Feb. 25, 2022

Speedy Rare Disease Drug Reviews

Speedy Rare Disease Drug Reviews

As Rare Disease Month comes to a close, we take a look at a major piece of legislation that impacts the FDA, and consequently, patients with rare diseases. 

With the Prescription Drug User Fee Act (PDUFA) up for renewal in Congress, much is at stake for the rare disease community. This act expedites the drug reviewal process for new treatments, including those for patients with rare and unmet medical needs. Without it, drug reviews would slow down dramatically. And speaking of the FDA, the agency finally has a new Commissioner, Dr. Robert Califf. How will he shape the agency? 

To give listeners an inside look, Terry and Bob speak with past FDA Associate Commissioner Peter Pitts, who explains the importance of PDUFA and what Dr. Califf will bring to the patient community. 

And to conclude rare disease month, Kate Pecora speaks with patient advocate Yolanda Bermudez. Hear her story as she discusses how her rare disease changed her cancer journey. 

Hosts: 

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

Guests: 

Peter Pitts, Co-founder and President of the Center for Medicine in the Public Interest 

Yolanda Bermudez, Patient Advocate 

Annika Wojtowicz, Patient Correspondent 

Jearlean Taylor, Patient Correspondent 

Links:

Prescription Drug User Fee Amendments | FDA

PDUFA Renewal and the FDA: What Do Patients Need to Know?

Twitter | PatientsRiseNow Health Subcommittee Hearing on PDUFA

Robert M. Califf M.D | FDA Commissioner

Peter Pitts | CMPI

The Affordable Insulin Now Act 

Creating a promising pathway for faster access to new drugs — and a Califf confirmation

Raphael G. Warnock

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Transcript

Dr. Bob Goldberg (6s):
The Senate narrowly confirming President Biden's pick to lead the agency. Dr. Robert Califf is a cardiologist. He already served as FDA Commissioner during President Obama's final year in office.

Dr. Robert Califf (18s):
The percent of the FDA budget, that's covered by these user-fees, has been growing over the course of time and will continue to grow. I think that's a good thing.

Yolanda Bermudez (26s):
Not reauthorizing these programs will be disastrous for the FDA and for patients.

Terry Wilcox (33s):
February 28th, marks Rare Disease Day. On this episode, we explore the critical role the FDA plays in reviewing innovative treatments for those living with rare diseases. Plus, what challenges lie ahead for the agency's new Commissioner, Dr. Robert Califf. Welcome to The Patients Rising Podcast, I'm your host, Terry Wilcox, Executive Director of Patients Rising, a hundred-thousand member-strong organization of patients with chronic illness. I'm here with my cohost, who will be wearing his Yankee pajamas until the baseball strike is over. He's our resident health policy and baseball expert, Dr. Bob Goldberg, co-founder of The Center for Medicine in the Public Interest.

Terry Wilcox (1m 17s):
I'm sorry, Bob, baseball is delayed, not because of COVID, but because of baseball.

Dr. Bob Goldberg (1m 23s):
I'm a little depressed. I always had a routine Spring Training Day. Buy a pack of baseball cards, and go to the batting cages. You think, Oh, COVID kept a lid on that stuff for awhile. We have an opportunity to do it and now baseball strikes. Just leaves more time, Terry, to dive into the latest healthcare policy news. We're talking about the regulations, and legislations, that are affecting people all over the country. We covered all, and we're explaining what the new developments mean for patients living with chronic disease every week.

Terry Wilcox (1m 60s):
Well, today's episode is focused on the Rare Disease Community, especially since Rare Disease Day is coming up on February 28th. We'll break down PDUFA, the Prescription Drug User Fee Act, which is currently up for renewal in Congress. Now, PDUFA is more than just an acronym. It's a key piece of legislation that helps keep the FDA funded, and well-staffed, to review new drugs in the pipeline.

Dr. Bob Goldberg (2m 27s):
For those waiting for potentially life-saving treatments, getting those new drugs reviewed quickly, and safely, is a high-priority. Their review of PDUFA happens every five-years, Terry, and it's generally viewed as must-pass legislation, particularly because the user-fees from industry funds most of the FDA's operations. There's also potential for other ideas of legislation to get tacked-on the PDUFA Bill that would also impact patients.

Terry Wilcox (3m 1s):
On top of all of that, the FDA finally, finally, has confirmed a Commissioner. Now, at the helm of the agency, is Dr. Robert Califf, who is no stranger to the role having served under the Obama Administration.

