March-In Madness

Joseph Allen  0:00  
I would say it's the most serious threat to our system I've seen in 43 years, we passed Bayh-Dole 43 years ago. The Economist Technology Quarterly said Bayh-Dole was the most significant law passed in the last 50 years. That's what allowed our public and private sectors to come together during the COVID pandemic. So now all that's in question.

Terry Wilcox  0:22  
This week on the Patients Rising Podcast, a proposal from the administration aimed at reducing costs, has experts saying it will backfire in a big way that's going to hurt you and me when it comes to getting medicines we need. Welcome to the Patients Rising Podcast. I'm your host, Terry Wilcox, CEO of Patients Rising. I'm joined by my co host, who is currently working on his kicking form, so he can be the kicker for the bills next year. He's Bob Goldberg, co founder of the Center for Medicine in the Public Interest. So you want to be a kicker, Bob?

Bob Goldberg  0:54  
Well, not after hearing all the death threats he got from missing the field goal. I mean, come on.

Terry Wilcox  0:58  
Come on. It wasn't to do...there were so many things they screwed up, Bob. Let's be clear. I mean, I watched the game. It wasn't all the kicker all day. 

Bob Goldberg  1:06  
No, it wasn't all the kicker. You know, Miss passes

Terry Wilcox  1:10  
I mean, Yeah. Yeah, some big ones actually

Bob Goldberg  1:15  
Bills fans now think they're cursed

Terry Wilcox  1:18  
.As a Cowboys fan I can see why you think that.

Bob Goldberg  1:21  
The Cowboys always gonna win the Super Bowl. But one thing you will not see me do is take my shirt off, even if it's indoors. I'm not Jason Kelce. So but look, you know, in the perfect world, the Bills need a field goal kicker who can make 100% of their field goals, take them to the Super Bowl. And I figured you know, I'm here almost 100% of the time, I could translate that accuracy and put it on the football field. I know that doesn't sound right, even as I say it, but you know, I'm given a job.

Terry Wilcox  2:00  
You are I mean, you do have a very high accuracy rate. I would totally agree with that. So more power to you if you want to go out there. 

Bob Goldberg  2:09  
Thank you. Thank you. 

Terry Wilcox  2:10  
So but actually, before we get into today's show, I wanted to address one thing from last week's show. If you listen to the last show, you would have heard we still mentioned Republican candidate Ron DeSantis. Just so you're aware, we recorded our episode earlier in a week. And then on Sunday evening, DeSantis actually dropped out of the race. We just wanted to apologize if there was any confusion. Now, today we're talking about another example of what we would describe as government overreach. Let's set the stage for our listeners, Bob.

Bob Goldberg  2:41  
Well, Terry, last year, end of the year, the Biden administration announced they would be working to curb drug prices, which is good, right? Well, it's not as simple as that have us believe, so in addition to the affordable price controls in the Inflation Reduction Act, which aren't a good idea, they also want to use something called march-in rights on drugs when they deem it to be an unreasonable price.

Terry Wilcox  3:08  
So what is an unreasonable price? Well, we've all tried to figure that out. I know I'm not sure, and neither are they. But we'll get into that in a little while. First, let's learn a little bit more about march-in rights themselves. Joe Allen is the executive director of the Bayh-Dole coalition, and the Bayh-Dole Act is actually what created march-in rights in the first place. Joe was actually a Senate staffer when this was passed. So who better to tell us about it?

Joseph Allen  3:35  
Bayh-Dole has been very successful. It's helped make at least 300 new drugs and vaccines, but it's had an impact across the spectrum. It's not just a drug development bill, it effects all federal research. Google came out of Bayh-Dole Honeycrisp apples came out of Bayh-Dole, in addition to a number of cancer therapies. When we're passing a law, though, we want to make sure that if we're letting somebody own a government funded invention, they're making a good faith effort to actually turn it into a product, which is difficult, we want to make sure you're trying we didn't want a big company, licensing any university technology just sit on it. And we also didn't want universities putting crazy terms in the license, like you had to hire the university president's daughter as CEO or build up a new football stadium. So we put a thing called march-in rights. And march-in rights simply mean if something really goes off the track, like, you know, somebody's either licensed an invention, or they're just having it sit on the shelf. Or if the university put a crazy term in there, which is going to stop people from developing it. The government can then march in and force the university to license another company.

