Organized by Physicians for Responsible Opioid Prescribing with the support of Brandeis University, the Johns Hopkins Center for Drug Safety and Effectiveness and the New York City Special Narcotics Prosecutor’s Office
Dr. Andrew Kolodny, Physicians for Responsible Opioid Prescribing:
Well, thank you for joining us for the side event. This event is sponsored by Physicians for Responsible Opioid Prescribing. That’s an organization. An NGO based in the United States that has been working on the opioid crisis.In particular, we’ve been focused on promoting more cautious, prescribing practices, and we’ve been focused on advocating for better regulation of opioid manufacturers, and in particular the way in which they market opioids in the United States.
I’m joined today by Dr. Caleb Alexander and Bridget Brennan. Dr. Alexander is an expert in pharmaco epidemiology, and he’s also a physician who treats patients and and practices as an internist, Bridget Brandon leads New York City Special Narcotics, Prosecutors office and I think it’s not just important, symbolically, that we have really leaders here, both in law enforcement and in public health. I think it’s in important message to send, because too often I and we see this both in the NGO community, but also in Member States. What seems to be an argument between whether or not the response to drug problems should be focused on supply control or law enforcement approaches versus demand reduction or public health approaches. I think you’ll you’ll understand after this talk, the importance of really addressing drug problems both with law enforcement and with the public approach. So I think we will get started with that first.
Dr. Caleb Alexander, Johns Hopkins Center for Drug Safety and Effectiveness:
Thank you, and good morning, and thanks for coming early in the day and starting your day with us, as you’ve heard I’m a practicing internist. I perform general medicine for adults, and I’m also a pharmaco epidemiologist. So my work focuses on the use and the safety and the effectiveness of prescription, medicines in large populations. I have served as a paid expert for plaintiffs in opioid litigation. So I’ve done a variety of work in the legal setting as well, advising cities and counties and states who are working to recover funds so that they can apply those funds to help prevent further harms from occurring. I trained as an internist in the late 1990s and I was told at the time I could remember very well being up late at night in the hospital, or sending patients home from the hospital and being taught that if a patient has true pain, you tell me what true pain is but that if they have true pain that one need not worry about the addictive potential of opioids, and or the fact that that invariably physiologic dependence happens if people take them for more than days to a week or 2, and I was part of a whole generation of clinicians that was trained at such, and and and in fact nothing could be further from the truth so there’s there’s an enormous amount of evidence of scientific evidence. This is what I do for my day job, and I can assure you that there’s an enormous amount of evidence about the clinical risks of opioids, and you will be hearing from my colleague Counsel Brennan regarding rogue prescribers and doctors that are way beyond the norms of modern medicine. But I’m not here to talk about that dimension of the opioid epidemic. I was trained in a good program, and I’m one of tens of thousands of clinicians, a generation of clinicians. That was trained essentially, that we were overestimating the risks of opioids.
I can assure you there are dozens and dozens of studies. There are enough studies that they’re very good, systematic reviews, that summarize the evidence regarding the safety of opioids.
One of the better ones was done by Voles and Calling, published in 2015, in a journal called Pain, and they estimate that among individuals taking opioids for chronic non-cancer pain between 21 and 29% of individuals have non-medical use what we call misuse and between 8 to 12% of individuals have addictions. Experience, addiction, and I can assure you that if the rates of harms that we see with opioids were pressured with virtually any other class of medicine the medicine wouldn’t even be on the market.
I mean if I told you that in your country, in Sweden or France, or Portugal, or wherever you’re whatever countries you represent. If I told you that 25 people died last year from a diabetes drug, I would bet dollars to donuts that the drug would be pulled from the market and yet in the United States we don’t have 20 people dying a year. We don’t have tenfold that 200. We don’t have a hundredfold that 2000. We have 1,000 fold that or more so. There are phenomenally high rates of harms from opioids. If you consider the-fold that or more so, there are phenomenally high rates of harms from opioids. If you consider the now, there are many myths that have allowed for the the epidemic to flourish in the United States, and they’re not just around safety. I mean another one is that opioids are effective for chronic non-cancer pain, when, in fact, there’s remarkably little evidence demonstrating their effectiveness for the long-term treatment of chronic non-cancer pain another is the notion. That no dose is too high. You know. We used to think well, if they’re not responding to 40 milligrams, just bump it up to 80, and what we’ve learned the hard way is that, in fact, you know that that when patients develop tolerance to opioids, they may be tolerant to the analgesic effects of opioids, but the toxicities are dose-dependent, and so the likelihood of respiratory depression, where other adverse events are dose-dependent another myth that we can use screening tools to identify who’s likely to experience adverse events so that we can sort out the people that are going to be addicted from the people that won’t. And that’s just pure BS, to use a technical term, that just isn’t true. We don’t have screening tools that allow for that sort of separation. Now a lot of these myths and myths can set. Misconceptions have been driven by industry, and and it’s it’s, you know, it’s not an accident that we’ve ended up in a place where we are now.
