Guest Host: Frank Sesno

Klebsiella pneumoniae on ChromID CPS Agar

Klebsiella pneumoniae on ChromID CPS Agar

Nearly 100,000 people die every year in the U.S. from hospital-borne infections. The most deadly of these are known as “superbugs” for their utter resistance to antibiotic drugs. Last year, one of these superbugs killed six people at the National Institutes of Health and it was months before doctors could locate the source of the infection. New antibiotics are scarce as drug companies consolidate and focus on more profitable drugs. The result is a health care population increasingly vulnerable to untreatable infections. Guest host Frank Sesno and guests discuss the rise in superbugs and what can be done to stop them.

Guests

  • Dr. David Shlaes president of the Anti-Infectives Consulting.
  • Dr. Edward Cox director for the Office of Antimicrobial Product, U.S. Food & Drug Administration.
  • Julie Segre senior investigator for the National Human Genome Research Institute.
  • Dr. Michael Bell deputy director of the Division of Health Care Quality Promotion, Centers for Disease Control and Prevention.
  • Dr. Henry Masur chief of the Critical Care Medicine Department at the National Institutes of Health Clinical Center.

Transcript

  • 10:06:56

    MR. FRANK SESNOAnd thanks for joining us. I'm Frank Sesno, sitting in for Diane Rehm. She's off today. As many as one in 20 patients in the U.S. develop hospital-related infections. Some of these spread rapidly and cannot be cured by antibiotics. Doctors at the National Institutes of Health battled one of these so-called superbugs last year, finally using DNA sequencing to stop its spread, but not before six people died.

  • 10:07:22

    MR. FRANK SESNOJoining me in the studio to talk about the growing threat from these antibiotic-resistant infections: Henry Masur of the National Institutes of Health, Julie Segre of the National Human Genome Research Institute, and, joining us by phone from Atlanta, Ga., Dr. Michael Bell of the Centers for Disease Control. Welcome to you all.

  • 10:07:40

    DR. HENRY MASURThank you.

  • 10:07:40

    DR. JULIE SEGREGood morning.

  • 10:07:41

    SESNOThank you very much for being here. Dr Masur, let's start with you. What is this thing we called superbug? And I know you don't like that term very well, so I'll let you rebut that as well. But what causes them, and why are they so dangerous?

  • 10:07:55

    MASURSince the 1940s when we first developed antibiotics, we've recognized that the more antibiotics we use, the more microorganisms find ways to be resistant. And over the years, this resistance has become more and more of an issue. We realize that if we develop new antibiotics, we can stay several steps ahead of the resistance.

  • 10:08:20

    MASURThe problem in the last decade has been that we're not developing new antibiotics nearly to the extent that we need to, so that, at this point, whereas 10 years ago, we might have had several antibiotics sitting on the shelf that could treat a resistant bacteria, right now, the pipeline for new antibiotics has dried up to the point where we have virtually nothing there for these highly resistant organisms.

  • 10:08:46

    MASURSo the problem really is that as we've used antibiotics over the years, the organisms have learned to become resistant, and we simply don't have any drugs to treat some of the most highly resistant organisms that we're confronted with now.

  • 10:09:02

    SESNOLet me be sure I understand what you mean when you say we are using all these antibiotics. Do you mean we, like, each individual, when I go over the course of my many years to my doctors and they prescribe antibiotics, I become less resistant or less responsive to antibiotics or we as a species, given the different kinds of infections that we're talking about, bacteria that we're talking about here, that are themselves developing and evolving?

  • 10:09:33

    MASURLet me give you my perspective, and Dr. Segre and Dr. Bell probably have a perspective they'd like to add as well. Antibiotics have been miracle drugs since they were first invented. They've saved countless human lives all over the world. And yet the problem is that we've come to expect that, for every illness, there will be a drug that would make us better.

  • 10:09:55

    MASURAnd thus, when we get illnesses caused by viruses, for instance, that are very common, we go to the doctor, and we have an expectation that our pediatrician or internist will give us an antibiotic even if, in fact, the data would suggest that these drugs will not help. The more we use and overuse antibiotics, the more we're going to drive resistance. But they're really a two-pronged problem in this country. One is that we could all do a better job of antibiotic stewardship, and by that I mean using antibiotics only where they're clearly indicated.

  • 10:10:33

    SESNOUsing them less.

  • 10:10:34

    MASURYes. The other problem I think we have to recognize is that in this country, 75 percent of antibiotics are not used for humans. They're used for animals. And these are not used to promote animal health. This is used to promote animal growth, which is a way of increasing the profits for the agribusiness so that one of the major issues to consider is if we reduce the use of antibiotics for animal growth, we would reduce the pressure on organisms to become resistant, and that would solve part but not all the problem.

  • 10:11:10

    SESNOYou're saying there's a correlation between antibiotic use in animals and the resistance of bacteria to those in humans?

  • 10:11:17

    MASURYes.

  • 10:11:18

    SESNODr. Segre, your take on this?

  • 10:11:23

    SEGREI would -- there are countries in Europe that have removed antibiotics from livestock because they want to preserve them for use in the human population. And the data would suggest that the level of antibiotics resistance has dropped in those countries. So I think that is one path forward. But to answer your earlier question about whether this is antibiotics at the level of the entire human population, yeah.

