How can the Food and Drug Administration approve a new potent opioid pain medication at a time when the opioid epidemic continues to claim an increasing number of lives due to opioid overdose? That is the question being raised by critics of this recent decision. The issue underlying this question is whether policymakers and the medical profession can remedy the excessive use of opioid medications in this country without going to the opposite extreme of under-treating pain. Media accounts abound describing non-addict pain patients who are struggling to maintain access to the opioid medication which they have obtained legitimately and on which they are now physically dependent.
The medication that sparked the current controversy – sufentanil – has already been available in an injectable form for 30 years. What was just approved was a new sublingual formulation. A spokesperson for the manufacturer argued that the sublingual tablet provides relief from a painful injury more rapidly than a swallowed pill while avoiding the need for intravenous administration. The FDA Commissioner weighed in by playing the injured-soldier-in-battle card, pointing out that sometimes injections were not feasible. The irony is that an injectable form of a medication is more addictive than a sublingual formulation of the same medication. Nevertheless, sublingual buprenorphine took years to gain approval despite the fact that an injectable formulation was already available.
The argument supporting this particular medication may appear to some as weak. But, while research is underway to identify less addictive pharmaceutical alternatives for pain relief, a fundamental question is whether the further refinement of addictive ones should be abandoned? The swinging pendulum analogy is often invoked around an issue such as the balance between managing pain and preventing addiction. I have not heard anyone arguing that we should return to the days of the 1990’s when, most agree, pain was not being adequately treated. On the other hand, the discrepancy is striking between the large amount of opioid medication used for chronic pain in United States compared to other developed countries.
A few more years will need to pass before it will be clear if we can reach a middle range in this country without swinging to an opposite extreme in pain management. While we are waiting, watch this space for new developments.