Print BCTV: Antibiotic Resistance -- CDC Threat Report; ACA open enrollmentupdate

Antibiotic Resistance

Transcript of BioCentury This Week TV Episode 167

 

GUESTS

Dr. Thomas R. Frieden, Director, Centers for Disease Control

Paul Fronstin, Director, Health Research and Education Program, Employee Benefit Research Institute

 

PRODUCTS, COMPANIES, INSTITUTIONS AND PEOPLE MENTIONED

Biomedical Advanced Research & Development Authority (BARDA)

National Institutes of Health

Food & Drug Administration

United States Department of Agriculture

Health & Human Services

Consumer Union

 

HOST

Steve Usdin, Senior Editor

 

SEGMENT 1

 

STEVE USDIN: 100 years ago, common infections were deadly killers. Is America going back to the pre-antibiotic era? This week, CDC Director Tom Frieden on the threat of antibiotic resistance. And in the Affordable Care Update, what Obamacare means for employees and employers. I'm Steve Usdin. Welcome to BioCentury This Week.

 

NARRATOR: Your trusted source for biotechnology information and analysis, BioCentury This Week.

 

STEVE USDIN: Starting from the first dose of penicillin, harmful bacteria have been evolving resistance to antibiotics. For decades, medicine kept ahead of the bugs, as pharmaceutical companies developed a stream of new drugs. But over the last two decades, two trends have combined to create a public health crisis -- overuse of antibiotics and a slowdown in new drug development.

 

Common infections are again becoming killers, making surgery, transplantation, and chemotherapy more dangerous. New drugs are urgently needed. And there are obvious ways to prolong the life of today's drugs. No single federal agency is in charge of combating resistance. Lack of coordination and accountability may be part of the problem.

 

In previous shows, BioCentury This Week has spoken with senior FDA officials, members of Congress, and biotech companies about promoting the creation of new antibiotics. Today, we'll interview the head of the federal agency responsible for coordinating the nation's public health response, Tom Frieden, Director of the Centers for Disease Control and Prevention in Atlanta.

 

Doctor Tom Frieden joins us now from the Centers for Disease Control in Atlanta, Georgia. Doctor Frieden, how big is the problem of antibiotic resistance? How many deaths is it causing? How many hospitalizations in the United States?

 

TOM FRIEDEN: We're seeing a big increase in antimicrobial resistance. We put out the first ever comprehensive report. More than two million infections a year, more than 20,000 deaths a year, in addition, about 14,000 deaths from C. difficile a year, a big problem, and one that's getting worse.

 

STEVE USDIN: So one of the things that strikes me about this problem compared to a lot of health problems is that in some ways, it's tractable. We've seen this coming for a long time. Antibiotic resistance is really predictable. And there are things that could be done that haven't been done that could have been saving lives.

 

And I want to talk about some of them and how you think that they could be improved. So one obvious one is the massive amounts of antibiotics that are fed to animals to promote growth in this country. According to your report, half of the antibiotics that are produced and consumed in the United States are consumed by animals.

 

Is that really necessary, and is there a way to cut that out?

 

TOM FRIEDEN: Well, first off, I think your first point is a really important one. Although it's a serious problem, it's not too late. There's a lot we can do to slow or even in some cases reverse antimicrobial resistance. So we need to take four key steps. And one of them is being better stewards of the antibiotics we have today. And that includes in the veterinary agricultural world and it includes in humans as well.

 

So antimicrobial stewardship is key. If you've got a farm animal who is ill, of course an antibiotic is very important. But we think the use of antibiotics on the farm is something that could certainly be decreased.

 

STEVE USDIN: In Europe, they pretty much cut it out. Why hasn't that happened here, and shouldn't it?

 

TOM FRIEDEN: Well, there are complicated issues that both the FDA and USDA are dealing with that try to improve use of antibiotics and stewardship in farm animals. And this is something that we do think is important. For example, the outbreak we saw recently of salmonella in chicken was an antimicrobial resistant and a more deadly or more virulent form of salmonella.

 

And that was possibly related to the use of antibiotics on farms. But controlling that isn't going to be so simple. It may include things like giving better vaccines to farm animals, so they don't need treatment in the first place.

 

STEVE USDIN: So the other thing you talk about stewardship is the use of antibiotics, overuse in people. About half of the antibiotics prescribed to people are inappropriate, according to your report. What can we do to get a better handle on that?

