Study Finds That Reducing Pain Medication Is Associated With an Increased Risk of Overdose and Suicide

Substantially reducing the doses of pain medication prescribed for patients on long-term opioid therapy is associated with a threefold increase in suicide attempts and a 69 percent increase in overdoses, according to a study published this week in The Journal of the American Medical Association (JAMA). The study reinforces concerns that the “tapering” encouraged by federal guidelines as a response to the “opioid crisis” causes needless suffering among patients, leading to undertreatment of pain, withdrawal symptoms, and emotional distress.

Alicia Agnoli, an assistant professor of family and community health at the University of California, Davis, and five other researchers examined the medical records of about 114,000 patients who had been prescribed “stable, high doses of opioids,” with a mean daily dose of at least 50 morphine milligram equivalents (MMEs), for at least 12 months. They identified more than 29,000 patients whose doses were subsequently reduced by 15 percent or more. They used hospital records to identify “overdose or withdrawal events” and “mental health crisis events,” including depression or anxiety and suicide attempts, during follow-up periods of up to a year.

hydrocodone-tablets-Ranjav-Raghav-Flickr

“Posttapering patient periods were associated with an adjusted incidence rate of 9.3 overdose events per 100 person-years compared with 5.5 events per 100 person-years in nontapered periods,” Agnoli et al. report. “Tapering was associated with an adjusted incidence rate of 7.6 mental health crisis events per 100 person-years compared with 3.3 events per 100 person-years among nontapered periods.” In other words, tapering was associated with a 69 percent increase in overdose events and a 130 percent increase in mental health crisis events. Suicide attempts were 3.3 times as likely when patients’ doses were tapered.

It is hardly surprising that patients who had been receiving stable doses of opioids for an extended period of time—doses that presumably controlled their pain effectively enough that they could function reasonably well—would experience distress when their doctors suddenly decreed that they would have to get by with less medication. The results of this study are consistent with earlier research documenting the danger of such one-sided, politically driven decisions. A 2020 study of veterans found that “patients were at greater risk of death from overdose or suicide after stopping opioid treatment.” Another study published last year found that discontinuation of opioid therapy was associated with an increased risk of heroin use.

The JAMA study is also consistent with numerous complaints from pain patients across the country who reported that their medication was arbitrarily reduced or cut off in response to the prescribing guidelines that the Centers for Disease Control and Prevention (CDC) published in 2016. As Agnoli and her co-authors note, the CDC “recommended against higher doses of opioids in managing chronic pain and recommended dose tapering when harms of continued therapy outweigh perceived benefits for individual patients.”

Although the CDC’s advice was not legally binding, and although the guidance said doses should be tapered only when medically appropriate, doctors, lawmakers, insurers, and pharmacies interpreted the agency’s warnings about daily doses exceeding 90 MMEs as a hard limit. “These and other widely disseminated recommendations have led to increased opioid tapering among patients prescribed long-term opioid therapy,” Agnoli et al. note.

The consequences have been repeatedly decried by the American Medical Association (AMA). “The 2016 Guideline is hurting patients,” AMA Board of Trustees Director Bobby Mukkamala said in a July 22 letter to the CDC. “Patients with painful conditions need to be treated as individuals. They need access to multimodal therapies including restorative therapies, interventional procedures, and medications. These include non-opioid pain relievers, other agents, and opioid analgesics when appropriate. Instead, patients with pain continue to suffer from the undertreatment of pain and the stigma of having pain. This is a direct result of the arbitrary thresholds on dose and quantity contained in the 2016 CDC Guideline. More than 35 states and many health insurers, pharmacies, and pharmacy benefit managers made the CDC’s 2016 arbitrary dose and quantity thresholds hard law and inflexible policy.”

In an April 2019 “safety announcement,” the Food and Drug Administration (FDA) said it had “received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased.” It said the consequences “include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.”

The CDC itself joined the FDA in warning doctors about the hazards of abrupt dose reductions. “The recommendation on high-dose prescribing focuses on initiation,” then-CDC Director Robert Redfield said. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.” Furthermore, “the Guideline also recommends that the plan be based on the patient’s goals and concerns and that tapering be slow enough to minimize opioid withdrawal.”

