By Pat Anson, Editor

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.

The Food and Drug Administration called the meeting to hear from pain patients about “challenges or barriers” they face in accessing treatment. Much of the testimony focused on the Centers for Disease Control and Prevention's 2016 prescribing guideline, which discourages opioids from being prescribed for chronic pain and has been widely adopted throughout the U.S. healthcare system.

“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.”

“It seems to me we are asking for our right to have a normal life. I don’t feel like we should have to beg others for our right to live. It is not by another person’s hand to dictate how my life goes,” another pain sufferer said.

Dozens of pain patients and advocates attended the day-long hearing in Silver Springs, MD, including many who came from out-of-state at their own expense. Some fought back tears as they testified. Hundreds more watched the meeting online.

Many patients said they had tried non-opioid medications or alternative pain therapies, and found them ineffective or had side effects. One woman who took the FDA-approved medication Lyrica said it made her suicidal.

“I am a three-time suicide survivor because of medications you guys approve... and I have actually given up on FDA approved medications. I only take herbs in raw forms. Every one of those drugs that you approved for me to take led me to almost die,” said Kelly Devine. “Stop controlling everything any person wants to use to treat whatever form of whatever disease they are dealing with. Let people have the choice of what we put in our body."

“I don’t know if you are aware, but pain patients are being extorted into having dangerous invasive procedures," another patient warned. "It’s happening all over the country. Pain doctors are saying, ‘You want your meds, you have to go have an ESI (epidural steroid injection).’ Extorting patients into having procedures just to get meds is not right.”

‘Too Many Prescriptions for Opioids’

The FDA’s public hearing was a hopeful sign that at least one federal agency is starting to listen to patients about the worsening quality of pain care in the U.S. 

President Trump’s opioid commission held five public hearings in 2017 without ever inviting a pain patient to testify.  The CDC also ignored the pain community when it secretly drafted its opioid guideline, relying instead on the advice of addiction treatment specialists, anti-opioid activists and academics. And the DEA ignored warnings from patients that further cuts in opioid production quotas could lead to shortages of pain medication, which are now occuring at many hospitals.

Will the FDA seek changes in the CDC guideline? The early indications are not promising.

“Unfortunately, the fact remains that there are still too many prescriptions being written for opioids,” FDA commissioner Scott Gottlieb, MD, said in a lengthy statement apparently written before the hearing began.  “We don’t want to perpetuate practices that led to the misuse of these drugs, and the addiction crisis. At the same time, we don’t want to act in ways that are poorly targeted, and end up disadvantaging legitimate patients.”

Gottlieb said the FDA was encouraging medical professional societies to develop their own opioid guidelines for different medical conditions. But he stopped short of calling for changes in the CDC guideline itself, saying it provides "helpful guidance to prescribers.”

“The CDC guidelines reinforce the need to treat pain carefully and adopt opioids as a last resort medication for most conditions,” said Gottlieb, who did not attend the hearing but will be briefed on it, according to FDA staff.