Darshan
Hey everyone, welcome to another episode of DarshanTalks. I'm your host Darshan Kulkarni. It's my mission to help help patients trust the products they depend on. As you may know, I'm an attorney, I'm a pharmacist and advise companies with FDA regulated products. So if you think about drugs, wonder about medical devices, consider cannabis or obsess over pharmacy. This is the podcast for you. I have to specify as a lawyer, this is not considered to be legal advice and should not be also considered to be clinical advice. So find a lawyer that's right for you. And ask them for the advice. I do these podcasts because they are a lot of fun. And because I find myself learning something new each time, however, it would be nice to know that people are listening. So if you like what you hear, please like leave a comment, please subscribe. If you if you want to find me, you want to reach out to me reach out to me on twitter at DarshanTalks, or just go to our website at DarshanTalks calm. Our podcast today is really kind of interesting because I've two separate directions I can take it. And the one I'm really interested in is the topic that was super hot in 2019. And we seem to have just ignored it for the last for the last year and a half at this point, almost literally a year and a half at this point. We're going to talk about the opioid crisis. So if you are a patient thinking about the opioid crisis, if you are a district distributor, a pharmacist, a manufacturer, and I'm wondering what's going on with the opioid crisis? Today's discussion should be really kind of interesting, because it'll tell us what what's going on. What's new. And where's that going? what lessons can be learned from this? Our guest today is the President and CEO of white law compliance group. He teaches law school mostly at Mitchell Hamlin, and is the editor at policy and compliance medicine update. He is a person that I routinely reach out to for advice. He's incredibly smart, and as you can tell from the pipe, incredibly professorial. I think that's the right word for it. So our guest for today, Seth Whitelaw Hey, sir. How are you?
Seth
I'm good. Darshan, thanks for having me.
Darshan
It's good to have you on. Let's talk a little bit about about this course you're going to be teaching at Mitchell Hamlin, which is on the opioid crisis. So let's start with Well, we all know what the opioid crisis is. But is it something that has died down? Is anything going on with it anymore? Or is life hunky dory at this moment?
Seth
No, it's not hunky dory, it started to die down. But I would say at the beginning of this year, and certainly in the last few months, it is seems to have taken on a life of its own. What we're seeing, not so much from the crisis perspective. But more from the litigation perspective. So we're saying new litigants being brought in, we're seeing McKenzie as a consultant brought in and I'm pocus health brought in for the work that they did with primarily with Purdue pharma. We have plenty of ongoing litigation in the MDL. There's a big case going on California has a separate action going on out there. So we're gonna see a lot more in this space that we're not nearly done yet. It kind of took a hiatus and a backseat to the pandemic. But I think it's picking up again.
Darshan
So let's talk a little bit about that. Because you raised some interesting points, this idea of bringing in McKenzie or bringing in publicists. That's a novel interpretation. I mean, I can totally see it under the False Claims Act, because it's such a broad law that enables anyone who's in that change we brought in, but this is an unusual situation. Can you talk a little bit about what's going on there? And why are these two companies being brought in?
Seth
Why in particular, these two companies are being brought in because they, at least the from the information that's available, and the documents that have been revealed so far in the case, these folks, quite frankly, were major drivers behind produce marketing campaign for oxy cotton. They were the ones who suggested targeting high prescribers. They were the ones who were pushing the narrative that somehow Oxycontin was less addictive. Had a less abuse potential, none of which is when you look at the data, none of which pans out. So they were active players in the space and I think you're also seeing they're being they're being brought in because Again, as these cases churn their way through the system, the amount of money we're talking about is huge. The scope liabilities, incredible. The companies themselves, they're in the distributors, there isn't enough money, even if you even if you bankrupted the mall to pay for this. So I think states and others are looking for ways to bring in other people would potentially be pockets.
Darshan
So this is an interesting comment you made, which is it's not about the money just
Seth
about you.
