Why Naltrexone Was Rejected for 40 Years w/ Percy Menzies

Speaker 1:

Percy Menzies was there at the beginning. A pharmacist by training, he helped launch Naltrexone at DuPont in the 1980s and later when

Speaker 2:

it was approved for alcohol dependence.

Speaker 1:

He believed that they had medication that could change millions of lives. Instead, he watched it run into resistance from doctors, treatment centers, and some of the most powerful organizations in the field. Percy eventually left DuPont and built his own treatment model around medication that he had spent years trying to get people to accept. This is a surprising firsthand story of how medication proven to help people struggle, who stood in its way, and why more than forty years later, Percy believes Naltrexone's moment may finally be here.

Speaker 2:

Percy, thanks for coming on today.

Speaker 3:

Thank you for inviting me. It's just a pleasure.

Speaker 2:

Got an amazing background that spans more than twenty five years in this recent project that you were telling me that was semi started as semi retired.

Speaker 3:

Oh, about forty years.

Speaker 2:

Forty years. We'll go with forty years. Yeah. I don't wanna jump over another fifteen there. So but why don't you give us some of this very unique background that you have?

Speaker 2:

Because you were at DuPont when Naltrexone was first launched. What was your role in bringing it to market there?

Speaker 3:

I was, I came as an immigrant from India in 1977, and I started working for this pharma company, DuPont Pharma, in 1981. And at the end of eighty and, of course, that time, our claim to fame was developing a range of medications from the opium poppy. So we had the super heavy duty drugs called Percodan, Percocet, Oxycodone, you know, which are used to treat chronic to treat acute pain. We also had developed this medication called Naloxone or NARCAN. So in '84, three years after I joined them, at the end of eighty four, Naltrexone got approved for the first nonaddicting drug to prevent people from relapsing to opioid use, especially those who are coming for coming from coming back home from residential treatment or from the from prison or jails.

Speaker 3:

And we must begin the market. We started the marketing in the early part of eighty five. I was a sales rep, So my job was to go to physicians, go to clinics, and tell them about this unique pharmacology of non of naltrexone, and the brand name at that time was called Trexan, t r e x a n, to help patients who are struggling with heroin addiction and who had a higher risk of relapsing when they came back home.

Speaker 2:

Oh, at that time, was that only was it only directed towards opioid at that time, or was it also alcohol?

Speaker 3:

It was only for opioids. It was the first nonaddicting opioid to be used to prevent people from relapse. It was before that, there was a medication, a very controversial drug called methadone. So methadone was offered as treatment, and it was based on this belief that once you are using heroin, you need to be on methadone for the rest of your life, almost akin to a diabetic patient being on insulin, which itself was a very was a very misleading theory, okay, hypothesis that had no place. So the federal government real realizes we had to provide a non addicting drug.

Speaker 3:

So they spent millions of dollars. This was a federal government project. So Naltrexone had nothing to do with DuPont. We only marketed because they just they saw that you cannot treat an addiction with an addicting drug. So methadone was supposed to be the stop gap arrangement to be used for a short period of time until the newer class of medications came on came online, and we could just offer people medical treatment similar to other drugs because no chronic condition has has been successfully eliminated with an addictive.

Speaker 2:

One of the things that I've noticed about you just already immediately talking before we hit record and now is that you are fully invested. So at that point in these early days, and you, know, you got you got you you have this new drug. What did you believe that Naltrexone could do for addiction treatment?

Speaker 3:

Now it was such a revolutionary drug, and my background was, his his pharmacy. I have a master's degree in pharmacy. So I immediately understood the interplay between the opioid receptors in the brain, the role of a substance that the body produces, which is similar to morphine called endorphins. So they were just being this this interplay of endorphins, opioid receptors, and a drug that prevents that binds with the opioid receptors and prevents the endorphins or opioids from binding with the opioid receptors was fascinating. I was absolutely enthralled by that.

Speaker 3:

And I said, I can we can I could explain to physicians how to treat blood clots because they had a drug called Coumadin and other substances? So I thought myself, I almost felt that I was an I was a knight in a shining armor going out to help people. So that's what I started. And to our shock, the of course, we can talk about it. The hostility that we encountered was absolutely shocking and I think very, you know, very demobilized.

Speaker 2:

Yeah. Because I wanna talk about this rollout because it didn't really go as you had expected. What was is there one specific memory or one conversation that you remembered that you were just taken back that you thought would go completely the other way as far as it was interpreted?

Speaker 3:

There are many, but the it's obviously at several levels. One is that we were shocked to find out that physicians had no interest in treating addiction. Physicians were trained when they went to medical school that if you have a patient that is addicted to drugs or alcohol, just get rid of them. They don't have a place in your in your private practice. So right off the bat, obviously.

Speaker 3:

And because of that, they had created these freestanding clinics called the methadone clinics. It was started off in around 1974. In the '70 during Nixon's time. And we'll talk about the the the the very critic the very controversial role of bathroom clinics. So they were supposed to be our main market, but you would go to them and offer them a treatment option.

Speaker 3:

So, yes, some people may need to be on a lifelong a lifelong methadone, but not everyone. If a patient requested that they be tapered off methadone and or Delskin, what are the other options? It should have been offered. It was never done. So the hostility was at every indifference on the part of physicians and outright hostility from the methadone because the methadone clinics needlessly saw this as an existential threat to their business.

Speaker 2:

Why do you think it is that doctors immediately said, this isn't for us? Is this and then we also, of course, had the clinics. But is did you look at this thinking we have a systemic issue right now?

Speaker 3:

The systemic issue was that, it's almost impossible to treat an addictive disorder in a physician's office. You need a team. And there's a long and a dark history of trying to treat addictions as a medical condition, and that has failed time and time again because we did not really understand the neurobiology of addiction. So in our, you know, misguided in our misplaced belief that these medications would help. For instance, we thought morphine would be a good treatment for alcoholism.

