Medical Research Funding at Risk with Rod Passman, MD

[00:00:00] Erin Spain, MS: This is Breakthroughs, a podcast from Northwestern University Feinberg School of Medicine. I'm Erin Spain, host of the show. Today we are checking in on a Northwestern Medicine clinical trial that could change the way we care for millions of people with atrial fibrillation, the most common type of heart arrhythmia. But this clinical trial is facing an unexpected challenge. There has been a pause in federal funding to Northwestern University that could impact this study's progress. While the trial has not been ordered to stop, funding has been temporarily frozen, raising questions about how long this work can go on without a resolution. This study led by Dr. Rod Passman aims to use wearable technology, an Apple watch, an iPhone app to personalize when AFib patients should be taking blood thinning medication. Currently to reduce risk of stroke from blood clots many patients with AFib are treated with lifelong oral anticoagulation therapy medications that come with risks that can impact quality of life, including excessive bleeding. This clinical trial funded by a $37 million National Institutes of Health grant is now underway at many sites across the country and aims to enroll more than 5,000 participants to investigate if wearable technology can reduce this reliance on blood thinners. I welcome Dr. Passman to the show today to talk about the progress of this clinical trial so far and how these recent developments in research funding could affect its future. He is the director of the Northwestern University Center for Arrhythmia Research and a professor of medicine in the division of cardiology, and a professor of preventive medicine at Feinberg, as well as a cardiac electrophysiologist at Northwestern Medicine. Welcome to the show, Dr. Passman. 

[00:02:06] Rod Passman, MD: I'm delighted to be here. Thank you for having me. 

[00:02:08] Erin Spain, MS: Let's start off by refreshing our listeners' memories into the work that you do, the research you do, and some of the patients you see in clinic with AFib, and how they've inspired you to lead this clinical trial. 

[00:02:19] Rod Passman, MD: Every week that we see patients in clinic and care for them and do procedures, we recognize sort of the gaps in, in knowledge. And I am a heart rhythm specialist. And the most common heart rhythm disorder, as you pointed out, is a rhythm called atrial fibrillation. It affects about 10 million people. And one of the big consequences of this, arrhythmia is that as a high risk of stroke, blood clots can form in the heart. Those blood clots can break off and go to the brain and cause a stroke. So people with atrial fibrillation who have other risk factors like high blood pressure, diabetes, even being a female, is considered a risk factor or being over the age of 65. So about 90% of the patients with AFib are recommended blood thinners to reduce their risk of stroke. And these drugs are quite effective at reducing stroke risk. But because they thin the blood, they increase the bleed risk. So we're always trying to manage the risks of the medication with the benefits. Many of our patients who take blood thinners don't mind being on them, but many patients have easy bruising. A nosebleed may curtail their lifestyle because they're afraid to go biking or skiing. Because if you have a traumatic event while on a blood thinner, it could turn it into a big event. These medications are also costly. The out-of-pocket expenses can be a couple of hundred dollars a month. So my question is, right now everyone gets treated the same. It doesn't matter how much atrial fibrillation you have, you could be in AFib 365 days a year and you take a blood thinner once or twice a day, or you could have AFib once a year, or you could have had an ablation done for your AFib or get treated with medication and the AFib may be gone. And you know what? All those patients are treated exactly the same with a lifetime of a blood thinner, with no regard of how much AFib they have now had in the past, or whether they were sort of the recipient of a successful strategy to control the rhythm. That never made sense to me. And that's really where my research comes in. 

[00:04:03] Erin Spain, MS: Yes, this one size fits all is not the approach that you think we should be 

[00:04:08] Rod Passman, MD: No, and we had to do this in the past because we understand that AFib could be asymptomatic. and therefore if you don't know when you're having an episode, how can we protect you against stroke? But, you know, could you imagine taking medication every single day for 20 years. Paying for that medication every day. Maybe suffering the consequences and side effects of these drugs when maybe you are not benefitting from them anymore. So instead of that one size fits all models we really want to personalize treatment. 

[00:04:34] Erin Spain, MS: So you've been working on a solution to a more personalized approach to treating AFib for many years, and a lot of this started with one particular patient. Can you take me back to that patient's story and why it motivated you to start looking into more personalized medicine and using technology to help you treat these patients? 