Bob Goldberg  4:36  
So Joe doesn't mention anything about price in that explanation. So where the heck is that coming from?

Joseph Allen  4:43  
20 years after Bayh-Dole, some people that didn't like Bayh-Dole, they want to go back to the old policies claim they found a secret meeting in the law: that the Bayh-Dole Act allows anybody to say I don't like the price of a new of a product that came out of government funded research. It's not reasonable, and the government should then march in and license other people. And Senator Bayh and Dole and everyone involved in this case said that's not how the law works. There have been a number of petitions filed in the last 20 years for price control. Everyone has been dismissed because people looked at it, including the Biden administration saying that's not how the law works. And then on December the seventh, all of a sudden, the Biden administration came out with a proposal that says, No, that is how the law works. Now you can do price control. So that's what the current issue is all about.

Terry Wilcox  5:29  
So essentially, this Act has been untouched and working for more than 40 years. So when Joe and his team heard the news come down that now march-in rights were possibly going to be used for price control, what was his reaction? 

Joseph Allen  5:44  
We were stunned, because the Biden administration in March of last year, issued one of the strongest denials of a march-in petition on price control I've ever seen. So this completely contradicts what the Biden administration did in March of last year. And so, you know, they said they're gonna have agencies look at guidelines for march-in rights. And, you know, no one knew what was going to be in there. But we were stunned. And as Senator Bayh's former staffer, I actually I was at the Commerce Department actually, one time I was in the agencies, and I actually oversaw the Bayh-Dole Act. So to me, it's the worst kind of thing you can have. Because, you know, the way our system works is, if people want to change the law, there's a process for doing that. You go to Congress, and you amend the law, or you repeal the law. Well, they didn't do that. They just come up with a new interpretation overnight. That contradicts what they just said before.

Bob Goldberg  6:37  
Well, what else is new? 

Terry Wilcox  6:39  
So Bob, how shocked were you when you heard this? 

Bob Goldberg  6:43  
Not that shocked? 

Terry Wilcox  6:45  
He is right, though. I mean, the Biden administration like is reversing their own stance.

Bob Goldberg  6:51  
Again, it's an election year, and there are gremlins in the administration and surrounding them, including patients for affordable drugs that have made this a top priority issue. You know, I've been pushing for this. So why not? I don't think there's ever been used?

Terry Wilcox  7:11  
No, I mean, they've never been used. In fact, Joe only had one instance where they could have been used.

Bob Goldberg  7:18  
Yeah, sorry, we're building up the suspense here, Terry and we've told you, this is bad. And we've talked a little bit about march-in rights in the last couple of shows. But we'll give you a chance now to have an expert explain why this will backfire. I mean, similar to almost every other government overstep, we talk about on this podcast, this is going to destroy and eviscerate innovation. So Joe says even without this being official, yet, he's getting calls from companies and saying they won't be investing.

Joseph Allen  7:53  
So it's making people right now say government funded research is toxic, stay away from it. I was just on the phone with a company that said, we're staying away from any kind of partnerships now until this is cleared up. So you know, the problem for patients is, universities are really good equipped with cutting edge research, we lead the world in that, but it has to be made into a product. And that's really an expensive process, and there's just no way around that. You know, it typically cost like a billion dollars, or $2 billion and 90% chance you're gonna fail. Well, people are not going to do that if somebody can just copy what you just did. It didn't cost them $2 billion, they just copy what you did. So it's having an impact right now.

