Several weeks ago I was approached by some colleagues to participate in a CME activity that would be presented as a debate between Physicians for Responsible Prescribing (PROP) and Professionals for Rational Opioid Monitoring and Pharmacotherapy (PROMPT) at the PainWeek national conference. Faculty was told that the primary focus of that debate panel would be clinical, and the number of clinicians balanced equally (2 aligned with PROP, 2 with PROMPT). Two other panelists, non-clinicians, were also on the panel to complement the discussion (one, a social scientist who conducts research on governmental intervention in prescribing and who originally suggested the panel debate), and an epidemiologist who studies and has published articles which examine the link between opioids and unintentional overdose deaths. The epidemiologist presumably would provide insight into the methodological issues concerning the link between opioids and unintentional overdose deaths.
In the last couple of weeks, the debate title and format, as outlined above, had to shift gears because of the last minute “misgivings” on the part of certain non-PROMPT faculty participants. In the last few days, the initial press release, which nicely outlined the original intent and title of the program as a part of Opioid Safety Day, was removed from the Internet by specific request.
Still, “the show will go on” and promises to be very dynamic.
Because of multiple queries to me asking why this has changed, who backed out, and what’s the new plan, I felt obligated to allay qualms about the information and intention that the program will still offer, and to clarify certain points.
The new title is “The Great Divide: The Debate on Long-Term Opioid Prescribing for Chronic Noncancer Pain. The program will be a discussion about the differing views of this controversial topic, and will touch upon recent activities of the two practitioner groups who are most vocal in the controversy, as seen by ubiquitous Internet and media coverage over opioid safety for chronic noncancer pain). Since they declined to participate, there will be no representation from PROP; and the PAINWeek panel will articulate the differing perspectives on the efficacy and risks regarding their long-term use in noncancer pain therapy.
So today I leave you with the top ten issues of clarification:
- PROMPT appreciates the opportunity to represent its views in an open forum
- PROMPT has made a commitment to participate and will honor that promise
- PROMPT is a “real” organization that represents legitimate opinions of clinical and non-clinical stakeholders in pain management
- PROMPT’s goal in the world is not to undermine any organization that maintains a different world view
- Nobody can guarantee that either side will benefit from a discussion or a debate on this topic
- It’s not about two groups or organizations; it’s about timely and relevant education that addresses contrasting opinions on long-term opioid prescribing for chronic noncancer pain
- It makes sense to have two neutral non-clinicians and an academic, well-respected moderator.
- Good, bad, or indifferent; we are here for the patients, not for selfish personal or group gain.
- We anticipate a substantial turnout with a robust Q&A session
- PROMPT is looking forward to your participation. See you in Vegas!
Please visit www.painweek.org for more information on the PAINWeek 2013 national conference. And, See Dr. Michael Clark’s comments regarding PAINWeek 2012 on Youtube HERE. This year should be even better if that’s possible!
#PROMPTisreal
Submit your questions to dw@aventineco.com for inclusion in our discussions at Pain Week. “The Great Divide” on chronic opioid therapy in noncancer pain . See you there!
I hope this is Dr. Fudin’s blog anyway I sent a letter to Dr. Fudin to thank him for what he did for all of us who suffer from non cancer pain as if cancer is the only pain that should be treated. I would like to post it here on the blog..
Thank god or what ever the powers that be that you stuck up for us. I’ve been in chronic pain for over 15 years and a lot of the facts that these doctor’s are putting out there are not true at all. We all know that some people abuse drugs but taking them from people who need them to live some what of a normal life is equal to torturing a person. If I were forced to live with no pain management like I did for a year recently I would just end it. there would be no quality of life at all. The worst part about this whole thing is that they know this and still would take it away. I have been following you all along, thank you for having the gut’s to get up there and risk your self for us. I cannot tell you how much I appreciate what you did. We need a good doctor like you to get up there and tell the truth.
