Race & Pain Medications

As part of my day job, I've been thinking a lot about policy efforts to curtail the misuse of prescription opioids.  I've written before about the huge escalation in both prescription rates and overdose deaths.  Current legislative proposals center on efforts to monitor opioid prescriptions in order to identify both patients and doctors who show a lot a prescription opioid use.  Would that these efforts were about insuring that people who need it have access to information about treatment, prevent overdose or how to use opioids safely.  For doctors, it would be nice to think that such monitoring programs would help identify people who need better coordinated care or better pain management.  Unfortunately, much of the conversation about prescription opioids is falling into our old punitive language about addiction and addicts.  And speaking of that language (which has always been highly racialized), how come no one is talking about the racial disparities in pain management?  Communities of color report more pain than other communities but have much less access to the pain medications they need (see for example, Mossey's recent review of the pain management literature).  It seems to me that this absolutely has to be part of the policy conversation about prescription medications.  The last thing we need is to make even harder for people of color to get the pain meds they need.

Addiction and the Pop Brain

Pardon the long absence.  Somewhere between finishing the PhD and moving, blogging fell by the wayside. 

Meanwhile, the discourse of around addiction has only been increasing.  Today’s New York Times includes a great example of how the neuroscientific language around addiction is encompassing an ever-widening array of phenomena.  On today’s menu of new ‘addictions’ is exercise.  Actually Kristof’s piece points out just how many substances and behaviors have been shown to ‘light up the brain.  I am reminded of Craig Reinerman’s interesting article -- Policing Pleasure. Food, Drugs, and the Politics of Ingestion – where he points out that brain imaging technology has revealed an “embarrassment of riches;” it turns out that many things – maybe even most things --  light up the brain.  For me this raises some questions.  First, if so many things (Kristof cites illicit drugs, sugar, sex, gambling, money, and altruism) activate our brain centers and “cause addiction,” does the word “addiction” begin to lose its meaning?  Second, how does the idea that these substances and behavior “change our brains” affect how individuals understand their own relationship to “addiction.”  Kristoff asserts that addiction neuroscience does not undermine free will.  But I am not sure how we are to hold onto the idea of free will while simultaneously understanding addiction as a brain disease that changes the brain and erodes the capacity for self-control. All the more reason why need to hear from those labeled "addicts" about what this new brain science means to them.

In any case, today’s NYT piece is evidence of the popularization of neuroscience to explain all manner of personal and social problems.  It seems very reminiscence of how genomics was (and often still is)  used to explain everything from diseases to personal habits.  Barbara Katz Rothman’s book, 

The Book of Life: A Personal and Ethical Guide to Race,Normality and the Human Gene Study, offers a great critique of the ideology of genomics as a lens for understanding life, the universe and everything.  With pieces like Kristof's gracing the New York Times opinion pages, we may be moving from the “pop gene” to the “pop brain.”

Photo credit: Credit: Mark Lythgoe & Chloe Hutton. Wellcome Images, images@wellcome.ac.uk

Call for Papers: Critical Perspectives on Addiction

Call for Papers:  Critical Perspectives on Addiction 
(Volume 14 of Advances in Medical Sociology)

Editor: Julie Netherland (City University of New York Graduate Center)

Series Editor: Professor Barbara Katz Rothman

Publisher: Emerald Group Publishing

Our understandings of addiction are rapidly changing.  New technologies and biomedical treatments are reconfiguring addiction as a brain disease, and the concept of “addiction” is expanding to cover an ever widening array of substances and behaviours, from food to shopping.  As addiction has taken up the discourse of neuroscience, gained some legitimacy within mainstream medicine, and become popularized through reality televisions shows and media attention to celebrity “addicts,” its cultural resonance has increased, but the meaning of “addiction” remains contested and confused.  Despite new efforts to medicalize addiction, moral and punitive frameworks for addressing addictions persist, and theories about addiction are also increasingly framed within neoliberal and public health ideologies that emphasize the individual’s responsibility to make him or herself “well.”  This edited volume of Advances in Medical Sociology aims to look critically at how addiction has been framed historically, how it being characterized and understood through contemporary cultural representations, how new treatments and technologies are reconfiguring addiction, and how “addiction” is being expanded beyond illicit drugs and alcohol to explain phenomena such as “excessive” eating and gambling and the exponential rise in prescription narcotic use.  This volume also seeks to examine how medical, behavioural and punitive frameworks for understanding and treating addiction come together to shape and control “addicts.”  Building on a rich sociological literature about drugs and addiction, this volume aims to interrogate the meaning(s) of addiction and critically examine the ways in which addiction is used as a lens for understanding individual behaviour, deviance, illness, politics, and policy.  Empirical pieces are especially encouraged.