Darshan
Excuse me, I have to even if it's online, I have to clarify, these are allergies, this is not COVID. But justify that we live in that world. But let's talk a little bit about that you talk about if there's not enough money to pay for everything, let's start at the beginning, which is these companies are asserted to be the companies that basically pushed this product and asserted that it has limited vision potential, if you will, I guess my question to you is, what is the gap? What is the difference between advertising and pushing a product? Because everyone's allowed to advertise? Is it the false and misleading component that made it problematic? Or was there something more to it?
Seth
No, I think it's the false or misleading component version. And I really do I think the real issue here is, they were saying things that they knew, or should have known were not accurate. And so I don't think anybody has a problem with companies pushy. advertising their products, being truthful about their their products being truthful. But that requires that sort of, as you well know, from the Food and Drug work we've done together, you know, the fair balanced concept, you have to get the positives and the negatives, you can't just give positives, that doesn't work. And these and I think what was happening, from what I've seen, certainly, they were simply emphasizing the positives and ignoring the negatives.
Darshan
So let's talk about that. Because you're talking about, let's say, publicists. I've never quite pronounced this right. pupusas, I believe is how it's pronounced. But But let's take them for argument's sake. And to be clear, I don't work with them. I don't have they've never been a client. Nor here. Yeah. And I haven't looked into their specific case, in enough depth to be able to comment on as we're talking about these as abstract entities and where the direction is right now on compliance. So the question I have is, number one, is this an indication that the DOJ and the O YG. And state inspector general's offices are now open and interested in exploring more cases against ad agencies and consulting companies? Or is this a one off you think just because of how this how it's played out?
Seth
I think it's an egregious example they're showing but I, if I were a consultant, and I am a consultant, it gave me pause as well, to the extent of, to what extent are you as a consultant aiding and abetting bad behavior. So making sure that your advice is sound, making sure that you're giving them all the risks and thinking about those incidences where you know, if your advice isn't going to be taken, and you know, they're not going to listen to you? Do you need to walk away? And I think I think for all consultants, I think it really gives us pause, to think about how we interact with our clients and exactly what it is we're doing for our clients.
Darshan
So I guess that's my question, though, right? When you when you start talking about how we interact with these clients, what we're going to deal with these clients. The truth is that there's often what I think of as the fog of war, which is, you're talking in there throwing ideas, you're trying to make sure make sure things happen. It's spitballing of ideas, and then someone settles in on Okay, here's where we're going to land up, this is the direction we're going to go. And then what you're going to do is you're going to make sure it lines up from MLR perspective, from your medical legal regulatory review perspective, that you've got your risks and your benefits appropriately outline, if you're the strategy phase, which I would imagine is what McKinsey did. I don't think Kinsey went out there and was pitching the product.
Seth
No, no, no, no, they did there. There are instances in both cases where they did do ride alongs with the reps, they did go out into the field. So in in some ways, it it's kind of unique in the sense that they were almost as if they were a pseudo Marketing Department of the pharmaceutical company.
Darshan
But I think you have to draw that line between marketing and sales, don't you in that marketing usually is everything we say will be reviewed, because it's all going to be on paper or an ad, like an ad that goes out. Sales, on the other hand is speaking. And that's where the list comes in. I'm asking I guess, it wasn't, as far as you know, McKinsey or pupusas, where they were they doing the ride alongs. And the capacity is sort of auditors, and they just did a bad job on now
Seth
they were doing it in a capacity to gain market data.
Darshan
Interesting, interesting. But let's say the game that market data, what makes them particularly liable? I mean, there's nothing wrong in getting market data.
