Written by Rosemary Johann-Liang, M.D., FAAP, President, AccessAbility MedCare, LLC on behalf of the National Physicians Alliance Food and Drug Administration Task Force
“Please write me that Z-Pak, Doctor, my son needs something strong to knock that terrible cough right off.” It is 4 pm, your blood sugar is at rock bottom and the thought of launching another “antibiotics do not treat viral illness” speech is too much to bear…but, Do your duty, you tell yourself. This mom’s eyes glint: “I will not take no for an answer.” You feel beaten and question yourself: Will writing a quick Z-Pak prescription so that Mom gets out of my office be so bad? It can’t be that bad?
The answer is actually yes, it can be that bad, bad for the individual patient and bad for our society as a whole.
In “Antibiotics Do’s and Don’ts” (Wall Street Journal, 8/19/2013), Sumathi Reddy describes recent studies documenting the frequency with which doctors prescribe antibiotics for self-resolving diseases, a practice which results in population harm. One examples came from the Centers for Disease Control and Prevention’s “Get Smart: Know When Antibiotics Work” program, where data showed that 80% of the patients who come into a doctor’s office with acute bronchitis (a self-resolving disease for which antibiotics have no evidence of benefit) are prescribed a broad spectrum antibiotic.
Antibiotics are grossly over utilized. This drives the spread of antibiotic-resistant pathogens in our society, which results in serious infectious diseases, particularly in the most vulnerably sick patients. Antibiotics also kill the “good” bacteria which compete with drug-resistant pathogens. Our injudicious use of these medicines has fueled the growth of “superbugs.”
Overuse of antibiotics also harms individual patients. Antibiotics are one of the most common drugs to cause serious side effects ranging from severe allergic reactions to dangerous heart rhythms. If you prescribe an unnecessary antibiotic to a patient with a self- resolving illness (such as colds, bronchitis, and vast majority of sinus and ear infections), you have not provided any benefit, but you have introduced risk and possibly caused harm. And yes, this is very bad indeed. So, what should doctors and patients do and what should we not do?
We all need to change our outlook on antibiotics, shedding the belief that antibiotics are a quick-fix for all sorts of ailments including self-resolving illnesses. We need to learn where antibiotics actually work and where they do not. We need to remember that antibiotics can cause dangerous—even life-threatening side effects. We need to recognize that the growing crisis of antibiotic-resistant pathogens could be accelerated, not solved, by the introduction and widespread use of new antibiotics that lack compelling evidence of benefit.
Stakeholders from academia and the pharmaceutical industry (PhRMA) are currently urging the Food and Drug Administration (FDA) to approve more antibiotics to combat the public health crisis by lowering the evidentiary standard required for drug approval. Pushing for simply approving more antibiotics without evidence of benefit is definitely what we should not do. The National Physicians Alliance and Public Citizen have submitted comment to the Docket Number: FDA-2013-N-0556 in response to FDA’s proposal to lower the evidentiary standard in their Draft Guidance “Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious Bacterial Diseases.” You can read the comment here. Everyone should be concerned that the FDA’s proposal encourages the approval of antibiotics based on inadequate and uncontrolled studies, presumably for a sliver of a very sick population.
However, once such medicines are approved and promoted, we will surely see the continued trajectory of unnecessary overuse of antibiotics for self-resolving diseases. It is head-in-the-sand thinking to imagine that these new medicine will used any more judiciously than current antibiotics, or that they will be marketed less aggressively. The stakes are high: risking harm without evidence of benefit. Moreover, the consequences of inappropriate trial designs in the setting of life threatening diseases are severe: death from ineffective treatment when effective therapies exist. Obviously drugmakers stand to profit from the introduction and broad uptake of new medicines. It is the job of the FDA to ensure robust, evidence-based standards for approval of new antibiotics, and it is our job as doctors and patients to hold the FDA accountable for this life-saving work.
As providers and patients, we should promote and foster appropriate use of antibiotics, infection control strategies, immunization and other disease prevention measures, as well as the development of rapid point-of-care diagnostics (this is key!!) that might limit the unnecessary use of antibiotics. We all must counter pressures put on the FDA to erode the current regulatory standard. We must advocate for a patient-centered FDA—an agency that approves safe and effective antibiotics based on adequate and well-controlled clinical studies. First, do no harm.