Aduhelm and how money and politics supersede science [PODCAST]

Listen and followApple PodcastsSpotifyYouTubeMore apps · Browse all episodes

“Sufferers of diseases, particularly terrible ones like Alzheimer’s disease, and their loved ones need and deserve something better than science can deliver today. However, the scientific rigor of the clinical trials process where approval is only granted to drugs with a clear benefit in excess of risk needs to return.

Imagine the position this puts neurologists in today. Having a conversation with an Alzheimer’s disease patient and family about why prescribing Aduhelm does not make sense. The only thing they would likely hear is they are being robbed of hope, false though it may be. And yet, if the American Academy of Neurology were to actively advise against using Aduhelm and every neurologist in the U.S. treating Alzheimer’s disease sufferers were to refuse to prescribe it, the message to the pharmaceutical industry and the FDA would be crystal clear.”

Wes Campbell is a health care economist.

He shares his story and discusses his KevinMD article, “Aduhelm and how money and politics supersede science.”

This episode is sponsored by Tradeoffs, available on your favorite podcast platform.

Did you enjoy today’s episode?

Please click here to leave a review for The Podcast by KevinMD. Subscribe on your favorite podcast app to get notified when a new episode comes out!

Do you know someone who might enjoy this episode? Share this episode to anyone who wants to hear health care stories filled with information, insight, and inspiration.

Hosted by Kevin Pho, MD, The Podcast by KevinMD shares the stories of the many who intersect with our health care system but are rarely heard from.

Transcript

Kevin Pho: Hi, and welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. My name is Kevin Pho, founder and editor of KevinMD. Today on the show we have Wes Campbell. He is a health outcomes researcher, and he wrote the KevinMD article “Aduhelm and how money and politics supersede science.” Wes, welcome to the show.

Wes Campbell: Thank you so much. It’s a pleasure to be here.

Kevin Pho: We’ll get into the article in a little bit, but first off, can you share your story and journey to where you are today?

Wes Campbell: I am a health outcomes researcher. I came to that kind of late in life. I spent the better part of a quarter century in executive leadership positions, primarily in academic medicine, mostly on the physician group side. I had a master’s in health administration from the Medical College of Virginia, and I might have been the first student in that program to do an administrative residency in a physician group, so it’s always been an area of focus for me.

My dad’s a physician, which is a big part of the reason why I’m not, although my younger brother did become a physician, and my younger sister is actually a registered nurse. So health care is kind of the family business in a lot of ways, and I wanted to be involved in health care and contribute. As I have learned more and had other leadership positions throughout the years, I have become more and more concerned with why we get the results that we get, which is why I went and got training in being a health care outcomes researcher.

Kevin Pho: Now, from your perspective and experience in health care leadership, and with physicians in your family, what would you say are some of the biggest issues that face the physician workforce today?

Wes Campbell: Well, I think the number one issue in the physician workforce, and this is a pre-existing condition, pre-pandemic, is this condition of burnout. It’s a big term. It captures a lot of different states of being, but primarily I would describe it this way: The practice of medicine is not getting easier. It’s getting more complex, more complicated. As we layer on things like electronic health records, work flows downhill to the clinicians, to the physicians, because systems simply can’t or won’t invest in the resources they need, and it gets harder and harder to practice medicine.

I saw this in my family, right? The hours, how hard it was to stay current with what was going on. My dad would be at home in the evenings, when he was home, and maybe he had the TV on watching the news, but he had a journal on his lap and he was reading. Well, that time is being supplanted by people spending two or three hours a night doing the notes from the patients they saw that day. How in the world do they stay current? Where does that time come from? It’s a finite quantity.

And so now we move into this era with COVID, and issues of clinician well-being, mental health support resources, and people experiencing PTSD, grief, and compassion fatigue. Even in the workforce today, I think the overwhelming issue is the state of well-being in the clinician workforce in this country, and what’s going to happen over the next five years, as we hopefully emerge from the pandemic, in terms of our ability to provide cost-effective, high-quality care.

Kevin Pho: Now, I talk about physician burnout on my site a lot, and of course, among the physician class, we know that burnout is a problem that certainly needs to be addressed. But I’m interested in hearing about you and your peers in terms of administrative leadership and executive leadership. Do your peers share the same views on burnout as you do?