This edited volume aims to be a benchmark text in the sociology of addiction, bringing together a broad array of critical perspectives and issues.  Therefore, we are calling for papers addressing a wide variety of topics pertaining to the sociology of addiction, including - but not limited to:

• Historical  and new efforts to medicalize addiction
• Critical interrogations of medical, public health, scientific, behavioural, moral, and punitive frameworks for understanding  and/or treating addiction
• Changing perceptions of addiction and addictive disorders within different settings and in the broader society
• The rise of novel applications of addiction frameworks (e.g., obesity as caused by ‘food addiction’) and novel treatments (e.g., deep brain stimulation, vaccines, and psychopharmceuticals, like buprenorphine and naltrexone)
• Critical analyses of non-substance addictions (e.g., gambling, shopping, sex, etc...) and how these support and/or challenge traditional notions of addiction
• Representations of addiction in the media and popular culture
• Addiction treatment interventions and how they reflect and/or shape larger sociopolitcal contexts
• The relationships between frameworks for understanding addiction, interventions to address it, and subjectivity
• The relationship between addiction and larger sociological constructs, such as racism, gender, structure/agency, etc...
• The rise in addiction to prescription medications and how this challenges existing conceptual, policy and treatment approaches to drug addiction.

This list should be treated as suggestive rather than prescriptive.  Papers addressing other relevant topics are welcome as are informal inquiries about proposed topics.

Potential contributors should email a 500-750 word abstract by October 3, 2011 to: julie.netherland@gmail.com .

Informal enquiries to this address are also welcome. Name and institutional affiliation of author(s) should also be supplied, including full contact details of the main author. Proposals will be reviewed by the editor, and authors notified by November 7, 2011. The deadline for full submissions (7500-8500 words) will be February 7, 2012. Publication of the volume is expected in mid- to late 2012.

Interesting NYT article on a new kind of drug trade

Today the New York Times has an interesting story about the street market for prescription narcotics.  According to the report, people are hanging out outside of drug stores asking passer-bys if they have prescription drugs they want to sell.  Seem to me like the explosion in prescription drug use has the potential to really challenge our existing drug policies.  It's hard to imagine, for instance, that the "war on drugs" will take aim at physicians in the same way it has at "drug lords" south of the border. 

White House Office of National Drug Control Policy Announces New Prescription Drug Abuse Plan

Finally, the White House Office of National Drug Control Policy is bringing some attention to the prescription drug problem and has recognized that the use of prescription drugs has far outstripped the use of any illicit substances, except marijuana.  It's great to see this issue getting some focus, and I hope, because prescription drugs are legal, it might challenge policymakers to come up with new ways of approaching drug policy.  The plan focuses on physician education and prescription monitoring, recognizing that the increase prescription drug misuse and overdoses has followed a dramatic increase in the number of narcotics being prescribed for pain in recent years.  Our drug policy has focused for so long on demonizing and punishing the relatively few users of illicit drugs, like heroin and cocaine, in ways that are highly racialized.  I am interested to see if this "new epidemic" shifts the stigma surrounding drug use and fosters a different kind of drug policy or just leads to a bifurcated system where some people get treatment and others go to prison.

