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Monday, February 17, 2014

The Search For New Antibiotics

Microbiologist Tatiana Travis works with tubes of bacteria samples in an antimicrobial resistance and characterization lab within the Infectious Disease Laboratory at the federal Centers for Disease Control and Prevention, Nov. 25, 2013, in Atlanta. (David Goldman/AP)

Microbiologist Tatiana Travis works with tubes of bacteria samples in an antimicrobial resistance and characterization lab within the Infectious Disease Laboratory at the federal Centers for Disease Control and Prevention, Nov. 25, 2013, in Atlanta. (David Goldman/AP)

Two drug companies, Roche Holding and GlaxoSmithKline, have announced they’ll ramp up research into antibiotics. They join a handful of other companies. This comes after pharmaceutical companies largely stopped working on antibiotics, citing high costs and little payoff.

But with drug-resistant “superbugs” killing more than 23,000 people each year, according to the Centers for Disease Control and Prevention (CDC), there have been calls for more research in the field.

Here & Now’s Robin Young takes a closer look at the search for new antibiotics with Kevin Outterson, editor-in-chief of the Journal of Law, Medicine & Ethics, who is working on this issue with public health officials in Iowa City.

Interview Highlights: Kevin Outterson

Why companies stopped investing in antibiotics

“They couldn’t make any money. Antibiotics, you know, typically are fairly inexpensive and we’re used to not paying much for them. On top of that, every time you bring out a new antibiotic, public health officials and people in hospitals want to limit the number of times it’s used. So for most businesses, that’s a pretty rough business model.”

On the misuse of antibiotics

“We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times for people just because they have some sort of a common cold — it’s estimated 18 million prescriptions a year — doesn’t help anyone who has the common cold. It’s a complete waste.”

On the rise of antibiotic-resistant bacteria

“It’s frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said on top of that, there’s another 14,000 dying from a horrible disease, intestinal disease, called Clostridium difficile [C-diff] in the United States. Together, that’s larger than the number of people who die in this country each year from AIDS. And we’re not — as bad as things are now, the more troubling aspects, or what might happen in five or 10 years if some sort of a pathogen was resistant to everything we had got out to the population. It sounds like a Hollywood movie.”

On the idea of ‘delinkage’

“The idea of delinkage is that the companies and governments agree — and it’s a contractual measure, they would agree by contract — that the government would pay a certain amount to the company for each year or for each decade that the drug is available. And that number would not change based on the number of people that actually needed it. So it’s like buying an insurance policy but it takes the volume incentive out of the hands of the companies and instead puts it into the hands of the clinicians, the doctors… In the last farm bill, the amount of conservation-related payments over a decade in the farm bill, I believe is in excess of $40 billion. For antibiotics, $2 or $3 billion a year would have an absolutely electrifying effect in fixing this sector and protecting us from a post-antibiotic era. So the amount of money we’re talking about is really quite reasonable compared to what we spend in other areas of conservation. So this is not a subsidy; it’s a different business model to recognize the fact we need antibiotics but we don’t want them oversold.”

Guest

  • Kevin Outterson, professor of law at Boston University and editor-in-chief of the Journal of Law, Medicine & Ethics. He contributes to the blog “The Incidental Economist” and his academic papers can be seen here.

Transcript

ROBIN YOUNG, HOST:

It's HERE AND NOW.

Two drug companies, Roche Holding and GlaxoSmithKline, have announced they'll join a handful of other companies and ramp up research on antibiotics. Now, you might think there's enough of that going on already, but many pharmaceuticals have stopped working on antibiotics because they say they don't make enough money selling them, and they've also been accused of selling too many, creating drug-resistant superbugs that are now killing more than 23,000 people every year which is also requiring more research for newer, more powerful antibiotics.

Kevin Outterson is law professor at Boston University and editor in chief of the Journal of Law, Medicine & Ethics. And he joins us from WSUI in Iowa City, Iowa, where he's working on this problem with public health officials there. Professor Kevin, welcome.

KEVIN OUTTERSON: Thanks. Glad to be here.

YOUNG: Well, let's explain the issue first. Why did companies stop investing in antibiotics?

OUTTERSON: They couldn't make any money. Antibiotics, you know, typically are fairly inexpensive, and we're used to not paying much for them. On top of that, every time you bring out a new antibiotic, public health officials and people in hospitals want to limit the number of times it's used. So for most businesses, that's a pretty rough business model.

YOUNG: Well - and you mentioned that public health workers also don't want antibiotics to be overused. They're both lifesaving and frowned upon.

