TO COVER OPIOID CRISIS MEDICAL CURE FAILURE, MORE LIES IN AMERICA’S TOP MEDICAL JOURNAL
Predictable confounding effects of naloxone (Narcan) provision and unreported community revivals for study group individuals enrolled in substitute opioid (MAT, MOUD) treatment programs nullify conclusion of treatment benefit
by Clark Miller
Published October 9, 2024
True to harm-predicting form, America’s top medical journal, Journal of the American Medical Association ( JAMA), has again published research with conclusions attributing benefit by reducing opioid overdoses and OD deaths to “gold standard” medicines for problem opioid use, while failing to account for the confounding factor that has consistently been evidenced as providing the only tenable explanation for such reductions – increasing availability of and/or differentially provided naloxone resulting in its higher instances of use of to reverse potentially lethal ODs, established as predictably, consistently accounting for such outcomes. Consistently and predictably, Narcan access, distribution and support for use are differentially higher for research treatment/intervention group individuals than those in control groups due to their enrollment in medication assisted treatment programs (MAT aka medication use for opioid use disorder, MOUD) and associated contact with medical supports, with other program and associated social service supports, and pharmacy interactions.
In those types of contacts for individuals receiving MOUD, Narcan would be provided, its use trained on, and replenished as needed. It is a standard of care for individuals receiving services for opioid use disorder (OUD) and would be grossly unethical to fail to meet that standard.
Below is more than is usually provided here in a post from the original research article. The descriptions of study design, results and other features will be important as we take those apart and find, examined and thought about, that the outcomes do not support any benefit in nonfatal overdose reduction or of opioid OD deaths, instead point to and further confirm the established failure of America’s expert medical opioid cures, instead fueling a worsening epidemic.
It may be best to simply begin with the few key points that are of interest and concern regarding this research, its presentation in America’s top medical journal, and its use to promote the use of American Medicine’s gold standard medical substitute opioid cures for problem opioid use and the crisis. Concern for anyone interested in this area of public health and associated healthcare institutions, and for those Americans and their families trapped in and at risk in the worsening crisis.
KEY POINTS
1. There were no beneficial effects (no statistically significant differences between control and treatment groups) for opioid overdose deaths for individuals enrolled in MOUD treatment.
2, For 12 statistical comparisons for beneficial effects of MOUD (buprenorphine or methadone X at 6 months and 12 months post MOUD enrollment X fatal ODs / nonfatal ODs / nonfatal or fatal ODs), 1 comparison was supported as real by statistical test – for buprenorphine MOUD nonfatal or fatal ODs at 6 months.
3. That apparent beneficial effect for MOUD is invalidated by the obvious confounding factor of predicted higher incidence of unreported nonfatal overdoses in communities for individuals enrolled in MOUD programs and provisioned Narcan compared to control group opioid users not receiving MOUD and associated services.
Those points are not what you see in the JAMA report abstract of “IMPORTANCE” or “CONCLUSIONS AND RELEVANCE” or even “RESULTS”.
It requires digging through the report to find them, which I recommend.
Let’s start with Key Point 2 – that’s called a scattershot approach, a “sketchy” move in the world of experimental design and interpretation.
Wait, what? No significant differences in lethal opioid ODs? That just can’t be, we know it’s effective, something’s just off, let’s try doing this with the data set, and this, run the tests again . . . until we get something
After all, a largest ever $350 million NIH study of the same MOUD cures provided in communities just reinforced what we already knew – that they are effective. It did reinforce that, didn’t it?
But what about Key Point 3 – that single, anomalous statistically significant difference for individuals newly enrolling in treatment services to be prescribed Suboxone, at six months, but not 12, experiencing fewer reported nonfatal + fatal opioid overdoses (but not fatal) compared to individuals who had ED contact and did not enroll in such services?
From a recent NPR news piece describing effects of longstanding and persistently intensifying campaigns to increase provision, training on, and community use of Narcan to prevent opioid overdose lethality –
“Some of us have learned to deal with the overdoses a lot better,” said Kevin Donaldson, who uses fentanyl and xylazine on the street in Burlington, Vermont.
According to Donaldson, many people using fentanyl now carry naloxone, a medication that reverses most opioid overdoses. He said his friends also use street drugs with others nearby, ready to offer aid and support when overdoses occur.
He believes these changes – a response to the increasingly toxic street drug supply – mean more people like himself are surviving.
“For a while we were hearing about [drug deaths] every other day. When was the last one we heard about? Maybe two weeks ago? That’s pretty few and far between,” he said.
And in a different community,
Some survivors of the overdose crisis said while the situation on the streets remains grim for many people, they believe the public health response is keeping more people alive.
Eric Breeyear, who lives in a recovery shelter called Good Samaritan Haven in Barre, Vermont, said he was given naloxone repeatedly after experiencing fentanyl overdoses. . . .
“I’m happy people’s lives are being saved, but on every street I see somebody in the middle of an overdose that could potentially be fatal,” Breeyear said.
He said being revived after repeated overdoses isn’t enough. He wants more done to help people in severe addiction heal and enter recovery, as he has done.
In Oregon, source of data for this study, the same effects would have been in play, over 2017 to end of 2020, the study period. Oregon responded in 2017 legislatively and through Oregon Health Authority (OHA) to promote community and professional availability, distribution, training, and use of Narcan including with “Good Samaritan” law, making Narcan available at pharmacies without a prescription or training requirement, guidelines for opioid prescribers to provision opioid users with Narcan, other measures.
Over that study period until the last 6 months or so, COVID-era loosening of prescribing and dispensing clinical and safety standards for buprenorphine were not yet in place, so that individuals in the study group engaging in MOUD treatment would have been required to engage in regular (real, not virtual) contact with prescribers and associated services and supports, all ethically and clinically obligated and compelled to dispense and provide training on Narcan, also would have been increasingly offered Narcan at each pharmacy visit.
Consider the typical study subject in the no-MOUD (control) group, after a medical encounter and with a diagnosed opioid use disorder (OUD), not engaging in MOUD services. If without training and provision of Narcan with involved significant others, under the circumstance of apparent opioid overdose and unlike subjects in the treatment-enrolled group, the urgent need would be to access EMR response or travel to an emergency department (ED).
How were “nonfatal” opioid overdoses identified and measured in the study? From “hospital discharge records” and “ED insurance claims for any opioid poisoning event”.
Subjects who had engaged in MOUD services and supports would almost certainly have been more likely to be able to be responded to by others in their social spheres in home and community settings with Narcan to reverse a potentially lethal opioid overdose, avoiding the expense and other negative outcomes of an ED visit or call for EMR response. Each of those community Narcan reversed nonfatal opioid overdoses (instances of high-risk opioid use) would have been unreported for this study.
To conclude with any degree of confidence and presumed validity what the research report attempts to suggest – that provision of substitute opioids in MOUD programs provided beneficial effect against overdoses – would require compelling evidence that those individuals enrolling in and engaging in MOUD treatment, with associated support contacts and pharmacy visits, had no higher probability than those not so engaging of being provided, trained on, and encouraged to involve family members and other associates in potential use of Narcan with signs of an opioid overdose.
Lacking that evidence, there is no basis for attributing benefit to American expert gold standard medical opioid cures, established as fueling rather than providing treatment value for high-risk opioid use.
This report is another in an increasingly predictable pattern of medical/media collusion distortions and lies generated to hide the lethality of celebrated expert cures for the lethal epidemic.
Know your enemy.
