Sunday, April 10, 2011

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).

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. 

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.

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