Remember before COVID jumped onto the front pages, the biggest epidemic was opioid abuse?  It remains a major killer.  On average, annual overdose deaths exceed 100,000 people, and a record 18.4 million people are addicted, with Black, American Indian and rural people most affected. If we can’t mandate workable solutions by Federal or State policy, can health tech and digital health offer a solution?

Opioid addiction and pain relief require massive health professional, patient, payor, policy and product innovator engagement.  The Food and Drug Administration has launched a new Overdose Prevention Framework, targeting unnecessary prescriptions, prolonged prescribing and counterfeit drugs, and supporting new treatments for substance use disorders and physician education.

But how can innovation be part of the public health and policy solution to create a balance between the imperative to monitor and reduce addiction risks?  How can innovation be part of the solution if regulators and payers do not partner with innovators?

Medika Life Editor-in-Chief Gil Bashe talks with serial entrepreneur and investor Jay Schiff, co-founder and CEO of Addinex Technologies, Inc., a young company focusing on one of the nation’s most pressing issues – opioids – to explore the possibilities and opportunities.

Jay is a Wall Street veteran who has invested more than $1 billion in small and mid-sized businesses. He has managed private investment businesses for Merrill Lynch, a $1 billion private equity firm, and a venture-backed finance company. Jay earned his BA in Economics from Cornell University and an MBA in Finance from New York University.

[Medika Life and FINN Partners have no business ties to Addinex Technologies.  This interview focuses on the critical role health innovators serve in exploring new paths to long-standing problems unaddressed.]

Gil Bashe: I understand you have engineered a dispensing system for opioids. Is that correct?

Jay Schiff:  Yes. I read several articles on the opioid epidemic and it struck me as odd that controlled substances like opioids were highly regulated and monitored until they got to the patient. From production to the pharmacy, they are treated as dangerous, with a high potential for abuse, but they were being dispensed with the same level of protection as Tylenol.

The child cap was invented in 1967. That’s more or less where the innovation stopped in terms of keeping the wrong people from accessing medication. And then what do you do with excess meds if you aren’t supposed to flush them down the toilet or throw them in the garbage, given 3.3 billion excess pills prescribed a year?

Bashe: The pill mills were, at first, just distributors filling the demand of the local marketplace of pharmacies. It’s sad how many people misuse opioids, how many people are addicted, and how many people tragically die each year. It’s one of the most significant causes of death in the United States. We can deal with this from a legal standpoint; we can deal with this from a policy standpoint; we can deal with this from an oversight standpoint, governance standpoint – you’ve chosen to deal with this from an engineering standpoint.

Schiff: Some things have been done from a legal and prevention standpoint. Certain states have limitations on initial opioid prescriptions – in New York; you can only get a seven-day supply. New Jersey is five days.

I talked to a doctor about that, and they said that’s not a limitation. If you prescribe a patient two pills every four hours, that’s 12 pills per day. Over seven days, that’s 84 pills: not much of a limitation. The reality is that doctors overprescribe opioids through no fault of their own.

Bashe: But we know that’s because many patients are in pain, and obviously, the doctors don’t want them to be in pain. But they also lack data.

Schiff:  Doctors don’t want their patients to be in pain, but does that mean they should give their patients 30 or even 90 pills? They can’t make an informed decision because that usage and pain level data is unavailable. Believe me. I searched everywhere.

If colleagues are prescribing 30 pills because they think that’s the correct number based on experience, that suddenly becomes the basis by which everyone prescribes.

But it’s not the correct method because we already know that doctors overprescribe after surgery, on average, by 70%, leading to 3.3 billion excess pills out there.

Good data is not available. The CDC put out guidelines in 2016. They’re now going back to the drawing board and coming up with updated guidelines. Again, it’s not based on actual usage data from the hundreds of millions of annual prescriptions; if it is based on some data, it’s just a tiny percentage of the whole picture.

Pain levels are also important. We did a study with Columbia University Medical Center where patients were asked, “What’s your pain level on a scale of zero to 10?” If their pain was a self-reported four or below, our app would automatically send them a message that their doctor would like them to switch to over-the-counter medication. At no time would we limit access, so the patient had no incentive to lie. We barely had any usage at those pain levels.

This feedback is essential because stats have shown that the longer you’re initially on opioids, the more likely you will become dependent on them. We can shorten that duration and therefore minimize the risk of dependency.

Opioids are supposed to be reserved for people suffering from severe pain. Other countries don’t use the same number of opioids as we do here. So, I think that data will help doctors more accurately prescribe and patients understand the risks of taking opioids for moderate pain versus switching to an OTC painkiller.

Bashe: Your dispenser system is password protected. The patient has a unique passcode for each dose they enter to get the medication dispenser as prescribed. How does that help? In other words, what’s to stop a cancer patient from accessing their meds and simply giving them away to other people?