Pharmaceuticalization and Anti-addiction Medications

Another draft section from dissertation
 

In contrast to theories about corporate interests and profit driving medicalization and pharmaceuticalization, a landmark 1995 Institute of Medicine Report concluded: “the disincentives for the pharmaceutical industry in the development of anti-addiction medications are formidable (Fulco et al 1995: 187).”   According to Alan Leshner, former Director of NIDA, “There are virtually no market incentives for pharmaceutical companies to develop medications for drug addiction” (Leshner 1999).  Indeed, NIDA’s Medications Development Program, founded in 1990 has received substantial government funding precisely to overcome the reluctance of industry to develop addiction medications on its own.  For example, NIDA received a $500 million infusion of cash in 1996 for new medication development.  Bup received significant assistance from this program and probably would never have been brought to market without the substantial support and involvement of NIDA.  The development of bup is best understood by placing it within a broader context of the market, regulatory and cultural forces that both foster and impede the development of opioid addiction medications.

Market Forces

There are no precedents for a highly profitable addiction medication.  Pharmaceutical companies traditionally base their business models of investments in medications with large sales potential (Mark 2009).  And while some kinds of addiction appear to be quite prevalent, there is no history of an addiction medication becoming a blockbuster (Mark 2009).  Estimating the potential market for bup is difficult and clearly depends on how one defines opioid dependence as well as the recommended course of treatment.  One of the primary confounders in estimating the market for bup has to do with the recent increase in prescription drug abuse. With the possible exception of alcohol, our cultural understandings of and our policy responses to addiction have centered on illicit drugs, like heroin and cocaine.  Largely absent from our conversations about drug policy is attention to prescription drug abuse, which is far more prevalent than any other kind of substance misuse except alcohol and marijuana.  Moreover, the medical community, especially those working for the medicalization of addiction treatment, have been reluctant to address this problem probably because the vast majority of “abused” prescription drugs come from doctors.

Epidemiological studies indicate that 1.7% of people aged 19–30 have tried heroin and 18.7% have used other opioids in their lifetime (Veilleux et al 2010).  Some studies suggest that about 58% of those who currently use heroin meet the criteria for dependence (Veilleux et al 2010).  The total numbers of those dependent on heroin are actually quite small from the perspective of a pharmaceutical manufacturer looking for a market --  approximately 212,000.  From a marketing standpoint, non-medical use of prescription opioids is a more attractive market than heroin use (see Figure below) --  in 2007, an estimated 5.2 million reported using prescription pain relievers nonmedically (SAMHSA 2009).

These high rates of prescription drug abuse are not surprising when one considers that between 1991 and 2009, prescriptions for opioid analgesics increased from about 45 million to nearly 180 million, a 4-fold increase (NIDA 2010).  As the figure below indicates, prescriptions for pain relievers have sky-rocketed along with deaths caused by individuals overdosing on these medications.

According to SAMHSA, in 2004 approximately 1.4 million people were dependent on or abused prescription pain medications.  Unfortunately, SAMHSA does not separate out dependence from abuse (misuse that does not rise to the level of dependence) (SAMHSA 2009).  Whether or not those who abuse, but are not dependent on opioids, would receive bup is unresolved.  According to the CSAT National Advisory Committee considering the regulation of bup:  “eligible patients should include vulnerable people who are using heroin often despite experiencing adverse effects on their lives, even is they are not physically dependent” (1999:18).   If the market for bup extends to both prescription opioids and heroin and to those who are “dependent” and “abuse” these substances, the number of potential customers reaches several million.

The potential market for bup is also affected by the course of treatment -- how long people should be prescribed bup.  The length of treatment is affected by two factors – the physical dependence of those taking bup on the medication and the social construction of opioid dependence.  There is little debate over the fact that bup, like any opioid is physically addicting and, therefore, it will be difficult for people to stop taking it.  Some scholars suggest that “people will substitute affordable treatment for drug use if it is accessible” (Charles 2003: 6).  That is, bup can be seen as essentially a substitution for heroin or other prescription opioids, but one that is legal, more economical, and easier to obtain from the user’s standpoint.  From a macro-economic standpoint, shifting people’s dependence to bup moves the profit from the sale of the addictive substance to the pharmaceutical manufacturer (and the healthcare system) away from the illicit drug trade.  This is not to deny that personal and societal benefits may result from this shift, but from the standpoint of who profits --  it is the healthcare and pharmaceutical industry.  Moreover, to the extent that the addiction being treated is caused by legally prescribed pharmaceuticals, the healthcare and pharmaceutical industry is profiting on both ends – from the original prescription of the addictive opioids (i.e., pain medications) to the prescription of the addictive treatment (i.e., buprenorphine).  Bup “treats” the harm caused by iatrogenic medicine while the pharmaceutical industry profits.