Speaker 3:

We thought cocaine would be a good treatment for alcoholism. So we use these medications in the mistaken belief that these are going to help patients, but the cure turned out to be worse than the poison and turned out to be worse than the dishonor. And because of that, it gave rise to these self help groups of, you know, Alcoholics Anonymous and so on because the the fact that alcoholism or drug addiction was a self inflicted problem. You cannot become a drug addict unless you imbibe the drug or unless you use it, right, or you treat alcohol. But since it was self inflicted, there was very little sympathy on the part of society to help these people.

Speaker 2:

Curious to know at that time, because we're many years later, and alcohol today is viewed very differently than it was back then, was there much more emphasis on the opioid issues versus alcohol? Was alcohol just a secondary thing when it came to Naltrexone?

Speaker 3:

Oh, absolutely. Alcohol was not even on the radar. Alcohol was pretty much relegated to Alcoholics Anonymous and self help groups and really was seen as a model of spiritual failing, which is best addressed and best treated through a spiritual model. What is called out? So what was concerning to the know, for heroin has always been a problem in The US.

Speaker 3:

Where where it got magnified and went out of control was what happened in Vietnam. So Vietnam changed the entire chemistry or the entire algebra of addiction because there was an unfounded fear that these GIs who are who are addicted to heroin are going to come back here and cause just enormous law and order problem because they they have training in the use of weapons. And if they can't find, their heroin or the opioids, they will hold up pharmacies, hold up people. And there was a totally unfounded fear. Because as long as heroin was confined into the black community, nobody cared.

Speaker 3:

It was seen as a peculiarly black pro problem. And if they're using heroin, so be we are not going to we wanna we are not gonna do anything. So the treatment of heroin addiction or opioids has a very strong racial component. What happened was so year when they suddenly found that the white white GIs in in Vietnam are getting addicted to heroin, then all alarm bells went up. It was a nine alarm fight or five alarm for the worst ever.

Speaker 3:

So it was a big concern. It was so and Nixon, you know, played a role because he wanted to be seen as a law and order president. And he was very concerned that, you know, this could be a big law and a big this could be a big issue for him, law and order. So he wanted to do something about it as the Vietnam War is coming to an end, and turn thousands of GIs were coming back.

Speaker 2:

Such a deep history. And here you are in the middle of it with a drug that could address this. You're going out. You're going to doctors. You're met with rejection.

Speaker 2:

You're going to clinics. You're met with his hostility. And then you've also said that special interest groups help to derail Naltrexone. What are you talking about there? Who who are they?

Speaker 2:

What do they have to lose?

Speaker 3:

The special interest group was the methadone clinics. Okay. Now you don't offer a narcotic drug in a clinic setting. It is completely counterintuitive. It has never been done.

Speaker 3:

So Nixon want created this. And if you read, there's a fascinating book that got published a few months ago called Addiction Inc by a brilliant history writer called Emily Duft. And she talks about so Nixon, in his misguided quest to bring about law and order, he spent tens of millions of dollars opening methadone clinics and offering free methadone to patients. I mean, that is just crazy. But that's the way he went about saying this this we do that.

Speaker 3:

And the way the methadone creates methadone clinics were created and the way private clinics opened up because to start offering an addicting drug does not require a PhD in the, you know, in market. And anybody can hang a shingle outside the door and start offering addicting drugs, and people will line up. And that's exactly what happened. In the New York area, there are physicians who left their practice and opened clinics and started offering methadone as under what is called investigative drug. It was not even approved by the FDA.

Speaker 3:

Keep that in mind. It was not even approved by the FDA, and yet they were offering methadone as an investigative drug. So the whole field got so badly corrupted and steeped into into shade business practices. And and it got it got legitimized when the methadone clinics were opened. So now that these clinics were opened and they were established, they did not want to lose a very lucrative business model.

Speaker 3:

They didn't want anything to to interfere or or even threatening their their business model or the belief that it's a this an insulin method was like like the insulin. And to make matters worse, what was even more disturbing was this belief that Naltrexone, because of its poor compliance, is only effective for the well-to-do people, physicians, airline pilots, business executives, and so on. So that led to a further segregation. One medication for a certain group of, you know, professionals and the rest of them gone. That even that bothered me even more.

Speaker 2:

Oh, so you've got we've got potential race issues, systemic issues. We have class and, yeah, class issues here. We could go so deep into it. Also, what you brought up there that many people overlook often is that addiction can be big business for many people, and it always doesn't always come from the right place, unfortunately. And so you're up against all of these factors, which I would think is incredibly challenging.

Speaker 2:

What did you feel like as you moved forward that you working with DuPont that they got wrong?

Speaker 3:

I'd you know, I I and, obviously, it was such a revolutionary drug. It was not a conventional pharmaceutical, like a beta blocker and, like, a calcium channel blocker to treat hypertension or to treat high cholesterol, any of those things. It was so unusual that we could not be Coupon did not really know how to how to project it. Secondly, no medication, especially in the treatment of addictive disorders where most of the where most of the treatment is paid by the federal government, if they are not from is not they are not going to support it, it's going to be very difficult to promote. But I believe the first strike against against Naltrexone or you can say at that time, Vutrexone, was the black box warning or the or the or the box the box warning.

Speaker 3:

The black box warning is a death knell to a pharmacy. And they they placed that black box warning on Naltrexone, and that was the really the beginning of the end fight. Because now physicians solve a very a very easy and ready excuse not to use it because there's there's many patients who are you who are using heroin. They already have some liver issues. They have liver infections and so on, hepatic infections.

