The number of new antibiotics being developed is “alarmingly low,” according to a new report by the Infectious Diseases Society of America.

By:  Global health reporter, Published on Fri Apr 19 2013 in
 

The world is running out of drugs that can kill “superbug” bacteria — and the number of new ones being developed is “alarmingly low,” with only four major pharmaceutical companies still in the antibiotic business, according to a new report released Thursday.

Superbugs are bacteria that have developed resistance to multiple antibiotics and our war against them is becoming increasingly asymmetrical; as they strengthen their ranks, we are in a process of disarmament.

Since 1998, only four antibiotics have been pushed out by the world’s 11 biggest drug companies, according to the report by the Infectious Diseases Society of America (IDSA) — and today, only four Big Pharma companies are still working on antibiotics at all.

The looming antibiotic shortage is especially dire when it comes to gram-negative bacteria, a particularly worrisome group that includes E. coli and Carbapenem-resistant Enterobacteriaceae, or CRE, which the U.S. Centers for Disease Control called a “nightmare” superbug last month. For gram-negative superbugs, there were only seven antibiotics in an advanced stage of development as of early 2013 — and one belongs to a drug company that recently filed for bankruptcy.

“(The result) did surprise us somewhat and certainly disappoints us,” said lead author Dr. Helen Boucher, an IDSA board member and associate professor of medicine at Tufts University. “It’s been 30 months since the last antibiotic was approved and it doesn’t really go very far to address the problem of gram-negative resistance that we’re so concerned about.”

In 2010, the IDSA launched a “10 X ’20” campaign calling for 10 new antibiotics by the end of the decade. Their new report, which will be published in the journal Clinical Infectious Diseases, surveys the current pharmaceutical landscape using data from public databases, company websites and interviews with drug companies.

The authors found that only two new antibiotics were approved in the United States since 2009, when they last did a status check on the industry.
The report’s findings are troubling but not altogether surprising, said Dr. Gerry Wright, an expert on antibiotic resistance and director of McMaster University’s infectious disease institute. Despite the growing superbug threat, the antibiotic pipeline has been drying up for some time now, he said.
“Everyone knows that there’s this massive problem on the horizon,” said Wright, who was not involved with the report. “The challenge is nobody knows how to fix it.”

Boucher said drug company representatives cited two major roadblocks when it came to antibiotic development; the first was the low return on investment. Drug development takes a lot of time and money and antibiotics are typically prescribed for just a few days; drug companies prefer investing in drugs that treat chronic or lifelong diseases.

Antibiotics are also cheap compared to other drugs. The current health-care system accepts the $50,000 price tag on cancer drugs that might give patients a few extra weeks but not “$5,000 for a course of antibiotics that might save their lives,” Wright said.

“That’s the insanity of the system,” he said. “Until the drug companies feel they can make some money, they’re not going to invest in this area.”

The second problem cited by drug companies is the “lack of regulatory clarity” from the U.S. Food and Drug Administration, Boucher said; it has become increasingly difficult for antibiotics in development to surmount all the necessary regulatory hurdles.

Even still, Boucher firmly believes the superbug problem can be turned around with a three-pronged solution: better infection prevention, more responsible use of antibiotics and a replenished drug pipeline.

“I think we can do it,” she said. “I don’t think we should accept going back to the pre-antibiotic era.”

[Full article published by the Toronto Star]