The Opioid Crisis — Solutions for a Rising Epidemic

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Transcript

State Bar of Michigan: On Balance Podcast

The Opioid Crisis — Solutions for a Rising Epidemic

02/22/2019

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Intro Welcome to State Bar of Michigan’s On Balance Podcast, where we talk about practice management and lawyer wellness for a thriving law practice with your hosts JoAnn Hathaway and Tish Vincent, here on Legal Talk Network.

Take it away, ladies.

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Tish Vincent: Hello and welcome to another edition of the State Bar of Michigan’s On Balance Podcast on Legal Talk Network.

JoAnn Hathaway: I am JoAnn Hathaway.

Tish Vincent: And I am Tish Vincent.

JoAnn Hathaway: We are very pleased to have Harry Nelson, Healthcare Attorney and author of the ‘United States of Opioids‘ join us today as our podcast guest to talk about his involvement with the opioid crisis enveloping the United States today. So Harry would you share some information about yourself with our listeners and also do share some information that you’re a native Michigander.

Harry Nelson: Yes, first of all it’s great to be with you. Thanks for having me on. Yeah, so I grew up in Southfield Michigan. I count myself as a faithful member of the Michigan, I asked for out here in Los Angeles. I tried to raise my kids to be strictly sports fans of Detroit sports and the University of Michigan.

My background was I graduated from the University of Michigan Law School in ’92, spent some time in Chicago where I got trained as a healthcare lawyer and relatively early in the days of healthcare law as a sort of distinct specialty. And then in 2001, came out to Los Angeles where I’ve built what’s the largest healthcare specialty law firm in Los Angeles.

We’re just under 30 lawyers doing a lot of work on physician-related issues, medication-related issues and a whole range of innovation within healthcare. So it is great to be on the podcast and always excited to reconnect with Michiganders.

Tish Vincent: Thank you for that introduction. We are constantly hearing updates about the latest development in the opioid crisis. Harry, can you clarify what exactly the nature of the crisis is? Is it pharmaceutical company greed? Doctors over prescribing? What’s the central problem at the heart of the crisis?

Harry Nelson: So when we talk about the opioid crisis, the problem that most people are referring to is over the last 20 years since the very late 90s, we’ve seen a quadrupling of the overdose death rate from opioids.

So as you noted, many people linked it to originally to the over prescribing of OxyContin which was heavily marketed by Purdue Pharma along with other opioid medications and that certainly is a — that’s the part of the crisis that drives the headlines. We had the death rate was — from all drug overdoses last year was 72,000 in 2017 with about two-thirds being opioids.

The other parts of the crisis are profound rise in the level of addictions in this country, roughly 20 million Americans with a substance use disorder, again, about two-thirds opioids and also just a massive problem of people living in chronic pain. So from my perspective, there’s absolutely a big problem of pharmaceutical marketing, well which is getting treated both in litigation and in work around how the FDA regulates big Pharma.

There’s a challenge in how physicians prescribe but there are many, many more points of system failure where we have to ask what was the role of government agencies in inadequately policing and responding to the crisis, what was the role of healthcare payers, insurance companies and pharmacy benefit managers in kind of turning a blind eye to the way that these medications were causing such enormous problems in this country and looking more broadly at a whole host of problems in our culture that really made America so ripe for this terrible crisis.

Tish Vincent: Very interesting. So many, many contributing factors.

Harry Nelson: Yeah I try to get people to really think about the crisis as a much deeper broader and more nuanced problem rather than just to look at any one individual culprit.

JoAnn Hathaway: Now, you talk in the book about how your legal work on issues related to the crisis drove you to actually write the book. So can you tell us about particular cases that led to the decision to write the ‘United States of Opioids‘?

Harry Nelson: Yeah. So shortly after I came to California in the early 2000, I was working with a number of physicians who were treating pain and addiction and I got involved in a number of cases where there were essentially celebrity overdoses.

