountability in Addiction Research
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"Not everything that can
be counted counts, and not everything that counts can be counted.
What really matters is not always obvious." – Albert
Einstein.
The amount of information in the addiction treatment field has rapidly
increased. This presents challenges of navigating efficiently through
the growing number of studies and identifying which evidence counts
the most; that is, which is most valid and of reliable quality.[1]
Added to this, the change in government oversight of methadone maintenance
treatment (MMT) programs requires stricter accountability for patient
outcomes, such as decreased illicit drug use and improved psychosocial
functioning. Increasingly, programs will need to gather and interpret
their own performance data, and adopt scientifically-validated outcome-enhancing
practices as part of the ongoing accreditation process.[2]
Where will MMT programs find the research evidence they need? Will
they be able to interpret it and put it into practice?
Introducing EBAM
Evidence has been defined as, "the data on which a conclusion
or judgment may be based."[1] More specifically, evidence-based
medicine is, "the conscientious, explicit, and judicious use
of current best evidence in making decisions about the care of individual
patients."[3] Along those lines, Evidence-Based Addiction
Medicine (EBAM) involves treatment practices based on the best
available external evidence gathered from authoritative and valid
sources.
The decision whether to implement research evidence depends heavily
on the quantity and quality of research available, and the assessment
skills of the user. According to one observer, "Interpreting
and judging medical research also involves subjective, not solely
explicit, processes."[1]
Defining Evidence
Recently, there has been an interest in the parallels of evidence
in medicine and in law. Just as a jury needs evidence from reliable
witnesses or forensic investigations to arrive at an impartial and
fair verdict, valid information is needed to help addiction treatment
providers answer healthcare questions and make clinical decisions.
In April 2000, the Agency for Healthcare Research and Quality and
the Institute of Medicine hosted an expert meeting to explore similarities
in how clinical practitioners, scientists, and legal professionals
interpret and use evidence. The result was a special issue of the Journal
of Health Politics, Policy and Law, titled "Evidence: Its
Meaning in Health Care and in Law."[4]
As the mandates of evidence-based medicine have challenged the medical
profession to consider the scientific validity of its methods and
procedures, the legal system has been similarly compelled to consider
the science underlying medical evidence presented during court testimony.[5]
The concept of accountability in these efforts has important implications
for the addiction treatment field, particularly MMT programs which
are always under scrutiny.
During the past decade, several Supreme Court decisions required
trial judges to ensure that scientific evidence entered into testimony
was supported by valid methods of research inquiry.[6] This triggered
a debate about what constitutes so-called "junk science" and
unreliable expert opinion.
Previously, healthcare practices that achieved "general acceptance" among
practitioners in a field of medicine were acceptable. The new rulings
required a much higher level of evidence, and the unsubstantiated
testimony of "experts" no longer carried much weight.[6]
According to recent commentary, "Many hoped that analysis of
the literature and evidence-based medicine would yield unequivocal
medical practice guidelines and put an end to squabbling over the
interpretation of evidence." However, it was found that some
areas of medicine lacked sufficient amounts of good evidence and
clinical practices were dominated more by hearsay or case reports.[6]
In much of daily clinical practice, including addiction medicine,
physicians may rely on biologically plausible assumptions, animal
studies, or even a handful of anecdotal reports to guide patient
care decisions. Further complicating matters, practitioners vary
widely in the standards of evidence they require for making such
decisions.[6]
Of interest, when it comes to assessing potential harm caused by
a drug or treatment, the FDA's threshold is much lower than the preponderance
of evidence beyond reasonable doubt required by the courts. The
mere "possibility" of a drug or treatment having some harmful
effect is insufficient and, in some litigation, the courts have explicitly
stated that an FDA warning is not adequate evidence to establish
causality. In particular, case reports often have been dismissed
by some courts as having little probative value (that is, they are
unacceptable as proof).[6]
NIDA-CSAT Partnership
To help provide better evidence for the addiction treatment field,
last September 2002, the National Institute on Drug Abuse (NIDA)
and the Center for Substance Abuse Treatment (CSAT) announced a $1.5-million
intra-agency agreement to help ensure that findings from NIDA-sponsored
addiction treatment research will be quickly and readily available
to practitioners. This funding will help support CSAT's 14 regional
Addiction Technology Transfer Centers (ATTCs).[7]
In an A.T. Forum interview with CSAT Director H. Westley
Clark, MD, JD, MPH, he noted that part of the role of ATTCs is
to help practitioners understand, interpret, and use the research. "CSAT's
focus is on services," he stated, "while the science emphasis
is with NIDA." Essentially, CSAT is a consumer of provided research
evidence and does not determine the design, analysis, or reporting
of studies coming from NIDA.
