The Food and Drug Administration waded into the fray of the opioid medication and chronic pain patient issues by hosting a “Voice of the Patient – Chronic Pain” event in July of 2018. The FDA has held a series of these “Voice of the Patient” events over the years on topics ranging from Alopecia Areata to Sickle Cell, and many things in between. The events are hosted at the FDA White Oak Campus in Maryland, and invite patients with various diagnoses to come and speak directly to FDA representatives about challenges, treatments, and barriers to care.
The FDA perhaps did not realize what they were in for – or maybe they did – when they scheduled the Chronic Pain topic. Where they usually got 20-30 patients attending, they got over 100 people in attendance for Chronic Pain, with 300 more attending remotely. There was national press coverage.
Pain News Network summed it up nicely:
Chronic pain patients are losing access to opioid medication, can’t find doctors willing to treat them, and are often treated as addicts, pain sufferers told FDA officials during an emotional public hearing Monday.https://www.painnewsnetwork.org/stories/2018/7/9/pain-patients-tell-fda-to-fix-cdc-guideline
The patient voices were apparently consistent that day:
“FDA, we are begging you. Correct the CDC’s egregious mistakes. Tell the country the truth about prescription opioids. They are safe and effective for 99% of us,” said Rose Bigham, who lives with chronic pain caused by Ankylosing Spondylitis, fibromyalgia and Crohn’s disease. “My new worst nightmare is being admitted to the hospital, being in agony and being denied pain relief.”
“CDC Guidelines have been a disaster for pain patients,” Rick Martin, a pharmacist disabled by chronic back pain, said in prepared testimony. “There is plenty of anecdotal evidence showing involuntary (opioid) tapering is rampant across the U.S. Many, many stories of patients who are inhumanely suffering, some with suicidal ideation.
“The FDA needs to take action. The FDA says it wants to know about challenges or barriers to accessing treatment. The challenge and the barrier is the CDC guideline. It should be immediately suspended. It should be reviewed and modified with pain management physicians and patient input.”
In March of 2019 the FDA released its report. It contains excellent – if sobering – summaries of what people with chronic pain face every day.
Many participants identified several challenges and barriers to accessing treatments to manage their chronic pain. They highlighted growing stigma on the use of opioid analgesics and the impact of stigma on their interactions with healthcare providers and others when seeking treatment, particularly being perceived as “an addict.” A common experience shared during the meeting is that of an individual living with chronic pain who has had successful pain management in the past using a stable dose of opioid analgesics but who now has severely worsened pain resulting from reduced access to opioids because of a change in their doctor’s practice or willingness to prescribe opioids.FDA Voice of the Patient Report – Chronic Pain
The report contains great detail about what participants shared that day. FDA also received 2,450 online comments online in addition to in-person participation.
Based on this report FDA is all too aware of the havoc caused by CDC’s prescribing guidelines. The question is: Now what will FDA – or HHS – do about it?