Two drug experts on why it took the F.D.A. so long to confirm their suspicions about phenylephrine.
 | By Alexandra Sifferlin Senior Staff Editor, Opinion |
Nearly 20 years ago, two pharmaceutical experts at the University of Florida, Randy Hatton and Leslie Hendeles, began a collaboration to look into a popular oral decongestant sold over the counter that they, and many other drug experts, suspected didn't work. |
Hatton, who manned a call center that pharmacists and other health workers across the state used for drug-related questions, regularly received calls about the decongestant, called phenylephrine. "Patients are telling me it's not working," the callers would say. |
Despite multiple studies, a Freedom of Information Act request and more than one petition to the Food and Drug Administration to take action, an advisory committee for the F.D.A. only recently confirmed their suspicions. Now the F.D.A. must decide whether to pull the ingredient from store shelves or demand changes to drug formulations. |
But Hatton and Hendeles argue that this situation is only the tip of the iceberg when it comes to certain drugs that don't work very well. |
"Just ask your local pharmacist about over-the-counter drugs he or she suspects don't work," the duo write in a guest essay. "It's an open secret among many of us who study pharmaceuticals that several ingredients, including ones found in common treatments like Robitussin, Mucinex and certain cough syrups, probably don't work as advertised." |
They argue that while the U.S. government has rules in place to review older drugs that potentially don't work, the process takes too long. The implications are varied and unfortunate, they say. "Right now, Americans spend billions on drugs that contain ingredients that will not help them. That's not just a waste of money — it could mean they are delaying appropriate treatment, which can lead to more severe illnesses." |
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