July 22, 2022

The Fight for Access with Government Agencies

The Fight for Access with Government Agencies

For 17 years, the gastroparesis community has fought for the FDA to allow it access to a treatment they say is necessary to improve quality of life. Gastroparesis advocate Michael Smith details the efforts to make sure that patient voices spur action...

For 17 years, the gastroparesis community has fought for the FDA to allow it access to a treatment they say is necessary to improve quality of life. Gastroparesis advocate Michael Smith details the efforts to make sure that patient voices spur action at the FDA. Plus, what this means for the broader impact of the FDA across the entire chronic disease community.

Terry and Dr. Bob also discuss the reignited conversation on drug pricing policies in Washington.  Kate speaks with migraine advocate Yuri about the misconceptions about this chronic illness and the struggle to get insurance coverage for necessary care.


Terry Wilcox, Executive Director, Patients Rising

Dr. Robert Goldberg, “Dr. Bob,” Co-Founder and Vice President of the Center for Medicine in the Public Interest

Kate Pecora, Field Correspondent


Michael Smith, Former Vice President of G-PACT and volunteer advisor to the Oley Foundation

Yuri Cárdenas, Patient and Migraine Advocate 


Dems try again on drug prices
FDA user fee timeline slipping, raising layoff-notice concerns

Feeling litigious, Vanda files another lawsuit against the FDA

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Terry Wilcox (6s):
Today, we look at the FDA's role in patient access to care. Plus, what the revival of drug pricing conversations in Washington, DC, means for you. That's up next. Welcome to the Patients Rising Podcast. I'm Terry Wilcox, Executive Director of Patients Rising. We're an organization that provides education, resources and tools for the 133 million Americans with chronic illness. I'm here with my cohost, who is renting-out the freezer section at Cosco to stay cool. He's Dr. Bob Goldberg, Co-Founder of The Center for Medicine in the Public Interest. Will you be podcasting next week from the Arctic Circle?

Dr. Bob Goldberg (47s):
Well, Terry, it is really hot. Ask me, how hot is it?

Terry Wilcox (52s):
How hot is it, Bob, because it's so hot here in Virginia and the DC area, it's like this is really swamp. Like we are in a swamp right now.

Dr. Bob Goldberg (1m 3s):
It is so hot here, Terry, that I saw two fire hydrants fighting over a dog. That's how hot it is. I noticed that you said something about the DC area. Well, it is so hot, that people are willing to stand between Chuck Schumer, and a camera, just for the shade. So, it really is hot out there.

Terry Wilcox (1m 29s):
It's hot everywhere.

Dr. Bob Goldberg (1m 31s):
I'm going out to Kansas City to talk with Terry Ramande about some of the stuff that we've been working on and it's going to be hot there too. It's hot everywhere. It is always hot on the Patient's Rising Podcast, no matter the season, or time of day, just because of all the topics we always talk about.

Terry Wilcox (1m 52s):
Well, of course! We're always talking about hot topics and one of the hottest topics that we talk about, is of course, drug pricing, which has been resurfaced by lawmakers.

Dr. Bob Goldberg (2m 4s):
Dredged up.

Terry Wilcox (2m 5s):
I know. We'll make sense of the reality behind these proposed policies, and what patients should know, and then we also have a spotlight on the FDA.

Dr. Bob Goldberg (2m 14s):
One of the big pushes the FDA has made in recent years, is patient-focused drug development, which is engaging patients in the design of clinical trials and what they should measure. One group of patients feels like their voices have not been translated into action. I spoke, this week, with Michael Smith, fellow Yankee fan and a long-time patient advocate for the gastroparesis community, about their fight to get a drug on the market - A drug back on the market, that would improve their quality of life. He shares the challenges, that he's encountered, in today's interview.

Terry Wilcox (2m 52s):
Well, folks, Michael will join us shortly, but first, this week's healthcare news headlines.