Terry Wilcox  8:31  
Now, Joe says innovation will be hampered because creating new drugs is such a huge risk, and we all know that. It's time, it's money, it's effort. So often, it's all for nothing anyway. And so now you're saying even if this works, the government can come in and take it from you?

Joseph Allen  8:49  
Small companies traditionally take a risk of big companies won't take, so a lot of times you'll find a university invention looks very promising, like immunotherapy, which actually won the Nobel Prize. It took 10 years, it took 10 years for the University of California to find any company that would actually look at immunotherapy. And that was a small company. Now it eventually won the Nobel Prize. But without that small company without the 10 years of trying to find a partner, that technology was sitting on the shelf right now. mRNA, just used for the COVID vaccine and actually has a really good promise for cancer. Same thing, it took 10 years to license it, it went to a small company, that company spent 10 years not making any money on it until suddenly the pandemic came. But that's how our system operates. You have small companies taking a huge risk. And they can't do that if it looks like some I can just say "I don't like your price" after you've succeeded.

Terry Wilcox  9:43  
Of course, we're focusing on the health impacts of this law. But Joe says it isn't the only sector that's going to be affected.

Joseph Allen  9:50  
And this is not just for drugs, this is for across the board. Energy companies, environmental companies, you know, chip companies, it's across the board and what drives American innovation is small companies taking a risk. And now we've put a sword over their heads, which again is not going to lower drug prices, but it just kills American innovation and the thing that we are best at which is having small entrepreneurs take a risk; If it pays off, that's fine; If they sell it to a larger company, that's fine. But without those small companies taking a risk, things like immunotherapy, mRNA, are sitting on the shelf somewhere, they're a research paper and not anything is ever practical.

Terry Wilcox  10:28  
Now, I'm curious about you know, one of the things I would love to see more universities weigh in on this, it seems like this could really affect them. Yes. In their research pipelines? I mean, I mean, don't you think? Maybe there's some op eds and things out there from from universities, but I really think, you know, they should be in a bit more of an uproar about this. So Bob, will this help prices at all? I mean, even in the short term? I don't see how it does.

Bob Goldberg  10:53  
No, no. I mean, if anything, it'll put pressure to raise the price even higher as a way of negotiating. And I don't even think it's going to get to that. I think there's going to be such an outcry that calmer heads might prevail. Because I think this is in part just an election year thing. But I think another part is that, like, as you pointed out, a lot of people haven't weighed in yet. And once they do, the consensus, and there is a broad consensus that this would be a disaster will weigh in. 

Terry Wilcox  11:28  
Well, then I think also because it is a political year, and things are every single thing that anyone says has to be viewed through a political lens, an overly political lens, and in this particular calendar year. So perhaps if it marches down, and seems to be a more serious problem, more people will weigh in to your point.

Bob Goldberg  11:50  
Yeah and look, this is additional risk. And if you're an investor, shareholder, or pension fund, you know, why would you invest in companies that are going to be punished for succeeding? Yeah, it just doesn't make doesn't make any sense. 

Terry Wilcox  12:06  
I mean, it's like say Wendy's wanted to walk in and say "I'm going to sell the Big Mac now, because your Big Mac is overpriced." So I'm gonna they're gonna give it to me to sell because we'll sell it for a better price. Like, yeah, I mean, it's crazy. I'm putting in a very simplistic term there.

Bob Goldberg  12:22  
but well, then I'll understand it.

Terry Wilcox  12:28  
Good, Bob. I'm glad you'll understand.

Bob Goldberg  12:31  
But time will tell. All things shall pass and all that other stuff. I don't know. I mean, just in the face of lethal stupidity, what do you do? I'm glad that Joe was able to join us this week. And we will hear more from him in a couple of weeks as well on an episode of the Healthcare Policy Pop.

Terry Wilcox  12:55  
Well that's right. We're excited to bring back our pop show as we continue the New Year. Remember, if you want a more detailed look at some of the policy perspectives of the various guests we speak with and the bills we discussed, the pop could be for you, you can find a link to the Healthcare Policy Pop in the show notes.

