The Food and Drug Administration should consider banning “ultra-high-dosage” painkillers from the market, and law enforcement must step up efforts to curb the flow of heroin and fentanyl into the United States if the nation hopes to come to grips with the opioid epidemic, two authorities on the crisis said Thursday.
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Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University, and Thomas R. Frieden, former director of the U.S. Centers for Disease Control and Prevention, said a comprehensive approach to the crisis also should include greatly restricting or eliminating the marketing of opioids for chronic pain; better insurance coverage and access to alternative pain treatments; and expansion of treatment and “harm reduction” measures such as needle exchange programs.
“There are no simple solutions to ending this epidemic,” Kolodny and Frieden wrote in an opinion article released Thursday in JAMA, the influential journal of the American Medical Association. “Effective programs need to address two separate priorities: prevention of addiction among people not currently addicted, and treatment and risk reduction to prevent overdose and death among the millions of individuals in the United States now addicted.”
About 33,000 people died from overdoses to prescription narcotics, heroin or fentanyl in 2015, a total thought to have increased sharply in 2016, although final data is not available. About 92 million people were prescribed an opioid analgesic – such as oxycodone or hydrocodone – in 2015.
In recent years, deaths from illicit street drugs have risen faster than those from prescription opioids.
Many of the recommendations from Kolodny and Frieden reflect expert consensus, including their push for expanded treatment and wider availability of the overdose antidote naloxone and for doctors to use more caution prescribing opioids. But other recommendations, such as banning high-dose opioids and improving data-gathering on the addiction crisis, have been heard less often.
“No current information systems enable real-time assessment of the numbers, patterns or trends of new opioid addiction,” the two wrote. “This makes it impossible to determine the trajectory of the epidemic.”
In an interview, Frieden said a small number of people may need an 80-milligram oxycodone pill for the pain of cancer or end-of-life illness. But that dose, taken twice a day, far exceeds an amount “associated with a greatly increased risk of death,” he and Kolodny noted in their article. An unwary user who takes a single pill containing that much oxycodone to get high risks a fatal overdose.
“These are dangerous drugs. They kill people,” said Frieden, a member of the journal’s editorial board. “And we should use them very sparingly and carefully.”
President Donald Trump said in August that he would declare the crisis a national emergency, but his administration has not formally done so.
Doctors and dentists have begun to get the message about prescribing fewer and less powerful opioids or trying non-opioid alternatives first after routine procedures such as tooth extractions, Frieden said. The number of prescriptions has begun to trend downward in recent years by perhaps as much as 20 percent. But the volume of prescriptions quadrupled between 1995 and 2010, so there is a long way to go, he said.
The article calls on the FDA to halt the misleading marketing of opioids for low back pain and other forms of chronic pain for which the risk posed by opioids greatly outweighs the benefits. It suggests narrowed drug labeling to discourage doctors from prescribing them for those purposes. “Patients with non-cancer-related pain have been the target market for opioid manufacturers and account for much of the increase in opioid consumption in the United States during the past 20 years,” Kolodny and Frieden wrote.
“There are some conditions for which pain is still undertreated,” Frieden said in the interview. “However, for chronic pain, we have gotten it wrong.” When compared with other treatments, he said, opioids are “much more dangerous, not any better.”