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The one that really affected me, the most was that when Michael Jackson died in 2009, there was a criminal trial for the doctor who had prescribed him a whole series of medications and was giving him an anesthetic propofol in a home setting that was inappropriate.

And what happened was I started getting telephone calls from other doctors who called and said, I also prescribed to Michael and I did it under fake names and I’m worried am I going to be next. And one of the cases that really to this day sort of still haunts me is that a doctor who was very agitated and worried that he was going to lose his license and I thought I had calmed him down in our conversation and but he didn’t show up for his appointment and I learned a couple days later that he had taken his own life and overdosed intentionally as a result of his panic about the case.

And for me, what I began to see as I did a number of these cases for physicians and then I started as a result of which I started doing work around the country on a whole series of crisis response to overdose where addiction treatment programs were basically afraid, the tragic events were going to cost them their licensure, started turning to me and asking me what they could do to demonstrate that they had understood the problem and addressed it.

What I realized was I had shifted out of the ordinary terrain that lawyers who work in healthcare to work on, which are issues like fraud and abuse and regulatory compliance and I was dealing with this profound safety issue and also with this deeper underlying crisis that really went to a profound spiritual and social crisis in this country.

And I felt like it was necessary to put some things out there in writing this book in order to share a message and hopefully get more people aware and involved in the work that needs to be done because this problem is not just, it went far beyond any legal problem that I was fixing for any one client or working or anybody was working on, it’s really a national epidemic that’s going to take a massive effort collectively to address.

JoAnn Hathaway: From a very lay perspective Harry, can you just add — I mean I’m just thinking here do you think it’s a contributory factor of the pharmaceutical companies failing to educate physicians regarding the addictive components of the medications or is that not accurate?

Harry Nelson: No, so there really — look there were some terrible things done by a big pharma that are only now coming out right. There was some intentional — it was clear — it’s clear the more that evidence is coming out through the opioid litigation, it’s become clear that Purdue Pharma for example and other opioid makers knew perfectly well that these drugs were being misused and that people were dying and they continued to provide incentives, they would fly doctors on fancy trips and take doctors out for fancy meals and pay marketers handsomely for selling more, more, more without paying attention to the consequences.

So there was a level of really outrageous behavior that’s going to need to be reckoned with. But for me, the bigger more challenging issue that we have to take on as lawyers and in the political solution is that the FDA is just — first of all, the FDA has so few resources to address the enormous regulatory needs but even more profoundly, the FDA solution to this crisis was to come out with a program called REMS, which stands for Risk Evaluation and Mitigation Strategies.

And basically what the FDA said was, okay, we’re worried about this problem so we’re going to require drug makers to put out more educational information for doctors so that doctors are more attuned to the risk issues. And the data, the early data has shown from some of these REMS is that doctors who read this material prescribe more of the drugs.

So we have a fundamental challenge in that the pharmaceutical industry is a very effective at getting doctors to prescribe more and more and the question becomes what other alternatives to pharmaceutical solutions, to pharmacology are out there that might be safer and more effective in addressing the problem.

Tish Vincent: That is just fascinating and terrible to think how huge this problem is, and how an effort to intervene even on a first level went sideways and then rather than have it be a prevention kind of an outcome, it amplified the problem.

Harry Nelson: To me, it points to a — the problem is not just the behavior of drug companies, it’s a structural problem in our system. We have such a massive need for access to care in this country that we — that the solution that we always prefer is the simplest solution and the simplest solution is always a pill.

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So for example, when we look at what the responses to the opioid crisis have been the two most striking responses have been the overdose drug NARCAN Naloxone that we’ve put in the hands of first responders and police to reverse overdoses and the spread of buprenorphine sold under brands like suboxone as a form of medication-assisted treatment for addiction.