Speaker 3:

You're not going to use this drug. And, obviously, the big issue was compliance. Methadone clinics survived because the methadone was given in a clinic setting. And even today, after after sixty years, it's the only drug that is given in a clinic setting that patients have to come in every morning, stand in line, and ingest the medication under the supervision of a staff member. And so you're you're giving a not you're giving a narcotic drug under supervision, and we expect people to be given Naltrexone.

Speaker 3:

And and we we expect them to take it on their own volitions. Is it not gonna happen? Because I do not want to give up my habit. I like my habits. I'm taking a legal narcotic.

Speaker 3:

I'm not willing to give it up because it's going to take a lot of counseling and training and behavior modification to head this field.

Speaker 2:

I'd imagine that that must have been incredibly frustrating and deflating. And what do you remember back going out, having these conversations, going back within the DuPont organization with your team and having conversations? What point were you just like, there's we're pushing up against too much of a hostile market. It's too hard to compete against it.

Speaker 3:

Seem to begin with, there was no competition. It was not like we were competing against another drug like in in pharmaceuticals. Try we're confused trying to convince, you know, a a clinic to change its to change its its clinical practice. But we also realized that the market for so when when they introduced naltrexone, it's the first drug that was approved by the federal government under the orphan drug. So right off the bat, there was also a belief that there's no way Naltrexone can compete with methadone or they will have a large enough patient population.

Speaker 3:

It will be for a very small population who will probably 200,000 patients. That's why they gave us an exclusivity under the orphan drug. So the first drug to be approved was Naltrexone. And I truly believe that the DuPont family did this out out of a sense of altruism. They really wanted to help society.

Speaker 3:

So, you know, we are the we are the company that market, you know, super heavy duty pain meds, and may I say, in a very responsible manner. K? So when this drug came out, they really wanted to help society. So we had an earlier drug, Narcan, which, you know, which should have been should have been celebrated as a major breakthrough. And I always say the the discovery or the development of naloxone should have been as important as the development of penicillin or the discovery of penicillin.

Speaker 3:

Because we developed a new class of medication that comes from opium but has the effects of exactly the opposite of opium. And that's why they're called opioid antagonists. So instead of celebrating this and saying that, hey. Now we have a new class, let's discover dozens and dozens of more medication in this class, it was seen with complete skepticism. So naltrexone, naloxone was fueled with complete skepticism.

Speaker 3:

Naltrexone was fueled with complete hostile because it was threatening somebody's somebody's market down.

Speaker 2:

It's baffling and at the same time not surprising. So, you know, let's skip ahead a few years. So a few years later, Naltrexone came back under a different brand, and this time it was for alcohol. What was the difference that you were seeing the second time around?

Speaker 3:

We marketed in '85. By about '87, '88, we just threw our hands up saying there's no way we can market this product. We cannot even give it away, so we stopped marketing. But this revolutionary new class of medication was of great interest to scientists who were curious to see why this you know, as I told you, at the interplay of endorphins, the opioid receptors. And lo and behold, this young scientist in city of Pennsylvania called Joseph Vopicelli, he found it to be very effective for alcoholism.

Speaker 3:

But, again, with alcoholism, quite excited. To begin with, it was still a major problem. One of the biggest problem after smoking was alcoholism. And we had really no competition because the only drug that was already there in the market for about fifty years was a was a controversial drug called Antipuse that you get sick if you drink on. So the market was wide open, and we were very hopeful that Alcoholics Anonymous, you know, a self help group who were always looking for the founder of of Bill Wilson, always was looking for science to come up with an answer.

Speaker 3:

So if I finally had an answer, we were very optimistic that this time it will get some traction. And by that by the time it got approved in 1994, I was hired up with the company. So I had I went from a sales rep onto a district manager and later on, you know, an associate product director. So now I had more inputting. So we thought this is going to be a much easier task.

Speaker 3:

So we changed the name because there was there was some issues with, you know, with Abbott about using the old name. So we came up with a name called Rivia. And this time, we felt very optimistic. Within weeks or months, we were shocked at the at the hostility we faced from the heavyweight groups like, Hazelton Foundation and Betty Ford, who were the main purveyors of, the 12 step, because they immediately insisted Hazelton Foundation said that alcoholism is not a medical condition, and medications have no role to play in the treatment or prevention of alcohol. And if the 800 pound gorilla threw this pill out, the chances of it get getting any traction was fortunate.

Speaker 3:

And then, of course, and I when I when it came to the alcoholism, we were just talking to a lot more physicians, and I didn't realize that so many physicians who claim to be treating addictive disorders were themselves in. I have never encountered that ever because when we talk to cardiologists or we talk to neurologists or surgeons, that would never come up because these people were qualified. They went into cardiology or neurology based on the qualifications, not on their antecedents or what the history was. So also turned out to be a big roadblock because many of them were very beholden to AA saying that they got well through AA, and that's the way. So all these all these situations converge together in a perfect storm that sunk Naltrexone.

Speaker 2:

So interesting. Well, first of all, to the comment around the doctors and the other professionals themselves checking it out, it has no distinction. Addiction doesn't discriminate. Anybody's avail can be in that, but you wouldn't think that it would go the other direction. You would almost think that in their predicament, if there was only a way that would have made it easier, that would make it more predictable with a higher success rate, that they would wanna support it.

Speaker 2:

That's what logic would say. So this is your second time around. You personally, I'm gonna ask this, how did that make you feel? What were you thinking?

Speaker 3:

You you know, really very dejected because we would say I said, doctor, can I leave you some? Because I thought I'd still consider myself a very good, quote unquote, salesman. I can convince physicians on the benefits on the pharmacology of a medication. But here it was, again, a complete, you know, brick wall. Doctor, can I leave you some clinical studies?

Speaker 3:

Not interested. Can I leave you some samples? Sorry. Not interest. I have no interest in using a medication because I now belong to a new religion called EEA, Alcoholics Anonymous.

