Points is thrilled to welcome Percy Menzies, president of Assisted Recovery Centers of America (ARCA), to discuss medication-assisted addiction treatment, naltrexone, and safe prevention sites.
Please tell Points a bit about yourself. How did you become involved in the world of addiction treatment?
I get asked this question often! In a word, destiny. I am a pharmacist by training and built a rather successful career in pharmaceutical sales back in India. Immigrating to the US, I felt confident about pursuing a similar career. It was no easy task. Going back to the late 70’s and early 80’s, it was uncommon for immigrants to be in sales and marketing. They had developed a reputation for being good engineers and researchers, but not for a field requiring interactions with physicians and other health professionals.
I faced many rejections, which made me more determined to continue trying. We were living in Kansas City and I saw an opening for a pharmaceutical sales job at Endo Laboratories, which was a subsidiary of DuPont. I applied and was called for an interview. I went to the library to read up on their products. Some of their drugs, like Coumadin, were familiar; others I was not familiar with.
To my surprise, I was told I wouldn’t be selling those. Instead, the company was expanding its sales force to introduce a revolutionary new “opioid” analgesic, which had a very low abuse potential and therefore was a non-scheduled drug. It belonged to a new class of opioids called “agonist/antagonist.” The drug, nalbuphine, was sold under the brand name Nubain, and I was told this injectable analgesic would be a game-changer. I got the job and we moved to Columbia, Missouri.
Endo’s claim to fame was developing medications from an alkaloid found in opium. The alkaloid, thebaine, could be chemically altered to turn it into highly potent opioid analgesics like Percodan, Percocet, and Numorphan. The quest was to develop a non-addicting opioid, which to this day has not been achieved.
But the chemists at Endo accomplished something else, too – they had also developed a new non-addictive “opioid” called naloxone, sold under the brand name Narcan. Naloxone was part of an entirely new class of drugs called “opioid antagonists.” These drugs were the polar opposites of “agonists” like oxycodone and oxymorphone. Instead of filling the brain’s opioid receptors, they blocked them. In Narcan’s case, this meant the drug kicked opioids out of people’s brains, restoring their breathing and heart rate after an overdose.
But Endo’s researchers didn’t stop there. A few years after I joined the company, we were tasked with introducing another breakthrough medication. This drug was naltrexone, sold under the brand name Trexan. Naltrexone was another antagonist, but it was different from naloxone. Whereas Narcan only lasted for 30 to 90 minutes, a daily pill of naltrexone effectively blocked the brain from absorbing other opiates for 24 hours. The goal was to prevent detoxified heroin users from relapsing by “shielding” the brain from an opioid’s effects.
For the first time in history, a pharma company had developed all three classes of opioids – agonist (oxycodone, hydrocodone), agonist/antagonist (nalbuphine), and antagonist (naloxone and naltrexone).
And I was tasked with selling them.
Who did Endo expect your customers to be?
The primary audience was going to be methadone clinics.
The long-term goal was to get methadone clinics to use methadone as a detox drug and then use Trexan as a long-term medication for relapse prevention. We thought this would be a welcome option, since methadone was a difficult drug to take. Patients had to come to a clinic on a daily basis for months or years. On naltrexone, they could take their medication at home.
The second important customers were psychiatrists, who were treating a small but growing patient population. In the 1980s, there was a growing number of “professional” prescription opioid users who sought treatment, including healthcare professionals, business executives, airline pilots, etc. For this group, going to a methadone clinic was not an option. Endo envisioned them getting Trexan from a private prescriber as well.
What kind of reception did you get when you went to sell Trexan?
In a word: hostile. The methadone clinics needlessly saw Trexan as an existential threat to their business model. Life-long methadone use was based on the “metabolic syndrome” hypothesis, which analogized opioid addiction to diabetes and methadone to insulin. Naltrexone upended this theory by proving that patients could end their opioid use and still prevent relapse. But the “metabolic syndrome” had strong support from methadone proponents like Drs. Vincent Dole, Marie Nyswander, and others. There was also the unfounded concern that naltrexone would cause anhedonia by blocking the endorphin receptors. Poor medication compliance was another commonly cited reason.
How did your experience selling Trexan lead you to opening your own treatment center?
