Pt dies of heart attack after being thrown into cold turkey withdrawal because of DEA raid

‘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 CDC says kratom, an herbal supplement, was a cause of deaths in 91 fatal overdoses in the United States from July 2016 to December 2017. USA TODAY

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.” 

17 Responses

  1. Just another lie by the system about kratom. Kratom alone did not cause OD’S, it was a mixture of street drugs with kratom that caused the OD’S. Quit lying government!!!

  2. It’s real. Doctors were scared to continue writing pain prescriptions based on the Center for Disease Control’s staunch stance against the opioid “crisis.” I believe that the CDC should be held accountable for any death that occurred because of their failure to plan accordingly. And ANY doctor who feared the CDC is not a doctor I would ever want. Trust a doctor who ha YOUR best interests at heart and NOT their own.

  3. Be careful: CDC is misleading in kratom stats, just like OD on opioids.
    93 deaths INVOLVED kratom, but vast majority were fatal mix of ,3 or 4 drugs.

    If our govt is forcing us off opioids, many states do not have medical marijuana or CBD sales, and now talk of kratom becoming a Schedule 1, what is left us? Neurontin? Endless steroid injections?

    Please be accurate. Our very lives depends on it!

  4. Dr. D’Agostino was my doctor, too. He was caring. He did urine tests, the pain contract, all of it. The DEA hurt a lot of people when they raided him. I would guess at least half, if not more, of his patients were elderly. How many of them have died after losing their pain medication?

    I am lucky because I was able to find a pain clinic about 2.5 hrs away that I travel to monthly for 2/3 the meds. It’s not ideal, but it’s better than nothing.

    I place blame of this man’s death and of any other of Dr D’s patient’s death squarely on the DEA and CDC.

    • Agree Agree lost my 25 year PCP when he could no longer fight or stand the constant strain and zero support when all the medical community just turned on each other instead of fighting back together. I’m sorry I agree this should be fought! Thank god for those who can and do!

  5. The CDC has done more than enough harm to chronic pain patients and to doctors. They were out of line dictating the use of medical drugs, the FDA does that. Instead of “rewriting” the guidelines, the CDC should be fully investigated for the creation of those deadly guidelines. Why was PROP allowed so much authority in dictating what medications that ALL doctors can prescribe patients? Why were they so secretive when they put the guidelines together?

    There are a lot of things about those guidelines that need a full investigation and those who took part in making the guidelines need to face the consequences of their recklessness and all the needless suffering and death they have caused. Keeping in mind that these folks supposedly work for the American people and that this entire anti-pain medication campaign was paid by our tax dollars.

  6. I find it quite funny at the fact that narcotic painkillers are just about the only pharmaceuticals which you can feel working. Well, not anymore. Pharmaceuticals are just about done. Everything about it from the top to the bottom is fraud. The pills don’t work, the treatments don’t work. I have never known pharmaceuticals to be effective in about 90%+ of cases.

  7. Kratom alone has NEVER caused a singleto death! Anyone who OD’d with multiple substances (including kratom), the FDA counted it as a kratom death! Those people ALL died of polypharmacudical abuse. Also, they supposedly did a survey by testing kratom and it showed heavy metals in it…I’m SURE they got it from a smoke shop and not a reputable vendor online who actually have their product tested by a 3rd party tester. The government is just upset because they can’t patent a plant and make money off it! It’s been used for 1000’s of years in Indonesia!! It’s been a life saver for so many people!

  8. Sick
    Heinous
    Terrible
    Predictable
    Criminal.
    Any other adjectives?
    Gruesome
    Bizarre
    Inhumane
    Disgusting
    We all predicted this outcome.
    Send these people to prison.

  9. People need to get in contact with his family and help them Find a lawyer

  10. What’s happening is downright criminal! the DEA, CDC, all of them should be sued and prosecuted for discrimination, denying sick ppl the right to live with tolerable pain, medical assault! A lot of veterans are effected as well.

  11. I am sickened by what is being done to us chronic pain patients! I HAVE ADHESIONS and if you look up one of the symptoms you will see it causes chronic pain SO WHY CAN’T I GET TREATED?!!!!!!!!!!!!!! I WANT TO LIVE A LIFE LIKE ALL YOU CDC, FDA, MA AND ALL THE OTHER MEDICAL ALPHABETS!!!!!!!! SHAME ON YOU!!!!! PPL ARE DYING BECAUSE OF YOUR NONSENSE!!!!!! I DIDN’T ASK FOR THIS! I AM IN BED NOW FOR NO REASON WHEN ALL I NEED IS MEDICATION TO WORK AND LIVE S LIFE BUT NO, SOMEONE WHO DOESN’T EVEN KNOW ME HAS DECIDED TO CONDEMN ME TO LIFE IN BED! MY FAMILY THINKS I’M NOT IN BAD SHAPE BECAUSE YOU SO HAVE MADE THE WORLD THINK OPIOD IS FOR ADDICTS, IT’S A BAD THING!!! IT’S NOT!!!!! IT IS THE LINK BEEN A LIFE OR A LIFE IN THE BED!!!!!!! PLEASE STOP IT AND HELP!!!!!!!!!!! WORK ON ALCOHOLISM, DRUNK DRIVING, GUN CONTROL SOMETHING ANYTHING BUT CHRONIC PATIENTS PLEASE!!!!!!!!

  12. “‘As we work to educate prescribers, we will continue to keep the pain patient in mind.'”

    Riiiight. And they’re going to give everyone a winning Powerball ticket, too.
    They’re sure as hell not keeping the pain patient in mind now, so “continue” is kind of a moronic word there, Throckmorton.

  13. Get the DEA OUT of the doctors offices, They have no medical degree and that is aganist the LAW, Put the all in jail NOW

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