CBS 60 Minutes plans to air its interview with a former FDA commissioner that the agency was wrong to allow long term use of opioids for chronic pain treatment.
Dr. David Kessler said the FDA inappropriately extended the market for opioid use in the 1990s despite a lack of studies on safety for long-term use for patients with chronic pain. The former commissioner now says Purdue Pharma, the owner of OxyContin, needs restrictions.
In the realm of take-backs, how long do you think we will need to wait for VA to admit its own culpability in the expansion of opioid use? Some of you may recall the Tomah VA Candyland scandal a few years back that forced VA to flip from excessive and careless opioid use to one that dropped veterans off their prescriptions without tapering.
One thing seems clear, when it comes to policing pharma, our federal agencies seem completely clueless when heading off problems with deadly implications.
Here is an excerpt:
The change in the FDA’s labeled indication for opioids such as OxyContin to long-term use gave big pharma a green light to push opioids to tens of millions of new pain patients nationwide. “You have a system of pharmaceutical promotion that changed the way medicine practiced and no one, all right, stopped it,” says Kessler. The marketing led to an over-prescribing of the dangerous drugs and a river of pills fueled the deadly epidemic, as companies were allowed to sell more and more pills at higher and higher doses. Kessler speaks to Bill Whitaker for a 60 Minutes report to be broadcast Sunday, February 24 at 7:00 p.m., ET/PT on CBS.
In 2001, after Dr. Kessler left the agency, the FDA officially relabeled the powerful opioid OxyContin to be used for an ‘extended period of time’ by chronic pain suffers. Originally approved based on science that showed it safe and effective only when used “short-term”, the label was changed without adequate scientific study. “We don’t know whether the drugs are safe and effective for chronic use,” Kessler says. “The rigorous kind of scientific research the agency should be relying on is not there.” The right to market for the new indication was ultimately granted to a whole class of opioids.
Dr. Andrew Kolodny, an addiction specialist at Brandeis University, has been trying to get the FDA to change the label and limit the marketing of opioids since 2011. He tells Whitaker opioids are essential drugs for pain management at the end of life and for short-term pain needs. “[But]If you’re taking them around the clock…you become tolerant to the pain-relieving effect…you’ll need higher and higher doses,” he says. “The treatment becomes more dangerous and the risk of death goes up,” says Kolodny.
Over the weekend, I watched an interesting piece from Democracy Now about the opioid crisis and the secretive Sackler family that owns Purdue Pharma. A link to that short piece is linked at the top.
What do you think about opioids and the role of big pharma in our every day lives? What will be the next opioid crisis?