Antibiotic Resistance and Development
A few months ago, Dr.
John Powers, Lead Medical Officer for Antimicrobial Drug Development
& Resistance at the FDA was interviewed by Fard Johnmar of Envision Solutions about
antibiotic resistance, developing new antibiotics and education of the
public. A portion of Powers’ commentary appears below.
Q: A recent USA Today article highlighted the dangers of methicillin resistant Staphylococcus aureus (MRSA), yet many people have never heard of it. What is the FDA doing to inform and protect people from/about MRSA and other resistant bacteria?
A: The FDA is doing a number of things. First, FDA is part of the Get Smart campaign, which helps educate the public about the dangers of the inappropriate use of antibiotics so as to preserve the benefits of antibiotics for the diseases in which we really need them. Second, in 2004 FDA put a rule in place mandating that pharmaceutical companies must put a notice in every antibiotic drug label reminding physicians that they should only prescribe if they know the patient has a bacterial infection. FDA also is co-chair of a government interagency task force of 11 different agencies focusing on antibiotic education, research, product development and surveillance. There are a number of drugs under development that appear promising for diseases due to Staphylococcus aureus, and at least in the test tube some of these drugs appear to have activity against methicillin resistant strains of the organism. Of course, we need to know that translates into benefits in terms of treating diseases in people in clinical trials.
Q: Over the past few years, the CDC (with the assistance of the FDA) has made educating the public on the dangers of antibiotic resistance a priority. In your mind, how effective have these efforts been?
A: I think that our efforts have been very effective. When you look at the rate of antibiotic prescriptions in areas where people don’t need an antibiotic, like viral infections, you see that they have decreased since we started educating on the appropriate use of antibiotics. We have to continue these educational efforts because if you stop, things revert to where they were before.
Q:
In your recent lecture during the annual CDC Get Smart conference, you
talked about the side effects associated with antibiotics. If the FDA
were evaluating a new antibiotic, would it tolerate a higher rate of
side effects in order to provide medical professionals with a new weapon
against bacteria?
A: We don’t develop drugs just to fight bacteria. We develop drugs to help people. Antibiotics usually help people by fighting the bacteria, but they are not always linked. Many drugs that have worked in the test tube end up not working in people, and many of those drugs fail due to safety issues in people. So, the answer to your question depends on what the benefits and risks are of an individual antibiotic developed for use in human beings, and what those uses might be.
I think that holding on to the idea that we are developing drugs only to kill bacteria really narrows our scope. We need a much broader view of antimicrobial development. There may be new drugs or biologics that help people but do so by mechanisms other than inhibiting growth of bacteria.
I’ll answer your question with a question: if you were the patient, would you take a drug with greater adverse effects, even effects that might rarely be fatal, for a self-resolving disease? For example, would you accept a drug whose adverse effect was death to cure a case of the sniffles? Probably not.
On the other hand, would you accept higher adverse effects for a drug that prevents mortality or death? Maybe. It’s important for people to understand that we treat humans not bugs. People don’t come in to the doctor’s office and say: I want my E. coli gone. They want their symptoms treated and to feel better, and they’d like the drug that makes them feel better faster than a different drug or than no drug at all.
Overall, bugs get a bad rap. We cannot live without them. The real issue is that everything is about balance. In drug development, we talk about balancing benefits and side effects. With bacteria, we talk about bugs that are good and those that are bad. If you sterilized your entire body, you wouldn’t live very long, as bacteria in your intestine help make clotting factors for your blood. Exposure to bacteria as a baby help the intestinal lining develop properly. It’s only when bugs get in the wrong place in the wrong numbers that they cause a problem.
Q: Please provide me with your general comments about the issue of antibiotic resistance and your suggestions for how we can get policy makers and the public to take action on this issue.
A: Overall, I think that people need to be more educated on the issue of antibiotic resistance and that inappropriate use of antibiotics can and does affect all of us. From a clinical trial standpoint, we need to develop ways to better evaluate whether a drug is safe and effective, and how to measure whether potential advantages in a test tube translate into real advantages for people.