Dr. Bob Goldberg (3m 14s):
You know, nothing like a close vote, just by having been a qualified person, to encourage more people to join public service. Right? So to explain all of this, I thought it would be good to hear from someone who has spent time working at the FDA and can bring us an insider look. That is, Peter Pitts, my good friend, co-founder, and President of The Center for Medicine in the Public Interest. Peter was also the FDA's Associate Commissioner for External Relations, and shares why PDUFA is so important, and what we can expect to see from Rob Califf when he's Commissioner.

Terry Wilcox (3m 54s):
There's no better time to have this conversation than now, as we close-out Rare Disease Month. Peter joins us shortly, but first this week's healthcare news headlines.

Robert Johnson (4m 8s):
In your health news, the CDC today making a major announcement about its COVID-19 mass guidance. The agency will relax its recommendations about wearing masks indoors. Many states already have made the move. The announcement is the first change to the CDC's indoor mask guidance since July. Sad news about the impact of the pandemic on children across the world. The virus has left more than 5-million kids without at least one parent or caregiver. The data is reported in a new study, published in The Lancet Journal. As you might expect, children in countries with low-vaccination rates faired the worst. New research says there might be a connection between extreme heat-waves and mood or anxiety disorders.

Robert Johnson (4m 51s):
A study in The Journal of the American Medical Association says disrupted sleep when it's hot, or a general worry about climate change, can contribute to mental health problems. Finally, there's mounting evidence of wide racial and ethnic disparities in kidney disease and treatment. A study in The American Journal of Kidney Diseases, says patients ages 22 through 44, face the biggest disparities. The authors blames a lack of insurance and access to healthcare. That's your health news update for this week, I'm Robert Johnson.

Terry Wilcox (5m 31s):
Before we talk about the FDA and rare disease, there are some health policy updates from Congress that we'll cover first. As we've talked about in the past episodes, the Build Back Better Plan has stalled, and it appears that some lawmakers are trying to take an alternative route to get some reforms through, which include Drug Pricing. One of those lawmakers is Senator Raphael Warnock, from Georgia, who introduced the Affordable Insulin Now Act, which would cap the price of insulin at $35 per-month. This would apply to both Medicare plans, and private plans, so this is a great standalone Bill.

Terry Wilcox (6m 13s):
It says capping at $35 per-month, Bob, was that the same thing that Medicare Part D was going to do, were they capping it at $35, no matter how many bottles you had, or was it $35 a bottle, pen or whatever?

Dr. Bob Goldberg (6m 29s):
It's $35 per prescription.

Terry Wilcox (6m 30s):
So this is actually better. This is more in-line with what I think it should be.

Dr. Bob Goldberg (6m 34s):
Yeah.

Terry Wilcox (6m 36s):
Because, we kept doing the math, and I was like $35 is still too high considering what the PBM is actually paying for that file. I think this is a good bill. We support Raphael Warnock on his ambition to get this passed. This is what I thought they should have done all along, with the popular pieces of Drug Pricing, that have bipartisan support. I am certain that this one does. I think it shouldn't be hard to get this through. Now, let's turn to more updates from Congress. The House has begun the process of reauthorizing the Prescription Drug User Fee Act, otherwise known as PDUFA, which we just talked about earlier. For all patients, especially those with rare diseases, or unmet medical needs, this is a major piece of legislation to look-out for.

Dr. Bob Goldberg (7m 25s):
To walk us through PDUFA, and what it means, I interviewed Peter. We talked about the role that PDUFA plays in accelerating access to new drugs, what the future impact will be going forward, and how it will interact with the new FDA Commissioner's agenda.

Peter Pitts (7m 45s):
The FDA is predominantly funded by what's called user-fees. That means if you want the agency to review your new drug application, or your application for a device, you pay for the privilege. The percent of the FDA budget that's covered by these user-fees, has been growing over the course of time, and will continue to grow. I think that that's a good thing. Why put this on the back of the taxpayer, when private industry can pay for what it wants, which is FDA review. A couple things to point out. People say the FDA can't be viewed as impartial if they are being paid by industry to approve their drugs. There's a misunderstanding there. PDUFA fees, MDUFA fees, and user fees, don't pay for approvals.

Peter Pitts (8m 27s):
They pay for reviews, and if your product does not get approved by the FDA, you don't get your money back. When people claim that the FDA is "in industry's pocket", putting it simply, they don't know what they're talking about.

