NIH LARGEST EVER STUDY AFFIRMS: EXPERT PROVEN, GOLD STANDARD OPIOID TREATMENT IS LETHAL
Medical/media collusion rationalizations for lack of benefit from “evidence based” opioid cures are revealing lies
by Clark Miller
Published July 26, 2024
The headlines have been creative and telling, writers faced with constructing a spun message that at all costs avoids, by way of rationalizations of treatment failures, cogent description of the meaning of outcomes of the large National Institutes of Health (NIH) study. Or a message better yet that distracts from those predictable outcomes with constructed illusions of gains not attributable to the gold standard expert medical treatment that failed in communities, has been failing for decades.
As below, in Politico, where reduced opioid OD deaths in one of the “intervention” (treatment) communities directly tied to expanded use of the emergency OD death reversing agent naloxone – not to any treatments for opioid use – is portrayed as success against a worsening opioid crisis driven by persistently mounting high-risk opioid use. That continuously mounting high-risk use, representing failure over decades of American Medicine’s proven cures, is precisely why campaigns to increase emergency revivals are desperately needed to slow rates of deaths – and mask a growing epidemic of untreated high-risk opioid use.
That subheader, LESSONS FROM FAILURE, as we will see will likely more than anything else written on the study hold true, beyond expectation.
And as we will see, below, the uniformly messaged interpretations of results of this “massive” study, far from providing any hope for effectiveness of expert approaches associated over decades with mounting high-risk opioid use and deaths, instead attempt to disguise clear results that incontrovertibly, demonstrably, intractably affirm the established, predictable lethality of those expert approaches.
But to set the stage, a most succinct and apt description of the study of randomized “intervention” and “control” communities compared for effectiveness of American Medicine’s proven, life-saving, gold-standard opioid treatments is provided by the research article title in the New England Journal of Medicine (NEJM). That’s the very same journal of course that determined it was warranted to publish a note – not deserving of any descriptors like “research” – by a medically trained doctor to the effect that it seemed that patients in a hospital setting provided time-limited courses of opioid drugs were not observed to develop clear signs of dependence. That meaningless medical contribution cleared the way for an alliance of insurance, pharmaceutical, medical, and public health institutions, against all longstanding relevant evidence, to institute runaway provision of prescribed opioids for all pain, generating what we know as the opioid crisis.
The title is, first of all, a marked and telling deviation from standard, expected representation of the goal and design of research, any research – always to in a scientifically rigorous and unbiased, objective, open, and not predetermined way – to express the hypothesis versus null hypothesis (an effect versus no effect) the research and statistical methods are designed to evaluate, to detect. In this case standards for objectivity and process undistorted by bias demanding a title more along the lines of “Community-Based Cluster-Randomized Trial on Effects of Selected Treatments on Opioid Deaths”. See the difference? The impulsive slip, “to Reduce Opioid Overdose Deaths” lets us know not only what outcome the research was undertaken for the sake of, also what outcome was desperately needed by America’s esteemed and trusted media and healthcare institutions in the context of persistently mounting high-risk opioid use and deaths the more those evidence-based treatments are provided.
We will refocus immediately below, but think for a minute.
Use your Google and look at the Medical/Media/Research/Institutional tight, uniform consensus over past decades regarding the effectiveness of the “gold standard”, “proven”, “life-saving”, “evidence based” medical cure for compulsive, high-risk opioid misuse and the opioid crisis: the provision of substitute, prescribed opioids buprenorphine and methadone under “medication assisted treatment”, MAT, their established effectiveness so solidly evidenced by research that they are considered “miraculous“, a “miracle” for opioid users trapped in the crisis.
Why then, decades into the crisis and with no sign of any doubt about the efficacy of the increasingly dispensed medical cures – so effective and safe that longstanding safety restrictions have been dropped – would there be a need to allocate $344 million in healthcare resources to attempt to detect beneficial effects?
Take some time to think about that.
That didn’t work out, hence the desperate, necessary, weak rationalizations that fall apart – we’ll get to those. More importantly the outcomes objectively analyzed affirm, unequivocally, the role of those “evidence-based” treatments in driving worsening lethality in the crisis.
Let’s take a look.
