Clinicians Say Giving Addicts Maintenance Methadone Serves Them and Society Best

By Christopher Williams, Sun Journal

Bangor Daily News May 27, 2012

When Zachary Tomaselli was sent to prison for sex crimes last month, he asked the judge to delay his sentence for a week.

The Lewiston man said he needed those seven days to wean himself off methadone, the drug he had been getting at a clinic to help him kick a prescription drug habit.

Thousands of addicts living “on the outside” visit Maine’s for-profit clinics for weeks, months and even years for their prescribed methadone doses. A large majority of those addicts are MaineCare clients, paying for methadone treatments with taxpayer dollars.

According to the Department of Health and Human Services, Maine spends about $9 million in state and federal funds every year to dose just over 3,100 MaineCare and Medicare clients every day. The state spends another $7 million a year to transport clients to methadone clinics.

That’s $5,140 per MaineCare patient per year.

Under the recently passed state budget, MaineCare clients are subject to a 24-month lifetime cap for methadone treatment. That cap is expected to save Maine more than $1.3 million a year.

According to Susan Sullivan, director of CAP Quality Care Clinic in Westbrook, patients there “are anxious and afraid of losing their treatment. Some are looking to be proactive and starting to taper themselves out because they don’t know what’s going to happen.”

If Tomaselli believed he could lick his drug habit in just a week, why wouldn’t — or shouldn’t — every drug addict do the same?

The answer, according to experts, is as complex as the subject of drug addiction itself.

Withdrawal is harsh reality

The good news for Tomaselli, experts say, is that he likely wasn’t in any danger of serious health risks had he decided to go cold turkey before trading his street clothes for jail garb.

The bad news — depending on how long he had been treated with methadone and at what dosage — is that his withdrawal might have been more grueling than his looming 3½-year prison sentence.

Dr. Michael E. Kelley, chief of psychiatry at St. Mary’s Regional Medical Center in Lewiston, said the effects of withdrawal from methadone are unique.

Because the medication is used as a maintenance narcotic for clients limited to a single dose each day, the drug typically stays in the body longer than other narcotics, he said.

“It is incredibly long-lasting,” he said.

That means withdrawal from that drug can linger for a week or longer. Sometimes up to a month.

Although not physically dangerous in an otherwise healthy adult, withdrawal can make you feel like you’re dying, Kelley said in an interview at the hospital, where he works as an addiction specialist, treating people with chemical dependency in residential and day programs.

“They can have a very miserable withdrawal,” he said.

It often includes severe flulike symptoms, including vomiting, diarrhea, sweating, chills and muscle cramps.

“But you won’t die,” Kelley said. The only possible medical risk is dehydration, he said.

The greater risk for narcotic addicts is relapse, experts say.

‘Jail isn’t a hospital’

While withdrawal from narcotics, including methadone, is usually safe, withdrawal from certain other drugs and alcohol can be dangerous, even fatal, according to medical experts.

Withdrawal from alcohol, benzodiazepines (tranquilizers) and barbiturates can be “very dangerous,” Kelley said.

Stopping those drugs too quickly can sometimes trigger seizures, heart arrhythmias and delirium tremens (in alcoholics), he said. The latter can be dangerous because those patients become disoriented and may inadvertently harm themselves.

Jails sometimes bring prisoners into the emergency room if they’re suspected of alcoholism or addiction to tranquilizers and show signs of withdrawal, Kelley said.

While the jail might let someone addicted to narcotics “tough it out,” they won’t take a chance on the other addictive populations, Kelley said.

“The jail’s not going to risk that,” he said. “The jail isn’t a hospital.”

When inmates come to St. Mary’s emergency department for medical clearance, hospital staff screens patients for drugs and toxic substances, checking their general health.

Doctors quiz the patients about drug use.

“Hopefully, they’ll be honest.” he said. But, too often they’re not. They fear their candor might get back to their probation officers. Although emergency room chats with doctors are confidential, inmates are on their guard generally and may not confide in the medical staff.

“Sometimes they lie to us,” Kelley said, “which is part of the scary thing.”

Doctors typically watch inmates suspected of drug or alcohol abuse for 12-16 hours, he said, but added, “There is no magic [time] line.” And there is no predicting a patient’s tolerance based on his or her history of drug or alcohol use.

No methadone for prisoners

At Maine’s correctional facilities, including its prisons, the state contracts its medical services with Corizon, a national company based in Tennessee. Three county jails in Maine, including Androscoggin County Jail in Auburn, also have contracts with Corizon.

The company has 150 health care professionals working at the state facilities. An additional 65 workers staff the three jails, according to Pat Nolan, a company spokesman.

Corizon would provide only written answers to questions posed by the Sun Journal for this story.

While it declined to detail how chemically dependent inmates are treated during intake at Maine’s prisons and jails, the company said it uses “standard, humane and medically approved detox protocols for these addictions.”

Inmates who attend methadone clinics prior to incarceration are not dispensed methadone at any of the correctional facilities where Corizon is under contract. Pregnant inmates using methadone are treated by an off-site OB-GYN doctor licensed in prescribing Buprenorphine, a semisynthetic opioid used to treat opiate-based drug addiction. After delivery, those inmates follow the standard detox protocols, Nolan said.

If an inmate were to come to jail or prison with a current prescription for Oxycontin or oxycodone, those drugs wouldn’t be dispensed, except in “very rare” cases, the company said.

Inmates with a medical marijuana certificate won’t be dispensed that drug at Maine’s prisons and jails, either, but substitutions could be considered on a case-by-case basis, the company said.