And so, for opioid addiction, on one level those are — it’s important, those are both important pieces of the puzzle, but the bigger question is like why does our system always — well it’s not easy to say why does our system prefer pills? The answer is because they’re cheaper and faster and more efficient, but the real question is how do more people get access to other tools; whether it’s mental health support, whether it is more interdisciplinary approaches that involve physical therapy and chiropractic and a whole range of non-pharmacologic solutions, that’s a much harder problem.

The reality is we have a massive need for people to get treated for pain and for addiction and we have a system that only can treat a small fraction of them.

Tish Vincent: Absolutely. In the book you are extremely critical of particular government agencies for not doing more to address the crisis, where do you see things going wrong in Washington DC with respect to a response to the crisis?

Harry Nelson: So you know, I think that the one — the good, only good news out of Washington DC is that there’s a bipartisan commitment to addressing this crisis. The challenge has been the some of the legacy agencies have responded kind of reflexively to the crisis in ways that have been damaging.

So I do in the book express a significant amount of criticism towards the DEA. In particular, the DEA has been responsible, since 1970, for enforcing the Controlled Substances Act and if you look at the way that the DEA has played a role in this crisis there are certain things that it has done that have been damaging and there’s been certain things that it has failed where it’s really failed to fulfill key functions.

So in terms of what it’s done wrong, the pressure — we decided in this country in a 1920 Supreme Court decision that the issue of regulating prescribing practices was a matter for the states to handle. It was really a state decision and yet the DEA has continued to put extreme pressure on physicians around the country and created a climate of fear that doctors are going to lose their ability to prescribe through just a series of overly aggressive measures.

When I go around the country and speak to the prescribing community and the addiction community and the public policy community, the consensus is that most of the pill mills and really dangerous prescribing practices have largely been dealt with and yet the DEA continues to just look for new targets.

So we’ve seen this pendulum swing where people in pain are having trouble getting access to medication because doctors are afraid of the DEA, so that’s one issue. But the other thing that’s troubling is that we have a desperate need for new pain therapies and we have all kinds of promising substances that the DEA has refused to allow people to research what has made very difficult for people to research, most famously cannabis.

I speak to and work with public universities around the country who all say the same thing. We have researchers who are dying to do critical research on the efficacy of cannabis to treat pain and other conditions and yet we’re federally funded so how do we get over the DEA position, right.

We had a case actually last month where Congress had overrode the DEA through the new Farm Bill on the scheduling of non-cannabis based hemp-sourced CBD, which is among other things being used to treat a whole series of conditions. So the DEA has been just intransigent.

And then finally, the biggest place where we would have hoped the DEA could be a valuable resource would have been in stopping the illegal trafficking of fentanyl and when you look at what’s going on what’s really happened is that while the DEA was so busy cracking down on doctors, the real problem beginning in about 2013 was the flooding of this country with fentanyl, from coming in by mail from China, coming across the border from Mexico, and the DEA literally took three years to realize that we had no mechanisms to even detect the inflows and to start to respond to it.

So I just think we have to ask ourselves what our agencies, like the DEA, doing are they really serving us and we’re seeing even that Congress is attuned to the need to really force a new level of action and changes at the DEA.

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JoAnn Hathaway: Harry, you had mentioned about the climate of fear that the DEA is putting in the minds of physicians across the country and I can only imagine the anxiety that this must be causing among these physicians when they are looking to and listening to the DEA and then having the duty to provide the standard of care to their patients and these patients who are in extreme pain and they’re looking at modalities to try and determine how to treat these people.

Do you see that this is causing a big anxiety in the medical community with the treaters?

Harry Nelson: Oh it’s a huge problem. 15 years ago, the government by the way was pressuring physicians to treat pain as the fifth vital sign and doctors were getting in trouble with medical boards for under prescribing for patients in need. And today, what I hear from pain medicine doctors around the country is that they just can’t take the risk of prescribing to new patients.