  • 10:11:54

    SEGREI mean, we see that people who haven't even ever been exposed to an antibiotic can become infected with a bacteria that is resistant to a carbapenem or a penicillin-type antibiotic even if they haven't seen that drug because those organisms develop the resistance in another person. So this is really about the community of patients, not just on an individual patient level.

  • 10:12:26

    SESNODr. Bell, let me pull you into the conversation here. We've heard what happened with NIH, and we're going to actually dive into the mystery and how that mystery was unraveled, but very disturbing obviously with these antibiotic-resistant bacteria claiming so many lives and doing it invisibly for so long. But how prevalent are these things that get called superbugs at America's other hospitals?

  • 10:12:50

    DR. MICHAEL BELLSo the bacteria that we're talking about today, the KPC or CRE, it's a group of organisms that are highly resistant to a certain category of antibiotics. And if we look at all of the health care-associated infections, they probably constitute about 20 percent of those. I would say, to put it in perspective, though, that although these organisms have spread essentially nationwide since they were discovered around 2001, CDC laboratories identified a new mechanism, and we've tracked it since then.

  • 10:13:24

    DR. MICHAEL BELLIt's in most states now, but it only affects about 6 percent of hospitals in this country. So it's comparatively early in its spread, which I think is a very important point because now is the time to attack it. If we sit back and let it continue to spread, it's going to end up being so common that the majority of infections will become untreatable. And that's not where we want to go.

  • 10:13:47

    SESNOJulie Segre, you want to jump in?

  • 10:13:48

    SEGREAnd I would only say that those numbers are already alarming in that if it's only in 6 percent of hospitals, that's already at a transition point where we really need to get out in front on this -- we, meaning hospitals.

  • 10:14:03

    SESNOLet me remind our viewers that you can join us for this conversation as it goes on this hour by calling us at 1-800-433-8850, or you can email us at drshow@wamu.org. Dr. Masur, would you tell us what happened at NIH last year?

  • 10:14:23

    MASURLast year, we had a patient transferred to our hospital from another institution who we recognized, as the patient was being admitted, had a highly resistant organism that had been identified at the other hospital.

  • 10:14:38

    SESNOSo you already knew that. We knew that we had a high-risk patient coming to that hospital.

  • 10:14:43

    MASURYes. And we're very accustomed in our hospital, as most hospitals in the United States are, in developing ways to isolate these patients so that we reduce the likelihood that organisms are transmitted from one patient to another. Since we recognized this early, we thought that we had this contained. But over the next weeks and months, we saw more cases.

  • 10:15:09

    MASURAnd as Dr. Segre can probably pick up the story, as we recognized that we were having more cases, the question came up: number one, how would we break this chain of having additional cases? And, number two, why was this happening despite the fact that we were culturing patents who were ill and that we were recognizing these organisms and isolating the patients?

  • 10:15:35

    SESNOSo you isolated the patients? You isolated the patient who had come to you knowing that she was a high-risk patient, right? You took all these precautions.

  • 10:15:44

    MASURWe did. And when we had a second case, a third case or a fourth case, as with other resistant organisms that all hospitals deal with on a routine basis, unfortunately, we institute additional measures. We cultured more patients, ultimately culturing all the patients in the hospital to see if they were silent carriers as well as active carriers. We educated and re-educated the staff to increase the likelihood of the staff work adherent to all of our isolation techniques. We hired monitors to watch our staff to make sure that they were following all the precautions.

  • 10:16:24

    SESNOUltimately, they spread at about one per week during this period of time as I understand it. Eleven people altogether died, six directly from KPC, others from the underlying conditions perhaps aggravated by the infections. Is that right?

  • 10:16:36

    MASURYes. We found two types of patients, some who were actively infected and others who had silent infection that we picked up by aggressive surveillance. Many hospitals don't do aggressive surveillance. But what made our study possible was that we have very good resources with hospital epidemiology that aggressively look at these transmission patterns. And by doing active surveillance to see even the patients who appeared well who had the organism were able to develop a cache of organisms. Then our scientist, Dr. Segre, could study to see how was this transmission happening.

  • 10:17:15

    SESNODoctor -- sorry, go ahead.

  • 10:17:16

    MASURYeah. Although, in addition to our isolation procedures, we also then intensively looked at the environment, looking to see if, on the floors, the bedrails, the equipment, we could find the organism to see if this was being transmitted by people or by the environment.

  • 10:17:33

    SESNODr. Segre, what was most striking to you as you dug into this?

  • 10:17:38

    SEGREThe question that engaged us as part of the team was -- Evan Snitkin, who was working in the clinical microbiology labs and also is trained in computer science, he observed that there was -- he knew that there was a second and a third case. And Evan and I had worked previously with the Department of Clinical Microbiology to understand how there might be multiple organisms that come into a hospital at the same time.

  • 10:18:13

    SEGRESo we had two hypotheses: one, which is that patient one who had already been discharged might have infected patients two and three and four, or separately, that there were two separate transmissions, and that was the scientific question that we set out to answer.

  • 10:18:30

    SESNOAnd that's the scientific question we'll return to after a brief break. You're listening to "The Diane Rehm Show." More on these superbugs that haunt our hospitals when we come back.

  • 10:20:04

    SESNOAnd welcome back to "The Diane Rehm Show." I'm Frank Sesno, sitting in for Diane. Today, we're talking about these very serious infections that sometimes are resistant to our antibiotics in this country and recently caused such terrible problems at the National Institutes of Health and elsewhere. Julie Segre, I'd like to come back to you. You started talking about trying to figure out the mystery, as it was, as you were diving into it at the National Institutes of Health.

