In the Summer of 1998, shortly before the American Methadone Treatment Association was to hold its convention in Manhattan, New York City Mayor Rudolph Giuliani announced his intention to end methadone maintenance (MMT) as a drug treatment modality in the five boroughs comprising New York City.[1]
Even after the Mayor's plans were reduced so they correctly reflected the amount of influence the City of New York, as opposed to New York State and the Federal Government, have over the availability of treatment for drug addiction, the Mayor pronounced that approximately one-half dozen city-related facilities[2] providing Opiate Agonist Maintenance Treatment (hereinafter "Agonist Treatment")[3] would gradually reduce the dosage administered to patients and all involved could be transferred to supposedly drug-free rehabilitative programs.[4]
The Mayor soon discovered that, rightly or wrongly, money is very often the key mechanism which determines the options available to an addict who desires to make the arduous attempt toward recovery from what is almost universally called the "disease" of narcotic addiction.[5] While New York City itself has more residents in Agonist Treatment,[6] as well as more residents who might benefit from such treatment, than anywhere else in the United States and perhaps the world, the city contributes to the treatment expense of a relatively small number of patients.
Undeterred, Mayor Giuliani commanded the so-called "detoxification" of all Agonist Treatment patients under his "jurisdiction" commence and approximately two thousand, one hundred (2100) patients who were too poor or otherwise unable to transfer off "City" programs and onto "private" ones had their dosages of agonist medication gradually decreased.[7]
In the interim, however, many proponents of Agonist Treatment, such as "Drug Czar" Barry McCaffrey and Dr. Robert Newman who heads the Agonist Treatment Program at New York Beth Israel Hospital[8] denounced the Mayor's crusade as a recipe for disaster. Mayor Giuliani responded by attempting to take what he claimed was the moral "high ground" by averring Agonist Treatment enslaved a population which, despite overwhelming medical, sociological and scientific evidence to the contrary, he insisted could live free of the medical treatment many of them had found, after years of trying, to be the sole means of controlling their disease. The Mayor attacked proponents of Agonist Treatment in the medical community as being inspired mainly by the greed driven.[9]
Approximately six months after initiating his "moral crusade" Mayor Giuliani, in an act of political courage rarely seen in the history of civilization, essentially admitted he had been wrong all along. The Mayor ended what must have surely been a nightmare for those patients subjected to his edict with the understatement that "maybe [his crusade against MMT was] somewhat unrealistic."[10]
The actual results of this moral experiment by the Mayor of New York? In about six months twenty-one patients (about 1% of the affected) had managed to "successfully detoxify" so that they were not receiving any agonist medication, and of these former patients, five had already relapsed into the abyss of heroin addiction.[11]
What is unknown, of course, is the crime, misery and deaths from overdose caused by the fact the Mayor's Crusade undoubtedly caused an atmosphere in which an unknown number of untreated addicts did not see MMT as a viable recovery option and continued in their active addictions.
While the Mayor was doing the honorable thing and confessing that his program was ill conceived, however, Senator John McCain of Arizona[12] was preparing to introduce S 423, the "Addiction Free Recovery Act of 1999" which, by way of pulling purse strings, would require an undetermined number of Agonist Treatment Patients across the nation to be "detoxified" to abstinence within six months if the Agonist Treatment Program in which a subject patient is lawfully enrolled accepts certain federal funds, whether or not those funds in any way impact on the treatment of the given Agonist Treatment Patient.
In other words, Senator McCain champions that addicts attempting or in recovery through Agonist Treatment across the nation be subjected to exactly the same "morally inspired" program which Mayor Giuliani tried and declared a failure in New York City only months before the introduction of S 423.
It almost seems as if there is a scheme to rid America of the substance abuse treatment modality found to be "the most effective treatment for heroin addiction" by the General Accounting Office[13] and virtually all who have ever studied it from any angle was developed for use by upward-aspiring politicians at a "retreat" hosted by a zealot would-be domestic policy advisor who had absolutely no regard for, or perhaps knowledge of, the over three decades worth of microscopic study to which Agonist Treatment has been subjected.[14]
In any event, Senator McCain introduced S 423 without cosponsors[15] on February 11, 1999, and it was referred to the Senate Finance Committee.
The Finance Committee is distinguished by the two somewhat juxtaposed anomalies with respect to this particular piece of legislation.
First, a fair number of its members represent States which do not authorize any Agonist Treatment. Contrary to Senator McCain's rhetorical corkscrews appearing both in S 423 and in his remarks contained in the Congressional Record at 1447-1448 concerning the subject, Agonist Treatment is hardly the nation's most proffered form of treatment for opiate addiction, only its most successful treatment in terms of long-term prevention of drug abuse by patients.
Secondly, two of the cosponsors of S 324, the bipartisan "Drug Addiction Treatment Act of 1999" (discussed below), are distinguished members of the Committee.[16]
What follows is an analysis of the impact of S 423 and any similar
provision on American Society as it enters the Twenty-first Century.
The Bill would do this by requiring providers of Agonist Treatment, which accept Medicaid in full or partial payment for the treatment and any provider which receives block grant funds which include money from the Substance Abuse and Mental Health Services Administration (SAMSHA), to cease providing Agonist Treatment to all patients within six months.
It is clear from the comments of Senator McCain entered into the
Congressional Record that the proposed legislation is based upon flawed
logic, a basic misunderstanding of addiction and the treatment modalities
used in combating opiate addiction and the mythology which has grown up
around Agonist Treatment over the thirty years in which it has positively
affected millions of Americans directly and indirectly.