We’re now in a setting where there’s enormous litigation taking place.There are many cases being brought against manufacturers, wholesalers, and pharmacies in the United States, and tens of billions of dollars being generated for these communities that have been devastated to try to apply to reduce further harms and so it’s really a unique point and time in the United States and North America. But we’re also at a point in time where the opioid industry continues to try with bearing levels of success, to repeat, to use the same playbook that was used in the United States and in North America in other countries around the world so i’d like to make one or 2 final comments, one regarding the continuing very high rates of morbidity and mortality from illicit fentanyl. It is true that most people dying of opioids this year in the United States will die from illicit fentanyl, not from prescription opioids, but what you will hear argued is that since there’s been a reduction in prescription opioids by 65% since the peak in 2010, since we have large reductions in prescription opioid volume and even higher rates of deaths from illicit fentanyl. What you will hear is that this is a demonstration that the problem really isn’t isn’t the health care system. It’s not prescription opioids, because we’re 65% down on prescription opioids. And yet more people died last year in the United States than ever before. And this also is just BS, this simply isn’t true.
So my own work and my own research team and that of many others, have done work demonstrating the important lag between when one turns off the spigot of of prescription opioids, and when you should expect to see the corresponding health gains if I told you that everybody in Vienna, or everybody in Austria, quit smoking cigarettes tomorrow. Would we stop seeing Emphysema a week from now? You know. Would you expect to see reductions in stroke a month from now? I mean, would it even be plausible to say that we’re gonna see reductions in lung cancer a year from now? Of course not. So there is an important lag, and unfortunately there’s an important lag between when you reduce the population level exposures, and when you should expect to see the commensurate health gains, and so there’s an unfortunately in the United States we have millions.
Of Americans that have opioid use, disorder and a lot of the morbidity and mortality a lot of the harms that continue to accrue arise from individuals that have opioid addiction already so we have an estimated 2 to 2.2 million individuals with active opioid use, disorder within the past year they fit the criteria, and another 2 to 3 million with a lifetime history of opioid use disorder, I mean the U. S. is only 330 million. So we’re talking about more than 1%. Maybe one and a half percent of the population that has a history of opioid use, disorder. And so my point is that that that population is a reservoir that contributes to enormous harms.
Going forward. The last comment that I wanna make is just about well, I wanted to acknowledge that the North American opioid epidemic is complex and multifaceted and dynamic, and you know my main hope is that together that we can learn and are experience in North America can help to inform your own country’s experience, so that your own country doesn’t have to go through the heartache and the social catastrophe and the health care, catastrophe that we have gone through in in the United States.
My final point is this, which is that I wanna be very clear that the epidemic is one that’s deeply, deeply rooted in the health care system in the United States, and by a profound mis-calibration on the part of clinicians on the part of patients, and on the part of policymakers and researchers. Such as you and I. Regarding policymakers and researchers such as you and I, regarding the risks and the benefits and the appropriate role of opioids in clinical practice.
So thank you again for coming, and I look forward to your questions and comments.
Next we’re going to hear from Bridget Brennan, and as I mentioned, Bridget Brandon is New York City’s special narcotics prosecutor.
Bridget Brennan, New York City Special Narcotics Prosecutor’s Office:
Well, good morning, everyone. Thank you so much for joining us today. And so early in the morning. I’m the Special Prosecutor for New York City, and that means I have the opportunity and the obligation to prosecute high-level narcotics trafficking offenses and because I’m the head of the agency, I’ve had a front row seat, as we’ve seen the opioid epidemic unfold across the United States. I’ve seen it sweep through New York City and the rest of the country.
