NORMAN — The United States consumes 99 percent of the hydrocodone used in the world. Opioids are over-prescribed and frequently abused. Overdoses from narcotic painkillers have quadrupled in the last decade.
This epidemic of abuse and addiction is why we think the U.S. Food and Drug Administration made a good decision last week to recommend tighter controls on narcotic painkillers such as Vicodin.
It’s also why we cannot fathom an FDA decision announced the very next day to approve a new high-dose narcotic painkiller without a formula to limit abuse and using a testing method that critics say biases the test in favor of approval.
Zohydro ER was approved even after the FDA’s own advisers recommended against it. It will be the first hydrocodone-only opioid and will be available in doses containing as much as five to 10 times more of the narcotic than other hydrocodone products on the market such as Vicodin, which also contains acetaminophen.
The narcotic in Zohydro ER is designed to be released over 12 hours, but it’s easy to see how it might be abused by people who could crush it, chew it or mix it with alcohol to get high.
“If the FDA was really interested in protecting the public, they would have said, ‘No thanks...we have too many people dying of opioids in this country to justify approving Zohydro,’” David Juurlink, a physician and director of pharmacology and toxicology at the University of Toronto, told John Fauber of the Journal Sentinel and Kristina Fiore of MedPage Today, who collaborated on an article about the FDA decision.
“Minus the pesky acetaminophen, plus the crushability, it’s a disaster in the making.”
We fear that Juurlink might be right — and so did FDA staff. Fauber and Fiore reported that a November 2012 memo from FDA staff predicted that the drug would be abused more than traditional hydrocodone products. The new drug will come in doses as high as 50 mg.
It was approved using a method known as “enriched enrollment,” in which, as Fauber and Fiore describe, drug companies are allowed to weed out people who either don’t respond well to a drug or can’t tolerate it before the actual clinical trial begins. Such a testing method is cheaper and makes it more likely that a drug will be found effective and potentially be approved by the FDA. Some experts think such a testing method is bogus, a poor substitute for more rigorous testing and, especially, for the real world.
Fauber reported earlier this month that for years, FDA officials and drug company executives have gotten together for annual private meetings at expensive hotels through an organization funded by the companies. Whether this coziness influences the agency’s decisions is hard to say, but it certainly calls into question FDA credibility.
What isn’t in doubt is that the FDA went all in on Zohydro. The agency said the drug gives physicians another option for patients who need an extended-release drug and for those who have become opioid-tolerant. And there certainly may be many benefits for a drug such as Zohydro if prescribed appropriately. But we think that FDA got this risk equation backwards, especially since an abuse-deterrent formulation of the drug likely won’t be available for months. From 1999 to 2010, the number of people who died after overdosing on narcotic painkillers rose from about 4,000 to about 16,000, Fauber and Fiore reported.
As Judith Kramer, a professor of medicine at Duke University, said during a hearing of FDA advisers last December, “With treatment of chronic pain, are we really, in the long run, helping people, or are we creating an epidemic? This drug will almost certainly cause dependence in the people that are intended to take it.”
That should have given FDA pause. That it didn’t is worrisome.