[00:04:55] Rod Passman, MD: A patient who I cared for and had a life changing bleed inside their head that forever affected his life and the life of his immediate and extended family. And at that time. We didn't have technology that could easily monitor the rhythm of nor did we have oral blood thinners that blood very rapidly when those rapid blood thinners came out maybe 13 or 14 years ago originally we said, okay, maybe we could personalize this. But of course, there was no such thing as a wearable device that could do it. So in the first iteration of this, we were using an implantable device, a little insertable cardiac monitor that can record the rhythm of the heart and let us know when you had an episode of AFib and we could call you and tell you to restart your blood thinner. The problem with that is that these devices are invasive, they're expensive, and the data doesn't go to you as the patient. It comes to me as your doctor. So if you had an episode of AFib on a Saturday morning, right, I would need to be available all weekend to see that episode and let you know. And that's clearly, uh, was useful in terms of a pilot study. We were funded by the National Institutes of Health. We showed that using this approach you could really reduce the time on the blood thinner in the pilot study by 95 percent. The question is how to expand this to the tens of millions of people around the world who could benefit from this strategy. And that's where the wearables came in. And multiple companies now have wearable devices and we've been working with Apple to sort of fine tune their algorithm so that now their watch in this trial, can alert you in real time if you're having an abnormal rhythm, remind you to restart your blood thinner and take it for a month. So if you had one episode of AFib a year, you would only need to be on the blood thinner one month out of the year. 

[00:06:41] Erin Spain, MS: Tell me where this clinical trial stands right now 

[00:06:44] Rod Passman, MD: now we're at about 85 centers. We're gonna go past 90 in the next few weeks. We've enrolled about 1700 patients so far, and the trial will ultimately enroll over 5,000 individuals. 

[00:06:56] Erin Spain, MS: Tell me about the design of this trial. 

[00:06:58] Rod Passman, MD: is a randomized trial. These are individuals who had a history of atrial fibrillation, but their clinician now believes that they have very few episodes, either because of lifestyle modification or medications or ablation, or a whole multitude of options. Everyone is coming to us. They're already on a blood thinner and they're on one of these new blood thinners called NOACs or DOACs. Half the patients stay on their blood thinner, which is the standard of care, and half are given an Apple watch with a customized algorithm in it. The algorithm is not commercially available. I don't recommend people do this on their own; the algorithm we're using is highly sensitive to episodes of AFib, and it's connected to a whole system that if you get an alert that you're having AFib, you need to acknowledge it on your phone. If you don't, you'll get texts, robocalls, and then a real person calling saying, you had an episode of AFib, you need to restart your blood thinner. So it's a, it's not blinded because not everyone gets an Apple watch and people know what arm they're in. But it is a randomized trial. And what we're. Really hoping to show that we could protect patients equally against stroke while minimizing their bleeding risk, reduce the costs associated with treating atrial fibrillation and improve quality of life. 

[00:08:05] Erin Spain, MS: So again, this is more than a decade in the making, and now you're at these beginning stages of enrolling people for this clinical trial, but now there are some major issues that could become roadblocks as you're continuing this work. Talk to me about the NIH funding challenges that have occurred at Northwestern University over the past few months and how this could impact your clinical trial. 

[00:08:27] Rod Passman, MD: We received notification that by the last week in March, the NIH had halted all funding to Northwestern University and this was allegedly in response to how Northwestern handled the protests on the undergraduate campus. Northwestern University is, amongst a, a list of about 10 institutions where research funds are being held back because of allegations that the protest on many undergraduate campuses against the war in Gaza had elements of antisemitism in it, and that in some cases these institutions did not deal with that antisemitism. Again, allegedly to the standards of this administration. So all federal funds were frozen, including tens of millions of dollars in research funds and some trials and studies were told to stop work altogether if they were involved in certain areas of research. Our trial was not told to stop. We were just told that we weren't being paid. So that's a difficult situation because we have 85 sites, the money that Northwestern gets goes to those 85 sites to support the infrastructure needed to enroll and follow patients and therefore without a resolution to this issue or some other source of funding this study, and many like it are under threat. 

[00:09:47] Erin Spain, MS: This puts you in an incredibly challenging and unprecedented situation. Where do things stand at the moment with this clinical trial and what needs to happen to make sure that this can continue and enrollment can continue and potentially improve the health of millions of people? 