In all, roughly 90 percent of the inmates who enter Maine’s prisons and other correctional facilities have a history of addiction to one or more drugs (including narcotics, benzodiazepines or barbiturates) or alcohol.

Relapse rate is high

So, why don’t all methadone addicts spend a week weaning themselves from the drug like Tomaselli?

Some may try. But most will need more time. And a small percentage likely will need to stay on methadone until they die, experts say.

Sullivan, the director at CAP, where opioid addicts are treated with methadone, said the first goal is to stabilize clients on a suitable dose of medication.

Opioid addiction is a brain disease, she said, best treated with medication and psychosocial support. Clients who come to her clinic get both.

Like any addiction, “It’s a progressive disease,” she said. “The longer you use, the worse it gets and the more you use … so that treatment is based on the individual.”

Studies have found that patients with this chronic disease undergo a change in brain chemistry in which they are lacking free endorphins which, for many, means they likely will need medication throughout their lifetimes, she said.

The long-term goal of treatment is to improve a client’s ability to function at home, at a job and in the world.

Studies show it works.

Typically, relapse rates are 70-90 percent among those who leave methadone maintenance treatment, she said, even among those who taper to zero.

An alternative for opioid addicts to being on a maintenance program at a methadone clinic may be to seek street drugs, which can expose addicts to hepatitis C and HIV through shared and dirty needles, blood clots and possible overdose, among other health risks.

Some may try prescription shopping, a ploy medical professionals are increasingly more aware of and on which federal and state drug agencies have cracked down.

A patient on Sullivan’s caseload was in methadone treatment before he tapered his dosage to zero and left, she said.

“Within a year, he relapsed,” she said. “And then he came to this clinic and he’s been here about 9½ years and he’s tapering out, decreasing his medication so he can leave. To zero eventually. That’s his desire.”

By taking a gradual approach, that client is more likely to succeed, she said.

She said patients and staff at CAP are anxious about the new 24-month MaineCare cap. Under the new DHHS rule, that cap can be exceeded with prior MaineCare authorization.

However, Sullivan said, “We’re waiting for the criteria for prior authorization. We have no idea what that’s going to be.” Once that process is established, “that will probably be the determinant on who loses treatment,” she said.

In the 10 years her clinic has been open, Sullivan said the number of clients has averaged about 550 at any given time.

“We’ve had over 3,000 patients come and go,” she said. “And some stay.”

The MaineCare cap will have an adverse effect on methadone clinics across the state, Sullivan said. Nearly 70 percent of all clients are on MaineCare. And, under the MaineCare reimbursement cap, that patient load is likely to decrease if MaineCare-capped patients can’t pay out-of-pocket.

Fewer than 200 methadone patients pay for treatments with private insurance, which leaves about 1,000 patients without MaineCare or private insurance paying for their own treatments.

Although her clinic exists to treat addiction to narcotics, some people who became addicted started with a doctor’s prescription for pain, she said.

Pain and narcotic addiction “are not necessarily mutually exclusive,” she said.

“Even addicts get real pain,” St. Mary’s Dr. Kelley said. Those are the ones who are likely to stay on methadone or Suboxone (a partial narcotic, offered by St. Mary’s instead of methadone) the rest of their lives, he said.

The other group that would have to stay on clinical treatment includes those who are so addicted they likely would harm themselves otherwise through risky drug behavior. No rehab program, however proven and long-term, is going to work for them.

“There’s just that once-in-a-while person that everything’s failed, no matter what,” he said.

But studies he’s seen show that opioid addicts who attend methadone clinics are less likely to contract HIV or hepatitis C and less likely to be charged with crimes. They work more days and achieve higher levels of education.

“So it does reduce the harm, not only to them, but to society, in many ways [to maintain methadone treatments],” he said.

St. Mary’s approach to addiction is that 99.9 percent of addicts can be weaned off and can stay off drugs and alcohol — “all chemicals,” Kelley said.

“And that requires a hell of a lot more than just taking a pill,” he said. “It requires learning about yourself, doing what we call the recovery work … learning why I use, how I can cope with life without drugs.”

Addicts who have been using drugs to cope with life will have to relearn how to cope without them. “That’s how they dealt with every single emotion,” he said.

And some addicts who have been abusing drugs since their early teens will have to learn those coping skills for the first time.

“How many coping skills do you have at 13 years old?” Kelley said. “Once you start using drugs for everything, you don’t learn new coping skills because you don’t need to. You’ve got a coping skill. It’s right there in your pocket. And so, some of these people are starting from scratch.”

Link to Poll

United Insurance Company of America Pays $37,500 To Resolve EEOC Disability Discrimination Lawsuit

United Insurance Company of America Pays $37,500 To Resolve EEOC Disability Discrimination Lawsuit
Federal Information & News Dispatch, Inc.
1-23-12