Schiff: In its simplest form, you can think of our dispenser as a speed bump. If the prescription is one pill every four hours, the patient could put the code in, get the dose, set it aside, and wait four hours for each dose. That is a tedious way to collect the medication for diversion. Worst case scenario, they’re back to where they started since there are currently no protections.

Bashe: Let me clarify – you’ve developed a specially engineered pill, tablet, or capsule container, correct?

Schiff: Yes, and we’ve patented it. It’s entirely mechanical, and keeping the price as accessible as possible was essential. It can’t be zero, but we can get it out there to as many people as possible and then collect enough data to enable doctors to determine, “Here is the right amount to prescribe.”

Once we have enough data, a doctor can see, “I have a male patient between the ages of 20 and 30 weighing between 160 and 190 pounds. He’s had surgery to repair a torn ACL, and I want to prescribe him 10 milligrams of oxycodone every 4-6 hours a week.”

We can produce a graph of what similar patients have taken, and based on that information, combined with how similar patients have reported their pain level –  – the doctor can determine how much to prescribe. The doctor can always choose another amount, but they will have access to objective data to decide the right amount for their patient.

Bashe: And the dispenser itself is locked. In other words, the pills are placed in the dispenser and closed at the pharmacy. They are only accessible by way of the timed passcode, which releases a drug based upon the indication of use, according to the physician’s recommendation.

Schiff: Correct. It doesn’t automatically unlock every four hours, for example. The patient gets the unique code for that individual dose in the app, and they can’t get the next dose code until it’s been four hours and it’s time for that dose.

One important distinction for those taking opioids is that those drugs are not ones of adherence. They should be taken as needed, but the goal is to reduce the amount. That’s unlike many other drugs, where you want to keep them on a set schedule.

We can accommodate both, but for opioids, we don’t want to send reminders to take them when they are not necessarily needed. We want patients to use the app to request access when pain levels warrant another dose, and if the time is appropriate per the prescription, it will give them the code.

Bashe: So, this is not just a one-time code for a patient. It’s a one-time dose passcode, assuming pills are left in the dispenser.

Schiff: Yes. Releasing one dose at a time has multiple benefits. It makes overdose more difficult because patients can die if they take too many opioids at once. Tragically, we have a family friend who died after an overdose following major surgery. Also, the individual dose codes keep other people out of your medicine. Even if the interloper figures out a code, they can only access one dose.

Another significant benefit is that the patient must engage with the app to get each dose. This allows the app to provide education and collect information to help with their treatment and future patients. Many app-only solutions suffer from poor engagement with the app, but that is not a problem with our system.

Bashe: And is it purchased by pharmacy chains or drug manufacturers? Who is the customer for your dispensing system?

Schiff: The patient is the customer. We want to get it reimbursed by insurance, but we don’t have that today. It’s something we’re working on. The doctor prescribes and the patient receives it.

Bashe: Often, when we look at growth hormone and the injector, or insulin and the injector, the therapy is generic. Insulin is generic; the injector is the brand, growth hormone is the generic the injector is the prescribed product.  In this case, if someone prescribes a specific opioid, is the opioid generic, and the device itself is prescribed?

Schiff: Yes. It doesn’t go to any pharmacy; it has to be a pharmacy we’ve partnered with. They have to know not just to give a bottle with the pills but to get the pills in our system so we can monitor and dispense when appropriate, along with the disposal mailer.

When the patient is done taking their opioids, we remind them to return the dispenser with excess pills. The pharmacy doesn’t just send our device with the pills in it but also sends a DEA-approved disposal mailer.

After the pain is gone or low enough to use an OTC painkiller, the patient is asked to use the disposal mailer: close it up, drop it into a mailbox, or bring it to the post office. It goes back to a disposal company we have a partnership with, and upon receipt, they scan the mailer and a confirmation of receipt goes back into our app. Our partner then correctly disposes of the excess medication.

In the Columbia University Medical Center study I mentioned earlier, 80% of patients returned the device, representing 84% of excess pills. Compare that success rate with a Johns Hopkins meta-study, for example, where 4% and 9% of pills were correctly disposed of. 

Bashe: So the customer – the patient – receives the medication via Federal Express? “Sign here, please.”  The patient signs for the drug in the device and has to activate it; in other words, after I’ve received the device and registered on the app, I’m now letting Addinex Technologies, and the doctor know the device is in my hands.

Schiff: Because it’s a controlled substance, delivery requires a signature.  The patient then goes into the app, puts in their patient ID and the device ID, and if that matches up, the app gives them a unique code for each dose as it becomes available based on their prescription.

