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FDA Insight: Episode 14 – Transcript

>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. Thank you so much for joining us for another great episode. This week we'll be discussing antimicrobial resistance, or AMR, which is a topic of great public health concern. FDA has partnered with other government agencies in industry to help combat AMR. My guest today is Dr. Steve Solomon, director of the Center for Veterinary Medicine here at the FDA. Dr. Solomon joined the FDA over 30 years ago and has served in a number of leadership roles across the agency during this time. Dr. Solomon, welcome to FDA Insight.

>> Steve Solomon: Thank you very much for having me on the show.

>> Anand Shah: Well, let's jump right in. What exactly is anti-microbial resistance or AMR?

>> Steve Solomon: So, it's ability of a microorganism, could be a bacteria, a virus, a fungi, to resist the effects of a drug intended to treat infections caused by these microorganisms. It's a naturally occurring evolutionary phenomenon. I remember reading a report some time ago that I just found fascinating, that scientists discovered a body of a early man buried in some frozen tundra, that it had helped preserve the body. And they took some DNA samples out and they found evidence of antimicrobial resistance in some of those genes, very early, thousands of years ago. But it's important because it threatens effective prevention and treatment of infections caused by these bacteria, virus, and fungi.

>> Anand Shah: So, what causes antimicrobial resistance?

>> Steve Solomon: Well, while it's a naturally occurring evolutionary phenomenon, as I mentioned. There have been added selective pressures on microorganisms. So, when you use an antibiotic, for example, and microorganisms are exposed to it, it then increases the pressures for resistance of these organisms to develop so some of them survive. And as we've developed and expanded the use of antimicrobials over the years, this has continued to expand. Some of the causes of that are, there have been overuse of antimicrobials, and it makes resistant bacteria more common. And sometimes people don't follow the right directions on how to use their antimicrobials. And that can, things that can lead to are overused or inappropriate use of them. People that have poor hygiene practices in parts of the world and there's no infection controls. Or sometimes it's when someone uses antimicrobials or antibiotics to treat something like a virus infection, like a cold.

>> Anand Shah: So is there a difference between antibiotic and antimicrobial resistance?

>> Steve Solomon: Yeah, the terminology really can be confusing, and it's often used interchangeably to refer to different aspects. When you're talking about the antibiotic, you're generally talking about bacteria resistant to the effects of a drug. When your antimicrobial resistance, it's a much broader term that describes any of the microbes we've talked about before, whether they could be fungi or viruses or bacteria that could develop the resistance, but they're often used interchangeably. The antimicrobial is the broader term. Antibiotic is the more narrow term. But they're often used together.

>> Anand Shah: That's really helpful. So, what is it about AMR that keeps you up at night?

>> Steve Solomon: It truly is a major global public health issue. The CDC has identified that it contributes to more than 2.8 million antibiotic resistant infections and 35 thousand deaths in the United States each year. So, what's the impact of those things? It becomes loss of effective treatment, options for treating infectious diseases. It becomes harder to control these infectious diseases and people end up taking longer to recover.

That means there's more prolonged hospital stays. That means more increased medical costs due to the longer duration of illnesses. Additional testing and use of more expensive drugs. And unfortunately, there's a greater chance of fatality when a physician is trying to treat a resistant infection and these disease resistant organisms as they develop continue to spread. And we continue to have more problems with antimicrobial resistance.

>> Anand Shah: Dr. Solomon, as we and our listeners know all too well, COVID-19 has been disruptive to many aspects of our lives. What impact has the COVID-19 pandemic had on antimicrobial resistance?

>> Steve Solomon: So unfortunately, we all see the statistics from COVID-19 of the number of people that get hospitalized and need intensive care unit treatment. So with those hospitalized patients, it typically involves courses of antibiotics and that often increases the potential for antimicrobial resistance.

And just simply being in various health care settings and having invasive procedures that people have had to have with COVID-19, when they're in ICU places and they're being intubated and on respirators, really give an increased opportunity for resistant pathogens to emerge and spread.

>> Anand Shah: Do you view AMR as a global concern?

>> Steve Solomon: Absolutely, antimicrobial resistance knows no country borders, and it really is a major global health issue. The travel that people used to do prior to COVID-19, the movement of animals, the movement of various commodities, allows the spread across borders and continents. So, it knows no borders or boundaries. And unfortunately, we see new resistant microbes are emerging and spreading. And part of our work is you can track their movements throughout the world.

