Sunday, April 10, 2011

The Regulation of Addiction Treatment

Another piece from my dissertation.  Very much a work in progresss.

History of Addiction Treatment Regulation in the US
The distinction between legal medicines and illicit drugs is relatively recent and changes over time. Indeed, the history of opiates is one of new formulations brought to market to treat addiction to older formulations.  Substances that start out as therapeutic medicines become drugs of abuse. How these distinctions between medicines and drug are made, maintained and challenged has everything to do with the prevailing logic about addiction as well as the professional, political and economic forces of a given era.  And while these distinctions are largely historical and artificial (heroin has been both a medicine and a drug), they become enormously significant because of the social, cultural and legal meanings and actualities we attached to them.
In the 1800’s, any adult could by any medicinal products made by any manufacturer for any reason (Parrish 2003).  Our current system of regulating, prescribing, and controlling medication evolved in the early 1900’s beginning with the passage of the Harrison Narcotics Act in 1914.  Designed in part to raise revenue and in part in response to efforts to professionalize medical practice, the Harrison Act required the registration and licensing of pharmacists, physicians and manufacturers; levied taxes on the sale of medicines; and restricted the sale and use of narcotics to those prescribed by a physician for a medical reason (Parrish 2003).  For the first time, narcotic use was divided into legal use for a medical purpose and criminal use. 
Having restricted the sale of opiates to medical use, the Harrison Act created a controversy over whether using opium or morphine to maintain an “addict’s” supply was a legitimate medical reason (Weinberg 2005).  It raised the question that remains in play today -- is addiction a medical condition that should be ‘treated’ by prescribing either the substance to which the person is addicted or a substitute/treatment medication?  Are ‘substitution’ therapies a legitimate treatment for a medical disorder or is it just another way of dealing drugs?  The Treasury Department,[1] then charged with the enforcement of the Harrison Act, argued that prescribing opiates to addicts did not constitute medical treatment and that doctors who made such prescriptions could be arrested for narcotics trafficking.  In 1919, just months before alcohol prohibition took effect, the U.S. Supreme court concurred with the Treasury Department, and in 1920, the American Medical Association condemned the prescribing of opiates to addicts (Jaffe 2003).  Physicians could then, as now, prescribe narcotics for medical reasons other than treating addiction, and the prescription of opiates for pain remains a widespread practice.  Heroin, for example, though it could not be legally manufactured in the U.S. after 1924 (DeGrandpre 2006), could still be legally prescribed for conditions other than addiction until the Narcotic Control Act of 1956 (Carnwath and Smith 2002).  Even today, opiates like methadone, can be prescribed by a physician for pain but not to treat addiction (unless through the highly regulated methadone clinic system). With these regulatory changes and without the support of the American Medical Association, physicians quickly withdrew from having any formal role in addiction treatment.  Rather than being seen as a medical condition that could be treated by doctors using prescribed narcotics, overcoming addiction came to be seen largely as a matter of transforming people’s will and behavior (Carnwith and Smith 2002; White 1998).
Following the passage of the Harrison Act, U.S. drug policies generally became more punitive and oriented towards criminal justice rather than a medical approach.  In the 1950’s, minimum mandatory sentences were imposed for selling opium, coca, cannabis and their derivatives.  And in 1970, the Comprehensive Drug Abuse Prevention and Control Act (also known as the Controlled Substances Act) established a 5-tier scheduling of drugs by the Drug Enforcement Agency purportedly based on the substance’s potential for abuse, accepted medical use, and accepted safety under medical supervision.   For example, heroin is classified as a schedule I substance because it is seen as having a high abuse potential and no legitimate medical use.  Methadone, in contrast, is a schedule II narcotic because, although it is seen as having a high abuse potential, it also has purported medical value (both for the treatment of opioid dependence and pain).  As a schedule II substance, it is highly regulated.  See figure below for examples of narcotic scheduling. 

Examples of Narcotic Scheduling Under the Controlled Substances Act
Most restrictive
Least restrictive
Schedule I
Schedule II
Schedule III
Schedule IV
Schedule V
Low dose formulations of codeine
Cough suppressants with codeine

Buprenorphine with naloxone

Hydrocodone (Vicodin)

Low doses of codeine

Oxycodone (Percoset)

Codeine (certain formulations)

NOTE: Scheduling based on purported abuse potential and currently accepted medical uses

The Controlled Substances Act (CSA), which plays a central role in the social construction of bup, was considered an unhappy compromise even when it was passed because it embodied all of the tensions and ambivalence in our relationships to substances and to drug policy more generally.  Courtwright (2004:11-12) argues that the CSA framework was intentionally flexible to “give experts the authority and the resources to continuously fine-tune the nation’s medico-legal response to the drug problem.”    As I discuss is more detail below, in the case of bup, the CSA meant both that bup proponents had to win over DEA officials and that the DEA had to so some creative interpretation of the science behind bup to justify reclassifying it as schedule III narcotic. 
Following the CSA, the trend in drug policy was towards increasingly harsher and more punitive laws to lock up those who either possessed or sold drugs.  Beginning with New York’s Rockefeller Drug Laws passed in 1973,[2] both states and the federal government established an increasingly draconian set of penalties for drug possession and use that resulted in the mass incarceration of those who used or sold drugs, particularly in among people of color.  Incarceration rates have sky-rocketed (see Figure below), largely as a result of increasingly punitive drug laws (Shiraldi and Ziedenberg 2000).

