"Many embedded research studies are granted a waiver of consent from patients, with the requirement that personal health information be protected from disclosure."
This means embedded pragmatic clinical trials (ePCTs) via NIH don't need patient consent.
rethinkingclinicaltrials.org/chapters/disse…
This means embedded pragmatic clinical trials (ePCTs) via NIH don't need patient consent.
rethinkingclinicaltrials.org/chapters/disse…
There are NIH ePCTs taking place in regard to pain and (conflating) addiction. There is also medication sparing programs for post-operative patients and for chronic pain through the HEAL initiative.
heal.nih.gov
heal.nih.gov
The Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) is the main ePCT taking place via the HEAL initiative. Meaning, patients are studied within the delivery model (EHR) and consent requirements likely waived via data protection
The NIH perpetuates this claim which is derived from inaccurate claims by the CDC:
"Recent decades have seen an overreliance on the prescription of opioids for chronic pain, which has contributed to an epidemic of opioid overdose deaths and addiction."
heal.nih.gov/research/clini…
"Recent decades have seen an overreliance on the prescription of opioids for chronic pain, which has contributed to an epidemic of opioid overdose deaths and addiction."
heal.nih.gov/research/clini…
However, CDC data instead proves a correlation between illicitly manufactured fentanyl (IMF) and polypharmacy. The CDC missed critical population health signals for over a decade in regard to IMF and polypharmacy deaths.
emergency.cdc.gov/han/2020/pdf/C…
emergency.cdc.gov/han/2020/pdf/C…
The overwhelming majority of overdose decedents are not patients on long-term opioid therapy (LTOT). The majority of overdose victims took either diverted prescription drugs or illicitly manufactured fentanyl with other substances.
medium.com/the-shadow/scr…
medium.com/the-shadow/scr…
CDC & state ME/C's have repeatedly failed to track specific drugs making it nearly impossible to discover which drugs were actually causing overdoses. A study of the PDMP showed hardly any of the overdose victims actually had a recent prescription for opioids. (See next tweet)
This fact further decimates the federal narrative regarding the overdose crisis.
"Only 39 (1.3%) decedents had an active prescription for each opioid detected in toxicology reports on the date of death."
journals.sagepub.com/doi/full/10.11…
"Only 39 (1.3%) decedents had an active prescription for each opioid detected in toxicology reports on the date of death."
journals.sagepub.com/doi/full/10.11…
It's clear CDC consistently missed critical health signals relating to IMF and polypharmacy in favor of a multi-agency crusade to target physicians and patients to reduce prescribing despite little correlation with overdose.
link.springer.com/article/10.100…
link.springer.com/article/10.100…
It appears the real objective is to institute STEP therapy in pain management using low/no evidence alternatives to increase profits in the healthcare sector. This, despite the fact that opioids were never a first-line treatment except in cases of severe injury or illness.
This systems approach to remediate the overdose crisis is focusing on the WRONG demographic which is why overdose rates continue to climb despite billions spent on remedial steps.
nymag.com/intelligencer/…
nymag.com/intelligencer/…
When are Americans going to demand that we stop paying for failure?
#OverdoseCrisis #OpioidCrisis #MedTwitter #PublicHealth
#OverdoseCrisis #OpioidCrisis #MedTwitter #PublicHealth
@threadreaderapp unroll please
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