United Insurance Company of America Pays $37,500 To Resolve EEOC Disability Discrimination LawsuitCompany Rescinded Job Offer to Recovering Drug Addict Because of His Disability, Agency ChargedRALEIGH, N.C. - United Insurance Company of America will pay $37,500 and furnish other relief to resolve a disability discrimination lawsuit filed by the U.S. Equal Employment Opportunity Commission (EEOC), the agency announced today.According to the EEOC's lawsuit, Craig Burns is a recovering drug addict who has been enrolled in a methadone treatment program since 2004. In January 2010, United Insurance offered Burns a position as an insurance agent in its Raleigh office, conditioned upon Burns' passing a drug test. After Burns' drug test showed the presence of methadone in his system, Burns submitted a letter to United Insurance from his treatment provider explaining that he was participating in supervised methadone treatment program and taking legally prescribed medication as part of the treatment. Upon receiving this information, United Insurance notified Burns that he was not eligible for hire and withdrew its offer of employment.Such alleged conduct violates the Americans with Disabilities Act (ADA), which protects employees and applicants from discrimination based on their disabilities. The EEOC filed suit in August 2011 in U.S. District Court for the Eastern District of North Carolina (Civil Action No. 5:11cv00430), after first attempting to reach a pre-litigation settlement through its conciliation process.In addition to monetary damages, the two-year consent decree resolving the suit requires United Insurance to conduct training on, among other things, an employer's obligation to conduct an individualized assessment in determining whether an employee or applicant is disabled under the ADA; appropriate methods of determining whether an employee or applicant poses a direct threat under the ADA; and the obligation to engage in an interactive process under the ADA when an employee or applicant requests a reasonable accommodation. United Insurance will also post a copy of its anti-discrimination policy at its headquarters in St. Louis."The ADA requires employers to make an individualized assessment of whether an individual can do the job rather than relying on fears or stereotypes," said Lynette A. Barnes, regional attorney for the EEOC's Charlotte District, which includes the Raleigh Area Office, where the original charge of discrimination was filed. "We are pleased that, in resolving this case, United Insurance is taking action to ensure that it fulfills its obligations under the ADA."

ASAM Redefines Addiction as a Brain Disease

ASAM Redefines Addiction as a Brain Disease
Pain-topics.org
August 26, 2011 (Friday)

Addiction is a primary, chronic brain disease, not just bad behavior or bad choices, according to a new definition from the American Society of Addiction Medicine (ASAM). Pain practitioners need to understand the ramifications of addiction — especially involving Rx-opioid use — as a complicating factor in patient care. However, casual use of the term “addiction” or inaccurate diagnosis of the disorder is counterproductive for effective pain management and unjustly stigmatizing to patients.

According to ASAM in a news release, when people see compulsive and damaging behaviors in friends or family members — or public figures such as celebrities or politicians — they often focus only on the behaviors or substance use as the problem. However, these outward signs are actually manifestations of an underlying disease that involves various areas of the brain.

“At its core, addiction isn't just a social problem or a moral problem or a criminal problem. It's a brain problem whose behaviors manifest in all these other areas,” said Michael Miller, MD, past president of ASAM who oversaw the development of the new definition. “Many behaviors driven by addiction are real problems and sometimes criminal acts. But the disease is about brains, not drugs. It's about underlying neurology, not outward actions.”

The new definition resulted from an intensive, 4-year process with more than 80 experts actively working on it, including top addiction authorities, addiction medicine clinicians, and leading neuroscience researchers from across the country. The full Public Policy Statement on addiction also includes this short version of the definition:

“Addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry. Dysfunction in these circuits leads to characteristic biological, psychological, social and spiritual manifestations. This is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors.” “Addiction is characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one’s behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.”

By defining addiction as a primary disease, ASAM stresses that it is not the result of other causes, such as emotional or psychiatric problems. Addiction also is recognized as a chronic disease — like cardiovascular disease or diabetes — that must be treated, managed, and monitored over a life-time.

Two decades of advancements in neurosciences convinced ASAM that addiction needed to be redefined by what is going on in the brain. Research shows that the disease of addiction affects neurotransmission and interactions within neural reward circuitry, leading to addictive behaviors that supplant healthy ones, while memories of previous experiences with food, sex, alcohol, and other drugs trigger craving and renewal of addictive behaviors.

Meanwhile, brain circuitry that governs impulse control and judgment also is altered in this disease, resulting in the dysfunctional pursuit of rewards such as alcohol and other drugs. This area of the brain is still developing during teen-age years, which may be why early exposure to alcohol and drugs is related to greater likelihood of addiction later in life.

“There is longstanding controversy over whether people with addiction have choice over anti-social and dangerous behaviors,” said Raju Hajela, MD, in the news release (he is past president of the Canadian Society of Addiction Medicine and was chair of the ASAM committee on the new definition). He further states, “the disease creates distortions in thinking, feelings and perceptions, which drive people to behave in ways that are not understandable to others around them. Simply put, addiction is not a choice. Addictive behaviors are a manifestation of the disease, not a cause.”

However, Hajela continues, “Choice still plays an important role in getting help. While the neurobiology of choice may not be fully understood, a person with addiction must make choices for a healthier life in order to enter treatment and recovery. Because there is no pill which alone can cure addiction, choosing recovery over unhealthy behaviors is necessary.”

COMMENTARY: The interface of pain, opioid analgesics, and addiction has been of great concern in the pain management field. Commonly, the term “addiction” has been loosely applied by practitioners, researchers, and the public, and this has frequently resulted in faulty diagnoses, unjust accusations, and stigmatization of patients.

Furthermore, there have been many studies in the field using definitions that inaccurately assess addiction among patients with pain prescribed opioid analgesics; consequently, more often than not, the prevalence of addiction has been inflated. Good quality studies, of which there have been few, suggest that de novo iatrogenic addiction in patients appropriately prescribed opioid analgesics for chronic pain is a relatively rare occurrence [see UPDATE here].

Will this reinterpretation of addiction from ASAM help to clarify the issues or add further confusion? In many respects, the definition is comprehensive but not entirely new thinking. In 2001, a trio of organizations — the American Academy of Pain Medicine, American Pain Society, and ASAM — released a consensus document, “Definitions Related to the Use of Opioids for the Treatment of Pain,” that defined addiction as follows:

“Addiction is a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.”