[00:10:03] Rod Passman, MD: right now Northwestern University continues to fund this trial, out of their own pockets. That is not how research should be done. Clearly we all hope that there's a resolution. We are in contact with the administration from Northwestern as well as our program officer at NIH hoping that there is a path forward. We're also obviously looking for industry support, philanthropic support. And to your point, you know, this really is a critical issue that we're dealing with because, you know, clinical trials affect everyone. You know, a trial like mine is at 85 sites and we're in red states and blue states. We're agnostic about what your politics are because atrial fibrillation is agnostic. And our goal here is discovery science. It's to help the millions of people in America who have this disease and the tens of millions of people around the world. And I wanna emphasize, you know, that this trial and many like, it will not only save lives, but our trial is gonna do it using, you know, American born technology and a reduction in the reliance on medications, which should be, the objective of everyone for us to live longer, healthier lives without, the need for excessive medical therapies. Hurting Northwestern hurts everyone. I also believe that it's hard for me as a physician scientist to recognize or to understand how these issues that went on in the undergraduate campus have anything to do with those of us who are trying to find cures for cancer and heart disease that really should be a priority to everyone. Regardless of what your political leanings are. 

[00:11:34] Erin Spain, MS: What are the different scenarios that you could see happening in the next six to 12 months? 

[00:11:38] Rod Passman, MD: Well, the best scenario is that the NIH turns on funding and supports Northwestern for the funds that they've already expended unexpectedly, uh, and that we resume. The other option is whether, you know, we would get philanthropic or industrial support to continue, and the last option is we would stop this trial. You know if we could not ensure the safety of every single participant, right, who have lent themselves to the advancement of science we wouldn't go on for an hour without that safety net in place. If we did stop this trial it would really be a crime, right? We've already spent millions of dollars in taxpayer money to get to this point. You know, we are four years away from answering this question that affects the lives of millions of people. To not get an answer in this go around, this may never come to an answer because I don't think that anyone would re-attempt this, moving forward given what we are going through at this point. So stopping this trial, honestly, our patients have an option. They could go back on the treatment they came in on, and we would never change this aspect of medicine. But it really, really deprives 'em of hope, right? That we will, in their lifetime, change the practice of medicine or maybe in the next generation, offer options that aren't available now. 

[00:12:54] Erin Spain, MS: Yours is not the only clinical trial at risk here. There are Northwestern clinical trials in oncology, for example, where there are potential lifesaving experimental drugs that are being used in clinical trials. What message do you wanna make sure patients and just the general public hear from you when it comes to the potential outcomes of this funding freeze? 

[00:13:15] Rod Passman, MD: If you are outraged by what's going on and the threat to medicine, I would say, you know, write a letter, pick up a phone to your, local politicians because people need to hear that a threat to science just doesn't affect, researchers in some ivory tower. This really affects them and their lives. And pretty much every pill that you may take, every procedure that you may go through came on the shoulders of people doing research. Many, many, many breakthroughs, come from places like Northwestern. So we should all be concerned if research is gonna be impacted. So I think it's my duty as a scientist to get the word out there . 

[00:13:50] Erin Spain, MS: Thank you so much for coming on the show and talking about where things stand right now with this clinical trial. Thank you for sharing your story. 

[00:13:57] Rod Passman, MD: Well, my pleasure. Thank you for the opportunity . 

[00:13:59] Erin Spain, MS: You can listen to shows from the Northwestern Medicine Podcast Network to hear more about the latest developments in medical research, health care, and medical education. Leaders from across specialties speak to topics ranging from basic science to global health to simulation education. Learn more at feinberg. northwestern. edu slash podcasts. 

Physicians who listen to this podcast may claim continuing medical education credit after listening to an episode of this program.

Target Audience

Academic/Research, Multiple specialties

Learning Objectives

At the conclusion of this activity, participants will be able to:

1. Identify the research interests and initiatives of Feinberg faculty.
2. Discuss new updates in clinical and translational research.

Accreditation Statement

The Northwestern University Feinberg School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement

The Northwestern University Feinberg School of Medicine designates this Enduring Material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Board of Surgery Continuous Certification Program

Successful completion of this CME activity enables the learner to earn credit toward the CME requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit.

Disclosure Statement

Rod Passman, MD, has disclosed his membership on advisory committees or review panels for Abbott Laboratories, Janssen, iRhythm, Medtronic, Inc. and the National Institutes of Health. He has received grant or research support from the American Heart Association and Abbott Laboratories. He also receives royalties or patent benefits from UpToDate. Course director, Robert Rosa, MD, has nothing to disclose. Planning committee member, Erin Spain, has nothing to disclose. FSM’s CME Leadership, Review Committee, and Staff have no relevant financial relationships with ineligible companies to disclose.

All the relevant financial relationships for these individuals have been mitigated.