  • 10:20:30

    SESNOI mean, this is a tough assignment to get, right? We've got this invisible bacteria that is causing such havoc. How did you proceed? How did you, and how does one crack that mystery as it's taking place?

  • 10:20:46

    SEGRESo this is something that the Human Genome Project has been putting forward as a mission for the last 20 years to increase the technology and the scientific base by which we can develop blueprints, DNA fingerprints for any organism. We developed all this technology for sequencing the human genome, which I've been a part of for 20 years.

  • 10:21:12

    SEGREBut when we heard about the situation, we immediately knew that this was something that we could perhaps make a real contribution with DNA sequencing. So we took each of those organisms and made DNA from them, and then we put them onto our new sequencing technology platforms. And we discovered the base pair, the -- all 6 million base pairs were read out from every organism. Then two organisms, their fingerprints would be compared.

  • 10:21:46

    SEGREAnd although they were not easy to -- they could not be distinguished by any clinical microbiology test, when we looked at the DNA signature and read it out, ACC, what we could understand immediately was that of the 6 million base pairs of each of these organisms, patient number one and patient number two only differed at two base pairs out of 6 million. If these were unrelated organisms, if these had come in with two separate patients, they would have been hundreds or thousands of base pairs different.

  • 10:22:20

    SESNOSo essentially, you were able to use this technology to say, it's the same bacteria here.

  • 10:22:24

    SEGREYes. It's a match.

  • 10:22:25

    SESNOThat's -- it's a match, and this is going through.

  • 10:22:27

    SEGREIt's a match.

  • 10:22:28

    SESNOAnd how did that help you at NIH determine what to do about that? You now knew that you had this, if I can be a little crass about it, killer on the loose.

  • 10:22:39

    MASURWe recognize that like many hospitals across the country, we did have this killer as well as unfortunately other resistant bacteria on the loose. And we have learned a lot over the years from other epidemics and from Mike Bell and his colleagues at the CDC. We were very familiar with their directives from 2009, 2012, and how to control these organisms. And yet it was clear that there was a lot we didn't understand. Was it the isolate from the throat? Was it the isolate from the urine?

  • 10:23:09

    MASURWhich isolate really was the biggest risk, and how did patients get transmission from one to the other? In the past, we would simply look to see who was in the same room, who had the same nurse. Now, we had a much a better tool. And I think the beauty of this is that on the NIH campus, the basic sign is like Julie Segre and the clinicians communicate. They talk about problems, and this is a solution, which Mike Bell would probably like to chime in.

  • 10:23:38

    MASURI think this will give us new insights into exactly where we need to focus our efforts so we can stop this transmission 'cause our goal after all is to make hospitals as safe as they can be for everybody. I think this gives us a wonderful opportunity to understand how to accomplish that.

  • 10:23:54

    SESNOWell, we'll talk to Mike Bell in just a bit. But joining us now is Dr. David Shlaes of Anti-Infectives Consulting. It's a drug development and consulting firm located in Stonington, Conn. Welcome to "The Diane Rehm Show," Dr. Shlaes.

  • 10:24:07

    DR. DAVID SHLAESHi. Thanks for having me.

  • 10:24:08

    SESNOWell, thanks for joining us. In your opinion, why is there such a shortage of new antibiotic drugs in this country? We talked about that earlier, and obviously, those are the kinds of drugs that one would hope would slay these killers.

  • 10:24:22

    SHLAESWell, there are a number of factors that lead to the situation we have in the U.S. right now. One is the general issue of the antibiotic market which is just not as promising for the use of antibiotics compared to treatment of chronic diseases. So the paradox is that antibiotics actually usually cure disease. They're one of the few classes of drugs that actually cure disease. And, therefore, you don't have to take them for very long.

  • 10:24:52

    SHLAESYou take them for a period of time. It's acute infection. You take them for a week or two, maybe at maximum, and you're cured. But other diseases like high cholesterol or chronic depression or high blood pressure, you have to take drugs for those conditions, which you do not cure with drugs, sometimes for the rest of your life. So there's a market disincentive, if you like. In addition, discovering new antibiotics has become much more difficult than it was, you know, 50 years ago, much more difficult. And so it...

  • 10:25:26

    SESNODifficult -- more difficult scientifically, medically?

  • 10:25:30

    SHLAESMuch more difficult scientifically to find new antibiotics because when you think about what you're trying to do with an antibiotic is you're trying to kill one living organism without killing another one. And this is actually not so easy.

  • 10:25:43

    SESNOSome of the numbers really are striking. Between 1945 and 1968, drug companies invented 13 new categories of antibiotics, between '68, 2012, just two new categories. And last year, the FDA approved just one new antibiotic.

  • 10:25:58

    SHLAESYeah. The FDA used to approve something like at least four new -- four to eight new antibiotics a year at the peak. And now we're down to, you know, one or two every four years.

  • 10:26:11

    SESNOBut shouldn't the FDA be most concerned about the safety of new drugs as they're brought onto the marketplace?

  • 10:26:16

    SHLAESRight. So now the other problem that we're getting to is the fact that regulatory agencies, especially the FDA, are actually contributing to the problem by making the clinical trial requirements so difficult, in fact, essentially infeasible, that for many of the kinds of infections that we see regularly -- and pneumonia being a big one -- we simply cannot develop the antibiotic so that they can reach market. It's not possible given the FDA requirements, so...