This episode of the Patients Rising Podcast is brought to you by the Patient Helpline. This free service is just one of the many ways we try to help our patient community. Patients oftentimes have trouble finding medical transportation, or trying to understand their insurance. And that's where we jump in. We have navigated hundreds of individual situations with patients. If you or someone you know has a healthcare question, challenge, or issue, we're standing by and ready to help to get in touch leave us a voicemail, or send us an email using the link in the show notes.

Bob Goldberg  13:51  
Now, we did want to share one more story before we go off the air today. And it's an update on something that we've been covering in the weeks past.

Terry Wilcox  14:00  
Well exactly. We're talking about another Prescription Drug Affordability Review Board, or for those of you who have heard us use the acronym, it's PDABs. And this time it's in Oregon. So I read this alert, you know about their meeting in Oregon, it's all insulin. Yeah. So before I dive into why I'm always I'm perplexed on the insulin thing, I feel like the insulin thing has been solved in so many ways, but maybe I'm missing something.

Bob Goldberg  14:33  
No, it has been solved. You'll get one or two people but either you can get a coupon or it's covered under Medicare.

Terry Wilcox  14:41  
I mean, aren't we already at the point where you can't charge more than $35 for it?

Bob Goldberg  14:45  
Well under Medicare Yeah, and again, you can get the product direct. This is to my mind, you know.

Terry Wilcox  14:52  
I mean, maybe are the quick pens even I even remember reading. It's like the quick pen or that I don't know it doesn't really matter about the drugs but catch us up Bob on the prescription drug affordability boards not Oregon's one of the first ones not the first. I think the first was Maryland. Yeah. But how's it going there? Do you know? Is it good, bad misleading, flailing?

Bob Goldberg  15:12  
I heard that people were complaining about the refreshments. I mean, that was their big, big, big concern. No Drake's Cakes or whatever.

Terry Wilcox  15:20  
None of those. No Voodoo Doughnuts.

Bob Goldberg  15:22  
No exactly, exactly.

Terry Wilcox  15:24  
I think that's an Oregon thing. Isn't that a Portland thing, Voodoo doughnuts?

Bob Goldberg  15:26  
I guess. 

Terry Wilcox  15:27  
I mean, that's not the capital 

Bob Goldberg  15:28  
But for both of these drugs, there are ways to get it at a discount. There's even generic equivalents, biosimilars that are now available for the injectables. So I just think they picked them because everyone's read about insulin in the paper, and it's easy and people can understand it. And that's gonna lead to nothing if one of these PDABs wind up saying we're not going, you shouldn't cover this new drug at all. Guess what, it's not going to be sold in that state. End of story.

Terry Wilcox  16:06  
Well I mean, that's not a thing the state wants to get into is, we're not going to, you shouldn't cover this drug at all, and then they get like, you know, every sad patient story known to man in their bad press. I guess this is probably a little bit easier to sort of manage insulin.

Bob Goldberg  16:23  
It's already "Oh, we've already solved the problem, Yay." 

Terry Wilcox  16:26  
They're managing a problem that's basically already been solved. But anyway, you know, it's always something good to follow anybody who's curious to learn more about PDABs, if you want to know more about if there's one, you know, percolating in your state, we're going to have some resources on the Patients Rising website in the near future, which we'll link to to sort of let you know. They're not in every state and they're not even being talked about in every state, but Oregon is one of them. So if you happen to live in Oregon, you can take a peek we'll put a link to the meeting in the show notes if you're interested.

Bob Goldberg  16:54  
Well, Terry, I have to go practice my field goal kicking now. The wind is actually behind me. So for my and that's all for today. We'll have another episode right here Monday. Make sure to follow the Patients Rising Podcast on your favorite podcast player, so you can be notified as soon as our new next episode is live.

Terry Wilcox  17:18  
Until next week for Dr. Bob and everyone at Patients Rising. I'm Terry Wilcox, stay healthy.