Another potential source of profit stems from the social construction of bup as a chronic, relapsing disease.  The chronic, relapsing disease model has become ascendant is recent years.   This particular construction of addiction means that individuals being prescribed bup will be taking it “for long periods of time, or perhaps even indefinitely in some cases” (CSAT NAC 1999).  Like insulin for diabetics, if opioid dependence is a chronic disease, then bup will be needed, if not forever, then for months or years.  In addition, acceptance of relapse as part of the “disease” means that, rather than being seen as a failure of the medication, relapse presents another opportunity to re-engage the patient/customer in a new course of treatment. The chronic, relapsing disease frame works to the benefit of the manufacturer by developing a customer base that will be advised by professionals to take their medication indefinitely and, if they should relapse and stop taking the medication, they will be encouraged to resume taking the medication as soon as possible. 

Despite the potential market for bup, realizing this market faces a number of barriers.  Addiction medications are competing with a very well established behavioral drug treatment industry as well as criminal justice responses to addiction.  Moreover, treatment for addiction is often not covered or has limited coverage by insurers (Finkelstein, Netherland et al 2011).  Both the delivery and payment of addiction treatment has historically been separate from medical care, which poses a number of financing barriers (Finkelstein, Netherland et al 2011).  Bup treatment, being one of the first and only medications for addiction treatment delivered in medical care settings poses unique financing challenges.  For instance, it is often not clear which payer is responsible for covering the cost of medication and which, if any, is responsible for the cost of visit, particularly if it involves counseling.  And because bup is considered novel (as one of the only addiction medications that can be prescribed in a physician”s office), many insurers, hospitals, and pharmacists do not cover it at all (Finkelstein, Netherland et al 2011).

Regulatory

The regulatory barriers to developing an addiction medication are clear --  if such medications can only be dispensed through the highly regulated and intensely stigmatized methadone clinic system, they will reach relatively few people.  In 2000, Joe Biden, then a Senator, lamented the ways in which the regulation of addiction treatment stifled the pharmaceutical industry’s involvement:

The difficulty of distributing treatment medications to addicts not only hurts those who are not getting the treatment they need, but also stifles private research.  I have often bemoaned the fact that private industry has not aggressively developed pharmacotherapies.  As we increase access to these drugs, we increase incentives for private investment in this valuable research (CR, 11/22/100, p. S9115).

Here, Biden recognizes that the longstanding prohibition on physicians prescribing medications to treat addiction creates a disincentive to industry to invest in the research and development needed to bring new medications to market.  Government regulation of addiction treatment --  which is, in fact, quite different from that governing any other “disease” -- suppresses the profit motive.  If addiction is to become like other diseases, then regulations must change so that industry forces can drive medication development. 

For bup to succeed economically, RB had to overcome the legal restriction preventing doctors prescribing medications for addiction treatment. RB clearly understood that trying to market bup through the existing methadone clinic system was unlikely to be profitable:

…from a corporate perspective it seemed unlikely that a drug confined to a limited number of clinics that were already comfortable using generic methadone would be used enough to justify the investment involved in taking buprenorphine through the regulatory process…  [T]o recover any significant portion of corporate expenditures… buprenorphine would need to reach the mainstream practice of medicine…[and] a period of market exclusivity would be needed to protect the product (Jaffe and O'Keeffe 2003)(p.S7-8). [emphasis added]

RB was unwilling to invest in bup without some prospect that it could be marketed outside of the methadone clinic system to the medical mainstream even though they recognized that this required a significant legislative change.  Moreover, they required a period of exclusivity to insure that they could recoup some of their investment without competition from a generic brand.  Reckitt Benckiser succeeded in achieving both of these aims.  Through the passage of DATA 2000, they expanded “access to treatment” (in the parlance of policymakers) and created a huge potential market for themselves. They also succeeded in insuring a period of exclusivity by getting bup protected by the orphan drug law.  Periods of market exclusivity are routinely granted to incentivize the development of new medications, so it is perhaps not surprising that RB obtained a 7 year orphan drug status that expired in 2009. 