The new definition, from ASAM, notes that addiction is characterized by 5 features:
1. Inability to consistently Abstain;
2. Impairment in Behavioral control;
3. Craving, or increased “hunger” for drugs or rewarding experiences;
4. Diminished recognition of significant problems with one’s behaviors and interpersonal relationships; and
5. A dysfunctional Emotional response.

These are quite similar to features noted in the consensus statement of a decade ago, and ASAM emphasizes that the 5 “new” features are not diagnostic criteria for addiction. Rather, the diagnosis of addiction requires “a comprehensive biological, psychological, social and spiritual assessment by a trained and certified professional.” However, this raises some concerns about the new definition:

• Who is a “trained and certified professional” qualified to make a bona fide diagnosis of addiction in a patient? Presumably, ASAM members are qualified; pain practitioners are not. However, chronic pain and instinctual human drives for pain relief may result in expression of any or all of the 5 features of addiction noted above, which can confound the diagnosis by someone inexperienced in both pain and addiction medicine.
  


• The ASAM document catalogs many of the interesting and important neurobiological structures and functions that have been discovered in research studies to play a role in addictive processes. However, this knowledge has not been translated into everyday clinical application for the diagnosis and treatment of addiction.



• ASAM further notes that “genetic factors account for about half of the likelihood that an individual will develop addiction,” and these are further influenced by environmental factors. This may be of some importance from prevention perspectives but, since a person’s genetic makeup cannot be remediated, it is unhelpful in the treatment of current addiction.



• The inclusion by ASAM of a spiritual dimension in their definition and the assessment of addiction, which is so prominent and important in 12-Step recovery groups, is controversial from a medical science standpoint. Delving into patients’ connections (or disconnects) with a “Higher Power” is generally outside the bounds of typical clinical practice.

Finally, it is curious that ASAM released this extensive definition of addiction at this time, when the American Psychiatric Association (APA) is finalizing the 5th revision of their Diagnostic & Statistical Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Is this new ASAM definition intended to complement DSM-5, to supersede the APA’s work in defining addictive disorders, or as a standalone interpretation of the disorders by ASAM? Interestingly, other than a major section heading in DSM-5 titled “Substance Use and Addictive Disorders,” the APA continues to shun use of the term “addiction” as a descriptor, as they have in the past.
In any case, the new ASAM document is recommended reading for all healthcare providers who want an understanding of addiction and addictive behaviors.

American Society of Addiction Medicine ASAM

Andrei Nesterenko MFA Spokesman Dept of Information and Press Russia

MINISTRY OF FOREIGN AFFAIRS OF THE RUSSIAN FEDERATION
DEPARTMENT OF INFORMATION AND PRESS
July 19, 2010
______________________________________

Replies by Russian MFA Spokesman Andrei Nesterenko to Media Questions regarding the appointment of Yuri V. Fedotov, to the post of Executive Director of the UN Office on Drugs and Crime

Q: What explains the choice candidate, Yury Fedotov, Russia's appointment as Executive Director of the UN Office on Drugs and Crime? Answer: When the question arose of replacing Ispoldirektora UNODC A. Costa (Italy), whose contract expires next month, the candidate of the current Russian Ambassador to Britain, Yuri V. Fedotov was proposed by us to UN Secretary General on a number of reasons. This is an experienced diplomat and an effective manager, who is deeply and fully owned by the United Nations issues. Prior to his appointment to London, he was Deputy Minister of Foreign Affairs, directly oversee the UN and UN organizations. Therefore, advancing Yury Fedotov on this post, we do not doubt that he will make a significant contribution to advancing the goals and challenges facing the UN in this direction.
Recall that Yury Fedotov was appointed to this position the UN Secretary General so that he - the choice is not only Russia, but Ban Ki-moon, too, which proves the objectivity of approach to this candidate. Question: What problem should be solved the new leader in office? A: As part of its powers Yury Fedotov headed one of the priority to the interests of the Russian Federation and, of course, the priority of the UN directions. After all, the UN Vienna plays an increasing role as a center for harmonizing international efforts in combating new challenges and threats of a criminal nature. In its terms of reference will include issues of international cooperation in combating the global threat of illegal drug distribution, including Afghanistan, corruption, cyber crime, laundering of proceeds from criminal activities, trafficking in persons, compliance with 16 international anti-terrorism treaties, etc. The role of the UN - the most to promote cooperation among States in these areas. Such activities include the provision of assistance (not only material) to those countries that need it, and find donors willing to provide such assistance, bilaterally or through the UN. Q: It is known that a group of representatives of the international network of harm reduction and organizations working on HIV / AIDS, addressed to UN Secretary General Ban Ki-moon with a letter in which he opposed the appointment of the representative of Russia to the presidency, citing the poor performance of the country in the fight AIDS. Do you shown concern justified? A: We believe this approach is totally unreasonable. It is no secret that there are influential and active forces interested in how to present the situation of HIV / AIDS in Russia as almost no catastrophic. But let's look at the facts. Yes, HIV / AIDS epidemic in our country as well as in most countries have not yet obtained reversed. However, there is every reason to hope that this will sooner or later we will achieve. One of the key elements of public policy in this area - the political will and awareness of the extent of the threat. As approved by the President of the Russian Federation in May 2009 National Security Strategy of 2020 the spread of HIV infection is recognized as one of the major threats to national security in health and health of the nation. The next most important factor - financing efforts. The turning point in this direction occurred in 2006, when the fight against HIV / AIDS has been allocated to twenty times more money than was allocated in previous years. And this trend continues unabated, and continues to grow. Many positive results are evident. To mention only one of them: last year, all HIV-infected people in need of treatment from the federal budget - and that 70,000 people - is receiving treatment. As you mentioned demarche, it seems, was dictated by the long-known desire of the international narkoliberalnogo lobby force in the same idea of the so-called substitution treatment or harm reduction offering under the guise of combating drug abuse and illicit drug use among high-risk groups to spread the "legal" drugs and devices for their use. The position of our country on this issue is well known. We reject this approach and our strong commitment to this line is in some circles irritation.


