New Treatments for Addiction Behavioral, Ethical, Legal, and Social Questions (2004) / Chapter Skim
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Appendix G: Costs and Benefits of Immunotherapies or Depot Medications for the Treatment of Drug Abuse
Appendix G: Costs and Benefits of Immunotherapies or Depot Medications for the Treatment of Drug Abuse
Pages 213-240
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From page 213... ...
One is whether the application of such a treatment technique to some particular patient or class of patients would be cost-justified, once it had been developed, approved, and marketed. For a treatment with high efficacy and acceptable side effects, answering that question will turn out to be trivially easy as applied to patients with severe and chronic substance abuse disorders because the benefits per application will be very large multiples of the marginal cost of production and administration.1 An efficacious immunotherapy or depot medication administered to a chronic heavy user of a low-recovery-rate drug (such as tobacco, heroin, alcohol, or cocaine)
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From page 214... ...
That development analysis uses the patient-by-patient analysis as its starting point, but the relevant part of the patient-by-patient analysis is not the part that deals with the interesting close questions such as the possibility of prophylactic use or use in cases of a relatively mild abuse disorder or a disorder not yet shown to be chronic. Instead it is the benefits in the cases that are most obvious in the patient-by-patient analysis -- patients with severe, chronic disorders -- that need to be summed and then measured against the costs of a development effort and its probability of success.
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From page 215... ...
There are reasons to expect that an effective immunotherapy or depot medication might turn out to have characteristics more appealing to those who make decisions about drug treatment than its current competitors. The most demonstrably effective drug treatments in use today are the opiate substitution therapies, which are highly acceptable to many, though far from all, persons suffering from opiate dependency but which remain controversial politically because they do not promise a "cure" for the underlying addiction.
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From page 216... ...
In the case of alcohol the benefits would be greater still, perhaps not great enough to justify making substantial investments now in the face of apparently discouraging technical facts, but great enough to justify some continued basic studies. The social damage from heroin is currently probably comparable to that from cocaine, especially considering its role in the spread of infectious disease, but the existence of a set of efficacious substitution pharmacotherapies somewhat lowers the potential benefits of developing a new treatment, and the wide variety of closely substitutable opiates and opioids would tend to reduce the value of an immunotherapy targeted at only a single molecule.
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From page 217... ...
Moreover, the extremely discouraging histories of pharmacotherapies for substance abuse other than the opiate maintenance agents give some reassurance that the opportunity cost of funds taken from other parts of the National Institute of Drug Abuse's medication development effort to support work on immunotherapies and depot medications is unlikely to be very high (see, for example, Tai, Chiang, and Bridge, 1997)
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From page 218... ...
In particular, let T be a depot medication or immunotherapy designed to reduce or eliminate, for a period of months, the bioavailability of D to a patient given T The relevant direct costs are the costs of T itself, the effort required to induce clients to accept it, and the ancillary treatment required to make it effective, plus whatever negative value is assigned to the side effects.
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From page 219... ...
The benefit picture is much more complicated, and estimating it numerically will require constructing a number of counterfactual hypotheticals concerning what would have happened had T not been available or not been used. One place to start is with a single representative individual, A, at risk of a drug abuse disorder involving D, in a world without T
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From page 220... ...
A then has monthly probabilities of moderating his or her use -- going back to being a casual user -- or quitting altogether and/or going into recovery. (Ex-casual users and ex-heavy users may continue to suffer harm due to their past use, but for these purposes it is better to attribute damage on an "accrual" rather than a "cash" basis, charging each month with the future as well as current consequences of that month's use.)
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From page 221... ...
Moreover, we ought to be able to understand the impact of any proposed intervention in terms of its impact on initiation, persistence, return, intensification, moderation, recovery, relapse, and the two harm rates. The sources of harm, both to the person suffering from a substance abuse disorder and to others, are multifarious and will vary from drug to drug.
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From page 222... ...
will greatly complicate the task of assigning a value to any new treatment technology because the group that volunteers to be treated with it may not be a random draw from the population suffering from the substance abuse disorder to which the treatment applies. The rate of recovery -- quitting from heavy use -- can be decomposed into a monthly probability, P(a)
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From page 223... ...
The reported high success rates in such attempts are often attributed to the subjects, having a great deal to lose and an unusual amount of self-discipline, but it may be the case that the temptation-reduction benefits of a daily dose of an antagonist in fact make quitting easier for this group than for other detoxified opiatedependent individuals who do not take an antagonist.8 A vaccine or depot medication would have this advantage to an even greater degree, since there would not even be a potential daily inner struggle over whether to take the medication, attempt to fake taking it, or leave the program entirely.) Reduced stress associated with the recovery attempt and increased probability of succeeding will tend to increase the rate at which patients undertake recovery attempts if T is present, compared to its being absent.
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From page 224... ...
While the option of readministration to extend the treatment's active life makes this question less crucial than it would otherwise be, it remains an important one and would be more important if diminishing efficacy or accumulating side effects made long-term application unattractive. Competing considerations make it unclear whether the post-direct efficacy relapse rates would be higher or lower for remissions secured through immunotherapies or depot medications than for remissions occurring as a result of other treatment approaches, through group selfhelp, or "spontaneously." On the one hand, a period of months of abstinence with no, or reduced, cravings due to the effective unavailability of the drug of abuse might make long-term success more likely.
