FDA’s new plan to study opioids’ effectiveness faces resistance

Lev Facher, STAT, April 19, 2023

The Food and Drug Administration’s latest plan to study whether opioids are effective as a chronic pain treatment is facing significant resistance from addiction and pain care experts.

A planned clinical trial, doctors and researchers argued on Wednesday, would not yield significant new information about whether opioids are effective as long-term treatments for chronic pain. The study, some charged, would be biased in favor of opioids’ efficacy — and by extension, biased in favor of painkiller manufacturers.

The pushback came during a Wednesday meeting of a federal scientific advisory committee focused on pain drugs. Throughout the hearing, members of the panel and outside experts lambasted what they viewed as inaction from the FDA, as well as perceived flaws in the clinical trial’s specific design.

“It lacks face validity,” said Maura McAuliffe, a panel member and an emeritus professor of nursing at East Carolina University.

Mary Ellen McCann, another panel member and a Harvard Medical School anesthesiology professor, said the trial represented “an awful lot of work for a very predictable answer.”

The contentious hearing is just the latest chapter in a long-running debate about the appropriate role of opioids in pain treatment, both for current patients and for future patients who wish to use opioids to manage persistent pain.

The FDA’s latest move to reconsider opioids’ effectiveness comes amid the most devastating drug crisis in U.S. history. Over 80,000 Americans die each year from opioid overdoses — though the vast majority are caused by illicit opioids like fentanyl, not common prescription drugs like morphine or hydrocodone.

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 “Far too many people develop an opioid addiction that started with a legal prescription, which is why it’s incredibly irresponsible that opioids can be prescribed for long-term use despite the lack of evidence on their effectiveness,” Sen. Maggie Hassan (D-N.H.) said in a statement earlier this year. “I now urge the agency to follow the advice of its external advisers to quickly revise its opioid labeling policies and remove this debunked claim from prescription opioid labels.”

In 2013, in response to the crisis, the FDA pledged to work with pharmaceutical manufacturers to conduct post-approval studies of many prescription opioids currently on the market. Subsequently, pharmaceutical companies formed a joint group called the Opioid PMR Consortium to conduct the research.

Still, in the decade since the FDA first pledged to pursue new research, no such study has been conducted. The agency’s most recent attempt, in 2019, was discontinued after the researchers in charge could not recruit an adequate number of participants.

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Under the new study’s design, trial participants would first be switched from their current prescription opioid to extended-release morphine. A randomly selected subgroup would then be switched, without notification, to a placebo group. That group would be tapered off opioids over the course of eight weeks.

That study design, however, has also been criticized on the grounds that it will not yield useful data and that it is biased in favor of preserving access to opioids as a chronic pain treatment.

“These arguments suggest a curious and persistent attachment on the part of the FDA to a statistical design that’s completely at odds with the agency’s professed commitment to a fresh new approach,” Caleb Alexander, a professor of epidemiology at Johns Hopkins University, said during the public comment portion of the hearing.

[….] “The design being considered seems to favor the status quo,” said Diana Zuckerman, the president of the nonprofit National Center for Health Research, during the public comment portion. “Is it ethical to require patients who are dependent on opioids to be given a high dose of morphine, followed by a rapid taper, followed by placebo? Won’t that potentially make them even more desperate and more reliant on opioids?”

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