  • 10:26:49

    SESNODr. Bell, would like to jump in with that? Is that -- is the FDA part of the problem here in a big way?

  • 10:26:54

    BELLYou know, I'm not the person who deals with regulation of drug approvals. I will say that there's always going to be a balance between rapid approval, easy approval and the certainty of safety for the consumer. And that balance, I think, is the key here.

  • 10:27:12

    SESNODr. Masur, what do you think?

  • 10:27:14

    MASURI think the FDA has been working very closely with the academic community, with industry and with the Infectious Disease Society to try to develop a more flexible policy for different kinds of patients and different kinds of drugs.

  • 10:27:28

    SESNOIn other words, to move quicker?

  • 10:27:30

    MASURI think there's been real progress in terms of developing new paradigms. But it's a complicated issue with many of these infections to prove that the drugs are safe and effective. And after all, we have a long history of recognizing that many promising agent turned out either not to be safe or not to be effective. So there's a fine balance, and I don't disagree with David that we need to make more progress in developing more rapid ways to develop them.

  • 10:27:55

    MASURBut I think it's a complicated issue. And I think that everybody has the same goal. We want more effective drugs on the market, and we want to limit their use to those situations where they'll be the most beneficial.

  • 10:28:06

    SESNODr. Shlaes, one last question for you. If you feel that the process should be speeded up and you feel there should be more incentive in the system for the pharmaceutical companies that are developing new antibiotics, what would those new incentives look like, in your view?

  • 10:28:21

    SHLAESActually, I'm not sure that we need new incentives. And the reason I say that is that markets in emerging economies are actually growing very, very quickly, and they now overbalance the U.S., which used to be the dominant market. So, in fact, if things don't improve at the FDA, the future is going to be that new antibiotics are going to be developed, and they're going to be available in Beijing but not in Washington.

  • 10:28:43

    SESNOWell, let me bring in Dr. Edward Cox. He's director for the Office of Antimicrobial Product, the U.S. Food & Drug Administration, the FDA. You heard your agency referred to many times here. I'd like to get your response.

  • 10:28:57

    DR. EDWARD COXYeah. Hi. Thanks for having me on today.

  • 10:28:59

    SESNOAnd thanks for joining us.

  • 10:29:00

    COXSo, I mean, we recognize, you know, the other problem out there with resistant infections, and patients do need new therapies. And, you know, we are committed to working on pathways to expedite development, particularly in the area of treatment of patients who have resistant infections. And we can't have a circumstance where, you know, patients are out there and, you know, not have treatments available. So we're working very hard to try and, you know, expedite, particularly for that area and to get new options out there for patients.

  • 10:29:28

    SESNOWhen you say you're working to expedite, what does that mean? Translate that.

  • 10:29:32

    COXSure. So, you know, for patients who don't have options, we're looking at clinical trial designs, you know, ways to do smaller development programs that will focus in on these more targeted indications, you know, patients who have resistant organisms. The development programs will involve, you know, smaller numbers of patients. That will get drugs out there to patients sooner. And as, you know, as Dr. Bell mentioned, too, there is this balance of risk and benefit.

  • 10:29:59

    COXYou know, we will, in that setting, have greater uncertainty about how the drug performs, but, you know, most people in the setting of, you know, not having an option to treat a serious infection, you know, that degree of uncertainty is reasonable to assume in that circumstance in order to have an option to be able to treat that patient's infection.

  • 10:30:14

    SESNOLet me remind our audience that you can -- and our listeners -- that you can join our conversation by calling us at 1-800-433-8850 or emailing us at drshow@wamu.org. We'll go to your calls and your questions in just a few minutes. Before we do so, I'll be taking another quick break in just a moment. But, Dr. Masur, let me come back big picture for just a minute. Nearly 100,000 people die in hospitals every year because of infections. I mean, going to a more, you know, 20,000-foot level, isn't this something to be very concerned about?

  • 10:30:46

    MASURI think the medical community has been very concerned about this for a long, long time. The question is what can we do about it? You know, the good news is that we are able to use immunosuppressive drugs. We're able to do transplants. We're doing surgical procedures that we could never do before.

  • 10:31:04

    MASURThe problem is that these patients then become so fragile, they become so immunologically weakened, they become susceptible to a lot of different infections, so that part of the problem is that we need better infection control. Part of the problem is we need new antibiotics. But we also have a larger population of vulnerable patients.

  • 10:31:24

    SESNOOK. But does that make the patient down the hall, who isn't as vulnerable, more vulnerable?

  • 10:31:30

    MASURWe're certainly concerned about spread within the hospital. But you have to recognize that, especially for the organisms we're talking about today, these do not generally affect people who are not debilitated. The people who are affected primarily are those who are debilitated, those who are in intensive care units and those especially around ventilators. So the risk to someone else, there is a risk that is quite small. And if you're out of the hospital, there really is no risk.

  • 10:31:55

    SESNOI'm Frank Sesno, and you're listening to "The Diane Rehm Show." If you'd like to join us, please give us a call at 1-800-433-8850, or send an email, as I mentioned, to drshow@wamu.org. We'll be moving to your comments and questions in just a minute.

  • 10:32:11

    SESNOJulie Segre, as the detective here, if I can say that about you, as you listen to this conversation and you think about the nearly 100,000 number that I just mentioned, what should consumers have in mind when they go to the hospital? If they're sick, if their own immunological system is, in some way, compromised, when they hear this conversation, is this cause for alarm? Is there anything they can do?

