Ep 85: Trump’s Policies and the Effect on Alzheimer's with George Vradenburg and Russ Paulsen

in this episode of the "BrainStorm" by UsAgainstAlzheimer's, George Vradenburg, Co-founder and Chairman of UsAgainstAlzheimer's, and Russ Paulsen, the organization's Chief Operating Officer, discuss the impact of the Trump administration's policies on Alzheimer's research with host Meryl Comer. The conversation highlights the systematic dismantling of the National Institutes of Health (NIH) and other critical agencies, which threatens to undermine Alzheimer's research and public health. Vradenburg and Paulsen express concerns about the lack of transparency in the reorganization and the potential negative effects on drug reviews and approvals due to significant cuts at the FDA. They highlight the importance of protecting key programs that support seniors and the potential global impact of these policy changes. Despite the challenges, both Paulsen and Vradenburg are optimism about scientific advances in diagnosing and treating Alzheimer's, including the development of blood tests and new treatments. Hear the call to action for listeners to advocate for continued support for Alzheimer's research and to contact their members of Congress to ensure that funding remains a priority. This is a must listen episode!  

This episode is sponsored by Genentech.

Transcript

George Vradenburg (00:00): 

FDA has been the sort of the gold standard around the world of assessing the safety and effectiveness of new drugs. Other regulatory agencies around the world typically follow the FDA. If that is damaged, the world is damaged. Our public health agency has been one of the strongest in the world. U-S-A-I-D, its extension around the world. Even CDC overseas is a hugely important public health agency. If those are deeply undermined, it's not only bad for patients and it's bad for America, it's bad for the world in terms of its health. 

Introduction (00:37): 

Welcome to Brainstorm by UsAgainstAlzheimer's, a patient-centered nonprofit organization. Your host, Meryl Comer, is a co-founder, 24-year caregiver and Emmy award-winning journalist and the author of the New York Times bestseller, Slow Dancing With a Stranger. 

Meryl Comer (00:54): 

This is BrainStorm and I’m Meryl Comer. While tariff wars and talk of recession consume the economic headlines, the Trump administration has moved systematically to dismantle the National Institutes of Health, the world's largest funder of biomedical research, pulling funding from critical agencies and shutting off already committed federal university research grads. Joining us to discuss the potential impact and where we go from here. George Vradenburg, Co-founder and Chairman of UsAgainstAlzheimer's and its Chief Operating Officer Russ Paulson. Gentlemen, thank you for joining us, George for advocates. Things feel very different now. It's like we're in crisis. A recent leak regarding the HHS budget signals 40 billion in cuts in the proposed restructuring of the NIH. That last year generated 94 billion for the economy and supported about 400,000 jobs. When it comes to Alzheimer's research, what's at risk? 

George Vradenburg (01:58): 

Well, there's not a great deal of transparency in exactly how this reorganization and reduction in force is actually working and what kind of impact it will have. It cannot be good because the number of people at the HHS who have skills and experience and insight are rapidly disappearing. If you fire 10,000 and rehire 2000, we simply don't know who's left at the senior or even middle level management of HHS at NIH. The reductions are significant. The reorganization is taking NIH from 27 institutes to eight. A number of being transferred out, a number of being canceled and terminated at CDC. A whole programs relating to the public health aspects of informing the American public about how to avoid Alzheimer's are totally destroyed. And FDA is being cut back significantly with the possibility of significant delays in drug reviews. But we don't know fully yet the impact. We know it is negative. We know that it's dangerous for patients, but we don't yet know the final outcomes 'cause not all of this has been transparent 

Meryl Comer (03:08): 

Trust. Do we know yet what cuts in services might directly affect patients and families? 

Russ Paulsen (03:15): 

We don't know a lot, as George was saying, but we know that there are things on the chopping block that protect seniors if they need a lawyer, if they feel like they're being financially abused. One of the first signals of Alzheimer's disease can be problems managing your finances, but sometimes it's actually someone's doing something nefarious. And the program that protects older seniors from financial exploitation is on the chopping block, for example. A lot we don't know, but we do know that there are some programs that really protect the people we care about that are apparently on the chopping block. 

Meryl Comer (03:51): 

Janet Woodcock, the former acting FDA commissioner called the Cuts Slow moving catastrophe that will set the agency and patients back 35 years. What are the ramifications of inevitable delays in drug approvals and how will that affect the pipeline for Alzheimer's therapies? 

