FIGHTING PROPs FDA PETITION
At the end of July the American News Report published my column on the Physicians for Responsible Opioid Prescribing’s (PROP) petition to the Food and Drug Administration (FDA) asking for changes in the labeling of opioid analgesics.(link to my article)
In essence, PROP wants to change the labeling for opioids that now includes use for moderate and severe pain to severe pain only.(see props petition @ www.citizen.org/documents/2048.pdf) It’s instantly discernible that PROPs strategy is to reduce the numbers of pain patients who’d be eligible otherwise to use an opioid analgesic.
Another restriction PROP asks for is that the FDA set guidelines that would only allow a patient to take no more than 100 mgs for pain on any day. This, of course, ignores the fact that many patients suffer from harrowing pain from diseases and injuries that only respond to much higher doses of opioids. If the FDA adopts this provision many patients would be sentenced to a living hell.
The third radical change that PROP petitions is to limit patient’s use of opioid analgesics to 90 days. That’s right, all you folks living with intractable pain, Andrew Kolodny et. al. would radically and, apparently, without a twinge of conscious, toss you and your families into a devouring pit of malignant pain. I continue to hope that PROP and its supporters are fully aware that pain kills. If they do, there is no evidence of it in this unbalanced approach to protecting the public from diverted medicine while protecting the needs of people with pain.
PROP cites several research papers in support of their petition. Robert Twillman PH.D. FAPM is the Director of Policy and Advocacy for the American Academy of Pain Management analyzed PROPs petition in a guest column for Pain-Topics.org NEWS/RESEARCH titled Group Petitions FDA to Change Opioid Label (http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.htm). “The petitioners include 9 statements purporting to provide scientific rationale and support for the requested label changes. These statements are based on scientific work that is as sparse as the body of evidence supporting long-term opioid therapy criticized by the petitioners as being insufficient.”
Twillman bases this statement on his thoughtful analysis of the research provided to the FDA in the petition. It is a fact that the research supporting the use of opioids and the research questioning it are at this stage of scientific inquiry suggestive at best. The need for continued reliable, dependable and repeatable research will help drive good policy.
PROPs petition has gotten a boost from Rep. Mary Bono Mack of California, who along with some House colleagues has in letter to the FDA asked that PROPs petition be put on the fast track to approval. This is not an alliance that pain activists can ignore. PROPs roll out of this petition smacked of very good public relations work. This in combination with political power needs our vigorous opposition. There can be no good coming to pain patients from this alliance. PROP is content to use political power to advance their extremist agenda. Again, I say extremist because there is nothing in this petition that comes close to protecting patients with pain.
I am now convinced that PROP and others want ultimately to prohibit pain patients from using opioid analgesics. I say this because PROPs petition looks, in my opinion, like a slippery slope. First they will only allow you 100 mgs. no matter how much you use to lessen your pain. Next, they’ll limit you to 90 days, after which, you are on your own. If you are tortured by “moderate” pain, well, there’s always ibuprofen.
Twillman in the same article above cited research by “Hall et al. [2008, ref below at end] for alcohol and other drugs, and that 56% of cases had no prescription for an opioid. The solutions for these problems differ greatly, depending on the mediating found that 79% of people dying from overdoses involving opioids tested positive factors between prescription and overdose death.”
Again, this isn’t definitive. Recognizing that this research needs to be repeated with different samples, its findings support what pain patients have come to ask: why should we bear the brunt of this war on drugs when it is people illicitly using our medicines and stupidly combining them with other drugs and washing it all down with a pint of Jack? I don’t mean this heartlessly as any death due to an overdose is tragic. But the question deserves an answer.
Readers can directly oppose PROPS petition by going to an editor’s edition to Twillman’s article at www.Regulations.gov: “Physicians for Responsible Opioid Prescribing – Citizen Petition; Docket ID: FDA-2012-P-0818” [click here]. The petition document is available there as a PDF. Also, there is a “Comment Now!” button at that site [or click here], so those interested can type-in comments or submit documents with comments directly to the FDA.