MINISTRY OF FOREIGN AFFAIRS OF THE RUSSIAN FEDERATION
DEPARTMENT OF INFORMATION AND PRESS
119200, Moscow G-200
Smolenskaya Square Hay., 32/34
tel.: (499) 244-4119
fax: (499) 244-4112
e-mail: mailto:dip@mid.ru
web-address: www.mid.ru

Painkillers Linked to Increase in Overdose Deaths.

Painkillers Linked to Increase in Overdose Deaths.
More popularity, availability of these medications may be reason, study suggests.
Steven Reinberg
HealthDay News, December 9, 2008

TUESDAY, Dec. 9 (HealthDay News) -- Deaths from overdoses of prescription drugs, primarily pain relievers, appear to be on the rise throughout the United States, new research suggests. West Virginia, in particular, has seen a large increase in such unintentional deaths, say government researchers, who have uncovered patterns of "doctor shopping" for drugs and overdosing on medications not used as prescribed. "We found that two-thirds of these deaths involved prescription drugs that had not been prescribed to the individuals who died," said the lead researcher, Dr. Aron J. Hall, an epidemic intelligence service officer for the U.S. Centers for Disease Control and Prevention. In addition, one in five had "doctor shopped," looking for physicians to prescribe pain medications, particularly opioids like methadone, hydrocodone and oxycodone, Hall said. "This epidemic of prescription drug overdose involves a substantial amount of substance abuse, and it affects not just West Virginia, but particularly rural areas of the country," Hall said. "It's been a problem throughout the country. Our study focused on West Virginia as the tip of the iceberg." Hall's group thinks that doctors and pharmacists have a critical role in preventing the misuse of these drugs. "It is essential that they counsel patients not only about the risk of overdose to themselves, but about the risks to those with whom they might share their drugs," he said. In addition, Hall advises doctors to use prescription monitoring programs, which can tell them if patients are getting drugs from other doctors. The report is published in the Dec. 10 issue of the Journal of the American Medical Association. For the study, Hall's team looked at deaths from unintentional overdoses in West Virginia in 2006. From 1999 to 2004, deaths from unintentional poisoning in the state increased 550 percent, the greatest increase for any state in the country. To determine the size of the problem in West Virginia, the researchers collected data from medical examiners, prescription drug-monitoring programs, and opiate treatment program records. In 2006, 295 West Virginians died from unintentional overdoses of pain killers, Hall's group found. Of these, 67.1 percent were men and 91.9 percent were between the ages of 18 and 54. Most on those who died (63.1 percent) used painkillers, but did not have a prescription for them. And 21.5 percent had prescriptions for these drugs from at least five doctors in the year before their death, the researchers found. Women were more likely to doctor shop than men (30.9 percent vs. 16.7 percent), and younger people used painkillers for non-medical purposes more than their older counterparts did, according to the report. In 79.3 percent of the deaths, people had used several medications. Opioids were the most common drugs used, accounting for 93.2 percent of the deaths. Of these deaths, only 44.4 percent of the victims had any evidence of having a prescription for these drugs, Hall's group noted. Methadone was the most common drug linked to fatal overdoses, accounting for 40 percent of the deaths. People who died from a methadone overdose were less likely to have a prescription for the drug than people who overdosed on hydrocodone or oxycodone, the researchers found. In 1997, two reports called for better management of chronic pain and encouraged the use of opioid pain medications. Since that time, the sales of these painkillers has gone up dramatically as have overdoses, deaths and recreational use linked to these drugs, Hall said. Dr. Adam Bisaga, an associate professor of clinical psychiatry in the division on substance abuse at Columbia University College of Physicians and Surgeons in New York City, thinks that improved guidelines for appropriate prescribing, along with training to detect substance use disorders in patients, might reduce the unintended consequences seen in this study. "This finding is not surprising. Opiates are generally very safe if used appropriately, but opiate abuse/dependence is an illness with high mortality rates," Bisaga said. "So the issue is not with the medication, but rather the detection and treatment of those who abuse and become addicted to opiates." In addition, there is a need to expand access to addiction treatment, particularly in high-risk populations, Bisaga said. "I strongly believe that present results could be directly used to justify implementing changes in practice and treatment to promptly reverse this worrisome trend that is likely to be occurring throughout the country, not just in one state," Bisaga said.

More information
For more on prescription drug abuse, visit the U.S. National Institute on Drug Abuse. Link to Article.

Methadone Maintenance 4 Decades Later

Methadone Maintenance 4 Decades Later Thousands of Lives Saved But Still Controversial Commentary by Herbert D. Kleber, MD JAMA 2008 (November 19);300(19):2303-2305
SUMMARY OF THE ORIGINAL ARTICLE

A Medical Treatment for Diacetylmorphine (Heroin) Addiction: A Clinical Trial With Methadone Hydrochloride Vincent P. Dole, MD, and Marie Nyswander, MD JAMA. 1965;193(8):646-650

Twenty-two male patients, addicted to heroin 9.5 years (median), were stabilized using oral methadone hydrochloride and then observed for approximately 1 to 15 months (median, 3 months). The medication had 2 main effects: (1) relief of narcotic hunger (craving); and (2) induction of sufficient tolerance to block the average illegal dose of heroin.