George Vradenburg (04:13): 

Janet Wilcock is absolutely right. She basically said, we're firing everybody but the doctors at this hospital. And basically the doctors can't do all of this without equipment, without nurses and without support. And so as a consequence, we're going to be left with what may be a very hollow set of institutions. What does that mean? It means that, as we've discussed, there is going to be a slowing of the research. The insights that tend to drive all these new potential medicines is going to be slowed. The actual development of those medicines through clinical trials will be slowed and the delivery of new medicines is going to be delayed. What does that mean at you? People are dying at maybe 2000 people a day. People are turning 75 at 2000 a day. That means more people are going to die of this disease sooner than they should. 

Meryl Comer (05:03): 

Russ, you've been involved in discussions about the need to protect key programs from a policy perspective, what are the most critical programs that need protection? 

Russ Paulsen (05:14): 

From a policy perspective? The programs that are at risk that need protecting span the entire pathway from people who are at risk of developing the disease to people who have it and need an accurate diagnosis, the state-of-the-art treatments for that disease. And they need a strong FDA to make sure that the treatments are up to snuff manufactured properly, that the inspections happen. And then we need to make sure that there are adequate folks at Medicare to pay for all of that. And in fact that if people run out of resources, as people with Alzheimer's often do that Medicaid is there as a backstop. 

Meryl Comer (05:55): 

Any insights in terms of a fundamental reshaping of how the N-I-H-C-D-C and FDA will operate going forward? 

George Vradenburg (06:05): 

We don't know yet. I don't think fundamentally the government financing through academic institutions and academic scientists has been a successful ingredient to tap into. As Russ was pointed out, the brains, not only from Americans, but all those foreign students who come to the United States and find the great opportunities that our educational institutions offer, and particularly in this particular space, FDA has been the sort of the gold standard around the world of assessing the safety and effectiveness of new drugs. Other regulatory agencies around the world typically follow the FDA. If that is damaged, the world is damaged. Our public health agency has been one of the strongest in the world. U-S-A-I-D, its extension around the world. Even CDC overseas is a hugely important public health agency. If those are deeply undermined, it's not only bad for patients and it's bad for America, it's bad for the world in terms of its health 

Meryl Comer (07:07): 

Support for Alzheimer's research. George has enjoyed bipartisan support as a top healthcare priority. In fact, your credit on the Hill is among those leading the charge. The president's 2026 budget requires congressional approval. Has there been slippage or will the funding remain static? 

George Vradenburg (07:28): 

Well, the funding levels this year from now until the end of September are at the same level as last year. That was the continuing resolution passed by Congress. But the NIH does not seem to be issuing the grants or spending the money. The edifice that we have built over the last 15 years as advocates is at risk. So we have had bipartisan support consistently for the last 12, 13 years in terms of building a program literally designed to prevent Alzheimer's. And every year increments in that investment have occurred as a result of a professional judgment budget put forth by NIA to determine what they need in the following year to make sure we're on a path to that, that edifice, that continuing growth is now totally at risk and we don't know what the Congress will be doing with this budget. Unfortunately, president Trump probably has much more control over this Congress than previous presidents have had over the congresses we've dealt with in the past. Traditionally, the president has proposed Congress disposes, but this president is a president that does not like what he proposes to be disposed of. So this may be a different outcome this year. 

Meryl Comer (08:42): 

Russ University and medical schools have come together to look at a more transparent model for funding what they call indirect costs. Is this a case of too little, too late? And will the targeted, targeted cuts to federal research grants be widespread? 

Russ Paulsen (08:58): 

Indirect costs are complicated to talk about, but fundamentally from a patient perspective, if funds for research are cut, that will delay a search for cures and an understanding of diseases. So I don't like to, as a patient advocate, like to think about indirect versus direct and all of this kind of stuff. If there's a cut to federal research dollars at the bottom line, if less research happens, that's bad for patients. 

George Vradenburg (09:24): 

Lemme just add to that. The assault on universities is broader than just the grants associated with research as important as they, they're not just limited even to Alzheimer's. American universities are under assault by the president who wants to change the orientation as he sees it, of these universities and their politics and their pedagogy. American universities have been central to the research enterprise and the biomedical enterprise. And Trump, whether it's an HHS grant or some other grant, the Trump is going to undermine the strength of those American universities and their role in getting the insights, developing the insights that are needed by companies to develop the drugs that will cure our patients. 

Meryl Comer (10:09): 

Us as a follow-up, the administration has now also threatened to stop international students from being able to study in the US as part of that growing pressure campaign against universities like Harvard and MIT. What's being jeopardized by this action? 