Robert Johnson (3m 1s):
In your health news, the Novavax COVID vaccine received CDC approval this week. Many on the committee, that reviewed the drug, said they hoped it's more traditional formulation will encourage holdouts to protect themselves from the virus. Overdose death rates are bad for all people, but they're especially high for some people of color. A new CDC analysis says overdose death rates spiked forty-four percent for black people and thirty-nine percent among American Indian and native Alaskan people. The rates for those who are White, Asian, Pacific Islander or Hispanic, all increased by about twenty-two percent.

Terry Wilcox (3m 40s):
At the same time that Medicare was deciding how to pay for a Biogen's Aduhelm Alzheimer's formula, the Alzheimer's Association was spending $1.3 million on lobbying work. The Association supported FDA approval of the drug, but not the price. It says the higher lobbying spending was partly because the organization held an in-person advocacy event this Spring, the first, since the start of the pandemic. Finally, today, nurses burned-out from working overtime during the pandemic, are leaving hospitals to work for telehealth providers. A nurse, who runs a remote nursing job board, told STAT News, the influx of job seekers has flooded the market. The result is that most new openings are closed in only a few days.

Robert Johnson (4m 23s):
That's your health news update for this week, I'm Robert Johnson.

Terry Wilcox (4m 32s):
Now, we can't do today's show, Bob, without talking about the biggest health conversation happening in Washington, DC, which is drug pricing. Let's be honest, it's really the only conversation happening in Washington DC. Congress is attempting to add drug pricing policies, including Medicare Price Negotiation, into the Reconciliation Package. Of course, we're always looking at things through the patient lens and unpacking what this means for patients at the pharmacy counter. This doesn't mean anything for patients at the pharmacy counter, unless you're a Medicare Part D patient, that reaches more than $2,000 in out-of-pocket costs.

Terry Wilcox (5m 14s):
Then, because the $2,000 out-of-pocket cap in Medicare Part D is something we are highly supportive of, but that's one piece of it, and we're supportive of that. Now, don't get me wrong. I think the $35 insulin is still out of it, in another bill, from what I remember. Then we've got the price negotiation, which now they say, it's only going to be fifteen drugs that won't come to market over the next ten years. I always say, what if it's one of your drugs and you're waiting?

Dr. Bob Goldberg (5m 45s):
Or what if it's more drugs?

Terry Wilcox (5m 46s):
What if it's more drugs than that?

Dr. Bob Goldberg (5m 48s):
It's just one more element of uncertainty. It will not lower the cost to patients at the counter. PBMs are still, in fact, they're doubly incented to increase spread pricing, because that cut is going to go to the government. Which raises a question, Terry, and it was a little bit into the weeds, but if the price negotiation isn't really making any changes, there's always a budget impact, but if it's not part of an overall budget package, how can it go through the reconciliation process and how can it pass with fifty votes as opposed to a two-thirds, majority?

Dr. Bob Goldberg (6m 29s):
That's the short-term question I have. If this passes, it's going to be bad for patients, unless there's a lot of fancy footwork done, when the regs are issued, about how this is going to be handled.

Terry Wilcox (6m 42s):
The main thing, I think, it opens you up to a slippery slope of drug price controls across the board. I mean, that's my biggest fear. Of course, obviously, I don't want any amazing drug for patients who are waiting for therapies, especially in the rare disease community, to not come to market, because R&D dries-up, because there's price controls on drugs.

Dr. Bob Goldberg (7m 5s):
Those are the drugs, once again, you know what's going to happen. ICER will produce one of its BS reviews to justify imposing price controls on a rare orphan drug, which they've done in the past. The indirect pressure will be applied, and rare disease patients are going to get screwed.

Terry Wilcox (7m 26s):
Yeah, absolutely. That's exactly what's going to happen. Nobody really wants to look at that. They just want some kind of a win. You and I both know that this is more politics than it is policy, at least sound policy, right? It's a lot of grand-standing and it's the only thing they really can get through, I think is one thing.

Dr. Bob Goldberg (7m 46s):
I also think that if the bill does pass, and is signed into law, that somebody ought to sue as being discriminatory against people with rare diseases.

Terry Wilcox (7m 56s):

Dr. Bob Goldberg (7m 56s):
We have just begun to fight, folks, if this thing comes to pass, or is passed into law, and signed into law. I'm just concerned, because the enemies of medical progress will seize on this and continue to grind away. They will take this as a victory, and they'll try to continue to push. They're not going to go away.