A combination of the methadone treatment and a comprehensive program of rehabilitation was associated with marked improvement in patient problems such as jobs, returning to school, and family reconciliation. No adverse effect other than constipation was found.

The authors note that "careful medical supervision and many social services" were necessary and stressed that "both the medication and supporting program were essential." The small size of the group studied and short duration of the follow-up would best describe this as a promising and exciting but preliminary report.

See PDF for full text of the original JAMA article.

Commentary

The effects of the article by Dole and Nyswander1 are best understood by knowing what preceded it. The current scientific consensus is that opioid dependence is a chronic and severe medical disorder, and withdrawal alone is usually followed by rapid relapse.2 A century ago, however, withdrawal was often considered adequate to treat narcotic addiction, with methods used often more dangerous than withdrawal. Individuals who relapsed were viewed as doing so out of choice rather than necessity.

The frequency of relapse, however, led to the establishment of narcotic clinics to legally provide heroin or morphine to individuals with addiction. By 1923, all these clinics had closed, deemed failures because they did not lead to abstinence. Federal agencies interpreted the 1914 Harrison Act as prohibiting maintenance of individuals with active addiction and threatened or prosecuted physicians doing so. Between 1919 and 1935, approximately 25,000 physicians were indicted under the Harrison Act and 10% were imprisoned. Despite 1921 and 1926 Supreme Court rulings that the act did not forbid such prescribing, most physicians avoided it, ending the role of the medical profession in treating patients with addiction for 4 decades.

Heroin became the street narcotic of choice. During World War II, with heroin scarce and purity as low as 1%, addiction hit a record low. By the late 1940s, the flow of smuggled heroin had resumed, but addicts were more likely younger, from a racial or ethnic minority group, and living in northern impoverished communities. Treatment was scarce, prison common, and relapse likely.3

Methadone Maintenance

Forty years after the last maintenance clinics closed, the 1965 article by Dole and Nyswander landed with a bang.1 Dole, an internist, believed narcotic addiction was a metabolic disease, not very different from diabetes; Nyswander, a psychiatrist, had frustrating years of treating individuals with narcotic addiction with psychotherapy only to see them relapse. Their study,1 conducted in New York City first at the Rockefeller Institute and later moving to Manhattan General Hospital, included 22 participants with heroin addiction. One year later, Dole et al reported empirical data on the induced narcotic blockade.4 Long-term follow-up studies later confirmed that therapeutic success on a larger scale was possible.

Methadone replaced morphine as the preferred agent for heroin withdrawal. As a maintenance agent for treating addiction, methadone prevents withdrawal for 24 to 36 hours, enabling a system in which addicted patients come for treatment once a day, in contrast to the 1920s clinics using short-acting opioids.

Following the 1965 article,1 scientists systematically expanded the science behind methadone maintenance treatment (MMT). Large-scale programs using more cost-effective induction methods opened in New York City, and the US Food and Drug Administration approved a limited use of methadone in large research programs.5

In 1970, the federal government faced 2 major heroin-related problems: heroin use and associated crime was increasing, especially in urban areas; and soldiers in Vietnam were using heroin. Concerned about possible increased crime when these soldiers returned home and influenced by the early success of DuPont's Narcotics Treatment Administration in reducing crime by treating individuals with heroin addiction,6 President Nixon announced the war on drugs on June 17, 1971, created the Special Action Office for Drug Abuse Prevention (SAODAP), and hired Jerome Jaffe to be its first director. This new federal structure was charged with coordinating and rapidly expanding drug treatment, including changing existing regulations.5

Even as SAODAP and New York City moved to expand MMT, strong reaction began against it, fueled partly by reports of methadone-related deaths and diversion, but primarily by its substituting one addiction for another. Psychosocial program advocates opposed MMT as likely to reduce concerns about poverty and social ills. The director of a therapeutic community remarked, "I think methadone is a great idea. We should give money to bank robbers, women to rapists, and methadone to addicts."7

In those first 2 years, more federally supported treatment capacity developed than in the previous 50 years. In 1974, two-thirds of the $750 million drug budget was devoted to treatment, research, and prevention, compared with the recent 25 years during which two-thirds of the budget targeted supply reduction.5

Positive Outcomes of MMT

Numerous studies have demonstrated the effectiveness of MMT for reducing illicit opioid use, morbidity and mortality, risk of human immunodeficiency virus (HIV) infection, illegal activities, and improving overall functioning. Patients in MMT had a 1-year mortality rate of 1% compared with 8% among patients who discontinued treatment.8 In a 1993 prospective study conducted in Philadelphia, Pennsylvania, HIV seroconversion rates were 4 times higher among individuals who were actively using street heroin compared with patients receiving MMT.9 Risk decreased in relation to length of time continuously receiving MMT; risk of hepatitis B and hepatitis C also was reduced but to a much lower extent.9

In a 1991 study, crime days per year among individuals addicted to narcotics decreased more than 70% while receiving MMT.10 In a random assignment study, patients in the standard and enhanced treatment groups had marked reductions in illicit opiate use and improvements in overall functioning compared with the minimal counseling group.11 However, the increase of for-profit MMT centers (often realizing very large profits), and decreased funding for nonprofit centers left many programs inadequately staffed. This remains a major unresolved public health problem.

