As opioid-related deaths continue to rise in the United States, researchers are barred from studying the very substance that could provide an antidote to overdose, says chemist Gregory Dudley.
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January 19, 2023
Fentanyl is approved for use during surgery and for the treatment of severe and chronic pain Bing Guang/Bloomberg via Getty Images
When covid-19 broke out, the United States and many other countries devoted enormous resources to research and developed antiviral drugs, vaccines and other treatments that quickly saved lives. This all-out mobilization stands in stark contrast to another major public health crisis that is still rocking the country: the drug overdose epidemic.
More than 100,000 people in the United States will die from overdose in 2021. This is almost double what he was in 2018. Most of these deaths were opioid related. But instead of pushing across the board to better and life-saving interventions in response to this crisis, policies have stifled research and stifled critical innovation. So our society is grappling with this crisis with one hand tied behind its back.
The synthetic opioid fentanyl is one of the substances at the center of the overdose epidemic. It is 50 to 100 times more addictive than morphine. Fentanyl overdose can be fatal. And an alarming amount of unregulated fentanyl is sold illegally across the United States.
However, it is also true that fentanyl is approved by the U.S. Food and Drug Administration for use in surgery and for the treatment of severe and chronic pain, including in cancer patients.The World Health Organization has designated fentanyl as an essential drug. increase. The line between critical and dangerous medicines is not always easy to define.
In the United States, the Drug Enforcement Administration classifies drugs into five different categories or “schedules,” depending on their medical value and potential for abuse. The lower the number, the more regulated the substance, and the harsher the penalties for illegal use or sale. Schedule I is reserved for drugs with no safe, approved medical use and high potential for abuse. Research on Schedule I drugs is very limited.
Fentanyl itself is a schedule II drug. In 2018, the Trump administration classified all “fentanyl-related substances” as Schedule I drugs, assuming they all had a high potential for abuse (and no medical use). We extended the classification of several times, perpetuating the original assumption.
The problem is that compounds chemically related to fentanyl can be more or less dangerous, more or less potent, or lessen its effectiveness. They may serve as an antidote to fentanyl overdose. The naive assumptions behind that 2018 decision impose the harshest drug penalties on countless substances (both real and virtual) that scientists study or study them. made it virtually impossible.
The intent of all this may be to stop the development of illicit drugs, but the implications are broader and more complex. The unique feature of “fentanyl-related substances” is their molecular structure, not their function, potency, or abuse potential. Structure is important, but function is of greater concern here.
Consider naloxone, an opioid antagonist or antidote that can reverse an overdose. Naloxone was used to prevent. Naloxone has a molecular structure related to morphine. It is the result of morphine-related research.
Could fentanyl-related research lead to new, and possibly better, life-saving interventions? The US National Institute on Drug Abuse has internally investigated a small number of fentanyl-related substances and found that at least one (unknown which one) exhibits antagonistic properties similar to naloxone. We should follow its lead, but research aimed at developing better fentanyl-related drugs is currently being halted.
Meanwhile, the illegal trade in fentanyl variants continues unabated and opioid overdoses continue to rise.
Last year, along with more than 100 other scientists, I wrote to the Biden administration calling for changes that would make it easier, not harder, to develop overdose drugs. Last October, New Jersey Senator Cory Booker introduced his TEST Act, which challenges the assumptions behind classifying all “fentanyl-related substances” as Schedule I drugs. As written, the TEST Act extends the temporary scheduling of fentanyl-related substances by two years, but the government will test these substances further, report the results, and remove those that do not belong from Schedule I. This is a widely-advocated common-sense approach.
We need to treat the overdose epidemic in the United States like an urgent public health crisis. The time has come to unleash the hand of the scientist and fight it with all the strength you have.
Gregory Dudley He is Professor of Chemistry and Chair of the Department at West Virginia University.