  • 10:32:42

    SEGREAs an individual patient, there certainly is a concern when you go into the hospital, especially if you're going in to be immune-compromised. It is the hospital's responsibility to keep the environment as safe as possible. So, as a patient, I would say that it is mostly the hospital's responsibility and not the patient's to be sort of constantly monitoring, as in our hospital when we actually put monitors into the intensive care unit to ensure the staff and even the people bringing the food trays. Everyone was following absolutely the strict procedures.

  • 10:33:23

    SESNODr. Bell, you want to jump in on this?

  • 10:33:25

    BELLYes. Thank you. I have to tell you that, you know, it's important to remember that everybody out there carries these organisms in their intestines. They don't all have the resistant form, but these are normal part of what we carry. These bacteria can cause an infection whether they're resistant or not if they get into the wrong place, so if they get into your bloodstream or your lung.

  • 10:33:45

    BELLAnd the way they tend to do that is when you have a catheter going into your bloodstream or a catheter into your bladder or a plastic tube into your lungs, on a ventilator. So the key here is we need to keep them from getting to where they don't belong. Also, it's important to remember that these bugs don't fly, and they don't walk. They move around the hospital on human hands or on contaminated equipment.

  • 10:34:08

    BELLAnd that's why CDC investigations have shown again and again that if people stick with the rules and use proper isolation, like Dr. Masur mentioned, we can stamp out these infections very, very effectively. Once you detect, you protect. The problem is that people cheat. It's very, very tempting, when you're very busy and trying to do a lot of things for a lot of patients, to cuddle to a corner, to slip into a room without putting on a gown, slip back out. And when that happens, that opens a pathway for the organism to be carried to yet another patient.

  • 10:34:39

    SESNOLet me go to the phone now because Shelly has been waiting patiently. She's calling from Detroit. Hi, Shelly. Go ahead with your question.

  • 10:34:45

    SHELLYReferring to the conversation and many others, I hear often that bacteria are learning to become resistant, and I kind of picture a one-room schoolhouse with the McGuffey Readers and these little amoebas out there going like that. And isn't it mutation? And when you make these comments like that, when you use an analogy learning, it makes me feel a little bit of sensitivity to Mr. Akin, thinking that women's bodies can shut down because it makes us seem that we can will something, and these bacteria are willing something.

  • 10:35:23

    SESNOAll right. Julie Segre wants to answer that. Go ahead.

  • 10:35:26

    SEGREThat's part of the scientific promise for the future. The group at NIH -- Evan Snitkin, Tara Palmore and I -- are continuing to look at how antibiotic resistance is being acquired by these bacteria.

  • 10:35:42

    SEGRESo we've sequenced the whole genome of organisms during patient courses of treatment to understand how they become resistant to these last-line-of-defense antibiotics like colistin to -- so that maybe as these bacteria are learning, we are studying what they are learning so that we can perhaps continue to outsmart them in terms of how they develop antibiotic resistance. We need to be right there with them in that classroom.

  • 10:36:11

    SESNOI've got a question here for Dr. Ed Cox from Jonathan in Washington: "Do we have any new antibiotics currently in the pipeline awaiting FDA approval? And if not, how long does it take once a new antibiotic is in the pipeline for it to become available to people?" That question from Jonathan in Washington.

  • 10:36:27

    COXYeah. So there are antibiotic drugs that are in development, that are in the pipeline. And, you know, the period of time that an antibiotic drug, you know, takes from the time that it enters into human studies initially to the point of approval, you know, can range from five to 10 years. In a more expedited approach, it may be possible to get that time down to three years.

  • 10:36:46

    COXSo his question is a good one, and it underscores the importance of having ongoing development of new antibacterial drugs because, you know, as we heard, you know, resistance will continue to erode away at our therapeutic armamentarium. So we need to have ongoing development in order to have options out there.

  • 10:37:02

    SESNOAnd very briefly, what's your take on this notion of incentivizing, whether more incentives are needed or not for the development of these drugs?

  • 10:37:10

    COXRight. So that brings a point that bears mention. Just recently, back in July, the Generating Antibiotic Incentives Now Act was passed. So the GAIN Act, as people refer to it, provides additional incentives for the development of antibacterial drugs, a five-year period of exclusivity. So that is, you know, an important piece of legislation that...

  • 10:37:33

    SESNOMaking some progress. A quick break. We'll return to "The Diane Rehm Show." More of your calls and questions about these very dangerous bacteria and what's happening in our hospitals right after this.

  • 10:40:04

    SESNOWelcome back to "The Diane Rehm Show." I'm Frank Sesno, sitting in for Diane today. We're talking about drug-resistant bacteria and the recent problems that afflicted the National Institutes of Health, a hospital there, where 11 people altogether lost their lives in part or entirely because of these drug-resistant bacteria that afflicted them. Our conversance this hour: Dr. Henry Masur, he's director of National Institutes of Health Clinical Center, Julie Segre, senior investigator, National Human Genome Research Institute.

  • 10:40:32

    SESNODr. Michael Bell is joining us, deputy director of the Division of Health Care Quality Promotion for the Centers for Disease Control and Prevention, and Dr. Edward Cox, director for the Office of Antimicrobial Product of U.S. Food & Drug Administration, the FDA. We want to thank Dr. David Shlaes for joining us earlier in the program. We want to go back to your questions as well now, and let's go back to Celestine. He's joining us from Dallas, Texas. Go ahead.