Wes Campbell: That’s a great question. I think it is a concern, for sure, but I think many organizations don’t exactly know how to deal with it. It strikes me that we talk about physicians as a homogenous blob, like they are this constituency that exists. But the examples of what a neurosurgeon needs support-wise versus what a family physician needs support-wise can be very different, right?

From the research that I have done, one of the major contributors to the burnout condition is patients and the things that they bring to the table, and just the interpersonal part of it, which can sometimes be very difficult for physicians. But a lot of it comes down to the clerical work, the administrative work that’s associated with this electronic environment that we live in. I think the research is pretty clear that the amount of time many physicians spend, the so-called pajama time, in their electronic health records is not a value-added exercise. They’re not reviewing results, they’re not planning for the next day, and they’re not coordinating patient care. They’re documenting care. And I think there’s a perception that many have, and I think there’s some truth to it, that this informatics platform that was supposed to be so powerful in helping physicians take better care of their patients is really just an exercise in capturing more revenue.

There are huge mismatches between the way organizations have approached creating incentives for physicians, in terms of their compensation even, and what physicians really want out of their practice. So I think there’s an understanding among organizational leaders that this is an issue, but I don’t know that they have a great grasp on the tools that they have at hand, even team-based care models, for instance, to try and address the problem. And there are limited resources, right? So they require investment, and that’s not always the easiest case to make.

Kevin Pho: So what do you see as a path forward? Because I completely agree with you: In order to successfully address clinician burnout, it does require some investment, or it does require some sacrifice in revenue, for instance, if physicians were to see fewer patients. What do you see as a path forward?

Wes Campbell: Well, for me, I’m hopeful that the path forward probably lies through value-based care, right? The incentives need to change. There’s a misalignment of those incentives now. So many clinicians that I know, so many physicians that I know, simply see themselves as salespeople working on commission. They get paid based on work RVUs, how many they’re going to produce in the future, and I think that production environment, that production mentality, creates this well of burnout that physicians live in.

There’s a big gap in organizational understanding in terms of how to move from this fee-for-service environment to a value-based environment. But my hope is that if we begin to value the quality of the physician-patient interaction, the outcomes that we generate, and the avoidance of cost, and organizations can understand how to calculate an ROI on a cost that doesn’t exist, then maybe there’ll be some change in the approach to the support mechanisms that we put around clinicians so that they can do their best work.

Physicians have a very unique role in our delivery system, in our society. There are things physicians can do that nobody else can do. We have advanced practice providers, we have nurse practitioners, and we have physician assistants, but at the end of the day, the physicians are the cornerstone of the delivery. If they aren’t incented correctly or appropriately, we wind up with this perverse environment we live in, where it’s not about how good the care you were able to provide was. It was how many patients you were able to see. I think it all flows from that broken approach to how we align and engage physicians, and if we can’t bring those pieces together, then I’m not sure how organizations are going to be able to step in.

Physicians should be an asset in the organization. Organizations invest in assets, right? They don’t invest in their human assets, their physicians and other clinicians, in the same way. My hope is that a transition to more value-based models, where we value the outcomes and there’s financial risk involved, would be some medicine to save that broken system.

Kevin Pho: All right, let’s transition now into the KevinMD article that you wrote. It’s titled “Aduhelm,” and for those who don’t know, Aduhelm is Biogen’s novel medication for Alzheimer’s that was controversially approved earlier this year, “and how money and politics supersede science.” Now, for those who didn’t get a chance to read your article, can you just walk my audience through it and share the story of why you decided to write it?

Wes Campbell: Yeah, so it was an interesting story. Let me start with why I decided to write it. So, in the context of what was going on in the community, in the political sphere, around this debate about science, particularly related to the SARS-CoV-2 virus and the COVID pandemic, people were actively avoiding vaccines. People were saying, “I’m not going to get vaccinated until the FDA approves this vaccine.” Public health officials were barking at the tops of their lungs, “We need to socially distance, we need to wear masks, and we need to get the population vaccinated.” And there was this great skepticism of science. It wasn’t just about that issue; we could talk about climate change, we could talk about any number of issues, but there’s this skepticism about science.

So my dad’s a neurologist. I’m interested in neurosciences. I’m not a neurosciences researcher, but I’ve always been interested in it, and I came by that honestly. I know from an economics perspective that Alzheimer’s disease and other dementias consume a huge amount of spending in the Medicare and Medicaid programs, right? 20 percent, with projections that it’s going to be a third or more by the year 2050. There are 10,000 baby boomers every day aging into Medicare, and these dementias occur in the elderly population primarily.

