The Norman Transcript

Columns

November 3, 2013

FDA should rethink

(Continued)

NORMAN —

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.

— Milwaukee

Journal Sentinel

Text Only | Photo Reprints
Columns
  • Norman Forward builds momentum

    The quiet campaign to build momentum for a citywide public works project is beginning to attract some attention....

    July 20, 2014

  • Tax those trees out of here

    I read your editorial “Pesky red cedars” in the Norman Transcript of Tuesday, July 15, 2014. I have attended two meetings where the problem of the eastern red cedar trees was discussed. Because of the drought conditions in Oklahoma, we ...

    July 20, 2014

  • Make gun safety a health issue

    Quick, are you more likely to die by a bullet or in a car crash? Common sense would seem to suggest the latter. Cars are everywhere. We are an auto-obsessed nation. To be American is to drive — everywhere. Teenagers itch to get behind the ...

    July 20, 2014

  • They just want to be free ... maybe

    Massoud Barzani, president of Iraq’s semiautonomous Kurdistan region, rattled many cages this month when he announced in parliament that the KRG would be moving ahead soon on a referendum on independence from Iraq. If Kurdistan goes ahead ...

    July 20, 2014

  • Congress must accelerate solutions

    Congress has roused itself, at the last minute, and now is scrambling to save the Highway Trust Fund. Better late than never. Better still will be if lawmakers agree to come up with the money to prevent the fund from becoming insolvent. ...

    July 20, 2014

  • The heavy burden of college aid

    Return on investment is a clear measure of what you get for your money. Incredibly, the federal government doesn’t apply that simple concept to the $137 billion a year it spends on college financial aid....

    July 19, 2014

  • James bears weight of Cav’s dreams

    LeBron James has done it all on a basketball court. He’s a great scorer, rugged defender, proven big-play leader and champion. But that might not be enough in Cleveland, where he’ll also need the powers of Merlin the Magician....

    July 17, 2014

  • Steve Boaz.jpg Breathing Rhythm Studio a center for creativity

    Recording engineer Steve Boaz has brought his musical ambitions to fulfillment in a downtown Norman studio.

    July 14, 2014 1 Photo

  • Matt Lauer is so last century

    How about we rename “The Today Show” the “Yesterday Show” since host Matt Lauer asks questions from 1953? Isn’t what Lauer asked GM CEO Mary Barra about whether she’ll do “well” at being simultaneously an executive and a mom about, oh, 30 ...

    July 14, 2014

  • Religion’s role shrinking

    Surveying the response to last month’s Hobby Lobby decision, I was struck by a comment from progressive Massachusetts senator and possible Democratic presidential candidate Elizabeth Warren....

    July 12, 2014