 

TOM FRIEDEN: We've been looking at antibiotic usage in the U.S. And we're very concerned about use in humans. As you say, about half of all antibiotics are either unnecessary or inappropriate. One place where we think we can make a big difference is in hospitals.

 

And we're encouraging every single hospital in America to have an antibiotic stewardship program to look at the pattern of antibiotic use, the pattern of infections, and to make sure that antibiotics are only used when they're needed, in the drugs that are needed, and only for as long as needed. And that kind of program, that stewardship program, can actually save a lot of money and prevent serious infections.

 

STEVE USDIN: And you talked about encouraging hospitals to do that. One of the key things on that also is surveillance. And again, looking at Europe, I can click on the European CDC website. And I can see what antibiotic resistance is at the national level, even down to the local level for specific pathogens, again, specific drugs.

 

And we don't seem to have that kind of data here. Do we need to do a better job of surveillance and reporting?

 

TOM FRIEDEN: We do need to track resistance much better than we're doing it now. And that includes both individual hospitals, individual states, and nationally. One of the things that's going to be really important for that are some newer molecular tools. For some microbes, we can now take a sample, not wait for it to grow up in the lab, do tests, and determine whether or not it's resistant.

 

That's really important because that will allow us to choose the right drugs and use better drugs, narrow the use of drugs to only those that are needed. In fact, we've got new tools, like rapid molecular sequencing. In just three or four hours, you can sequence an entire genome with this.

 

As we learn more about it, we'll be able to figure out what part of the genome predicts resistance and then which organisms have that, so we can choose the right drugs and only use the drugs that are necessary for that patient and sometimes rule out that they've gotten an infection at all from better testing. So advancing molecular detection, figuring out how to use the microbial genome to unlock the power of that genome to better detect respondent prevent infections and reduce resistance I think has a lot of potential.

 

STEVE USDIN: Thanks. We've been discussing the growing health threat from antibiotic resistance. CDC's estimate of deaths from antibiotic resistant bacteria is sobering. More with Doctor Tom Frieden in a moment.

 

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NARRATOR: You're watching BioCentury This Week.

 

 

SEGMENT 2

 

STEVE USDIN: We're talking with CDC Director Tom Frieden. Doctor Frieden, the CDC's threat report identifies three pathogens that are of most urgent concern. I'm wondering if we could talk about each one in turn very briefly, why they're a concern, and what can and should be done to make things better, starting with C diff. You mentioned that already.

 

TOM FRIEDEN: Well, C diff is an infection that occurs because of antibiotic use. When someone uses antibiotics or has contact with someone who's used antibiotics, they can get this infection that can be very severe. There are 14,000 deaths a year that mention C diff and are related to C diff.

 

And this is an infection, which, like others, we can greatly reduce. We've seen parts of the U.S. and other countries improve antibiotic use, improve the cleaning of the environment, as it can spread from patient to patient, and drastically reduce C diff levels by 50% or more. So we know we can make progress with C diff, but it's going to require a few things. One is better use of antibiotics.

 

Two is better diagnosis, what we call detect and protect. Find the patients and protect them and others from them. And three is environmental cleaning. We're learning better how to clean hospitals and nursing homes so that it doesn't spread from one patient to another. So with these three things, we think we can actually reduce C diff.

 

But right now, it's a serious problem. It causes lots of hospitalizations, lots of deaths, and many of them are preventable.

 

STEVE USDIN: So the second one is CRE.

 

TOM FRIEDEN: CRE, or carbapenem-resistant enterobacteriaceae, this is really a nightmare bacteria. This is a type of organism that's resistant to all or almost all antibiotics. And it can spread rapidly, not only between patients but between different species of microbes. This is very unusual.

 

We haven't seen this before. We've seen now this class of resistance. It's spreading. It's now in 44 states. Just 10 years ago, we were seeing the first cases. And it reminds us that we really are all connected globally.

 

It emerged in other countries and came here. And now, it's spread all over the U.S. But again, there's good news here, because we can reverse it. We've seen in Florida and in another country where comprehensive programs were put in place. Again, that same detect and protect, we've driven it down.

 

So it's possible to stop it. But if we don't, we're looking at really a terrible scenario. If this gets out into the community -- and now, it's mostly in hospitals -- if it gets out into the community, then routine urinary infections and other simple infections could become very difficult to treat and require intravenous antibiotics or expensive new generation antibiotics, which we would be at risk of losing as well.

 

So this is truly a nightmare bacteria. We have sounded the alarm, partly because it's so serious but partly because it's not too late. We can reverse it.