Russ Paulsen (10:27): 

America has been the world leader in understanding disease, in finding diagnoses, in finding cures. We have been the beneficiary of the world's expertise in that and we've developed incredible breakthroughs in the United States with scientists from all over the world. But America's been the beneficiary. If we start limiting the folks who can come, we put that at risk. And if we start cutting funding, we put it further at risk because even Americans might end up having to go overseas to do the work. And then those countries are the primary beneficiary of the research. We are in a global competition and we do not need to have China win. 

Meryl Comer (11:10): 

George 

George Vradenburg (11:12): 

Russ said it well and better than I could. 

Meryl Comer (11:14): 

Gentlemen, you've both been traveling globally to the World Dementia Council Summit in London onto the Alzheimer's and Parkinson's conference in Vienna. George, give us an update on the mood internationally. And Russ, I want to ask you, what's an update scientifically, George? 

George Vradenburg (11:32): 

But for what's happening in the United States? And that's not just what's happening to HHS, but that happens to do with tariffs. The destruction of U-S-A-I-D, the Europeans are very befuddled about what's happening to America. Used to be their partner from national security in an economic point of view, and they're seeing their partner and their friend of 80 years sort of completely change its character. So they're very worried about what's happening to the United States and as a consequence to the partnership that Europe has traditionally had with the United States from national security to economics and everything else. So with that said, the conferences that are going on in Europe, which talk basically within our field are really upbeat. People are seeing the approval of new drugs. People are seeing that new companies are coming to the full, people are seeing more clinical trials. People are seeing more research being done. And one of the striking things that struck me in the recent Vienna conference was how young people are, young people have been drawn to this field as a consequence of the excitement around the drugs, the neuroscience insights that have been occurring. 

Meryl Comer (12:40): 

Russ, your takeaway? 

Russ Paulsen (12:42): 

I mean, I think George hit it right on. There was a split screen of excitement in the conference rooms and confusion and, and little concern in the hallways. And one of the other reasons that we've had this growth in the workforce that George referred to is that there has been the ability to fund research positions, which is one of the things that's at risk right now. I think scientifically Merrill. You know, years ago, the only way to really diagnose Alzheimer's disease definitively was after someone had died and they looked at their brain and there were clinical diagnoses made by doctors reviewing symptoms. Turns out, even with specialists, those clinical diagnoses were wrong somewhere 30 to 40% of the time. And there was a big leap forward a couple decades ago with the ability with pretty expensive imaging technology to diagnose the pathology of Alzheimer's before someone dies while they're still alive and to understand what's going on there. 

Russ Paulsen (13:38): 

But what we've been talking about for the past couple years is, is the advancement of the ability to look at someone's blood and tell whether they have the pathology of Alzheimer's disease. And that is really coming into the mainstream where for at least a lot of people, you won't need to go get a PET scan of your brain, but you can just get a blood sample to know whether you have the pathology of Alzheimer's disease. And that has benefits for people who are sick. It has benefits for people who want to be in clinical trials. 'cause If you're going to be in a clinical trial for Alzheimer's disease, it's really better if you actually have Alzheimer's disease than if you don't. So getting that right is important. So the diagnostics are really moving forward and the ability to do that with blood and then ultimately less and less amounts of blood is huge. New technologies and treatment, whether it's getting drugs into your brain, which turns out to have pretty good defenses against letting foreign things like drugs into it. And there's some advances around that. There's the active immunotherapy and later this year we will know whether the active ingredient in Ozempic actually can prevent the onset of Alzheimer's disease That hasn't read out yet. If it does, it'll be a game changer. 

Meryl Comer (14:50): 

George, how pivotal was the European Union's determination to approve chebe? The treatment designed to slow Alzheimer's disease progression? 

George Vradenburg (14:59): 

Believe it or not, 27 governments sitting around a table in Brussels finally decided to approve this first drug chebe in Europe. They're going to impose and appropriately so some risk mitigation measures for the safety of these drugs, but it would've been a clear deterrent for companies developing products in this space, had Europe decided not to approve this drug for use in Europe. So the drug has now been improved in Europe, the United States, Japan, China, and another half a dozen countries. And I think that is a positive move forward to your point about having some positive news. And next up it will be whether or not Europe approves the Lilly drug Keim, which has been approved in the United States, Japan, and China. And so I do think that that is a positive move forward. It's a signal to other pharmaceutical companies that they can get into the business that there is a path to market. And we are seeing through our clinical trials operation more companies coming forward and starting more trials. So there is a positive innovation chain of events that is beginning to happen as a result of the approval of these first two drugs, which is independent of what is being done in terms of the reorganizations and cutbacks at HHS. 

Meryl Comer (16:18): 

As a follow-up, Russ, with patients now hitting the 18 month mark of treatment on Chebe, has the focus shifted from safety to efficacy? 