Seth
No, I think that it's been How does it translate into the messaging that you're suggesting the company do. So there's, they were suggesting to de emphasize the abuse risks. They're emphasizing targeting high prescribers only, they were emphasizing all the things that Purdue finally did. Today drive market share, and drive market share. From what is at least what has been revealed in in so far, driving market share from the standpoint of ignoring what was going on in the market in with the crisis and in real time. So they knew this was a problem. They knew that putting large amounts of the large volumes of these opioids out there, were going to cause a problem. But all they were focused on was driving that market share, not dealing with the risks. And there, it wasn't, at least as the cases presented, they weren't giving a balance here. They were giving just here's how to drive market share, guys.
Darshan
So ethically speaking, obviously, assuming everything you're saying is right, that's just inappropriate. But legally speaking, do they have a duty to talk about balance? Because that balance would really the duty would fall in this specific specific case of produto? Wouldn't it?
Seth
Yeah, the duty would follow Purdue. But I do think, you know, if, if all you're giving is the rosy picture, and you know that there's a negative picture. All right, I think if you're being a true trusted adviser, which is what consultants are supposed to be, you have a duty to point out the positives and the negatives.
Darshan
So you're saying that they didn't, which is interesting. It's extending a new duty, which I'm not sure I've heard off before, which is consultants have a duty to now talk about risks and benefits, which has always fallen, legally speaking only on the manufacturer?
Seth
Well, the duty fault? Yeah, you're correct. I think it's a change in who's where the duty lies. I think consultants have always had a duty to balance their advice. I think consultants have always had a duty to be fair, is fair and balanced and objective as they can make. I think when I give advice to clients, it's not only do I give advice about the risks, yeah, well, I you know, I will also point out, well, he can do this. But these are the but these, you know, this is this, this is where it's problematic. Yeah. It's not clear, it's gray. But at the same time, you need to be aware that you're not doing this in an environment where this is where you can put a rubber stamp and say everything's okay. And I think consultants have a duty to say that.
Darshan
I would agree with you ethically, for sure. I'm, I'm, I'm struggling. If, if a court would argue would agree, because I've never I've never seen that in any, like, do we wouldn't call in to the FDA, the food drugs and cosmetics act? I argue so. And contract law doesn't require that. So where does that actually come from?
Seth
Well, they're arguing, at least in the Massachusetts case with Buddhists that are public nuisance.
Darshan
That's an interesting argument. So explain that. What is the public nuisance law? And how does that play out? And this
Seth
varies by state. Okay, so this is a state concept, but basically, the public and when you see public nuisance, for those of us who doesn't remember our law school days, you know, it's how do you control pornography? How do you deal with the polluter? Yeah, factory. I mean, those are those are the real, traditional public nuisances. This is this really started with the Oklahoma case, with j&j. Washington's jumped on board Massachusetts has jumped on board, saying, depending on their state laws, can we say that by dumping all this product into the marketplace and knowing that it was going to cause harm, you guys are essentially acting as a public nuisance. I'm oversimplifying, but that's pretty much the gist of it.
Darshan
The gist is that you should have known better you put this you allow to enable these products to go into the market. And that constitutes a public nuisance. And therefore we're gonna,
Seth
you did that through false advertising and misleading advertising. And but it's the doctors and let's
Darshan
let's play you being the DOJ me being publicists or McKinsey for the second, my argument would would be, I didn't do that. I gave cert I gave, I was hired to tell Purdue how to raise the N. Just to be clear, I've never worked in either one of those. But But I'm sort of playing this out. I was hired to talk about how to raise awareness, I did that I was not, I was not hired to tell them the risks, I was not hired to say that all this other work, because that would have changed the amount of money I would have charged them, that would have changed what I would have, if I would have even been hired, they would have said stay within your lane. That's not what I'm asking you for. We already know the risks.
Seth
And I think they were used, they were being used more as what you what we you and I would consider the in house marketing department for that
Darshan
explain how that plays out. They were considered the in house mark, but they didn't review ads or create ads didn't
Seth
know what the creative. I do believe that created some sort of marketing material for them. But they certainly created the plan for which the marketing material was then created. So they created the marketing plan, okay. And they post that smart and they really pushed this marketing plan. Sure.