One of many summaries of the study and outcomes appeared in MEDPAGE TODAY –
As we will see very shortly, below, any credible, adult mind familiar with the evidence would have been compelled to write a very different headline and subhead, something close to:
Gold Standard, Expert Medical Opioid Treatment Affirmed as Increasing Overdose Deaths in Large NIH Study
– Longstanding “evidence based” practices have been associated for decades with persistently increasing deaths in worsening crisis
That accurate headline, of course, is not something we have seen or will see, anymore than we will a truthful headline like:
Overwhelming Evidence Identifies Cause of the Millions of COVID Deaths Worldwide as Reckless, High Risk U.S. Funded Research and Lab Leak
– Top U.S. public health figures’ lies about viral origins protected by media reports, while questions remain about ties to bioweapons research
That would be unthinkable, that that could be said, be allowed.
But we’re getting ahead of ourselves.
Back to the MEDPAGE TODAY piece –
The study’s evidence-based practices focused on “increasing opioid education and naloxone distribution, enhancing access to medication for opioid use disorder, and safer opioid prescribing and dispensing. The intervention also included a series of communication campaigns to help reduce stigma and increase the demand for evidence-based practices,” according to a NIDA press release.
The authors found that intervention effectiveness on the rate of opioid-related overdose deaths did not appear to differ based on location or participant demographics, including age, sex, and race or ethnic group.
They had prespecified a 40% reduction in the rate of overdose deaths related to opioids between the two groups, but conceded post-study that such a target was “clearly ambitious. The trial may have been underpowered to detect substantially smaller yet clinically meaningful differences.”
Okay, let’s start there. “Prespecified” ? Don’t be misled. The 40 percent reduction was what they hoped for, not a feature of study design or what the statistical analyses tested for, instead those statistical tests aimed at detecting any significant difference at all. And did not. That way of expressing it is a distortion, at best a weaselly way to mislead.
From the NIH release –
did not result in a statistically significant reduction in opioid-related overdose death rates
And –
Despite the success in deploying evidence-based interventions in participating communities, between July 2021 and June 2022, there was not a statistically significant difference in the overall rate of opioid-involved overdose deaths between the communities receiving the intervention and those that did not
My take on X –
To that we could, and should, add that –
Prior to and through the years of design, planning, and implementation of the study, there have been no signs of deviation by experts or in media accounts from the decades -long universal consensus:
– That MAT substitution opioids buprenorphine (Suboxone) and methadone are effective, life-saving “miracle” drugs that cure opioid dependence by relieving withdrawal symptoms and manage cravings for more dangerous opioids, displacing the use of high-risk opioids
– That over the decades of an increasingly lethal opioid crisis, their “proven” effectiveness would have and will reverse the crisis if only more could be dispensed to diseased brains.
– That the basic neurochemical and pharmacological modes of action for these gold standard medical cures ensure their effectiveness for other opioids including prescribed pain medications, heroin, and fentanyl.
Co-author Redonna Chandler, PhD, director of the HEALing Communities Study, told MedPage Today that the study had a January 2020 start-date, so just 2 months before the COVID-19 shutdowns. “The COVID pandemic had a huge impact on our community members and all the settings where we were trying to implement the evidence-based interventions,” she stated.
And Chandler noted that effects of the interventions may have also been tempered by the rapidly evolving illicit drug market, especially with the emergence of new drug mixtures such as fentanyl and xylazine. NIDA Director Nora D. Volkow, MD, stressed in the press release that in “the era of fentanyl and its increased mixture with psychostimulant drugs, it’s clear we need to continue developing new tools and approaches for addressing the overdose crisis.”
Huh! So, COVID effects actually disallowed implementation of the two main evidenced based interventions? Expansion of provision and use of lethal OD-reversing naloxone (Narcan) and of the proven medical cures? That seems to be an overt lie, see below, beginning at “Were the evidence based interventions implemented, or not?”
In any case, rationalizations for COVID effects as worsening prevalence of high-risk opioid use, overdose, and overdose deaths were never supported by evidence and have been invalidated by the continuous surges in those outcomes in the months and years since COVID effects began moderating and dissipated and by evidence invalidating that those effects were ever important. See here, for example.
What about xylazine?
In the 4 states selected for the study communities – Kentucky, Massachusetts, New York and Ohio – prevalence of xylazines as an abused substance ranged from moderately high to moderately low among all states over the study period.