Today’s most deadly drug is illegal fentanyl. Illicit fentanyl is killing record numbers of Americans reducing our life expectancy and now we’ve learned that opioids are the leading cause of poisoning death for children under 5 years old.
I’m here today to describe just how that crisis began again. I had a front row seat. The worst drug epidemic in American history began with legal prescription drugs that are highly addictive. They’re widely over, prescribed and laid the groundwork for the opioid epidemic that we’re experiencing today. Now Dr. Alexander described the limitations of opioids as painkillers, and
Dr. Kolodny will detail what happened when powerful pharmaceutical companies promoted these medications and American governmental agencies failed to appropriately regulate them.
I will describe how unscrupulous physicians setup practices to provide addictive medications.
Sometimes with no medical examination, in large quantities, and with no plan to ever taper their patients off or discontinue the pays.
Those doctors found it was an easy way to make money.
How did I come to this? I started to hear of diversion on the street that pills legal pills were being sold sold on the street, but I also started to hear complaints from parents that they lost their children to addiction.
I started to hear from treatment providers that we work with addiction treatment providers that they were, seeing many people who are experiencing addiction because of these pills, and that they were seeing the people then turned to heroin because heroin was cheaper and gave them a faster high and as I understood what was going on I’m a lawyer. I don’t have a medical background. I don’t know how this works. So I searched.
This was about now, 13 years ago, for medical expert who could help me, and that’s how I found Dr. Kolodny I found a Youtube of his talk on the Internet, which seemed to intersect with exactly what I was seeing.So I reached out to him and asked him to speak to our attorneys and our investigators.
We have a staff of about 200 in my office to explain to them the dimensions of this problem, because I wanted my office to investigate this as criminal action. Now in the United States, we don’t generally prosecute people for prescribed for poor prescribing practices, but this was something very, very different.
This was doctors who are seeing dozens of patients, hundreds of patients with no medical examinations, no follow up, no, nothing giving them addictive prescriptions, and the people were dying. Many people were dying, and Dr. Kolodny helped explain to my staff what was happening, and helped to educate us. It was a very close partnership, which I think we need if we’re going to be tackling these kinds of issues.
So, what I want to tell you about is just one physician, because I think it exemplifies the kinds of issues that we were facing. That doctor was Dr. Stanley Lee. From 2008 to 2011 during the week he worked at an anesthesiologist in the hospital they worked full time but one day a week. He ran a cash only pain management, clinic in Queens, NY. One of the boroughs of New York, and we got a complaint from a citizen about that. The citizen said that there’s a doctor running a practice one day a week, and there are young people lined up outside his door every Saturday, and they look healthy. I don’t know what’s going on, and we conducted an investigation to try to figure out.
We obstructed those same observations, and we use some of the other tools that we have available to us to see that as prescribing was very, very high for one day a week practice.
It was one of the highest that medical experts that we consulted with has seen, and then we started conducting a search among medical examiners and corners who do reports after people died of sudden, unexplained deaths, and we learned that quite a number of his patients had died in total. At the conclusion of our investigation.
We learned that in that 3 year period we’re looking at 16 of his patients had overdosed and died, and you know, that’s a pretty high number, especially for the age group he was treating so. Of course that was only the number who died of overdose. There were other deaths associated and certainly destroyed, lives associated with that practice.
There was one former patient who was addicted to an opioid drug, who rob to pharmacy on a Sunday afternoon to get those drugs, and he killed 4 people in the process, including a 17 year old cashier who is working there part time. He was desperate to get the drugs, and he was driven there by his wife, who was also a former patient of Dr. Lee. And so we see this exactly. This trajectory of how the addiction led to destroyed lives overdosed deaths, and other crimes.
And so we’ve worked closely together with Dr. Kolodny and other health experts on this problem, and there have been advances. But some there are some myths that I just want to point out to you. One of them is, and if you wanna just show that first slide, this is what we saw. This is when I started looking at it was not until about 2,010.
But this is a slide that shows the consumption of Oxycodone. I take that because that’s the one we saw being sold on the street the most that’s the one that was most often prescribed.
Sometimes we’re seeing dangerous combinations of prescriptions prescribed. And actually, when they went in to see Dr. Lee, it was not really much of a visit.They were given a number like you get in a bakery a number, and they were called by the number, not by their name.
