Over the objections of its own medical experts, the Food and Drug Administration late last year approved a powerful new prescription painkiller, Zohydro, that could unleash a public health plague on the scale of the one caused by the introduction of OxyContin almost 20 years ago.
An FDA advisory committee, made up of experts in anesthesiology and surgery, voted 11-2 late last year against approving the new painkiller, which is pure hydrocodone, five to 10 times stronger than Vicodin and can be easily crushed for snorting or injection.
No wonder law enforcement, state attorneys general and members of Congress,, including U.S. Rep. Hal Rogers of Kentucky, are trying to undo the FDA's decision.
One of the expert panelists who voted against approving the new drug, Dr. Alan Kaye, a professor of anesthesia at Louisiana State University School of Medicine, said: "I happen to live in the real world, and I would think that the study population is very different than the real world population. And as such, I certainly feel there would be quite a bit of morbidity and mortality that would result."
That's doctor-speak for "this drug will kill a lot of people" — both legitimate patients and abusers who will acquire the drug illicitly.
The drug's pure formulation is an advantage for patients taking it for a long time because, unlike other painkillers, it contains no acetaminophen which can damage the liver. Unfortunately, the maker of the drug, Zogenix, says it will be several years before the extended-release pill can be reformulated to deter abuse by crushing.
OxyContin maker Purdue Pharma reformulated its highly profitable product in 2010 to deter abuse. That, along with a crackdown on pill mills and prescribing practices in many states, has gone a long way to dry up OxyContin abuse.
Unfortunately, heroin, much cheaper and harder to regulate the dosage, is taking its place among those who had become dependent and, sadly, among new users.
Overdose deaths in this country from prescription painkillers rose from about 4,000 in 1999 to 16,000 in 2014. Now heroin deaths also are on a steep rise.
As Rogers knows all too well, some parts of Kentucky have been devastated by the prescription drug plague, costing, he said, his Southeastern Kentucky district "nearly an entire generation when crushable OxyContin was first prescribed. ... I fear this crushable, pure hydrocodone pill will take us backward with a new wave of addiction and tragic, untimely deaths."
It's notable that the expert committee overruled by the FDA raised other concerns about Zohydro aside from the potential for addiction. Also, at about the same time the FDA approved Zohydro it made it harder to prescribe painkillers like Vicodin that have been on the market for years.
Bills to revoke the FDA approval have been introduced in both chambers of Congress. Whether they can overcome the powerful drug lobby remains to be seen.
Meanwhile, Americans are left to wonder whether the FDA serves the public interest or the pharmaceutical industry's bottom line.