The Morning Journal (Lorain, OH)

10K deaths mean more help needed

Emergency classifica­tion for fentanyl analogues set to expire Feb. 6, but Congress could pass extension or make drug classifica­tion permanent

- By Andrew Cass acass@news-herald.com @AndrewCass­NH on Twitter

Lake County Crime Lab officials said in 2019 they continued to identify new synthetic opioids and fentanyl analogs that they never saw in the county before.

Fentanyl and its analogues contribute­d to more than 10,000 overdose deaths in Ohio between 2014 and 2018, according to the Ohio Department of Health.

In February 2018, the U.S. Drug Enforcemen­t Agency took an emergency step against fentanyl analogues, making them Schedule

I drugs, placing them in the same category as drugs like heroin and ecstasy. That emergency scheduling is slated to expire Feb. 6, leaving it in Congress’ hands to determine whether to extend or make permanent the emergency scheduling or let it expire.

U.S. Attorney General for the Northern District of Ohio Justin Herdman is among those who want the DEA’s designatio­n made permanent.

Herdman called the DEA’s emergency scheduling of the analogues a “critical step for federal law enforcemen­t, as it allowed us to pursue criminal prosecutio­ns for those selling fentanyl analogues that, while having the same deadly consequenc­es as fentanyl, were still legal because of their slight chemical distinctio­n.”

“Prior to the emergency order, for instance, charging a drug dealer with selling analogues like acetylfent­anyl or furanylfen­tanyl, which pose as great a risk to public safety as fentanyl, was a laborious process fraught with legal pitfalls,” Herdman wrote in an opinion piece that appeared in the Canton Repository.

The U.S. Department of Justice also wants to see the emergency scheduling made permanent.

“The lethality of fentanyl is virtually unmatched,” DOJ officials said in a June 2019 Senate Judiciary Committee hearing. “It is 30 to 50 times more potent than heroin, which is quite lethal in its own right. That unmatched lethality is not reflected in sentencing ranges for fentanyl traffickin­g, which punish dealers of fentanyl and fentanyl-like substances less severely than sellers of less lethal drugs.”

Fentanyl was first introduced more than 50 years ago and was approved for treating severe pain in the early 1990s, typically for advanced cancer patients.

It’s since become a more commonly prescribed painkiller. U.S. doctors wrote 6.65 million fentanyl prescripti­ons in 2014. The vast majority of the fentanyl and analogues contributi­ng to overdose deaths in the United States comes from outside the country, according to the DEA.

“Due to their high potential for abuse, fentanyl and various fentanyl-like substances were controlled in Schedule I or Schedule II of the Controlled Substances Act (CSA) on a substanceb­y-substance basis,” DOJ officials told the Senate committee. “Unfortunat­ely, clandestin­e chemists have with relative ease created new synthetic variations of fentanyl by introducin­g minor structural modificati­ons, resulting in new, non-controlled fentanyl-like substances. These substances are specifical­ly engineered to skirt U.S. law.”

The DOJ officials said the emergency scheduling has made it “easier for federal agents to seize fentanylli­ke substances and, investigat­e trafficker­s of these substances, and for prosecutor­s to prosecute such trafficker­s.”

The Senate on Jan. 16 passed legislatio­n that extends the emergency scheduling for another 18 months, until May 6, 2021. The bill now moves on to the House of Representa­tives for further considerat­ion. The House Judiciary Committee’s Subcommitt­ee on Crime, Terrorism, and Homeland Security will have a hearing on the subject Jan. 28.

Sen. Rob Portman, R-Ohio, said in a statement the extension was a “compromise” but was pleased with its passage.

“However, we must take action to criminaliz­e these drugs permanentl­y,” Portman said. “Fentanyl knows no zip code and is devastatin­g individual­s and families in Ohio and all across the country. This is a vital step in our efforts to keep fentanyl out of our communitie­s so that law enforcemen­t can keep these dangerous synthetic opioids out of our communitie­s.”

Portman and West Virginia Democrat Sen. Joe Manchin last year introduced a bill that would make the Schedule I designatio­n permanent. The bill has been endorsed by all state and territoria­l attorneys general.

According to Sen. Sherrod Brown’s office, D-Ohio, the senate’s unanimous support of the DEA classifica­tion extension comes while the Government Accountabi­lity Office puts together a report on the classifica­tion to “inform future policy in this space.”

“We know all too well the toll fentanyl has taken on our state,” Brown said. “That’s why I continue working with local partners and colleagues in congress to keep this dangerous drug out of Ohio and provide Ohio communitie­s the resources they need as they continue to work to address the addiction crisis that continues to grip our state.”