In the "Findings" and the Congressional Record, Senator McCain seems to attempt to draw some sort of causative correlation between the rise in the number of individuals using heroin in America and the fact that over recent years there has been a relatively stagnant number of patients undergoing Agonist Treatment. In fact, the only logical inference which might be drawn from the cited numbers by one who understands Agonist Treatment is that if Agonist Treatment was made more widely available, with less bureaucratic red tape and at a more affordable cost, as "Drug Czar" General Barry McCaffrey maintains it should, the number of individuals addicted to illicit narcotics would probably be lower, and the number of those in beneficial treatment would likely be higher.
Senator McCain feels "[Agonist Treatment is] disgusting and it
is immoral. It does serious harm to the humanity of those people who have
mustered the courage to walk into a clinic seeking help to free themselves
from addiction. It is the ultimate in cruel irony that our government's
first response should be to trade the shackles of heroin for the shackles
of methadone."[17]
After over thirty years of medical, sociological and political
scrutiny, Agonist Treatment has been determined to be the most effective
and successful treatment modality for those suffering from an addiction
to illicit narcotics by every respected researcher, from the National Institute
of Health to the General Accounting Office.
Passage of the Bill into law would have an impact upon a far greater number of Agonist Treatment patients than one might think at first blush. Further, the Bill all but guarantees increased traffic in and usage of illicit narcotics as well as the criminal activity and risks to the public health associated with illicit opiate usage.
The Bill will cost both the Federal and State governments unknown but substantial amounts of money in revising present legislation pertaining to Agonist Treatment, in addition to increased costs for public health and criminal justice. The Bill will also cause the federal government to expend unspecified sums unnecessarily by requiring a series of studies which have been conducted ad nauseum over the past four decades, albeit no such study has results supporting Senator McCain's position.
Senator McCain's apparent agenda is to ban Agonist Treatment in America. As this position cannot be supported by any medical, scientific, sociological or pragmatic basis, the Senator's position can only be characterized as resting upon some sort of "moral" ground, although one is hard pressed to see the morality of an agenda which would guarantee an increase in the unregulated traffic in and addiction to illicit narcotics and the misery such activities cause individual addicts as well as their families and society.
During the Nixon Administration, as part of the "War on Drugs", Agonist Treatment, then only in the form of MMT, went from an experimental treatment available to a few hundred individuals to become a conventionally accepted means of battling heroin addiction. As a result of the recognition of the value to MMT, the number of patients undergoing such treatment increased from four hundred (400) in 1968 to over seventy-three thousand (73,000) in 1973.[21]
Over time, methadone (until recently the only substance conventionally
used for Agonist Treatment in America) became the most studied drug in
history.[22] Further, what had been predicted by the
political and scientific proponents of this treatment modality came to
pass. Those opiate addicts properly treated with MMT drastically
reduced their usage of illicit drugs, and largely ceased engaging in criminal
activities of any kind.[23] Dozens of independent studies,
conducted by critical evaluators in different countries have agreed that
maintenance with methadone is both safe and effective over periods of years
when the medicine is prescribed in an adequate daily dose.[24]
It is clear Agonist Treatment is far superior in obtaining the result of abstinence from illicit drug use than is any other form of treatment. Studies have repeatedly demonstrated that individuals who attempt to overcome narcotic addiction either without Agonist Treatment, or by ceasing Agonist Treatment too soon have only a ten to twenty percent chance of success.[25]
Given the clear success of Agonist Treatment in arresting the abuse of illicit drugs by patients and its overwhelming support by the medical community which deals with narcotic addicts, it is difficult to understand why some politicians take the position that Agonist Treatment is an immoral way to treat narcotic addiction instead of the gold standard of substance abuse treatment modalities the National Institute on Drug Abuse proclaimed it in 1997.
According to a study soon to be released by the American Methadone Treatment Association there are approximately 175,000 patients in Agonist Treatment in the United States at the present time. At the same time, there are presently approximately 825,000 Americans who are addicted to illicit narcotics.[26,27] Accordingly, of the one million Americans who might presently benefit from Agonist Treatment only about 17.5 percent, or less than one in five individuals receive it. This may in part be due to the difficulty involved in entering Agonist Treatment as well as it's strict, regimented structure, the social stigma of the treatment, the required counseling and, of course, the limited number of treatment slots, as well as the high cost of those slots.
Of course Agonist Treatment is not the answer for everyone. It is, however, a national disgrace that after thirty years America can only offer it to fewer than one in five who might benefit when it is recognized as the gold standard of substance abuse treatment modalities. Clearly American addicts could easily be offered far more opportunities for Agonist Treatment at a fraction of the cost spent to incarcerate those who, but for the absence of the pragmatic option of receiving Agonist Treatment, would never have committed the crimes for which they are imprisoned.
At present, forty-two of the fifty states permit some form of Agonist Treatment.[28,29] Agonist Treatment is carried out only at special clinics authorized to do so by the legislatures of both the separate states and the federal government (hereinafter Clinics). Clinics are strictly controlled by various Federal Agencies and authorities in each state.