Stigma

In addition to regulatory disincentives, the stigma surrounding addiction and its treatment for both “patients” and physicians has been cited as impeding the development of anti-addiction medications (Fulco 1995; Leshner 1999).  The stigma surrounding drug addiction as well as the ambivalence around its status as a disease may also be the reason why there are few, if any, established patient advocacy groups calling for the expansion of medication treatments for addiction.[1]  And despite the high prevalence of people thought to have opioid dependence, stigma is widely perceived as keeping them from seeking treatment. 

Perhaps even more daunting for industry than patient stigma is the stigma surrounding physicians who treat addiction (see previous Chapter).  The restriction on physicians prescribing medication to treat addiction, which dates back to the court decisions following the Harrison Act, stemmed directly from the perception that much of the blame for addiction fell upon the physicians and pharmacists who manufactured and sold addictive medications (e.g., tonics containing opiates or cocaine) (Weinberg 2005).  Moreover, many of the early medical cures for addiction soon became seen as addictive agents themselves. This is especially true with opiate dependence, where synthetic (and legal) opiates have long been touted by medical experts as the solution to addiction.  Bup is just the latest in a long line of such “medications.”  For example, morphine was once used to treat addiction to opium; heroin to treat morphine addiction; and methadone to treat heroin addiction.  This historical cycle of addiction medications prescribed by physicians becoming the cause of addiction has contributed to the stigma surrounding addiction medicine (Weinberg 2005).  The recent rise in and attention to addiction to prescription drugs has re-raised the specter of the drug-peddling doctor.

The ways in which pharmaceutical companies and doctors were implicated in causing addiction historically have continued to impact addiction treatment today.  Some scholars believe that medical professionals have actively abjured their role in the treatment of addiction and have thus discouraged the development of pharmaceutical treatments (Weinberg 2000).  Since doctors got out of the business of addiction treatment following the passage of the Harrison Act, medical education has largely excluded any attention to addiction or to treatment.  On average, medical students receive 12 hours of education on addiction (Miller et al 2001), and only 8% of medical school curricula require a course on addiction (Physician Leadership on National Drug Policy 2000).  Even if one overcomes the regulatory barriers to physicians’ treating addiction as NIDA and RB did, one must still overcome the reluctance of physicians to treat addiction and to be tainted by accusations that bup is just another addictive drug.

---

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
Heroin	Methadone	Buprenorphine	Low dose formulations of codeine	Cough suppressants with codeine
	Opium	Buprenorphine with naloxone
	Morphine	Hydrocodone (Vicodin)
	Fentanyl	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.

DATA 2000 & the Congressional Record

Hi all-

Over the next few weeks, I'll be posting very rough drafts of sections from my dissertation. Apologies in advance for the missing references and rough writing and numerous typos. To start, here's a section where I take a look at the Congressional Record surrounding the passage of the Drug Addiction Treatment Act of 2000 (DATA 2000), a piece of legislation that restored the right of physicians to treat addiction by prescribing narcotics in office-based settings (a privileged that had been revoked following the Harrison Act of 1914).

Congressional Debates about DATA 2000

The congressional record surrounding the passage of DATA 2000 shows just what an important role buprenorphine [bup] played in transforming U.S. drug policy. Politicians rely heavily (though selectively) on scientific and pharmacological arguments about bup, emphasizing, in particular, its low potential for diversion and abuse. They hold out visions for the way the legislation will transform the lives of addicts and “effectively put America on the right road to fighting and winning the heroin addiction war (Levin, CR, 2/17/02, p. S00156).” Most remarkably this transformation rests on a medication that. At the time, was two years away from even being approved for use by the FDA.