I was with the company for barely five years when DuPont Pharma decided to stop promoting Trexan. It was disappointing to see physicians showing little or no interest in the medication, and, of course, the hostility from the methadone clinics. Because to me, I thought it was a very useful drug. I believe the discovery of naltrexone should have been a “penicillin moment,” a time when we realized we had a very effective tool to prevent relapse, as opioid use started to rise.
But the thought of opening my own treatment centers was nowhere on the radar. Instead, I focused on promoting these medications to a larger medical audience, ranging from surgeons to family physicians. I became a rising star at DuPont based on my knowledge of pharmacology and selling skills. I wanted to spend the rest of my life in the pharmaceutical world.
But I was disappointed again in the late 1990s, when naltrexone was rebranded as ReVia and marketed for the treatment of alcohol use disorder. Naltrexone works just as well on cutting down alcohol consumption as it does on preventing opioid overdose. But ReVia was rejected too, just like Trexan was – this time by adherents to the AA model, which rejected all medications, even naltrexone, as a viable treatment option.
With rates of opioid use and alcoholism on the rise, the frustration and failure I felt promoting naltrexone became the impetus for opening my own treatment center in St. Louis in 2001. I wanted to bring treatment to the doorsteps of patients who were being devastated by drugs and alcohol. Naltrexone worked well in clinical studies. What would it take to replicate these conditions?
I had the answer: same-day outpatient detox and stabilization services, along with relapse prevention counseling on an outpatient basis in the evenings of weekends. Confidentiality and affordability were key.
What is ARCA?
ARCA (which stands for Assisted Recovery Centers of America) is the culmination of my efforts to standardize the treatment of addictive disorders.
ARCA started strictly as a private self-pay treatment program in 2001, working exclusively with patients struggling with alcohol disorders. To operate a confidential private program, I opened the clinic in a medical building. My patients were many of the same “professionals” I couldn’t convince other doctors to treat: internists, cardiologists, dentists, family physicians, and dermatologists. But leasing a suite in a traditional medical building was no easy task. When I first told the manager about the work we would do, he politely but firmly told me he could accept us. His concern was patient behavior, that they’d cause problems and disruption. I assured him that ARCA would be different, and he reluctantly agreed. Ultimately, we became one of the best tenants, and our patients felt comfortable walking into our office there.
I also developed considerable experience treating opioid addiction among physicians. The drug most commonly misused by anesthesiologists and nurse anesthetists was -- you can guess – fentanyl! This was long before fentanyl became a street drug. Back in 2001, the only medication we had to treat OUD and AUD was naltrexone tablets. We could not use methadone because of the restrictions, buprenorphine didn’t yet exist on the commercial market, and Antabuse was not very practical since it made patients vomit. So ARCA had experience in the early 2000s using naltrexone to treat both alcohol and opioid disorders.
By 2003, prescription opioid addiction was becoming a problem in St. Louis, and by 2005, our clinic was inundated by calls for treatment. Buprenorphine (SUBOXONE/SUBUTEX) was approved in 2002 and we were one of the first clinics in St Louis to use this medication to detox patients off opioids. The protocol was 2-3 weeks of a buprenorphine taper and then start patients on naltrexone tablets. The success of the program was based on observed ingestion of naltrexone, either at the clinic, at a pharmacy, or by a family member.
After about six years of operating as a private clinic, the State of Missouri encouraged/demanded all state-funded agencies offer medication-assisted treatment (MAT), as opposed to just social detox and 12-Step meetings. By 2008, the heroin problem was raging in St Louis. Most of the heroin came from Chicago, which was a distribution point. We were happy to help and in 2009, ARCA opened a clinic downtown to make treatment more accessible to those who needed it most: people coming out of correctional facilities, homeless patients, and the growing number of people using opioids. Now we exclusively work with the minority, homeless, and correctional population. For the longest time this group was overlooked, and the overdose statistics reflected the urgent need to do more for this group. We opened two more clinics in the heart of downtown, an area often called a “treatment desert.” We also have a state-of-art mobile clinic.
When did ARCA start offering buprenorphine maintenance treatment?