Only twenty-nine of the forty-two states which allow Agonist Treatment allow the use of Medicaid to pay for all or some part of that treatment.[30]
The National Institute on Drug Abuse (NIDA), the National Institute on Health (NIH), the American Medical Association (AMA) and the American Society of Addictive Medicine (ASAM) have all praised Agonist Treatment as the most effective and successful modality in combating opioid addiction.[31]
The States and Federal regulatory bodies also allow the use of methadone, over periods ranging from days, weeks and months, to "detoxify" narcotics addicts by tapering their doses to a point at which they are no longer receiving any methadone. The Bill would render all Agonist Treatment carried out by Clinics affected by its provisions to essentially employ a "detoxification" regimen on all patients, regardless of whether, in the medical judgment of the Clinic physician, such detoxification would be worthwhile for a particular patient and despite the fact that such procedures have an eighty to ninety percent relapse rate.
At first glance it may appear the Bill will only impact the treatment options of the indigent, as nothing in it specifically places restrictions upon "private" clinics which are fully supported by patients. If this were the case, the Bill would be of questionable legality in light of the "equal access" provision afforded Medicaid patients under 42 USC 1396a(a)(30). At the same time, as heroin addiction--particularly that which continues for at least a year[32]--is well known to go hand in hand with financial ruin and poverty, it could be said the Bill is likely to ban access to effective Agonist Treatment for many, if not most, of those who would benefit the most from it (i.e., long term, hard core addicts).
The average cost of Agonist Treatment is approximately $12 (twelve
dollars) a day for treatment[33] in the United States.[34]
In all but largest of the major urban centers of the United States,
the Clinics affording Agonist Treatment are located so as to deny most
patients any pragmatic choice as to where to seek treatment. Many,
if not most, patients in Agonist Treatment who personally pay out of pocket
the full cost of treatment at Clinics which happen to accept Medicaid from
others will receive the treatment mandated by the Bill.
Accordingly, tens of thousands of patients who pay for their own treatment would have that treatment terminated and be detoxified by passage of the Bill as drafted merely because they attend Clinics which accept Medicaid and/or other governmental subsidies due to what are ultimately purely geographical reasons.[35] Many of these individuals who are able to pay on average approximately $12.00 a day to remain in Agonist Treatment do so because they realize that only by continuing such treatment will they remain the productive, tax paying citizens they became with the assistance of Agonist Treatment.[36]
Another consequence of passage of S 423 would be to force the individual states, as well as the Congress, to redraft a plethora of legislation and regulatory provisions which have been the ever evolving result of over three decades of studying Agonist Treatment. Each State which permits Agonist Treatment has chosen to enact and impose its own system of regulations pertaining to those who qualify for treatment, the nature of the treatment permitted within the state, and often the duration of that treatment. The expense of the regulatory and statutory renovation which would be necessitated is unfathomable. This is particularly true in that at the present time regulatory control of Agonist Treatment in America is in the process of undergoing a major metamorphosis in light of the sound judgment of General McCaffrey and The NIH Consensus Statement on the Effective Medical Treatment of Opiate Addiction issued in November, 1997.
The Bill mandates that the NIH conduct certain studies which, although vaguely described by the Bill, are studies that have already been conducted. Without Agonist Treatment at all, the relapse from abstinence for narcotic addicts approaches 100 per cent.[37,38]
When Agonist Treatment is terminated before medically indicated, as surely would happen under the Bill's mandate that patients be permitted treatment for some arbitrary period of no more than six months, the relapse rate is at least eighty to ninety percent.[39] It is noteworthy that it took Mayor Giuliani and his staff about six months to realize his "Anti-Methadone Crusade" was an abysmal failure.
If the studies called for by the Bill are not deemed redundant, it would seem far more sensible to conduct the suggested studies before placing a limitation on treatment.
Perhaps these studies will prove that Senator McCain stood as a great visionary in the field of substance abuse treatment at the end of this millennium. That remains to be proven, and frankly, the evidence against such being the case seems likely based upon past studies. Nevertheless, as literally thousands of people go off Agonist Treatment at medically contraindicated times each year, for a variety of voluntary and involuntary reasons, including the social stigma of the treatment modality and an inability to pay for the treatment,[40] there is already an ample pool of subjects for any scientific tests to determine whether anything like the success rate of Agonist Treatment can be achieved through non-pharmacological means.[41]
Indeed, given the thousands who must cease Agonist Treatment due to financial concerns,[42] such a treatment modality would be applauded both by addiction medicine specialists and by many Agonist Treatment patients. It simply contradicts common sense to, as the Bill dictates, force many more patients off of treatment which works with the hope that some scientifically proven alternative treatment which is as successful is discovered given the great weight of present medical knowledge. Doing so would be akin to an airplane pilot tossing his parachute out of the window of a crashing plane on the sheer hope that there might be a spare parachute somewhere in the plane.
It was a basic tenet of the Reagan and Bush Administrations that the states knew the needs of their citizens better than those officials inside the Washington Beltway and, therefore, state legislatures could better determine how to use the money paid by their own citizens in state taxes combined with portions of federal taxes returned to the states in the form of Medicaid funding and block grants.
Senator McCain, in urging the passage of the Bill, seems to dispute this tenet, at least as far as certain medical treatments are concerned, although he cloaks his disdain for State's Rights in terms of morality, characterizing Agonist Treatment as something forced on unwitting citizens by the Clinton Administration for some nefarious, immoral reason, not unlike Mayor Giuliani at the outset of his 1998 "experiment."
Senator McCain's position totally ignores that the states are each free to determine if they will even allow Agonist Treatment within their borders and that whether one accepts the Bill's own findings or the declaration of J. Thomas Payte, M.D. attached hereto as Exhibit 2, it seems that only one in five people who might truly benefit from Agonist Treatment can avail themselves of it, a ratio which has remained stagnant for years.
