Integrity With Industry

Speaker 1:    Welcome to The Practical Dermatology Podcast. In this episode, we hear from Dr. Colby Evans, former chair of the National Psoriasis Foundation board of directors, plus a conversation between Dr. Neal Bhatia and Dr. Jules Lipoff. Now here's Dr. Colby Evans with an update on the Safe Step Act.
Dr. Colby Evans:    I'm Colby Evans. I am a board-certified dermatologist, and I'm the past chair of the board of directors of the National Psoriasis Foundation. [00:00:30] And you are asking about the step therapy legislation, specifically the Safe Step Act that had some traction last year, but as is often the case, as was the case in Texas when we passed similar legislation back in 2017, things change at the governmental level, especially at the last minute. And so the Safe Step Act is back this year. It has been reintroduced with bipartisan support, [00:01:00] and it was reintroduced in September of this year. So our hope is that with support of the dermatology community and the patient community, we are going to see it in front of the House and Senate hopefully early next year.
    So to remind everyone, step therapy is a process where insurance companies require patients to fail, usually older, less expensive, less effective medications for whatever condition you're treating before [00:01:30] they will cover newer and sometimes more effective medications. And this can be a problem for a lot of reasons. Over 120 million Americans have chronic diseases. There are many new treatments that are much more effective than things we had in the past, and patients are often being required to experience more side effects, less effective treatment, longer delays in care because of step therapy.
    In [00:02:00] 2017, as I mentioned, we passed in Texas a law to put some guide rails on this process, and that has been helpful, but unfortunately, over 90% of commercially-insured patients have insurance that's regulated by the federal government, so in our case, the Texas state law does not apply to them. So we really need federal legislation to replicate what most of the states have done to try to limit the impact on patients of step therapy.
    The Safe Step Act [00:02:30] puts some guardrails on the process so that patients have a specific timeframe, like 24 to 72 hours or maybe faster if it's a life-threatening emergency, when they can get a decision, an appeals process or an exemption process so that if it really is not appropriate for this patient to have the older treatment, they have some way to put that in front of the insurer and get resolution quickly.
    I think [00:03:00] this is really critically important for our patients. The community I'm most familiar with is the psoriasis community, a lifelong and chronic disease, and a disease where we've had tremendous progress in therapy in the last 15 or 20 years. At least 41% of our patients with the National Psoriasis Foundation have experienced this process before. Of course, I mentioned it delays care, but sometimes it really denies care because [00:03:30] the process is so complicated with the paperwork, the appeal, the denials, the reappeal, and everyone has to be involved in that, the patient, the insurer, the doctor, and if there's a breakdown at any point, sometimes the patient just doesn't end up getting treatment at all and ends up coming back a year later never having gotten any kind of treatment.
    And that really is a failure. Obviously, it's a failure for the patient, it's a failure medically, but really it's a failure economically [00:04:00] too if the patient has a substantial side effect that was unnecessary from an older drug or if their disease is just never treated, and then the cost of their pain and suffering, the cost of absenteeism from work, disability all continues to build up because we didn't have some simple safeguards to make this process more user-friendly.
Speaker 1:    Next, Dr. Neal Bhatia is joined by Dr. Jules Lipoff.
Dr. Neal Bhatia:    Hi, I'm Dr. Neal Bhatia. I'm chief medical editor of Practical [00:04:30] Dermatology, and we're doing a little conversation today with a friend of mine, Dr. Jules Lipoff from Pennsylvania. Dr. Lipoff and I have some great ideas to share as well as some good conversations. So Jules, say hello and introduce yourself to the gang.
Dr. Jules Lipof...:    Hey, Neal. Thanks for inviting me to join. Yeah, I am a dermatologist practicing in Philadelphia. I am a clinical associate professor adjunct at the Lewis Katz School of Medicine at Temple University, and I'm also the Philly medical director for the Dermatology [00:05:00] Specialists.
Dr. Neal Bhatia:    Dr. Lipoff and I are going to share some ideas on ethical guidelines and working with industry and how to make some ethical interactions with industry in this day of age where pharmaceutical industry has changed from what it was in the 1970s and even more so as we hear about scrutiny of ethics. We want to talk a little bit about how to navigate our field, and Jules is one of the experts on ethics in medicine, period. That's just in dermatology. So I'm anxious to share this conversation with him.
