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Shifts and Shoutouts: Updates in Clinical Research
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Released: August 19, 2024

Expiration: August 18, 2025

John Marshall
John Marshall, MD

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John Marshall, MD: Hey, everybody. John Marshall with Oncology Update. Welcome back. This is episode 5. 

We now have a really cool function called ask a question. Click on that. Send us something. We hope to get back with you with an answer. 

Most of the time, you know, you see these things and it's all nailed down, and you know exactly what you're about to get. Not so much with this. We’re really trying to bring to you the current days news. What's going on in our world in the world of cancer, both in the science world, the social world, and the business world. And you know what? You just can't script that kind of stuff. It just happens as it happens—so a little bit of Oncology Unscripted.  

OncoBuzz
First, the news of the day. U.S. News and World Report just came out again. Guess which one was the number 1? Of course, it's MD Anderson. Number 1 again. The top tier teams, it's like the Yankees going against the Dodgers. It's always the same teams year after year. But congratulations to that fabulous group down in Houston, Texas. 

We here at Georgetown are just pumped that we got our NCI renewal; our comprehensive status for a fresh five years. Always a good moment for NCI Cancer Centers, either to get it or to maintain it. So, thank you for all the hard work that went into that.  

Big news out there. Friends of Cancer Research gave out annual leadership awards—Monica Bertagnolli, our new head out at the NCI doing a fabulous job, as well as Brett Guthrie. So great people who well deserve the Friends of Cancer Research Leadership Award. So, kudos to them.  

Just some business news out there.  

Lei Zheng, MD, PhD, who was a UT San Antonio person all along, just named the Executive Director of their fabulous Mays Cancer Center. 

Mark Burkard, MD, PhD, he's a good human as well. University of Iowa, just named him their new cancer center director. He was at University of Wisconsin. So, he moved kind of, I don't know, south a little bit. Still will not be such great weather, although it was probably a little better weather than Wisconsin. We'll see how it goes there. So, congratulations to him.  

On the clinical research front, some news that maybe doesn't really make it here to the U.S. so much, is that the E.U., which has been doing a lot of our major clinical research lately, making up for some of the gaps that we certainly haven't been filling as well. They've had a sort of sudden halt to clinical research because of some new regulations around devices and things one uses to test and measure stuff. So, you can imagine scans and other things like that. So, there's some new regulations there that is sort of thrown a monkey wrench into E.U. clinical research. And my guess is, it may take them a bit of time to figure that out, but hopefully they will figure that out fast.  

The one piece of news that really caught my eye this cycle was not something you would see in the journals that hit your door. Maybe not something you'd see in any of your feed, and this is from the Federal Trade Commission. So, there was a Federal Trade Commission report that had to be voted on, and it's all about the anti-competitive harms of pharmacy benefit management industry, PBMs, pharmacy benefit managers, PBMs, and we know in the cancer world, these things have become huge. But on July 9th, not too long ago, the FTC voted 4 to 1, I'm reading this to not get it wrong, to release an interim staff report around pharmacy benefit managers, the powerful middlemen, inflating drug costs, and squeezing Main Street pharmacies. 

You and I know this is going on out there. We're feeling it. Our patients. Maybe not. Interestingly, they're a little bit on the sideline about this because in the United States, we don't judge value around here.  

PBMS: THE POWERFUL MIDDLEMEN
John Marshall, MD: This is going to kick off one in a series of the middlemen in our world. We are going to talk about CROs, clinical research organizations, certainly going to talk about electronic medical records. They're sort of our data middlemen. But for this episode, we're going to talk about pharmacy benefit managers.  

Now benefit. I love that word. I get benefits for my job here at the university. It's in my benefits package. What these pharmacy benefit managers are taking advantage of is that that's money that I don't really feel. I don't really see. It's going to pay for things and they're getting, of course, their cut. So, we're going to try and drill down on this.  

Now, as we usually do, we did a pretty extensive literature run, and there are some papers here and there. There's a JCO paper. It was a little while ago. Lancet had one, but nothing really recent about the impact of PBMs on our medical world. 

So, what we did, because we went out and found a couple of really good experts that we're going to be interviewing.  

But let me talk a little bit about just these PBMs and the impact that they are having. So, for example, a couple of or three PBMs or at least these are now big companies that are of course vertically integrated, but they've gotten so big that they're thinking about buying practices. 

And one of the practices that's out there being considered is Florida Cancer Specialists and Research Institute. Now, I know a lot of the people at Florida Cancer. It's a great health care system. The cancer community is outstanding, McKesson, Cencora, and Cardinal Health, not commenting, but there are suggestions that they're out trying to buy this organization, and they're worth about 3 billion out there in the open marketplace. And then what you could see is you've not only got, you know, pharmacies and hospitals and all of that. But now you own the physicians as well in this. So that's going to be an interesting thing to watch out for is that.  

But let me show you another sort of side mark of this. And this is this thing that I recently heard about called Lilly Direct. Now, Eli Lilly, right? They are solid company. They've been doing a lot. They've got a lot of innovative drugs that are out there. But they had something called Lilly Direct, so I went on to their website. You should do this too. And what it is, is a website for patients who might not have a doctor, or whose doctor might not be willing to prescribe a medicine at Lilly sells. There's some weight loss drugs in there, by the way. And you can click and it says, do you have a doctor or don't you? And if you don't, they give you one and you have a visit, I assume, with that doctor. But then Lilly mails you the drug. There is no in between pharmacy. So now you're even being sidelined as a physician to where Lilly will be providing the physician through some mechanism and then will be mailing you the drug directly to remove this middleman. A different kind of strategy to cut out that PBM and now your own pharmacy or your local pharmacy from that pathway as well. It'll be just coming direct from Lilly.  

Now the big ones, of course, are CVS Caremark, Express Scripts, and OptumRx, and those three companies have nearly 80 percent of the market share. And of course, this is a subject of a recent House Oversight Committee review to look at that and see if there is any, you know, is that clean? Is that what are the rules in there? Are we getting the best for our buck there?  

On the other end of the country, Blue Shield of California actually kicks out CVS Caremark as a PBM, and they basically are starting up their own new pharmacy model. 

So, there's a lot of big, moving parts in this space. Some of you out there are familiar with PBMs and all of this world, I was not when I started to get into this world a little bit more in my roles. And so, there's a lot to learn a lot to know. And I do think we represent an important voice in this process, not just victims of it, but part of it that we can influence some change. 

I encourage you to listen to it. A couple of interviews that we did with people who are really smart about this subject, so you too can be a little smarter about it and maybe have some influence on this in your own way.