ARCA was one of the first clinics in 2002 to offer buprenorphine as an effective detox medication. When buprenorphine was first introduced it was for detox followed by a gradual taper, or, in the case of ARCA, naltrexone tablets. The long-term maintenance with buprenorphine came 6-8 years later. As the opioid epidemic skyrocketed, the guidelines from SAMHSA switched to emphasizing long-term maintenance with buprenorphine. Tapering and switching to naltrexone were no longer recommended.
Now ARCA offers both naltrexone and buprenorphine treatment, as well as comfort meds for those going through detox and withdrawal.
ARCA isn’t only treatment services. It also offers housing, access to social services, and a wide variety of other programs. Tell us a bit more what else ARCA is offering to St Louisans.
When we started working with the indigent population, we quickly realized the enormity of their needs. Drug addiction throws patients into a survival mode. I call it internal homelessness. By the time patients come to us their needs are intense. They have employment, legal, marital, medical, and psychological issues, and so many more. All of these must be addressed. Giving them a prescription for buprenorphine or naltrexone is a good start, but it’s woefully inadequate as a total treatment protocol. I describe treatment as putting Humpty Dumpty back together – it takes all the king’s horses and all the king’s men. The two most critical needs are housing and jobs. The federal and state governments have realized this and have made substantial funding available for housing. When patients come to the clinic, the social workers do a needs assessment and make every effort to help. ARCA’s motto: make treatment attractive.
Tell us about ARCA’s outcomes and success. Do patients like treatment there? Have you impacted overdose deaths in St. Louis? What’s some tangible evidence of ARCA’s impact?
The best testimony of ARCA’s success is we’ve been in business for 23 years, we’ve grown every year, and we expect the growth to continue for the foreseeable future. The secret to our growth is always striving to improve and refine the services. Our two operating principles are humanizing the treatment and making it attractive to our patients. We listen to our patients and our staff to incorporate changes. We collaborate with St. Louis University School of Medicine and that relationship has worked well for both organizations. Their fellows in addiction medicine train at the ARCA clinics. Several of the well-trained fellows now work for us. We have made our treatment protocols and algorithms available for anyone and welcome treatment professionals from other organizations to visit the clinic. With 2,600 active patients in our clinic, we feel are making an impact on addressing the opioid crisis and turning the corner.
How is ARCA funded? Do you have sufficient funds for your services?
We are now a state-funded agency. The state has been very good about providing funding for housing, transportation, medication, drug testing, and other behavioral services. Obviously, the funds are limited, and we have to live within our yearly allocation. The increased funding during Covid is no more. We are hoping to receive something from the Opioid Settlement Funds, but Missouri is still figuring out how best to use the money.
If ARCA could expand, what would you like to do?
The greatest need is housing. We would like to open more housing units and open more treatment sites. A big challenge is finding staff and reimbursement rates. Since our program is so heavily medical-based, our fixed costs are high. The treatment of addictive disorders is still heavily tilted towards self-help programs. You have often heard the statistics that less than 10% of the 23 million patients impacted by this malady receive MAT services. An area of great potential is web-based treatment programs, especially for the treatment of alcoholism. I envision offering patients throughout the country access to a physician on the web and have medications like naltrexone made available.
Part II: Naltrexone
You are one of the country’s most vocal proponents of naltrexone. What is different about naltrexone treatment versus traditional opiate agonist therapy?
In a word, the difference between agonist and antagonist therapy is medication “compliance.” The withdrawal or negative feedback of OST (opioid substitution treatment, the daily use of methadone or buprenorphine) is a strong motivator for patients to stay on the meds. Since naltrexone has no positive or negative feedback, a patient can skip a dose and not feel any different. Patients on OST focus more on the medication and are often less interested in the wrap-around services, like individual and group counseling. Our biggest challenge is convincing patients to stay on either of the two meds. They often believe they are “cured” and want to get off all medications, not realizing they are putting themselves at a high risk of overdose if they relapse. The key to long-term success is staying on either naltrexone and OST and working on getting back into a thriving mode.
What does naltrexone treatment require from the patient?
Surprisingly not much. We take time to educate the patient on what naltrexone is, why it was developed, how it works, etc. Unfortunately, patients and many staff members know little about this medication beyond it being an “opioid blocker.” The key is answering the two most common questions: Will I become a zombie on naltrexone, and will it affect my sex life? (The answer to both is no.) We also educate the patient on the danger of overdose if they stop the medication and start using opioids again. This caution applies also to buprenorphine.