Speaker 3:

And don't try to con Just the few of them who started using it, they really didn't know how to really how to educate their patients, how to, you know, how to tell the patient what it is and why it is they done because all it was called an opioid blocker. So that negative connotation continued to hurt the to hurt the product. And the black box warning became even more magnified because the majority of the patients with alcohol use disorder, they have elevated liver enzymes. So they have liver damage. So now we are asking you I'm asking a doctor to use it.

Speaker 3:

That is a potential does it that is a potential of causing liver damage. Oh, no. I'm not gonna touch that. So they had enough excuses to reject. And patients and some of them, some physicians would prescribe it, write write a script and say says, Mike, take this take this pill every day.

Speaker 3:

If Mike wants to drink every, why would I? So many of them would not even fill the prescription. Others would have it filled. We just sit on there on the shelf, not take. Because anything that that affects your survival instincts, this affects your survival.

Speaker 3:

So the body has been tricked into believing that you need alcohol as much as you need food and sleep or sex. So giving that up, it's a huge undertaking. And I can do it for a short time, but certainly not for the normal. So it was very frustrating to see that happening. But used correctly, the medication worked like a charm.

Speaker 3:

And then, of course, I got an I was I realized that if if Naltrexone's major problem was comp was patient compliance, why not treat like methadone? Because methadone is given in a clinic form because of the fear of over of overcompliance. If give somebody a month's supply of methadone, it'll probably be gone in three days. But if I give you a month's supply of Naltrexone, it's gonna be thrown out. So why not create a virtual clinic where the patient came to the and took it under under the supervision of a staff member, what we call a direct observed therapy?

Speaker 3:

If they can take it just three days a week, they came on a Monday, they came on on a on a Wednesday, and not on a Friday, it worked like a shock. And I field tested it. But then most physicians didn't have the the the wherewithal that did they didn't have the facilities to to use this. The other problem we also encountered was that many of the patients who got a prescription from the physician for Naltrexone, they also had to go out to see a therapist. And I have never seen therapists who are so indifferent were so hostile to the medication.

Speaker 3:

They were even more hostile than the physician because ninety five percent of them in recovery themselves. So that message was that all these things don't work. These are fads. Okay? They come and go.

Speaker 3:

K. Well, if you want to really get well, follow my path. Lose everything, and virtually be under a bridge, and then we'll rebuild your life. So that was the message. So the host so if you if my therapist is so anti against the anti medication, why should I change my mind?

Speaker 3:

So that was another, you know, black so all this in the black box warning, the physicians not really educating patients about Naltrexone is and the hostility from therapists, all these things combined to scuttle to scuttle them. We could not even give it away. I mean, we tried everything, stock bottles, samples, nothing.

Speaker 2:

Couldn't even imagine the level of frustration. I'd say you probably were beyond that. You know? Beyond frustration. I think that's you being nice and cordial here.

Speaker 2:

But, I mean, you have something that obviously works. You know it works. You can't move forward because all of these different things, anywhere from doctors blocking you to clinic special interest to a dogma about how recovery is supposed to look like and not willing to budge beyond that. We sort of know and listeners that we're seeing a resurgence and adoption and a new light in this medication. But before we move, you know, to the present day, can you give me the next step or the next milestone that you kinda hit?

Speaker 2:

Where did it go from here?

Speaker 3:

Yeah. So I worked for DuPont for eighteen years, and Naltrexone was was the north star that kept attracting me to telling me, he said, this is telling me this is the path you have to navigate. I cannot I've had so many medications, but Naltrexone absolutely gripped my imagination. And the imagination also turned into a determination because used correctly, whenever I tried I think I tried I tried it in courts. I tried it in in homeless shelters.

Speaker 3:

One of the most amazing experiment I did was getting Naltrexone in a homeless shelter. This is in Arizona. Now if you were always said that Naltrexone Naltrexone is only for the motivated patients. So this this caseworker from a homeless shelter said, he's, of course, would you please consider giving me Naltrexone for my homeless patients? And I told him, I said, you're out of your mind.

Speaker 3:

I said, they have no motivation to get friend. He says, you don't believe. He says, you offer them something. It'll help. So based on the DOT model, direct observed model, I said, okay.

Speaker 3:

I'll give you some samples of Naltrexone, but it has to be you they cannot take it home. He said, well, they don't have a home. So what that I'm sorry about that, but they have to come to the to the shelter three three days a week to take it. That's not a problem at all. And this was a huge this was a big shelter in Phoenix, Arizona.

Speaker 3:

They also had a medical clinic there. So everything fell in place. And all these these patients would come three days a week to take it. And the and they also had AA meetings because they had AA meetings every day. And the look since it was at the shelter and this caseworker was running it, there was no issue about hostility against Daltrexone.

Speaker 3:

And the and the results were absolutely amazing. Now these guys are bathing. They've been grooming themselves. Clean clothes. So he asked a reporter, would you want to do a story on this?

Speaker 3:

He say, out of your mind, he said, who's going to see us? Who's going to write a story about you know, which editor will allow a story about drug addicts, you know, alcoholic? So, no. Just come. This guy came for two, three meetings, and he wrote a story.

Speaker 3:

And the editor said, this has to go on the front page of the newspaper. That that was the Arizona Republic. So I realized that if you create a treatment infrastructure, show them how to create that. It's it's going to work. But I had difficulty create.

Speaker 3:

I did it in drug courts. I convinced judges how to give it, you know, and to involve the local pharmacist into that. And the more I did this, the more I was convinced that this is my calling. I'm going to change the field. So after eighteen years with DuPont in the year 2001, I left the company and I said, this is my Because I knew all the top researchers.

Speaker 3:

I knew how to do that, and that's how I started. Direct observed therapy. You come to my clinic three days a week. Each time you come to take the pills, can have a cup of coffee. You can grab a granola bar, dig the two pills, and each time you come in, that becomes a teachable moment.