In the congressional hearings about DATA 2000, the committee acknowledges that they are working to pass legislation that would not apply to any existing medication:

S324 would not apply at this time to any approved product. It would apply to buprenorphine and buprenorphine/nx [nx = naloxone], if approved, and to any other narcotic drugs in schedule IV or V which are approved for use in the maintenance of detox treatment, if certain conditions are met (Hearing, p.12).

This is one of the only times in the entire congressional record that the unavailability of bup is acknowledge. Much more commonly, bup is the absolute centerpiece of arguments for the passage of legislation. Senator Daschle asserts: “this is one way in which are can fight and win the war on drugs -- by blocking the craving for illegal substance (CR, 11/10/99), p.S144472).” As Senator Levin remarks:
This legislation…will allow us to effectively utilize a new medical discovery of a substance called Buprenorphine, which has proven to be an extraordinarily effective means for combating heroin addiction by blocking the craving for heroin (CR, 11/22/2000, p.S9111).

As this quote suggest, it is not just bup’s existence that is used to justify this legislative change, it is also its particular pharmacological properties -- even though DATA 2000 could theoretically apply to a medication with completely different pharmacology than bup. The pharmacological property that is referenced most often, almost exclusively, in the congressional record surrounding DATA 200O is bup’s low potential for diversion and abuse. Senator Levin incorrectly asserts: “Of critical importance is the fact that Buprenorphine is not addictive like methadone so the likelihood of diversion is small (CR, 11/22/2000, p.S9112).” In a letter from Donna Shalala, then Secretary of Health and Human Services, she notes:

Published studies suggest that it [bup] has very limited euphorigenic effects and has the ability to precipitate withdrawal in individuals who are highly dependent on other opioids. Thus, buprenorphine and buprenorphine/nx products are expected to have low diversion potential (Hearing, p.10).

This emphasis on low abuse and diversion is potential is important not only to address concerns that bup will become another drug of abuse but also to justify circumventing the restrictive regulations that govern the dispensing of methadone. Alan Leshner of NIDA tells the committee considering DATA 2000 that:

The current regulations for administration and delivery of narcotic medication in the treatment of narcotic dependence was written for the use of full agonist medications such as methadone with demonstrated potential for abuse and do not take into account the unique pharmacological properties of these drugs [like bup] (CR, 1/28/99, p.S1092).

In addition to the pharmacological properties advocates of the legislation also point out a number of key provisions within the legislation also deigned to prevent diversions. Levin notes, “the legislation includes protections against abuse (CR, 1/28/99,).” (The specific provisions are analyzed in more detail below).

Of course, bup is not simply heralded because it has low potential for diversion. It is also constructed as that which can “help those who abuse drugs to change their lives and become productive members of society (Hatch, Hearing, p.2).” It is also a political strategy to argue against those who are focusing their “drug war” efforts on interdiction and incarceration. Senator Moynihan makes an impassioned plea to include a public health approach in drug policy relying entirely on the neuroscience of addiction:

Congress and the public continue to fixate on supply interdiction and harsher sentences (without treatment) as the ‘solution’ to our drug problems, and adamantly refuse to acknowledge what various experts now know and are telling us: that addiction is a chronic relapsing disease; that is, the brain undergoes molecular cellular and physiological changes which may not be reversible. What we are talking about is not simply a law enforcement problem… it is a public health problem and we need to treat it as such (11/10/99, p.S144473).

