Bradley Burnam woke up one morning, looked in the mirror and found one ear twice it’s normal size and his face swollen and discolored. He would spend the next several years in and out of the hospital fighting a relentless infection that would not respond to available treatments. The experience took him from patient to "mad scientist" to biotech company founder. In this episode, Bradley takes us through his desperate journey to find a cure. We also talk with the leader of an organization helping to get more antimicrobials to the marketplace.
Bradley Burnam woke up one morning, looked in the mirror and found one ear twice it’s normal size and his face swollen and discolored. He would spend the next several years in and out of the hospital fighting a relentless infection that would not respond to available treatments. The experience took him from patient to "mad scientist" to biotech company founder. In this episode, Bradley takes us through his desperate journey to find a cure. We also talk with the leader of an organization helping to get more antimicrobials to the marketplace.
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Click HERE to watch the documentary-style film Race Against Resistance presented by the AMR Action Fund and funding support from Pfizer Shionogi and MSD.
Speaker 1 (00:06):
My life has depended on the use of antibiotics. I wouldn't be alive today without antibiotics. And now, they're not working to save my life any longer.
Speaker 2 (00:19):
It's, uh, definitely a pandemic, there's no question about it. One of the things that we struggle with is that it's a pandemic not of a single disease. We are choosing not to pay attention to it. We have made it silent. It's actually not that silent. It is actually not that hidden. We are sort of hiding from it rather than it hiding from us.
Theresa Brady (00:46):
In 2021, I am BIO aired, an episode called Anti-Microbial Resistance to Silent Pandemic. At that time, of course, we were in the middle of a very loud pandemic, COVID-19. As the world came together to address this urgent problem, other health threats garnered less attention. While necessary, this diversion meant that one of the leading public health threats of the 21st century was continuing in silence. Anti-microbial resistance or AMR kills over a million people every year making it a leading cause of death globally.
(01:22):
Starting November 18th, the World Health Organization will ramp up the decibels on the threat of AMR with its annual world AMR Awareness Week. We agree, this issue deserves a bigger megaphone. In today's episode, we take you through one person's harrowing journey, fighting a multi-drug resistant infection, and experience that took him from patient, to mad scientists, to biotech company founder. We also discuss incentives and pathways to sustain the failing AMR ecosystem. I'm Theresa Brady, and you are listening to I am BIO.
Bradley Burnham (01:58):
So one night after a typical day in the hospital, I went to bed as if nothing was different. I brushed my teeth, I'm sure I glanced in the mirror and saw a normal reflection looking back. But nine hours later, when I woke up and looked in the mirror, half of my face, my scalp, and my entire ear was black, swollen. My ear was about twice its normal size. Literally overnight, my life changed. I developed an abscess about the size of a chestnut behind my ear. It spread that quickly. It spread into areas that weren't just threatening my appearance like the cartilage, but into my head, my scalps, my ear canal, my nerves.
Theresa Brady (02:58):
This is Bradley Burnam.
Bradley Burnham (02:58):
My name's Bradley Burnam, founder and CEO of Turn Therapeutics. We develop novel therapeutics and medical devices for infectious disease, advanced wound and dermatology targets.
Theresa Brady (03:08):
Bradley was not always in the drug development business. You might say he's an accidental biotech founder. He started his career as a medical device salesperson.
Bradley Burnham (03:18):
After my graduate work, I landed in medical device sales, uh, pacemakers, to be specific. In that job, you get to sort of play doctor. You wear scrubs, you're in the operations, you check on patients in their hospital rooms, you visit them in the emergency room. It's a very first-person job, and I very much enjoyed that. But at the same time, I was also exposed to the environments they were in. And when you work in the pacemaker industry, you have to put these plastic wands on people's chest, and it communicates with the pacemaker. And they'll touch your, hand and they'll thank you, and they'll want to give you hugs, and you touch the bed rails, and you can't help but be in these environments, and you don't know what else is going on with these patients. I probably picked it up from a sick patient or from a patient who was carrying this organism and it ended up in me.
Theresa Brady (04:06):
Bradley tells us that at first, he didn't know he had anything going on behind his ear.
Bradley Burnham (04:11):
I was not aware that the abscess was behind my ear. So nothing in my everyday routine, not washing behind my ears, not taking a shower had warned me that something was there. Maybe my skin had been discolored and I couldn't see it and my hair was covering it, but there was no swelling. There was no pain. I just woke up and it was as if this had appeared overnight.
Theresa Brady (04:33):
Bradley's father is a physician and works at a local hospital. The morning that Bradley woke up to a swollen and bruised face, he knew who to call.