Terry Wilcox (8m 21s):
We've talked a lot about this process. We've talked quite a bit about the reconciliation process and what's happening here right now, but basically for our listeners, the House passed a bill on drug pricing, and other things, and the Senate has not really passed anything yet. The only way they could really get the drug pricing bill passed as a bill, would be to get sixty votes, and they don't have that for the bill. Therefore, they can get it passed in what's called reconciliation, which they only need fifty-one votes for. That's really the main thing our audience needs to know is, if they can, there's a lot more parameters and guard rails around reconciliation.

Terry Wilcox (9m 4s):
I'm not going to get into the policy weeds of that, but there's more benchmarks they have to meet to do the reconciliation process, which seems right now, could happen. We'll see, but there's one piece of the drug pricing legislation, that's in this particular reconciliation process, and that is the negotiation of drug price setting, is what we like to call it. It's kind of insane. It's sort of an insane process. The thing is, it's going to be ten drugs the first year and then up to twenty-five by year, blah, blah, blah. I'm not going to read it all. If you're really interested, we'll link to it in the show notes, and you can take a look at what it says.

Terry Wilcox (9m 45s):
The thing is, like I said earlier, it's a really slippery slope between, we're going to do ten drugs now, and we're going to do every drug later, and then we end-up like Europe, or the UK specifically, where we don't have access to new medications, because we didn't meet the benchmark or whatever. It's not there yet, but it's kind of the beginning of that. That's where the fear comes from and the trepidation from folks like us, and others, about where are we headed after we do ten drugs. What's next?

Dr. Bob Goldberg (10m 21s):
Right, exactly.

Terry Wilcox (10m 22s):
Also in Congress, the lawmakers are cutting it close to reauthorize the FDA user fees, which we've talked about quite a bit. We talked about them, at our Fly-In, with a lot of our advocates. Our listeners will probably know them by their acronyms like PADUFA, which is the Prescription Drug User Fee Act. These are incredibly important, as we've discussed, since they keep the FDA funded, and well-staffed, to review new drugs. If that funding drops off, the review process will slow-down significantly, and ultimately, leaving patients in limbo. This is the big thing to know about the UFA package, if it doesn't pass by the 30th of this month, or by the time the Senate goes on August recess, then the FDA has to start handing-out pink slips that say, you might lose your job on October 1st, right?

Dr. Bob Goldberg (11m 15s):
Yeah. Right.

Terry Wilcox (11m 16s):
There's a lot at stake here, and if it doesn't pass by September 30th, then people are losing their jobs, for a minute, until they figure it out.

Dr. Bob Goldberg (11m 26s):
There's a lot of gamesmanship going on, and I like to think it would be resolved, but who knows. Down the road, there will be a reauthorization. It may take longer. Hopefully it will avoid, like you said, there's a point where if they don't pass it by 'x", layoff notices go to FDA employees on August 1st. Then, if it's not passed by October 1st, there's no user fee money and no money for the jobs.

Terry Wilcox (11m 57s):
That's right. Bob, I think this all segues nicely into your conversation with Michael Smith. He's one of those patients eagerly, very eagerly, waiting for action from the FDA to help him, and others, who live with gastroparesis.

Dr. Bob Goldberg (12m 13s):
He has been eagerly waiting for almost a decade.

Terry Wilcox (12m 16s):
I know, I think his patience is wearing thin. I've had many conversations with Michael.

Dr. Bob Goldberg (12m 21s):
Why we even call people, who are with health problems, patients, is another issue. It's like, just stay there patiently. Sometimes it does take longer than you'd want, and with respect to gastroparesis, gastroparesis is when a part of the stomach, that is involved in digesting and producing enzymes, is paralyzed. Food can't adjust properly. There are drugs called pro-kinetic medicines, which resets the electrical rhythm of the digestive tract to help digestion function properly, but they were taken off the market due to a side effect called, Long QT Syndrome. That's basically, an elongated beat in your heart, which can increase the risk of a fatal heart attack.