    And, Jules, [00:05:30] you and I, we have a little bit opposite career dynamics. My career is in clinical research. I'm surrounded by the pharmaceutical industry in terms of trials. In academics, it's a little bit more firewalled off and such. But there are ways to be involved with industry that, I guess the best way to say it is not going to raise flags, but also to have healthy boundaries as well as healthy future plans. But give us your perspective on what do you see as where working [00:06:00] with pharma is now, and how would you teach your residents, if they wanted to come to you and say, "Dr. Lipoff, I want to get involved with working with the pharma industry"? What would you tell them?
Dr. Jules Lipof...:    We need to recognize that medicine is a difficult practice, that we constantly practice in different ways. We're learning new technologies, new medications, we're looking for new information, and we are dependent on the pharmaceutical industry to come up with great innovations, and they have done a lot of great things for us over time. While we are also dependent, we [00:06:30] may not have interests that align completely, right? There can definitely be conflicts of interest. The interest of a for-profit company is to make money to enrich their shareholders, right? And that's not necessarily in line with what is the best for your practice or your patients, etc, etc. It may be, but not necessarily.
    So it makes a lot of sense that when we are delivering care for our patients, we want our patients to have confidence that [00:07:00] we are only making decisions that are purely in their best interest. We want to make sure that we don't get the impression that we are enriching ourselves, and not just the impression, but that we actually are not enriching ourselves. And it may be important to set up certain guardrails, certain hospitals, and for residency, usually you're not allowed in many institutions to even meet with representatives nor accept any gifts, meals, etc. [00:07:30] And usually in private practice and beyond, there are much less restrictions, but we certainly have like the Sunshine Act so that payments and disclosures are made public so that at least someone could interpret if someone might have conflicts.
Dr. Neal Bhatia:    Yeah. And that's well said, because that is a good summary where we sit, and again, in today's industry, right? I mean, I was trained in the '90s, where pharma reps were coming into the middle of the clinic, dropping off pens, [00:08:00] dropping Post-It notes, they were bringing coffee, even more so, obviously, even more exorbitant back in the day.
    But there was always a question about letting adults be adults, which I wrote an article about decades ago. Well, not that long ago. But it was about, again, you get educated on a commercial enterprise, and like you said, it is for profit and there is a method of why drug reps come in. But now we're in an era where pharma is very firewalled, right? You have sales [00:08:30] and marketing and professional relations, and the medical affairs, they often are not even allowed to be in the same room, which is also very interesting when you think about a collaboration event.
    And even more so, I think it's important for those of us starting in our career to maybe ask mentors like yourself and me, "How do I navigate which side of the firewalls do I want to be on?" There are those who just want to go to work, they'll hear about the commercial aspects of drug access, but [00:09:00] then there are others who want to get into clinical research trials where med affairs is more the people they want to talk to. And then somewhere in between, someone may want to be a promotional pharma speaker or someone may want to just learn more about the science of the drug that the pharma rep can't speak to.
    And I still go back to the days where we'd get these pens, and yet the perception was, "Well, now I got this pen, so the next prescription I'm going to write, I'm going to look at this pen and say, 'Well, yeah, that's what I'm going to give to the [00:09:30] next patient I see,'" which we all know is nonsense, at least today's nonsense, I hope. But give us your perspective on what you've seen in terms of that perception of the new firewall of pharma, and what guardrails would you help to spread to not only our younger derms, but even some of us in our later stages of career?
Dr. Jules Lipof...:    Well, I think you're bringing up a few different types of interactions that a physician might have with industry. We have the prototypical drug rep [00:10:00] visiting an office or giving a gift or a meal, that kind of interaction. We also have the interaction with giving talks, perhaps, on behalf of a company. And then we have interaction like collaborating or consulting with a company. I'm going to come off as especially austere and limited in my interactions, I draw especially strong firewalls for myself, but that does not mean that I do not interact with industry, right?
    So [00:10:30] the truth is is that the purpose of drug reps is to change prescribing habits of doctors. I mean, they may describe it as they give information, whatever, but ultimately that is the main purpose. They obviously believe in their products, and they feel that it should be prescribed, but that is the purpose of those interactions. So the truth is, if something didn't effectuate moving prescriptions in a certain direction, they would not do it. So they wouldn't be visiting, they wouldn't be detailing, they wouldn't [00:11:00] be sampling. They wouldn't do these things if it didn't work. And the reason why it works is doctors do not believe they can be influenced. But the truth is, there is real data that shows doctors that accept these things prescribe name-brand medications at a higher rate than average doctors. So it works.
