This week I want to share two articles about opioids and how the FDA plays a part in their approval, regulation and maybe even their problem. The first article is the transcript of an interview by CBS’ 60 Minutes with a drug manufacturer about the FDA’s role in the opioid epidemic. The second article is about how the FDA will require new studies to be completed about the effectiveness of opioids for long-term use. Below you’ll find these articles and my thoughts on their implications.
Disclaimer: The views and opinions expressed below are those of Mark Pew, Senior Vice President of Product Development and Marketing, and do not necessarily reflect the views of Preferred Medical.
This video is an interview with Ed Thompson, a drug manufacturer who has spent many years producing opioids for Big Pharma. Thompson wholeheartedly believes the Food and Drug Administration (FDA) is responsible for starting the opioid epidemic we are now facing in America. He places blame on the FDA because originally opioids were approved only for short-term use and had scientific evidence to back it up. However, in 2001 the FDA changed the label of Oxycontin that allowed it to be available for extended use with no new science.
I’ve heard that FDA approval is the “gold standard” for assessing a drug’s efficacy. And they do have a high bar of proof from what can be a laborious clinical trial process. But what if the “FDA ignited this opioid crisis” by changing the label to support the use of OxyContin for chronic pain to “daily, around-the-clock, long-term… treatment” without any evidence to support it? Well…do you remember Zohydro? The FDA’s advisory committee recommended to NOT approve it and yet the FDA did anyway. Interestingly, it was the MA Governor in 2014 that effectively killed the momentum. Is this interview with a disgruntled industry exec (who shouldn’t be believed) or someone offering an insider’s perspective (as a public service)? I’ve long said there are many stakeholders that share the blame, and because I like alliteration they all started with P’s—Big Opioid Pharma, prescribers, pharmacists, payers/insurance companies, patients and politicians/policymakers (where the FDA would fit). They—and others—are equally culpable. It will take all of us to #CleanUpTheMess then prevent the mess.
Some studies have already shown that opioids are not effective for long-term chronic pain users and can cause tolerance and addiction to the drug. Soon the FDA will require drug companies to test whether opioids should be restricted to short-term use or if they are in fact effective managing pain beyond 12 weeks. However, critics state that the research is already there and the FDA should not be changing the rules around opioids.
Some might say this approach to validating long-term efficacy of opioids is several thousand lives too late. Some might say the evidence does not (and has never) support their chronic use while others might say the evidence is “inconclusive.” Maybe there are even some that say the evidence is clear. There certainly are a number of individuals using them for chronic pain with varying results. I prefer to be optimistic and say this will be helpful additional input to make good clinical decisions. Sometime in the future. Because it’s going to take a while for these studies to be done. There is little motivation for Big Opioid Pharma to move quickly on this initiative (there is no deadline for compliance that I can see). What we as a society are struggling to identify is…how to determine “Appropriate, Not Zero, Opioids.” It was irresponsible to prescribe so many long-term opioids without proper evidence. It is likewise irresponsible to say all opioids are bad and force people off opioids without proper tapering and equipping them with coping skills. We have to find the delicate balance between appropriate and inappropriate use. Quick.
To read everything on my mind this past week, please visit me on LinkedIn at https://www.linkedin.com/pulse/marks-musings-march-11-mark-rxprofessor-pew/.
Until next week,