Bradley Burnham (04:41):
I called him. I met him in the emergency room. He called an infectious disease colleague of his, and he took one look at me and he said, "You need emergency surgery." To evacuate the infection, to put a drain in, to get the infected fluid out, it was a pretty elaborate procedure. You know, that procedure actually took about four hours, so, you know, it was called a resection where they removed not just the infection but the area around it, you know, much like they would do with the tumor. So they removed the infected area, the tissue, use that for the culture, but also I lost a lot of skin, some cartilage. Fortunately for me, the surgeon happens to be a craniofacial expert. So he was able to salvage some of the appearance in terms of the way that he closed it. Little did I know that I'd be back in about two weeks for another one though, at that point.
Theresa Brady (05:25):
Bradley's response to his ordeal is probably how most of us would respond. "Wow, that was terrible. I'm glad that's over and I got through it."
Bradley Burnham (05:34):
At that point, when you're in kind of emergency mode, especially with a complete lack of knowledge in the subject as I had, you're going through this terrific ordeal. You spend four hours on an operating table, and you wake up with head bandages on, drains in your ear, and, you know, you're on three different antibiotics, and you get sent home. You're told to come back six days a week for god knows how long to have the wound packed, uh, with new dressing. And you sort of, I guess, you would think that maybe the problem's fixed, kind of like you broke an arm really bad. They go in and they pin it back together. So maybe subconsciously, I was thinking, "God, that sucked." But, um, I certainly wasn't thinking, "I wonder when the next one is."
Theresa Brady (06:15):
Then the doctors tell Bradley that his infection is not normal.
Bradley Burnham (06:19):
When the doctors cultured the organism, they explained to me that this was not a traditional bacteria that you would just get like a staph infection on the skin. This is not just something that would be a common thing that would come up. It was in fact something called a gram-negative, which they were advising me or, or essentially explaining to me was almost certainly picked up while I was working in the hospital from one of the patients or services and somehow managed to get behind my ear. The working theory is that I picked it up, maybe scratched behind my ear, you know, maybe it got embedded back there and just took hold and changed my life.
Theresa Brady (06:51):
Bacteria and fungi adapt and evolve over time to become resistant to treatments. This is what we call antimicrobial resistance, and it is what Bradley battled for several years after a simple scratch behind the ear.
Bradley Burnham (07:05):
It was just keep removing it, keep digging it out. Keep hitting them with more antibiotics. Keep culturing it. You know, we'd lose one on the list for sensitivity 'cause of how many times I'd been on it. Add a different one, maybe this one will help more. Maybe Rifampin or Clarithromycin or Cipro. I was always on Bactrim double strength, that was the one that was a constant I recall. But they would just mix and match these drugs and hope that one would suppress the recurrences. The first one was less than two weeks after. It had spawned as satellite lesions or satellite cysts, sort of branches of the infection. You know, it reminds me of that scene in the Matrix, where there's all these pods sort of, you know, attached to these branches, and they described it to me in that way where these, these giant abscesses would essentially spread through these, you know, these branches and then they would have little babies, and then those would grow and they'd have to go back in and get them.
(07:54):
And unfortunately, the systemic antibiotics, which were, I mean, tough. I was on some, some big gun drugs, you'd think that they would stop these from recurring. But it wasn't. So it was six days later that I was back in getting four more satellite lesions removed. It was another resection I saw in the notes, and I don't think I remember all of them, probably on purpose in my brain, but I know it was at least 19, 20 times total surgeries.
Theresa Brady (08:25):
20 surgeries and multiple antibiotic cocktails could not stop the resistant bacteria. It kept coming back. Out of desperation, Bradley started to do his own research.
Bradley Burnham (08:35):
Because I was working with people who I considered to be some of the smartest doctors on earth, we're talking world-famous infectious disease experts, brilliant surgeons. I had a whole team of people with resumes that you could jack your car up on probably, and this is the best thing that they could give me. So you start to get curious, what's going on with your health? Is this gonna go on forever? How are other people treating this? Maybe we're missing something. And I just started searching. A blank page on Google treating infections, looking up the organism that I was culturing every single time and how are other people treating this infection? And I started to learn more about how bacteria evolve, you know, the tools that they were using. Some of the research was very disturbing.
Theresa Brady (09:16):
Bradley's research led him to create a dressing for his wound.