    For me, we all have our biases, we all have our prejudices in how we do certain things. How I mitigate that is I do not meet with drug reps, full stop. I do not meet with them. [00:11:30] I do not accept any meals, period. That is because even though I do not think I'm biased, I hope I'm not, I'm sure I have my tendencies, when I prescribe a name-brand medication for someone, and there are certain name-brand ones I prescribe a lot of, but I want the patient to know when I recommend that, and if they saw that I received a lot of payment from a certain company, well, can they know for sure that [00:12:00] that's my full opinion or have I been influenced because of that money? It's my fiduciary responsibility to make sure I'm looking out for their primary interest. And I'm sure most doctors certainly are, even if they have taken payments or other things, but to me, I'm protecting against even the misimpression that someone could have, right?
Dr. Neal Bhatia:    Yeah. And that's very important to bring that up, especially the concept that a payment isn't always in cash, right? There is something to that that, yeah, not only can be [00:12:30] as part of influence, but also it goes past from where simple marketing now becomes a little bit more involved, right? I think somewhere in there is the magic line that we always have to watch, and I think that's where, when I think about mentorship, it's like how do we groom the next generation to be wary of what that's coming from? But finish your thought about what were...
Dr. Jules Lipof...:    I also want to comment a little bit about speakers and key opinion leaders. I don't think that key opinion leaders and speakers are biased. [00:13:00] I think where the bias comes from is that a drug company is going to be selectively picking out the experts whose views align most closely with their own. So it's amplifying the data and evidence that favors them and maybe silencing or pushing down the voices that disagree. So I have some good friends who talk for companies, and it works well for them because, hey, they really believe in this drug and they get paid [00:13:30] to say what they think. What could be better, right? But it is an environment that would discourage disagreement and would discourage talking about negative things. It's not like a fully-open conversation, right?
    So to me, personally, when I want to get information, and I'm editor of dialogues and dermatology for the AAD, I'm active with the literature I publish, it's not as hard for me to stay active as other people who are too busy and have to rely on these things, but I just [00:14:00] find that there's too much of a conflict of interest. I don't take any scientific information from a drug rep, and I just go straight to the literature. I use UpToDate. I use OpenEvidence. I use all these reliable sources, and I find that works for me. But I know that realistically we all just have to mitigate and do the best we can. And it's not that people are trying to do anything wrong or are doing anything harmful, but I think we have to be aware of [00:14:30] how we can be influenced. We know that, for instance, historically, the most sampled medication in history, I don't know if you know what that was, but it was Vioxx.
Dr. Neal Bhatia:    Vioxx. Oh, gosh, I would've never guessed it.
Dr. Jules Lipof...:    It's known to increase MIs and other things, an NSAID thought to protect the stomach perhaps, but then led to cardiovascular issues, and it was taken off the market. So I'm more hesitant to start with the newest, most expensive medicines that are least likely to be covered by insurance that might have sustainability [00:15:00] issues that people are dependent on, samples and other things. I want to make sure that I am, one, open to all the newest things, but also relying on what has the greatest large body of evidence, right? And so I might be a slow adopter in some ways, but if someone has a difficult problem, I'm going to be very aggressive with it whatever I can get my hands on.
Dr. Neal Bhatia:    Right.
Dr. Jules Lipof...:    This is how I draw the lines. I'll just also mention that I don't want to sound like I'm completely divorced from reality [00:15:30] of how pharmaceutical industry is so connected with our world. I'm willing to share my opinion, I'm willing to consult for companies, I've taken grants. I've had two quite large grants from Pfizer to fund research related to telemedicine and to access to medication with acne, and I'm grateful for that. So that's a disclosure there. But that was very specifically unrelated to [00:16:00] specific things that I do. And I have to disclose that. That could potentially bias me in certain ways. I've been on advisory boards. But I'm actually not allowed to promote anything as being the editor of dialogues. That's a restriction in my contract with the AAD. But to me, this is sort of a guardrail for me. I'm not accepting, I'm not being told what I can say. I'm willing to offer my opinion and work with industry to make sure that they deliver excellent products and [00:16:30] do it in an ethical way, but on the reverse, I want to be restrictive in what I accept.
