Twenty years ago, AT Forum published an interview with Vincent P. Dole, MD, about his vision for methadone maintenance treatment (MMT). The interview was full of hope that methadone treatment would be better accepted in coming years. Dr. Dole’s hope was that the younger generation of physicians would be better educated about MMT, easing access to treatment and doing away with the stigma associated with medication-assisted treatment for opioid addiction.
Heroin addiction came to the attention of Dr. Dole, a researcher at The Rockefeller Institute for Medical Research in New York City, in the early 1960s. (In 1965 the Institute became The Rockefeller University.) Unlike the prevailing viewpoint, which was that addiction was a criminal behavior issue, or at best a lack of willpower, Dr. Dole proceeded upon the assumption that addiction is a disease. He changed the focus of his laboratory from obesity to heroin addiction, and looked at new pharmacological approaches to heroin addiction.
In 1963 Dr. Dole recruited psychiatrist Marie Nyswander, MD, who later became his wife, and clinical investigator Mary Jeanne Kreek, MD, and the next year, they started studying heroin addicts. Within six months they established that methadone, a synthetic opioid that had been used for short-term detoxification in a few clinics, could be used as a maintenance medication. Their studies showed that methadone is long-acting, prevents withdrawal symptoms, and relieves craving, while at the same time—at appropriate dosages—blocking the effects of euphoria from heroin and other opioids.
Dr. Kreek undertook long-term studies of the safety and effectiveness of methadone, which led to the Food and Drug Administration’s approval in 1973 of methadone as a long-term pharmacotherapy for opioid addiction.
In 1988 Dr. Dole received the Albert Lasker Clinical Medical Research Award for postulating the physiological basis of narcotic addiction and for developing methadone treatment for heroin addiction.
Dr. Nyswander died in 1986, and Dr. Dole died in 2006. Both had expected much from MMT.
But in the past two decades, little has changed, and both would have been disappointed.
In July, AT Forum interviewed three people who knew Dr. Dole well—Herman Joseph, PhD, Bob Newman, MD, and Dr. Kreek, all of whom are also disappointed, but still working to make MMT more accessible on a global as well as local basis.
There was complete agreement among the three on this point: stigma has not abated since the 1990s, and in fact is possibly even worse. “From the very beginning, we were accused, even by medical people, of substituting one drug for another, and that stigma persists to the current day,” said Dr. Joseph, a retired social scientist with the New York State Office of Alcoholism and Substance Abuse Services (OASAS). That stigma, although to a lesser degree, is now also applied to buprenorphine, he told AT Forum.
Studies showing the effectiveness of methadone should have reduced stigma, and that’s what Dr. Dole had hoped. “He was disappointed,” said Dr. Joseph, who wrote his dissertation on MMT.
Take the case of Robert Lepolszki, who at the age of 28 died of a heroin overdose. He had been in MMT, but had relapsed because he was forced by a drug court to taper off methadone. This happened last year. Mr. Lepolszki had obtained a job and reunited with his family, but because of a previous offense, occurring before treatment, was brought before the Nassau County’s Felony Treatment Court in New York State. Dr. Joseph and Joycelyn Sue Woods wrote about the case in an important article on stigma and MMT, to be published in the Journal of Addictive Diseases.
Mr. Lepolszki was given the choice by Judge Frank Gulotta, Jr. to go to prison or taper off methadone. He chose tapering, to avoid incarceration. Like the vast majority of patients who stop taking methadone, he relapsed. He was found dead in his bed six weeks later of a heroin overdose.
“When learning of the death of Mr. Lepolszki, the judge’s only comment was that methadone is a crutch and a substitute and has no place in his court,” the article stated. “To this day, methadone is not allowed in that court,” Dr. Joseph told AT Forum.
As a result of Mr. Lepolszki’s death, a bill has been introduced into the New York State legislature that would ban judges from ordering people off of methadone and buprenorphine. The bill is likely to be signed into law next year.