Naltrexone is currently available in a monthly injection form called Vivitrol. Can you tell us a bit about Vivitrol’s development? It’s surprisingly controversial.
I would direct your readers’ attention to NIDA monograph 28, which elucidated the rationale for a sustained release preparation back in 1981.
But in summary, since naltrexone does not cause any withdrawal, compliance has been a challenge. Patient retention on daily naltrexone tablets was low.
A small pharmaceutical company called Alkermes recognized this, and worked to develop a sustained-release delivery system that would release precise quantities of the medication over 30 days. The development of Vivitrol was partially funded by the federal government, and in 2010, a pivotal study was done in Russia to obtain FDA approval for the drug. Some have criticized this work, arguing that the study was not “realistic” since buprenorphine and methadone are banned in Russia, and clinical outcomes would have been different if it were conducted in the U.S. But it was still the largest study ever done using naltrexone pills, and it was done for a good reason: Russia was undergoing a heroin epidemic at the time. And naltrexone helped.
Despite the controversy, your patient population is doing well on Vivitrol. Can you talk about how you use the drug, and how your patients respond to it?
When we expanded our program in 2009 and started treating St. Louis’s homeless population and clients coming from the correctional system, we offered patients a choice of treatments, and that was a big deal. Most of our patients had been on methadone before and did not want to go back on it. Now they had a choice of buprenorphine or naltrexone. We take the time to explain to the patient the unique features of each medication and how they can start on one and switch to the other if need be. But patients really like Vivitrol. It’s not uncommonatient to come to the clinic and say, “I want the shot!” The success of the ARCA clinic is giving patients a choice. I wish more clinics did it.
We are razor-focused on outcomes. We use about 150 Vivitrol injections a month. There is no coercion, pressure, or financial incentive to use one medication or the other.
Part III: Safe Prevention Sites
Points readers are probably familiar with supervised consumption centers (SCCs), like OnPoint in New York and the one I visited in Switzerland in 2023. These are places where people who use drugs can consume them under medical supervision, with professionals who can respond in an emergency. These sites are extremely controversial, and for the most part they’re banned across the United States, even as they’re embraced in Europe and Asia.
You have a concept that builds on SCC's but offers some alternatives. Tell us about safe prevention centers (SPC).
SPCs can best be described as the next logical level of harm reduction, now that harm reduction is more available. Naloxone is an over-the-counter product now – it doesn’t require a prescription anymore. And there are centers in most American cities where people can access harm reduction kits, with naloxone, fentanyl test strips, syringes (where it is legal), first aid supplies, gauze, band aids, etc.
SPCs would expand on those ideas, by helping people access the prescription medications they need to get off street drugs and onto naltrexone.
First, SPCs would provide a supply of comfort meds – like clonidine and cyclobenzaprine – which are critical in the detox process. These drugs break the cycle of withdrawal, and make a huge difference in stabilizing patients.
Then, assuming the SPC can secure a statewide prescription for naltrexone, patients would be able to obtain a small supply of naltrexone pills (10-15), to prevent relapse to drug or alcohol use until the next appointment with the physician. Patients would receive detailed information on naltrexone, and sign a consent. Then, ideally, the patient will continue naltrexone therapy. SPCs make access to this drug easier and fast – the same way access to naloxone has been made easy and fast.
Since more and more treatment clinics offer medication assisted treatment and many of them – like ARCA -- have onsite pharmacies, such clinics are well-suited to becoming SPCs. Another potential opportunity is mobile clinics that could go to high-risk areas and offer both naloxone and naltrexone. I believe we need to spend as much time and funds as possible on educating potential drug and alcohol users on prevention options, and that includes naltrexone, which is very effective at preventing overdose death. SPCs can also be funded by opioid settlement funds.
It's the right time to try it. For the first time in years, we’re finally seeing a 10-14% drop in overdose deaths. We’re not sure what caused it, but this is a unique opportunity to take prevention to heights. I believe SPCs – and naltrexone – are an important, but historically underused, answer.