AI - Good or Bad for Your Health?

Naomi Lopez  0:03  
AI is absolutely being used in healthcare and it's been used for a number of years. In fact, the Food and Drug Administration has approved or certified hundreds of devices that use AI.

Terry Wilcox  0:16  
This week on the patient's rising podcast, AI, AI, AI. Everyone is talking about artificial intelligence, even the White House. But is that a good thing or a bad thing for your health? We speak with someone who says, depending on how it's used, it could be either. Welcome to the Patients Rising Podcast. I'm your host, Terry Wilcox, CEO of Patients Rising. I'm joined by my co host, who has his cybertruck on eternal backorder. He's Bob Goldberg, co founder of the center for medicine in the public interest. So how many years have you been waiting? Bob? Is it time? Have you asked Elon for a refund?

Bob Goldberg  0:55  
Terry, it turns out that the cyber truck was parked in the cloud, of course, but it's got $1,000 in parking tickets and a boot. So I'm just hoping that I can use AI to get my deposit back. In the meantime, we can discuss how this new technology, this tool, is shaping patients access to healthcare.

Terry Wilcox  1:16  
Well, I'm so happy to hear that Bob. And I hope our patients feel the same way. And I must say even Elon Musk would want to hear about today's episode, because it's all about artificial intelligence and how it's currently being used in healthcare. As somebody background, President Joe Biden just signed what is being called a sweeping artificial intelligence Executive Order, which covers well, quite a lot. Now, Bob, we don't have to go through the entire order by any means. That would take several episodes because this is so wide ranging. But when you first saw this come out, what did you think?

Bob Goldberg  1:54  
I thought this was a product of Chat GPT. A lot of repetition, and it was done, really, you know that everything is so broadly defined in terms of security, and so on, in large part because the regulations and all the other things have to be promulgated by Congress. So look at this as sort of a wish list, if you will. They think that this will force Congress and allow for other people, patients, in particular, to have a say on how this executive order should be applied, particularly to healthcare. But that's enough from me. Let's hear from Naomi Lopez. Naomi is the founder of Nexus Policy Consulting, and she's been working to help legislators understand AI.

Naomi Lopez  2:43  
Joe Grogan, who was the former director of the Domestic Policy Council in the last White House, and I co founded this working group in order to come up with a set of principles to help lawmakers think about and navigate this very complex issue that's going to be impacting every aspect of our lives. But we're particularly interested in how it impacts healthcare.

Terry Wilcox  3:06  
How does Naomi see AI when it comes to health applications?

Naomi Lopez  3:10  
It is something that provides enormous value to the researchers that are trying to find new treatments for patients, for those who are designing the trials, to get it across the FDA finish line, for doctors who use it to diagnose particularly complex medical cases, and for treatments. And so there really is widespread use, there's even more applications available. For example, a recent JAMA article showed how you could actually use chat GPT, for example, to better communicate with a patient. So there really are a lot of applications that we haven't even thought about and that aren't being used yet, but are going to be coming online very quickly.

Bob Goldberg  3:53  
So AI is good and healthcare is saved. And we're all going to have treatments right now, right? Because AI is going to do all the work for us. Well, not quite yet.

Unknown Speaker  4:06  
So the FDA has issued guidance on the use of AI in developing treatments, and they will be doing a lot more in that area. But what's important to know and to understand is that, for example, their most recent initiative that's been announced, is going to select a very small number of diseases to focus on. There are 1000s, as you know, 1000s of rare and ultra rare diseases. And yes, it's going to be probably very helpful for the select few that get picked. But we're still going to be waiting on the federal government to move swifter.

Terry Wilcox  4:43  
Well, that is an understatement, especially for those patients in the web, haven't we? I mean, when it's not even just healthcare. Let's be clear. I've been waiting on the federal government for something for a year now and I keep getting a letter that says there still looking.

Bob Goldberg  5:03  
Generated by a chatbot I'm sure.

Terry Wilcox  5:05  
Yeah, okay, I'm glad you're still looking into it, but anyway. So Naomi says, this is all, you know, we've got a lot happening right now, and stuff is already happening. But there's still, you know, obviously a ton of work to do. And we even find that now with the FDA because putting AI aside, Bob, the FDA really already moves really slow, which we discussed last week on the Promising Pathway Act for ultra rare diseases especially, because sometimes they can't even really get off the ground, they can't fulfill trials, they can't fill up.

