SUNDAY, JUNE 24, 2018

Experts fear antibiotics not being advanced fast enough

Fewer and fewer antibiotics are being restocked, leading some doctors to fear that this practice could have a devastating overall impact.

At the core of the problem is the debate over whether drug companies seeking U.S. Food and Drug Administration approval for antibiotics should be required to run much more stringent clinical trials, according to a report.

The FDA believes they should, with officials citing advances in the science of clinical trial design and a series of humiliations involving trials for drugs the agency had approved, including the antibiotic Ketek.

Ketek, a ketolide antibiotic manufactured by Sanofi-Aventis, was initially approved the the FDA in 2004 and touted as the first of a new class of antimicrobial agents that could circumvent antibiotic resistance, reports.

The drug, however, was eventually linked to dozens of cases of severe liver injury and was subject to a series of increasingly urgent safety warnings, sparking two Congressional investigations of the FDA's acceptance of fraudulent safety data and inappropriate trial methods when it reviewed the drug for approval.

“We don't want to approve products that don't work,” Dr. Joshua Sharfstein, the FDA's principal commissioner, told

Drug companies are also abandoning the antibacterial business, citing high development costs, low return on investment and the stalemate with the FDA.

The pharmaceutical industry and some infectious-disease doctors say the proposed rules will make it so difficult and expensive to gain approval for new antibiotics that the few remaining companies will abandon the field altogether.

The debate over setting new guidelines for antibiotic clinical trials has lasted almost a decade. In two years, there have been at least nine meetings among the FDA, pharmaceutical industry scientists and doctors, but the group has agreed on little besides the dire need for new antibiotics.

Doctors fear the United States will eventually be defenseless against bacteria that can resist all existing antibiotics, which would mean more victims of illnesses like staph infections that drugs used to conquer easily, reports.

Dr. Brad Spellberg, an expert on antibiotic resistance, called the situation catastrophic.

“I fear the conversation may be beyond all hope,” Spellberg told “We've hashed and re-hashed the same things over and over… The end result is exactly the same: No drugs.”

Infectious disease physician and scientist Dr. Lou Rice, vice chairman of the Department of Medicine at the University Hospitals of Cleveland, also stressed the need for antibiotics.

“People have to understand how much of our medical way of life is completely dependent on antibiotics,” Rice told “We would have no transplants without antibiotics. Much of cancer we are able to treat because of antibiotics…This is a big problem that will alter our way of life.”