Dr. Bob Goldberg (13m 8s):
Now, gastroparesis patients have been fighting for access to it ever since, and collecting data during that time, showing that (a) patients were willing to take the risk if there was, and (b) the real-world data doesn't seem to be a risk at all. I'm going to let Michael, who did a great job during our interview, talk about why they think the benefits of these drugs outweigh the risk, and what they've had to do to try to move the needle. So, here's Michael.

Michael Smith (13m 35s):
We really need these medicines to build the bridge to a new age, that you're familiar with, of regenerative medicine that will eventually regenerate these digestive tract organs. You've had the pleasure of working with a gentleman, who I've had the pleasure of getting to know, Bob Parrarie. He's part of a group of innovative physicians, who were working hard, to get us to that next period and really need those prokinetics to build that bridge. Only now, after about seventeen years' worth of debate with the FDA, are we really able to get some of those back on the market.

Dr. Bob Goldberg (14m 9s):
Michael also highlighted how the data, and the patient perspectives collected from the gastroparesis community, haven't necessarily translated into FDA action.

Michael Smith (14m 19s):
We were part of one of the first patient communities, that was part of an initiative called, the Patient Centered Drug Development Initiative, that was organized genetic lines a few years ago. We constructed a data registry of about 1200 patients, through my old group G-PACT. That information was provided to the FDA about seven or eight years ago, and also, a separate sister registry at the NIH, provide an accumulation of data from about a thousand patients, that really should provide them with a fairly good picture of what the concerns may be here at this point. It's not to say that listening session, which was ongoing, has been not successful, that has led to clinical practice guidelines for gastroparesis.

Michael Smith (15m 3s):
It still has not resulted in the degree of clarity that we really need on these drugs. What's been most shocking, Bob, are at least two developments through the pandemic. The first one, we still struggle with an IND on one of our more important drugs, DON paradigm, which has never been fully approved in the US, although it's been fully approved in the nearly every other industrialized democracy on the planet. It's an IND process, that hasn't worked properly for a number of reasons, since the pandemic started. In some of our patients, who have tried to under doctor's advice, seek to get the medicine from overseas, have seen their medication seized by the FDA.

Terry Wilcox (15m 48s):

Dr. Bob Goldberg (15m 48s):

Terry Wilcox (15m 49s):
I mean, that's a really tough spot. What channels does the gastroparesis community have? What do they have to go through, within the FDA, in order to regain access to these medications? Is it even possible? Is there a path?

Dr. Bob Goldberg (16m 6s):
This has been going on forever, and when I talked to Michael, he outlined what maze these drugs have to go through. I asked him again, why are they hitting a roadblock? Here's Michael again.

Michael Smith (16m 21s):
We deal with the GI drugs community within CDER of the FDA. It's interesting and I think you've seen this contrast as well. You know that some of your patients may not be familiar with, there are at least three different divisions of the FDA, that handle the regulation of various products. We have not had as many difficulties with the device division, which has improved an Enterra GI pacer to the FDA and more recently, over the course of the past few months, some very innovative testing and diagnostic technologies for our patient community. There is a very promising company called <inaudible> that has gotten some products approved, that may very well revolutionize the imaging of our conditions, but it's been a consistent set of concerns tied to CDER.

Michael Smith (17m 7s):
You're shortly familiar with, and you've introduced me to her, Janet Woodcock, personally seems sympathetic to our concerns. There are other sympathetic individuals within the agency, but I think when you get the regulatory scheme together, when you get everybody into a room, something happens that we have yet to fully understand, in which our products don't get approved fairly often. If they do get approved, they might get approved under rather severe restriction. That patient centeredness, over the course of the past fifteen or seventeen years, has resulted in improvement of dialogue, but not approval of action.

Terry Wilcox (17m 56s):
I really feel for Michael and the whole gastroparesis community. Obviously, I've been following this. It's how we originally got connected to Jim, who is our head-of-patients. He handles all of our patient engagement, at Patients Rising, through the gastroparesis community. One of the worst things that patients like Michael, and others, have to deal with, is they're already sick. They're not getting what they need and they're trying to figure-out how to get it. They have to deal with this giant bureaucracy called the FDA, or fill-in-blank. If you're a Medicare patient, you have to deal with Medicare, you have to deal with CMS.

