Antibiotics: The Broken Promise (Part 6)
In the previous installments of Antibiotics: the Broken Promise, we’ve painted a bleak picture for the future of a precious resource. But we can change the course of the future. There’s already legislation in the works. As our Katie Gibas tells us, in order to succeed, every individual must take personal responsibility.
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UNITED STATES -- What will happen with antibiotics is up to us and what course of action we decide to take. But there’s no question that sickness is going to get worse before it gets better.
"It's my father, in his lifetime, that they didn't have antibiotics, so when you're talking about, let's say my grandchildren someday, will they see a time when there aren't good antibiotics for many of their infections. We hope that won't happen, but I think it's a worry. And of course the time to do something about it is now before the cat's completely out of the bag," said Helen Jacoby, St. Joseph’s Infectious Diseases Medical Director.
We’ve already established that it’s going to take discipline from both doctors and patients. But it’s also going to take legislation. The Generating Antibiotic Incentives Now or, GAIN Act, was passed last year. It gives drug companies longer exclusivity periods before generics can come out and a fast track FDA review of the product.
“The actual components in GAIN are probably not going to have the immediate impact that we would like, but they're a great first step and a sign that Congress gets that there's a big problem in this area,” said Dr. Brad Spellberg, Harbour-UCLA Professor of Medicine.
As of right now, GAIN is the only law dealing with antibiotic resistance.
Other legislation has been introduced repeatedly but never voted on.
The Limited Population Antibacterial Drug Approval or LPAD proposal would allow for smaller FDA studies that would speed up getting a drug to market and drastically reduce costs.
Spellberg said, “For directing the development to where the public needs the drugs, you would have much faster studies, much smaller studies and much less expensive studies, so it would serve as a powerful economic incentive.”
The Strategies to Address Antimicrobial Resistance or STAAR Act would create a federal network to monitor antibiotic use.
“There's not a transparent system for reporting and collecting that information, so the people who have tried to get the estimates have had to get at it by various, circuitous routes and whatever you come up with, people will argue over whether it is accurate,” said James Johnson, Infectious Disease Society of America.
“We lack the basic infrastructure in this country to map where resistance is occurring, what kind of bacteria we're having problems with, where those bacteria are located and where antibiotic use is occurring in the United States,” Spellberg said.
Europe already has a similar monitoring system in place called the EARS-net. It tracks all antibiotic use and resistance by country and bacteria.
The legislation here in the U.S. was introduced several years ago, but has not been brought for a vote.
Spellberg said, “I think STAR is perceived to be not necessarily budget-neutral, whereas I think GAIN is perceived to be budget neutral. And right now, I think the thought is, if we have to invest in building this infrastructure of surveillance network sites, that’s something that's not attractive if it's not budget neutral.”
But health professionals and scientists say legislators must start taking action before it’s too late.
“Let's say we turned around antibiotic discovery tomorrow, it's still 10 years before you discover a new drug and it hits the market. So you're looking at a decade lead-time minimum, assuming we turn things around tomorrow. We're making slow, at best, incremental progress in terms of infection prevention and antibiotic stewardship, protecting out antibiotics,” Spellberg said.
And to do that, we need to start thinking of antibiotics as precious limited resources.
Spellberg said, “When you use an antibiotic, it affects how the antibiotics are going to work in me. And that's not true of any other drug. The spread of resistance affects all of us. So these are a shared, collective public resource, and we have not been treating them like that. And that's how we need to begin to think of them.”
Experts say once we’re able to change attitudes, they’re positive the political action will follow.