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Fentanyl overdose deaths spike in men, minorities; group seeks opioid moratorium

Overdose deaths from the synthetic opioid fentanyl have spiked in men, particularly in African-Americans and Hispanics, the U.S. Centers for Disease Control and Prevention reported in a new analysis.

The report comes as a consumer advocacy group has called for a moratorium on the approval of new opioids in the midst of the epidemic and another new report showing too few Americans have access to addiction treatments.

Fentanyl is a manmade drug that is 50 times more potent than heroin and 100 times more powerful than morphine, according to the CDC.

While fentanyl is approved and prescribed in the U.S. to manage severe pain, its illicit production and sales have been at the heart of the U.S. opioid epidemic in recent years, fueling the significant rise in overdoses and deaths, health officials said.

About 36,000 Americans died of overdoses involving fentanyl from 2011 to 2016, the CDC reported in its March 21 analysis.

In 2011, there were 1,663 fentanyl-related deaths. But in 2016, that figure shot up to 18,335.

The CDC said the rate of drug overdose deaths involving fentanyl increased exponentially for both sexes, though it was much more rapid for men than women — 8.6 per 100,000 versus 3.1, respectively.

Particularly alarming was the sharp increase in fentanyl deaths over the six years in African-Americans, which leaped to nearly 141% per year, the largest annual percentage jump, the CDC said.

There was also a large increase in fentanyl overdose deaths in the Hispanic population, which rose to 118.3% per year.

The greatest increases by age over the period observed were in younger populations — the 15-to-24 and 25-to-34 age groups, with jumps of 93.9% and 100% per year, respectively, the agency reported.

The smallest average annual percent change occurred among adults 65 years and over, 41.6% per year.

The CDC said the U.S. region hit the hardest by fentanyl overdose deaths over the six years studied was New England — Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont — which had an increase of nearly 144%.

The illicit fentanyl sold in the U.S. is mostly made by chemists in China, who then ship the illegal products through the international mail system, according to law enforcement officials. Some of the fentanyl comes across the southern border into the U.S. from drug cartels in Mexico.

The U.S. Food and Drug Administration has been working with online companies, like Facebook Inc.and Alphabet Inc.'s Google, to rid the internet of advertisements and websites illegally promoting and selling fentanyl and other illicit drugs and held a summit with the companies last year on the matter. The agency plans a second summit in April.

Watchdog group calls for opioid moratorium

Meanwhile, the U.S. consumer watchdog Public Citizen and the head of the FDA advisory committee that scrutinizes pain drugs filed a citizen petition calling on the U.S. government to impose a moratorium on approving any new formulations of opioids in the midst of the epidemic.

The petition is calling for the moratorium to stay in place until the July 2017 recommendations from the National Academies of Sciences, Engineering and Medicine, or NASEM, aimed at preventing more opioid addictions and death are fulfilled.

"The mission of the FDA is to protect the public health. In the eyes of many experts, as it relates to opioids, they have failed," said Raeford Brown, chair of the agency's Anesthetic and Analgesic Drug Products Advisory Committee, who co-authored the petition.

In a call with reporters, Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said the FDA's actions of continuing to put new opioids on the market has contributed largely to the national epidemic.

Wolfe criticized the FDA's decision in November 2018 to approve AcelRx Pharmaceuticals Inc.'s Dsuvia — a drug that is up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine.

He noted that it took the FDA six years before it asked Endo International plc to remove its powerful oxymorphone product Opana ER from the U.S. market, even after the drug was strongly linked to an HIV outbreak in Indiana.

"The FDA tilts very dangerously, very frequently towards making the opioid industry happy," Wolfe told reporters.

When FDA Commissioner Scott Gottlieb disclosed on March 5 that he was resigning and leaving the agency in April, Public Citizen gave him a "good riddance" on Twitter, saying he was "entangled in an unprecedented web of big pharma ties."

On the March 21 call with reporters, Wolfe also called for Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, who has been at the agency for over 30 years, to step down, saying such an action would be an important step towards ensuring regulators put an adequate regulatory framework for opioids in place.

Wolfe and Brown also were skeptical the FDA would follow through with Gottlieb's recent pledges to require manufacturers to conduct long-term studies on already marketed opioids to evaluate whether the drugs maintain their effectiveness with chronic use and for the agency to seriously consider if new medicines in the class should be required to offer some comparative benefit over existing ones.

Treatment lacking

The CDC report and the Public Citizen petition came as NASEM reported that even though the FDA has approved three drugs for opioid-use disorder, or OUD — methadone, buprenorphine and naltrexone — most Americans who could benefit from the treatments are not getting them.

Misunderstanding and stigma towards OUD played a key role in patients not receiving the treatments, the academy said. In addition, it said inadequate education and training of healthcare professionals, restrictions on treatment settings and the fragmented U.S. healthcare system were major barriers to the OUD drugs.

The U.S. National Institutes of Health revealed on March 21 that it was launching a phase 1 trial under its HEAL initiative to test a new drug from Amygdala Neurosciences Inc to treat cravings associated with OUD.

Under the HEAL initiative, the NIH is pursuing longer-acting formulations of drugs to treat OUD, vaccines to protect against fentanyl and heroin overdoses and new non-addictive therapies to manage pain.