Clearly the Bill is really based upon the "moral" notion that Agonist Treatment patients and perhaps the nation would be better off if access to Agonist Treatment was denied to increasing numbers of Americans and that society would be better served if the recovery attempts of these individuals were dependent upon sheer will power.
The question therefore is whether the moral objections to a treatment modality held by Senator McCain should prevail over the "morality" of forcing tens of thousands of individuals off Agonist Treatment and back into the abyss of active addiction in the event they lack the degree of willpower necessary to overcome a medical condition. For, on this point, the studies are clear. Eight or nine out of every ten forced out of treatment will relapse, joining legions of illicit narcotic addicts, spreading infectious diseases, committing crimes, going to prison and dying.[43]
Senator McCain is simply wrong in his averment that Agonist Treatment has become America's first response to opioid addiction.[44] His statement ignores the State and Federal Regulations and requirements for admission to treatment which patients must satisfy in order to obtain a treatment slot. The criteria an addict must meet to be accepted for Agonist Treatment and the nature of the treatment offered varies widely from state to state. Few if any states employ only the Federal Regulations as criteria.
Undoubtedly one reason for this political disregard of medical
statistics and simple fact lays with the confusion of the "professional"
usage versus the colloquial uses of the words "addiction" and "dependence,"
a confusion which also seems to fuel the moral outrage Senator McCain has
about Agonist Treatment even being offered as a treatment option to American
addicts.[45]
The Short Title is, of course, "The Addiction Free Treatment Act of 1999", which, in context, implies that Agonist Treatment involves "addiction" to the Agonist used in the treatment. That this is the Senator's view is reinforced by his usage of the phrase "methadone addicts" in the Bill. Indeed, a study of the "Findings" which form a part of S 423, as well as the pertinent part of the Congressional Record, make it clear Senator McCain in no way distinguishes between those normally-functioning citizens who happen to be long-term Agonist Treatment patients and junkies lying in narcotized stupors in doorways and alleys.
As used medically, however, "addiction to a drug" and "physical dependence upon a drug" are two separate and distinct conditions. As discussed below, although a person who becomes addicted to opiates through unsupervised usage is likely to form a physical dependence upon them, it is also true that people who develop a physical dependence to narcotics in connection with the treatment of chronic pain very often become physically dependent on narcotics but are not medically considered "addicts."
By a similar token, it could be said that the vast majority of Agonist Treatment patients are physically dependent upon methadone or LAAM, although they are not addicted to either drug. Rather, Agonist Treatment has assisted them in keeping their respective addictions (e.g., to heroin or morphine) in remission. If the Agonist Treatment patient's treatment is improperly or abruptly terminated, the 80% to 90% who inevitably will relapse will not scour the streets for methadone or LAAM but will seek the drug which led them to seek treatment in the first place, and that drug is usually heroin.
Methadone has a long half life, has a very slow onset and remains effective in the body at stable levels until the next scheduled dosage.[46] LAAM is similar, although it has a longer effect on those who take it.[47]
These pharmacological features, coupled with the phenomenon of "tolerance", which is associated with all opioid agonists, result in nullifying the peaks and "valleys" of altered consciousness experienced by the user of shorter-acting narcotics (e.g., heroin, morphine or codeine) while the patient becomes increasingly unable to distinguish any appreciable effect from a stable dosage of methadone or LAAM.[48] Indeed, as Agonist Treatment patients who enter treatment, either for substance abuse or pain management, are opiate tolerant to an extent, and all opioids are "cross-tolerant", the Agonist Treatment patient generally feels no narcotic euphoria or any analgesia from the proper dosage of methadone or LAAM.[49]
This phenomenon also creates a "blockade" effect, meaning the person on a proper and stable dosage in Agonist Treatment must consume an amount of an illicit opiate in order to get any euphoric intoxication.[50] While it is not impossible to surpass this blockade, given the purity of the drugs used in treatment, attempting to surpass the "blockade" simply is not financially realistic for those prescribed a therapeutic dosage. Besides, Agonist Treatment, properly conducted, removes the craving to attempt to surpass the "blockade."[51]
Addicts almost universally desire the quick onset and abrupt peak associated with narcotics with short half lives (e.g., heroin, morphine, Percodan, et cetera). Addicts and "casual users" find a recreational sort of pleasure from the use of short-acting opiates. Very few, if any, patients associate "fun" with the consumption of methadone or LAAM, just as a person with high blood pressure does not have "fun" while under the influence of medication to normalize his blood pressure or the person diagnosed as "bipolar" has "fun" taking lithium.[52]
Addiction is commonly explained by doctors specializing in its treatment as an inability to stop using a substance (e.g., heroin) utilizing willpower alone, despite the fact that continued usage has or is causing negative events in the users life, such as problems at school or work, within the family, among one's peers et cetera.[53]
Physical dependence upon a drug simply means that if deprived of the substance for a sufficient period of time, the dependent person shall become ill and, in the case of some substances, may die.
Physical dependence on narcotics without addiction is not uncommon in the context of prolonged medical treatment of chronic pain requiring aggressive analgesia. Such people are, however, likely to be able to experience only some discomfort when the narcotic is withdrawn, and most do not experience the chronic craving characteristic of opiate addiction; a craving which continues long after all physical manifestations of withdrawal have subsided.[54]
The argument that Agonist Treatment is merely the substitution of one narcotic for another is specious and has been voiced since methadone maintenance was introduced.[55]
This attitude is unfortunately held not only by the general public, but by many in the medical community and even by many Agonist Treatment patients themselves. The argument serves to keep otherwise treatable addicts out of Agonist Treatment altogether, a result from which no one in society save heroin pushers benefit. The truth is that Agonist Treatment is among the greatest weapons against those who profit from the human misery of drug addiction.