Darshan
But you don't have to talk about risks in a marketing plan, you have to talk about the benefits in the market, or at least the direction or the operational element of the marketing plan. The the actual pieces would end up being part of the actual advertising piece that goes along with it. And again, we haven't seen neither you nor I, as far as I know, I've seen the actual pieces. And we don't have details on what actually happened there. But we're just sort of playing this out. So what
Seth
And to be clear, what I'm basing my comments on Darshan is the complaints have been filed. So what I've seen is the actual Yeah. Which was, I think, would bleedings, which, of course, is only one side. So we haven't seen what they can come up with for a defense.
Darshan
Fair point. So let's take that second part of this, which is what they can come up with for a defense. But before we do defense both What do you and I work in the compliance space? So are you seeing more of us going out there and talking to ad agencies and talking to consulting companies, because let's be honest, DOJ is not typically going after one and two man shops. They're going after the McKinsey's because they want to make an example out of it.
Seth
And this again, these are more state settlements that we're talking about in the state governments going after the EPA, because one of the big changes, as we've seen with the opioids is that while the feds have press certain cases, Purdue insists, in a very handful of others, you know, by and large, this is being driven at the state level.
Darshan
Why do you think the states are doing this when the federal government is not usually statius? Follow the federal government ride the coattails because the states
Seth
are the ones who are paying for the fall. They're paying the EMTs. They're paying for the oxycodone, they're paying for addiction treatment. They're covering all these costs, that they're not getting reimbursed by the federal government for any of it. And it's taking a toll on their communities. And they, they're looking to pay for it.
Darshan
So this is them really trying to address their rising medical costs. Is that is that I think
Seth
a large part? Yes, I think it is. I think it's also the fact that they have also seen, I've seen a rise in state actions in other areas as well, where the feds have decided that they're not pressing it hard enough, or they don't want to press it. And the states are going Ah, you're not, you know, again, each state has a duty to protect the public health and welfare of its own citizens. They're saying okay, well, federal government if you're not going to do it, we're gonna do it.
Darshan
Is this an opportunity I think for and this is I'll be fully honest, this is caused due to me Watching billions last night. But is this? Is this an opportunity for State Attorney General's offices to make their names?
Seth
Absolutely. No question about.
Darshan
So this and again, I'm not I'm not questioning, I feel like I'll give you a example of where I feel. Um, so as you know, I'm a pharmacist as well. And one of the things I struggled with was, I'd gone to India and I landed up meeting a friend. So I was working in a hospital in the US, I went to, went back to India met a friend, he's a physician there. And it's interesting that the patient had just been through diabetic foot surgery, okay, and they gave him ibuprofen. And I was like, That's ridiculous. You can give someone who's got two foot surgery, ibuprofen, and me and my then ex, my dead wife, my current ex wife laughed at that situation going, I can't believe that is okay. Like, that's the standard of care there. On the other hand, he went, he was like, No, this is normal here, and patients deal with it fine. And, in retrospect, I still can't tell whether I was fooled. If I should have known better, or it was just standard of care. That's what I saw every doctor doing for every patient and the life so I guess it comes for me, I guess I'm looking at the opioid crisis and going at the physician level, at the prescriber level, at the pharmacist level? Um, how do you decide what is appropriate? What is the standard of care? versus because pain is not something that we can calculate? The I mean, the bit, the best thing you have? Are these pictographs? Where you go, how do you feel super smiley or no, not a smiley? So if we were doing this, right, and we are, you are a pharmaceutical company? And let's say you want to educate people? Do you kind of go until you feel less smiley, number seven? Don't don't ask for any opioids, but how do you? How do you prescribe? How do you do this? Right? If you're trying to be a good pharmaceutical company. I
Seth