For the most part, Clark believes the quality of available research
is adequate: "From our perspective the issue is less a matter
of the quality of the research, but how we can get that information
to change practices in the field." For example, very few MMT
programs use contingency contracting, although there is a good research
base to support it. Conversely, some programs still use negative
reinforcers, or punishments, that have not been demonstrated as effective.
However, "being current with the literature and changing one's
behavior are two different things," Clark observed. There are
about 14,000 addiction treatment locations that are consumers of
CSAT-provided information, with a wide range of backgrounds in understanding
and using research.
With the accreditation process, MMT clinics are under pressure to
guide their practices by research-based evidence, and Clark suggested, "I
see research as moving us beyond basic clinical care. For example,
by looking at different therapeutic strategies that have been validated
by the research."
However, he also believes that some programs are not ready to act
on what leading-edge research is recommending. They need to focus
on basic care issues, case management, and quality controls.
In a pragmatic sense, Clark stressed, "It is important not to
hold the addiction field to a higher standard than we hold the rest
of the healthcare system." At the same time, he believes that
the addiction treatment field has matured to the point where it is
time to adopt evidence-based medicine approaches, which other medical
disciplines have emphasized for at least the past decade. "When
new and effective strategies become evident we need a process by
which practitioners are trained in implementing them," he says.
Addiction Research Adequate?
While Clark is optimistic, it is worthwhile noting that a search
of the ATTC web sites (http://www.nattc.org/)
did not uncover any information or training specifically addressing
principles of evidence-based medicine. Also, it must be recognized
that the addiction treatment field, in particular, has been burdened
over the years by a predominance of small clinical trials, inconsistent
study designs, and inadequate reporting of results.
For example, a team from the Cochrane Collaboration (a worldwide
group of scientists specializing in systematic reviews of research
literature) recently set out to determine whether tapered methadone
dosing is an effective strategy for managing withdrawal from opioids.[8]
An extensive search produced 20 randomized controlled clinical trials
for analysis.
Next April, A.T.
Forum will be conducting a special workshop at the
AATOD Conference titled,
"Can Addiction Research Be Trusted?" Along with this, an extensive
educational booklet on
"Understanding EBAM (Evidence-Based Addiction Medicine)" will be introduced
to provide essential information and guidelines for assessing and using research
evidence in clinicical practice. |
-
However, the treatment approaches
in those trials widely varied, many of the experimental designs
were incomparable and enrolled small numbers of patients, and most
study reports were missing critical information to fully assess
their validity. Outcome data could not be compared and summarized
across trials because many results were presented in graphical
form only or were missing key statistical data.
-
Despite their many reservations
regarding research quality, the authors did conclude that methadone
was beneficial in reducing withdrawal severity. Although, they
cautioned, withdrawal was not demonstrated as a long-term treatment
and the majority of patients eventually relapsed to heroin use.
Furthermore, recent commentary in the Journal of the American
Medical Association has challenged the ethical propriety of enrolling
patients in small-scale, poorly designed clinical studies that do
not provide valid answers to research questions. Such trials, in
which having too few participants distorts the results, are called "statistically
underpowered."[9]
The authors expressed concern that patients are being exposed to
the risks and burdens of experimental procedures, and time and money
are expended, for purposes that are likely to be of limited clinical
value, if any. [9] The extent to which this might apply in the addiction
treatment field is worthy of reflection.
Help on the Horizon
Research in addiction medicine is continually evolving, yesterday's "best
practice" may become tomorrow's outdated relic. Yet, are today's
practices the best possible? As one author noted, "The practice
of medicine has lagged behind conceptual and educational advances
in relying on scientific evidence to drive clinical decisions."[10]
Accurately predicting outcomes or benefits of a drug or treatment – for
individuals and/or particular clinical settings – is difficult,
if not impossible, in many instances. Further complicating matters,
it has been suggested that judges of medical research, whether in
the courtroom or the clinic, are frequently faced with murky, dubious,
narrow, conflicting, or irrelevant evidence. Fortunately, techniques
are available for appraising the relevance and validity of individual
studies as well as bodies of research evidence, and for linking them
to daily practice.[1]
Savvy consumers of medical evidence do not necessarily need to know
how to design research studies or perform statistical analyses. Although,
they should understand and know how to interpret a number of key
concepts, such as: probability tests of hypotheses, confidence intervals,
relative versus absolute risks, and numbers needed to treat for a
desired result.
Besides the NIDA/CSAT partnership, other assistance is on the horizon.
The theme of the next American Association for the Treatment of Opioid
Dependence (AATOD), April 13-16, 2003, is "Integrating Evidence-Based
Practices Within Opioid Treatment."
