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!
7 thoughts on “PROMPT to PROP; The Ball’s in Your Court”
I have been in chronic pain and in a pain clinic for over 10 years. I had a botched up shoulder replacement surgery that left me with no use of my left arm and hand, the pain is excruciating. It is my left shoulder and I am left handed. I later found out that the replacement shoulder had not been used by surgeons in over 7 years and was pulled from the market 6 months before my surgery. Needless to say I found out after the statue of limitations. I decided to try and have a shoulder reversal (remove the prosthetic and put in a new one.) The surgeon was top rated in this type of surgery and I would do anything to be out of pain. Unfortunately, the damage the previous surgeon did was too much. I left the hospital with a spacer in my shoulder and had to return in three months for another surgery to try and get the new shoulder in. I came out of surgery worse than I went in. I do not have usable rotator cuff, more nerve pain, and more debilitating pain in general. I had a spinal cord stimulator implanted to help with nerve pain, another waist of time and surgery. My pain doctor has had me on pain meds for as long as I can remember. To this day I have never once taken any more than what is prescribed to me and never will. I am a 64 year old disabled wife, mother, and grandmother. I am not someone looking to get high or misuse my medicine. I was just told that I need my right shoulder replaced and am terrified. I’ve gone through too much for someone to tell me I don’t need opioids to help my pain. If the day ever comes that I can’t make it on what is prescribed I will volunteer as a “poster senior” as someone who abuses their medicine. Until then I wish the people behind limiting medicine would please read this. I function normally everyday and am not walking around high on drugs, just waiting for my next “fix”. I hope this will give you just a little insight of a day and life of a person who suffers in pain and is legitimate in her usage. Thank you
I agree with Dr. Portenoy. He has brought up a very important set of points. The PROP vs PROMPT debate reminds me, unfortunately, of the Senate. Individual agendas, inflexibility and personal attacks. Obviously this is not everyone in this debate, but clearly, and understandable, there is much emotion being injected into these discussions. This is the last thing we need, our own personal agendas clouding the discussion and not allowing us to make any progress. PROP should be thanked. We, the pain profession, have not been proactive – in a universal sense, at least from my perspective, and we have “allowed” government to impose their own notions, frequently misled and misguided, on pain medicine, e.g., HB 1 that was just passed in Kentucky. PROP has made a stance, they have come together, put together a document and made a public statement. PROMPT has responded, but PROP was the initiator. For this alone they should be thanked, they have started the discussion and the process of, hopefully, consensus. There are clear problems with the PROP statement, some of which have been outlined in these emails. However, let us not engage in individual assassinations and insults. The PROP folks have a point. Opioids have a tremendous potential for harm. PROMPT has points as well, opioids have helped patients and are one potential tool we can use to treat chronic pain patients. We should both be able to come to the table, as professionals, engage in a discussion and perhaps even come up with a combined consensus on the use of opioids. Personal agendas and emotional attachments to those agendas should not be part of this discussion. What is the data, what are the scientific findings, and most importantly, by using such data can we find common ground? There is no reason why we can’t come to such an agreement, perhaps I am naive (Dr. Portenoy has spent years trying so perhaps I am just that). However if we do, then we set the agenda, we set the tone for pain medicine in the US. The danger, and this is significant, is that the government steps into the vacuum and does it for us, something, I wold assume, none of us would want to see. The last thing we want is to end up like the Senate … So I humbly ask all of us, PROP and PROMPT and others, to engage in honest professional discussions, as both Dr. Portenoy and Fudin have suggested. Respect one another’s positions. We must do this, if we want pain medicine to survive in any multi-modal sense. Again having the Senate define medicine is a frightening notion to me … (frankly having them define anything is frightening to me) … We must avoid this!
John Peppin, D.O., F.A.C.P.
Associate Medical Director, Hospice of the Bluegrass
Palliative Care Center of the Bluegrass
2312 Alexandria Drive
Lexington, Kentucky 40504
Director, Center for Bioethics, Pain Management and Medicine
1121 Four Wynds Trail
Lexington, Kentucky 40515
Hi jeff I was in a car accident in 97 broke 53 bones was a very bad day to say the least I go through hell every day I’m 45 yrs old with 2 kids that I have to try to keep up with j hear the same shit from doctors soon as you tell them your on pain meds they think that I’m drug seeking I went to a doctor in Osceola wi at 830 am not once did I ask for pain meds but to see if they could figure out why I couldn’t walk after being accused of faking twice in 10 an a half hrs of being there i finally ripped out my iv an left to go get my kids which was a half hr away the doctor called me an said that I had to go to regions hospital in mn I was packed full of staff infection an that I would be dead by morning I told her to go f herself that she accusing me of faking an hung up she called me back an told me no matter how mad I was at her that I would be dead by morning if I didn’t go so my wife told me that i better go so I listened and went but my point is that these doctors act like people want to be on meds to get by day to day that s not the case at all I an probably every person who is on meds take the stuff to try to live a little bit better than the alternative we are all suffering that live this shitty hand we got dealt there are tons of examples of ways to die that stem from driving all the way to flying to drinking and going to a job we hate because that’s what we have to do to get by so all this shit is fucked up its just one more thing for the world to pass the buck if u want to know more I would be happy to tell people thanks for reading hope u can make a difference for the people that really appreciate it thanks
Thank you for sharing Shon.
Well said, every aspect of life will be controlled, literally saying you don’t know whats better. Once lost its gone forever. You should be presented with the positive & negative effects of your treatment & the final decision is YOURS.