think a couple things you do write LaRoche on his one is where you have where your sales reps pick up on signals, for example, that a doctor really isn't seeing patients. He's just writing scripts, the pill, their traditional pill mill, for one of a better way to put it. I think at that point, you have to start to say, should we be selling to this individual? Should we be calling on this individual? You know, it's clear that this person isn't necessarily doing, you know, doing their patients of service? I think there are lots of patients. Look, I think the dilemma here is, number one, there aren't, there aren't really good alternatives between opioids at the very top of the medication and say, Tylenol at the bottom or ibuprofen. There, the middle ground has been kind of blank for many years. We're not seeing a whole lot of new compounds coming out. I think it's one of the unfortunate parts of the cannabis scenario that potentially cannabis could fit somewhere in that middle. And we're only seeing it being allowed and really tested at the state level, we're not really seeing it. We're not seeing any real programs from a federal level perspective, because it's still schedule one controlled substance. And there's the belief it has absolutely no medical use, despite the fact that they're certainly sub state, I think a substantial body of evidence to say, while a lot most of it's anecdotal. Maybe there's something here, maybe we need to test it in a real true, controlled clinical trial setting. Now to see whether it really is effective or not. And then if it is, figure out a way to approve it. But we're not saying that. I think the manufacturers and and distributors are also in a kind of a rock and a hard place because once you see that, what you think is bad behavior, who do you report it to? You go tell da do you go to DOJ do you go to FDA? I think there's a quandary for a good company that's trying to do the right thing. But I think the company itself has to make that decision as to whether or not and who it sells to, and whether it's comfortable with those selling practices. A good company does doesn't want to drive sales only they want to drive sales to the right patients. And if they have a sense that that's not happening, then they're not doing the patients who shouldn't be getting their product, any services by allowing that to happen. If they have a bill ability to adjust course, I think you also need to figure out how to insert a or make sure that if your sales reps, see those things, and report those things, they don't get penalized for that, because Don't forget, they're making money on their bonuses, and we're making money on what they sell. So if they lose the doctor who in their territory that is 50% of their target, that they are going to take a net, they're going to have a negative financial benefit unless you make adjustments. And I think you have to make adjustments for that. Especially if you really want to say you want your sales reps to do is sell and sell correctly, not just sell. Yeah, don't just sell to anybody who will read the script, but sell to the right doctors, the ones that are trying to do the right thing that are, you know, not just giving this stuff out like candy. And again, I'm oversimplifying,
Darshan
of course. But one of the things I think is fascinating is an example of where that happened. And it happened wrongly, I think I forget which company it was, but it was in the news that they It was a distributor that distributor something like six times the amount of oxy cotton required to kill all the people in that in the county.
Seth
Right to definitely, there are plenty of there's plenty of point data points like that these numbers, the scary part of this is the numbers are not close. I mean, this isn't These aren't narrow bands we're talking about we're talking about amounts and quantities and quotas, however you want to frame it, where somebody somewhere should have said, Hey, wait a minute, this doesn't make sense. Why is the roof? Why is the pharmacy in West Virginia, asking for this amount of product? What's really going on here? And I don't think I don't think, you know, I think the signals were there. I just don't think people paid attention to the signals or wanted to pay attention to the signals. Which is my bias on this.
Darshan
We have to bring you on to discuss this further. Because we haven't even touched the surface yet. And usually, like I said, I aim for about 1520 minutes. And we are at almost double that right now. Wow. So yeah,
Seth
we could talk about this for hours.
Darshan
Right? As I told you, there are four general questions, I tend to ask my, my audience, or my guests, the first question, is there a question you'd like to ask the audience based on what we discussed?
Seth
Yeah, I think I think, from my perspective would be, how do we improve the relationship between the compliance folks, because that's what I do. And the business folks such that the business folks will, you know, will listen, I'm not saying they will always take the advice, but they at least listen, I think what scares me the most are situations where compliance isn't getting listened to at all. I'm not saying that we're always right, because we're not. And I'm not always saying they always have to take the advice, which they don't. But I do think what scares the living daylights out of me or the business folks to take risks without really understanding the risks that they're taking. And those have grave consequences, not only for the company in themselves, but also, ultimately, at the end of the day, the losers in this, are the patients because of the company get shut down and no longer makes the medicine. Yeah, yeah, the patient forces the medicine.
