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Tuesday, July 11, 2023 7:42:11 AM
Assuming we use a dictionary definition of the word "proof" which the CMS certainly will.
Read the survey questions they asked at the end of that study. They did not ask whether the participants used less opioids. They made a list of pain relief medications at baseline (the start) but at the end they merely asked whether the participant used less medication -- that does not prove "less opioids."
A survey is weak science at best so it wouldn't really matter much if they had asked specifically about opioids, BUT THEY DIDN'T ASK so this study can't be used as evidence that RecoveryRx reduces or eliminates opioid use.
Dr. Ilfeld is a completely different subject. His current Pilot Study specifically measures opioid use and THAT is what the CMS wants. The academic question is: will the CMS accept a Pilot Study? I assume everyone knows that Pilot Studies are underpowered and are designed to establish the feasibility of a subsequent full study. The NOPAIN Act is a LAW and there's no telling how stringent the CMS will be when interpreting the evidence submitted to them for non-opioid treatments.
Will the BIEL CEO pump Ilfeld's Pilot Study as NOPAIN evidence for RecoveryRx? You bet she will -- she's pumping the old Survey Study even though it proves nothing about opioids, and she just pumped the Cesarean trial on Twitter even though it didn't use opioids. Unfortunately, the CMS is not fooled by pumping, but the BIEL CEO isn't pumping to fool the CMS -- she's pumping to fool investors, IMO.
"Ya think?"
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