Speaker 3:

And we offer them, very kind to them, very compassion to them, and the results were absolutely amazing.

Speaker 2:

What a what an incredible story. So you left this longtime position to follow the calling calling, which and you basically, at a grassroots level, started to just hustle this clinic here, this shelter here, this organization here. How long did that go on? Because we're gonna get into this in a minute around the current, but was that slow? Were there challenges?

Speaker 2:

Oh. Did it was it running uphill and then all of a sudden, it's like you reached the proverbial tipping point?

Speaker 3:

Well, it was very, very tough because, you know, when I opened the tunnel, the skepticism was absolutely shocking. Based on three on three issues. One was I'm not in recovery. I did not realize to break into this into this group, you have to be almost in recovery. It's almost a prerequisite.

Speaker 3:

So they say you are not in recovery, so you don't know who we are. You're you're a normie, so they call us normies. Okay. You're a normie. Secondly, you're not a physician, and you are trying to promote it.

Speaker 3:

And and thirdly, you're trying to promote a medication that has been thoroughly discarded by the medical community, by the therapists and counselors, and by AA. And you think you're gonna succeed? But don't even darken the doors of our of our clinics and our our offices to the point that my wife, you know, was in tears. She said, our children are starting to, you know, Catholic schools. How are we going to survive?

Speaker 3:

They should be in tears. And I would just be pleading up, but I said something just told me that we things will be And she said, I can't promise you. But the only one who had faith in me was my amazing wife, Judy. She's a nurse by trainee. So two of her stuff.

Speaker 3:

So then I said, okay. I went to the addicted physicians for a pro program that treats addicted physicians. They are called physicians health program. And I went to them, and I said, look. You know?

Speaker 3:

Many of them, you send them away for residential treatment, and then they come back. They had a very high risk of relapsing. Why don't you consider my program? And I told them what I do. I went to a judge, and I said, judge, you are seeing this revolving door.

Speaker 3:

Right? Patients coming in, relapsing, going back to jail. Why don't you consider my program and send me the worst patient? But the thing is that they have to come to my clinic three days a week to take this and so on. They were skeptical, but, you know, they're impressed with my sincerity and my passion to do something for them.

Speaker 3:

Okay. We'll try this. I remember this one judge. They sent me one patient. The guy did so well.

Speaker 3:

They sent me another patient. And the second guy did so well. After the third patient that just shows up at my clinic saying, what the hell are you doing with them? They're they're doing so good. And that's what happens.

Speaker 3:

That's why I call it an amazing medication so that for that one patient who takes it in the right way, that's a silver bullet. For that patient, it's not it's not a not a magic pill for the entire community, but you take one patient at a time. And when they start taking this pill and and you do the and you have the counseling, the psychiatric help, and all that, it is amazing how well they start. And so I started by some very difficult patients, and then I would I went to reporters because my background was, you I had some background in marketing. And I said, would you want to do a story on one of these patients?

Speaker 3:

And I would ask these patients, hey. What do you want to tell your story about to a reporter? Because you did not commit any crime. You did not rape anyone. You did not hold up a stoke.

Speaker 3:

Just just because you got affected by alcohol, there's no crime in this. And I want to tell my story. And that's how it's smuggling. But the diehard, the clinics that were established, most of them were essentially, you know, based, self help based. They were very skeptic.

Speaker 3:

So they had unfortunately, nothing to do with. But I started treating the well-to-do people, and it slowly grew. And then my wife started to you know, I was able to breathe a sigh of relief. Be able to buy meat maybe once a week instead of eating beans and rice at every ridiculous. That's that's how it started.

Speaker 3:

It's early grew. Then, of course, I had several major breaks that I to tell you as we go along. But it's initially the first three, four years was And there were there were times I said, did I really make a mistake? And, you know, and I said, I maybe I should go back into pharmaceutical sales.

Speaker 2:

In that journey of yours where there was a lot of challenges, I'd imagine that there's one or two stories that really stick out in your mind that maybe at the point of even throwing in the hat, you said, no. This is evidence. I'm gonna keep going. Is there one or two patient stories anonymized that you kind of remember that just stand out?

Speaker 3:

I mean, there there are dozens of them. I remember this guy, he was in a serious car accident. He was drunk. He was in a serious car accident. So he was almost handicapped, and he was one of my first patients who, you know, he repeatedly canceled the appoint One of the biggest challenges was people not keeping the appoint Mhmm.

Speaker 3:

And he finally showed up, and we became in the this when he finally showed up, I said, why did you not show? And he says, I came yesterday, but I could not find your clinic. Said, oh, he hadn't heard those excuses before. So I was kind of angry with him. Then he finally shows up.

Speaker 3:

And when he shows up, it just breaks my heart that the guy was in a walker, so handicapped, he could not control his alcohol. And he said because he got some compensation for it from his car accident, whatever it is it was, he he paid cash. He paid for the entire program. He paid at that time, he used to charge $3,000 for a six month program. This was in nineteen two thousand one.

Speaker 3:

And he did so amazingly well that after five years when he died, he said, whatever you collect for my funeral, give it to the ark. All donations to be made to ark. Then I had a physician who was to be sent away to a residential program, and he's just begged of that of that of the counselor or the executive director of the physician's health program to give him a chance because he's I've got a I've got a young family. It'll be very difficult. Can you please help me?

Speaker 3:

And then the guy said, okay. Let me try your program. Because with the for the well-to-do people, this was another challenge. The people who are very wealthy physicians, professionals, they could not believe that an outpatient program can be just as if they had this they had this misconception that I have to go away to Newport Beach, or I have to go to Malibu and Arizona, pay $30,000 to get to. And I was trying to tell them that I said, you get well in the natural environment with your work and live.