  • 10:40:59

    CELESTINEHey, good morning everybody. Thanks for taking my call. I just want to make a little contribution to the conversation. The practice in the hospitals, usually when there's an infection, you start up with the big guns, what we call empirical therapy. And then they do a culture and sensitivity. Then when the results come back, you de-escalate. And what you see a lot of times is that doctors sometimes forget to de-escalate those medications, so the patient is on a broad spectrum antibiotic that they don't need for prolonged period of time. Now, this is where the pharmacist comes in. The...

  • 10:41:38

    SESNOAre you a pharmacist?

  • 10:41:39

    CELESTINEYes, I am a pharmacist.

  • 10:41:40

    SESNOOK. OK.

  • 10:41:41

    CELESTINEI'm a brand-new pharmacist.

  • 10:41:42

    SESNOA brand-new pharmacist. Well, congratulations.

  • 10:41:45

    CELESTINEThank you very much.

  • 10:41:46

    SESNOSo where do you -- so tell us where you come in.

  • 10:41:48

    CELESTINEAnd so -- oh, the pharmacist comes in and tries a call, hey, Dr. A, does the culture and sensitivity says this person is, you know, this is -- can we switch to this? A lot of times the doctor said, yes, yes, yes. We'll do it, you know? And sometimes -- so the fact that a lot of times we forget to de-escalate is one of the causes of unnecessary antibiotic use and one of the causes of resistance. The second one is you see some doctors that want to use the big guns, like you want to go linezolid, Zyvox, before you try like...

  • 10:42:23

    SESNOThat's a particular antibiotic.

  • 10:42:26

    CELESTINEExcuse me?

  • 10:42:26

    SESNOThat's a particular antibiotic you're referring to. Yeah.

  • 10:42:28

    CELESTINEYes. Yes.

  • 10:42:29

    SESNOA big gun as you call them. OK.

  • 10:42:31

    CELESTINEYes, before you try like the, you know, the more common like Vancomycin or other, like, cheaper alternatives that would do the job as well, you know?

  • 10:42:39

    SESNOAll right. Well, let me balance this off of Dr. Masur and see what he has to say this idea that, first of all, the pharmacist should be part of the conversation, and second of all, the doctors are going for the big guns before they go for the slingshots.

  • 10:42:51

    MASURThose are both excellent points. It really depends on the situation, but, clearly, if a narrow-spectrum drug can be used rather than a broad-spectrum one, one should choose the narrow one. And the sooner one can reduce antibiotics the better. But we also have to recognize that, for instance, if you're in the ICU and your life hangs in the balance, you need to be treated with a very broad range because we can't afford to be wrong.

  • 10:43:15

    MASURIf, on the other hand, you're an outpatient, you're not that sick, you can use narrow spectrum, and if the culture comes back showing something different, your doctor has, you know, time to change without adverse affecting you. But those are both wonderful points, and hospitals need to focus more on reducing the spectrum as soon as they can.

  • 10:43:34

    SESNODr. Bell, would you tell us about what the CDC is doing with this so-called Emerging Infections Program? I think in 10 states it is.

  • 10:43:42

    BELLSure, and before I forget, I want to reiterate what you just heard.

  • 10:43:46

    SESNOOK.

  • 10:43:47

    BELLThe antibiotic stewardship, keeping the antibiotics that we have as effective as possible by using them wisely, it's not an exciting topic. And while I agree completely that we need new drugs, it's kind of like getting a new credit card after you max one out. You can't just keep maxing out the credit cards and ordering new ones. You need to preserve what we have.

  • 10:44:08

    SESNOWell, you know what, before you go on, I want to engage you on this because this actually happened in my experience very recently. I was talking to someone I know quite well who had had a cold, told me that he went to a doctor and was now on antibiotics. My reaction was, why are you on antibiotics, and do you know that this is not just about taking something to make you feel better?

  • 10:44:27

    SESNOThis could have a long-lasting effect in terms of your responsiveness to antibiotics for the rest of your life conceivably. Am I right about that? Was that -- I didn't say anything. Maybe I should have.

  • 10:44:38

    BELLYou're absolutely right. It's something that we need to be sensitive to not only as patients requesting antibiotics that we don't need but also in hospitals, like you heard Dr. Masur say, to clamp down on some of the big guns. Use them only when they're essential so that -- it's a matter of saying that even if we have three new drugs next year, if we use those foolishly, they're going to stop working as well.

  • 10:45:01

    SESNOWell, I think -- let me come back to the consumer, the patient again, because how does a patient know whether it's a big gun or -- what they're being prescribed?

  • 10:45:09

    BELLYou know, I think there are some areas where, as Dr. Segre said, you have to kind of trust your clinician. But it's always OK to ask. And I think that this is true across the board when it comes to...

  • 10:45:19

    SESNOSo what do you ask? What do you ask?

  • 10:45:20

    BELL...making sure that you're safe. Well, so for one thing, what are you giving me, and why do I need it? How long do I need to be on it, and is it necessary? These are straightforward questions that anybody can ask and deserves an answer. I think the other thing is I mentioned that these catheters that go into your bloodstream and whatnot are a highway for some of these bacteria to go where they don't belong.

  • 10:45:42

    BELLAsking how long this needs to be in and what day it's coming out and then reminding people if you're in the hospital, that's another way to reduce your risk. I think that asking these questions can be challenging. Even as a doctor myself, I find it hard to ask sometimes, and it's not a bad idea to bring a friend or a family member with you to help you out.

