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.