Comments on Pain-Topics.org News/Research UPDATES: Probability Blindness & Fallacies of FDA REMS

I direct my own pain relief program without much d...

2009-09-15T01:04:05.248-05:00

I direct my own pain relief program without much doctor input, at this point in my treatment, just AS LONG AS I do not exceed my prescription amounts. We have noted that our PCP will not give us a refill one day ealier than indicated by the calendar. Thereby our own REMS, for both myself and my husband. Perhaps if there was more education offered, people could be trusted to handle their own

Yes, we did submit commentary to the FDA along the...

2009-09-14T14:02:24.073-05:00

Yes, we did submit commentary to the FDA along these lines; although, at the time, we did not specifically reference the concept of “probability blindness.” From off-the-record remarks that we’ve heard, the FDA seems to be aware that they need better data for decision-making -- but that may not deter their forward progress on REMS. The REMS for the recently approved EMBEDA product was announced

Stew, I'm wondering if you made these comment...

2009-09-14T13:04:52.429-05:00

Stew,

I'm wondering if you made these comments during the REMS open comment period to the FDA. They are all valid points and I would hate to know that the same points hadn't been made to the FDA group making the decisions about these policies.

The REMS initiated for the Embeda product was reasonable, as far as I could tell as a non-prescriber. There weren't too

Very strong points made. Unfortunately perception...

2009-09-14T09:57:01.344-05:00

Very strong points made. Unfortunately perception often overtakes reality leading to reactive decisions vs strategic ones. Add to the mix that what FDA is really seeking to address are criminal issues related to opioids(diversion and third party misuse and abuse)by implenting tactics guided at medical care and safety, a domain where FDA's authority resides. An apparently disconnected