So here’s this monoclonal antibody treatment that is developed, and if you dig into it a little bit, the clinical trials for the treatment, and this surrogate endpoint of a reduction in the beta-amyloid plaques, it doesn’t really prove out in the clinical trials. In fact, the risk of having a stroke associated with taking Aduhelm was greater than the cognitive benefit shown in the moderately impacted individuals of the clinical trial. So the science to that seemed pretty clear to me, right? I’m not an Alzheimer’s researcher. I’m looking at this from the outside, not involved in the clinical trial.

And then the price per treatment is over $50,000 a year. Well, if you do some simple math, right, you’re talking about spending as much on this drug as the entire Medicare program spends a year right now. So the numbers don’t work, not to mention the fact that the trust fund is going to become itself.

So as I was thinking about this, I started to get a little bit angry. People were worried a year ago, in the run-up to Project Warp Speed, that politics was going to result in the FDA being pressured to approve a vaccine without proven safety or efficacy. And this is not the first drug that has gone through this accelerated approval process. In the space, there was a drug for Duchenne’s muscular dystrophy, and ALS, controversial, but the dollars were a lot smaller and the lives impacted were a lot fewer.

I started to get a little angry about it, that on the one hand we were imploring people to listen to the science, and on the other hand we were making policy decisions that seemed not to be about the science, that were about power, about money, and about politics. It concerned me with this particular approval. There are more than 5 million people with Alzheimer’s disease today. That number is going to increase dramatically over time. It consumes vast resources, and it affects lives in a very profound way. The timing of that decision, in the context of what was happening in the public, was pretty bad, and it kind of made me angry, frankly, and I felt like I needed to call some attention to that.

Kevin Pho: Now, to be clear, what do you think exactly were the financial and political influences that perhaps influenced that FDA approval of Aduhelm?

Wes Campbell: Well, it’s a great question, and I have to say I don’t know for sure. But I will say that in the political sphere, first of all, we don’t have a permanent director of the FDA. We have an acting director, and not to impugn that person’s credibility by any stretch of the imagination, but the committee on neurosciences therapeutics, the advisory committee, unanimously voted against approval, and that recommendation was not followed.

So where is that pressure coming from? Well, Biogen is a large company. They make a tremendous amount of money, and their stock soared after the news and the approval decision. Certainly they’re spending money lobbying. I don’t know, lobbying in Congress, lobbying other individuals who may be influential with the approval process. I don’t know any of the details of that. I don’t want to presume any ill will on anyone’s part. But I think the existence of the dollars at stake, the existence of the politicization of the FDA as an entity in general, it’s not new; it’s been happening over years and years. This is not the first controversial approval on the part of the FDA, but it all landed with a boom for me with this particular drug and this particular approval process.

Kevin Pho: Alzheimer’s, obviously, is one of those diseases where we don’t have a lot of great treatments. What’s the role of patient advocate groups when it comes to these borderline experimental treatments for diseases where we simply just don’t have a lot of good options?

Wes Campbell: Yeah, that’s a great question, and you’re getting at one of the things that motivated me to write this article. It relates to the issue that we were talking about, how difficult it is to practice medicine and how organizations are not necessarily supporting that. I put myself in my dad’s shoes, right? I’m a neurologist. I’m a memory disorder expert. I have a family sitting in front of me with someone suffering from Alzheimer’s disease, a terrible disease. All dementias are horrible diseases. They’re wanting some hope, some treatment, and I need to tell them that yes, this drug is approved, but I can’t prescribe it, because I don’t believe it’s going to offer benefit, and the risk of harm exceeds any benefit I might believe it would offer.

I think patient advocate groups can play an important role in helping to educate those that are concerned about this particular issue, whether it’s the Alzheimer’s Association or other patient advocate groups, about what the implications of this particular drug really are. And I think they can maybe interface with companies like Biogen and other big pharma companies with some hope of helping to set the research right.