The "substitution" argument misunderstands Agonist Treatment. Rather than acting simply as a substitute or replacement for illicit narcotics, Agonist Treatment, utilizing the long half lives of methadone and LAAM with the phenomenon of tolerance as discussed above, involves a stabilization or correction of a possible lesion or defect in the body's natural chemical system.[56] Additionally, counseling inevitably is a condition of Agonist Treatment.[57]
As noted, while people may become physically dependent upon an opioid in the course of a medical procedure, such people rarely become addicts. Rather they go through a brief period of the physical discomfort of withdrawal and never seek out or crave narcotics again. Addicts, whether predisposed genetically or chemically altered by the process of becoming an addict, are now believed by most physicians who work in the area to be somehow different than the aforementioned medical patient.
A good comparison to Agonist Treatment is the use of insulin by
certain diabetics. In each case, the individual takes the medication
daily (or, in the case of insulin, multiple times a day) because it substitutes
for chemicals normally secreted by the pancreas. Without insulin,
the insulin dependent diabetic will fall into an almost drunken-like stupor,
followed by a coma and death. The patient in Agonist Treatment takes
an oral medication once daily (twice in a few cases) in the case of methadone
and once every other day in the case of LAAM. The narcotic agonists
used essentially substitute for the body's natural endorphins.
Both opiate addiction and insulin dependent diabetes fit the
disease model quite well. In both cases, administration of the prescribed
drug does not result in intoxication but, rather, a physiological normalization.[58]
Certainly the Congress of the United States would not limit federal funding which in some way assisted insulin dependent diabetics from remaining free of the syndrome they experience when deprived of insulin. It is doubtful Senator McCain is of the opinion that insulin dependence is immoral, although most insulin dependent diabetics could control their disease with diet and forego insulin, a drug which, if less a shackle than methadone, is only so because it is not over regulated as many believe to be the case with methadone.[59]
It is presently unknown, but strongly suspected, that the difference between addicts and non addicts is something which is genetically predisposed. It may be triggered by extended opiate usage and, perhaps, a multitude of factors. Nevertheless, whether that suspicion is correct or whether the addict alone is to blame for his deplorable lot in life is irrelevant to dealing with the problem.
Many may champion being "tough on drugs" to gain a political advantage, but it seems ludicrous to equate a "tough" stance on drug abuse with making recovery from it more difficult for the individual with the problem.
Congress would not dream of denying Medicaid benefits to a person who required a triple bypass operation because he ate at a "fast food" restaurant daily and smoked heavily. Likewise, Congress would never consider a bill which would deny emergency room service to an indigent drunk driver who drove his car off a bridge while on a road he should have never turned down but did so only because of his inability to follow directions in his drunken stupor.
While the exact neurobiological mechanism(s) involved in the disease of addiction are poorly understood at present, people who become addicted after chronic exposure to opioids are metabolically different than those who do not become addicted despite the fact they may become dependent on the drug.
Whether one becomes an opiate addict or can successfully live an abstinent life after being physically dependent on opioids is not a question of simple lack of will power or moral values.[60]
It should also be kept in mind that the term used in the Findings of the Bill--"Methadone addicts"--is incorrect if only because those who use methadone legally use it to remedy the problems they had within their families or at work or in life. Agonist treatment does not cause the problems but is intended, and does help, to put the recovering addict in a position to solve those problems created by his addiction.[61]
The Bill is indisputably inspired by Senator McCain's view that Agonist Treatment is somehow immoral. In the remarks entered into the Congressional Record in connection with the introduction of the Bill, Senator McCain referred to MMT as "an Orwellian addiction swap" and stated it was immoral for Agonist Treatment to be the government's only treatment option for narcotics addicts. As noted above, the Senator is sorely misinformed on the factual issues concerning the array of available treatment options open to any given addict. His rhetorical characterizations, such as "methadone addicts" and "Orwellian addiction swap" demonstrate his true interest lies not with the facts or medical science or the good of the addict or the general public but with some moral problem the Senator has with the usage of drugs to treat drug addictions, regardless of the scientific evidence that such drugs work.
While one can only speculate concerning Senator McCain's views as to morality in general, historically drugs which intoxicate have been the target of moral crusaders. The narcotic agonists employed in Agonist Treatment will intoxicate non-patients who are narcotic intolerant, as will those which are the subject of S 324 (discussed below). As used in Agonist Treatment, however, these drugs simply do not cause intoxication or euphoria in patients.[62]
While one could go on endlessly about government's often futile attempts to legislate different versions of morality,[63] in this instance, it is clearly a moot point. Narcotic agonists, being themselves inert substances, can be neither moral nor immoral. It is the intoxicating nature of the drugs which constitutes the arguable immorality surrounding them. Prescribed in a manner which not only avoids intoxication by the drugs used in treatment, but also blocks the ability of the patient to become intoxicated through the ingestion of other narcotics, the use of drugs like methadone and LAAM in Agonist Treatment is about as immoral as a beta blocker used to combat high blood pressure.
Within the past several years, various corporations have advertised "cures" for narcotic addiction which consist of rapidly ridding the body of opioids while the addict is under analgesia and then places them on a daily routine (sometimes implanting a drug dispensing system under the skin) of Naltrexone pills.[64]
Naltrexone is an opiate antagonist in that it blocks the effects of narcotics (in a physiologically similar way to the manner in which long acting agonists do) but does not block the craving for the narcotic, as does Agonist Treatment.