>> Anand Shah: Let's focus on our efforts at FDA, on AMR. FDA has advocated for the use of a one health approach to public health challenges like anti-microbial resistance. Can you tell us about what a one health approach is?

>> Steve Solomon: Love to, one of my favorite topics. Thank you. Just to clarify one health recognizes that human health, animal health, environmental, and mental health are all intrinsically linked together. And when you design a one health approach, thinking about all those aspects, you're designing and implementing programs, policies, legislation, research in which you need to have multiple sectors, or varied disciplines, communicate and work together to better achieve public health outcomes.

One health approaches are used for many type problems, zoonotic diseases, which are when animals can be sentinels for human diseases and transmit them. It's used in translational medicine, where advances in veterinary medicine and veterinary research can translate to human medicine. It's involved in food borne illness. Nutrition aspects are all one health issues. But one of the major pieces of one health antimicrobial resistance is key. So once again, one health is just a critical component of trying to address the issue of antimicrobial resistance.

>> Anand Shah: So, Dr. Solomon you may have touched on this, but why do we need a one health approach for antimicrobial resistance?

>> Steve Solomon: So, what many of the same antimicrobial drugs used to treat humans are also used to treat animals, both food producing animals and our companion animals. So, since these same microbes can both affect humans and animals, for example, salmonella might be one, they often share a common ecosystem. So, we get the environmental impact there. So, combating antimicrobial resistance because it requires this multifaceted approach where we're both looking at human health, veterinary health, animal health, and environmental health. And that's the intersection why it's important for AMR. We need a strict one health strategy to effectively detect, respond to and prevent outbreaks across sectors.

>> Anand Shah: Let's focus on our animal friends. How does the Center for Veterinary Medicine, which you lead, work to address antimicrobial resistance in animals?

>> Steve Solomon: So, the Center for Veterinary Medicine issued a five-year multipronged action plan that we call Supporting Antimicrobial Stewardship in Ordinary Settings, and it's designed to slow the resistance arising from the use of antibiotics in animals. Once again, the term slow is important because the development of AMR, as I said before, is a constant pressure. While what contributes to human antimicrobial resistance that is due to the use of antimicrobials in animals is not fully known, we believe our efforts to enhance the judicious use of animal antimicrobial drugs and try to preserve their utility for human medicine.

The other piece that we spend a lot of time on at CVM is our nationwide antimicrobial resistance surveillance program. It's called the National Antimicrobial Resistance Monitoring Program, or NORMs. We run this in conjunction with both the Center for Disease Control and USDA. And a central theme for the next five years, because we just issued a normed five-year strategic plan, is looking at this lens through one health, which I just mentioned.

>> Anand Shah: Dr. Solomon, you mentioned our federal partners, such as CDC and USDA, the federal government recently announced a national strategy for combating anti-microbial resistance. Can you tell us about what the national strategy includes and specifically what FDA's role is in the government's response?

>> Steve Solomon: Love to. The national strategy is a plan for the US to work with both domestic and international partners to reduce the threat of AMR. They have five major goals. To slow the emergence of resistant bacteria and prevent the spread of resistant infections. To strengthen the one health surveillance monitoring system, as we just talked about. To advanced development and use of rapid and innovative diagnostic tests. To accelerate research and development for new medicines. And to improve international collaboration.

The FDA is role in that is we're helping to facilitate efficient product development, developing new antimicrobials. Promoting the appropriate and responsible use of antimicrobials, and disseminating information, so making sure the antibiotics are used appropriately. Supporting the development and enhancement of tools for conducting surveillance. And advancing the regulatory science to understand antimicrobial resistance.

>> Anand Shah: That's great. And how can our listeners help to reduce the impact and limit the spread of anti-microbial resistance?

>> Steve Solomon: So as we mentioned before, you really should use antibiotics as directed. And only when prescribed by a health care professional. I know many people may say, though, "I've got leftover antibiotics, I felt bad before. Can I just use them again?" You should not share or use leftover antibiotics. And just good hygiene, good preventive controls, washing your hands, following all food safety controls, avoiding contact with sick people, all or just common-sense measures to help the spread.

>> Anand Shah: Dr. Solomon, as we wrap up, I want to thank you for taking the time to join us this week on FDA Insight.

>> Steve Solomon: Thank you again for having me. I enjoyed having this discussion with you.

>> Anand Shah: Thank you. In the weeks ahead, we'll be covering a variety of topics that are important to public health. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app, such as Apple Podcasts or Google Podcasts. We're also on Spotify and Pandora. So whatever platform you're on, thanks for listening.

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