What is interesting about this quote is that Moynihan moves quickly from the molecular level to the level of public health. Biden make a similar move when he invokes medical science to solve a social problem. He says: “it only makes sense to unleash the full powers of medical science to find a ‘cure’ for this social and human ill (Hearing, p.22).” On the one hand, comments like these seem to epitomize medicalization -- a social problem is recast in medical or, at least public health, terms. On the other hand, it is important to note that, even those who rely on a scientific paradigm, do not propose doing away with law enforcement approaches to drugs. Biden, for example, introduced DATA 2000 in conjunction with a bill aimed at harsher enforcement against methamphetamine labs. In fact, the only person on record arguing that DATA 2000 should completely transform our approach to addiction is a scientist from Colombia University who says: “The major innovation of the FDA approval and the Drug Addiction Treatment Act, however goes well beyond the particular medication and instead to how we thin about addiction (CR, 10/17/02 p.S10658).” The politicians use the scientific language strategically to advance their goal of expanding treatment approaches to addiction, but they do not use it completely replace more punitive approaches.

In fact, the political arguments in favor of DATA 2000 center on the need to expand drug treatment capacity. Because this was a major goal of the legislation, politicians had to grapple directly with why they could not simply expand methadone or deliver bup within the methadone treatment system. And they had to do this without alienating methadone treatment providers. As discussed above, one important strategy used was to distinguish bup from methadone pharmacologically, arguing that it has less potential for diversion and creates less euphoria and, therefore, is more suitable to be dispensed in a physician’s office. The other strategy as to argue that bup would reach a different kind of “patient” -- one that would not seek treatment in a methadone clinic.

Throughout the congressional record, proponents of DATA 200 suggest that bup, specifically, and office-based treatment, more generally, has the potential to increased treatment capacity by reaching a different kind of drug users. Why is more treatment needed? Although there has been a significant gap between the number of people who are dependent on heroin and other opiates for decades, when discussing DATA 2000, legislators cite the increase in first-time heroin use among teens in the 1990’s as the need for more treatment capacity. There begins to appear in the congressional record the idea of segmented treatment, where some kinds of addicts “need” methadone” and other need bup delivered in the privacy of their local doctors office. Wesson, then President of the American Society of Addiction Medicine, tells the Senators considering the legislation:

Some [opioid abusers] need the highly-structured, behavioral modification services and maintenance with methadone or LAAM. Others require less intensive drug abuse treatment… such as buprenorphine, provided within the context of physicians’ office (CR, 1/28/99, p.S1092).

Exactly what kind of patients need more structure becomes clearer as one reads on. Leshner from NIDA testifies at length about how bup is uniquely appropriate for a new kind of heroin user:

Narcotic addiction is spreading from urban to suburban areas. The current system, which tends to concentrated in urban areas, is a poor fit for the suburban spread of narcotic addiction… [There is] an increase in the number of younger Americans experimenting with and becoming addicted to heroin. … Treatment for adolescents should be accessible, and graduated to the level of dependence exhibited in the patient. Buprenorphine products will likely be he initial medications for most dependent-dependent adolescents (CR, 1/28/99, p.S1092).

Leshner, like several others in the congressional record, draw on a culture of fear about the new threat of extra pure heroin reaching young children to give a sense of urgency to the legislation. But he does much more. For example, the urban/suburban divide can certainly be read as code for race and class as can the “graduated levels of dependence, which is a more refined way of distinguishing the long-term, “hard core” user from the neophyte. Importantly, Leshner cites no studies here that demonstrate bup’s higher efficacy among those with “graduated levels of dependence or among adolescent users because not such studies had been done at that time. Despite its lack of empirical basis this notion that bup is better for newer, less severely addicted people became a fact that was repeatedly cited throughout the policy debates.

By arguing that bup is better for some kinds of addicts, legislators are able to suggest that some people will be bale to avoid the methadone system. The implication is that white, suburban adolescents in particular should not have to go to urban methadone clinics to receive treatment alongside of the ‘real’ addicts. In the congressional committee report on DATA 2000, the hard core addicts (those being treated with methadone) are basically banished and portrayed as beyond redemption:

Methadone treatment is largely reserved for those who have been addicted to relatively high levels of opioids (generally heroin) for a relatively long period of time. Typically, an addict cannot be enrolled in a methadone program until he or she has been addicted for a year, by which time the drug has done its damage and the addict can no longer work productively. (Comm Report, p.13)

At the congressional hearings about DATA 2000, we learn another reason why the methadone system is not suitable for all addicts – the stigma associated with methadone:

The stigma and prejudice against patients in methadone treatment comes not only from the fear that they may be denied access to certain jobs, child custody or even medical treatment, but also from prejudice within the greater community, where they are likely to be labeled as weak and as ‘trading one drug for another (Hearing, p.12).’