Terry Wilcox (18m 36s):
I know Michael and he's like - Give me the checklist. Give me the thing that I have to do to make you say, "yes". What are the things you need, for us to prove to you, so you will help us get what we need as patients? We need you. They can't do this when they can't get access without them. Rather than just constantly saying, "no", what is the path to "yes" and it doesn't seem like anybody is giving him that, or is there something I'm missing?

Dr. Bob Goldberg (19m 13s):
Here's my thinking about it. (a) I think part of the problem is, and maybe this is my Patients Rising Now, and the advocacy, it's not enough to go through the checklist. If you go through the checklist, and you're a small group of patients, that's not going to be enough, unfortunately. Even with a sympathetic voice, or individuals such as Janet Woodcock. (b) Long QT is one of those safety, that sets off fire alarms in the epidemiological community. I think the attitude is, if they do it for DON paradigm, then they've got to do it for all these other drugs with long QT.

Dr. Bob Goldberg (19m 54s):
So, it's this, "We know best" kind of thing. Even though most of the data out there, including what the gastro community has done themselves, international studies have showed that the risk of arrhythmia, which is a function of the long QT, is modest and can be managed. It doesn't increase the risk relative to other kinds of drugs with long QT issues, like cancer drugs, for instance. Finally, believe it or not, Terry, there is an organized constituency around this QT issue, which includes people like Arnold Ventures and Public Citizen, and other people who are using this as the bloody flag of safety to discourage the use of medicines they don't think should be on the market.

Dr. Bob Goldberg (20m 41s):
Everyone's focusing on other things, and this always seems to drop to the bottom of the list. We need to come-up with other strategies to make this a higher-level issue, because as you pointed out, it bears directly on some of the key concerns of the Patients Rising community, about the role of the FDA in designing patient-centered protocols and this whole issue of using these kinds of safety scares as a way of discouraging accelerated approval. It is very, very concerning and important.

Terry Wilcox (21m 20s):
I definitely think there's a voice for this community. This is one thing we really need to get to the bottom of, not just for the gastroparesis community, but for all the other communities that are struggling in the same way. You and I both know that the FDA has made pretty great strides in patient engagement and creating more patient engagement, but it's one thing to just talk to the patients and allow them a voice. It's another thing to take action on their voice. To really, actually, take their voice and act on it, because they know it's important. I'm not blaming anyone specifically at the FDA.

Terry Wilcox (21m 59s):
It's bureaucracy. It's like, how do we figure-out how to get through that, in a meaningful way, so that communities like the gastroparesis community can get access to what they need?

Dr. Bob Goldberg (22m 13s):
Before we enter a conversation, Michael gave a perspective of what is going on in the lives of people with gastroparesis, who don't have those medicines.

Michael Smith (22m 22s):
I've heard too many stories, of late, of young teens or twenty-something patients, who are actually choosing to go to hospice, rather than looking to face treatment that the FDA kind of restricts at this point. You shouldn't need to be a practicing attorney, like myself, or a public policy leader, like yourself, to simply get a prescription filled at a pharmacy. We shouldn't continue along that path. It's too easy, particularly linked to long COVID, and COVID 19, to get aspects of these conditions that these treatments really need to be more available, and government really needs to work in concert with the patient community. We're not trying to make a profit from this.

Michael Smith (23m 3s):
What we're really trying to do is, we're trying to return to function. It's return to function of an essential organ system. There is nothing esoteric about your ability to eat, to drink and the ability to absorb nutrients. If the engine doesn't work, the rest of the body doesn't function.

Terry Wilcox (23m 22s):
Well, I cannot agree with him more. We all know that. So, folks, if you're interested in this topic, or other topics that we've discussed, please go to the show notes. We will link to everything we've discussed today. If you're interested in getting involved with us, there's also a link to learn more about becoming a patient advocate or signing up for our Patients Rising Advocacy Masterclass. We hope you do. This episode of the Patients Rising Podcast is brought to you by Patients Rising Concierge, a new service, from Patients Rising, that helps patients, and caregivers, find the resources they need to find stability and support throughout their healthcare journey.