.Bashe: So you talked earlier about the challenge of payers. Is this because the device is not on the formulary with the medication? Payers are dealing with this challenge of effective pain management, and they get concerned about misuse, abuse, or addiction, putting them in the spotlight. What’s your specific challenge to the reimbursement?

Schiff: There isn’t a CPT code for a dispenser. It’s much more than a dispenser. We spoke with some of the payers early on in our process, and they expressed interest but wanted us to come back with hard data that shows our device achieves what we know it can. That is why we’ve been doing clinical studies. Columbia is now doing a phase II study and we’re working with two other major medical centers on other studies.

Bashe:  It sounds like your app provides the code like many security or multi-factor authentication systems. You’re emailed a code if you want to access PayPal on a new device. Sometimes they give you a one-time code for sending money as a security measure. It’s basic cyber security.

You’re operating in an area where people can accidentally misuse or intentionally abuse a product. Your work gives us data on what is going on between the patient and access to the pill.

Schiff: Yes, and I would add to that. We’re adapting our system to be able to dispense a drug called suboxone, which is widespread opioid addiction treatment. It comes in a film strip, and nobody could dispense it effectively before us.

For addiction patients, instead of asking them, for example, “What’s the pain level,” we can ask them, “What’s your craving level right now?”

If their craving levels are high the app can contact their doctor to alert them that the patient needs support.  We’ve added a video recording component, as well. It’s optional, but because the only way that doctors can currently confirm that patients who take suboxone or methadone are adhering to their prescription and not diverting it, is that they are required to get a urine analysis once a week or every other week. We can have the patient take a video of every dose that shows they’re taking it each time they say they are so their provider can track it.

It reduces liability for the doctor and keeps patients on track, knowing they’re accountable. Up to 28% of suboxone prescriptions get diverted, and we can help keep those patients on track. It’s hard to break an addiction, and if we can help keep them on medication-assisted treatment, that’s highly valuable.

Bashe: There is a saying that culture crushes innovation. What’s the culture around this topic, in your opinion?

Schiff: Glacial inertia. It’s a very slow process to change anything in this space.  

For example, many people have endorsed using the device for methadone treatment. Patients on methadone must go to a clinic every day and stand in line, sometimes requiring a long trip. It’s time-consuming and stigmatizing. Our system can provide more comfort than take-home methadone is properly used, but current regulations stand in the way.

I’ve been trying to speak with politicians to get their take on it, but it’s not easy. One of the things that we’re exploring is tapping into this vast amount of money coming from the opioid settlements.

Many states and localities plan to use the money to pay for Naloxone. Naloxone is a great drug to reverse overdoses, but there’s only so much money to spend on Narcan. There’s money available in these settlements to try new methods to prevent and treat opioid addiction.

Bashe:  My last question deals with technology and the digital divide. As you said, this dispensing technology is based on an app with a smartphone that connects to the device. Is that correct?

Schiff: It is, and I know where you might be going with your questions. It’s available on any smartphone, Android or iPhone. We’ll also soon be developing a version of our system for text and phone so that you don’t need a smartphone.  You text or call, put your information in, and it gives you back your code. The doctor can ask whatever questions they want to monitor your progress, just like with a smartphone. We want to make it as accessible as possible. We are also offering Spanish language in addition to English.

Bashe: How about seniors?

Schiff: That’s where the phone option comes in. That would make it easier. I will caveat that our study did not involve seniors, and though that’s typical for a study like this, that’s data we should get.

One of the interesting pieces of feedback that we got is that with a child-proof bottle, you have to push and turn it, which can be difficult for an older patient or one with an upper extremity injury or weakness. Our system solves that issue, but you’re right: we have to study this more with older people, people with arthritis, and other disabilities. We’re trying to make it as straightforward as possible, but it will not be perfect immediately. Also, doctors don’t have to prescribe it to patients who can’t easily use it.

Bashe: Yours is an exciting story of innovation. Historically we’ve looked at controlled drug monitoring systems that cast a suspicious eye on the patient. This system is not set up as, “Hey, I know you’re trying to scam the system, so I’ll make it super hard for you to get too drunk.”

This is “How do I make it appropriate to understand when you’re taking the drug and when you no longer need it.”

Schiff: That’s what we’re trying to do. Not everybody feels that way when they see the device, but the feedback was very good from the research, and people appreciated that someone was looking out for them.

Along with medical devices, technology can play a major role in helping health professionals overcome some of the pain medication addiction challenges.  However, the obstacles may not be engineering or generating sufficient clinical data from in-real world patient studies.  Federal regulators and payers need to jump aboard as allies. The barriers facing Jay Schiff and other innovators are similar – obtaining reimbursement coding, securing conversations with health professional associations and finding provider partners to test new ideas.  Along with innovation, collaboration may be among the essentials to success.