‘Fighting the wrong war’: Chronic pain patients push feds to change opioid policies

https://www.usatoday.com/story/news/health/2019/07/12/opioid-rules-reassessed-amid-outcry-patients-needing-painkillers/1705026001/

David Lackey spent 40 years running his machine repair business, despite having a body wracked by arthritis, degenerative disc disease, bone spurs in his shoulders and fractures in his back and spine. 

After the Drug Enforcement Administration raided his pain doctor’s offices in January, seized medical records and prohibited any more opioid prescribing, Lackey only lived 34 more days.

The Odessa, Texas man died of a heart attack in March, after a month-long withdrawal that left him in bed shaking or in the bathroom vomiting and with diarrhea, his daughter, Gina Bruton, said.

Facing a backlash from chronic pain sufferers nationwide, federal health officials are rethinking policies that led to abrupt cutbacks to those who legitimately need these painkillers to function.

Federal measures made a broad-based effort to cut opioid prescribing and slow an overdose epidemic that kills tens of thousands of Americans each year. However, the Centers for Disease Control and Prevention officials acknowledge the agency’s influential 2016 chronic pain guideline has been used incorrectly to justify harmful practices such as rapidly reducing pain pills or doctors abandoning patients.

The CDC plans to update and expand the guideline with new research and is coordinating with public safety officials to ensure patients such as Lackey aren’t discarded when a doctor’s office is raided or closed.

In April, the Food and Drug Administrationwarned about reports of serious harm from slashing or discontinuing medication for opioid-dependent patients, including withdrawal, pain, psychological distress and suicide.

This fall, the FDA is expected to finalize plans to add warning labels to opioid medications about the risks of abruptly stopping the drugs. The FDA also proposed in May that drugmakers be required to offer limited-count blister packs of pills as an option to patients. These packs could be in low, medium or high-dose packs or be tailored to different procedures, such as hernia operations or appendectomies.

And a Department of Health and Human Services advisory task force in May reported on how to weigh the needs of 50 million chronic pain sufferers while tightening prescribing to prevent opioid addiction. The Pain Management Best Practices Inter-Agency Task Force recommended ways to allow pain sufferers to function and improve their quality of life.

Total U.S. opioid prescriptions have declined each year since 2012, a trend that accelerated after the CDC guideline issued in March 2016. Still, overdose deaths have continued to climb as pharmacies dispensed fewer pain pills, largely driven by illegal drugs such as heroin and fentanyl.

Vanila Singh, who chaired the HHS task force, says it could take time for state medical boards, doctors and others to bring nuance to prescribing opioids.

“I am not advocating we go and mindlessly prescribe,” says Singh, chief medical officer of the HHS office of the assistant secretary of health. “It has to be where the stigma of being the patient or the doctor or clinician who is prescribing is lessened. It is still a hard ship to turn.”

‘Doctors are afraid of the DEA’

Bruton believes pain patients and doctors have been unfairly targeted.

“Sure, the warning labels should be there,” says Bruton. “But in my opinion, they are fighting the wrong war.”

The CDC’s clarification is that its guideline was intended for primary care doctors, who increasingly are turning away pain patients. 

“Doctors are afraid of the DEA and worry their livelihood will be lost, so they are trying to protect themselves,” says Bruton.

Like her father, Bruton’s husband, Vernon, works in heavy machinery repair and was a patient of Carl D’Agostino, a pain doctor who was disciplined by the Texas Medical Board in June 2018 for failing to maintain paperwork that showed he monitored patients through urine drug screens, pill counts and medical histories. D’Agostino did not return calls from USA TODAY.

Vernon Bruton now has to travel 700 miles round-trip to a new pain doctor in San Antonio, Texas. She says there are only four or five pain management doctors in an area of about 200,000 people.

He takes a small dosage of opioids to treat his degenerative disc disease and neuropathy, some of which stems from a car crash when he was young and drove off a bridge, landing in a creek bed upside down in his truck. He was found six hours later.

“Every day he worries his will be the next doctor raided,” says Bruton.

Because he couldn’t get copies of his medical records from the FBI, no new doctor would take Lackey on as a patient. The 74-year-old was still working part-time for his business and needed his 60 milligrams of hydrocodone a day to “be functional,” says Bruton.

“He was never completely out of pain,” says Bruton. “He just wanted to be able to participate in life.”  