Even the authors of the guidelines worried that their advice had been “misimplemented” in a way that was hurting patients. “Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” Deborah Dowell, Tamara Haegerich, and Roger Chou wrote in a 2019 New England Journal of Medicine commentary. Those policies and practices, they said, included “inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The CDC is mulling revisions to its advice. “A revised CDC Guideline that continues to focus only on opioid prescribing will perpetuate the fallacy that, by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end,” Mukkamala warned in his letter to the CDC. “We saw the consequences of this mindset in the aftermath of the 2016 Guideline. Physicians have reduced opioid prescribing by more than 44 percent since 2012, but the drug overdose epidemic has gotten worse.”

Whatever the revised guidelines say, the damage already has been done, and policies based on the original version will be difficult to unwind. Furthermore, the CDC’s recommendations, while highly influential, were just one part of a broader strategy, implemented at the state and federal levels, to reduce opioid-related deaths by discouraging prescription of pain medication.

How has that worked out? Agnoli et al. note that “opioid-related mortality has continued to rise,” which is a bit of an understatement.

The government indisputably succeeded in driving down prescriptions. Per capita opioid prescriptions in the United States, which began rising in 2006, fell steadily after 2012. Yet in 2019, when the dispensing rate was lower than it had been since 2005, the U.S. saw more opioid-related deaths than ever before. Last year, according to preliminary estimates from the CDC, that record was broken once again: Opioid-related deaths jumped by 40 percent. As opioid prescriptions fell, the upward trend in fatalities not only continued but accelerated as nonmedical users replaced legally produced, reliably dosed pharmaceuticals with highly variable black-market drugs of unknown provenance and composition.

Even if it were ethical to demand that patients live with treatable pain as the price of reducing opioid-related deaths (which it isn’t), the government has not achieved that tradeoff. Instead we have worse outcomes across the board: many more patients suffering from pain that could be relieved and many more drug-related deaths. Far from harm reduction, this looks like a strategy of harm maximization.

JACOB SULLUM is a senior editor at Reason.

 

Department of Health Care Services

Provider Alert: Lags Medical Center Closure: Issued May 21, 2021
https://files.medi-cal.ca.gov/pubsdoco/newsroom/newsroom_31152.aspx

On May 19, 2021, the Department of Health Care Services (DHCS) temporarily suspended select Lags Medical Center locations from participation in the Medi-Cal program, as a result of an ongoing investigation by the California Department of Justice (DOJ), Division of Medi-Cal Fraud and Elder Abuse.

This temporary suspension will continue until the DHCS determines that it is no longer appropriate to do so under applicable law. Twenty-eight California sites operated by Lags Medical Center in the following counties may be impacted by these closures: Los Angeles, Ventura, Santa Barbara, San Luis Obispo, Kern, Tulare, Kings, Monterey, Santa Cruz, Fresno, Madera, Merced, Alameda, Stanislaus, San Joaquin, and Sacramento.


When you visit the Lags Medical Centers website, you’ll notice a message that states:

“To Our Valued Patients,

We would like to thank you for the trust you have given us as your Pain Management providers. Our top priority is the health and well-being of our patients, families, staff, and community. In this unprecedented time, we are deeply committed to keeping everyone safe.

Please be advised that due to unforeseen circumstances Lags Medical Centers will be closing effective May 19th, 2021.”

Phrases such as “unforeseen circumstances” make it difficult to determine whether there was any patient abuse or billing issues that were deemed potential hazards. Also, a voluntary shutdown is unlikely without a threat behind it.

Terrorism is the use of force or violence against persons or property in violation of the criminal laws of the United States for purposes of intimidation, coercion, or ransom, to create fear among the public and get immediate publicity for their causes.

In the interest of public safety, a sudden lawful search and seizure must have a written warrant that clearly outlines what is being investigated. The only exception to this is medical record privacy, which is protected by HIPPA Laws.

Due to the freedom of speech and the First Amendment, we have the right to speak out and petition the government for a redress of grievances. Under the Fifth and Fourteenth Amendments, Lags Centers and Dr. Francis P. Lagattuta are protected by law.

If Lags and their patients have been following prescription guidelines and do not meet the addiction or illegal activity qualifiers, no laws have been broken. Therefore, this action shouldn’t have been taken. Once savelagsmedical.com is ready, we ask you to share your story in support of Lags Medical. We also encourage professionals to share their expertise.

This Go-Fund-Me is set up in the amount for the state of California Medical Malpractice limit, in support of Lags Center, Dr. Francis P. Lagattuta, and the formation of the Save Lags Alliance.

