Illustration: Shoshana Gordon/Axios
The Food and Drug Administration's attempts to manage the overdose crisis by reining in on the use of narcotics are weighing on patients with chronic pain, who say the result has been harder-to-fill prescriptions and heightened withdrawal and suicide risks.
The big picture: The FDA for years grappled with criticism it helped fuel the opioid epidemic by approving products like OxyContin and a tablet 1,000 times more powerful than morphine.
- Now, patient groups are concerned the agency is proposing a large study of opioids' long-term effectiveness in treating chronic pain without enough of their input.
- Addiction experts say its clinical trial design could be tilted toward benefiting manufacturers.
- And while the FDA has encouraged the development of alternative pain control methods, safety concerns and insurer resistance to covering them have hindered adoption.
- The result is more opioids have been approved in the last five years than non-opioid options.
Driving the news: FDA outside advisers this week slammed the agency's proposal and, without a vote, recommended the agency reconsider pursuing the study.
- Pain care specialists criticized how the plan wouldn't address addiction potential or improve care for the millions of Americans managing chronic pain.
- The National Council of Independent Living, a disability rights organization, also noted that these decisions are being made and discussed without patients involved.
- The nine-hour meeting on Wednesday came a week after the FDA announced it's now requiring both instant and extended-release opioid pain medicines to carry warnings about overdose risk and potential for increased sensitivity to pain.
Details: The study’s design would have participants shifted from prescription opioids to extended-release morphine while a randomly selected group would be switched to a placebo without being told.
- There would then be an eight-week period where the placebo group would be weaned off opioids — a factor agency officials acknowledged could result in high dropout rates and challenges in recruitment.
- Diana Zuckerman, president of the National Center for Health Research, questioned the ethics behind the FDA's proposal during public comment, saying that, "In addition to withdrawal, won't that potentially make them even more desperate and more reliant on opioids?"
- Andrew Kolodny, medical director of the Opioid Policy Research Collaborative, asked why administering non-opioid alternatives wasn't considered.
- "Wasn't it the practice of switching patients from [instant release] opioids to [extended release] opioids what got us into this mess in the first place?"
Between the lines: A crackdown on opioid prescribing hasn't stopped overdoses from rising in recent years as the epidemic becomes defined more by fentanyl-laced counterfeit pills than painkillers prescribed in clinical settings.
- But some chronic pain patients say the agency's latest moves have made physicians more likely to deny needed pain relief out of fear of regulatory scrutiny.
- In an online public comment, Earenya Chapman wrote that "this has left patients with no alternative but to suffer in silence."
- The policies to limit prescribing have also led to "life-altering harms" including overdose, unemployment and death, said Theo Braddy, executive director of the National Council of Independent Living.
- Some studies have found chronic patients may have an elevated suicide risk following discontinuation of opioid therapy.
The bottom line: The U.S. continues to grapple with how to slow the addiction crisis while helping millions of Americans with conditions causing chronic pain, leaving both public health issues at risk of getting worse.
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