‘At the end of my rope’

The CDC acknowledged that there may have been unintended consequences from its 2016 guideline. Officials emphasized that the CDC is not a regulatory agency and its guideline is voluntary. Nevertheless, state health departments, insurers and other cited the guideline as reason for implementing opioid limits.

A common restriction: Limiting daily opioid intake at 90 morphine milligram equivalents per day – equal to two 30-milligram oxycodone pills.

“A lot of groups have taken that number and said, ‘We need to either taper [patients] down to that amount or we need to stop them,’” says Sharon Tsay, a medical officer with the CDC’s division of unintentional injury prevention. “That was not the intention. Some individuals need higher levels. People have physical dependence, whether or not they have addiction. So it’s actually very unsafe.”

Along with the federal Agency for Healthcare Research and Quality, the CDC is collecting new data to update and expand its pain guideline. The agency described the research as a priority but would not say when it expects to publicly release the information.

41% refuse new pain patients

Other research shows one consequence of the prescribing crackdown is that doctors are reluctant to take on new pain patients. A University of Michigan study published Friday in the Journal of the American Medical Association found that 41% of 194 primary clinics surveyed refused to take new pain patients. 

Rebekah Leonard knows the difficulty of finding a pain doctor. A bulging disc, nerve damage and a botched back surgery have put the Reidville, South Carolina woman in constant pain since the late 1980s. 

She says a fentanyl skin patch provided steady relief for years. But when her primary-care doctor retired five years ago, it took six months to find a pain specialist who put her on a strict, tapering regimen. When Leonard failed to take off one pain patch before putting on another, the pain doctor refused to continue to treat her, she said. 

She’s been without pain medication for more than three years and spends 23 hours a day on her bed or sofa. She rarely leaves the house.

“I’m at the end of my rope,” Leonard says. “There are many people in this situation. You don’t seek any solutions. After awhile, you don’t have the energy for it.”

From Vicodin to kratom

Tucson, Arizona resident Jacqui Gerschefske still has lingering back pain from an auto accident six years ago caused by a drunk driver. Her primary care doctor prescribed 5 milligram dosages of Vicodin and oxycodone, which allowed her to stand for 8-hour shifts as a convenience store clerk.

“She knew I was stable and she knew I was not abusing,” Gerschefske says.

Her doctor retired and her new doctor refused to prescribe her the same regimen, so Gerschefske began taking a herbal product, kratom. The FDA has warned consumers to avoid kratom because of risk of addiction, abuse and dependence.

The FDA tested 30 kratom products and says it discovered “significant levels of lead and nickel” that are unsafe.

Gerschefske says because she no longer has access to a doctor willing to prescribe opioids, she will stick with kratom despite the FDA warnings.

“My new doctor doesn’t prescribe pain pills,” Gerschefske says. “This was my solution, and I’m thankful that I have it.”

Feds want to prevent new cases of addiction

Public comments on the FDA’s blister pack proposal have been largely negative so far, with suggestions that regulators focus on illegal drugs and look for solutions that don’t make it harder for people with painful conditions to open their pill packs. 

Dr. Yngvild Olsen, a Baltimore addiction medicine physician, notes the proposed blister pack rules are targeted at patients with acute pain, such as after injuries or surgery. She doesn’t expect it will help or hurt chronic pain patients much. But it could help prevent some addictions from starting.  

“Certainly there is a percentage of people who get started on opiods for acute pain and continue to use and may go on to misuse,” she says.   

Olsen, co-author of “The Opioid Epidemic: What Everyone Needs to Know,” said the CDC guideline was applied in ways it was never intended.  

It “was really never meant for people already on opioids,” she said. “Unfortunately, that’s what happened.” 

Dr. Douglas Throckmorton, deputy director for regulatory programs in FDA’s Center for Drug Evaluation and Research, says the agency has “never lost sight of the needs of pain patients.” 

“We know that every action we take could have a big impact,” he said.  

Although doctors still routinely give 30-day prescriptions to opioids for procedures that rarely require more than a couple days, Throckmorton says he believes they can “change in response to conditions and education.” 

“The goals that the CDC has mirror our goals – education and to reduce inappropriate prescribing of opioids,” said Throckmorton. “As we work to educate prescribers, we will continue to keep the pain patient in mind.” 

Filed under: General Problems