Bradley Burnham (09:20):
I turned my garage into what probably looked like a drug lab to my neighbors, in retrospect (laughs). Um, I, I made some, you know, likely questionable purchases of chemicals at the time. Got barrels of petrolatum from distributors. I made a barrel warmer out of, you know, Home Depot pipe warmers that they might use in the Midwest, uh, to keep the pipes warm during the winter. I was using a garden shovel to shovel the petrolatum out of the bucket and a a $69 mortar mixer from Amazon as my homogenizer. So it literally probably looked like a meth lab. I- I'm nearly certain, in retrospect, in my garage and I probably tried over 100 times. I wanted something they could leave in there because one of the things that is the, the most awful memory is the daily wound packing and gauze removal, 'cause it was a horrible thing to go through.
(10:06):
I mean, my job six days a week including Saturdays, was to go to the doctor's office for this dressing change, and we're talking feet of gauze being packed into your head. And I wanted something that would be comfortable. And then when they left it in there, if it was in there with the gauze, maybe it could attack the biofilm, and maybe it wouldn't have to go in for another surgery.
Theresa Brady (10:25):
Before applying his invention to himself, Bradley had it tested.
Bradley Burnham (10:29):
You can find labs on the internet throughout the country, throughout the world that will just take something that's sent to them and try it on an organism. And it's not even overwhelmingly expensive. I think it was 400 bucks to try it against the organism that I was battling, maybe another 300 for another. So I paid them to see how well this concoction worked against the organisms that I was battling, and they sent me very colorful, wonderful reports saying, you know, "It kills 99.99 plus percent of this organism." And I knew I was onto something. I applied it to myself sometime in 2014. And over time, you know, the wound started to heal. It started to close, you know, and which is obviously a sign of the reduced bioburden in the area 'cause the wound doesn't want to close when it's infiltrated with such an incredible amount of infection and bacteria. And I don't recall another lengthy surgery after that, and I don't recall the notes showing one either. So it was pretty miraculous.
Theresa Brady (11:24):
Bradley's Miracle was the basis for founding his company, Turn Therapeutics. And he tells us his motivation was that he wanted patients to have access to what he had. He sought and received FDA approval for his antimicrobial wound dressing, and began giving away thousands of samples.
Bradley Burnham (11:42):
The doctors told me when they were interested in carrying the product as well, that there's something here. So at that point, I actually had to start asking, "How do I start a company?" I was a career student, gone W-2 pacemaker rep, who then ended up with a multi-year infection process. And I'd never heard of quarterly taxes until I was 35. So as far as corporate law, business development processes, you know, adventure raising, whatnot, I definitely had to phone a friend call Lifeline at that point. And luckily I have people around me that are much smarter than I am who have helped me along the way.
Theresa Brady (12:15):
Every day people contract bacterial and fungal infections that do not respond to antimicrobials. Very few actively pursue a cure on their own like Bradley did, which begs the question, why would they have to? Why are new antimicrobials not reaching the marketplace?
(12:39):
When we come back from a break, we'll discuss why the market for new antimicrobials is broken, and what can be done to address our dwindling supply before it is too late.
(13:01):
In case you missed it, discover the documentary style film Race Against Resistance: The Life And Death Struggle To Save Antibiotics, presented by the AMR Action Fund and funding support from Pfizer Shionogi and MSD. Race Against Resistance draws significant attention to the global crisis of anti-microbial resistance by taking viewers into the lives of those affected by drug resistant infections. You can stream it now on YouTube.
(13:42):
The rise of AMR is rapidly rendering our anti-microbial arsenal ineffective. And yet, innovation is declining in this critical, sector and the ecosystem is on the verge of collapse. Our next guest is working to change this perplexing paradigm of the current marketplace.
Kevin Outterson (13:59):
I'm Kevin Outterson, professor of Law at Boston University and executive director of CARB-X. The mission of CARB-X is to make sure that we have new vaccines, new antibiotics, and diagnostics to help us do the right thing with the drugs we have.
Theresa Brady (14:13):
As Kevin explains, most of us take antibiotics for granted, but their value is immeasurable.
Kevin Outterson (14:19):
How many people listening to this have your lives been saved by antibiotics? And most people may not be able to raise their hand, but how many of you have had a tooth extracted, or had any sort of surgery, or had any sort of immune suppression therapy, or cancer treatment, or had a cesarean section or, you know, done anything that's really within the realm of advanced modern medicine? And I'm telling you that if you had any of those things done, you may not know it, but your life was supported by the safety net of antibiotics. Antibiotics are probably the most valuable drug class in human history in terms of what else has saved more lives over more years than antibiotics.