That’s a meaningful and significant factor in this study, at the same time largely irrelevant for the obvious reason. The 34 communities placed in the “intervention” (treatment) and 33 in the control groups were randomized. That is, we confidently predict no difference between intervention and control community groups prior to interventions with respect to level of xylazine prevalence in drug abuse and in opioid overdoses. Randomization would have evened that out. Randomization would have ensured that whatever differences were to be detected between control and intervention community groups could have been more confidently attributed to effects of the evidence-based treatments implemented – enhanced provision of the life-saving substitute opioid medications in the intervention group, along with higher levels of potentially lethal overdose reversals due to naloxone campaigns.
In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population.
The same, of course is true of effects of the opioid fentanyl in illicit, high-risk economies of opioid abuse in those groups of randomized communities. Whatever risk of overdose death due to fentanyl involvement existed in the communities – equalized in control compared to intervention communities due to randomization – that equalization would have assured that beneficial effects of the “evidence based” interventions would have been detected as differences in OD deaths, if any such benefits occurred.
The fabricated rationalization of the opioid fentanyl driving a worsening opioid crisis that otherwise would have been reversed years ago by American Medicine’s cures has always served as a desperate, evidence-free distraction from failure of those cures, the rationalization dismissed here, and here, and here for example.
The interventions were implemented into the assigned communities between January 2020 and June 2022, then a 12-month comparison period was conducted from July 2021 to June 2022. In total, the intervention group implemented 615 out of the 806 strategies: 254 involved overdose education or naloxone distribution, 256 involved the use of opioid use disorder medications, and 105 involved prescription opioid safety.
However, only 38% of these strategies were underway before the comparison period began in July 2021, the researchers said, and during that comparison year (July 2021 through June 2022) across communities, 4,517 deaths were linked with opioid overdoses. After the comparison period, the control communities received interventions from July 2022 through December 2023.
Only “38% of these strategies were underway” prior to the beginning of the comparison period?
Good thing then, that the two most important were implemented in the intervention communities: 1) focused naloxone campaigns that saved lives by reversing otherwise lethal opioid overdoses and 2) American Medicine’s proven cure for the opioid crisis, MAT opioids buprenorphine and methadone.
Were the evidence based interventions implemented, or not?
From the study’s co-author Redonna Chandler, PhD, director of the HEALing Communities Study –
“In terms of the main study finding, we did find that we were able to implement the study and that we were able to get evidence-based practices — with known ability to reduce overdose fatality — into communities,” she added.
And from the NIH, in its press release –
A data-driven intervention that engaged communities to rapidly deploy evidence-based practices to reduce opioid-related overdose deaths – such as increasing naloxone distribution and enhancing access to medication for opioid use disorder – did not result in a statistically significant reduction in opioid-related overdose death rates . . .
AND
successfully engaged communities to select and implement hundreds of evidence-based strategies over the course of the intervention . . .
AND
intervention communities successfully implemented 615 evidence-based practice strategies (254 related to overdose education and naloxone distribution, 256 related to medications for opioid use disorder, and 105 related to prescription opioid safety). . . .
AND
Despite the success in deploying evidence-based interventions in participating communities . . .
[emphasis added]
That seems fairly clear, doesn’t it?
Here’s America’s top drug expert Nora Volkow, head of the National Institute for Drug Abuse (NIDA), acknowledging implementation of MAT in the intervention communities while desperately attempting to equivocate –
“This study brought researchers, providers, and communities together to break down barriers and promote the use of evidence-based strategies that we know are effective, including medications for opioid use disorder and naloxone,” said NIDA director, Nora D. Volkow, M.D. “Yet, particularly in the era of fentanyl and its increased mixture with psychostimulant drugs, it’s clear we need to continue developing new tools and approaches for addressing the overdose crisis. Ongoing analyses of the rich data from this study will be critical to guiding our efforts in the future.”
Huh! So, the participants in the $344 million study promoted the use of the evidence based treatments? Did they not implement them in the intervention communities?
Who is lying about implementation?
And with fentanyl – an opioid in use on the streets for a decade or more now – should the “proven”, life-saving, gold standard MAT medical cures have worked, or not? If not, why is it that the public has not been informed of this over the past decade of hundreds of thousands of opioid overdose deaths? Not informed until just now, after results of the massive study detected no benefit from NIDA’s medical cure for high-risk opiod use?