Speaker 3:

And I would actually I would sometime when I give talks, I would carry a dog with me. So this is the Pamela's dog. If the bell should ring with the mouth but the but the mouth should not sallow it, that is effective treat. That's what Naltrexone does. It allows you to get well in your natural environment where you are bombarded with all these cues and triggers, and they don't help you, then they don't affect you, that is that is successful treatment.

Speaker 3:

And I said, look at the benefits of my program as complete confidential. You don't have to go for thirty days and lie while you were absent for thirty days. You know, you can come in the for treatment in the evenings or weekends and find it and convince these people. The big concern and then this is, how can your program that charges $3,000 for six months be better than a $30,000 program? You know, how the mindset we have.

Speaker 3:

Absolutely. Yeah. So all these things are, you know, a test. So then I would start using analogies like, okay. I said, if you want to quit smoking, a very addicting habit.

Speaker 3:

How many of you go to Arizona? How many of you go to California? Why should it be any different for alcohol or for drug addiction? And I would take a lot of time explaining to them, you know, what is Naltrexone? Why was it developed?

Speaker 3:

What are its benefits? And then my success was based on involving the family, especially the spouse, because I would describe addiction, alcohol addiction, alcohol, and as a family disorder. That somebody tossed a stick of dynamite into your living room, the whole family. So let the family members be be involved with this. So the family members, like the spouse would watch them take the pills.

Speaker 3:

Or if that did not work, they would come to my clinic to take them. If they were physicians, I would arrange for them to be arrange the pills to be given in the in the hospital pharmacy. Said before you go to surgery, take your two pills. If you don't show up, the pharmacist would call me, and I would call his department chair, and the guy's goose was coached. So there are some very simple down to earth measures you can take that strikes a good balance between if your punishment not and and recovered.

Speaker 3:

And they were surprised at how how cost effective a Medicare program like ARCA was. And I and I started offering this to anyone who wanted because what I was doing was not copyright. It was not a you know, it was not some family secret in the cooking. Anybody can let the company train at my clinic. And so I was very good about sharing my protocols, going out, giving talks to people, training.

Speaker 2:

It's so funny how some people's minds is places the value on the cost, but the one of the beauties of this is that it doesn't require inpatient, that it is much more accessible from a cost perspective, that more people can get access to this, which is the beauty of it. But then at the same time, you're still fighting a little bit of what you the black box warning. So before we move forward, I wanna ask you a little bit about that because people do get spooked when they read on online now around Naltrexone with side effects or maybe the liver risks that you mentioned there. What are you seeing in your practice when anybody brings that out?

Speaker 3:

So, you know, the company that makes naltrexone is locally based here. It's called. They also make methadone. So they were in a big quandary. So they make the bulk naltrexone, and they also make the methadone.

Speaker 3:

So they wanted to promote naltrexone. And I told them that if you want to really succeed, let's let's petition the FDA to remote a black box warning. So that's never going to So they didn't make any effort to do. Then there's a small biotech company out of Boston called Alcohol. They developed a long acting form of Narcan of Nalox Naltrexone called Vivitrol.

Speaker 3:

So they came to me and said, we really we want you to be our consultant. We want you to work with you about with how to promote this medication. I said, I'll work with you on one condition that we petitioned the FDA to remove the black box hopefully. And I said, I'm doing it. And on the base on the basis of my clinic experience, in all the years that we use Naltrexone, that is starting in 2001 and they came to me in in 2006, I've not had a single patient whose liver enzymes went up on Naltrexone.

Speaker 3:

Indeed, when people would come with liver damage, elevated elevated liver enzymes, I would be thrilled. Sorry for a different for a different reason because that became a squirk. And I said, John, look what I've done to your liver. We will start you on Naltrexone. Once you stop drinking, you'll be amazed when your liver heals.

Speaker 3:

And they were absolutely amazed. The family members would be amazed, you know, that. And so and I said, let's petition the FDA. So I testified, and my testimony was submitted to the FDA. And guess what?

Speaker 3:

The first drug where the FDA warning was remote, the black box warning was remote was Naltrexone. It doesn't have a black box warning. That happened in 2013. And now the irony is that that if people if people with serious liver failure, see serious liver damage, what is called compensated liver, are drinking, what's the standard medication? Naltrexone.

Speaker 3:

Naltrexone. So it has gone to the other extent. So now I I'm okay. I can I can send you some of those people? They said, give us one single reason why you would not use Naltrex.

Speaker 3:

It has been remote for the last and now The United and the WHO has now has now listed our naltrexone as an essential medication in the treatment of alcoholism. So, yes, all these years, it has gone. So Mike, what I'm concerned about is this the rejection of Naltrexone also halted the the the search into newer medication. Why did we just stop at Naltrexone? Why not develop 15 new medications?

Speaker 3:

It's like an antibiotics. We did not stop just with penicillin. We developed hundreds of antibiotics. And I really believe that Naltrexone or opioid antagonist, not just naltrexone, but opioid antagonist, have the broadest score and application in the treatment of a whole range of addictive disorders. So just not just alcohol and opioid addiction.

Speaker 3:

Now Naltrexone is used for gambling addiction. Naltrexone is used for people who are self mutilators. There are so many. And the reason is very simple. Naltrexone is so incredibly safe.

Speaker 3:

If there are no benefits, you did not do any damage to them. You did not get them addicted to something. They did not have serious health issues or serious side effects. So you can use it with great. Just goes on, and it is used for meth addiction.

Speaker 3:

It is used used for smoking cessation. Indeed, one of the first waste loss drug that was approved is called Contrave. And Contrave is bupropion with Naltrexone. Much professor now, Naltrexone is having a new lease on life.

Speaker 2:

Naltrexone now seems to be having a moment. It's having more conversations. We're having one here. It's in telehealth. GLP one conversations are more mainstream attention as well when it comes to addiction.