Dr. Neal Bhatia:    Yeah. That's well said, because actually, what you just described encompasses the different roles we can play. And especially as an advisor, whether you're involved in trials, or by teaching, or even just if you're being chosen, I always say the best advisors are the ones who tell people what not to do, and that goes against the environment that you were talking about in a promotional [00:17:00] setting where there's kind of a cheerleading and maybe not really much room to disagree. And I've actually been at promotional speaking where someone asks a question about or contrary to what's being presented, and nine times out of 10, the speaker will say, "Well, I can't talk about that. That's not in the deck," or, "That's not compliant to have this conversation," right? So there's a-
Dr. Jules Lipof...:    If you're a speaker for a promotional company, you're being evaluated by the company how good a job you do, and if you were to [00:17:30] agree with a criticism in a public forum on it, that could be a knocks against you and you're less likely to be invited back to give the talk again. So there is this inherent pressure, this conflict of interest that keeps you in line even if no one actually says anything to you, right?
Dr. Neal Bhatia:    I do remember the good old days of promotional speaking. It's kind of how I got started, and I think many of us did. But we were the ones who wrote the slides, who spoke at CME meetings on those topics, [00:18:00] and industry would come to us for being part of that. Now we're seeing that it's a little bit more about sometimes prescribing volume, sometimes about who's showing an academic interest, but there's often a bias the other way that says, "I'm using promotional speaking to get to speak at other meetings." So it's definitely reversed in that respect.
    So just to wrap things up, I'll give you this scenario. So, again, thinking [00:18:30] about in terms of ethics and some of the things we've done together on building ethics, is there something that, again, maybe in a academy format or some other things besides the Blue Journal, any kind of institutional ideas that we as a specialty should maybe incorporate as basic guidelines, or should it just be, "Everyone, good luck on your own and just don't screw up"?
Dr. Jules Lipof...:    I think there should be some guidelines. I think residents and young doctors get really mixed messages. [00:19:00] I mean, we tell people, "Be ethical," but then at the AAD, there's all this free product and all these free things being thrown at you, and you see doctors who are sitting through pretty mind-numbing marketing pitches just to get free stuff, and there's got to be a better way to learn how to navigate all of this. I mean, it's also a lot of social peer pressure to participate in all of this. I mean, personally, [00:19:30] I feel like my dignity is kept. I don't have to engage in conversations with people who, frankly, its job is to kiss my ass. I just, I want to be honest with people. I mean, it's their job, I want to respect them, and they're salespeople, but if a mechanic tells you, "Yeah, you need a new tire," you really want to trust it, and not that he's getting kickback from Goodyear, right?
Dr. Neal Bhatia:    Yeah. The gig's on and it's true.
Dr. Jules Lipof...:    But it's [00:20:00] a little different when it's your car than it's a human being and medicine, right? We need to have higher ethics than a mechanic would have, right?
Dr. Neal Bhatia:    Well, and fundamentals. It comes back to the fundamentals, and your own knowledge base should supplant anything that might be commercially brought to you in that you know the knowledge of the science and what it does to the skin, for example. But, I mean, to learn, we learn from each other. Like you say, there's other avenues. We still want to have a good partnership with industry [00:20:30] without saying, "Okay, we're not going to cross lines that make us not do our job to its fullest."
Dr. Jules Lipof...:    I don't want to sound like I'm overly critical of industry. I mean, this is any capitalist society, any company, this is how you have to act in your own self-interest, and I have lots of friends who work for industry and do excellent work developing amazing treatments and other things, but there's more money put into marketing than there is into research, [00:21:00] and I think we really got to protect ourselves and be humble and know that we can be influenced. We may be very smart, but that's why they can influence. They wouldn't be doing things if they didn't work. I think we can practice ethically and also interact and have positive relationships, but as long as we're protecting our patients' best interests, I think that is the way forward.
Dr. Neal Bhatia:    [00:21:30] No, I agree. Well, here's what we're going to do. I'm going to find you, I'm going to buy you a couple of Yuenglings, and we're going to do part two of this at one of the Center City bars and finish this up.
Dr. Jules Lipof...:    Sounds good. Anyway, thank you for inviting me. I hope this is the kind of conversation you're looking for.
Dr. Neal Bhatia:    Oh, please. This is great. This is exactly what I wanted from you, which is why I need to do this again with you, and we'll do it for more stuff.
Dr. Jules Lipof...:    Thank you.
Dr. Neal Bhatia:    All right. And we'll talk to everyone again. Thank you.