  • 10:46:02

    SESNOYou're not -- if you have trouble asking the question, imagine the rest of us. Would you tell us, though, very quickly, because I want to get back to the phones, about the Emerging Infections Program?

  • 10:46:11

    BELLYes. So CDC has multiple ways that we track problems in public health. We track infections in hospitals, and we monitor how successful hospitals are at reducing those infections. We also use the Emerging Infections Program to have a constellation of locations around the country, partnering with State Health Departments and academic centers to look at whole communities with regard to some of these infectious diseases. So, for example, with resistant organisms, we're tracking these things not only within a hospital but across the health care system and into the community.

  • 10:46:44

    BELLWe're seeing that, for example, in Chicago, some of these long-term acute care facilities where people go to be on a ventilator for a long time can contribute tremendously to amplifying these resistant organisms. And when people leave that facility and go back to a regular hospital, they carry the resistant organism back with them. That kind of movement around the community is something we're seeing as a major contributor to some of these problems.

  • 10:47:09

    SESNOOK. Let's go to the phones. Dr. Jeff Burke joins us from Baltimore. Hi, Jeff. Jeff, you there?

  • 10:47:16

    DR. JEFF BURKEYes, I am.

  • 10:47:17

    SESNOSorry. Go ahead.

  • 10:47:18

    BURKEThank you so much. OK. I'm going to ready fast as I can.

  • 10:47:21

    SESNOPlease be fast.

  • 10:47:22

    BURKEAnd if you could kind of itemize these questions for me in its how, when and how extensive, so -- and then there's the second part.

  • 10:47:33

    SESNOAll right. Well, let's -- let me help you here. Let's do the first part first.

  • 10:47:35

    BURKEHow -- the when and how valuable, and who did how much and how extensive was the work on bacteria? And also on virophages, was there a lot of work? And the second part is about Eli Lilly -- and I remember them being called an ethical drug company versus this for-profit, for deregulation, you know, convention that's been going on in Florida right now.

  • 10:48:03

    SESNOOK. Let's separate those two. Let's start with the bacteria phage. Is that what you referred to?

  • 10:48:09

    BURKEYeah. How, when, how valuable and who did how much work and how expensive was the work out?

  • 10:48:18

    SESNOJulie.

  • 10:48:19

    SEGRESo phage are small -- very small organisms that attack bacteria. And in 1950s at Rockefeller University, there was a -- and Cold Spring Harbor Laboratories, there was a tremendous interest in phage, and they specifically attack certain classes of bacteria. I think that something that people have kept on the research idea would be, could we use other organisms to keep these drug-resistant bacteria in check?

  • 10:48:54

    SEGREBesides antibiotics, can we start to use sort of other probiotic approaches to have maybe the bacteria of someone's gut, someone's gastrointestinal tract recover enough to be able to out-compete these drug-resistant organisms? I think keeping an eye on the entire microbial community is a really good idea in terms of how we can promote the health of the overall patient.

  • 10:49:23

    SESNODr. Masur, there's a question from Susan, who wants a little -- wants us to fill in a little bit on what took place at NIH. She writes, "After identifying the superbug by DNA analysis, did they ever determine how the infection moved from one patient to another at the NIH facility?"

  • 10:49:39

    MASURWe didn't conclusively prove that. There are certainly a number of very suspicious clues about where we found the patient, about the temporal sequence of when it spread from one patient to another. But whether, in fact, it spreads on hands or whether it spreads from an environmental source, like an X-ray machine or a bed rail, that we're not so certain of.

  • 10:50:02

    MASURAnd again, Julie may want to contribute something as to what her suspicions are. But that's why we're doing this kind of investigation. We want to understand that. So once we understand how, then we can look at interventions that are more effective.

  • 10:50:15

    SESNOJulie.

  • 10:50:16

    SEGREAnd that we weren't able to exactly pinpoint it. But that's why we stepped up and escalated the hospital practices on all fronts. That's why we isolated the patients. That's why the equipment that was used on those patients was never used on other patients in the hospital. The staff who treated those patients never worked in the rest of the hospital. So we stepped up on all fronts because that was the best way to keep the patients healthy.

  • 10:50:46

    SESNOBack to the phones. And Ron joins us now from Boston. Ron.

  • 10:50:49

    RONHi. Good morning. thank you for taking my call.

  • 10:50:51

    SESNOThank you.

  • 10:50:51

    RONOne of your earlier guests touched on this. And I'd like for you guys to explore a little bit more about the use of antibiotics to raise animals -- healthy animals just to make them larger. Can you please go into why this is a bad thing, and what steps are being taken to prevent this from getting worse?

  • 10:51:08

    SESNOOK. Dr. Cox, you want to jump in on that since the FDA is in the middle of all of these things?

  • 10:51:14

    COXYes. So the use of antibiotics in animals is an important issue. And it's an area that my colleagues in the Center for Veterinary Medicine have been engaged on, working on in order to try and address it. I'm probably not the best person, though, to address the antibiotic issues 'cause the area that I work in is more on the human medicine side. And our focus is, you know, trying to get pathways out there for the development of new antibacterial drugs.

  • 10:51:35

    COXSo, you know, the questioner is asking an important issue, but probably I'm more better focused on the issues of getting, you know, antibacterial drugs out there available for human patients.

  • 10:51:44

    SESNODr. Masur.

