Obama Administration Seeks To Ease Approvals For Antibiotics
RENEE MONTAGNE, HOST:
And let's hear more about drug resistance. Doctors are worried that they will soon run out of drugs to treat many, even most, dangerous infections.
NPR's Richard Knox reports that the U.S. Food and Drug Administration wants to change the way it approves antibiotics.
RICHARD KNOX, BYLINE: Every day, in hospitals all over America, thousands of patients die of infections that used to be curable. But the antibiotics used to treat them aren't working any more.
DR. HELEN BOUCHER: We are potentially alarmed and certainly want to get the message out that the time to act is now.
KNOX: That's Dr. Helen Boucher, an infectious disease specialist at Tufts Medical Center in Boston. She says the problem needs to be solved sooner rather than later.
BOUCHER: Not five years, but shorter-term.
KNOX: Otherwise, she says, surgeons might become reluctant to perform operations that inevitably carry a risk of infection.
BOUCHER: We might be to the point where we have to really be concerned about doing the procedures that all of our patients have come to expect they can have safely in America - hip replacements and appendectomies and cesarean sections for childbirth and all these things that modern healthcare provides.
KNOX: And that's just one possible effect. The FDA's chief drug officer, Dr. Janet Woodcock, says the basic problem is that many large drug companies have abandoned antibiotic research and development in recent years for more profitable lines of business, such as drugs for diabetes, cancer and obesity.
DR. JANET WOODCOCK: The pharmaceutical industry for a variety of reasons has largely gotten out of antibiotic development. So the pipeline, those new drugs coming along, is drying up. And we're really worried we'll have resistant organisms and no medicines to treat them.
KNOX: Woodcock, with the support of leading infectious disease specialists, is pushing for a major change in the way that antibiotics to treat patients with drug-resistant infections are approved.
WOODCOCK: Where we're talking about life-threatening illness, you can do much less study and get those drugs out there, if in fact they'll be limited to those kind of uses.
KNOX: Since the drugs would be intended only for certain patients - not just anybody with an infection - companies wouldn't have to study them in thousands of patients. She thinks that would entice companies back into the market because it would be much cheaper for them to win approval.
WOODCOCK: We would still find the drugs to be safe and effective. But we wouldn't have these massive studies that you would do when you're exposing huge numbers of people.
KNOX: Dr. John Powers of George Washington University doesn't think it's such a great idea to change the standard. Now antibiotics, like all new drugs, must be shown to work and be safe in studies that compare people who get the new drug to those treated with alternatives.
JOHN POWERS: That would be a tragedy of monumental proportions, if somebody would decide to change that standard.
KNOX: Powers says if companies were allowed to try their antibiotics without a comparison group, it'd be like getting half the score of a football game.
POWERS: I don't know if they won or lost unless you tell me what the other team did too.
KNOX: Powers used to work for the FDA evaluating antibiotic drug applications. He says the new plan is something that industry has long wanted.
POWERS: A lot of the discussion around this has been about how to cut corners and decrease the standard by which these drugs should be approved. If we say that we're developing life-saving new drugs, then we ought to be able to show that they actually save lives.
KNOX: Woodcock says she hopes Congress will pass legislation soon to make it easier for the FDA to approve new antibiotics.
Richard Knox, NPR News. Transcript provided by NPR, Copyright NPR.