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From page 225... ...
Obviously, highly toxic, illegal, expensive drugs with highly socially disruptive markets, high chronicity, and poor alternative treatment options offer greater potential savings per month of active heavy use avoided than drugs with the opposite characteristics. Drugs with close and comparably harmful pharmacological substitutes not affected by the proposed therapy will be less attractive candidates for treatment insofar as some users make the substitution and wind up comparably dependent on the substitute (e.g., see Fairbank, Dunteman, and Condelli, 1993)
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From page 226... ...
Again for concreteness, assume that a successful quit reduces the expected cumulative lifetime periods of smoking -- the length of the active addiction career -- by 20 months, a fairly modest estimate given that smoking careers are typically measured in pack-years and that the median successful cigarette quitter succeeds in quitting and not relapsing on about the sixth try. That would put a value on successful quitting of $500 × 20 = $10,000.
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From page 227... ...
So far we have considered T merely as a means of increasing the probability that a quit attempt will succeed rather than fail. If T were sufficiently low in side effects so that it could be repeated prophylactically to prevent relapse, a successful quit using T will in fact be much more valuable (much longer lasting on average)
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From page 228... ...
The social value of having T available would be the value of the total additional reduction in expected cumulative lifetime smoking generated by T treatment compared to the next-best treatment, plus the additional reduction generated by increased quit attempts (T treatment as opposed to no treatment) , plus the value of reduced discomfort from T-assisted quit attempts compared to non-T-assisted quit attempts, plus the saved financial costs of non-T-assisted quitting.
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From page 229... ...
A typical member of the population of 2 million or so heavy cocaine users in this country is estimated to spend $10,000 to $15,000 per year on the drug (Office of National Drug Control Policy, 2001)
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From page 230... ...
, if the nonfinancial external costs and the net costs to the substance abusers themselves came to an equal amount, if half the total were attributable to cocaine, and if 80 percent of the cocaine-related damage is due to 2 million heavy cocaine users, then the damage per person per year is $60,000, or $5,000 per month. With a cocaine-dependent population about one-fifteenth the size of the nicotine-dependent population, and the benefits of a month's remission from cocaine about 10 times those of a month's nicotine remission, the total potential gain from a "cure" for cocaine abuse would therefore be of the same order of magnitude as the total potential gain from a "cure" for cigarette smoking, assuming that the two problems turn out to be comparably chronic in the absence of such a breakthrough.13 (The apparent stabilization in aggregate national consumption of cocaine suggests that the outflow from the heavy-cocaine-using population is slower than was 12An introspective thought experiment: If you had a cocaine-dependent child or spouse, what would you be willing to pay per month of remission?
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From page 231... ...
Thus the legal demands that criminally active heavy cocaine users desist from cocaine
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From page 232... ...
(Testing might still be needed to deter, or detect, substitution of other drugs.) Thus an immunotherapy or depot medication would greatly simplify the challenge faced by criminal justice agencies and the courts in converting their legal hold over criminally active cocaine users into effective pressure on them to quit.
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From page 233... ...
Assume that one-third of the roughly 1.5 million criminally active heavy cocaine users in this country could be induced to accept such a therapy and that the result of that therapy was, as assumed for tobacco, a 70 percent increase in the chance of a successful quit attempt, where a success would cut 20 months, valued at $5,000 per month, off the expected length of the active addiction career (net of substitution with other drugs)
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From page 234... ...
The potential benefits of developing an efficacious immunotherapy or depot medication are therefore extremely high, even compared to the benefits of developing such treatments for cocaine or nicotine. However, even a very high reward for success cannot justify a major development effort unless and until a technically plausible approach is invented.
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From page 235... ...
(That might not be true for cigarette smoking if the treatment has to be repeated frequently.) But the price of any such therapy, if it is developed along conventional pharmaceutical company lines, will be much greater than its marginal cost.
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From page 236... ...
The combined uncertainties about the quantity and purity of drugs acquired on the illicit market, how effective the therapy is, and how much a user's tolerance declines because of a period of abstinence might create significant overdose risk with respect to cocaine, heroin, or methamphetamine. In the case of cigarette smoking, overdose seems unlikely to be a risk, but if the word were to spread among smokers that, say, smoking two cigarettes in quick succession, and doing so with attention to maximizing nicotine absorption, would get enough nicotine through the blockade to do its job, the temptation-reducing aspect of the immunotherapy or depot medication would be noticeably reduced, at least for some patients.
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From page 237... ...
The discussion up to now has assumed that (except for possibly overenthusiastic application to offenders) immunotherapies and depot medications would be used only in the treatment of persons with diagnosed substance abuse disorders.
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From page 238... ...
It might be found that lowering the chronicity of the substance abuse disorder increased its incidence substantially, with unknown impacts on steady-state prevalence. That risk would be especially severe if the efficacy of the new therapy as perceived by potential drug users, especially young people, exceeded its efficacy in practice.
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From page 239... ...
Office of National Drug Control Policy.
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From page 240... ...
. Cigarette smoking among adults -- United States, 2000.
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