(15:02):
It's really transformed our ability to live and to have medicine at a sophisticated level. Imagine if you had to worry about dying from an infection, if you had a knee or hip treatment or a cancer treatment. If, if any of these things had a significant risk of death from infection, we just would do them less often. Antibiotics not only save lives directly, but they make most things in our modern medical arsenal both safer and more effective. So if we lost antibiotics, we would lose something of almost unlimited value. Trillions upon trillions of dollars of the value.
Theresa Brady (15:38):
The value of antimicrobials is clear, but they're often outsmarted by the bacteria and fungi they are designed to target. And this can lead to the development of superbugs.
Kevin Outterson (15:49):
A superbug is the microbe, a virus, or bacteria that has been exposed in its history to so many different types of antibiotics or antivirals that it no longer is susceptible to anything that we have. So this would be a bacteria that not only is resistant to one antibiotic, but maybe to two or three different entire classes of antibiotics. And doctors are down to either one or, or sometimes no drugs on the shelf that can kill it or stop it from killing the patient. So not all bacteria are superbugs, and many bacteria have developed resistance to one or two things and they're not quite there yet. But the directionality is inevitable. The bacteria will evolve in response to the selective pressure of antibacterial use. And it's just a matter of time. The US Centers for Disease Control, uh, CDC estimates, 35,000 Americans die every year from these drug resistant bacteria, the super bugs that you talked about, the bacteria alone.
(16:54):
A similar number in Europe, much worse around the world. The most recent data we have is almost 1.3 million people dying around the world because of these bacterial superbugs. Not even counting tuberculosis, not counting AIDS, or viruses, just the bacteria, 1.3 million. Put that in perspective, that's more people than what AIDS kills globally or tuberculosis or malaria. This is actually a larger killer than those diseases, and something that will continue to get worse unless we improve in our infection prevention and control, and continue to innovate to bring the new drugs that we need to respond to these evolving superbugs.
Theresa Brady (17:39):
Because antimicrobial resistance is inevitable, we must continue to innovate and bring new drugs to the market. However, these products face unique market challenges as Kevin describes.
Kevin Outterson (17:51):
Penicillin is an amazing drug for some things. It still works today for a lot of things, it doesn't work anymore. And I think scientists will be thrilled to invent another drug as amazing as penicillin. And in a sense, that's what we have to do every generation. It's a unique challenge for the antimicrobial field. Harder and more challenging than all the other drug classes for which the drugs just work forever.
(18:21):
For the past three decades, I've written and other academics have written about how the business model for antibiotics is broken, how a new antibiotic is to the market. And unlike other drugs, you actually don't want to use them. You want to take the new antibiotic and use it as little as possible, save it for the future. Let's not generate resistance, and that's a great idea for public health. It's a terrible idea for the company. It's driven many of them into bankruptcy.
(18:54):
So for the past 20 years, unfortunately, everything that I predicted has turned out worse than I suggested. And large companies have left the field to the great extent. And the smaller companies are starved for capital. They scrap together money, they try what they can, they do it as carefully as they can. And seven of these small companies have made it to the market with the new antibiotic in the past decade. Of those seven, all of them have either gone bankrupt, or had to sell their company at a fraction of the cost of what it took to create the drug or in the process right now of a liquidation, you know, winding down. So if you think about it, in the early stages of R&D, maybe 2 or 3 hundred companies started over more than a decade, they all worked, seven, made it to FDA approval. All the other ones failed for scientific reasons along the way, but seven made it and they should be able to celebrate.
(19:54):
Every one of them is having a negative economic result, bankruptcy, or something akin to that. That discourages investment. That is why the large companies left. That's why right now, even the small companies are having trouble attracting capital.
Theresa Brady (20:10):
Kevin says that in this space, conventional business fundamentals do not apply.
Kevin Outterson (20:15):
Any other product that anyone creates, I mean, drugs for sure, but everything, when you finally get approval to sell it, you sell it (laughs). You know, as you make money. Elon Musk did not make money by not selling Teslas. You made money by selling Teslas or anything else. You need to sell the product. It's true for drugs, it's true for everything. But for antibiotics, because of all the problems we've talked about today on resistance, we wanna be careful with the new antibiotic. Sometimes the older antibiotics still work in most of the cases. And so we take the new thing and put it on the shelf, and it sits on the shelf for a year or two or three, and it's used only in the rarest cases, year five and year six. Let me tell you, the little company went bankrupt in year two, 'cause they cannot survive without revenues.
Theresa Brady (21:06):
The lack of new drugs in this class can impact the treatment of other diseases such as cancer, making the case to do something about the problem that much stronger.