Average methadone maintenance doses of 60 to 120 mg or higher have consistently better results than use of lower average doses, especially because heroin purity is now often greater than 40%. Methadone's plasma half-life, once stabilized, averages 24 to 36 hours with a range of 13 to 56 hours. However, as many as 10 days may be needed to reach a steady state, and new patients, either to MMT or given methadone for analgesia, are at risk for fatal overdose. Most deaths have been from methadone prescribed for pain rather than from methadone treatment programs.

Although MMT has been lifesaving for thousands of individuals, it is not a panacea. High levels of psychopathology remain. Abuse of cocaine and benzodiazepines and disruptive behavior are problems in many programs. Many patients do not change their behavior even when services are available. What to do under such circumstances remains contentious, given the likely severe postdischarge consequences vs the effect on other patients and the possibility that more intensive residential intervention might be helpful.

During the past 2 decades, evidence has accumulated regarding the neurobiology of opiate dependence. Opiate dependence is now seen as a brain-related disorder with genetic and environmental overlays characteristic of a medical illness. The endorphin system and opioid receptors have now been discovered. Dole was ahead of his time.1, 4, 12

Safety

Studies on MMT in the 1970s by Kreek found no long-term damage to the heart, kidneys, liver, or lungs.13 Long-acting maintenance medications normalized the neuroendocrine alterations induced by short-acting opioids12 with minimal psychoactive impairment. MMT has been shown not to impair driving ability. In the past decade, it was found that methadone, especially at high doses, when beginning treatment, or when combined with certain drugs, may lead to QTc prolongation and possibly to torsade de pointes, a potentially fatal cardiac arrhythmia. A black box warning was added to the prescribing information for methadone in December 2006. However, the clinical significance of this abnormality is not yet clear regarding deaths.

Federal Regulations

MMT is one of the most heavily regulated medical treatments in the United States.5 With few exceptions, methadone may only be dispensed for opioid withdrawal or maintenance by certified opioid treatment programs. An increasing number of take-home doses is permitted, depending on the patient's history of illicit drug use and employment, with a maximum 1-month supply after 2 years. Regulations and decreased public financing have made it more difficult to start or expand programs. An Institute of Medicine review14 concluded, " . . . current policy puts too much emphasis on protecting society from methadone, and not enough on protecting society from the epidemic of addiction, violence, and infections that methadone can help reduce." However, regulation that is too lenient may lead to worsened problems and increased hostility; a balance is needed.

Stigma

In the late 1980s, the backlash against MMT became stronger. Community complaints about loitering and bartering of drugs outside clinics exacerbated the hostile environment. Complaints often coincided with decreased ancillary supports.

In 1988, the White House Conference for a Drug-Free America, vehemently antimethadone, demonized methadone and the National Institute on Drug Abuse and called for a congressional investigation.7 In 1990, the Office of National Drug Control Policy reversed this position, and its White Paper on treatment stated clearly that methadone maintenance was both legitimate and an important part of the spectrum of drug abuse treatment.7 Ironically, even though 12-step programs have often been hostile to MMT,15 Dole, a friend of the cofounder of Alcoholics Anonymous recounted, "He [Bill W.] suggested that in my future research, I should look for an analogue of methadone, a medication that would relieve the alcoholic's sometimes irrestible craving and enable him to progress in AA toward social and emotional recovery. . . . "15

In the United States, approximately 260 000 individuals are currently receiving MMT (M. Perrino, written communication, October 2008), although it is estimated that fewer than 10% of individuals who are addicted to heroin and prescription opioids are receiving MMT. Worldwide, about 1 million individuals are receiving MMT; in some countries such as Russia, government opposition to agonist maintenance prevents its use even when high HIV rates exist.

The long-acting sublingual partial agonist buprenorphine, a Schedule III opioid, has been available since 2002 for office-based prescribing by physicians with special training5 and with current limits of 100 patients per physician. Approximately 140 000 patients are now receiving maintenance using buprenorphine (R.E. Johnson, written communication, October 2008) and results to date appear comparable to MMT albeit with somewhat different populations. It is not clear whether it will be any easier to remain abstinent after withdrawal from buprenorphine treatment than from MMT, especially if inadequate ancillary support is provided. While buprenorphine's formulation makes overdose or diversion to parenteral use less likely, like all µ agonists, this drug has that possibility and limited diversion is already occurring.

Methadone: Terminable or Interminable

The benefits of long-term methadone maintenance are borne out by data.2 Two years of MMT appears to be the minimum duration before attempting withdrawal.5 Even patients receiving maintenance for long periods with substantial lifestyle changes often relapse after leaving treatment, and death rates are much higher than for individuals who remain in treatment. For many patients, therefore, years or even lifetime maintenance may be needed, but there is often patient and family opposition. Office-based medical maintenance has been used on a limited basis for patients stable at least a few years with generally successful results, although some patients increased their use of illicit drugs. This approach avoids the clinic problem of mixing stable and unstable patients but the number of eligible stable patients appears limited. Ultimately, the problem of interminable maintenance vs relapse may require learning how to reverse the brain changes associated with addiction. Until then, long-term agonist treatment remains a reasonable alternative.

Review: Electrocardiogram Characteristics of Methadone and Buprenorphine Maintained Subjects

Byrne Review: Electrocardiogram characteristics of methadone and buprenorphine maintained subjects
Comments by A. Byrne
September 22, 2008

Athanasos P, Farquharson AL, Compton P, Psaltis P, Hay J. Journal of Addictive Diseases 2008 27;3:31-35

These authors from Adelaide, South Australia report a relevant and reassuring ECG study from a ‘normal’ addiction clinic setting.