If you have an elderly parent who needs help with frequent infections or medication issues, Senior Helpers of NJ can help. They provide in home health care in Brick, Jackson, Manchester and Toms River NJ.
Q: A recent USA Today article highlighted the dangers of methicillin resistant Staphylococcus aureus (MRSA), yet many people have never heard of it. What is the FDA doing to inform and protect people from/about MRSA and other resistant bacteria?
A: The FDA is doing a number of things. First, FDA is part of the Get Smart campaign, which helps educate the public about the dangers of the inappropriate use of antibiotics so as to preserve the benefits of antibiotics for the diseases in which we really need them. Second, in 2004 FDA put a rule in place mandating that pharmaceutical companies must put a notice in every antibiotic drug label reminding physicians that they should only prescribe if they know the patient has a bacterial infection. FDA also is co-chair of a government interagency task force of 11 different agencies focusing on antibiotic education, research, product development and surveillance. There are a number of drugs under development that appear promising for diseases due to Staphylococcus aureus, and at least in the test tube some of these drugs appear to have activity against methicillin resistant strains of the organism. Of course, we need to know that translates into benefits in terms of treating diseases in people in clinical trials.
Q: Over the past few years, the CDC (with the assistance of the FDA) has made educating the public on the dangers of antibiotic resistance a priority. In your mind, how effective have these efforts been?
A: I think that our efforts have been very effective. When you look at the rate of antibiotic prescriptions in areas where people don’t need an antibiotic, like viral infections, you see that they have decreased since we started educating on the appropriate use of antibiotics. We have to continue these educational efforts because if you stop, things revert to where they were before.
Q:
In your recent lecture during the annual CDC Get Smart conference, you
talked about the side effects associated with antibiotics. If the FDA
were evaluating a new antibiotic, would it tolerate a higher rate of
side effects in order to provide medical professionals with a new weapon
against bacteria?A: We don’t develop drugs just to fight bacteria. We develop drugs to help people. Antibiotics usually help people by fighting the bacteria, but they are not always linked. Many drugs that have worked in the test tube end up not working in people, and many of those drugs fail due to safety issues in people. So, the answer to your question depends on what the benefits and risks are of an individual antibiotic developed for use in human beings, and what those uses might be.
I think that holding on to the idea that we are developing drugs only to kill bacteria really narrows our scope. We need a much broader view of antimicrobial development. There may be new drugs or biologics that help people but do so by mechanisms other than inhibiting growth of bacteria.
I’ll answer your question with a question: if you were the patient, would you take a drug with greater adverse effects, even effects that might rarely be fatal, for a self-resolving disease? For example, would you accept a drug whose adverse effect was death to cure a case of the sniffles? Probably not.
On the other hand, would you accept higher adverse effects for a drug that prevents mortality or death? Maybe. It’s important for people to understand that we treat humans not bugs. People don’t come in to the doctor’s office and say: I want my E. coli gone. They want their symptoms treated and to feel better, and they’d like the drug that makes them feel better faster than a different drug or than no drug at all.
Overall, bugs get a bad rap. We cannot live without them. The real issue is that everything is about balance. In drug development, we talk about balancing benefits and side effects. With bacteria, we talk about bugs that are good and those that are bad. If you sterilized your entire body, you wouldn’t live very long, as bacteria in your intestine help make clotting factors for your blood. Exposure to bacteria as a baby help the intestinal lining develop properly. It’s only when bugs get in the wrong place in the wrong numbers that they cause a problem.
Q: Please provide me with your general comments about the issue of antibiotic resistance and your suggestions for how we can get policy makers and the public to take action on this issue.
A: Overall, I think that people need to be more educated on the issue of antibiotic resistance and that inappropriate use of antibiotics can and does affect all of us. From a clinical trial standpoint, we need to develop ways to better evaluate whether a drug is safe and effective, and how to measure whether potential advantages in a test tube translate into real advantages for people.
If you have an elderly parent who needs help with frequent infections or medication issues, Senior Helpers of NJ can help. They provide in home health care in Brick, Jackson, Manchester and Toms River NJ.
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