When they got in there they were in there long enough for him to write a prescription, and for them to give him cash, and then they were out, so he would literally see a 100 patients on a Saturday but in any event, the next slide please so this is the oxycodone you can see how the trajectory of the procedures field increased, and when I was looking at it was 2010.
It hadn’t quite peaked yet, but it’s certainly come near its peak and it then tapered off, as the State did, and the Federal Government did start to finally regulate these drugs and people became aware of their problems.
Next slide, please. But look at where we are in 2010, first in 2011, 2012. Next slide, please. So this is a graph of the illegal drugs. This is our seizures of Fentanyl. Heroin mixtures from 2016 to actually, it’s from 2,010 to 2,022, and that top line is heroin. That’s the drug. We started to see. Come in right in back of the oxycodone.
The prescription pills. They’re developed a very large illegal market for drugs and people with these are our major seizures on the left are the pounds of drugs we were receiving in a single year. And if you look at this trajectory of the heroin seizures the yellow line, you see that the heroin seizures were peaking and beginning to peak at the same time the oxycodone prescriptions were peaking so one didn’t replace the other the heroin didn’t replace the oxycodone they’re going up at the same time, and then the Fentanyl came in.
The Fentanyl is the orange line, and the mixtures are the orange and the lighter orange line. Now Fentanyl, these seizures are lower, because that’s an extremely potent drug. So you don’t need as much of it both to get high or to kill people. And so those that’s what followed. The heroin.
And now in New York it has. It is really just replaced heroin and it’s killing lots and lots of people. It’s a we’ve had a record number of overdose deaths in New York City. So that’s why I’m here today. I just want you to know that.
Certainly this can happen in any country anywhere. No one’s immune from this, because, as Dr. Alexander explained. There’s a you know, there’s a physical relationship between the patient and this kind of drug.
And so if these drugs get out of control, it lays the foundation for illegal drugs to come in which is happening across the United States and don’t think that the US and Canada are the only countries that can be affected by Fentanyl. Fentanyl is made from synthetic components and can be produced anywhere in Mexico. It’s being produced often grazing raising lands in makeshift labs under conditions with no quality control.
Of course, and so it can be produced anywhere and can happen to any country, and I would hate to see this kind of thing happen anywhere else. We’re trying desperately to rein it in in the United States. So thank you for your interest, and I wish you all the best, and thank you for your attention.
Dr. Andrew Kolodny, Physicians for Responsible Opioid Prescribing:
Thank you and I, just before I begin, I just want to point out that what we heard from Dr. Alexander was the way in which many well intended physicians inadvertently harm their patients, created cases of opioid use disorder and also created opioid use disorder by stocking medicine, chess with this highly addictive drug, the pill mill doctors, the drug dealing doctors that Bridget Brennan has worked to to process these were doctors who were really profiteering, really exploiting individuals with opioid use, disorder, and in in many ways it was the well intended doctors that created the epidemic of opioid use disorder. The mortality in has been driven by many of the pill mill doctors in Black Market opioids in recent years.
So let me get started. I’d like to just begin with framing the opioid crisis in the United States. These are different headlines that have appeared in us newspapers in the past couple of years, and you know we talk about the opioid crisis frequently in the Us. And and hopefully, it’s getting national attention. The but you know, how should we frame the problem? How should we understand? What’s what’s driving it? I think the correct way to understand that is, as an epidemic of opioid use, disorder when we frame it that way. It means that the reason we’ve seen Fenanyl flood into the United States the reason we’re experiencing record high levels of related overdose deaths. The reason we’ve seen a soaring increase in infants born opioid-dependent outbreaks of injection-related, infectious diseases impact on the workforce the driver behind all of these health and social problems has been a very sharp increase in the prevalence of opioid use, disorder in the United States today, about 4 to 5% of the adult US population may be suffering from opioid use, disorder.
That’s a very large number of Americans to make sense of the mortality statistics that you may come across. We heard there were 100,000 drug overdose deaths in the United States, and in 2,022, to make sense it’s important to understand the epidemiology.
Roughly, we have 3 groups of Americans suffering from opioid use, disorder. The first 2 groups on this slide are individuals who develop their opioid use disorder from prescription opioids.
It’s a younger group that became addicted to prescription opioids and then switched to the black market and an older group that really hasn’t switched that much and has really continued to overdose from prescription opioids. The third group are really survivors from the heroin epidemic of the 1970s that bled a little bit into the 1980s that the first 2 groups are disproportionately white and suburban and rural. The third group is disproportionately non-white and urban.These are individuals who develop their opioid, use disorder in their teen years from heroin use.