Dr. Bob Goldberg (8m 42s):
It's sort of like paying a mortgage application fee. If you don't get the mortgage, you don't get your fee back. PFDUFA, by statute, gets reviewed every five years. That allows Congress to evaluate whether it's met the progress that the FDA has agreed to as PDUFA, and how changes can be made to the next round. Every five years, there's a five-year plan, so to speak, of the kinds of things that they're going to use the user-fees for, and the agency is graded based upon the metrics and benchmarks that are set every five years. There are a lot of players involved from the pharmaceutical industry, to lawmakers, and finally, as Peter discusses, patients.

Dr. Bob Goldberg (9m 26s):
Here is Peter talking about that.

Peter Pitts (9m 31s):
When it comes to user-fee agreements, you have to ask yourself who's around the table negotiating. The FDA ,obviously, industry and patient groups, which is a new addition to the adult's table. Generally they were at children's table, now they're with the big people making the tough decisions. These three groups agree on what they want the legislation to look like, and then they protect it for Congress, for Congress to review and debate. That debate is going to begin shortly in the Senate, in front of the Health, Education, Labor, and Pensions Committee and the Health Committee. Hopefully, it will go smoothly. I don't see any reason why it shouldn't. What senators often try to do is what they call "hanging ornaments on the PDUFA Christmas tree". In other words, what we have is the must-pass legislation and hanging onto it, as an ornament, specific legislation that they want to pass along with it.

Peter Pitts (10m 18s):
For example, Senator Mike Braun, Republican from Indiana, sits on the Health Committee. He has a bill, which I think is a good bill, called The Promising Pathways Act. He wants it to be attached to PDUFA, and that will be discussed during the Senate Hearings, which should start relatively soon.

Terry Wilcox (10m 40s):
So, Bob, Promising Pathways Act - Braun has put this forth. I read in STAT News, a piece in STAT News, that this had come-up in conversation with PDUFA, which is kind of why we're talking about it. Peter says he thinks it could be promising, or that he thinks it is a good bill. I read the basics of it, and on its face it sounds good, but sometimes can get a little bit leery of more bureaucracy. What is the good and the bad? This is totally your opinion. Obviously it's our opinion, but what is the good and the bad of The Promising Pathways Act, as we look at it, as it relates to being passed with PDUFA?

Dr. Bob Goldberg (11m 26s):
Senator Braun has introduced two bills. One is called The Adapt, or Accelerated Drug Approval for Prescription Therapies Act, and that would amend the FDA statute to create a specific accelerated approval passing-lane for drugs already approved for sale in other countries. It has another layer of review that focuses on quality-control, supply-chain, et cetera, designed to target the problem with drug shortages. I don't quite know how it does that, but that's one way to expedite the approach. I don't know if it's been brought up in PDUFA. Promising Pathways would require the FDA to establish a rolling priority review for drugs intended to treat, prevent, and diagnose life-threatening diseases or conditions.

Dr. Bob Goldberg (12m 13s):
This is where my concern pops-up, which is, it would grant a time-limited approval to drugs that demonstrate safety and early evidence of efficacy. Then you'd be allowed to add other end-points to demonstrate, and use real-world data, to demonstrate efficacy under review. To my mind, that's accelerated approval, or should be.

Terry Wilcox (12m 33s):
That's what I was confused by. Why do we need to start a new Promising Pathway if there are some things we need to fix in accelerated approval? Let's have that discussion, but do we need another lane? They sound very similar and that was kind of my issue as well.

Dr. Bob Goldberg (12m 51s):
The only difference would be, this would probably replace, to a certain extent - The FDA's response will be, Listen, we already have this. We already have the tools to do this on a regular basis. Promising Pathways would require, I guess by law, that this would be the preferred pathway for drugs with unmet needs. In principle, it's a good idea. There are some other things that complicate the matters a little bit, like having to apply for renewed status, for two-year periods, for the existence of the product. Janet has spoken in the past about seamless clinical trials, seamless drug development.

Dr. Bob Goldberg (13m 34s):
I think if you want to make this statutory, and protect it from the anti-accelerated approval crowd, that's great. I think it does need a little bit of reworking so that it's not as clunky, which I don't think was the intention. You want it streamlined. You want all drugs to go through this process. One of the problems with accelerated approvals that requires a randomized controlled trial, in many cases, to substantiate benefits. To my mind, that's useless. You want to use the real-world evidence to not only validate its effectiveness in existing populations, but expand the indications as well, which is rolling approvals, to my mind.

