Drug companies are struggling to develop new and more effective antibiotics to combat the growing worldwide threat from drug-resistant germs. In this second of her 2-part report on "Battling Superbugs," we examine the looming public health danger, and the challenges drug companies face in bringing new antibiotics to market.
Medical experts watching the rising tide of drug-resistant bacteria have begun sounding the alarms. They say life-threatening infections could jeopardize surgeries, cancer treatment, organ transplants, and many other specialized medical procedures.
And some warn that if new anti-microbial drugs are not developed within the next few years, billions of people will be left nearly defenseless against some lethal bacterial infections.
Such concerns have prompted the Infectious Disease Society of America (IDSA) to call for the development of 10 new antibiotic drugs by the year 2020, an initiative the group calls "10 by 20."
“The 10 by 20 initiative is IDSA’s challenge to the global community to come together to bring the right group of people together. People in government, industry, academia, policy makers to figure out the right combination of incentives that both will motivate companies who want to develop new antibiotics and also to find new ways to manage these products over time," said Robert Guidos, Vice President of IDSA.
Experts say that the hour of reckoning has arrived, and that if efforts to combat the problem are not launched now, dangerous diseases eradicated long ago could make a comeback.
Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention, shared that concern recently with Capitol Hill lawmakers. "If we don't improve our response to the public health problem of antibiotic resistance, we may enter a post- antibiotic world in which we will have few or no clinical interventions for some infections," he said.
Recent studies have shown that there are very few new antibiotics in the development pipeline that would work against lethal infections born out of bacterial resistance such as Methicillin-resistant Staphylococcus aureus, commonly known as MRSA, or carbapenem-resistant Klebsiella pneumoniae, or CRKP for short.
About 2 million MRSA infections have been reported in U.S. hospitals each year since 2002.
Barry Eisenstein is Vice President of Cubist, an American drug company with a new anti-MRSA drug in development, as well as many others.
He says neither the federal regulatory environment nor the pharmaceutical market are favorable for companies trying to develop antibiotics. “The expense and difficulty of doing these...trials for the most important diseases have become very hard and very difficult to the point that many of the big companies have actually gotten out of the field of antibiotic development because they don’t feel that it’s worth the investment," he said.
Some drug company executives contend that financial returns on investments made in a new antibiotic are significantly lower than for other new drugs reaching the market.
“Think about the cholesterol-lowering drug - it’s not uncommon for many of the statins to be bringing in $5 - 10 or more billions per year. For an antibiotic to sell at a half a billion is considered a blockbuster, almost unheard of," he said.
Eisenstein says the push to make "a perfect drug" that is both safe and effective beyond a shadow of doubt has considerably slowed the pace of new antibiotics reaching the market.
To get companies back in the antibiotics game, Eisenstein says two things have to be done.
“The regulatory risk - to decrease the great hurdles to get approval and increase the likelihood of being able to get a drug approved in a shorter period of time, at a higher proportion of probability. And then on the economic side, to enable the companies to have greater incentives to overcome what we call market failure," he said.
Drug companies note that the newest antibiotics, typically, are likely to be prescribed more carefully and used more sparingly - meaning slower sales and smaller profits for the companies that develop them.
Neverthless, public health experts say one new antibiotic has already been approved for use in the United States, and they are hopeful that the ambitious goal of developing nine more by 2020 can be achieved.