Saturday, January 22, 2011

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the right of physicians to treat addiction by prescribing narcotics in office-based settings (a privileged that had been revoked following the Harrison Act of 1914).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.