Kevin Outterson (21:15):
I published a paper a couple of years ago, which looked at the relationship between these bacterial superbugs and cancer. And not surprisingly, the leading cause of death for people with cancer in the United States is cancer. You know, that's not a surprise, but we're making progress against cancer. The number two cause of death for people with cancer is infection. Their immune systems have been suppressed. Many things are going on in their body. They spend a lot of time in hospitals. And bacterial and fungal infections are the number two cause of death for people with cancer. If the patient survives the cancer but dies from a bacterial infection that was treatable 30 years ago, but isn't today because we don't have the new drugs to replace the ones that no longer work. So let's do both. Let's beat cancer and also survive the infection.
Theresa Brady (22:08):
So how do we create an environment that incentivizes the continual development and innovation of new antibiotics and antifungals? Kevin's organization, CARB-X aims to help repair the current marketplace by providing funding to early stage companies in the sector.
Kevin Outterson (22:25):
CARB-X is designed to replenish the global pipeline of antibacterial products so that our children and grandchildren have something that's useful as opposed to something that doesn't work anymore. It's funded by four governments and two foundations in order to fund amazing research around the world. It takes a product from the moment, which it's a good idea that's left the university all the way up until the moments in which it's been successfully first tested in people. Most of the companies that CARB-X partners with are actually very small. There might be a biotech that has 5 or 10 or 15 people in it.
Theresa Brady (23:02):
Government initiatives and nonprofits like CARB-X are doing important work in the race against evolving bacterial and fungal resistance. But these efforts may not be enough. Kevin describes a policy approach that could stabilize and sustain the failing antimicrobial ecosystem.
Kevin Outterson (23:20):
And that solution in the US is called the Pasteur Act. A different way to pay for antibiotics so that we get what we need, great new antibiotics, but we find out a way to do that without bankrupting the company. The Pasteur Act fixes the problem with how we buy antibiotics. We don't want the new antibiotics to get to the market and be sold aggressively. We also don't want them to get to the FDA approval and to sell so little that the company goes bankrupt. We need a way for the companies to be paid, but paid for delivering the antibiotic as available as opposed to paid for selling a million units of it.
(24:01):
The Pasteur Act is like a subscription. It says that the company will get paid for bringing the antibiotic that meets the highest quality standards and is approved by the FDA, and they're gonna get paid the same every year for a decade, a significant amount that rewards their investors and makes it clear that there's a positive economic case for being an antibiotic R&D company. The company has to provide whatever the US government would need. It might be a little, it might be a lot, it might be hardly any in the first three years and a lot more in year eight. It's a subscription. The government gets as much as it needs so the people, the US get as much as we need, and the company gets a steady flow of income.
(24:45):
This is not how we buy most things in terms of drugs, but it is how we buy, uh, streaming services and television or, or magazines or, there's a lot of things we buy on subscription. People buy meat on subscription. You know, there's all sorts of things in the economy we buy in this model. We just haven't done it on a large scale before for antibiotics.
(25:09):
So Washington DC has all sorts of issues right now, (laughs) as everyone is well aware, but the Pastoral Act, last time I checked, has exactly the same number of Republicans and Democrats that are co-sponsors. It is one of those rare things that people agree on, and bacteria are equal opportunity killers. They don't care if you're a Republican, Democrat, or don't vote, you know. (laughs) It's, it's all the same to the bacteria.
Theresa Brady (25:45):
Addressing the broken antimicrobial marketplace is a complex and ongoing challenge. Creative solutions like the Pasteur Act and organizations like Carb-X could help us develop a sustainable flow of effective products that are there when we need them. Bradley's story clearly demonstrates the dangers of battling an infection for which there is no available treatment. Patients cannot wait any longer for life-saving antimicrobials, and the crisis will only grow with continued inaction. But there are proposed solutions. As Kevin notes in our conversation, in a divided Washington, the Pasture Act has bipartisan support.
(26:24):
Its passage could help transform this historically challenging but invaluable sector. I wanna thank Bradley for sharing his frightening story and his intense efforts to find a cure. And thanks to Kevin for breaking down the challenges of AMR and explaining the urgency of finding solutions now. And thank you all for listening. Make sure to subscribe, rate, and/or review this podcast and follow us on X, formerly Twitter, Facebook, and Instagram at I am Biotech. And subscribe to Good Day Bio at bio.org/goodday. This episode was produced with help from Lynne Finnerty and Kourtney Gastinell. It was engineered and mixed by Jay Goodman, with theme music created by Luke Smith and Sam Brady.