OUTTERSON: We should think of this as a global resource that needs to be conserved and taken care of. And so antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times to people just because they have some sort of a common cold. It's estimated 18 million prescriptions a year wouldn't - doesn't help anyone who has the common cold. It's a complete waste.

YOUNG: Well, it causes all sorts of problems when antibiotics go into the water system, et cetera, but also it creates these antibiotic-resistant superbugs. And so you have the antibiotic-resistant bugs growing while you had companied stopping research in antibiotics. That can't have been good.

OUTTERSON: No. It's frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said, on top of that, there's another 14,000 who are dying from a horrible disease, intestinal disease called Clostridium difficile in the United States. Together, that's larger than the number of people who die in this country each year from AIDS.

And we're not - as bad as things are now, the more troubling aspects are what might happen in five or 10 years if some sort of a pathogen that was resistant to everything we had got out to the population. It sounds like a Hollywood movie.

YOUNG: Yeah - well, yeah. So there is some legislation in Congress now, something called Limited Population Antimicrobial Drug Approval Mechanism. What is that?

OUTTERSON: Yeah. The LPAD is trying to make it easier for companies to bring a drug to market. And I have to say that I'm not entirely a supporter of this idea, because what it would it definitely would bring more drugs to market, more antibiotics to the market more quickly on the basis of very limited clinical studies. So if we're going to bring new drugs to the market, we have to be all the more careful about the safety features and to be sure that we cannot allow it to be overused in situations in which it's being given to people for the common cold or ear aches. We have to save it for the folks that are really dying in hospitals from multidrug-resistant organisms.

YOUNG: Well - but then don't we get back to the same problem that companies that making - sell drugs don't make enough money if more people aren't using them even if it's for the wrong reason. And with this in mind, you suggested something called delinkage.

OUTTERSON: So the idea of delinkage is that the companies and governments agree, and it's a contractual measure. They would agree by contract that the government would pay a certain amount to the company for each year or for each decade that the drug is available. And that number would not change based on the number of people that actually needed it. So it's like buying an insurance policy, but it takes the volume incentive out of the hands of the companies and instead puts it into the hands of the clinicians, doctors.

YOUNG: It sounds a lot like farm subsidies, you know, that the government would be involved with an industry. But I'm just wondering, when it comes to antibiotics, do you think there are going to be people who worry, I don't want the government holding on to the antibiotics?

OUTTERSON: Well, to mention farm subsidies, in the last farm bill, the amount of conservation-related payments over a decade in the farm bill, I believe, is in excess of $40 billion. For antibiotics, two or $3 billion a year would have an absolutely electrifying effect in fixing this sector and protecting us from a post-antibiotic era. So the amount of money we're talking about is really quite reasonable compared to what we spend in other areas of conservation. So this is not a subsidy. It's a different business model to recognize the fact that we need antibiotics, but we don't want then oversold.

There are other innovations in addition to new drugs that can dramatically help resolve this problem. One would be if we had a diagnostic device that could tell the doctor, with the patient sitting in front of them, this person has a virus - the common cold - not a, you know, bacterial infection. That could save 18 million unnecessary prescriptions a year. On top of that, there's a smart group of doctors in Boston, and they got together some engineers at MIT, and they've created this device that can immediately end the pain of earache for a child who's, you know, screaming in the doctor's office. It's a remarkable device. It's undergoing clinical trials now. That device could eliminate 23 million unnecessary prescriptions of antibiotics in the country.

YOUNG: So is the idea get behind these devices, as opposed to taking of antibiotics?

OUTTERSON: No. The (unintelligible) idea is to do both and. You know, it's belt and suspenders. We definitely need drugs. We need them, and we need to protect them. But while we're spending money on innovation, we should think also about other areas that are innovative, as well, that can reduce the demand for antibiotics.

YOUNG: Kevin Outterson, law professor at Boston University, also editor in chief of The Journal of Law, Medicine and Ethics, commenting on two drug companies, at least, deciding to get back into the business of investing money in researching antibiotics. Kevin, thanks so much.

OUTTERSON: Thanks.

(SOUNDBITE OF MUSIC)

YOUNG: And your thoughts: Do you think the government should get involved in subsidizing research into antibiotics, or into other devices that could cure things like a child's earache? A device that could stop a child's ear ache, and they wouldn't need an antibiotic. Let us know if you think the government should get involved in that kind of research. Go to hereandnow.org. Leave a comment. We'd love to hear from you. You're listening to HERE AND NOW. Transcript provided by NPR, Copyright NPR.


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