Dr. Fudin – I am so glad that you have created this group to responsibly talk about the benefits of pain management drugs and help patients who REALLY need it. Having been fighting pain for over 15 years of RSD/CRPS, Fibromyalgia, Arthritis, and many back issues, my life has become dependent upon these medications for ANY quality of life. I can say wholeheartedly that if PROP is to get what they ask for, there will be suicides by the thousands of pain patients all over the country as we would not be able to deal with the extreme pain and the loss of quality of life – however little it is to each one of us. I can still barely do a portion of the physical tasks that I would like to do and so many that I cannot do at all. I run the Kansas City Chronic Pain Support Group and work with US Pain Foundation as well as 2 other pain related groups in Kansas City. I can see and deal with people every day who are fighting their pain bravely and just want to have some quality of life to continue to try to make their lives bearable. With the guidelines that PROP is wanting, I can see easily myself wanting to commit suicide because I would not be able to handle it. The pain of RSD/CRPS and all of its accompanying issues that have gone Full Body as well as the Fibromyalgia pain and Arthritis pain among others, I KNOW that I could not deal with it and I know that others would not be able to deal with it either. I can see so many people just giving up and giving in which is the total opposite of what we are trying to teach people in pain to do. I support you and your group fully and if there is anything that I can do to help, just let me know! I will do what I can to make sure that PROP does not go through and that the pain medications that are currently available (and hopefully new ones down the road) stay available to all the people that rely on them. I do realize that there are people that may misuse their medications or addicts that are just out there to get them regardless but the majority of people in pain take their medications exactly how they are prescribed and have signed pain contracts and do random monitoring. I would do whatever it takes but there are some things that are getting out of control too, like having to provide so much personal information and issued identification cards to be able to even pick up a prescription. Those people have no right to know my information nor are they covered by HIPPA regulations so it is turning into a BIG problem! (Specifically at Walgreen’s Pharmacy) Please let me know if there is anything I can do to help you in your efforts to make sure that pain medications are kept available to those of us who need it most. Thank you so much!
Lisa, Thank you for both of the though-provoking comments. I’m glad that this forum offers an open line of communication for you and fellow chronic pain patients.
I’m very pleased the FDA did not jump to conclusions and make label changes without considering the benefits of pain medications and how they outweigh the risk for those that suffer from chronic pain. One must see that opiates are of great advantage for those that suffer from chronic pain. Without them more people would be suffering needlessly. Without them I would suffer needlessly.
I think back on all the things chronic pain has taken from me. Instead of being negative about it I’m grateful for my time here on earth even with chronic pain. One can complain all the time or be satisfied they have their chronic pain under control. There is no one good reason why anyone that suffers from chronic pain should not have access to these life saving medications. These medications have saved me from great suffering here on earth. I will always be grateful for the help I received from the doctors that have helped me get through the worst of times over the past 23 years. For those that say we have no proof opiates work and are safe for long term suffering. Well 23 years is proof enough for me.
Also I want to thank Dr. Fudin for starting PROMPT , he has put things in perspective. Enough has been said from Dr. Fudin and suffering people so we can get past these negative issues at hand.
We must keep moving forward and but these things behind us so we can gain more ground and see to it that all people that suffer from chronic intractable pain get the correct pain treatment they need.
Regards,
Mark S Barletta
I agree with you so much Mark. We can either complain everyday about our pain or get a positive attitude – whether that means reevaluating your life and finding new things that interest you that you are able to now do or to make adjustments to the things you already love to do, and realize that there is so much life to live, even in intractable chronic pain. My favorite quote is ONE DAY AT A TIME! It gets me through every tough time that I go through even if I have to change it to one hour or sometimes even one minute at a time! One way to find joy in your life is to reach out to others that are also dealing with chronic pain and to educate others as to the issues of dealing with chronic pain! If you are unsure if you can do this, just take it one step at a time. Find somewhere – like US Pain Foundation – that works within your limitations and always wants you to take care of yourself first – to become an ambassador and try to make a difference in the lives of others living with similar issues that you are dealing with on a daily basis. Start a support group in your area! I can’t tell you the amount of joy that I have received from others since I started my Support Group in 2006. There is not a week that goes by that I don’t get a Thank You for being there for me from someone. It really makes you feel so good to know that you might just be the one person that another needed to talk to today – or to meet for a soda or a coffee, etc, just to chat for a while. We are all able to make a difference, however small or large, by just volunteering to be a mentor or a support group leader or a pain ambassador or just to be there for your friends! We all have purpose in this life, even if dealing with daily chronic pain!!! Find your passion! Live it! 🙂
I am a chronic pain patient who, ironically, is allergic to nearly every opiate ever made and thus take a whole cocktail of other stuff to deal with my Ehlers-Danlos pain. Meanwhile, I saw the relief the pain meds gave my father for his amputated feet, and how very, very much he needed those medications when his doctor forced him to quit them just to prove he could and treated my father, a minister, like a criminal for wanting to not be in pain. There is no call to treat people this way. People who are in pain deserve to be treated with respect and care, not suspicion. And if there are dishonorable people out there faking pain, they should be ashamed, but not because we made them feel ashamed, because their actions are hurting people who are already in so much pain they can barely function.