  • 10:51:45

    MASURWell, just to try to make this concrete. Just keep in mind that if the cow that you're going to then eat as steak has been given antibiotics, we know that the flora, the bacteria in that animal will become drug-resistant. Then when you start handling the meat or you eat the hamburger, the organisms that are in that hamburger are not drug-sensitive. They're drug-resistant.

  • 10:52:11

    MASURSo if you don't handle the meat properly, if you don't cook it thoroughly, when you get an infection, instead of a drug-sensitive organism, you'll be infected by a drug-resistant organism. Is this a problem? It's a huge problem.

  • 10:52:25

    SESNOYou're listening to "The Diane Rehm Show," and I'm Frank Sesno. If you'd like to join us, call 1-800-433-8850. Send us an email to drshow@wamu.org. We are after all talking about our health, so this is a pretty relevant thing. This is an email from Sherry in Florida. "Please elaborate on the type -- types of hospital-borne infections." She writes, "My dad is not one to use antibiotics often, if at all. He was, thank God, in excellent health before this happened. The condition he's in, the doctors say that it may have saved his life." Mike Bell.

  • 10:52:56

    BELLCan you say the question once more?

  • 10:52:58

    SESNOThe observation -- it's not a really a question -- is to elaborate on the types of hospital-borne infections.

  • 10:53:03

    BELLSo there are a range of things that we see in health care facilities. Most of them are focused, as I mentioned, on infections that are related to devices. So catheters that go in the bloodstream, catheters that go into the bladder and plastics that goes into your lungs to help you breathe. We also see infections related to procedures like surgery, where if the skin preparation and so on is not perfect, there can be infections after an operation. We also see C. difficile, which is a diarrheal disease that is increasingly spreading.

  • 10:53:38

    BELLIt's related to the overuse of antibiotics. And that's another very important infection that we're seeing spreading in hospitals. All of these are things that can affect essentially anybody if you have a catheter of that sort and in particularly with something like C. difficile. If you're exposed to antibiotics and the organism, you can become very ill.

  • 10:54:00

    SESNOAll right. Let's bring Lucille in. She calls us from Peoria, Ill. Hi, Lucille.

  • 10:54:05

    LUCILLEHi. My observation is that not just the hospitals are to blame for not being vigilant and the patients being vigilant about microbes, but also the doctors' offices. I had been exposed many times to situations where I see people not doing something that -- like licking their fingers, handling the pagers and coming to, you know, prepare the patient and touching the patient. So this is my observation that isn't just at hospital. This is rampant, I believe, you know, not just the hospitals but outpatient.

  • 10:54:50

    SESNOAll right. Well, let me ask Dr. Masur to weigh in on that. Not just a hospital problem, but what she's saying -- Lucille is saying is throughout the medical system.

  • 10:54:59

    MASURI think throughout our society, we have to more conscious in the risk of transmitting infections, whether it's food handlers, whether it's people who use the same salad bar that we use or whether it's people on health care organizations. I think over the last decade, largely through leadership from the CDC and professional organizations, health care professions are much more vigilant than they used to be.

  • 10:55:20

    MASURDo we have a long way to go? Absolutely, in terms of educating, in terms of changing behavior, so I think it's a valid observation. But I think we are making progress, but we have a long ways to go.

  • 10:55:31

    SESNODr. Cox, let me give you the last word here over at the FDA. As you think about the challenges ahead and you think about the problems that we've heard, the challenges that we've heard about today, what is the FDA's response? You talked about accelerating some of these processes. You've talked about keeping people safe. You've also talked about whether further incentives are involved. This is complicated stuff.

  • 10:55:54

    COXIt is complicated. And I think, you know, as we've heard throughout the conversations, there is the importance of, you know, the FDA working with folks at NIH, working with academia, working with professional society, such as the Infectious Disease Society of America, in order to, you know, make sure that there are pathways out there for the development of new drugs.

  • 10:56:12

    COXAnd as Dr. Bell's talked about, the importance of stewardship so that those drugs are used carefully, so that we preserve our utility as long as possible, and then the importance of infection control, you know, steps that can be taken to slow the spread of resistance in health care settings whether it be doctor's office or hospitals, so all very important.

  • 10:56:30

    SESNOAnd finally -- OK. And finally, Mike Bell, in the seconds remaining, is there a Web page out there where people can find out about hospital-related infections and just be more informed consumers?

  • 10:56:39

    BELLYes. Thank you for asking. If you to go to cdc.gov, cdc.gov/hai -- that's health care-associated infections -- you can go to our main page with all the information for not just patients, but also clinicians, state health departments, hospital systems, you name it.

  • 10:56:55

    SESNOWell, thank you very much. And thanks to our guests today very much. To all of our callers, sorry, we couldn't get more calls in. We had a lot of folks waiting obviously. This is something that cuts very close to home, talking about disease and prevention and the new medicines that are on the way to help us along the way. Thank you very much for listening. I'm Frank Sesno. This is "The Diane Rehm Show."

  • 10:57:14

    ANNOUNCER"The Diane Rehm Show" is produced by Sandra Pinkard, Nancy Robertson, Denise Couture, Susan Nabors, Megan Merritt, Lisa Dunn and Rebecca Kaufman. The engineer is Tobey Schreiner. Natalie Yuravlivker answers the phones. Visit drshow.org for audio archives, transcripts, podcasts and CD sales. Call 202-885-1200 for more information.

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