 

STEVE USDIN: So the third one on your urgent list is kind of a surprise. I think it's something most people would've thought had been dealt with a long time ago. It's gonorrhea.

 

TOM FRIEDEN: Yes, I think people would be surprised to know just how many gonorrhea infections there are in the U.S. and around the world. And it doesn't just have the reproductive tract infection. It can also cause pelvic inflammatory disease, it can cause joint infections, it can spread from the routine kind of infection to a more serious kind.

 

And what we're seeing around the world is a growing resistance to the last good drugs we have for this organism. So what we've done is adjust our treatment recommendations to try to preserve the last good drug we have for these.

 

STEVE USDIN: So all three of these things are really urgent, bad situations. And they could get far worse. But all three have something common also, as I said at the start. There are things that could be done about them. Are we responding as a nation on the scale that we should, with the resources that we should, with the coordination and leadership that we should to deal with these?

 

TOM FRIEDEN: There's really a lot that's being done. We're working very closely across the federal government. The National Institutes of Health is exploring ways to bring new antibiotics to market. Another part of the Department of Health and Human Services called BARDA is investing in new antibiotics. We're working with the private sector to look at new ways to bring antibiotics to market and with Congress at ways to increase the incentives for companies to invest in new antibiotics.

 

We're also working with hospitals throughout the country. For the first time ever, we have essentially every hospital in the country tracking hospital acquired infections and beginning to think about how they can implement effective stewardship programs and reduce those infections. We work with the voluntary sector as well.

 

Groups like Consumer Union have been real leaders in bringing out the problem. But this is a problem that you can't just simply say, well, do this one thing and it's going to go away. We need a comprehensive approach.

 

STEVE USDIN: Clearly. We're going to get back to that. First, even with the best stewardship, evolutionary pressure will make antibiotics ineffective. While there's a need for continuous development of new antibiotics, the pipeline's been drying up in recent years. We'll talk about how to get more new drugs to patients in just a moment.

 

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SEGMENT 3

 

NARRATOR: Now, back to BioCentury This Week.

 

STEVE USDIN: Overcoming the threat posed by antibiotic resistance -- today we're talking with CDC Director Tom Frieden in Atlanta. Later, we'll get an update on what the Affordable Care Act means for employers and employees. Doctor Frieden, there's a tremendous need for new drugs, new antibiotic drug development. Companies haven't stepped up to the plate.

 

They're not doing enough. What needs to be done? Does the government need to do something to create more incentives, to do anything else to increase antibiotic drug development?

 

TOM FRIEDEN: Creating new antibiotics isn't easy. It may be that the lowest hanging fruit has already been found in terms of effective antibiotics. But it's important. We need to restart the pipeline. We need to incentivize companies. We need to have a partnership between the government and the private sector.

 

And a lot of that is happening, but it's not going to happen overnight. We don't expect a lot of new drugs out there, new classes of drugs for at least another five or 10 years. And that's why it's so important that we preserve the drugs that we have today.

 

STEVE USDIN: And then talking about stewardship and the need to preserve the drugs that we have today, is part of what we need more not only surveillance but accountability on the part of the hospital system, on the part of physicians, on the part of even parents to really make this a higher priority? It seems like nothing important is really going to get done if there isn't some level of accountability somewhere.

 

TOM FRIEDEN: We really all have a role to play. Patients need to understand that more drugs is not always better drugs. The right treatment is the best treatment. That may not be antibiotics for every infection, for every illness. Doctors need to have better stewardship of antibiotics.

 

Hospitals and healthcare systems need to systematically track and improve their antibiotic stewardship and use in anti-microbial patterns. We need to invest in tracking, preventing, and stopping outbreaks of drug-resistant organisms. After all, it costs us about $20 billion a year to care for resistant organisms in our healthcare system.

 

So we do need to invest more in prevention. And that's what we're trying to focus on.

 

STEVE USDIN: And we're talking about invest in these costs. Does CDC have the money that it needs to do the surveillance that should be needed to use more advanced technologies that you mentioned and to do the kind of campaigns that are needed to promote stewardship?

 

TOM FRIEDEN: The President's budget for fiscal '14 has a request for an increase of $40 million, so we can better use advanced molecular techniques to find things like resistant organisms and stop them faster. But whatever resources are entrusted to us, we're going to use them as effectively as we can to protect Americans, because that's what we're here to do.

 

STEVE USDIN: Did sequestration affect your ability to protect Americans from antibiotic resistance?