A lot of doctors who treat pain have legacy patients they’ve been seeing for ten plus years who are on large dosage of opioids. We measure opioid dosages by what’s called MME, Morphine Milligram Equivalents, and like 250 would be a very large dose. So a lot of pain doctors may have patients who they’ve been seeing for ten years who are getting those kind of doses and are resistant to tapering off.

But if you talk to most pain doctors today, they will not give doses more than a quarter to a third of that, because any going above 80 to 90 MME is a trigger for DEA action and Medical Board Review in many states. And so, we’re seeing a whole — we have just literally millions of people around the country who are being turned away from doctors’ offices and hospital emergency rooms and don’t have any obvious place to turn except to illegal sources.

So this is a massive problem that I think we still have a lot to reckon with.

JoAnn Hathaway: Now in the United States of opioid, you argue that one consequence of the crisis has been a significant number of changes to US laws and regulations and I know you addressed that just a bit earlier. But can you share the most important aspects that the legal community should be paying attention to?

Harry Nelson: Sure. Yeah. I think you can draw a direct line between the beginning of the opioid crisis and the passage of the Mental Health Parity Act in 2008, which really said to health insurance plans you can’t discriminate between substance use disorder and mental health treatment and medical surgical treatment, a coverage and also, you can draw that same line to the Affordable Care Act and the inclusion of substance use disorder treatment in the Essential Health Benefit.

So I think that there’s been a significant change in our laws at a Federal level and that plays out also in the states relating to the need to address this crisis and it’s going to take decades for us to actually enforce and really have mental health parity and make sure that people are getting access to care.

So and we even saw one of the most interesting pieces of the whole political back-and-forth over the Affordable Care Act, was that nine Republican senators resisted the effort to repeal the Medicaid expansion and roll back Medicaid as the administration had wanted to do because of — very clearly because of the opioid crisis.

So the most significant change has been this awareness of a need to reform our health care laws to deal with the immediacy of the overdose threat and more broadly to expand access to addiction treatment. And then I think that we’re seeing the laws change in a whole series of other more subtle ways in terms of changing standards for law enforcement, in responding to crises, in responding to overdose, we’re seeing changes in the health care provider, insurance disputes over what’s covered.

I think, frankly, I think that you can tie some of the pressure to change laws related to marijuana to the pressure for more access to alternative therapeutics. So I think there’s plenty of places for lawyers to be paying attention to how our laws have adapted and are continuing to adapt and lots of places where we need more — more work to not only as advocacy but just to help the business and government or nonprofit organizations working around these issues just to get caught up to what’s going on.

Tish Vincent: I wanted to share that on January 28^th at the American Bar Association mid-year meeting, the House of Delegates adopted Resolution 108, which urges expanded access to treatment for opioid addiction, education, and advocacy efforts, support for families and legal and policy reforms to address the opioid crisis.

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They see this as such a significant problem that they’re throwing their weight behind it and asking the lawyers and judges and law students in the country to become educated about this issue.

Harry Nelson: Yeah it’s — thanks for mentioning that. This is the problem here is so big and by the way getting worse, we are seeing the overdose death rate go up at nearly a 15% year-over-year level and likewise, the rates of addiction and pain and there’s so much work to be done here and it starts with awareness. That’s one of the big messages that I tried to get out there in the book is that even just beginning to recognize the magnitude of the problem and on a personal level in our families, in our communities and in a workplace is to recognize the extent to which people are struggling with these issues directly or having family members and friends do so is a big piece of the puzzle.

So it’s a starting point of awareness and advocacy on the part of the legal profession, it could be an immensely valuable piece here and I give credit to the ABA for calling attention to it.

Tish Vincent: So have these legal changes that we’ve been discussing, do you see that they’re making a difference? Do you see that a solution to the problem is progressing? Is it getting better or what do you see?

