Bioelectronics Corp (BIEL)

[GetSeriousOK]

Is there now a “problem” with “Pilot” just as there was a problem with your opinion that a “Study” is not a “Clinical Trial”. Remember that one?

No, I dont "remember that one." What post number was that? I don't recall picking the word "Study" as the problem. My problem has always been with the term "Pilot Study." If I omitted the word "Pilot" I'd like to see exactly what I said. What was my post number?

I see #326818 in February when I said "The fact that it's a "STUDY" is not the issue; the issue is that it's a "PILOT" Study...."

The words you quoted describe the problem with Pilot Studies perfectly, in the context of whether or not the CMS will accept a pilot study as proof that the ActiPatch reduces opioid use. I've never said they definitely WON'T, I always said they MIGHT, but it is absolutely not the slam dunk you imply, which means it's a problem.

And do I have to explain to you why Rawe's 2011 Preliminary Study won't satisfy the CMS? You're quoting BIEL's "evidence" page without reading the actual study, aren't you? Better read the study before you use that study as evidence, because it failed to show a statistically significant reduction in opioid use.

https://www.bielcorp.com/biel/wp-content/uploads/2013/03/BioElectronics-Postoperative-Pain.pdf

The P value was .07 which means the results are statistically insignificant. Rawe had to manipulate the data to achieve the P value of .002. I understand why YOU missed this, but the CMS will not miss this:

The statistics for patient use of narcotic medication are shown in Table 2. The means were 11 pills per patient in the active group and 18.1 pills per patient in the placebo group, representing a 68% increase in narcotic medication use in the placebo group (P = 0.07, nonsignificant increase).

That's the problem with Underpowered studies like Ilfeld's Pilot Study and Rawe's Preliminary Study (with only 18 participants). The small group size can skew the results. The CMS knows this even if YOU don't.

Here's the exact requirement from the NOPAIN Act again. It's important to read this literally, from the perspective of a government entity like the CMS:

...that has demonstrated the ability to replace, reduce, or avoid opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal.”.>>>>

"wordsmith." LOL