 

TOM FRIEDEN: Sequestration was a big problem. It reduced our ability to continue programs, it cut back on our efforts. After all, resistant organisms and other health threats didn't get cut 5%. But we did, and that reduced our ability to support state and local governments, hospitals, healthcare providers at finding, stopping, and preventing health threats.

 

STEVE USDIN: The other issue about microorganisms is that they don't know anything about national borders. A lot of these are international issues. Is the world community doing enough? And is the United States doing enough to be able, for example, to detect emerging threats in Asia or Africa or other unexpected places?

 

TOM FRIEDEN: We coordinate closely with countries around the world. But much more is needed. There are too many blind spots out there. There are too many places where dangerous microbes and other health threats may be spreading, and we're not tracking it. So what we do at CDC is, we help other countries build their systems to find, stop, and prevent health threats.

 

That helps them, and that helps us, because we are all connected by the air we breathe, by the water we drink, and by the food we eat.

 

STEVE USDIN: You say that more needs to be done. Is that something where, again, the United States needs to take more of a leadership position? And do we need to have more investment in that?

 

TOM FRIEDEN: We're looking very closely at that, because we do think more is needed to address those blind spots around the world, to help countries find threats so that they can protect themselves and us. We've had some pilot programs in several countries to extend that beyond what we've done in the past. They've gone very well.

 

There is good cooperation across the U.S. government on this. And we think more is possible and needed in this area.

 

STEVE USDIN: Thanks very much. Coming up in this week's Affordable Care update -- website glitches have put the spotlight on the individual market. But most Americans get insurance through their employers. What does the ACA mean for them?

 

NARRATOR: Now in its 21st year, visit biocentury.com for the most in-depth biotech news and analysis. And visit biocenturytv.com for exclusive free content.

 

SEGMENT 4

 

STEVE USDIN: It's open enrollment season, and employees around the country are learning what their health insurance options will be in 2014. To discuss the intersection of Obamacare and employer health coverage, I'm joined by Paul Fronstin of the Employee Benefit Research Institute, a nonprofit research and educational organization.

 

Paul, employees are getting these letters around the country, telling them what their options for next year are for open enrollment. And a lot of them aren't liking what they're seeing. And some of them and some employers are blaming the Affordable Care Act for it. Is that legitimate?

 

PAUL FRONSTIN: Well it's partly to blame. Employers have been making changes to their health plans for years. This is nothing new. But the Affordable Care Act is affecting some aspects of health plan design. It's been taking place over the last couple of years, and it's continuing to be implemented. So some of the changes people are seeing now can be blamed on the Affordable Care Act.

 

STEVE USDIN: What are they, and how does that work?

 

PAUL FRONSTIN: For example, employers have to offer essential health benefits. So employers that may not have been offering certain benefits before have to offer them now. Certainly the mandate has been delayed, so that's not something that people would necessarily see at this point.

 

STEVE USDIN: The Employer Mandate.

 

PAUL FRONSTIN: Employer Mandate, that's right.

 

STEVE USDIN: So the fact that they have to have these essential health benefits, that's a minimum standard. That might make some insurance policies more expensive.

 

PAUL FRONSTIN: That may make them more expensive. Some of the taxes that are being added may make them more expensive. And the cost of health coverage has been going up already. Even though the cost increases have been moderating -- this year they were 4% -- they're still running about four times the rate of inflation. So as long as they're outpacing inflation, people feel that in their wallets.

 

STEVE USDIN: So you mentioned the Employer Mandate has been delayed for a year. But there's still reports out there that some employers are limiting hours of employees so that they will be considered part-time workers and won't fall under the employer mandate when it kicks in next year, or that they are reducing the number of employees so that they won't be above that 50 person threshold that makes them some subject to the Affordable Care Act. Is there any truth to that?

 

PAUL FRONSTIN: They're anecdotes, and I think the anecdotes are true. But are these trends? We don't know yet. There's a lot of factors that go into a worker's mix of employees, whether full time and part time, and how that varies across the country. So it's hard to say that it's only because of the Affordable Care Act that that's taking place.

 

Right now, we just know the anecdotes. And the anecdotes that you tend to get early on tend to be the bad stories rather than the good ones.

 

STEVE USDIN: Are employer's going to dump employees onto the exchanges rather than continuing to offer their own insurance?

 

PAUL FRONSTIN: I think when the Affordable Care Act first passed, the initial reaction was that it makes lot of sense to do that, because the penalty is a lot less than what employers are spending on health benefits. But then reality kicked in, reality being that employers had been offering this benefit, health insurance, voluntarily for as long as they've been offering it.