Harry Nelson: The data shows that certainly the overdose death problem is getting worse. We had like about a 15% jump from 2016 to 2017. We haven’t seen the 2018 data yet but there’s every reason to think that the problem is continuing to get worse. But I have to say that I do think the legal changes are reflecting a profound change in our awareness of the need to provide, for example addiction treatment resources.

So the numbers are about 20 million people with the substance use disorder and about a million and a half of those people get treated every year. And these changes are forcing an awareness of that gap and now the question is how do we deal with it. So I do think that there’s going to be a lot — there’s long term promise and the changes being made but we have a few — we have years to go before the numbers on the ground of the suffering actually start to get better.

JoAnn Hathaway: Harry I think one of the things that jumped out at me was when you talked about awareness. I think that’s huge when you talk about substance abuse disorders because I think in general, anyone thinks that when there is a substance abuse that it’s self-inflicted issue and as I understand it and please correct me if I am wrong, in many instances with the opioid crisis that’s not the situation and it’s not necessarily self-inflicted, it’s pain treatment as you had indicated earlier and otherwise can you speak to that briefly to educate our listeners?

Harry Nelson: Yeah it’s a great point. So yeah, so the challenge here is that opioids — effectively opioids are compounds that interact with these receptors in our neurons and our nervous systems to relieve pain and produce pleasure. And so, it’s the pleasure piece is what drives the illegal use but that pain relief, that opioids offer is really fundamentally distinct on a biochemical level than any other category of medications that we currently have available, which means that a lot of the people who have a dependency and an addiction, are people who needed or continue to need these medications and this is not a situation where anybody — where we should take a broad brush and just say we need to get rid of these.

That’s the part of the challenge here is that it’s not about illegal use entirely, it’s really in large part about people who have a genuine problem of pain and they need access to these medications because these are the best we’ve got in spite of their addictiveness and there are other risks. So I think it’s a great point and it’s a part of the big challenge here that makes it impossible for us just to eradicate opioids and instead figure out a way to live with them where we need them and try and control the harms that are being caused in other places.

JoAnn Hathaway: We heard that you had pledged to share $1 million of your 2019 online profits to charities across America, can you elaborate on this and also tell our listeners how they can get your book?

Harry Nelson: Absolutely. So yeah, my feeling was that the point of putting this book out there was not only to increase awareness but to actually begin to do something. I’ve had the privilege as a result of this work of being in direct dialogue with government, policymakers and with leaders of some really inspiring nonprofits out there doing some critical work.

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And one of the important pieces for me was to make sure that this book wasn’t just another example of kind of rubbernecking at this crisis and sort of head-scratching but was actually doing something.

So I’m thrilled that we’re going to be — would be partnered with organizations like Young People in Recovery is one, National Association of Recovery Residences and then an organization that I sit on the Board of the Behavioral Health Providers Foundation, we’re very committed to developing tangible resources for use in the workplace in schools, in medical practice to try and do something.

So yeah and if people are interested in reading more, learning about the book, the website notanotherstat is the main website, notanotherstat.com, where I’m selling the book. The book is on Amazon also, and if people want to reach me and I’m delighted to talk to anybody part of what I’m hoping and part of what’s been happening and what I’m hoping will continue is to get more people to share stories because I think it really humanizes all the many phases of this problem and a pain that is causing and I think it’s very — it’s a really valuable thing.

So people can reach me through my law firm nelsonhardiman.com at [email protected] and I appreciate JoAnn and Tish I really appreciated having me on and spending time talking about this important issue.

JoAnn Hathaway: Well, it looks like we’ve come to the end of our show. We’d like to thank our guest Harry Nelson for a wonderful program.

Tish Vincent: Yes, this has been a very important topic. I am so glad that you joined us and that our listeners get to hear about the excellent work that you’re doing. Thank You Harry.

This has been another edition of the State Bar of Michigan: On Balance Podcast.

JoAnn Hathaway: I am JoAnn Hathaway.

Tish Vincent: And I am Tish Vincent. Until next time, thank you for listening.

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