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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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  • Jen

    Since so many people develop a resistance to antibiotics, I think it might be wise to invest research in coming up with alternative mainstream ways to treat health issues without antibiotics, creating resources for those in need (i.e. the elderly, children, and those with chronic compromised immune systems). After all, one of the reasons antibiotics are used is that people with immune system issues who have extreme difficulty kicking any particular illness are prescribed these repeatedly. This way companies would avoid making a harder drug and be able to focus on the wellness of the individual in question.

  • christy

    Two thoughts. I understand that the majority of antibiotics are given to livestock. Shouldn’t this conversation include a discussion about this practice and encouraging eating less meat that contains antibiotics? Secondly, The US uses 80% of all pharmaceutical drugs in the world yet is 37th on the list of “healthy countries”. I don’t think we need more technology to, say, make ear infections go away in the office, but get back to the basics of prevention and getting the word out about what these other populations are doing to achieve higher health levels….many falling into the diet and lifestyle category of living. Our bodies come with a greater capacity to heal than we realize.

    • ruckndl

      One reason the U.S. is ranked so low is that we do not have a national health program, and thus, people receive little preventive medicine and primary care. We will not obtain one until we have a publicly funded health care system in at least one state–that’s the way our system works. About 20 states are working on one. I am familiar with SPANOhio.org.

  • Joe

    Not only should the gov’t. “get involved” in antibiotic research, etc. – the gov’t. should basically take over the entire pharmaceutical industry by hiring the “best and brightest”, and setting up R & D facilities in some of the abandoned military bases to invent and develop the next generation of drugs. This would eliminate, once and for all, the drug industry’s constant justification for their obscene profits and prices.

  • Maria Johnson

    This interview shows the true hand of the pharmaceutical industry. If a particular pharmaceutical line fails to generate a boatload of revenue, they want to abandon it or coerce the taxpayer into becoming a ‘cash cow’ for research that seasoned investors don’t want to touch. Like aspirin or acetaminophen, antibiotics are so simple and effective when taken appropriately, that no further development really needs to be conducted on them. Serious trouble arises only when over-use occurs. The love of money and the obsession to acquire more of it can seriously cloud even the brightest minds. Please use all that talent and energy seeking the good for your fellow man. You may very well be the beneficiary of ‘that’ research one day.

  • Maggie

    I believe that antibiotics themselves have/are creating the biggest health epidemic of all and that the money and research needs to be in the area of probiotics not just for digestive issues but on health issues across the board. Healthy bacteria in the body is important for many things including production of vitamins, neurotransmitters, hormones etc. When we take an antibiotic we are taking a bomb in our bodies that does not discriminate against good and bad bacteria and weakens our immune system and inhibits many functions of the body. This opens the door for a cascade of illness to develop.

    The reason that antibiotics are used in livestock is because they cause the animals to gain weight. We have to make the connection to weight gain in humans as well and to many other diseases.

    “Antimicrobials (including antibiotics and antifungals) and other drugs are used by veterinarians and livestock owners to increase the size of livestock, poultry, and other farmed animals. The use of some drugs is banned in some countries due to food contamination or concern about increasing antibiotic resistance in humans and (to a lesser degree) in animals.” Wikipedia.

    Antibiotics are very important and life saving in certain cases but great care needs to be taken to minimize their use and when used to restore the bodies natural flora to a healthy state as quickly and thoroughly as possible.

    • ruckndl

      Make no mistake about it, although our intestines are populated with what is called bacterial flora, the right bacterium can kill people. All medications have side effects. The issue is the cost benefit ratio.

      • Maggie

        Hi and thanks so much for the reply. An analogy. There is a civil war One side is good, fighting for the rights of the people. The other one is evil and wants to kill everyone. The evil side is gaining ground big time and looks like it may win. Big brother realizes what is happening and comes in to help. Does it kill both sides and walk away and let the pieces fall where they may? Does it kill both sides and then try to rebuild a new army? Does it kill the evil army and shore up the good one? Does it send in reinforcements to the good army and totally overwhelm the evil army?

  • Mattyster

    I think it’s very important for the government to invest in R&D of all kinds. Not everything of value is profitable, so since the purpose of business is to be profitable, if we leave all R&D to the private sector much valuable research will never be done. Yet another reason it makes no sense to “run government like a business”.

    • ruckndl

      This is why we have a National Institutes of Health in Bethesda, Md. They fund a large amount of the basic biomedical research done in the county. Their budget is being squeezed as is most non-military enterprises in this military empire.

      • Mattyster

        I agree completely. It’s important for citizens to generously fund objective science. It’s good for everyone, individuals and business.

  • ruckndl

    One way to slow the development of resistant organisms is to stop using antibiotics for marginal benefits in agriculture. The Union of Concerned Scientists had a campaign for that at least a decade ago to no avail. Second, not using antibiotics until the temperature of persons gets over 102-103 degrees is another useful rule of thumb. Third, we have been here before. Perhaps thirty years ago the federal government had an “orphan drug” program for precisely this sort of purpose. I do not know why it died. Perhaps it had a built-in lifespan. Finally, a legitimate role of government is to do what is socially beneficial but that private business cannot or will not do. View it as a public utility.

  • Jane

    What about gut bacteria research instead? Fecal transplants can cure antibiotic resistant c-dif almost immediately.

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