SILVER SPRING, Md. — One pain patient lay on the floor. Another leaned against the wall, easing her back. A third paced to and fro.
At this week’s Food and Drug Administration hearing on chronic pain, accommodations were at the forefront.
And the agency says it wants to be accommodating in other ways as it tackles the opioid crisis. Thus, a meeting was called simply to listen to people’s stories about their pain and how they may, or may not, handle it.
It was a room full of some very unhappy people.
“Suicide is always an option for us,” said Mariann Farrell of Pittsburgh, who says she has multiple conditions, including fibromyalgia and the post-herpetic pain that can linger after shingles. Farrell was one of several dozen people who traveled to the FDA’s headquarters outside Washington to ask the agency to ease restrictions that they say has made it harder for them to get opioids.
Sandra Flores, a former emergency room nurse from Tucson, Arizona, roused rounds of applause as she told of her repeated efforts to get opioid prescriptions for her pain. Flores said she was diagnosed with adhesive arachnoiditis, an inflammation of the membranes protecting the brain, spine and nerve endings.
“I am seeing the true face of medicine,” Flores said. “Now they are throwing me in the trash.”
The FDA said it wants to consider the needs of patients with chronic, intractable pain as it considers the problem of opioids, and as it encourages drug companies to come up with safer alternatives.
“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,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
“In most circumstances, opioids should only be used for the treatment of acute pain and prescribed for short durations of time,” he added.
“However, the FDA is aware that there are certain circumstances — such as in the treatment of metastatic cancer pain and the episodic treatment of migraine pain — where the drugs are administered over longer periods. In select patients and for certain medical conditions, opioids may be the only drugs that provide relief from devastating pain.”
The FDA, Centers for Disease Control and Prevention and other medical groups agree not only that there’s an opioid crisis, but that it has been driven in no small part by overprescribing.
The CDC reported last year that the number of prescriptions for the painkillers tripled between 1999 and 2015. “A generation of providers dispensed these medicines too liberally, and were slow to address the signs of misuse and addiction,” Gottlieb said.
The CDC says more than 42,000 people died from opioid-related overdoses in 2016, a 30 percent increase from the year before. Synthetic opioid overdoses killed 20,000 of them. Opioid overdose deaths are so numerous they have helped drive down U.S. life expectancy.
So the CDC has issued guidelines recommending that doctors cut back on opioid prescriptions, and advising patients to try anything else they can before asking for the powerful and addictive drugs.
They recommend first trying Tylenol or drugs such as ibuprofen or naproxen, which are in a class called non-steroidal anti-inflammatory drugs, or NSAIDs. They also recommend trying low-tech options such as ice, physical therapy and massage. And, the CDC says, patients may have to change their expectations about living with pain.
But the CDC and FDA do not regulate physicians. States do.
At least 28 states have some limits on opioid prescriptions, according to the National Conference of State Legislatures. Seventeen limit prescriptions to three to 14 days.
Others have prescription drug monitoring programs to keep watch for providers who might be writing prescriptions too freely.
The pain patients who traveled from across the country to testify to the FDA say they are feeling the effects.
Flores, who said she was diagnosed with her painful condition two years ago, said she can no longer find a doctor to prescribe her opioids.
“I have yet to have a doctor accept me as a patient,” Flores told NBC News.
“No doctors will fight. They just don’t want to get into trouble. They have forgotten the people these drugs were made for.”
Flores said she worried she was failing as a mother, her teenaged son unwilling to put her down as an emergency contact. “He knows I often don’t answer the phone because I am in bed,” she said.
“When can I have medicine so I can just be comfortable in my body?” she asked.
It’s clear who they blame for their reduced ability to get opioids.
“To the FDA — we are begging you. Correct the CDC’s egregious mistakes,” said Rose Bigham of Seattle, who spoke on behalf of the Alliance for the Treatment of Intractable Pain.
“The CDC recommendations have done irreparable harm to people in pain.”
Fears of being denied pain relief
More than 90 percent of the patients at the FDA meeting and watching online said they had used NSAIDs and more than 80 percent said they had used opioids to control their pain. And 77 percent said they had used gabapentin (Neurontin) or pregabalin (Lyrica), both anticonvulsant drugs also approved to treat pain.
As for non-prescription treatments, 68 percent said they had used dietary supplements or herbal remedies to treat pain, 47 percent said they had tried medical marijuana or other cannabis-based products, 68 percent had tried acupuncture, massage or other complementary therapy and 47 percent had tried counseling or other psychological treatment.
“None of them are covered by insurance,” Bigham noted, to applause and loud cheers.
Bigham said she has ankylosing spondylitis, a form of arthritis affecting the spine.
She said she has tried NSAIDs, muscle relaxants, antidepressants, injectable drugs, cortisone and an electric current therapy called transcutaneous electrical nerve stimulation. “I remain on opioids to this day,” she said.
“My new worst nightmare is being admitted to the hospital, being in agony, and being denied pain relief,” Bigham said to more applause.
Charlotte Diggs of Atlanta said it’s not easy to get alternatives to opioids, either. Her physician was not forthcoming about possibilities when he was treating her for complex regional pain syndrome. “He didn’t offer it,” she said. “I had to hear about it and then ask him,” Diggs told NBC News.
"They have forgotten the people these drugs were made for.”
Flores said she wasn’t sure if talking to the FDA would help. “I don’t know if it is just a formality.”
But the FDA staffers said they genuinely wanted to consider patient perspectives, and listened quietly to lengthy, often tearful, tales of untreated pain, lost jobs and days spent in bed.
“We don’t have expectations for what we are asking,” said Dr. Sharon Hertz, director of FDA’s Division of Anesthesia, Analgesia and Addiction Products.
“If we thought we knew, we wouldn’t be asking.”
The agency is inviting public comment through Sept. 10.