PROMPT initially became a concept on August 3, 2012 after I read the July 25, 2012 PROP Petition to the FDA. I can’t print the adjectives that came to mind on 8/2/2012 when I first read the petition; let’s just say “incredulous” was the nicest adjective on the list. Puzzling to me was the register of “physicians” that dared to sign their name to such a poorly thought out document. After one night sleep I thought, perhaps the intent was a valiant effort to improve safety. But, talk about missing the mark! Surely these signatories are aware of the data from several states showing that reduced access to prescription opioids increases heroin consumption and abuse. And this PROP proposal is from some research scientists no less, some with whom I have worked! I was appalled to say the least. After I calmed down a bit, my very first blog post on the subject went up, Label Changes for Opioids, FOR or AGAINST, “Duking it Out with Opioids”. This post brought 30 intense comments.
I quickly worked to recruit clinicians nationwide that were similarly baffled by the PROP petition, which by the way couldn’t have come at a worse time considering the opioid regulatory uprisings in Kentucky and Florida. In a short time, we had over 30 well recognized medical clinicians from various specialty areas, almost all of whom see pain patients daily and have a significant scientific research and publication background. We responded to the PROP petition with a PROMPT letter dated 8/17/2012. Many blog posts have appeared since August 3rd, listed below.
Label Changes for Opioids, FOR or AGAINST
We Intend to be PROMPT with a Challenge to PROP FDA Letter
PROMPT Members Speak Out
Has the Prop Petition Brouhaha Been Worthwhile?
A “PROMPT” Response to the PROP Opioid Petition
Chronic Opioid Patients Speak Out Against PROP
So here we are, exactly 3 weeks to the day after the initial blog post on 8/3/2012. After countless telephone calls, live meetings, e-mails, texts, and tweets, we are no further ahead than 3 weeks ago. The only thing that has changed is increased panic amongst legitimate chronic pain patients, especially those in the states of Florida and Kentucky where getting an opioid RX filled these days is like living in a Police State.
It’s not about opioid policy being too far to the right or left, it’s about right or wrong for the chronic pain sufferers. It has become clear to me that various personalities will make it difficult for any meaningful outcome without some sort of summit and collaboration among the troops; this should include various professional societies, clinicians, and even patient/citizen representation. I will give the authors of PROP one thing; they sure did rile enough well-respected patient advocates (clinicians and otherwise) to do something STAT!
This afternoon, I sent out two tweets that said “PROMPT proposes withdraw of FDA PROP petition/all groups collaborate for a more patient-friendly petition” and “The gauntlet is down. PROMPT wants PROP petition withdrawn so a rational patient friendly collaborative proposal can be submitted.” As of this post, I have heard nothing. Our offer stands PROP petitioners; we want to play nice in the sandbox for the betterment of patient care and public safety. Let’s work together, as infighting will not likely result in any positive outcome for anybody, not the least of which is our patients. The ball is in your court!
Note: Posted notes from patients and advocates have been moved to the link indicated below. Thank you for your comments. Keep them coming!