In the 1996 interview with AT Forum, Dr. Dole responded, as he had many times, to the criticism that methadone is a “crutch.” He said; “That seems like a vague charge that has no answer. A crutch is not a bad thing if you have only one leg, yet it’s not nearly as good a solution as it would be if you could re-grow your missing leg. Since we can’t regenerate a leg, why not use the crutch to get about and lead more normal lives?”
Nobody knows what Dr. Dole would have thought about Vivitrol, the extended release injectable form of naltrexone. Although the oral form had already been approved for opioid dependence, it was not a viable alternative to methadone, because nobody wanted to take it. “The point is, Vivitrol is naltrexone, and it doesn’t relieve craving,” said Dr. Joseph. “That craving is what methadone is treating. It’s physiological, it’s symptomatic of a metabolic alteration, of a change in brain chemistry” from chronic use of opioids. “Methadone normalizes the brain, and Vivitrol doesn’t,” he said.
Access to Treatment
“I’m afraid his hope has not been answered,” said Dr. Newman of Dr. Dole’s beliefs that the United States is emerging from its “medieval” views about opioid addiction. And Dr. Newman thinks that stigma is worse not only in the United States, but even in other countries, with Australia a possible exception. “Vince would have been disappointed, and God knows I’m disappointed,” said Dr. Newman. “Opening up a clinic is just as tough today as it was 45 years ago.” It should be as easy as opening up a dentist’s office, he said.
Dr. Newman would like to see more office-based treatment with methadone. “I’m not sure which side Vince was on in those days, but I think there’s been a concerted attempt to protect the monopoly of OTPs,” he said. “They fought bitterly to prevent buprenorphine from being accepted, and fought even more bitterly against interim treatment.”
With waiting lists of a year or longer, what could be more straightforward than having patients get methadone doses from the clinic—even if no counseling is available? But for many, of course, that proposition is far from straightforward, because they feel that patients would be done a disservice without the counseling aspect of treatment.
Dr. Kreek agreed that methadone is overregulated. “One should be able to access medical maintenance in an office,” she said. But Dr. Dole couldn’t figure out how to do this legally. At Beth Israel Medical Center in New York City, David Novick, MD, followed by Edwin Salsitz, MD, have done this, under a special allowance from the federal government. But office-based methadone is not widely available despite the fact that the revised 2001 federal guidelines made it legal to enter medical maintenance after initial entry into a program throughout the United States.
The phrase “medication-assisted treatment” should be done away with, said Dr. Joseph—and many agree. Researchers and experts prefer phrases like “opioid agonist therapy,” because “the doctor is treating the patient, and the prescription for methadone or buprenorphine is the medication.”
In addition, the phrase “medication-assisted treatment” blurs the distinction between agonists like methadone and buprenorphine, and antagonists like naltrexone. Although the phrase technically includes medications for alcohol use disorders and depression, it often is used to refer only to the three medications approved to treat opioid use disorders.
Dr. Joseph first faced patients with heroin addiction in his caseload as a probation officer in New York City in the 1960s, and the epidemic of the 1970s convinced him that methadone needed to be made more accessible. In the 1980s he created an office-based and pharmacy-based methadone maintenance program. There was even a drugstore program—patients could get their medication from a drugstore—but it was shut down because the new owners didn’t adhere to Drug Enforcement Administration regulations. The state is now focusing on “recovery”—which is not the same as treatment—it’s similar, but to someone who is addicted and needs treatment, it’s a very different message. The message should be, he said, that medications are the foundation of recovery.
Finally, the word “substitution” must be eliminated from descriptions of methadone and buprenorphine, said Dr. Joseph. “They are medications.”
Dr. Dole would have no trouble with buprenorphine, because it is based on the same principles as methadone, said Dr. Newman. He might have had concerns about the ceiling effect, and possible problems associated with whether it could control craving as well as methadone. “But he would have appreciated the fact that suddenly this treatment is available to a lot of people under bearable conditions, where they don’t have to go to a clinic 90 days in a row.”
Dr. Dole was pragmatic, said Dr. Newman. He would think it better to give patients buprenorphine than nothing, if methadone were not available. “I think he and Marie [Nyswander] would both say that anything has to be better than abandoning people on the streets.”