Included in that work is the Fentanyl Sanctions Act, which was enacted late last year. According to his office, the bill gives U.S. officials “new sanction tools to target foreign opioid trafficker­s in China, Mexico and other countries.”

His office added the bill will also “better enable U.S. diplomats and law enforcemen­t officials to maintain pressure on the Chinese government to implement and strictly enforce China’s commitment to treat all forms of illicit fentanyl as illegal.”

Concerns over longterm scheduling

In July, nearly 50 organizati­ons signed a letter sent to Senate Judiciary Committee leaders asking them not to extend the DEA’s order. Among the organizati­ons who signed the letter were the ACLU, the Drug Policy Alliance and the NAACP.

“We believe the (Senate Judiciary) Committee is right to be concerned about fentanyl-related deaths, but this approach merely repeats the mistakes of the past by exacerbati­ng our incarcerat­ion problem,” the organizati­ons wrote in the letter. “The committee should move away from the belief that increased enforcemen­t powers for the DEA will translate into reduced overdose deaths. Instead, the committee should embrace public health approaches to the overdose crisis.”

The coalition of opposing organizati­ons pointed to testimony DOJ officials made to the committee in June. The officials stated that if the DEA’s emergency scheduling lapses, cases would revert to being prosecuted under the Controlled Substance Analogue Enforcemen­t Act of 1986.

The DOJ officials stated that under the Analogue Enforcemen­t Act, several elements of proof are “presumed, or simply not relevant to routine controlled substance prosecutio­ns.”

Under that law prosecutor­s must prove that the substance involved in the case was “intended for human consumptio­n.” They also must prove that the substance is a “controlled substance analogue.” That requires proof that it has a “substantia­lly similar chemical structure as a Schedule I or II controlled substance” (in this case fentanyl) and that it either has a substantia­lly similar effect on the central nervous system as a Schedule

I or II controlled substance, or “in a particular case, was intended or represente­d as having such an effect.”

The coalition of opposing organizati­ons wrote that the DOJ’s testimony shows there is a mechanism by “which DOJ and DEA can prosecute unschedule­d fentanyl analogues.

“And though the government regards these elements as a mere speed bump to quickly securing conviction­s and lengthy sentences, they exist for a reason: it is impossible to tell from a substance’s chemical structure alone whether it would have any effect on the central nervous system, let alone a ‘substantia­lly similar’ effect as a controlled substance analogue,” the groups wrote.

Another concern is the public health impact of a long-term Schedule I designatio­n. In July, eight Democratic U.S. Senators sent a letter to Health and Human Services Alex Azar with concerns that public health agencies were not being “adequately consulted regarding the scheduling.”

The group included Kamala Harris of California, Amy Klobuchar of Minnesota and Cory Booker of New Jersey.

“We are concerned that the failure to engage necessary health experts vests far too much authority to a lawenforce­ment agency and may result in action that will deter valid, critical medical research aimed at responses to the opioid crisis, including efforts to identify antidotes to fentanyl-analogue overdoses and improved treatment options,” the senators wrote. “We are also concerned that by sweeping a broad set of substances onto Schedule I, with no scientific consultati­on, we risk erecting unnecessar­y research barriers to drugs that may have great potential to society, and criminaliz­ing substances that have no psychotrop­ic effects.”

The senators’ letter came days after Reuters reported an expert from HHS National Institute on Drug Abuse “quietly warned Senate staff at a private June 20 briefing that permanentl­y placing all fentanyl analogues into Schedule I poses problems.”

The NIDA expert told Reuters making the drugs Schedule I long term would make it harder for researcher­s to win approval to study the analogues to potentiall­y develop new approaches to fighting the opioid epidemic.

HHS spokespers­on told the outlet at the time that the department did not have a position on the scheduling but acknowledg­ed the department did have concerns. The spokespers­on said the analogs could be used to develop and test new medication­s for preventing opioid addiction and overdoses as well as slowing down valuable research.

 ?? OHIO DEPARTMENT OF HEALTH ?? This chart shows the number of unintentio­nal drug overdose deaths in Ohio from 2009to 2018. Source: Ohio Department of Health, Bureau of Vital Statistics.
OHIO DEPARTMENT OF HEALTH This chart shows the number of unintentio­nal drug overdose deaths in Ohio from 2009to 2018. Source: Ohio Department of Health, Bureau of Vital Statistics.

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