Figure XX:  Trends in Incarceration Rates (per 100,000)
(in thousands)

While the general trend after the 1900’s was to treat the non-medical use of narcotics as a crime, there was always some recognition that addiction might be more amenable to treatment than incarceration.  In 1919, in what Conrad (2002) has called the “swan song of the medical era” for addiction, 40 carefully regulated narcotic clinics were opened in the U.S. with the goal of providing morphine to opiate addicts until they could be “cured.”  However, by 1923 these clinics were closed, in part due to the urging of the American Medical Association (AMA) which was trying to distance the medical profession from having any role in supporting or fostering addiction (Conrad 2002).   According to White (1998: 119), “[i]t was universally understood that physicians had a played a significant role in the development of this problem through their excessive administration of narcotics to their patients.”  Ever since this strategic move by the AMA, the role of physicians in the treatment of addiction has been minimal --  that is, until the Drug Addiction Treatment Act of 2000 and the FDA approval of bup in 2002.
Following the passage of the Harrison Act and the subsequent court decision barring physician treatment of addiction through prescription medications, addicts were either locked up or sent to ‘narcotic farms’ where they were ‘rehabilitated’ through behavioral therapies, isolated to prevent the spread of addiction, and removed from the temptations thought to encourage their drug use (White 1998).  During this same period, individuals who classified themselves as “addicts” developed Alcoholics Anonymous and the 12-step method of treatment, which favored ‘self-help’ over professional interventions.  For the next several decades, addiction treatment relied on a variety of self-help or behavioral models, all of which held abstinence from all drugs (and many medications) as their ultimate goal (White 1998).  These kinds of treatments reinforced the notion that changes in environment or behavior could overcome addiction, a failure of will or morality (White 1998).
The return to using a drug/medication substitute to address the problem of addiction did not re-occur until the advent of methadone in early 1970’s.  Methadone marked a profound shift in U.S. drug policy but also revealed the deep ambivalence of policymakers and the public over drugs and drug treatment.  Indeed, methadone was not originally billed so much as a medical treatment but as a solution to the problem of urban crime (White 1998).  Early research on methadone showed that methadone reduced crime and the consumption of heroin while allowing individuals to return to “productive citizenship” (Jaffe and O’Keefe 2003).  The first studies focused on, not only how methadone reduced heroin use, but how it increased people’s ability to get and hold a job and reduced their need to obtain money for heroin through illegal activities (Nelkin 1973).  The Nixon Administration, elected on a law-and-order platform, faced enormous pressure to solve the ‘drug problem’ and rising rates of urban crime and became champions of methadone treatment.  Drawing on a small group of pioneering scholars who lobbied for a medical approach to addiction, Nixon create a national network of methadone programs that was serving 80,000 by 1973 (White 1998).
However, many people viewed methadone treatment as simply substituting one drug for another (White 1998), and the regulatory apparatus that grew around it reflects methadone’s ambivalent status as both a legitimate medication and a drug of abuse.  As methadone treatment became institutionalization in the 1970s, it became mired in a maze of bureaucratic and regulatory restrictions.  The Department of Justice and Treasury opposed methadone, and in the early 1970’s, the FDA imposed strict rules on how it was to be dispensed essentially creating a special, closed system for methadone treatment (Jaffe and O’Keefe 2003).   Rather than being distributed like other medications, methadone was (and still is) dispensed through a highly regulated system of clinics. Daily attendance is generally required, and patients must consume their doses on site in front of staff.  The amount of the dose is also carefully regulated, and unlike other medications, methadone cannot be taken home or self-administered without special permission and privileges.  Even the form of the medication – a thick syrup --  is designed to guard against the diversion of the drug and to insure that it can not be illegally injected.  In short, from a regulatory point of view, methadone (when prescribed for addiction treatment) is like no other medication in the U.S.   As Jaffe (2003: 55) puts it, methadone represents a “substantial departure from the usual practice of allowing licensed physicians to use their own professional judgment, guided by the drug’s labeling to determine how to prescribe a medication.”  Because of their historical role in fostering narcotic addiction, the general prohibition on prescribing narcotics for treating addiction, and methadone’s excessive regulation, very few physicians are involved in methadone treatment.  Rather, methadone clinics generally have a medical director who oversee the prescriptions but are largely staffed by counselors and other mental health professionals.
This ambivalence over using medications to treat addiction was codified in 1974 through the Narcotic Addict Treatment Act.  The Act gave the newly created Drug Enforcement Agency (DEA) control over the storage and security of drugs used in the treatment of addiction and required the DEA registration of practitioners, but it gave the Department of Health and Human Services responsibility over setting treatment standards (Jaffe 2003).  While there was some limited success in the 1990’s to ease methadone regulations, the dual system of oversight that includes both the criminal justice (in the form of the DEA) and the medical (in the form of Health & Human Services) approach to dealing with addiction medications remains in place.  It is into this confusing and contradictory regulatory world that bup entered.

[1] Early efforts to control substances focused on taxation strategies.  Therefore, the regulation of narcotics began as a function of the Treasury Department.  The Federal Bureau of Narcotics was created in 1930 but still operated under the Treasury Department. As drug control efforts focused more on law enforcement strategies, new administrative structures were created at the federal level, including the U.S. Interdepartmental Committee on Narcotics in 1954 and the Drug Enforcement Agency in 1973.
[2] The Rockefeller Drug Laws were toughest drug possession and sales laws in the country, establishing mandatory minimum sentences for relatively low-level offenses and greatly curtailing the discretion of judges to offer alternative penalties or sentences.  Despite the fact that these laws were criticized for treating non-violent offenses as harshly as violent ones, they quickly become the model for other drug laws across the country. In 2009, more then 35 years after their passage, some of these laws were reformed to curtail the use of mandatory sentencing and restore judicial discretion over many drug offenses.

1 comment:

  1. Your descriptions really underscore how inhumane methadone administration can be.