This treatment, to be successful, requires the recovering addict to ingest medication on a daily basis in order to assist in recovery. Naltrexone may also be used to block the effects of opioids in anyone else who desires it and can find a physician willing to prescribe it to assist the person in refraining from narcotics.
While these individuals may not go through withdrawal if deprived
of Naltrexone, they continue with the medication because without a daily
dosage they fear they will soon find themselves in the nether world of
opiate addiction because they will relapse.
The same can be said of many long term, stable patients in Agonist
Treatment. They do not detoxify to abstinence even though they are
getting no more euphoria from their daily dose than they do from a cup
of decaffeinated coffee.[65] Knowing themselves, however, they
fear they will inevitably relapse without their medication.
Senator McCain may consider this weak and immoral, but the same thing can arguably be said of many people who continue with Twelve Step meetings decades after their last drink or snort or pill or injection.[66] Indeed, some people are characterized as being "addicted" to Twelve Step Meetings and attend a number of meetings of the over two hundred organizations based on the Twelve Steps to help deal with real or imaginary problems.
It is difficult to believe Senator McCain or the doctors whose statements appear in the Record at 1447 and 1448 would consider the man with twenty-five years of being clean and sober who still attends five Twelve Step meetings a week to be weak or immoral or merely substituting the meetings for his preferred mode of intoxication.
Yet logically, to be consistent, Senator McCain must arrive at such a conclusion because, as pointed out previously, methadone and LAAM do not intoxicate in the context of the patient in Agonist Treatment, and what is there that really makes someone who stays clean through the help of a dose of medication and counseling at a Clinic any different from a person who uses the Twelve Steps for decades to remain free of his particular addiction?[67,68]
Clearly, both people merely want to do what they know will help
them prevent a relapse of their respective addictions. No government
grounded in individual liberty should limit the treatment options available
to such people.
As it is only logical to assume Senator McCain does not consider the morality of inert substances like methadone, LAAM or Buprenorphine to be good or bad in and of themselves, his objections should clearly apply to the drugs for which maintenance of addicts would be approved under S 324, for those drugs are not only habit forming but many have shorter half lives than methadone or LAAM leading to the possibility that the addict so maintained has a better chance of getting high from the prescribed treatment.[71]
In the "Findings" incorporated in S 423, Senator McCain has opined:
(7) The Federal Government should adopt a zero-tolerance
non-pharmacological policy that has as its defined objective
independence from drug addiction.
(8) The approach of the Federal Government should
be to address a range of human needs and conditions that contribute to
recidivism among recovering heroin addicts
and that should be designed to provide opportunities for former heroin
addicts to become drug-free, self-sufficient, productive members
of society."
Accordingly, S 324 is impossible to reconcile with S 423.
Passage of S 324 would represent a stride forward in broadening treatment options for addicts who are addicted to Schedule 3 pain killers or who have short term or relatively minor addictions to stronger narcotics. Such a law would be a blow to criminal elements. Passage of S 324 could well mean a huge step forward in the number of illicit drug addicts who seek affordable and more anonymous treatment than is able to be offered in a clinic setting. The relative convenience which it will permit patients by allowing them to pick up their medication at a pharmacy just like anyone else on medication will surely remove some of the stigma associated with other forms of Agonist Treatment which currently require regular visits to Clinics, the nature of which is fairly obvious to any passerby.
What S 423 represents is a giant leap backward to the days before the Nixon Administration, where the only time an addict could find a brief escape from his illness was after indulging in illicit narcotics.
Why should America go backward when General McCaffrey, the NIH,
the NIDA and the Senators sponsoring S 324 are attempting to lead America
forward into the next millennium? With common sense and luck, the
next century will feature fewer addicts and more treatment that works for
those who are afflicted with the disease of addiction.
Any legislation in the drug treatment field which could have such an impact upon life in the United States should be based upon sound medical research. The Bill introduced by Senator McCain is not so grounded. Instead it is based upon mythology and a basic misunderstanding of the treatment modality it seeks to alter.
Agonist Treatment is not perfect. It is not the solution for every opiate addict. It is, however, far and away, the best treatment in terms of achieving the goal of stopping illicit drug usage.
Given the results of over three decades of research and clinical observation, there should be no question that Agonist Treatment must remain an option available to every opiate addict who might possibly benefit from it.
Agonist Treatment is by no means a "magic bullet." It is, however, the best solution of its kind for opiate addicts and for a nation desperately in need of as many viable solutions as possible to an ever increasing problem.
If anything, Congress and state legislatures should take action to make Agonist Treatment a more available and affordable option for as many as could benefit from it. America and Americans deserve no less.
Respectfully submitted,
____________________
William W. Read, Attorney at Law
on behalf of ARM;
ADAM/NorCal, Methadone Awareness; the individual members of TexNAMA
as Citizens of Texas and Marc Shinderman, MD, a Citizen of Illinois
1 Source: New York Times, 8/14/98.
2 Including the lauded KEEP program at the correctional facility on Riker's Island.
3 As used herein the phrase "Agonist Treatment" refers exclusively to Methadone Maintenance Treatment (MMT) and LAAM maintenance Treatment, both of which are described in greater detail below.
4 Many of the programs which the Mayor saw as "morally appropriate" use a plethora of very dangerous drugs with which to treat patients, either on a short or long term basis, and some such practitioners opt for surgery to save the addict from himself.