Russ Paulsen (16:28): 

I don't think the conversation can ever completely leave safety. These are drugs that have some side effect risks and we can't ignore that. But I think what is changing is the conversation about whether the benefit is meaningful to patients. And I think that people are starting to understand that if you ask patients six, seven months of time in an 18 month window, that I don't advance potentially more if the time goes on is absolutely meaningful just as it would be in cancer. The conversation about these drugs will always have safety and efficacy, but what is changing is people are understanding the patient perspective, which is that for many patients, not everybody, this is a seriously meaningful amount of time 

Meryl Comer (17:14): 

For UsAgainstAlzheimer's has teamed up with other groups, disease groups. Where does the efforts stand now and what would we be looking for next? 

Russ Paulsen (17:24): 

These cuts and proposed cuts and further proposed cuts affect almost every American. The chronic diseases, at least half of Americans are living with some kind of chronic disease and the cuts aren't limited to Alzheimer's. We all have a common need for the pathway to cures to be as smooth as possible and as fast as possible for every chronic disease in America. We also have common cause that these government dollars should be spent extremely efficiently. We are completely supportive of efforts to make the government money spent very efficiently, but we need any kind of cuts, reorgs, whatever for all of these diseases to be made with consultation, with patients, with transparency, and with a plan to make sure that nobody gets hurt. 

Meryl Comer (18:15): 

George, can we look ahead beyond the immediate budget concerns, what are the key priorities for us against Alzheimer's to accelerate progress in Alzheimer's research and care? 

George Vradenburg (18:28): 

A little difficult when the alligators are around your ankles to look at the sunset in the horizon. But with that said, industry is not going away, at least for the large companies. They have a time span on their discovery and drug development efforts, which is longer than four years, so they will continue. My concern is that the biotechs, which have a much shorter time horizon on what they can do, given the limited duration and patience of their investors, may be hurt. As a consequence, we will be working very hard to make sure as much as we can that other countries around the world pick up some of that slack. We're working with the European Union on developing their Horizon program to provide funding for biotechs in Europe. And we'll be working with industry to develop much more significant range of potential solutions to the challenge of Alzheimer's through medical devices and new kinds of technologies. So we will be working with industry, pursuing and supporting their work and advocating to the extent we can repair work at HHS and filling in what has been lost in the first three months of this administration. Less than three months, but we will be working the rest of this year as we get more visibility into what the impact of these cuts and reorganizations are to see what needs to be repaired 26 and 27 budgets. 

Meryl Comer (19:53): 

Russ, what actions can our listeners take to help ensure that Alzheimer's remains a top priority? 

Russ Paulsen (19:59): 

It's a good question. Alzheimer's has become a top priority thanks to legislative action, and it's been a consensus driven bipartisan support. We need to make sure that bipartisan support continues. So people who worry about people with Alzheimer's, people who have Alzheimer's, people who care for people with Alzheimer's can contact their member of Congress, let them know we cannot afford to take our foot off the gas. Now, we have made major progress in understanding Alzheimer's disease and diagnosing Alzheimer's disease and ultimately progress toward a cure. But we won't get there if we take our foot off the gas or if we make cuts without a plan for making sure that everything functions properly. After the cuts, 

Meryl Comer (20:43): 

George UsAgainstAlzheimer's has played a pivotal role here at home as an early supporter of napa, the National Alzheimer's Project Act, and internationally through the Davos Alzheimer's Collaborative and the CEOi, connecting research policy and support for families with the recent proposed cuts, do you see that role shifting in any way? 

George Vradenburg (21:07): 

Absolutely not. Our single guiding light is what is in the interest of patients and caregivers and families here in the United States and around the world. That is not going to change, and we will be active here in the United States. We'll be active globally. We'll be active with governments, with industry, with academic scientists, and with other patient groups to make sure that we do not lose sight of our guiding star, and that in fact we do not lose our mission and we will pursue our efforts consistently and consistently and persistently through the coming years. 

Meryl Comer (21:40): 

Thank you, gentlemen. Our guests have been George Vradenburg, co-founder and chairman of UsAgainstAlzheimer's, and its Chief Operating Officer, Russ Paulson. That's it for this edition. I'm Meryl Comer. Thank you for brainstorming with us. 

Closing (21:57): 

Support for BrainStorm by UsAgainstAlzheimer's comes from Genentech. Genentech is prepared to ask tough questions to help tackle the root causes of systemic inequities in healthcare. Subscribe to brainstorm through your favorite podcast platform and join us for new episodes on the first and third Tuesday of every month.