This is the most forthright admission in the congressional record about methadone failure as a system and as a medication. Those associated with methadone are hard-core, urban heroin users who are not being treated medically. Rather they have simply substituted one drug for another. One of the interesting things about theses ongoing debates about different types of addiction is the complete absence of any mention of prescription drug abuse, which far exceeds the abuse heroin and was then, as now, rapidly escalating and causing huge numbers of deaths. The only reference to an opioid addiction other then heroin is this veiled one in a letter from Secretary Shalala:

It [bup] would be available not just to heroin addicts, but to anyone with an opiate problem, including citizens who would not normally be associated with the term addiction (CR, 11/22/2000, p.S9113).

What is clear from this quote and others is that bup is seen as an opportunity to reclaim “addicts” and “addiction” from the stigma that surrounds it and the existing medical system to treat it, methadone. However, it was certainly not lost on everyone that what was essentially being proposed could result in a two-tiered system of addiction treatment. The only opposition to DATA 2000 in the entire congressional record was from a group of legislatures who felt that the law was too narrow and should be accompanied by a massive new investment in all drug treatment systems. They summarized their opposition this way:

Bup is expected to be an effective treatment of mild to moderate heroin addiction. A majority of heroin addicts are severely addicted. Thus, many persons who are in the treatment gap will not benefit from the bill for pharmacological reasons. … The bill may help some heroin addicts… These will be mild to moderately addicted persons with the financial resources to obtain access to a physician or other healthcare provider who will either dispense or prescribe the medication. The bill does not dress the need of most heroin addicts; namely, those who are severely addicted or who lack the financial resources to see a doctor (Com. Report, p.29).

This notion of segmented treatment helps explain why the methadone clinic lobby did not oppose DATA 2000 and, on fact, was on record supporting the rescheduling of bup to make it available in doctors’ offices. While there is not evidence to support the claims that bup is better for those with mild to moderate addiction, it is true that methadone is more widely supported through government programs (both Medicaid and state funds) than bup (see next chapter). This argument about different kinds of addicts not only helps construct the bup patient as someone who is less addicted, suburban and likely white; it also preserves a clientele for the methadone clinics. As long as bup is targeted to a different population and is not replacing methadone, then it poses no real threat. Despite some fairly harsh critiques of methadone as both stigmatizing and as a system that has killed the potential of other medications to expand treatment capacity (several commentators attribute LAAM’s failure to the fact that it was subject to burdensome methadone clinic regulations), there are repeated assurances throughout the record that the methadone system is needed and that bup will not replace and, in fact, may strengthen the role of methadone clinics. According to Secretary Shalala:

Buprenorphine and buprenrophine/nx would not replace methadone. Methadone and LAAM clinics would remain an important part of the treatment continuum. … This could mean that methadone clinics could admit additional patients currently on waiting lists, for whom methadone or LAAM is the most appropriate treatment choice (Hearing, p.10).

It should be noted that despite or perhaps because of efforts to assure the methadone clinics that they would not be losing any business, DATA 2000 does not seem to have faced much opposition. As noted above, the original efforts failed largely because of opposition from the FDA and DEA, which were consulted and ultimately convinced to support DATA 200 through the inclusion of the safeguards against diversion discussed below. The only opposition on record for the 1999-2000 effort came from those whom wanted Congress to pass a more comprehensive bill granted a significant increase in funding to SAMHSA. Like much legislation, DATA 2000 was bundled with several other bills that also improved its chances of passing. In addition to an ecstasy anti-proliferation bill and an methamphetamine anti-proliferation bill (based on traditional law enforcement approaches of interdiction and legal penalties), DATA 2000 was attached to the popular reauthorization f the children’s health program. On October 17, 2000, President Bush signed DATA 2000 into law.