5 While the American Medical Association and other respected authorities have pegged it as a disease closely akin to alcoholism and analogous to other disorders, the various governmental entities which make up the United States, with the truly ironic exception of the State of Arizona, increasingly fill prisons with those exhibiting the symptomology of the illness.
6 Approximately 36,000 according to the New York Times.
7 Source: New York Times, 8/14/98, AP, 1/16/99.
8 Probably the largest program in the United States, which include a geographically vast one administered by the Veterans' Administration.
9 Source: New York Times 8/15/98.
10 Source: Associated Press, 1/16/99
11 Sources: ibid; New York Times 1/17/99.
12 Interestingly, Senator McCain was elected to represent the same people who have twice in this decade, over the "better judgment" of their legislative representatives, voted to "medicalize" heroin. Indisputably the greatest beneficiaries of S 423, if the overwhelming evidence is to be believed, are heroin dealers. That there is a logical connection is ludicrous
13 Source: New York Times, 8/18/98
14 Vincent Dole, M.D., What Have We Learned from Three Decades of Methadone Maintenance Treatment?" Drug and Alcohol Review 13 (1994):3-4.
15 The lack of co-sponsors is interesting in that a similar resolution introduced by Senator McCain late in the 105th Congress was co-sponsored by Senators Cloverdale and Coates.
16 Specifically Senators Hatch and Moynihan. Additionally several other members may have announced their support for S 324.
17 All references herein to the Congressional Record are to Record of the 106th Congress at p. 1447 to 1448, hereinafter cited as "Congressional Record."
18 Vincent Dole, M.D., What Have We Learned from Three Decades of Methadone Maintenance Treatment?" Drug and Alcohol Review 13 (1994):3-4.; Institute of Medicine, Treating Drug Problems, vol. 1 (Washington, DC: National Academy Press, 1990), 1; Ernest Drucker, "Harm Reduction: a public health strategy," Current Issues in Public Health 1 (1995): 64-70; Institute of Medicine, Federal Regulation of Methadone Treatment (Washington, DC: National Academy Press, 1990), 1.
19 Dole, Drug and Alcohol Review 13 (1994):3-4.
20 Op Cit. Dole, Drug and Alcohol Review 13 (1994):3-4..; See also: Gordon and Lipset, Intellectual and Functional Status of Methadone Patients After Nearly Ten Years of Treatment , NY State Office of Drug Abuse Survives, 1975; Babst, Newman, Gordon and Warner, Driving Record of Methadone Maintenance Patients in New York State, Narcotic Addiction Control Commission, 1973.
21 Op Cit. Dole, Drug and Alcohol Review 13 (1994):3-4.
22 NIH Consensus Statement on the Treatment of Opiate Addiction, 1998,
Ex. 1.
23 Institute of Medicine, Federal Regulation of Methadone Treatment
(Washington, DC: National Academy Press, 1990).
24 Op Cit. Dole, Vincent P. "Drug and Alcohol Review 13 (1994):3-4.
25 U.S. Dept. of Health and Human Services, Center for Substance Abuse Treatment, State Methadone Treatment Guidelines, DHHS Publication No. (SMA) 93-1991 (Rockville, MD: DHHS, 1993).
26 Either illegal drugs like raw opium or heroin or illicitly or fraudulently obtained pharmaceutical narcotics such as morphine.
27 See Declaration of J. Thomas Payte, MD, attached hereto as Ex. 2.
28 In the United States it is left to the legislatures of the separate states to determine whether their populations will benefit from Agonist Treatment, whether by cost/benefit analysis or simple discretion.
29 On January 28, 1999 a bipartisan bill, S324, "The Drug Addiction
Treatment Act of 1999" was introduced by Senators Hatch, Moynihan and Levin.
That Bill has been referred to the Senate Judiciary Committee. If
enacted, S324 would make it legal for physicians to maintain narcotics
addicts (outside of the clinic environment presently required for
LMT and MMT), on at least certain Schedule 4 and 5 controlled substances,
most notably the agonist/antagonist Buprenorphine. As the drugs referenced
by S 324 are not referenced by S 423, and nothing in S 423 would prohibit
unlimited Medicaid reimbursement or federal block grant sums being used
for the treatment authorized by S 324, the treatments referenced in S 324
are not included in the definition of "Agonist Treatment" as used herein,
although S 324 does authorize Agonist Treatment simply using different
agonists in a different manner (i.e., through prescriptions for drugs filled
at pharmacies and taken without supervision instead of the often-criticized
Clinic regimen long associated with, MMT and LMT).
30 Source: the American Methadone Treatment Association.
While S 423 is predicated on federal funding for a very small number of
people, its impact, as will be discussed, is vast and will require the
rewriting of many state and federal statutes and regulations.
31 NIH Consensus Statement.
32 The minimum length of time a person need be addicted to narcotics in order to initially qualify for Agonist Treatment under the Federal Regulations governing such treatment. [ń291.505 et seq. Federal Regulations on Methadone Maintenance Treatment] 42 CFR 46698. States are free to, and many do, require longer addiction histories and multiple attempts at trying to -detox to abstinence+ without relapse to addiction.
33 Source: American Methadone Treatment Association
34 A fact which is arguably due to massive over regulation of Agonist Treatment, as methadone and LAAM are themselves relatively inexpensive drugs.
35 The United States District Court has also ordered some Clinics to accept MediCal (California's version of Medicaid) as payment, and further have ordered Clinics may not treat Medicaid patients differently than those paying cash. While the matter has only been litigated within the 9th Circuit, 42 USC 1396a(a)(30) creates a Federal Right to equal access of Medicaid patients to treatment, and authorizes suit under 42 USC 1983 where such equal protection of law is not afforded. See, e.g., Sobky v Smoley (E.D. Cal 1994) 855 F. Supp. 1123.
