There is finally a bit of good news about the terrible opioid epidemic that has taken the lives of 565,000 Americans. As the Wall Street Journal reported January 30, Vertex Pharmaceuticals has a promising drug candidate in clinical trials, VX-548, that holds the promise of replacing opioid pain drugs with a non-opioid substitute.
While some policymakers may think the opioid epidemic has moved beyond prescription opioids, there is evidence to suggest that prescription opioids are still an important gateway drug to heroin and fentanyl. One 2022 study surveyed 148 users of prescription opioids non-medically, fentanyl, or heroin and found that 90 percent had started their drug use with a prescription opioid, either one prescribed by their doctor or obtained illicitly from a family member or on the street.
If this study is correct, then non-opioid pain drugs capable of replacing traditional opioid therapies could have a significant effect on the opioid epidemic.
For years, the federal government has been aware that non-opioid pain drugs could be a silver bullet for the opioid epidemic. The National Institutes of Health has a program in place, the HEAL initiative, that will pay for clinical trials for non-opioid therapies. The feds doubled funding for this program in 2018, allocating $1.1 billion.
Likewise, in 2022, the Food and Drug Administration announced that the development of non-opioid therapies would be an “important priority for the FDA,” and the agency would offer support to drug developers during clinical trials and held out the hope of “fast-track approval” for these non-opioid drugs.
Every federal health agency, from the Centers for Medicare & Medicaid Services to the Centers for Disease Control and Prevention, offers advice to patients and physicians about how to substitute non-opioid therapies for traditional opioids.
Even Congress got into the act in 2022, enacting the “NOPAIN Act” designed to support research on non-opioid therapies and increase reimbursement for these drugs in federal health programs.
In a supreme irony, 2022 was also the year Congress enacted the Inflation Reduction Act, creating some of the most powerful disincentives for drug developers to conduct research on non-opioid pain relievers. The IRA directs the federal government to slap price controls on “small molecule” drugs four years earlier than large molecule drugs (sometimes called biologics). This law will diminish research on promising non-opioid pain drugs because many of these drug candidates are likely to be small molecules. One can hope that Vertex’s promising drug is all that is needed because it is unlikely that there will be many similar drugs in the future. (Vertex’s promising new drug is a small molecule.)
Small molecules can more easily pass through the “blood-brain” barrier, the body’s natural filter preventing foreign substances from entering the nervous system. For certain types of pain, the drugs that can penetrate this filter would be essential.
Yet, research projects for non-opioid small-molecule pain drugs will be curtailed significantly. With price controls arriving for these drugs four years earlier, investors will shy away from these projects because of the lack of potential returns. Some legislators think the solution to this problem is to enforce price controls sooner — five years after approval — for all drugs. This, of course, would make the problem worse.
One biotech entrepreneur testified to Congress that he has surveyed 100 of the top venture funds that invest in biotech. Eighty-five percent of the venture capitalists surveyed indicated that they were seeing less funding for small-molecule projects as a result of the IRA.
In January, congressmen Greg Murphy of North Carolina, Don Davis of North Carolina and Brett Guthrie of Kentucky took a critical first step in addressing this “pill penalty” by introducing the bipartisan Ensuring Pathways to Innovative Cures (EPIC) Act — legislation that would fix this major oversight within the IRA.
Without Congress taking swift action to pass the EPIC Act, non-opioid pain relievers will undoubtedly be a casualty of this declining investment in small-molecule research.
This is your federal government at work. Every federal health agency has been working, and spending money to support non-opioid pain therapies and then, in a legislative frenzy to spend money that was the IRA, Congress sloppily enacts a law that will significantly diminish the chances of finding substitutes for opioids. For the sake of the hundreds of thousands of Americans who have died of opioids, Congress should reverse this law.