The Medical Community
The hope that physicians would be the ones to educate the public about the value of methadone was not fulfilled, all three of our sources stressed. In fact, physicians have stigmatized the addict population, said Dr. Newman. “The popular—and incorrect—conception is that addicts are evil, they look bad, they smell bad, and they’re going to destroy your practice,” he said.
In addition, physicians know that some of their medical colleagues who work in OTPs have agreed to the premise that “these patients alone among medical patients in the world cannot even be trusted to pee in a bottle without being observed.” This just perpetuates stigma for methadone patients, said Dr. Newman.
The ultimate irony is that a physician can go to jail for writing a prescription for methadone for opioid dependence, but the same doctor can write a prescription for methadone for pain—even if the patient is a heroin addict, said Dr. Newman. Of course, a physician who does this for more than two or three patients will be in trouble.
Dr. Kreek has a special perspective. Unlike Dr. Joseph, who worked with heroin addicts and was an early advocate for methadone treatment, or Dr. Newman, who founded and advocated for methadone treatment in the United States and abroad, she worked side by side with Drs. Dole and Nyswander to demonstrate the effect of methadone as a maintenance treatment for opioid addiction. She wrote the New Drug Application for methadone to get it approved by the Food and Drug Administration. She is horrified by the stigma of methadone today, and Dr. Dole would be too, she said.
However, Dr. Kreek thinks there is hope for methadone, mainly because of the inexorable progression of the opioid epidemic today. The response is no longer only to lock up the dealers, but also to get treatment to the users. She cited a recent report from the federal Centers for Disease Control and Prevention (CDC), which focused on methadone, buprenorphine, and naltrexone as treatment. “Vince would be so delighted that the CDC had medications as one of its main points,” Dr. Kreek said.
That said, however, even years later, methadone is still the best way to target the mu receptor, which is where morphine acts in the brain, Dr. Kreek pointed out. Methadone is also long-acting, so it can be taken once a day without causing euphoria. Finally, Dr. Kreek said that counseling is essential. “You don’t expect a street person who’s been involved in nefarious dealings to turn into an angel overnight.” (Not everyone agrees with this view; Dr. Newman, for example. But that is a debate for another place and time.)
Even the treatment field itself needs to be more accepting of methadone. Dr. Kreek also cited the death of Philip Seymour Hoffman of an opioid overdose, noting that he had been to many treatment programs—but all were drug-free. “It’s unethical not to offer buprenorphine or methadone,” she said. “It’s malpractice.”
Dr. Dole would be pleased to see the acceptance of methadone in other countries, said Dr. Joseph. For example, in Portugal, methadone is widely used throughout the whole country. “Vince would be happy about China, where 300,000 people are in treatment,” agreed Dr. Kreek. “But he would have apoplexy about the situation in the United States, where we now have only 300,000 people in methadone maintenance treatment.”
But treatment in the United States, especially for people in the criminal justice system, has far to go before Dr. Kreek’s, and Dr. Dole’s, visions can be fulfilled.
For the 1996 interview, go to http://atforum.com/interview-dr-vincent-dole-methadone-next-30-years/
Novick DM, Salsitz EA, Joseph H, Kreek MJ. Methadone medical maintenance: An early twenty-first century perspective [Epub ahead of print June 25, 2015]. J Addict Dis. PMID:26110221. http://www.ncbi.nlm.nih.gov/pubmed/26110221
Woods JS, Joseph H. Stigma from the viewpoint of the patient [Epub ahead of print June 15, 2015]. J Addict Dis. PMID: 26076048. http://www.ncbi.nlm.nih.gov/pubmed/26076048
Zachary Talbott (Posted on 8/18/15) – Great article, and one that’s very important for us to have. ONE thing, though… we actually DO know what Dr. Dole would have thought about Vivitrol because he was very clear about using antagonists in general. Go here: http://cdrwg.8k.com/mono2-2.htm#Implications and then scroll down to “Alternative Theory” (Dr. Dole is referring to using antagonists like naltrexone as this “alternative theory”)….