DEA Restrictions Delaying Fentanyl Research That Could Save Lives

By Kelly Burch 04/24/18

NIDA's Nora Volkow says the DEA’s regulations are preventing potential public health advances in confronting the opioid epidemic. 

scientific researchers looking through microscopes

Deaths caused by fentanyl and other synthetic opioids have increased 500% in five years, killing 20,000 Americans in 2016 alone.

Despite that, research to help understand the deadly opioids and possibly develop lifesaving measures to counteract their effects has been delayed by tight restrictions by the Drug Enforcement Administration (DEA), according to the National Institutes of Health (NIH). 

“A study that I would have been able to start two months ago is now on hold,” Nora Volkow, director of the National Institute on Drug Abuse, part of the NIH, told Fortune. “We are a lab in the middle of NIH, we will do everything very, very properly. There’s nothing like being in the middle of it to realize how hard these complications are.”

Fentanyl is a Schedule I drug, although it’s difficult for federal authorities to regulate synthetic opioids since manufacturers are constantly tweaking their formulas to avoid the law. Still, the Schedule I designation makes it difficult for researchers to obtain permission and samples to study. 

Volkow says that the DEA’s regulations are preventing potential public health advances in confronting the opioid epidemic. “We owe it to the public to be able to have facts with respect to these chemicals,” she said.

Research into fentanyl and other synthetic opioids is particularly important because the opioid overdose reversal drug naloxone does not work against some of the stronger drugs.

The NIH and others in the healthcare sector are currently researching alternatives that could help save the lives of people who have overdosed on synthetic opioids.

Specifically, Volkow wants to research how synthetic opioids act on the brain, and why they depress breathing for longer than traditional opioids like heroin.

Many people who overdose on synthetic opioids die because they are not able to breathe, even after multiple doses of naloxone have been administered. 

Volkow said it can take the NIH up to a year to get approval from the DEA to study fentanyl. Other researchers are incredibly frustrated with the delay. 

“If they could figure out a way to streamline, it would be a lot better,” said Kim Janda, a professor of chemistry at the Scripps Research Institute in La Jolla, California. Janda leads a team working to develop a vaccine that would prevent fentanyl overdoses by keeping the drug from reaching the brain.

Despite the fact that Janda already had a license to work with Schedule I drugs, it took months for him to get DEA approval to work with fentanyl specifically. 

“It can be very frustrating for researchers, we want to do this stuff now,” he said.

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Kelly Burch writes about addiction and mental health issues, particularly as they affect families. Follow her on TwitterFacebook, and LinkedIn.