I mentioned that the right way to frame the Opioid crisis is an epidemic is as an epidemic of opioid use disorder. I’m gonna show you that happening the epidemic began in the year 1996.
This is 3 years into the epidemic. The states that show up as red or maroon are the states that have the highest rate of individuals seeking treatment for addiction to prescription opioids, and what you can, but I’d like you to see is what happens to the color of the map as we go forward.
Many more states had turned red, or maroon. 2003, 2005, 2007 and 2009 by 2009, just about every state in the United States had seen a very sharp increase in the prevalence of the number of people suffering from the condition of opioid use, disorder.Why did the map turn red? Well, I think the first and best answer to that question came from the CDC. This was a graph that the CDC. Created and what they’re showing us with this graph is that as sales increase in the United States for opioids, deaths increased directly in parallel with the increase in sales. This is another slide from the CDC. And on this slide the green line represents prescriptions for opioids or opioid consumption.The red line represents deaths involving prescription opioids, and the blue line represents opioid use disorder, and what you can see is that as the prescribing went up, it led to parallel increases in rates of addiction and overdose deaths. The what drove this very sharp increase in opioid, prescribing that would lead to this epidemic was a multifaceted campaign that changed the way the medical community thought about opioids, the risks were minimized. The benefits were exaggerated. That very campaign that influenced the medical community in the United States, and regulators in the United States has been launched internationally, and one of the countries that was central to this in the United States, which in many other countries goes by the name Manday. Pharma has has worked very hard to influence the international community, and in many countries across the globe we are seeing opioid prescribing increase because of this use of the same playbook that worked so well in the United States it, a playbook that involved using influential clinicians. Involves using pain organizations that in effect are front groups for industry that promote very aggressive prescribing. And downplay the risks of opioids. And this slide that you’re looking at comes from a report and investigation a bipartisan investigation that was done by 2 members of Congress in the United States to look at the way in which the World Health Organization was influenced their investigation led WHO to remove 2 guidelines that had misinformation about opioids in them. As you know, opioid consumption, as I mentioned, is increasing in many countries.
The the top line. Here is the United States, but we have seen many other countries are beginning to follow in our footsteps. These countries include the Netherlands, Sweden, Switzerland, France, the UK, Australia, and many other nations.And I’m just mentioning the countries where reports have been published showing the increase in prescribing and the increase in opioid-related harms. Certainly this phenomenon is occurring in countries that have not reported this data. Very often we hear advocates for increasing opioid, prescribing talk about the need for balance. This is a slide that was shown at a meeting in the United States that the Food and Drug Administration, it was shown by a pain organization funded by Purdue Pharma, and the idea behind this slide the message that was communicated to the FDA was that if the FDA were to put a drug called Hydrocodone in a more restrictive category that it would be punishing this pain patient for the for this abuse by these teenagers in this photo. The idea was that that policymakers need to be balance don’t harm the pain patients in your effort to deal with misuse. This is a false way to frame the problem. We don’t have these 2 distinct populations of so-called drug abusers where the harms are limited to that, to the drug abusers and pain patients who are claimed to be helped by opioids. There is a tremendous amount of overlap in the United States. Individuals with chronic pain, of have been disproportionately harmed by the injuries in prescribed. We’ve seen 35% of individuals with on chronic opioids meeting criteria for opioid use disorder in a study of prescription opioid overdose decedents, 92% of the decedents were receiving opioid prescriptions for a diagnosis of chronic pain.
In summary. The United States is in the midst of a severe epidemic of opioid use, disorder, and overdose deaths caused by an oversupply of prescription, opioids this phenomenon is repeating itself in other nations we must think about balance differently too often the idea about balance is promoted, as if all harms STEM from diversion and abuse. We must recognize that harms can also result from medical use. Regulators and clinicians really do need to balance the risks versus benefits. Better to do that. They need to understand the risks they need to understand that, especially with long-term use, effectiveness. Really isn’t there? In fact, the long term use of opioids. We can even see pain. Worsen. It’s a phenomenon called hyperalgesia, and lastly, regulators really do need to appropriately balance risk versus benefit for their societies. Thank you.