Please support us and share your story today!

Mark C.

Mark Chumley and FatherHi there! I’m Mark, a 60-year-old with over 35 years of experience in the entertainment industry. I’ve spent most of my career in production in Los Angeles. I lived a virtually pain free life until I turned 38 in 1999. 

In 1999, I moved back to Santa Ynez Valley in Santa Barbara County, California US where I still live today. I was diagnosed with osteoporosis and my family doctor of 20 years introduced me to opioid pain management. 

Hydrocodone-Ibuprofen 7.5 has delivered phenomenal results for me and continues to do so in 2021, 21 years later. This course of treatment has allowed me to maintain my dignity and will hopefully keep me working until I retire at age 62 or 65. 

Phillip P, my 85-year-old stepfather has a history of heart attacks and strokes. He has also been on opioid pain management for 25 years, from 1996 to present day. While life isn’t always easy for us, we have a great support system that helps us maintain our personal dignity and a high standard of living.

Both myself and my stepfather have a strong, long standing relationship with Lags Medical Centers and deeply respect their patients, doctors, and employees. We firmly believe their shut down was unfair. It was their services that have led us to make the best treatment choice and significantly improve our quality of life. 

We do not feel at risk while using their services and have not discovered or been presented with anything other than the addictions of others and overdose concerns we are not qualified for. If you have interest in long-term use, we welcome all inquiries or studies.

“Hang in there, Lags! We will be back!”

Mark C. and Phillip P.
Solvang, California. 

Taking Care of Patients After Pain-Management Clinic Closes

Neighborhood Clinics Takes Up Where Lags Left Off

After Lags Medical Centers closed 29 of its California locations in May, patients who had sought help for debilitating pain were suddenly without support. An element of their treatment was likely to be opioids, which are highly useful in attempting to alleviate pain but carry a downside of physical addiction. With the sudden closure of Lags, a nickname for founder Dr. Francis Lagattuta, Santa Barbara Neighborhood Clinics was among the health-care providers who assumed the treatment of patients they had previously referred to Lags.

The Lags centers, which were headquartered in Santa Maria, had come under fire by the California Department of Justice for fraudulent billing and potential patient harm, and the state Department of Health Care Services temporarily suspended it from the Medi-Cal program. Lags had advertised that it treated more than 30,000 patients in California, and the California Department of Health Care Services (DHCS) has been working to create transition plans for its patients, concerned about their dependence on controlled medications like opioids, the high risk of withdrawal or accidental overdose, and the dangers of their long-term use.

When treating those with pain, “You need to have a multi-pronged approach to help them manage the pain and the expectation of the pain, because you’re never going to get to a pain score of zero,” said Dr. Charles Fenzi, CEO and chief medical officer of Santa Barbara Neighborhood Clinics. This requires involving mental-health experts and physical therapists and is different from prescribing.

In 2019, as many as 1.4 million people in the United States were estimated to have a substance-use disorder related to prescription opioids. According to Dr. Fenzi, the opioid epidemic is “as bad here as it is anywhere in the country.”

In advisories from the state health care department after Lags closed, medication-assisted treatment (MAT) providers were told to consider using buprenorphine in treating an opioids addiction to mitigate the impact of withdrawal symptoms. The treatment plan combines medication with counseling support to address the behaviors and compulsive patterns associated with opioid addiction in a “whole-patient” approach. In using this treatment, Fenzi stated, “The idea is to help people start their recovery without the fear of getting sick by using a safer medicine.”

In addition to the Neighborhood Clinics, the Santa Barbara County Department of Behavioral Wellness also has a program that utilizes medication-assisted treatment. Fenzi said these institutions especially assist those who are underserved or under-insured. His clinics’ mission was to provide “whole person care to a segment of the population that doesn’t traditionally have access to that.”

SBNC offers a strategy that Fenzi called “no wrong door.” He explained, “If somebody comes to us and says, ‘I really want to get well,’ we should figure out how to do that, and we should get them to the right place.”

While the long-term impact of the Lags clinic closures is unknown, the COVID-19 component in the crisis is worth noting. Fenzi stated, “With the lockdown that occurred in March of last year and the seclusion of these folks, I think we’ve seen a lot more overdoses and people with ill effects from their substance-use disorder.”



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