Terry Wilcox (14m 12s):
Well, a lot of times, those standardized control trials are not possible in the Rare Disease space, and I mention that, because it's Rare Disease Week.

Dr. Bob Goldberg (14m 24s):
Who's going to enroll in something like that?

Terry Wilcox (14m 25s):
Who's going to enroll in that to the point they really need to rethink this. I think they need to clarify accelerated-approval to this end, but we'll see how it goes. The one big news we have for the week, which we've already kind of mentioned his name is, we have the Senate-confirmed Commissioner, Dr. Robert Califf. This is his second stint as the FDA Commissioner. What did Peter have to say about Dr. Califf's priorities in your conversation?

Dr. Bob Goldberg (14m 59s):
One of the big issues for Dr. Califf, and one that he was asked about repeatedly, during the Confirmation Hearings is accelerated approval. Peter gave us a great recap of what Dr. Califf said publicly during his Confirmation Hearings about accelerated approval.

Peter Pitts (15m 13s):
When Senator Wyden asks Rob Califf to "cleanup accelerated approval", Rob Califf says, "Yes", but that doesn't mean stop doing it or use it less. It simply means use it better. The beauty of Rob Califf, as Commissioner, is that he understands the tools of 21st century science that are required to do accelerated approval right. Ways to validate real-world data so that it's real-world evidence. Ways to measure the efficacy of products once they are in the real-world, so they can understand how to reevaluate the label, or even reevaluate whether the drug should remain on the market. Rob Califf, beneath that "aw shucks"

Peter Pitts (15m 53s):
Southern-exterior, has a razor-sharp mind that understands exactly what needs to be done to serve the public health and that's the good news.

Dr. Bob Goldberg (16m 4s):
So that's what he said about Califf, and relatedly, another major issue for patients and a hot-topic we just spoke about a few minutes ago, with respect to Promising Pathways, is clinical trial design. Specifically how to diversify clinical trials, not just by ethnicity or race, but by genetic variation and morbidity. That's something, as Peter points out, Dr. Califf knows a lot about and will bring a lot to the FDA in the process.

Peter Pitts (16m 32s):
One of the great things about Rob Califf is, he is probably one of the country's - not probably, but definitely, is one of the country's leading clinical trialist. He understands the intricacy of clinical trial design. The opportunity right now, to change the way we do clinical trials, is upon us. For many reasons, not the least of which is, people recognizing that we need to have a greater diversity of people in these clinical trials. That a clinical trial "looks like the American population", is not the answer. We need clinical trials that look like the disease state. For example, for cardiovascular disease where African-Americans over-represent, the clinical trials need to over-represent African-Americans. That's our opening to thinking about new and creative ways, not to recruit political trials, but how to design clinical trials.

Terry Wilcox (17m 20s):
I can't agree with him more on that. You and I have talked about the clinical trial redesign and how to think about clinical trials since I met you, since we've been doing this. How we do it, as the John Arnold, Andrew Kesselheim wing of the clinical trial debates.

Dr. Bob Goldberg (17m 43s):
We need to basically follow people in the real-world as much as possible and use computers and algorithms, well-validated ones, to do the rest. That means in addition, something we've talked about on the show, is you want to collect all the data and update it regularly in real-time. Registries are very backward looking. They require so much time and effort, and I think one of the things Califf is going to look at is, how to rely upon real-world data that's constantly being updated in the real world. Doing so without burdening the patients.

Terry Wilcox (18m 23s):
So folks, if you want to learn more about any of the topics mentioned today, head to the links in the show notes, it's all there. 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. From finding a professional advocate to help with insurance challenges, to legal and tax council, 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.

Terry Wilcox (19m 16s):
To learn more, visit patientsrisingconcierge.org, or email us at askusanything@patientsrising.org. Up next, to help us mark this special episode on the Rare Disease Community, Kate Pecora brings us her conversation with Yolanda. Take a listen.

Kate Pecora (19m 27s):
Today, I'm starting out with Yolanda Bermudez. I wanted to talk to her about her healthcare journey and some of the conditions that she's living with after a cancer diagnosis, and recently coming out on the other side of that. Yolanda, how are you doing?

Yolanda Bermudez (19m 41s):
Hi. I'm good.

Kate Pecora (19m 42s):
Do you mind sharing a little bit about your journey to diagnosis and then to advocacy?

