
The FDA wants to hear from you—but don’t be distracted by the title. A noted chronic pain advocate believes this is an opportunity for chronic pain advocates to comment.
The official announcement is that the FDA wants input and comments from stakeholders, including racial and ethnic minority, underrepresented, and underserved populations in establishing strategic priorities for the Office of Minority Health and Health Equity.
That’s where Richard “Red” Lawhern, Ph.D., saw an opportunity.
Here’s what he wrote:
“I assert that “underrepresented” populations must be understood to include millions of patients who have been disabled by chronic pain, and who have been grossly under-served by the medical establishment and HHS. These patients have also been ill served by the fatally flawed and ethically unsound US CDC 2016 guidelines on prescription of opioid analgesics to adults with chronic non-cancer pain.”
Lawhern, a noted advocate for chronic pain who has built a considerable following among activists, said that the government “must sponsor trials and a systematic trials review to assess the very wide range of genetically mediated natural metabolic rates for opioid analgesic medications in patients with pain.’
He went further.
“It is past time to return prescribing decisions to qualified doctors in collaboration with their patients,” he wrote. “There is no present evidence-based consensus on what comprises “usual prescribing practice” in pain management employing prescription opioids.”
Lawhern believes there is an historical bias against co-prescription of opioid analgesics and Benzodiazepine medications essential for management of sleep disturbance, depression and anxiety in pain patients.
“This bias is founded almost entirely on association of benzo drugs with opioids in postmortem blood toxicity screens. There is no published trials data to evaluate interactions of these drug classes in patients who are monitored while alive. However, we know that under-treated depression is strongly associated with bad outcomes in pain management, including suicide. Research on drug interactions between these two classes in live patients needs to become a priority for FDA.”
If you want to comment, do so here.