Bob Goldberg  5:41  
I'll tell you why, Terry, because, you know, I think Greg Simon used to say, you know, medical innovation today, in the United States is like driving a Porsche on a dirt road. It applies, particularly with rare diseases, we should be using AI and the guidances are already there. We have AI and machine learning discussion papers to be used for finding ways to reduce the need for human trials. to impute or infer from certain endpoints outcomes. We need less regulation and more people that are willing to integrate these technologies, using rules of the road into drug development, and diagnostics, and manufacturing, you know, all across the board. So we know in general, that AI can help, obviously, and we've talked a little bit about it. But we have other specifics, and Naomi takes us through a couple of examples of how this can actually help patients.

Naomi Lopez  6:42  
Tufts recently estimated that a phase three trial generates 3.56 million data points. To not use AI in evaluating clinical trials and not monitoring patients is frankly irresponsible. Now, there have to be guard rails around the data, the patient privacy, consent, of course, all of those things are very important and already exist. It's not like that we have to reinvent the wheel here. But the idea that you're going to stall, because the federal government is engaged in this power grab to control it is going to do a lot of harm and detriment to patients who could potentially benefit from this much sooner.

Terry Wilcox  7:28  
As we mentioned, at the top of the show, the White House is also getting involved. Now President Biden signed an executive order on AI. And it's so wide ranging. It concerns Naomi and she thinks it should concern patients too.

Naomi Lopez  7:45  
I think that Americans, but especially those who have loved ones facing rare and ultra rare diseases, or those that have those illnesses themselves, really should be concerned. This executive order sets the stage for federal oversight of AI and all of healthcare.

Bob Goldberg  8:03  
Yeah, so one of the things that Natalie worries about is that AI is already progressing and thinks more government involvement will hinder that.

Naomi Lopez  8:12  
It's really important to acknowledge that today, the day that we're speaking, AI is used in more than half of the value chain of drug development. So using the reliance on machine learning and AI has already happened, it's being done. And so any effort on the part of the federal government to engage in a power grab, that would not only regulate the use of AI and AI enabled tools in the drug development process, or, in fact, what they pretty much explicitly stated is that they want to create a new regulatory system is going to be detrimental to the innovation that's currently taking place.

Bob Goldberg  8:52  
I think the heart of Naomi's concern is the fact that A: they want AI models that are dual use, which means it can be used for obviously, for more than one thing to report on their intent and how they're going to be using it and how they train and test the models. And so I know that's already being done in the private sector. But the other problem is that they want the National Institute of Standards and Technology to develop guidelines for vetting the impact of AI on all these different ranging from privacy to equity to patients, students, workers intellectual property. If this becomes the conduit or the gatekeeping function, it will function like the FDA does for medical innovation. That's not good.

Terry Wilcox  9:46  
Yeah. I mean, Naomi definitely says she doesn't believe that Washington control is the answer. I can understand, wanting to have some kind of you can hear it in the bills and the discussions that are happening on Capitol Hill. You can obviously pinpoint it in this giant, sweeping executive order that's basically like we want our hands and everything. I think we need to be very thoughtful about the power of such a tool and not reining in innovation before it even happens. We're not, you know, not putting the brakes on something that could save lives. And you know, we have to look at it from the patient, there's many ways to look at AI.

Bob Goldberg  10:32  
And listen, and every time a new technology emerges, seems to become more ubiquitous, whether it's cloning, sequencing the human genome, driverless cars, and now of course, AI is in everything. We have to be careful avoiding what is known as a precautionary principle, which is, the best example is someone invents fire, we go, well, let's not use fire, because it could be that you could burn your house down. So we're going to wait until we do studies to see if how many houses have burned down before we use it for anything else. That slows down progress and poses a huge cost.

Terry Wilcox  11:13  
Absolutely. I could not agree with you more.

Bob Goldberg  11:16  
So thanks to Naomi for sharing her thoughts and insights. And I know the subject is going to come up again and again with us. So I'm sure we'll be checking in with her in the future. And for more information on Naomi and her work, you can use the link in the show notes.