Yolanda Bermudez (19m 48s):
July of 2018, I got pregnant with my second pregnancy with my daughter. A few weeks after finding out that we were pregnant, I was like no more than eight-nine weeks pregnant, I felt a mass in my abdomen wall. I was told that it was a lipoma, nothing to worry about, they're cosmetic, there's no need to worry about it. I had my daughter and I lost the baby weight. I'm fairly thin as it is, so within months, I have a flat stomach and you can see a bulging-ball. Like now, I have a golf ball. It started off as a little ball and now it's hard. Lipomas are not supposed to be hard, they're supposed to be squishy and gooey. My husband, I'm just so thankful that God gave me such an incredible partner, but he was like, just go check it out.

Yolanda Bermudez (20m 31s):
If it freaks you out, go check it out. We have the insurance and thank God we do. I went ahead and did that. We got a CT scan done of only my abdomen. We see a mass, and they classified it as a hematoma, which is a collection of blood, which once again, is not supposed to be hard. It's supposed to diffuse on its own. We go see a surgeon, and this is now August, and it started in June of 2019. At that point, I meet with a surgeon, get scheduled and he's like, I don't think that's a hematoma, but let's find out. Let's get it open and we'll get it diagnosed. I go in for what's supposed to be a one-hour inpatient/outpatient procedure. I ended-up staying at the hospital for three days.

Yolanda Bermudez (21m 12s):
I had a large desmoid tumor removed from my abdomen wall. They're rare. I was told how rare they were, but no one ever did any test or anything to follow-up. I even asked, but they're like, it's just the fact that you had it in your abdomen wall is incredibly rare. My surgeon, at every follow-up, literally paraded me like a little unicorn and was like, tell this med-student. I told so many med-students my story, because it's rare to find it on your abdomen wall.

Kate Pecora (21m 46s):
So after speaking with your doctors, what was the next step for you?

Yolanda Bermudez (21m 50s):
I end-up getting a colonoscopy and I'm so thankful to Fari, because if it weren't for him, I don't know if anyone else - He saw all of my medical record - I sent him my CT scans. I told him everything I already had done, and kind of a backstory, maybe it's linked. It was totally linked. It was completely linked. I had a colonoscopy done and he woke me up, and I think he was more scared than I was to tell me. He was like, you have a colon of a seven-year-old. I remember telling him, I'm like, I'm a healthy one. He's like, no, you have hundreds of polyps in your colon and it's very, very rare for someone your age to have it.

Yolanda Bermudez (22m 34s):
I actually think you have this very rare condition called FAP. There is a mass in there too. I said, what are the odds of it being cancerous? He's like, I've seen thousands of these. I can't tell you, without needing a biopsy, and immediately within minutes he's like, you're going to be okay. His bedside manners were incredible. That's when I got my full diagnosis, because they were like, we're not gonna wait for genetics. We've ran genetics. He sent me immediately a referral to City of Hope here in Glendora. Out of the gate I was in really good hands and I'm so thankful, because I just went with it. I was in such a fog, such a daze.

Yolanda Bermudez (23m 15s):
I have an eight-month old, I have a two-year-old. I can't have cancer. I can't have this rare thing. It just kept getting worse. Like, the news was bad. It was stage-four. It had gone to my lymph nodes. They couldn't guarantee that there was any activity in my uterus. Within a week we knew like, hey you have cancer and it's spread and it's bad. They told me immediately, you're going to have to have a hysterectomy.

Kate Pecora (23m 42s):
You mentioned that you had a rare condition known as FAP. Can you explain how this impacts your type of cancer?

Yolanda Bermudez (23m 50s):
I have a broken APCG mutation, which causes the body to not stop cancer from growing. It makes tumors, and it makes weird stuff, and most of the time it's cancer. So far I've had three of the things that happen at a very low-grade percentage, so my odds, like I just tell people I'm going to go buy a lottery ticket, because all the things that have happened that are not, you know, it's a very low chance that you might get thyroid cancer.

Kate Pecora (24m 13s):
This is something that you are going to have to manage moving forward, right? This is something that you have to think about every single day and I understand how stressful and overwhelming that can be. What are some of the things that you are really consumed with, and considering as a person who is going to have to manage this day-to-day, more-or-less, for the rest of your life?

