Frustrated Pain Patients Meet With FDA About Opioid Access

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Frustrated Pain Patients Meet With FDA About Opioid Access

By Maggie Ethridge 07/12/18

A group of pain patients met at FDA headquarters to share their personal stories in a bid to get the agency to ease opioid restrictions.

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Patient-Focused Drug Development Meeting
Photo via YouTube

The FDA called a meeting in Washington, D.C. to listen to pain patients' experiences of lacking access to opioids to manage their symptoms.

A group traveled to the FDA’s headquarters outside the nation's capital to ask the agency to ease restrictions that they say has made it harder for them to obtain opioids.

NBC News reported on the stories of some of those who urged the FDA to consider what it is like to have acute or intractable pain and be unable to find relief.

Dr. Sharon Hertz, director of FDA’s Division of Anesthesia, Analgesia and Addiction Products, told NBC of the informal meeting, “We don’t have expectations for what we are asking. If we thought we knew, we wouldn’t be asking.”

The Patient-Focused Drug Development Meeting included harrowing stories of suffering. Sandra Flores has a condition called adhesive arachnoiditis, which is an inflammation of membranes in the brain, spine and nerve endings. She has repeatedly attempted to obtain the correct drugs for her pain.

“I am seeing the true face of medicine,” Flores said. “Now they are throwing me in the trash.”

FDA Commissioner Scott Gottlieb made an emphatic statement on the plight of pain patients without access to relief. 

“Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide. This is unacceptable. Reflecting this, even as we seek to curb overprescribing of opioids, we also must make sure that patients with a true medical need for these drugs can access these therapies,” said Gottlieb, according to PatientEngagementHIT.

The FDA does not regulate physicians' prescribing habits; states do. As of now, 28 states enforce limits on opioid prescriptions, says data from the National Conference of State Legislatures.

Although the FDA, CDC and most major medical institutions agree that limiting access to opioid prescriptions is a necessary step in fighting the opioid epidemic, they do not want intractable pain patients to suffer.

Under the new regulations, many doctors have simply stopped prescribing out of fear of lawsuits. Flores has been unable to find a doctor that will take her on as a patient. “No doctors will fight. They just don’t want to get into trouble. They have forgotten the people that these drugs were made for.”

Rose Bigham, speaking on behalf of the Alliance for the Treatment of Intractable Pain, said in the Washington meeting, “To the FDA—we are begging you. Correct the CDC’s egregious mistakes. The CDC recommendations have done irreparable harm to people in pain.”

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