Terry Wilcox (24m 8s):
From finding a professional advocate to help with insurance challenges, to legal and tax counsel, to local caregiving resources and so much more. Our team is standing by to help you navigate the healthcare system and connect you to the services you need. To learn more, visit patientsrisingconcierge.org, or email us at askusanything@patientsrising.org. Now, let's listen to Field Correspondent, Kate's, conversation with Yuri Cardenas, a patient and migraine advocate.

Terry Wilcox (24m 49s):
Take a listen.

Kate Pecora (24m 50s):
Today, I'm speaking with Yuri. We're going to speak a little bit about yourself, your information and some of the major challenges you've been living with that have put you into advocacy.

Yuri Cardenas (24m 59s):
Thank you so much for this opportunity to speak with you. My name is Yuri and I'm disabled. I'm also queer and mixed Chicanx, which I share, because people like me are under-represented, impacted the worst by my disease, and have more barriers to getting help. I live with migraine disease, atypical strabismus, anxiety, depression and PTSD, but none of that had a disabling impact on my life until my migraine disease transformed into chronic migraine, nine years ago, and ended my career as a Senior Producer. I've spent these last nine years advocating, all the time, in every aspect of my life, because I have to.

Yuri Cardenas (25m 47s):
Starting with the long road of trying to find doctors who believe you, understand your disease and what medications might affect you personally, from explaining to loved ones what accommodations you need, from trying to find safe spaces for support, here of the global majority, and then there's the never-ending time spent trying to get access to what the doctors prescribe. I'm talking hours with multiple insurance admins, nurses, pharmacists, et cetera, for one treatment.

Kate Pecora (26m 17s):
When we talk about migraines, and we've talked about it a little bit on a previous podcast, I think that a lot of people kind of misunderstand it as headaches. It certainly is. That's one of the symptoms of it, probably the biggest one, but there's more than just having headaches when you have migraines. I know you've described that it can be kind of frustrating to get validation within chronic disease communities that are invisible. Can you share some of the difficulties that you've had when it comes to living with migraine and participating in day-to-day work? You said you kind of gave-up part of your career, because of your diagnosis, so let's talk about that.

Yuri Cardenas (26m 56s):
Sure. Thank you so much for bringing this up. I'm advocating all the time. I've also advocated with Congress and Senate at Headache on the Hill. One office asked why migraine disease is so severely underfunded by the NIH, National Institute of Health. Dr. Rob Cowen responded that it's thanks to the stigma. It's a woman's disease. People are faking. It's just a headache. Headache is headache and migraine is migraine. I can't say it enough. Like you said, headache is one symptom of migraine disease. Migraine is a full-body neurological disease with a lot of intense and disabling symptoms beyond head pain. Another contributor to stigma is that migraine is a spectrum disease, meaning it varies considerably from person to person.

Yuri Cardenas (27m 44s):
So, my migraine attack is very different than yours. Because of these assumptions that people have about the way another person's body would work, migraine is highly stigmatized, dismissed and misunderstood. It's one of the most disabling diseases worldwide, according to the World Health Organization, but it's not even included on Social Security's disability list. I personally had to stand in front of a federal judge, twice, to explain what migraine disease is and no one should have to go through this. I've had my disability income stopped and I had to fight to get it again. Nine years in, my disability income is continually under threat.

Yuri Cardenas (28m 25s):
That impacts healing.

Kate Pecora (28m 26s):
You mentioned it a bit, in the beginning, that there are challenges when it comes to getting the management of migraine that your doctor recommends or prescribes for you. There is no shortage of medications available to people with migraine, but I think a lot of people have to go through a trial-and-error process to be able to get on a treatment that works for them. When it comes to that medical management piece and trying to find the right provider that will listen to you and validate some of the considerations that you have about your personal situation, like you said, everybody's symptoms are slightly different. When it comes to finding somebody who is able to set you up with a treatment plan, what has been your experience there?

