Chronic pain patients, overlooked in opioid crisis, getting new attention from top at FDA
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The Food and Drug Administration is working to address how the opioid epidemic response has affected chronic pain patients, who often can’t get relief.
Tough state laws on prescribing that took effect Sunday, Centers for Disease Control and Prevention (CDC) dosage guidelines and state and federal charges against doctors who prescribe opioids are an overreaction to addiction, according to several dozen people with unremitting pain who contacted USA TODAY.
CDC researchers said in an article in April in the American Journal of Public Health that they overestimated the number of Americans who have died of prescription opioid overdoses. Because of inaccurate tracking methods, the CDC said it incorrectly counted many overdoses from illicitly manufactured synthetic opioids such as fentanyl as prescription drug deaths.
The CDC had estimated 32,445 Americans died from overdoses involving prescription opioid pain medication in 2016. The CDC’s new estimate of fatal overdoses from prescription opioids is 17,087, or 53 percent of the original estimate.
Even though state laws say chronic pain patients who need medication will receive it, “that’s not what’s happening,” says Lauren Deluca of Worcester, Massachusetts, who founded the Chronic Illness Advocacy & Awareness Group last year after her own challenges getting the opioid painkillers she needed.
The Food and Drug Administration (FDA) is trying to undo some of the damage through a host of actions that include a public meeting July 9 on chronic pain drug development and the challenges pain patients face in getting the treatment they need.
Moriah White of Braxton County, West Virginia, calls herself an “opioid war casualty” and said she welcomes any help the government is willing to offer. She had to leave a job teaching special education because of the condition fibromyalgia, which makes her skin feel like “a sunburn scrubbed with a wire brush.”
Danny Elliott’s pain doctor was charged last week in a “takedown” in Florida and Georgia of 600 doctors accused of health care fraud and illegal opioid prescribing by Justice Department and Drug Enforcement Administration officials. The former pharmaceutical industry salesmen was electrocuted in1997, which left him with a traumatic brain injury that was so painful he contemplated suicide. He is trying to find a new doctor. His previous one was the first “who actually gave me some relief from my pain.”
DEA Miami Field Division Deputy Special Agent in Charge Jaime Camacho said last week that the agency is “committed to ending the opioid crisis that continues to plague Florida and endanger the welfare of our communities.”
Clinical psychologist Michael Schatman, editor in chief of the Journal of Pain Research, who describes himself as an “opioid moderatist,” said about 90 percent of people are better off without opioids.
But it’s the 10 percent who need them that are terribly harmed by policy and enforcement actions pushed by groups he said are “radically anti-opioids.”
“For years, federal and state legislators did nothing, leaving it up to state medical boards and the regulatory agencies, which was the problem,” said Schatman, research director at Boston Pain Care, which has treated hundreds of patients without an overdose or suicide. “Now all of a sudden, state legislators are passing incredibly draconian laws that are and have the future potential to literally kill people.”
He cited laws, such as one that took effect July 1 in states including Florida, that tighten regulation of doctors who prescribe opioids and other controlled substances. End-stage cancer patients and the elderly don’t have long enough to live to become addicted and suffer needlessly because of the law, Schatman said.
Florida House Speaker Richard Corcoran, who attended the bill signing, defended the approach, according to the Orlando Sentinel.
“Is that an inconvenience? Yes,” said Corcoran. “Is an inconvenience worth saving 50,000 lives nationwide? Absolutely.”
That attitude has led some doctors whose patients have had no problems with opioid prescriptions to back away from prescribing them. Schatman said there’s a big difference between depending on opioids to survive and becoming addicted to them.
Cathy Mitchell, a disabled registered nurse, suffers from a long list of injuries and diseases, including osteoarthritis, post-major lumbar surgery for ruptured discs, cervical scoliosis and bilateral carpal tunnel syndrome.
Disabled since 2013, she said only opioids provide the pain relief that allows her to “function daily.”
She has to go to a pain clinic every 28 days and her primary care doctor every three months. After 10 years of being treated for pain and anxiety “without causing any problems,” Mitchell can no longer be treated for both.
Making matters worse for what’s estimated to be millions of patients, the Centers for Medicare and Medicaid Services plans to drop coverage of opioid medications above a certain dosage starting next year.
Elsewhere at the Department of Health and Human Services, the FDA’s plans include encouraging medical device development for pain and hosting a drug development meeting July 9 that focuses on how hard it is for patients with chronic pain to get treatment and what solutions exist.
“The reality is that the opioid drugs work for certain patients, and there are certain situations where the opioids are the only drugs that work for those patients,” FDA Commissioner Scott Gottlieb said.
The FDA’s success will be tested by the fact that physicians are largely policed by states and that even as opioid prescriptions go down, overdose deaths increase as many suffering from addiction have moved on to heroin, often in combination with other drugs. The FDA recommended that doctors reduce opioid prescriptions, but doctors and their medical societies remain opposed.
State medical boards have been especially aggressive in some states going after the licenses of doctors for overprescribing opiate painkillers.
Chronic pain patients across the country said that when physicians lose their license or stop treating pain patients, it can be difficult, if not impossible, to find a new doctor willing to take them on as a patient.
In Virginia, then-Governor Terry McAuliffe boasted on a panel in October that the state led the nation in reductions in opioid prescribing, including a drop of a third in the prior six months. Doctors aren’t allowed to prescribe or refill a prescription for opioids for longer than 10 days without a written explanation.
Two years ago, the state medical board suspended the license of Jenny Austin’s primary care doctor.
Austin, a former investment banker, had to take so much time off from work for crippling pain from migraines and a neurological disorder, she sought a higher dose of painkillers. She continued to see her Virginia doctor even after she moved to Louisiana, because she was “desperate to find a solution that would reduce my hospitalizations.”
Instead, she’s out of work and bedridden much of the time.
To help remedy this, the FDA is considering encouraging medical professional societies to develop evidence-based guidelines on appropriate prescribing and the possibility of incorporating new prescribing information on opioid painkiller labels.
Schatman is skeptical the efforts will make much difference, in part because he said “there’s no empirical evidence that apps and other ‘medical devices’ can improve the quality of pain medicine in the United States.”
“The opioid pendulum has swung awry,” Schatman said. “This current climate of opiophobia is … leaving patients more dysfunctional, with diminished quality of lives, severe hopelessness and increasing suicidality in the chronic pain patient population.”
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