Perhaps, as Clark suggested, the addiction treatment field should
not be held to a higher standard than the rest of medicine,
but neither should evidence in the field be of a lower quality than
in other disciplines. MMT programs are held accountable by government
oversight and accreditation processes, so evidence-based addiction
medicine (EBAM) approaches are urgently needed.
1. Mulrow CD. Proof and policy from medical
research evidence. J Health Politics, Policy and Law. 2001;26(2).
2. Jackson RT. Treatment practice and research issues in improving
opioid treatment outcomes. Science & Practice Perspectives (NIDA).
2002;1(1):22-28.
3. Sackett DL, Richardson WS, Rosenberg W, Haynes RB. Evidence-Based
Medicine: How to Practice & Teach EBM. New York, NY: Churchill
Livingstone; 1997.
4. Available online at: http://www.ahrq.gov/clinic/jhppl/. Access
checked October 9, 2002.
5. Shuman DW. Expertise in law, medicine, and health care. J Health
Politics, Policy and Law. 2001;26(2).
6. Kassirer J, Cecil JS. Inconsistency in evidentiary standards for
medical testimony. JAMA. 2002;288(11):1382-1387.
7. NIDA and SAMHSA to expedite transfer of findings from treatment
research into clinical practice [press release] Washington, DC: SAMHSA;
September 30, 2002. Available at: http://www.samhsa.gov.
8. Amato L. Davoli M, Ferri M, Ali R. Methadone at tapered doses
for the management of opioid withdrawal (Cochrane Review). In: The
Cochrane Library, Issue 3, 2002. Oxford: Update Software.
9. Halpern SD, Karlawish JHT, Berlin JA. The continuing unethical
conduct of underpowered clinical trials. JAMA. 2002;288(3):358-362.
10. Eisenberg JM. What does evidence mean? Can the law and medicine
be reconciled? J Health Politics, Policy and Law. 2001;26(2).
Survey
Results - HCV Support
In the Spring 2002 edition of AT
Forum (Vol. 11, No. 2), as part of a series on "Liver
Disease in MMT," readers were asked to comment on the available
support for patients in methadone maintenance treatment (MMT) who
have hepatitis C (HCV).
A first question asked about the percentage of patients with HCV who
are also receiving treatment for the disorder. The 85 responses submitted
were quite varied, ranging from 0% to 100%. On average, 17% of HCV-positive
patients were receiving treatment (95% Confidence Interval was 12-22%,
meaning the most likely average of those receiving treatment was in
this range). However, it should be remembered that A.T. Forum surveys
are informal and may not be representative of all clinics.
Survey questions also solicited "yes," "no," or "don't
know" responses to the following:
Does your MMT clinic have support programs for patients with HCV?
Are there HCV-support groups in your community?
Approximately 118 persons responded to each question via feedback cards
or at the A.T. Forum website (www.atforum.
com). The graph depicts a summary of those responses.
Only about a third of clinics (36%) offered HCV support programs, whereas
such services were reported in more than half (52%) of communities.
Still, in neither case, does this appear to represent extensive availability
of support groups or other services for MMT patients, and from 20%
to 32% of respondents simply did not know if support was available.
One MMT patient in California, who is also a clinic clerical staff
member, commented that there are no clinic-sponsored HCV-support services,
although there are groups in the community. One of those groups comes
into the clinic every few weeks; however, their basic message is that
there is no cure for HCV and patients must be careful not to infect
others.
Apparently, there is much room for improvement in support services
and, also, for better informing patients of clinic- and community-based
resources.
Good News for HCV+ MMT Patients
 Late
last August, the National Institutes of Health released the "Final
Statement" from their panel convened in June 2002 to issue
new guidelines on the treatment of HCV. Titled "NIH Consensus
Development Conference Statement: Management of Hepatitis C:
2002," it provides an update to a 1997 statement on the
same topic.
The new statement specifically
endorses treatment for HCV in persons on methadone. It says, "Access
to methadone treatment programs should be fostered for HCV-infected
IDUs whether or not they are receiving treatment for HCV. Methadone
treatment has been shown to reduce risky behaviors that can spread
HCV infection, and it is not a contraindication to HCV treatment.
Efforts should be made to promote collaboration between experts
in HCV and healthcare providers specializing in substance-abuse
treatment."
Hopefully, these guidelines will be adopted by the medical community
to help overcome prior reluctance in treating MMT patients for HCV.
Meanwhile, MMT providers and patients should be aware of the document
and bring it to the attention of liver treatment specialists.
The full text is available at http://consensus.nih.gov, or by calling
1-888-NIH-CONSENSUS (1-888-644-2667).
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