I mean, this is an example. I’m not an expert in this by any stretch of the imagination, but this beta-amyloid hypothesis is just that. It is not proven, and there are dissenting opinions, and again, in my very simplistic view, as to whether the beta-amyloid plaques are the result of or the cause of Alzheimer’s disease. I think through public advocacy, through congressional lobbying efforts, through working with pharmaceutical companies, and through engagement with the professional organizations for physician groups, the American Academy of Neurology perhaps in this case, the patient advocacy groups can provide an important conduit of information between these groups that maybe really aren’t talking to each other.

Kevin Pho: I read within the last few days that the sales of Aduhelm actually are very low, and Biogen is considering cost-cutting measures because those sales are significantly below their projections. In that context, what do you think is the path forward for Aduhelm?

Wes Campbell: Oh, wow, that’s a really good question, and I’m not sure I have a great answer for it. I think the path is to the sidelines, frankly. I think the reason why you’re seeing the sales as low as they are is, and it’s primarily neurologists that would be writing this particular drug, they’re just not going to do it, right? Because of all of the issues that we’ve talked about.

It goes back to the issues about burnout and what it is that physicians really want out of their roles, right? What do they really see themselves doing? I have yet to meet a physician in my career who wanted to provide poor patient care, right? I know that sounds a little bit ridiculous, but I think we need to take a step back and contemplate that for a minute. Physicians want to provide good care to their patients. They want to provide safe, effective treatments that are going to improve the health status of their patients. And I think, by and large, neurologists looked at this and said, “We’re not going to do that. It’s not proven, it’s going to cause more harm, and it’s outrageously expensive.”

And 40 percent of Americans in this country, at least according to the reports, couldn’t afford a $400 emergency expense, right? So how are they going to afford $56,000 for Aduhelm? I think that’s what we’re seeing with the low prescription rates of this: The physicians, the delivery system, are saying, “That’s not where we’re going to make our investment. We’re not going to put ourselves behind this particular product, because it doesn’t work. It doesn’t accomplish the goal that we’re seeking, which is to improve the health status of our patients.”

Kevin Pho: We’re talking to Wes Campbell. He’s a health outcomes researcher, and he wrote the KevinMD article “Aduhelm and how money and politics supersede science.” Wes, from your perspective as a health care leader, what would you say are some of the trends that may affect physicians going forward?

Wes Campbell: That’s an excellent question. I think the number one trend I see right now is that organizations all around the country understand they need to align and engage physicians, that the success of health systems is dependent on the success of their relationships with physicians. At the same time, I don’t know that many organizations understand what in the world that means, what alignment is and what engagement is. I think they throw things at the problem without really understanding what that problem is, and then their attempts to resolve it, to improve alignment, improve engagement, and reduce burnout, don’t work. And so they lose some enthusiasm for it, or they find themselves just perseverating on this spot, and they can’t decide which way to move.

Those are big catch-all terms, alignment and engagement. We could spend hours talking about what I think they mean. I think that’s the number one struggle right now. If you’re a health system executive, you know you want aligned physicians, you know you want engaged physicians, but you’re not exactly sure how to do that. Figuring that out for your organization, I think, is the number one pathway to success in the future.

Kevin Pho: And my final question: What’s your take-home message that you want to leave with the KevinMD audience?

Wes Campbell: Oh, thank you for that question. My take-home message would be for clinicians, particularly for physicians, all right? And it’s about these issues of alignment and engagement. Your voice should be powerful, but you have to use it. And it’s very difficult, particularly for non-clinicians, no matter how empathetic they may be. I think you deserve to have empathetic colleagues and leaders who make efforts to make your job easier.

You need to speak together with that voice, but nuanced enough so that we understand it’s not a one-size-fits-all solution, right? The differences in the needs between the neurosurgeon and the family physician befuddle organizations. It can’t be a one-size-fits-all approach. And so use your voice, speak up, and draw the line. Organizations have to have physicians, right? Who admits patients to the hospitals, right?

So I think that would be my take-home message. I think you can demand from your leadership a higher degree of empathy, and you can provide your leadership with more cohesion in your voice around what specifically it is that you need to do your job better. And then you can watch very closely, because the difference between words and deeds starts to show up here. If we’re talking about resolving these issues, but organizations aren’t putting their money behind resolving these issues, then you have a very good indication about their authenticity.

Kevin Pho: Wes, thank you so much for sharing your time and insight, and thanks again for being on the show.

Wes Campbell: Thanks. I appreciate that.

Listen and followApple PodcastsSpotifyYouTubeMore apps · Browse all episodes