Do Americans need more of your “ongoing analyses”? Or the truth?
More about implementation of the interventions in the massive study –
From the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) press release –
A data-driven intervention that engaged communities to rapidly deploy evidence-based practices to reduce opioid-related overdose deaths – such as increasing naloxone distribution and enhancing access to medication for opioid use disorder – did not result in a statistically significant reduction in opioid-related overdose death rates during the evaluation period , , ,
AND
Launched in 2019, the HEALing Communities Study is the largest addiction prevention and treatment implementation study ever conducted and took place in 67 communities in Kentucky, Massachusetts, New York, and Ohio – four states that have been hard hit by the opioid crisis. . . .
AND
“Even in the face of a global pandemic and worsening overdose crisis, the HEALing Communities Study was able to support the implementation of hundreds of strategies that we know save lives,” said Redonna Chandler, Ph.D., director of the HEALing Communities Study at NIDA. “This is an incredible feat for implementation science, and shows that when we provide communities with an infrastructure to make data-driven decisions, they are able to effectively implement evidence-based practices based on their unique needs.”
[emphasis added]
Here’s the subheader for that SAMHSA release –
COVID-19 pandemic and increasingly dangerous drug supply among factors that may have contributed to diminished impact of intervention
That’s a clear lie, you may have noticed. There was no “diminished impact of intervention”.
Instead, the outcome was no beneficial effects attributable to the implementation for a year of the expert gold standard treatment, substitute opioid dispensing as cure for high-risk opioid use.
Okay, let’s recap, evaluate, and get to the point,
by subjecting the design and outcomes of this study, for the first time ever, to analysis, critical thought, and interpretation.
Something we know with certainty is that there were, in fact, significant, powerful effects due to interventions in the intervention communities.
That’s right, the headlines are clearly falsifications, for example these:
Here’s how we know, with certainty, that those headlines are necessarily false.
Decades-old, pervasive, expanding, and remarkably effective campaigns to distribute and effectively use naloxone (Narcan) to reverse otherwise lethal opioid overdoses are found to consistently decrease opioid OD deaths when and where they are implemented. Necessarily and incontrovertibly so, because each successful use of naloxone decreases the tally of opioid OD deaths by 1 in a locale or over a time period.
That effect shifted the state of Utah from one of the highest among states in per capita opioid deaths to one of the lowest. The same effect has been demonstrated everywhere the data have been looked at, and that includes one of the areas in the NIH study intervention group, Toledo-Lucas County in Ohio, described here in Politico.
Efforts in that area focused narrowly on the naloxone campaign:
“Strategies included offering videos on using naloxone, the opioid overdose reversal drug, and a mobile van for educational outreach and naloxone distribution. And the communities had access to a staff who coordinated and analyzed data, designed interventions and helped with marketing.
The data provided a clearer view of Lucas County’s drug problem, showing which ZIP codes and demographics were seeing the most overdose deaths. And it allowed the coalition to bring deaths down 20 percent.”
That’s a 20 percent reduction in opioid overdose deaths in one area with narrow focus on expansion of use of naloxone, compared to no effects overall in OD deaths for intervention versus control groups of communities in the study, intervention communities generally expanding both naloxone use and provision of prescribed MAT opioids.
If there is a miracle drug in the opioid crisis, it is naloxone.
We are led to the point of necessarily facing some incontrovertible, unequivocal facts and conclusions driven by the evidence we’ve been considering.
– Intervention communities in the study successfully implemented naloxone campaigns
– That would have, necessarily, reduced opioid overdose deaths in those intervention communities compared to control communities and overall for the control versus intervention groups of communities.
– That means, necessarily and indisputably – because overall, there were no differences in OD deaths between groups – that there had to have been other forces unique to the intervention communities that increased opioid overdose deaths.
That conclusion is inescapable.
Inescapable and foreseeable, predictable.
Because we know exactly why opioid deaths increased in those intervention communities, the increases masked and balanced by the effects of Narcan saves, with the net result of no statistically detected differences compared to control group. That has been established here, in hundreds of posts marshaling the relevant evidence, for years.
