The board of directors of the American Academy of Pain Medicine (AAPM) says a petition to the FDA that calls for new limits on opioid painkillers is seriously flawed and could be harmful to patients if implemented.
The petition, submitted to the FDA last month, calls on the agency to limit the dose and duration of opioid prescriptions, and to limit the approved use of opioids to severe non-cancer pain. The petition was signed by dozens of doctors, researchers and public health officials, many of them associated with Physicians for Responsible Opioid Prescribing (PROP), which lobbies against opioid abuse and overprescribing.
“We have serious concerns about the petition and believe the rationale for the requested changes is seriously flawed, potentially harmful to patients with debilitating pain conditions for whom opioid therapy is indicated, and without substantive scientific foundation,” the AAPM wrote in a letter to the FDA.
The letter, signed by 12 members of the AAPM’s board, said there was no scientific evidence showing that the use of opioids to treat moderate pain was any more or less harmful than prescribing the painkillers for severe pain. It also questioned the petitioners’ request to limit prescriptions to 90 days for the treatment of non-cancer pain.
“Pointedly stated, this change effectively eliminates the use of opioids for chronic non-cancer pain. This is a radical position that would leave an untold number of pain sufferers with few treatment options given the on-label restrictions imposed by many insurers, including Medicare/Medicaid,” the AAPM’s letter states. “Theirs is truly a ‘throw the baby out with the bathwater’ approach.”
“We believe that the adoption of the recommendations in the PROP petition to lower doses or duration would provide a false sense of security for patients and practitioners,” said Lynn Webster, MD, president-elect of the AAPM. “In our view, a more effective means to address this problem would be enhanced prescriber education and adherence to principles of practice, including ongoing monitoring for aberrant behaviors and early signs of addiction.”
One area of agreement the AAPM has with the petition is the lack of scientific evidence supporting the long term use of opioids.
“Indeed, little research has focused on the question of long-term effectiveness of opioid therapy for chronic non-cancer pain. The majority of recommendations from a practice guideline endorsed by the American Pain Society and the American Academy of Pain Medicine are based on lower-quality evidence. At best, the literature has shown inconsistent effectiveness of opioids for chronic pain,” the AAPM letter states.
“In a way, their document helps make our case because they agree with us on the most central point — that evidence to support long-term use and high dose prescribing is lacking,” wrote Dr. Andrew Kolodny, one of the founders of PROP, in an email to American News Report.
“If AAPM wants to defend the right of drug companies to advertise high dose and extended use of opioids for moderate chronic pain as safe and effective, the burden of proof is on them,” said Kolodny. “We don’t have to prove this. The law requires drug companies to prove that products are safe and effective for use as advertised. It doesn’t require the public to prove that they’re not safe and effective.”
Kolodny stressed that doctors would still be able to prescribe opioids “off-label” for moderate pain, even if they were only approved for severe pain.
“At the end of the day, if FDA implements the label changes we’re requesting, doctors will still be able to prescribe long-term opioids to chronic pain patients who need them and AAPM knows this,” wrote Kolodny.
The AAPM is one of several pain organizations under investigation by the Senate Finance Committee for its financial ties to the pharmaceutical industry. The committee has asked for a detailed account of payments by three drug makers to the pain organizations and several prominent physicians. Lynn Webster, along with Drs. Martin Grabois, Rollin Gallagher, Perry Fine and Bill McCarberg are among those listed. All five signed the AAPM’s letter to the FDA.