The day after the Food and Drug Administration said it would change the prescription guidelines for some opioid painkillers, millions of chronic pain patients and their physicians are still trying figure out who “won” the often bitter debate over the safety and long term effects of the drugs.
“I would call it a small victory,” said Dr. Andrew Kolodny, one of the founders of Physicians for Responsible Opioid Prescribing (PROP), which filed a citizens’ petition with the FDA last year demanding major changes in the labeling guidelines for painkillers to stop doctors from over-prescribing them.
“I think the new labeling will hopefully lead to extended release opioids being used as a last resort when all other options fail.”
On the other end of spectrum is Dr. Jeffrey Fudin, a vocal critic of PROP and its petition, who says the agency’s decision was a victory for pain patients — including many who worried they would lose access to pain medication.
“I feel sorry for the many patients nationwide that anguished day after day and sent thousands of anxiety stricken e-mails to politicians, the FDA, and to me. But they all owe this country and the FDA a debt of gratitude,” Fudin wrote in his blog.
So who won and who lost this contentious debate?
We may not know the answer for years – which may have been the FDA’s goal in crafting a carefully nuanced policy that seems to give a little to everyone.
One of PROP’s main goals was to have the guidelines for opioids changed so they are no longer routinely prescribed for “moderate” pain. That the FDA agreed to do, updating the labeling so that extended release opioids are indicated for the management of severe pain only — “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
“When you read the full language on the label, it’s pretty darn good. I actually like the new indications,” says Kolodny.
But a major disappointment for PROP was that the FDA is only changing the labels for 20 extended release opioids, such as OxyContin and Opana. The labeling guidelines for short acting opioids like hydrocodone – which are much more widely prescribed – will remain unchanged.
“Everything they did was limited to extended release and I could see no rationale for that. That was a terrible mistake,” said Kolodny, who is Chairman of the Department of Psychiatry at Maimonides Medical Center in Brooklyn, NY.
“The FDA needs to go much further to prevent harm caused to pain patients by over-prescribing of opioids.”
PROP’s next course of action may be in court. Kolodny says he is considering legal action against the FDA to compel the agency to comply with the federal Food, Drug and Cosmetic Safety Act, which requires drug companies to prove their products are safe and effective before putting them on the market.
PROP’s petition states the long term safety and effectiveness of opioids in treating chronic pain has never been established. The FDA, in a sense, agreed with that point. The agency now wants drug makers to conduct more research and post-marketing studies on the safety of opioids.
“The idea that the FDA thinks they need to keep studying this when we have 16,000 people dying from opioid overdoses every year, 125,000 deaths in a decade, and they want to study this further? It’s hard for me to be happy about that,” Kolodny said.
“That’s why if we go to court, we are fairly certain the courts would require FDA to do its job properly.”
But a court battle could go on for years. What about the immediate effect on pain patients and their access to extended release opioids?
Kolodny says the label change, which is expected by December, is unlikely to affect patients already prescribed extended release opioids. But physicians may be more reluctant to prescribe long-acting opioids to new patients without trying other therapies first, such as over-the-counter pain relievers.
“Right now you’ve got prescribers who’ve been misled to believe that the compassionate way to treat someone with chronic pain is to put them on extended release opioids. They think it’s compassionate and its evidence based, but it’s neither,” said Kolodny, who insists PROP is not trying to take opioids away from anyone.
“All these patients who write in when you have a column on this who think my group wants to take their pain pills away from them. We don’t,” Kolodny told National Pain Report.
“I know very well that the majority of them are going to need to be on opioids for the rest of their lives, even if their pain problem went away. They’ve been made dependent on opioids and I know that many of them function okay. They take the pills the way they’re prescribed. I don’t think it’s really helping their pain, but they’re doing okay on long term opioids and I don’t want anyone to take away their pills from them.”