We are presented with a comparison of 35 methadone maintained patients, 19 on buprenorphine and 17 controls. Methadone doses varied from 15-145mg daily, being in the common range used clinically around the world. Most subjects were in their 30s and 28 of 71 (39%) were female.

No significant difference in QT interval was found between the three groups. There were 2 methadone patients and one control with long QT when defined as 430ms or longer for males (450 for females). None was over 475ms (the threshold at which risk of torsades occurs is believed to be 500ms). There was a trend for longer QT intervals in those on >60mg daily as well as some increased U waves reported in methadone patients. These findings are consistent with Lipsky’s findings from 1973, but the clinical significance, if any, is unclear. Like other prospective studies on this subject, these authors do not report any cases of torsades.

The authors conclude: “Although an association is thought to exist between high methadone doses and elongated QTc, methadone and buprenorphine, at commonly used daily doses, remain safe agents for opioid substitution therapy.”

As an exercise I contacted two prominent addiction experts in Adelaide on this subject. One had seen no cases and the other was aware of one possible case some years ago. This is on a long background of good quality methadone treatment, both private and public, in that city.

It may be timely to examine the evidence for claims that methadone treatment in addiction is accompanied by a significant risk from arrhythmias, including death. Despite there being no body of case reports (or perhaps because of it) a number of authors attempted to assess methadone’s role in cardiotoxicity by using indirect and unconventional methods.

For example, Fanoe (ref below) prefers QT/torsades as an explanation for up to 30% of his subjects reporting syncope on MMT in Copenhagen. Since the incidence of torsades is 0-1% annually, this explanation is not credible, especially coming from a country with extremely high alcohol statistics). Chugh (ref below) used a methodology looking at post mortem structural heart disease in those dying suddenly with or without therapeutic levels of methadone in the blood. His deduction for QT changes without a single case report seems hard to understand. Wedam (ref below) wrote “To compare the effects of …[methadone] … on the corrected QT (QTc), we conducted a randomized, controlled trial of opioid addicted subjects.” [our italics] In fact they performed a retrospective re-analysis of old analogue ECG tracings from a 1990s RCT, finding more than 10% had QTc over 500ms. This is not consistent with other reports on the subject. No torsades cases were reported in the study groups.

A review of the world literature by Justo (ref below) found only 40 documented cases, 85% of whom had two or more risk factors. Few of these reported cases bear much similarity to those commencing ‘normal’ clinic or community addiction treatment. The QT/torsade cases tend to be significantly older, female sex, and to involve co-medications, very high methadone doses (up to 1200mg daily or ten-fold ‘normal’ doses) as well as certain metabolic (potassium or magnesium deficiencies) and genetic states (familial long QT syndrome).

I believe that it is now possible to restate unequivocally that ‘normal’, guideline-based methadone treatment is safe and effective. The cardiac arrhythmia issue appears to be based on a combination of factors rather than a consequence of standard methadone treatment. Knowing the risk factors, most cases could probably be avoided using good clinical practice (see Sticherling). A pre-treatment cardiograph would not have detected any of these cases.

As well as a dearth of relevant case reports, some have given advice without due consideration of the benefits of methadone treatment in the absence of a suitable alternative in a large proportion of cases, especially high-dose subjects (see Kakko). While methadone induced torsades may indeed occur, it must be in extremely low numbers and would probably be swamped statistically by reductions in endocarditis cases alone (as reported by Krantz in 2001 - ref below).

In practical terms, this means that existing methadone patients needing other medications, methadone doses over 200mg or who develop HIV and/or have other risk factors should have a cardiograph, just as they should have electrolytes, liver function tests, etc performed as a matter of clinical course.

We need to ensure that as clinicians we continue to ask the question: what is the evidence?

Comments by Andrew Byrne.
Redfern Clinic.com News

References:

Fanoe S, Hvidt C, Ege P, Jensen GB. Syncope and QT prolongation among patients treated with methadone for heroin dependence in the city of Copenhagen. Heart 2007;93;1051-1055.

Chugh SS, Socoteanu C, Reinier K, Waltz J, Jui J, Gunson K. A Community-Based Evaluation of Sudden Death Associated with Therapeutic Levels of Methadone. American Journal of Medicine 2008 121: 66-71.

Wedam EF, Bigelow GE, Johnson RE, Nuzzo PA, Haigney MCP. QT-Interval Effects of Methadone, Levomethadyl, and Buprenorphine in a Randomized Trial. Arch Intern Med 2007 167;22:2469-2473.

Justo D, Gal-Oz A, Paran Y, Goldin Y, Zeltser D. Methadone-associated Torsades de Pointes (polymorphic ventricular tachycardia) in opioid-dependent patients. Addiction. 2006;101:1333-1338.

Sticherling C, Schaer BA, Ammann P, Maeder M, Osswald S. Methadone-induced Torsade de Pointes tachycardias. Swiss Med Wkly 2005;135:282–285.

Kakko J, Grönbladh L, Svanborg KD, von Wachenfeldt J, Rück C, Rawlings B, Nilsson L-H, Heilig M. A Stepped Care Strategy Using Buprenorphine and Methadone Versus Conventional Methadone Maintenance in Heroin Dependence: A Randomized Controlled Trial. Am J Psychiatry 2007 164;5:797-803.

Krantz MJ. Clinical Concepts- Cardiovascular Health in MMT Patients. Available from: Addiction Treatment Forum 2001 No 4