It turns out, as explained and established here in multiple posts, that precisely as in the avoidable – avoidable if not for the cowardice and gross incompetence of American Media – generation of the opioid crisis as we know it enabled by fabrications by America’s medical/research/media collusion, there has never, not ever, been a legitimate body of research evidence to confidently establish, let alone strongly support, the use of substitute opioids (bupe or methadone) as treatments or as beneficial for opioid dependence.
Instead, all lines of diverse evidence point to what should be obvious – the runaway dispensing of opioids that are routinely used with other, illicit opioids (methadone), and/or serve as consumable, commodity and currency in street economies of illicit high-risk opioid use (bupe) have in fact fueled the lethal epidemic.
The most potent ways in which the “miracle” doctor-dispensed pills and other magic potions predict failure is to instill in compulsive substance users the belief that passive interventions to adjust brain chemistry are “treatments”, are addressing a generic neurobiological block or deficit or disease of the brain that explains addiction, instead lethally instilling passivity, dependence and lies, and robbing compulsive substance users of the necessary factor established as central to stopping problem use, self-efficacy, the shift to belief in one’s own competence, autonomy, strength, and effective use of resources with inner psychological change to do away with the compulsion to escape distressing inner states by use of chemicals.
So, yeah, it’s all a lethal, avoidable, predictable debacle of cowardice, incompetence, diminished capacity, and criminally disordered behavior.
But considering the institutions and main players, should we be surprised? American Medicine? The New England Journal of Medicine? America’s Media and most trusted institutions?
Here’s Director of the NIH at that time, throwing a third of a $billion at the doomed study, the HEALing Communities Study of medical interventions for the entirely non-medical condition of compulsive substance use – Francis Collins.
Collins, informed readers will remember, colluded with Anthony Fauci to coerce scientific consensus by lie, to force censorship of public speech deviating from that fabricated consensus about the COVID response, and to use intimidation and his position to generate lies to hide the NIH-funded lab leak that caused COVID resulting in the deaths of millions.
Here’s more about his NIH HEALing Communities Study in a post here at A Critical Discourse from 2020, the title predicting the obvious, now established, public health outcomes.
It’s all a lie.
A highly profitable, lethal, criminal lie. Created and protected by an American Medical-Media collusion that is pathological in its level of negligence, incompetence and mendacity.
Longstanding research paints a clear picture: the compulsive behavior of problem use of mood-altering substances as well as most chronic pain (centralized, non-cancer chronic pain) are psychogenic (driven by distressing and unbalanced inner states including thinking and feeling) and psychosocial (driven by outside stressors and effects of past disturbing events) in nature, not biomedical (physical), the indicated treatments are longstanding evidence-based effective psychotherapies like cognitive behavioral therapy (CBT) and psychodynamic therapy to address the emotional, environmental and cognitive deficits and disturbances driving them, with no effective medical treatments supported by evidence.
There are no medications and never will be.
Because there is no disease, brain condition, or condition at all to treat with any medical intervention.
Because compulsive substance use is not remotely a medical condition – on any critical examination, the “evidence” for the fictional brain disease model dissolves, is invalidated by all longstanding lines of relevant evidence and reasoning.
The outcomes of the fabricated medical model and medical approach – just as for the runaway prescription of addictive opioid medications for common chronic pain, an entirely non-medical condition with no biomedical treatments – were predictable from the start.
The evidence lies all around, and buried, on a national crime scene.
Back to our current post –
All that’s left now is for continuation of normalcy, of the types of transparent and lethal lies that generated and now perpetuate the crisis, perhaps more frenzied or overtly desperate.
Like this bold interpretation of outcomes of the largest study ever of its kind designed to affirm beneficial effects attributable to American Medicine’s expert proven cure, reported in Daily Caller –
“Program director Redonna Chandler referenced the pandemic as one reason for the study’s outcome, noting that the study “doesn’t negate, in any way, the evidence that suggests the strengths of those interventions,” STAT News reported.”
Right. We can disregard the outcomes of our $334 million study because we know, it was already established, that our cures for an increasingly lethal epidemic are effective.
The lies are bold and lethal, delivered with the confidence, disregard for truth and the wellbeing of others, and the lack of insight characteristic of the disordered personality.
Pathological.
Faucian.
Triumphantly American.
