By Kelly F. Merrill
Unintended Consequences
Attempts to muscle the Opioid Crisis into submission have been a total failure. Predictably, policy crackdowns on opioid pain-relievers were useless in mitigating overdoses due to illicit-fentanyl, which continue to rise. In 2017 alone, 72,000 people died of overdoses in the U.S. – more than the Vietnam, Iraq and Afghanistan wars combined. Worse still, the very measures intended to curb the Crisis have had devastating consequences for pain patients and the doctors who treat them.
The most far-reaching consequences began with the controversial CDC Guideline for Prescribing Opioids for Chronic Pain in 2016. Though intended to be voluntary recommendations for primary care physicians, the Guideline was widely adopted by states as law. And DEA fueled the country’s anti-opioid fervor using the Prescription Drug Monitoring Program to ramp up targeting and prosecuting of physicians – even going so far as to raid the clinic of renowned Dr. Forest Tennant, who’d won a lifetime achievement award for his work in pain medicine two months prior.
The most conscientious of practitioners became fearful, administrators got nervous and everyone began thinking about liability. As a result, too many patients have suffered outright abandonment, forced discontinuation or radical reductions in the opioid analgesics they require to function. It’s lead to dangerous and lethal, unintended consequences for patients in the form of street drugs, cardiac events, suicides and mercy killings.
Thomas Kline, M.D., a former Harvard Medical School program administrator, has been documenting patient suicides since the wide-scale misapplication and adoption of the CDC Guidelines by states. “We have a terrible problem, we have people committing suicide for no other reason than being forced to discontinue opioids – pain medications – for chronic pain,” he urges. “It’s one of the worst health care crises in our history. There are millions being tortured.”
Push-back
As a result of the hostile regulatory and legislative environment, few providers are willing to take on patients who require opioid analgesics – even those in suicidal levels of pain – as evidenced in a 99-page report by Human Rights’ Watch released in December of 2018, detailing the harmful, real-world consequences of the country’s failed efforts to control the Opioid Crisis.
In March, the collective voices of over 300 medical professionals, including three former drug czars, weighed in – collectively calling for clarification of the CDC Guideline that is being misused to discontinue or precipitously reduce opioids at the peril of patients.
By April, FDA took the unusual measure of issuing a Safety Communication, warning physicians not to abruptly discontinue or rapidly reduce dosages due to reports of serious patient harm, including acute withdrawal, unmitigated pain, psychological distress, and suicide.
Then, one day after the warning and three tumultuous years after the publication of the Guideline in 2016, the CDC finally responded to the community’s concerns. “The Guideline,” issued Director Robert Redfield, “does not endorse mandated or abrupt dose reduction or discontinuation” and that physicians should work to “reduce dosage only when patient harm outweighs patient benefit of opioid therapy.” (emphasis included.)
Prognosis
Brian Kaufman, D.O., owner of Total Health & Spine, is a board-certified Pain and Addiction Medicine specialist. He believes this is a long overdue clarification of the CDC Guideline and a significant change in tone from FDA. “I am hopeful this signals a pendulum shift that results in both governmental regulatory change, as well as the medical community being more moderate in their approach to these unfortunate patients.”
For many, these developments are too little too late. There are large swathes of the state where there is no longer pain management available for patients. Veterans, grandparents, mothers and lobstermen alike have told me their stories – about the impact of untreated pain – how their lives are forfeit because they are ill and cannot find care.
Patients tell me they just want a piece of their lives back – to go to work, spend time with their kids, attend church, mow their lawn, walk their dog or just be of use. And after enduring failed interventional therapies and damaging surgeries that leave people in pieces, opioid pain-relievers – the very drugs that have been so maligned – are compassionate chemistry that allows people to function in the world.
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If you are a pain patient, caregiver, physician, pharmacist or another medical professional who has been impacted by the Opioid Crisis, please email me at merrillWEN@gmail.com or find me on Facebook at Pain Advocacy Alliance.
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Merrill is an activist and artist. She has navigated medical systems and pursued relief in the U.S. and South America and is informed by her experience consulting with experts in the field. She worked as a paralegal at FDA law firm Hyman, Phelps & McNamara in Washington, D.C., where she also wrote for Dietary Supplement & Food Labeling News.
REFERENCES
https://www.hrw.org/report/2018/12/18/not-allowed-be-compassionate/chronic-pain-overdose-crisis-and-unintended-harms-us Mills, Laura et al. “”Not Allowed to Be Compassionate” | Chronic Pain, the Overdose Crisis, and Unintended Harms in the US.” Human Rights Watch. December 18, 2018. (“HRW Report”)
https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm?utm_campaign=FDA%20MedWatch-Opioid%20Pain%20Medicines%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua U.S. Food and Drug Administration, FDA Safety Announcement “FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.” (Feb. 9, 2019) (“FDA Safety Annoucement”)
https://healthprofessionalsforpatientsinpain.org/the-letter-1 Alford, Daniel Health Care Professionals for Patients in Pain to CDC, “Health Professionals Call on the CDC to Address Misapplication of its Guideline on Opioids for Chronic Pain through Public Clarification and Impact Evaluation,” March 6, 2019. (“300HCP letter”)
https://img1.wsimg.com/blobby/go/3d70257f-a143-4a5b-b9df-f7d265df0d3d/downloads/Alford%20Final%20.pdf?ver=1554957603807 Redfield, Robert. CDC Director Robert Redfield response letter to Daniel Alford, April 10, 2019 (“CDC Response Letter”)
https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm U.S. Centers for Disease Control, CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (March 18, 2016) (“CDC Guideline”)
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