Yuri Cardenas (29m 4s):
It's been an uphill battle for me, and at this point, I actually have medical PTSD from it all. I've basically been a lab rat, for the past nine years, trying one treatment after another and trying to find doctors who believe me. I've had nurses - I tell them what an issue is, and they run a test and say, oh, you have that issue. It's like, yes, I told you that. I've seen over thirty specialists at this point and five neurologists. I've tried over forty preventative treatments. The list goes on and on. You name it and I try it. I've tried a five-day hospital stay and I'm really lucky that I work with top headache specialists, but all the medications I've tried so far have failed me.

Yuri Cardenas (29m 50s):
This year, I haven't been able to get any of the new treatments they've recommended. I can't afford them. I've been putting my nine years' experience advocating, to insurance, but insurance still denies it. I see people getting back to episodic migraine, from chronic migraine, and I see they have financial security and are able to try multiple costly treatments at once. It's incredibly exhausting and depressing.

Kate Pecora (30m 18s):
You've taken a big look at looking at health disparities, specifically around addressing pain and chronic disease communities and how that can be addressed within minority communities, specifically. Could you share some of the work that you're doing in identifying those gaps, and bridging solutions, to be able to close some of them?

Yuri Cardenas (30m 37s):
Yes, I am happy to talk about this. I am currently obsessed with highlighting the disparities in healthcare and migraine, and uplifting migraine organizations and support groups, to support the people most impacted by migraine disease. Sadly, migraine hits black and indigenous people even harder. It's a harrowing disease, and it's not made any easier by the systemic racism and bigotry in the medical industries. One study found indigenous people have the highest prevalence of migraine disease in the US. Another study found Latina have the highest rate of chronic migraine and another study showed people who aren't identifying as one-hundred percent heterosexual have a fifty-eight percent higher chance of migraine.

Yuri Cardenas (31m 25s):
I sit at the intersection of all of these, so, is that what happened to me? The research is scant in terms of why this is happening. We need more research. We desperately need better treatment options and better access to treatments. The people impacted the most should have more help. I can't say it enough. I've talked about this disparate impact with Congress and Senate. I spent the last year focusing my few spoons trying to uplift the Disparities and Headache Advisory Council, and migraine organizations, to be less white-centered and to create safer and more supportive spaces for the entire migraine community. Another piece of my work is improving language to be less harmful.

Yuri Cardenas (32m 9s):
For example, many discourage using the term minority, but ultimately, I think we can all work together. I don't give up hope. I believe we can create the world we need.

Kate Pecora (32m 19s):
A lot of times people will go back to talking about how health providers need to be educated about this. Do you think that this is on a provider-to-provider basis, or getting people out of medical school, or is this something larger that has to do with the communities and the support services that we're providing people on a larger societal level?

Yuri Cardenas (32m 45s):
It hits every aspect of systemic racism. Unfortunately, it affects everything in our lives, and I think we have to approach it at every angle. I've been reading a lot of studies, lately, about how different populations aren't safe with their doctors. We absolutely need to educate doctors, but it's also amongst people's cultural issues, in terms of, there's a lot of bias against migraine. Again, you can just suck-it-up and move on with your day and that can be different from culture to culture, but that can be another reason people don't seek care. I like to think that me, struggling through these experiences, I can share to help others not have to.

Dr. Bob Goldberg (33m 32s):
Thanks again, Kate, and thank you, Yuri, for advocating on this important issue. If there's a healthcare issue that's affecting you, or a loved one, we want to hear about it. You can share your story right here on the podcast. All you have to do is send an email to Terry, and me, at podcast@patientsrising.org.

Terry Wilcox (33m 51s):
That concludes the show for today. We thank you for joining us for another episode of the Patients Rising Podcasts. If you like what you've heard, leave us a rating and a review. We'd really appreciate it.

Dr. Bob Goldberg (34m 0s):
While you're there, make sure to give us a "follow" on your favorite podcast app, that way you won't miss out on any of the upcoming episodes.

Terry Wilcox (34m 10s):
Speaking of the next episode, we have a great conversation set-up next week on the No Pain Act and how to expand patient access to treatments beyond opioids. Until then, for Dr. Bob and everyone at Patients Rising, I'm Terry Wilcox - Stay healthy.