Speaker 2:

Do you think that in regard to these medications that we're finally getting back well, not back on track, getting on track?

Speaker 3:

Not quite yet, but I think the big break, I believe, would come when Naltrexone is made over the counter. I think it's time for this medication to be made over the counter where we involve pharmacists and the general pop and the general population to be available about Naltrexone is. Because one of the sad part of it is that hardly any report knows about. And reporters have a tendency to go to the same database and read about Naltrexone. Some of it is so outdated that they will they will regurgitate the same thing that they read.

Speaker 3:

They have never been there. So many reporters have come to my clinic to see how our patients are doing. I mean, they think that are that Naltrexone the St. Louis is in some kind of a backward that we don't have indoor plumbing and we don't have, you know, paved roads here. As I come to my clinic, spend a day or two.

Speaker 3:

So what where we have gone, Mike, is that we have virtually no patient. We are struggling. Now we have 2,700 active patients and a staff of 90 people. It's all because we showed results. Now if we were not showing good results, there would there would have been no way.

Speaker 3:

People would have written on the Internet and just devastate because, you know, if you don't like something, you know, you tell 10 people. And the and the paradox of what we do is that most patients who do well are very well-to-do people, they are they are reluctant to tell their story to people, especially the very well-to-do people. I I do not want to talk about my recovery. That can you know, why are you willing to write on Facebook or LinkedIn or on or nothing of that sort? So that's the irony of it.

Speaker 3:

And the other challenge we have to do is we have to get the treatment, I mean, the the general public or consumer advocacy has to increase because GNP one through through through public advocacy, consumer Today, if you have an alcohol problem, what's the first thing you do? You become anonymous. Join Alcoholics Anonymous. Don't talk about your addiction. That has to We have to convince the community that that addictive disorders is not some kind of a crime.

Speaker 3:

There's nothing to hide. And most of the time, when I almost every patient that comes here said, why did you wait so long? I didn't know there's a treatment for that. I didn't have insurance. I didn't have the money.

Speaker 3:

And in Missouri funds, the treatment is free. Everything we do is free. The the the initial physician, the worker, the medications, everything is so but here, people are not aware of. So we have to change the field. It is going to happen one thing.

Speaker 3:

I mean, I'm just so thrilled that, you know, you took the time to interview me, and we need more of these interviews and less than let the public know about it. Did did you get to see the the documentary we did on Naltrexone?

Speaker 2:

I have not.

Speaker 3:

Okay. Anyway, there's a there's an interesting story. So there was a local investigative reporter who posed as a drug dealer and went to China. Okay. So he just contacted them and said, look.

Speaker 3:

I want to do a big time drug importation of fentanyl. Can I come down? So he goes to China. He goes to the labs. He goes to the fulfilling center, the packaging centers, and takes copious notes, takes pictures, and he writes a best seller called fentanyl.

Speaker 3:

It's worth reading. He won he once he published the book, he was invited to testify before congress and so on. So it was at a book signing ceremony, and we got into a little bit of an argument because he didn't know any much about addiction treatment. I said, you're talking about treatment. If you don't make if you don't mention Naltrexone, you're you're missing the boat anyway.

Speaker 3:

It's a long story. He said, I never heard of it. It just brushed me off. Then he came back several months later. It resulted in an amazing documentary called addiction.

Speaker 3:

It is called antagonist, and I'll send you the link. It's not out for for general viewing yet because you want to submit it to several film festivals. But look at it. It's long, but it's worth it. So we are seeing these kind of breaks that finally can happen, and meeting Ian was a positive.

Speaker 3:

I was very impressed with what he is doing.

Speaker 2:

First, I wanna check that out, so please do send me the link. Second, you mentioned something there that I know so well over this the years that I've been working in that you have these great results. You work with somebody that's so happy, but the consumer advocacy is so reserved in private because the perception still, even though that narrative is changing slowly, that just like the word you said, there's normies and then there's me. And, you know, I don't wanna tell the normies because I don't want them to think what they think about me or what they might think about me. So that's such a challenge.

Speaker 2:

But that leads me into this question because around Naltrexone, there is this new narrative. There is with Sunnyside, we're saying, it doesn't have to get to rock bottom or to a severe addiction for you to have medically assisted treatment that not everybody turns into an alcoholic overnight and there's there's different stages in that that you could address it with medication. How do you feel, first of all, about this narrative? And second, I guess the question would be, do you think that this might start to drop that hesitation around consumer advocacy?

Speaker 3:

I think there's come to a point that naltrexone is very unlikely to go back to the the horse is already out for a good reason. Now we need to find a way to saddle that horse and let people ride it because there are several issues they are dealing with. For instance, physic patients are reluctant to go to a physician and say, doctor, can I what do you call it? Can I get a prescription? Because they might be going to the same family doctor, and they have concealed their alcoholism for years.

Speaker 3:

Now they want that. That's why telemedicine has taken off so well because now I can almost do it unanimously. So I can do that. So that's the if that if that drug is made over the counter, can you imagine how many more people will, to call it, will will seek help? Just imagine you have a little a little announcement in the pharmacy saying, you know, ask me about treatment for alcoholism, or they can go to the Internet.

Speaker 3:

That is why I'm passionately advocating to make Naltrexone over the country. Just like NARC, NARCAN languished for decades. I asked people, do you know when was when did NARCAN get approved? And not one person gets the answer right. 1971 when you were probably a teenager or not even born.

Speaker 3:

1971, for a decade, it's it's sat on the shelf. Now Naltrexone is a household word, not because physicians are prescribing it, because we made it an over the counter. We increased the access to it that you could, you know, be at statewide. Why not naloxone, Narcan, and Naltrexone are identical in the pharmacology except for the duration of action. Right?

Speaker 3:

Narcan lasts for thirty minutes. Naltrexone lasts for for twenty four hours. So you have a medication that can make a huge difference, especially with alcoholism. With alcoholism, it is rare to have a product that is so incredibly flexible. You want to cut down on your drinking?

