FDA Failed To Properly Police Program Meant To Curb Opioid Epidemic At Height Of Crisis, New Documents Show
In 2011, the FDA asked opioid-makers to pay for safety training for more than half the physicians prescribing the drugs, and to track the effectiveness of that training, as well as other measures, to reduce addiction, overdoses and deaths. But even when deficiencies in these efforts became obvious through the agency's own review process, it failed to fix the flaws. Meanwhile, a new study finds opioid deaths rise when auto plants close.
The New York Times:
As Tens Of Thousands Died, F.D.A. Failed To Police Opioids
Newly unearthed documents show that the Food and Drug Administration failed to use its policing powers to make sure a program to curb improper prescribing of opioids was effective, researchers say. The lax oversight, they point out, occurred as the epidemic was growing and tens of thousands of people were dying from overdoses each year. In 2011, the F.D.A. began asking the makers of OxyContin and other addictive long-acting opioids to pay for safety training for more than half the physicians prescribing the drugs, and to track the effectiveness of the training and other measures in reducing addiction, overdoses and deaths. (Goodnough and Sanger-Katz, 12/31)
The Hill:
FDA Can't Prove Effectiveness Of Opioid Safety Strategy, Analysis Finds
The strategy was launched in 2012 to address risks tied to extended-release and long-acting opioids, which were more associated with greater risk of addiction, unintentional overdose and death than their immediate-release counterparts. The REMS program was intended to be the FDA’s primary tool “to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse,” according to the researchers. (Weixel, 12/30)
CNN:
Opioid Epidemic: The FDA Can't Prove Its Strategy Worked
As part of the FDA's strategy to clamp down on inappropriate prescribing and misuse of these drugs, the agency mandated that drugmakers offer education on safe prescribing, and that they create medication guides informing patients of risks. The FDA also required companies to provide reports on prescriber behavior and patient safety. But the new study concluded that "more than 5 years after implementation, the FDA was unable to assess whether these outcomes were achieved." (Nedelman, 12/30)
The New York Times:
Opioid Deaths Rise When Auto Plants Close, Study Shows
The last two decades have brought both a sharp decline in automaking jobs in the United States and the rise of a deadly epidemic of opioid abuse. According to a new study, the two trends may well be related. The study, published Monday in JAMA Internal Medicine, found that opioid deaths were about 85 percent higher among people of prime working age in counties where automotive assembly plants had closed five years earlier, compared with counties where such factories remained open. (Chokshi, 12/30)
The Washington Post:
Fatal Opioid Overdoses Spike In Counties Where Auto Plants Close, According To New Research
“Major economic events, such as plant closures, can affect a person’s view of how their life might be in the future. These changes can have a profound effect on a person’s mental well-being, and could consequently influence the risk of substance use,” said Atheendar Venkataramani, the study’s lead author and an assistant professor in the University of Pennsylvania’s Perelman School of Medicine, said in a news release. “Our findings confirm the general intuition that declining economic opportunity may have played a significant role in driving the opioid crisis.” (Telford, 12/31)
And in other news on the crisis —
NPR:
In Rural Areas Without Pain Or Addiction Specialists, Family Doctors Fill In The Gaps
Dr. Angela Gatzke-Plamann didn't fully grasp her community's opioid crisis until one desperate patient called on a Friday afternoon in 2016. "He was in complete crisis because he was admitting to me that he had lost control of his use of opioids," recalls Gatzke-Plamann. The patient had used opioids for several years for what Gatzke-Plamann calls "a very painful condition." (Sable-Smith, 12/30)
The Star Tribune:
Overdose At St. Paul 'Sober Home' Sheds Light On Unregulated Industry
The homes serve a vital role in helping people with substance use disorders return to mainstream life; yet they are unlicensed and largely unregulated by state health and social service agencies. Many of these privately owned homes market themselves as drug-free, therapeutic environments, but many provide little more than a bed in a shared room and limited on-site staff, according to advocates and counselors for people with substance use disorders. Tenants are frequently required to waive their rights as renters, which means they can be evicted on a moment’s notice, even for minor transgressions. (Serres, 12/31)
The CT Mirror:
From Prison To The Grave
Accidental drug overdose deaths tripled in Connecticut between 2010 and 2018, with the proportion of overdose victims with prior involvement in the criminal justice system slowly increasing during that time. Former inmates account for more than half of the people who died from drug overdoses between 2016 and 2018, according to an analysis of new state data. In 2015, this same group made up 44% of the people who died from an overdose. (Lyons, 1/2)