36 See, e.g. Declaration of Katharine Bolton attached hereto as Exhibit 6.
37 NIH Consensus Statement ; Declaration of Laura Carlson, attached hereto as Ex.4; Declaration of Roberta Deschne, Ex. 5.
38 Recent HBO America Undercover on the Black Tar Heroin epidemic in San Francisco.
39 Declaration of Payte, Ex. 2.
40 ibid.
41 With Success defined as the individual remaining abstinent from opiate use a year to eighteen (18) months post detoxification.
42 This is especially burdensome when both adults in a family are on Agonist Treatment in order to remain free of illicit narcotic use.
43 Declaration of Payte, Ex. 2
44 Congressional Record.
45 Congressional Record.
46 Physicians Desk Reference, 1999 edition.
47ibid.
48 "What Have We Learned from Three Decades of Methadone Maintenance
Treatment?" Drug and Alcohol Review 13 (1994):3-4; Declarations of
Carlson, Deschne and Bolton (Exhibits 4, 5 and 6).
49 In addition to those patients exposed to aggressive narcotic treatment
for pain who were part of the small minority who became addicted due to
legitimate medical procedures, there exists anecdotal evidence that some
patients who have been "abandoned" by other sectors of the medical community
enter Agonist Treatment because of physical pain. While methadone
is considered a very good drug for analgesia, the dosing protocol
for the treatment of pain is quite different than that used to control
substance abuse, which does not cause any real analgesia. Such
patients are among the most tragic victims of this nation's War on Drugs.
50 What Have We Learned from Three Decades of Methadone Maintenance Treatment?" Drug and Alcohol Review 13 (1994):3-4.
51 Dole, Drug and Alcohol Review 13 (1994):3-4..; See also: Gordon and Lipset, Intellectual and Functional Status of Methadone Patients After Nearly Ten Years of Treatment , NY State Office of Drug Abuse Survives, 1975; Babst, Newman, Gordon and Warner, Driving Record of Methadone Maintenance Patients in New York State, Narcotic Addiction Control Commission, 1973.
52 Declaration of Bolton, Ex. "6".
53 Declaration of Payte, Ex. "2".
54 ibid.
55 ibid.
56 ibid.
57 What Have We Learned from Three Decades of Methadone Maintenance Treatment?" Drug and Alcohol Review 13 (1994):3-4; See also: Bolton Declaration, Ex. "6".
58 See, Declaration of Payte, Ex. 2; Declaration of Carlson, Ex. "4"; Declaration of Deschne, Ex. "5"; and Declaration of Bolton, Ex. "6."
59 NIH Consensus Statement, Ex ÔAŐ; What Have We Learned from Three Decades of Methadone Maintenance Treatment?" Drug and Alcohol Review 13 (1994):3-4.
60 Declaration of Payte, Ex "2."
61 See, e.g., Declarations of Carlson, Deschne and Bolton (Exhibits "4", "5" and "6"); and What Have We Learned from Three Decades of Methadone Maintenance Treatment?" Drug and Alcohol Review 13 (1994):3-4.
62 ibid.
63 Something which, to an extent, is necessary, such as in the laws against homicide and theft.
64 Various companies and/or physicians have, or at last have attempted to patent their own version of this procedure, which is known commonly as a "UROD", an acronym for Ultra Rapid Opioid Detoxification. Some such companies claim they have a 100% success rate. That claim is made solely with "success" defined as the procedure ridding the body of opioids within a brief period. No long-term studies--not even to determine whether the patients remain opioid free after six months--have been conducted. Nevertheless, while the procedure has some very harsh critics who have undergone it and relapsed, it also has some very satisfied patients--both those who continue on Naltrexone therapy daily and those who are wealthy enough to simply repeat the procedure whenever their heroin habit gets out of control.
65 See: Declaration of Carlson;, Ex "4", Declaration of Deschne, Ex. "5" and Declaration Payte, Ex. "2".
66 As previously noted many patients in Agonist Treatment are regular attendees at Twelve Step Meetings.
67 It should be pointed out that one of Senator McCain's arguments is also equally comparable to a Twelve Step Program: he complains that methadone and LAAM do nothing to prevent the abuse of other substances. While this point is factually arguable, a Twelve Step Meeting addressing, say, alcohol, technically, according to AA's World Services is not intended to deal at all with any other addiction or problem.
68 Many people in Agonist Treatment also attend 12 Step Meetings to safeguard their sobriety.
69 Darvon is an example of a Schedule 4 narcotic.
70 While Buprenorphine or the other drugs approved would probably be insufficient to treat someone on Agonist Treatment or who has a long addiction history, it appears to be very promising in the treatment of addicts with relatively minor physical dependence.
71 Actually, whether a substance is or is not habit forming in this context is irrelevant, as Agonist Treatment, as well as the treatment which would be allowed by S 324, utilizes the "habit forming" quality of the drug in order for the treatment to be successful. However, Senator McCain seems to feel that is the only thing which should concern anyone discussing this topic.
72 Institute of Medicine, Federal Regulation of Methadone Treatment
(Washington, DC: National Academy Press, 1990), 1; Declaration of Marc
Shinderman, MD attached hereto as Exhibit "7."
Mayor Giuliani to "The Addiction Free Treatment Act of 1999" [S423]
an analysis submitted on behalf of ARM