Speaker 3:

Okay. You can take Naltrexone. I want to just drink, you know, instead of a case of beer, I want to just drink two. Naltrexone or beer. I can take a I can take a 100.

Speaker 3:

Okay. I want to you know, I'm a beer. I work enough in the field. You know, just like I'm promoting Naltrexone. Like, are you familiar with with the prep in HIV treatment?

Speaker 3:

It's called pre exposure prophylactic. So people who are in high risk sexual behavior and they have a risk of of getting or getting infected with HIV, they take anti HIV medication as a prophylactic. Why not use Naltrexone as a prophylactic? It can make a huge difference. We need to increase this.

Speaker 3:

We need to really raise the awareness apart. Here is a medication that was developed almost sixty years ago. It has been used clinically for the last forty years, and we are still hesitant to that. If somebody has a better answer to this, I would like to hear it. But there's nobody has come up with a thing that they are talking about prevention.

Speaker 3:

We have no prevention strategy. The only prevention strategy we have is the widespread availability of naltrexone. You can't do that with buprenorphine. You can't do that with methamphetamine. With naltrexone, because of its because a nonaddicting drug, non opiate, you can increase its access tremendously.

Speaker 2:

But

Speaker 3:

why they're not doing it? I don't know. We need to get reporters. We need to get investigative reporters to really write about this story.

Speaker 2:

I can fully see that the conversation, for example, the picture that you painted with it being over the counter, all of a sudden, becomes more of a mainstream thing. Because if I had known it's a very isolating and shame based, as you know, addiction or relationship or however you wanna define it. But the thing is that after I actually knew the statistics, I could put myself back into a room and realize there were multiple people within that room that were dealing with some version of the very thing that I felt that I was hiding. And you need to bring that conversation out and realize that it it isn't as uncommon as you think it is, and it isn't something that you need to hide from.

Speaker 3:

Yeah. So we have to raise the awareness about it, because especially groups like like churches, They have to get off this belief that, you know, it's a spiritual feeling, alcoholism. If more churches talked about, you know, alcoholism to the cock to their congregants, talk about how much help could almost every church basement as an AA group that meet. And, a, now, of course, foundation and Betty Ford have made a 180 degree turn. Now they are they are strongly advocating.

Speaker 3:

But look at the damage that has been done for thirty years with their stance. So now they're advocating, but we shouldn't take it to the next level that it should be a household thing. And and it's and by making it over the counter, in the early stages of alcoholism occur, you'll find yourself drinking a little too much. Take a pill. You don't wait until you're lost two toes before you can seek treatment for debt, for diabetes.

Speaker 3:

You don't work wait until you come to stage four of cancer to seek treatment. You have and the early signs occur, and the human the human has an amazing alert system. The the conscience will tell you, Mike, or Percy, you're drinking a little too much. Right? Do you feel that is that happens, you you have a resource.

Speaker 3:

But right now, if you find a physician or to go to telemedicine, you know, that's good that we have that. But majority of the time, they don't have the resources. How many people are aware about Sunnyside or other programs? But if it is you can go to your local pharmacy and pick up a imagine what a big difference it can make. We can bring down those death rates significant.

Speaker 2:

Absolutely. And those two can intertwine in that you can it can start with the medication that leads to the support that you need that you might not have even known ever existed. Exactly. All right, I want to end this with a little bit of a time machine question here. And that is, if you had a time machine and things were still going the way that or would go the way that you'd like to see them, what would alcohol treatment look like, let's say, in ten or maybe twenty years from now?

Speaker 3:

Alcoholism would be like treating allergies. You cannot get rid of an allergy, but you can do something to control it. So use some just medication. I would like to see at least a dozen new medications that would treat it in very different ways. Just like GLP.

Speaker 3:

Once we came up with a new class of medication called GLP ones, look at the explosion. The the discovery of of opioid antagonist should have been a similar event in in the history of medicine. And I would like to like to see more research being more money being spent on research and more pharmaceutical companies are being getting involved because right now, they have no interest in it. After they saw the the disaster, what happened with Naltrexone or with with acamprosate or with Nalmefene, the pharma industry has no interest. And the pharma industry has no interest in developing another addicting drug.

Speaker 3:

Imagine if GLP wants an addicting drug. And you heard me say this over and over again. You cannot end an addiction addict an chronic condition, an addiction with an addicting drug. It cannot be done. It's only for a short for a short period of time.

Speaker 3:

Use it in the acute phase, but not for the chronic. We saw what happened with treating chronic pain with opioid. And we think we can do that. I mean, how how in the world can you treat alcoholism with just two medications? We need dozens more.

Speaker 3:

So I hope it was a helpful interview, and it was hope we can let the word out to the thousands of people who are struggling to put their lives back to you.

Speaker 1:

It's been

Speaker 2:

way beyond helpful, and it's been fascinating and enlightening. If anybody's listening and they wanna learn more about you or maybe find out a way to just reach out and say thank you, is there some place that they could go?

Speaker 3:

They can send me an email or they can go to my clinic. It's called arcamidwest.com, arcamidwest.com, or they can even just put my name, Percy Menzies, and I'm come midwest.com, and I'm very good about responding to people. New convert I get, every new patient I've helped, that's one soul saved.

Speaker 2:

Percy, thank you so much for coming on today, sharing all you've done, your entire mission behind it. I respect it so much. So from from my heart, thank you.

Speaker 3:

Good luck. Keep the keep the good job. Good work. Thank you.

Creators and Guests

Mike Hardenbrook
Host
Mike Hardenbrook
#1 best-selling author of "No Willpower Required," neuroscience enthusiast, and habit change expert.
Why Naltrexone Was Rejected for 40 Years w/ Percy Menzies