Darshan
I like to answer the question just as a first shot so that people know what what options are, what my answer would be, help address the issue of trust, I think, compliance. We're so quick to say no, Yes, we are. That people that companies kind of don't want to ask us those questions. Because we may say No.
Seth
and No, as you know, Darshan knows the easy answer. I mean, the easiest thing for any compliance person to say is no. The hard part is to say no, but
Darshan
no, here's how you do it. Yeah. Or,
Seth
yeah, get your objective. I get what you're trying to do. Yeah. The way you want to do it, the way you're proposing to do it isn't, is gonna get you into some real serious trouble. But if you do it slightly differently, you can probably get to that same objective. But stay out of trouble. Yeah. As I tell my clients, my job is to say is to tell you where the sidelines are, and keep you in bounds at all times, and give you the widest possible playing field to play on. As long as you're in bounds. That's great. And, and go do what you do best, which is the business part of the of the world. My job is to tell you where the sidelines are, and keep you from going out of bounds.
Darshan
Great. Um, second question for you. Yeah. What did you learn this week?
Seth
What I learned this week, again, we're working on the course that we're working on is that if you look at if you look at the data around the opioid crisis, one of this one of the interesting things that you see is that the, although deaths due to prescription opioids have gone down like four and a half percent roughly in the last 10 years. deaths from synthetic opioids, fentanyl in particular have gone up almost 1000, a little more than 1,000%. So what's really driving the crisis? In fact, you have to look at it in phases. So if you say the early 1990s to the mid 2000s, a lot of it was fueled by oxycodone, hydrocodone, oxy cotton, the opiate, the traditional opioids, and heroin as well. But, and then you'd start to look at where we are today. You see, it's less to do with prescription opioids and a lot more to do with the synthetic stuff. The fentanyl
Darshan
Okay, okay, um, I'm sorry, I keep hearing Simon, I live in Philadelphia as UNICEF and we keep having the cars bus bias of the ATVs. So I keep trying to go try to kill my volume as much as often as I can
Seth
understand.
Darshan
Um, the other question I want to ask you is what has made you happiest in the last month?
Seth
Oh, I think being able to get out and see people again, it started to make me happy again. It's the it's the little things like being able to go out with my wife to breakfast somewhere.
Darshan
Very, very cool. So I'm going to just recap the conversation we had, we actually ended up talking about your summer course, we landed up talking about the opioid crisis. We very briefly touched on essentially manufacturer defenses and distributed defenses, but really talked a lot more about the McKinsey's and pupusas and the consultant liability that goes along with it that we're now seeing you touch on multidistrict litigation. And we talked a lot more about this new emerging public nuisance law that we're going to that's been reinterpreted as a new theory of defense, especially in this context, we talked a little bit about the difference between advertising and pushing and the distinction being on on addiction potential and and the role that companies and compliance departments have to play as we continue Did I miss anything?
Seth
No, I think you got it all
Darshan
awesome. Um, so as we as you mentioned earlier, nothing this podcast should be legal or political advice. It's an educational entertainment purposes only for those of you who missed it said where can they find you?
Seth
Give me my email is s Whitelaw at White law compliance Comm. You can find me on the web. You can find me through LinkedIn.
Darshan
There you go. Um, if you liked this podcast, please like leave a comment. Please subscribe. You can find me on Twitter DarshanTalks, or go to our website at DarshanTalks comm said this was awesome having you on. Thank you so much.
Seth
Thank you.
Seth
This is the DarshanTalks podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on twitter at DarshanTalks or the show's website at DarshanTalks.com