 

STEVE USDIN: Since the Second World War.

 

PAUL FRONSTIN: Basically. And they've been offering it for business reasons. They're concerned about recruitment and retention. They're concerned about worker health and how it affects productivity. And none of those business reasons have disappeared.

 

So the reality is employers are still wrestling with wanting to offer a good benefits package to be competitive in the labor market. Yet they're being squeezed because of the cost increases. So they're trying to manage basically between a rock and a hard place on how to offer valuable benefits while managing the cost.

 

STEVE USDIN: So is it inevitable then, Affordable Care Act or not, that basically health insurance options for employees, they're just going to get worse?

 

PAUL FRONSTIN: It's hard to generalize that, because you see a couple things happening. One, clearly people are paying more for their insurance, and they're paying more for health care services when they need them. But there are exceptions for that.

 

For example, oftentimes employers have been carving out coverage for diabetes. In other words, if you have diabetes, oftentimes you'll see that your drugs are free. And other high valued services are free, because employers are trying to make sure that if you have a certain disease, you stick with the treatment regimen, don't have complications, and stay out of the hospital.

 

And employers are introducing wellness programs. In some cases, they're providing incentives that look like carrots. And sometimes they look like sticks, but ultimately, to get workers healthier, which would be a win-win for the employer and the employee.

 

STEVE USDIN: And the Affordable Care Act comes in that also, it gives employers, it gives insurance companies new carrots and sticks for wellness.

 

PAUL FRONSTIN: It gives them the ability to increase the size of the incentive, basically from 20% of the cost of the coverage to 30%, and in some cases, like in the case of smoking, 50%.

 

STEVE USDIN: So basically what you're saying is that employers will be able to say, look, if you're not a smoker, your insurance is going to be a lot cheaper than if it is. Paul, there's a lot of talk and a lot of attention now on the healthcare exchanges and the debacle that they've been from an IT standpoint. But the idea of exchanges is broader.

 

There are employers who are looking now at setting up exchanges for their employees. How do those work, and how are they different from the federal and state exchanges?

 

PAUL FRONSTIN: They're called private exchanges. And keep in mind, like you said, they're not new. They've been around a long time. The federal government has been offering a private exchange for 50 years. We just don't call it a private exchange.

 

Basically the way they work is that the employer - you could drop the term "exchange" -- and just say that employers, when they're offering a private exchange, are offering their employees more choices and more transparency. So oftentimes they're offering people a choice of 20 or 25 different health plans from five different insurance companies. And there is much more information about the cost of the various options and lots of tools that people can use to help them navigate their choices to make informed decisions about their health insurance.

 

STEVE USDIN: And those exchanges, some of them have been online, like the one that the federal government works in. They work. It's not like healthcare.gov and the state exchanges that have been plagued with so many problems.

 

PAUL FRONSTIN: They work, but they're are a lot different, because they're not verifying your income, they're not checking to see what size of a subsidy you may get, they're not checking to see if you're eligible for Medicaid. It's simply an enrollment tool and a tool that provides you the options that are available to you.

 

STEVE USDIN: From the employer's standpoint then, what are some of the kind of new things, the innovations that they're looking at bringing in to try to improve care and reduce cost?

 

PAUL FRONSTIN: Well, they've been offering wellness programs many years. But one of the new twists on wellness programs is biometric screening. So employers will provide incentives for you, on a voluntary basis, to go out and get your blood checked. And a third party will look at that and contact you and talk to you about what they may have found so that certain diseases are identified early.

 

And you could take some actions to avoid further complications that may be more costly.

 

STEVE USDIN: So they might say, for example, you've got high lipids. You should go see your doctor about getting on a statin or something. Is that the kind of thing you're talking about?

 

PAUL FRONSTIN: Exactly.

 

STEVE USDIN: And is there a concern that among employees that their employers are going to find out that they have a health condition that's very expensive or that might interfere with their work and that might actually be used against them?

 

PAUL FRONSTIN: There are concerns about privacy, but employers have gone to great lengths to make sure that the third parties they're using for these programs have a firewall between the employer and the third party so that information is not shared between those parties.

 

STEVE USDIN: Well, thanks very much. That's this week's show. I'd like to thank my guests, Tom Frieden and Paul Fronstin. Remember to share your thoughts about today's show on Twitter.

 

Join the conversation by using the hashtag #biocenturytv. I'm Steve Usdin. Thanks for watching.

 

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