Terry Wilcox  11:39  
This episode of the Patient's Rising Podcast is brought to you by the Patient Helpline. The free service is a great way to get your questions answered about medical transportation, health insurance, even caregiving. All of these topics and more can be covered in a phone call or in an email to our helpline. Our navigators have handled issue after issue for patients and caregivers just like you. If you or someone you know has a health care question, challenge or an issue, we are standing by and ready to help. Get in touch, leave us a voicemail, or send us an email using the link in the show notes.

Bob Goldberg  12:18  
Before we go today, we did want to applaud the bipartisan leaders of the Senate Finance Committee, because they released draft legislation that includes several policies that target consumer hostile actions on the part of pharmacy benefit managers.

Terry Wilcox  12:36  
Bob we can always applaud that. 

Bob Goldberg  12:39  
Yes. 

Terry Wilcox  12:40  
So this bill includes provisions that would make Medicare Part D plans offer a high discount biosimilar on their formulary starting in 2026.

Bob Goldberg  12:53  
The other provision is that it protects older adults during the out of pocket costs phase by making sure that what they pay out of pocket, whether it's a coinsurance or what's in the doughnut hole until they don't all smoothed out to the net price, not the list price. Right now, Terry, when I you know, pick up a brand drug in the doughnut hole, I'm paying a percentage of the discounted list price, but that's nowhere near the net price. I could be saving hundreds of dollars a year because of that.

Terry Wilcox  13:27  
Well, that seems to me such a no brainer. And it seems to me that if we did that we wouldn't actually really need the Inflation Reduction Act. But that's a conversation for another day. 

Bob Goldberg  13:37  
Yes, it is. Yeah. 

Terry Wilcox  13:38  
And it also would ensure that those on Medicare have access to pharmacies. 

Bob Goldberg  13:45  
Yes. And that's something you know, you should take a victory lap around that too, Terry because you remember, when the military health, TRICARE tried to limit retail pharmacies by getting Express Scripts to sort of close down their network, people backed off pretty quickly and it's because there's a need people should not have to travel 20 miles this is where I could come in again 20 miles to pick up a prescription.

Terry Wilcox  14:11  
Well, I mean, I know it's crazy. And a lot of times I just recently went through this whole conversation with both my mother in law and my mom on the phone and I was like look anytime you're getting a new medication and you want to check it like say on Cost Plus Drugs and you know, which is the Mark Cuban website or any good RX or whatever. I was like, you should know something especially about Cost Plus Drugs. I said because now you can get the price on Cost Plus Drugs, and you can go to any Kroger in the country and get that price. You don't have to wait for Cost Plus Drugs to mail it to you, which is so great. So a link folks to that legislation is in the show notes. Now finally today we wanted to make sure to honor veterans listening and around the country, Veteran's Day was observed on Friday. And we have many members who are both veterans and patients. And we didn't want the holiday to go by without our gratitude. Obviously so much happening in the world right now. It's definitely a time we should be honoring our veterans. 

Bob Goldberg  15:15  
Yeah, yeah. And just to paraphrase Ronald Reagan, he said, you know, some people wonder all their lives have they've made a difference. Well, veterans don't have that problem. And they know better than anyone else the price of freedom. And even today, you know, it was the paraphrase the Gipper again, you know, they've suffered the scars of war, and we can offer them you know, no better tribute than to remind ourselves every day, the price they paid, and to hold this day, close in our in our hearts.

Terry Wilcox  15:50  
The boys and I went on Veterans Day observed because they didn't have school that day, we went to the US National Army Museum, which was fantastic. I highly recommend it. I know it has nothing to do with healthcare, but it was a really great museum. 

Bob Goldberg  16:05  
On my to do list. 

Terry Wilcox  16:06  
On your to do list.

Bob Goldberg  16:07  
Yeah. Well, that's all for today. We have another episode right here Monday. Make sure to follow us on your favorite podcast player, so you can be notified as soon as a new episode of the Patient's Rising Podcast is live.

Terry Wilcox  16:23  
Until next week for Dr. Bob and everyone at Patients Rising. I'm Terry Wilcox, stay healthy.