BY

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD.,  LEROY BAYLOR,  ADRIENNE EDMUNDSON, WALTER L. SMITH BS., NATASHA DUVALL, PHARMD., LEROY BAYLOR, BS., MS., MS., BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

“CHANGE CANNOT WAIT”

The US ‘War on Drugs has had a profound role in reinforcing racial hierarchies. Although Black Americans are no more likely than Whites to use illicit drugs, they are 6–10 times more likely to be incarcerated for drug offenses. Meanwhile, a very different system for responding to the drug use of Whites has emerged.” 

A group of Black Pharmacy Owners found themselves under racist attack by the United States Drug Enforcement Administration (DEA). They organized together along with a diverse group of Black Scholars into a Think Tank called the North Star Pharmacy Group and began identifying and exposing systemic racial drug policies and injustices in healthcare delivery policies within both DEA/DOJ. They’ve further exposed a long history of racial targeting of black community leaders, black-owned pharmacy businesses, and physicians by DEA/DOJ; there is a demand for Congress to ACT, to investigate this agency. 

WE OWE A GREAT DEBT TO THE WORK OF RICHARD LAWHERN Ph.D., A NON-MEDICAL PERSON WHOSE INSIGHT TRAINING AS AN ENGINEER MAKES OUR CAUSE POSSIBLE

FROM: RICHARD LAWHERN Ph.D.

For: Barbara Houry      

Director, National Center for Injury Prevention and ControlAdministrative Staff, NCIPC Board of Scientific Counselors

and 
      All sitting members of the BSC    

The following article describes conditions for which you are jointly and individually responsible, which constitute an unjustifiable “Injury” to millions of chronic pain patients, family members, and physicians.  In a just world, many addressees of this note would now be facing criminal or civil indictment for public malfeasance and medical negligence.  

The circumstances you have created have already resulted in the predictable and unnecessary deaths of hundreds of pain patients by suicide, when they were overcome by pain and withdrawal that were utterly unnecessary and medically unjustifiable.  Hundreds of thousands of others have been denied effective pain carte and disabled.   

I call upon the NCIPC to immediately repudiate and withdraw the 2016 CDC Guidelines on prescription of opioid analgesics to adults with chronic non-cancer pain.  This class of medications is now known beyond any reasonable contradiction to be safe and effective for the great majority of chronic pain patients.  The so-called “opioid crisis” was not created and is not being sustained by doctors prescribing to their patients.  That “crisis” is instead sourced in socio-economic factors and fed by street drugs marketed by international cartels.
You owe the American public the courtesy of a public acknowledgment of your errors and misdirection.  Either fix the problems you have created or resign!  

Richard A. Lawhern, PhDPatient Advocate
Publications:  http://www.face-facts.org/Lawhern

Abrupt Cessation of Long-Term Opioid Prescribing Common

— Most Medicare patients stopping long-term opioids experienced ‘falling off a cliff drug changes

Medicare beneficiaries were increasingly likely to have long-term opioid therapy stopped in recent years and medication changes often were abrupt, not tapered, an observational study showed.

Long-term opioid discontinuations among Medicare Part D beneficiaries increased by 49% from 2012 to 2017 and most were rapid, “falling off a cliff” drug changes, reported Michael Barnett, MD, MS, of Harvard T. H. Chan School of Public Health and Brigham and Women’s Hospital in Boston, and co-authors.

The proportion of abrupt opioid discontinuations increased over time, from 70.1% in 2012 to 81.2% in 2017 (P<0.001), they wrote in the Journal of General Internal Medicine.

Patients on long-term opioid therapy “face significant stigma and misunderstanding in the current healthcare system,” Barnett said. “There are many reports of patients being indiscriminately discontinued from their medications, but little data to investigate these concerning reports,” he told MedPage Today.

“The vast majority of long-term opioid users whose therapy was discontinued had an extremely rapid, abrupt taper that was far outside of guideline recommendations,” Barnett added. “It would have been concerning to find that, say, one in four long-term opioid users had abrupt cessation of their therapy but we found that it was most, even among those with very high daily doses of opioids.”

The CDC and FDA have published cautions against abrupt tapering, citing it as dangerous to patient health, noted Beth Darnall, Ph.D., director of the Stanford University Pain Relief Innovations Lab, who wasn’t involved with the research.

This study highlights the pervasiveness of poor tapering practices occurring from 2012-2017 and the extent of pain care disparities, she observed. “As of 2017, these alarming trends continued to increase,” Darnall told MedPage Today. “There is a desperate need for improved healthcare and safety measures for people with chronic pain taking prescribed opioids so they are not subjected to unethical and dangerous practices.”

The CDC’s 2016 guideline for chronic pain opioid prescribing prompted a big focus to reduce overprescribing. Some state agencies and insurance companies used the guideline to push hard dose limits and abrupt tapering, which the CDC later said was inconsistent with its recommendations.

“In 2018, a group of us authored a letter to HHS calling for urgent action against forced and abrupt opioid tapering,” Darnall said. “In 2019, HHS issued guidance for patient-centered opioid tapering that promotes consensual tapering practices.”

In their study, Barnett and co-authors looked at claims for a 20% sample of Medicare beneficiaries on long-term opioid therapy for at least 1 year, defined as four or more consecutive quarters with more than 60 days of opioids supplied in each quarter from January 2011 through December 2017. People with a cancer diagnosis besides skin cancer and hospice patients were excluded, as were people on an average daily dose of 25 morphine milligram equivalents (MME) or less during their initial 12-month long-term opioid therapy period.

Most (70.3%) long-term opioid users in the study were eligible for Medicare due to disability. Mean age was 60 and 58% were women.

Long-term opioid discontinuation was defined as at least 60 consecutive days without opioids supplied. The researchers evaluated whether discontinuation was tapered or abrupt by comparing patients’ daily MME dose in the last month of therapy to their average daily dose in a baseline period of 7 to 12 months before discontinuation. By the last month of therapy, patients with abrupt discontinuation had at least a 50% reduction in their baseline average daily dose.

The study identified 258,988 long-term opioid therapy users; of these, 17,617 (6.8%) discontinued therapy. Adjusted rates of discontinuation increased from 5.7% of users in 2012 to 8.5% in 2017. Increases in annual discontinuation rates were similar for people on lower (26-90 MME, 5.8% to 8.7%) and higher (more than 90 MME, 5.3% to 7.7%) doses.

People eligible for Medicare because of disability had a greater increase in the probability of discontinuing opioids from 2012-2017 (adjusted rates 5.9% to 9.2%, 56% relative increase) compared with people not eligible due to disability (5.2% to 7.0%, 35% relative increase, P<0.001 for interaction).

While it was common for patients on lower daily MME doses to have long-term opioids stopped rapidly, the majority of patients on very high doses — even over 200 MME — who stopped also had an abrupt discontinuation, Barnett and co-authors reported.

“We need more education and support for patients on long-term opioid therapy to taper in a clinically rational way and maintain excellent continuity of care with their pain management team,” Barnett said.

The study had several limitations, the researchers noted. Data represent Medicare beneficiaries only, predominantly the disabled Medicare population, and may not apply to other people. The intended tapering strategy for these patients wasn’t known and it’s possible the data reflect a bias toward abrupt discontinuation.

• Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s, dementia, MS, rare diseases, epilepsy, autism, headache, stroke, Parkinson’s, ALS, concussion, CTE, sleep, pain, and more. Follow 

Disclosures

Barnett is retained as an expert witness for government plaintiffs in lawsuits against opioid manufacturers. The other authors have no conflicts of interest to disclose.

FOR NOW,

YOU ARE WITHIN THE NORMS