Yolanda Bermudez (24m 36s):
Yeah, I've learned to really do the day-to-day. I would mentally file things like, okay, first we're dealing with chemo, that's the major thing. Put radiation in the back. Put surgery in the back. Put testing in the back. Put two years in the back. Now, I'm at the two-year point, and it's like, oh my God. I told myself I would deal with it when I got to it, and it was really hard, and it's become really hard. I know it's going to take years for me to even digestively be able to eat. Now, having to explain it to people. Last night I told myself, it took a year to come to terms with the fact that it's going to take a lifetime to figure out what my body likes to eat. So I'm at the day-to-day.

Yolanda Bermudez (25m 16s):
I have CT scans that I need to schedule. I have catastrophes, and really weird procedures I get done to me now, that are coming up. So I'm like, I know City of Hope is going to call me and they're going to schedule and going to take care of it, but at some point, I need to be like, no girl, you need to call, because it is your life. If they don't schedule it, they're going to schedule it for another three-four months out, so you need to be on top of it. So it's hard, it takes a little-by-little. I'm like, okay, I woke-up and I feel good. You need to have that momentum. You need to get yourself doing that or else you get in a rut, and then getting out of it, it's like, oh my gosh, you have to like crawl yourself out of that valley, because that's what my depression is like.

Yolanda Bermudez (25m 59s):
That's how I see it. It's a mountain. You have your valleys and you have your peaks. It's amazing when we're at the peak, but when we dive-down to that valley, it's hard to crawl back-up.

Dr. Bob Goldberg (26m 16s):
Thank you, Kate. Now it's that time of the show where we get to hear from you, the members of our Patients Rising Community. We have several rare disease advocates joining us today to share their experiences in honor of Rare Disease Month.

Monica (26m 29s):
Hi, I'm Monica. I'm from Washington State Congressional District Five and I have several rare diseases that are all related to one another. The one I currently struggle with most, is intestinal dysmotility. Basically, that means that my intestine doesn't push food through fast enough, causing it to kind of back-up. I've really struggled a lot with doctors, just not knowing what to do with me, which is why I think it's such an under-researched disease that doctors need more education about. No matter how rare diseases, patients like me, aren't going anywhere. We'll continue to be passed from doctor to doctor, just because they don't know how to treat it. I've even been in this case where doctors straight- up didn't take me seriously until I was hospitalized for a severe obstruction for about a week.

Monica (27m 10s):
It was then when they started believing me when I said my own disease is severe. Even then, a lot of doctors still insist on doing the same test and the same ineffective treatments over and over instead of actually going out and learning about the disease. Intestinal dysmotility can happen to anyone. It can be debilitating and it can change your life. It will continue to do that until there's more funding and research provided towards curing the disease.

Darlene Taylor (27m 39s):
I am Darlene Taylor, cancer survivor. I'm from the state of Maryland from the Seventh Congressional District. My life has had some unexpected outcomes. I guess you can say, life happened at the tender age of three-years-old, I developed a rare form of cancer called rhabdomyosarcoma. Because of the location of the tumors, radiation I had to undergo ostomy surgery, which left me with two permanent ostomy bags since the age of three. I was cancer-free a year after my diagnosis and treatments, which my parents were very grateful. As the years went on, And I got older, I discovered who I can be in spite of my medical circumstances.

Darlene Taylor (28m 25s):
My insecurities, they didn't change overnight, but God showed me I am a survivor and I will bring about change through my life challenges. Now, I'm using my voice through my cancer survivorship and ostomy journey to help educate, communicate, and bring awareness of certain issues. My aim is to bring attention to insurance companies that we need policies changed for the betterment of our health. Certain resources has definitely gotten better and I'm hoping more is on the horizon. I am the change I want to see., so therefore I will keep fighting for better. We are all different to make a difference.

Darlene Taylor (29m 5s):
So let's do that.

Dr. Robert Califf (29m 7s):
As always, we thank you for sharing your stories with us today. If there is a healthcare policy issue impacting you, a family member, or a loved one, we want to hear about it. You can share those experiences right here on the podcast. Just sends an email to Terry and me at podcasts@patientsrising.org - podcast@patientsrising.org.

Terry Wilcox (29m 28s):
Thank you for tuning into this week's episode. If you want to hear more patient's stories, or health news updates, be sure to rate and review us on your favorite podcast app.

Dr. Robert Califf (29m 41s):
Stay ahead of the latest updates and news that impacts patients. Just like you be sure to follow us wherever you listen to podcasts.

Terry Wilcox (29m 41s):
Join us right here again next week for another new episode, until then, for Dr. Bob and everyone at Patients Rising, I'm Terry Wilcox - Stay healthy.