Squash ‘Superbugs’ With Fast-Track Antibiotics Approval
In the battle between humans and infectious bacteria, humans have had the advantage, at least since antibiotics were introduced into our arsenal 70 or so years ago.
Now, however, our weapons appear to be turning against us as germs have found ways to outfox antibiotics.
Consider a germ-altering gene known as NDM-1. As reporters Jason Gale and Adi Narayan explain in an article in the June issue of Bloomberg Markets magazine, this bit of DNA is showing up in dozens of bacteria strains, from E. coli to cholera -- even outside hospitals. The gene carries as many as nine mechanisms for resisting even the world’s most potent antibiotics.
The renegade gene, which has been known to scientists for only a couple of years, seems to have arisen in India (NDM-1 stands for New Delhi metallo-beta-lactamase-1), but traces of it have been found in at least 40 countries. It has been causing stubborn, sometimes deadly, infections.
What can be done? One challenge is to eradicate the conditions that foster NDM-1’s spread. These are especially prevalent in India, where poverty, crowding and poor sanitation allow germs to travel widely, and where antibiotics are cheap and widely available without a prescription. When people use these drugs too often or take inadequate regimens, germs get exposure to the medicine without being killed by it -- allowing them a good opportunity to develop a resistance.
So India, though it isn’t the only country where antibiotics need to be more tightly managed, has more than the average amount of work to do. A government task force last year recommended that pharmacists be required to keep records of antibiotics sales, to make it harder for them to flout the requirement that customers have a prescription. The task force also called for the most powerful antibiotics to be restricted to hospitals only.
The international medical community should do its best to assist with these efforts and, especially, help Indian doctors keep a clear, public count of the number and kinds of bacteria developing a drug resistance via the NDM-1 gene.
A second challenge is to keep a steady stream of new antibiotics in the pipeline, and this is where the big pharmaceutical companies based in Europe and the U.S. come in. Sadly, the marketplace gives drugmakers little encouragement to do this work. Antibiotics, used irregularly and for a week or two at a time, aren’t as profitable as medicines to treat chronic ailments, such as high blood pressure. And the sophisticated new antibiotics the world most urgently needs would be used only rarely, to kill bacteria that are resistant to existing drugs.
As the Infectious Diseases Society of America, an organization of doctors, recommends (and as Bloomberg View has argued before), the development of new antibiotics should be supported with research grants and rewarded with tax credits.
We are glad to see that Congress has included the bipartisan Generating Antibiotic Incentives Now (GAIN) Act in the FDA user-fee reauthorization bill that is due to be passed by October. GAIN would extend by five years a company’s ability to exclusively market a new antibiotic, and it would direct the FDA to streamline its process for approving such drugs.
The FDA is considering a high-speed pathway for some new antibiotics, which would allow for limited approval based on only a small clinical trial, rather than the two large ones usually required. Drugs sanctioned in this manner would be restricted for use in a narrow population -- presumably, people with a specific drug-resistant infection. But the tradeoff would be worth it: According to Robert Guidos, vice president of public policy and government relations for the IDSA, this approach would help at least seven companies bring new antibiotics to market, including one that has an antibiotic in the works to fight NDM-1.
Here’s something to keep in mind: Without effective antibiotics, low-risk, routine medical procedures could suddenly become high-risk -- all because of the threat of deadly infection. Better to fight NDM-1 and its ilk now than to give them a better chance to penetrate our defenses.
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