Urgently Needed Antibiotics Research Is Put on Risky Fast Track

Wednesday, June 05, 2013
GSK, winner of antibiotics deal (photo: Kirsty Wigglesworth, AP)

With hospitals and doctors in need of solutions to combat so-called “super-bug” infections, the federal government wants to fast-track new medications—and that has some health experts concerned.


For instance, the Department of Health and Human Services plans to pay pharmaceutical manufacturer GlaxoSmithKline $40 million (and possibly upwards of $200 million) to help it develop medications to combat antibiotic resistance and biological agents that terrorists might use.


“We are facing a huge crisis worldwide not having an antibiotics pipeline,” Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, told The New York Times. “It is bad now, and the infectious disease docs are frantic. But what is worse is the thought of where we will be five to 10 years from now.”


Supporters of speeding up new drugs want new antibiotics immediately tested on severely ill patients, rather than taking the customary and legally approved route of conducting time-consuming studies involving potentially thousands of patients. A number of lawmakers have said they are prepared to support legislation that will allow for expediting the process. The alternative, supporters say, is for physicians to use older, more dangerous remedies, like Colistin, an antibiotic that can cause kidney damage.


Critics, however, warn that similar life-threatening outcomes could result from rushing new medicines to market before they’ve been sufficiently tested.


“There is really no way of knowing how these drugs are going to perform,” Dr. John H. Powers, a former FDA antibiotics reviewer who is now an associate professor at George Washington University in Washington, told the Times.


Tens of thousands of people every year die from infections that are resistant to antibiotic treatment. Most of those infections are acquired in hospitals.

-Noel Brinkerhoff


To Learn More:

Pressure Grows to Create Drugs for ‘Superbugs’ (by Barry Meier, New York Times)

GSK and BARDA Collaborate to Develop New Antibiotics (by Marie Daghlian, Burrill Report)

Drug Pipeline for Worst Superbugs "On Life Support": Report (by Julie Steenhuysen, Reuters)

“Near Absence” of Antibiotics to Combat Deadly New Bacterial Strains (by Noel Brinkerhoff, AllGov)


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