As readers are well aware, on July 25, 2012, Physicians for Responsible Opioid Prescribing (PROP) submitted to the U.S. FDA a Citizen Petition requesting a labeling change for opioid analgesics. This certainly stirred up a hornet’s nest of concerned activity and, during the ensuing weeks, a very large number of professionals in the pain management field have devoted countless hours of valuable time in discussing and largely disputing issues raised by the petition. Has all of this commotion been worthwhile or a waste of our time?
Considering just the multiple articles on this subject developed for the Pain-Topics UPDATES site, the articles and commentary here at the PainDr.com blog, the excellent and thoughtful response letter developed by the American Academy of Pain Medicine, as well as ongoing examination by the FDA of the numerous comments submitted to the Petition docket at regulations.gov, the costs in precious time and effort expended by very busy healthcare professionals have been enormous.
I would contend that, judging from the preponderance of commentary to date coming from all directions, the petition represents the opinions of a small minority of professionals in the field who have proposed an untenable and unproven hypothesis. Specifically, that compared with opioid analgesic prescribing practices following indications on current product labeling, patients would be afforded superior effectiveness and safety if opioids were restricted to a dose of ≤100 mg/day of morphine or its equivalent for no more than 90 continuous days and only for severe pain in the case of noncancer conditions.
Evidence in support of that hypothesis presented by PROP in their petition has been thoroughly considered, discussed at length, and disparaged as inadequate and/or of dubious quality by the many articles, letters, and comments in opposition. I have asserted previously in a Pain-Topics UPDATE that the petitioners’ claims may raise reasonable suspicion for justifying further investigation but, in themselves, they do not represent clear and convincing evidence to merit the proposed actions.
In clarifying PROP’s position, Andrew Kolodny, MD, president of PROP, stated in a Pain-Topics UPDATE, “the purpose of [the petition] is to prohibit drug companies from promoting long-term use of opioids for conditions where use has not been proven safe and effective.” There is an inference that opioid manufacturers have encouraged applications of opioid analgesics that exceed the implicitly approved limitations of current labeling and that the FDA has neglected its responsibilities of assuring that the products are safe and effective for purposes that they are being prescribed.
These are disturbing allegations that could merit further consideration and debate within the medical community, and with an examination of much more comprehensive evidence than presented in the petition. Open and fair-balanced dialogue among healthcare professionals regarding such matters plays an essential role in ultimately improving patient care; however, “fair balance” has not been characteristic of the debate thus far in print or otherwise surrounding opioid analgesics.
In a sense, PROP curtailed debate and did an “end run” around traditional channels of scientific discourse, as well as their peers, by expressing their demands in a Citizen Petition directly to the FDA, while also enlisting support from the Congressional Caucus on Prescription Drug Abuse and news media. A rebuttal letter submitted to the FDA by PROMPT (see below), which includes the letter from the American Academy of Pain Medicine, seems to clearly indicate that the petitioners’ perspectives are not consistent with those of their peers in the pain field. Comments at this blog, PainDr.com, by Jeff Fudin and the many other professionals chiming-in generally confirm that as well.
What has come of all of this?
In its broadest sense, the petition raises important questions about the safety and effectiveness of long-term opioid analgesics for chronic pain, whether cancer or noncancer in origin. A great many of us have invested considerable time in pondering these issues, both in print and discussion; however, no truly new insights or guidance have emerged so far from deliberating the petition — in my opinion.
Still, it is probably good that evidence presented in the petition has been re-examined — or perhaps considered for the first time by some professionals — to confirm that it is biased, misleading, and largely of low quality. As a result, it is now more apparent than ever that there is a need for more and better scientific evidence to help guide safe and effective opioid prescribing for chronic pain.
As an evidence-driven organization, I seriously doubt that the FDA would change opioid labeling merely on the basis of this petition; however, the agency is in the unenviable position of, if nothing else, having to invest the manpower, time, and our tax dollars in gathering and assessing public commentary, and responding to the Congressional Caucus and to the petitioners. If, as part of the process, there is a truly objective, fair balanced, and comprehensive evaluation of all relevant current evidence surrounding these issues, it could be a positive step — however, I am skeptical about that happening.
Perhaps, a most favorable outcome of the petition has been inspiration for the formation at this PainDr.com blog of PROMPT — Professionals for Rational Opioid Monitoring & PharmacoTherapeutics. This nascent organization recognizes that all healthcare professionals, not just physicians who prescribe opioids, have a stake in better pain care resulting from the safe, individualized, and effective prescribing of all pharmacotherapy.
As it develops and grows, PROMPT could be a major force in fostering a more objective and balanced dialogue surrounding issues raised by the petition — and beyond. Or, will it fizzle once the brouhaha of the PROP petition fades away? Time will tell.
Stewart B. Leavitt, MA, PhD, has more than 30 years of experience in healthcare education and medical research/communications serving numerous agencies and organizations nationwide. He was educated in biomedical communications at the University of Illinois Medical School, Chicago, and then served as a Commissioned Officer in the U.S. Public Health Service at NIH. His other graduate degrees (MA, PhD) are from Northwestern University, Evanston, IL, specializing in health/medical research and education, where he also was an instructor and a Ford Fellow researching urban healthcare delivery systems. In 2005, Dr. Leavitt founded Pain Treatment Topics (Pain-Topics.org), where he currently serves as executive director and editor in chief and, prior to that, he was the founding editor of Addiction Treatment Forum (ATForum.com) in 1992, which he worked on for 15 years.