Today no one is responsible for what they do, the item did it, we the government knows what best for you..Somebody in some part of the country may get hurt, etc. Nothing changes, just more non thinking assholes with all the answers.
My wife had a broken hip & her doctor said to use extra strength Tylenol, She’s a moron. I’m a pharmacist & a retired Cop of 20 years, it6’s a lot different in the real world. People don’t fit one standard guideline, etc. What’s the use, Ignorance is bliss John and we live in a blessed society.
I injured my back in the Marines and more joints working for TSA. The doctors feared prescribing to many pills so they prescribed higher strength timed released pain meds. The VA only got 5mg oxycodone pills so they switched me to 35-70 Fetynal 72hr pain patches. Then I was switched to Oxycotin and Opana ER with oxycodone immediate release. I earned two weeks of vacation, caught an item from TSA’s Red Team that every officer in the nation missed. My attendance was getting bad bc the doctors kept quitting so my dosage kept changing. At my peak since the doctors just doubled the strength instead of giving more pills was 2 Oxycotin 160mg pills/4-6hrs plus 1-2 30mg/4-6hrs. I talked a doctor into giving me 300 30mg/pills/12days which, was a lot of pills but less than 1-6th what the VA/pain doctors gave. I noticed higher strength pills don’t last any longer after a month and having more pills in lower strength makes it easier to control your tolerance. A 160mg Oxycotin pill is 32percocets without Tylenol but you really need to take 1/4-6hrs with no pain relief in the long term that’s just so you don’t go through withdrawal. When it doesn’t work your only option is to take two 160mg pills. When patients get to higher strengths it would be better to give someone the same amount on 5mg pills. They can break the pill in quarters, half’s, thirds, or 1/6ths to increase or decrease dosages. You can email me. I was in a car accident and my friend knew someone who could get some pain meds since I quit going to the doctor. The doctors won’t prescribing you 1days worth, they want you to go to a pain doctor who wants you on timed release medicine 2-3x/day. I only wanted 2-3pills since 2-3 high strength timed release pills would, never work for me regardless how high. 12 5mg pills would be better than 2 320mg oxyotin pills. Anyways the pill was fake and I overdosed/got higher than one beer buzz would do for the first time. I’ve never gotten as high as what one hit from a marijuana cigarette or two beers would do. I blacked out. I ate 2 160mg pills/4hrs working 16hrs/day at TSA and earned extra vacation for catching prohibited items and test bags higher than the national average and was in the top 1-5% in the nation. Considering my attendance was spotty when doctors change my dosages it shows how good I was when I was there. Not bragging just pointing out I wasn’t high and how good the pains meds made me perform better.
Speaking as one who has tried to engage those with extreme views about opioid regulation on many disappointing occasions, I would urge our community of professionals concerned about patient care to avoid pursuing any effort to negotiate on the details of a request to FDA. We should not buy in to the proposition that opioids need relabeling by the FDA. The public health problem of prescription drug abuse should be addressed by clinician education, smart regulation that does not pose high risk of worsening the existing problem of poorly treated and uncontrolled chronic pain (as the REMS are trying to do), better use of current law enforcement approaches to eliminate pill mills, and more research into the safety and effectiveness of opioid drugs. The PROP petition is inappropriate because 1) FDA should follow the science only and there is no science to support the demands, 2) FDA should not change its standard approach to labeling for one class unless it plans to apply a new stardard to all other drug classes without evidence of long-term safety and efficacy, e.g., antidepressants, neuroleptics, NSAIDs, and many others, 3) the likelihood that the change will adversely affect patients is very high because non-experts will look to the label as reflecting a standard of care and withhold therapy from patients who could benefit, and some payers will push the costs of treatment onto patients by claiming that off-label use does not deserve coverage.
In my view, the proper response of FDA to the PROP petition is simply to reject it as unsupported by the science and practice of medicine. Thankfully, this is what the counter-petitions and letters to the docket are saying.
The PROP petition is a tactic and it is wonderful that our community is responding to FDA with the analysis it needs to push back. Unfortunately, it may have trouble doing so. To prevent the next step, which would be legislation to force FDA to make label changes, or to do worse, I would suggest that our community make clear several points: First, the pronouncements and proposals of PROP repeatedly demonstrate very little understanding of pain medicine. Most egregious is the lumping together of a very diverse patient population with chronic pain into a group called “chronic non-cancer pain”. Pain specialists know that subgroups, like low back pain patients with substance use disorder, advanced multiple sclerosis patients, and elderly patients with disabling joint pain, differ greatly, and we know that there are mediators of individual risk (such as history of substance abuse) that vary within each pain population. We know that the term “cancer pain” is vague when referring to the millions of patients who are long-term survivors. The approach taken by PROP does not worry itself with these nuances. Second, the pronouncements and proposals of PROP demonstrate no critical evalution of the risks associated with chronic opioid therapy. There are many egregious examples that could be cited, but perhaps the most is the statement that there is a dose, e.g., 100 morphine equivalent mg, which when traversed, imparts unacceptable risk to the individual. This conclusion suggests that we know something about opioid molecules that we do not. It originates from population-based claims data, which in the realm of science should be viewed as hypothesis-generating, not evidence. PROP does not feel the need to note that these findings should never be considered dispositive. Third, PROP proposals are unbalanced, in that they never address the potential unintented consequences of increased pain. PROP ignores history that even includes a 2001 position statement endorsed by DEA and 21 professional organizations (www.deadiversion.usdoj.gov/pubs/advisories/newsrel_102301.pdf).
PROP has filled a vacuum and I am happy to see pain specialists and palliative medicine stepping up to ensure that science is respected and patients’ voices are heard.