Jeff,
I’m taking this somewhat out of context, but as an outcomes researcher, I disagree that data from observational studies would never meet the rigorous criteria required for scientifically based decisions of peer reviewed prescribing guidelines.
There are several issues here: efficacy vs effectiveness, potential for bias, and quality of the study, what data are available when the guideline is constructed (including whether the question can be evaluated in an RCT) and how well the study was carried out, among others. In the I think even the EBM methods literature warns against blind acceptance of RCTs and supports use of the best available literature .
Best,
Scott
Scott, Thank you for this post. That’s what I like to see…comments from an EXPERT researcher!
Are any of these physicians pain specialists? If they are not I do not feel like they have the qualifications to make recommendations on how much medicine a chronic pain patient needs just to be able to tolerate the day. Nothing makes our pain go away completely and our life is already so limited. I worked in healthcare for 30 years in Quality, Risk Management and Performance improvement. I also was a clinical data analyst and we always used Statistical Process Charts with a huge amount of data before making such blank statements or reccomendations. Where is your data to back this? You can’t count the few people who are dug addicts as part of the study. If this was the case why are you not asking for alcohol to be taken off the market? It sure kills many people and causes many health care dollars to be spent on all the diseases this “drug” causes.
My doctor went to school for many years as he is double boarded in Anesthesiology and Neurology. He worked with some of the top neurologists at UCSF and saw the need for people with severe nerve damage to get proper pain management. He is not a PHD who has no qualifications to make recommendations on how much pain medication a person needs.
I believed the doctors who told me that if I had this surgery that it would not only take away my pain but it would allow me to continue my career and even my hobby of snow skiing. Well it didn’t so I let another doctor work on my lower back because he said well your cervical fusion is not going to make the pain go away until we work on your lumbar spine. I believed these doctors, I worked with them, I knew them for years.
Well none of that happened in fact it just started my spine to herniate everywhere below or above my fusion. I thought I was dying. I woke up feeling like their was an elephant on my chest the HR director came and picked me up because I could not move to take me to the hospital. I was there for a week on IV Dilaudud and they discovered my T1 – T3 was herniated. They said I need more surgery I said no more. So I tried physical therapy, acupuncture, tens units, acupressure, a spiritual healer. I tried everything to be able to work and live with this pain for 5 years.
Then after I would not allow them to cut on me anymore I was sent to a Pain Specialsit. By now I could barely walk, at night it felt like their were hot knives cutting my legs, and I was tied down. I would wake up screaming for God to take me. I thought so many times of taking my life. My pain Specialsit kept working with me to try and find a medicine I could take and continue my work I was put on so many different drugs, they caused me to gain weight, I was sick to my stomach, it was horrible. At lunch time while my office mates were enjoying lunch I was in surgery getting a steroid injection or at physical therapy. I was working 8 hours a day at the office and another couple hours at home.
Then I developed a small Morton’s Neuroma on my toe and it caused me pain and it was hard to walk so my podiatrist said we have to take it out, well I thought this is no big deal. Well it was the straw that broke the camels back. After that surgery I was in pain 24/7 I could not walk, pain was shooting up my surgery leg and then it went to the other leg. Soon my arms were shaking and in pain. They sent me to UCSF and I was seen by two wonderful neurologist who did so many different tests, blood work, nerve study, test after test. I then got the results and a 5 page letter saying I would probably never be able to work again. I had Peripheral Neuropathy, Small fiber Neuropathy, spondylosis, DDD, arthritis of the spine, failed spicial fusion, their was more but I don’t recall. Surgery was no longer an option.
So it took me a few years to find the right combo of medications that gave me some relief and still let me feel like I was not in a fog. I don’t abuse my medications, but they are the only thing that makes my life bearable. I can do maybe one thing a day and then I am in pain and have to rest. You are right about their being deaths because if I have to go back to a life of screaming at night, hitting my head on the wall I will choose to end my suffering. I barely have much quality of life but without my medications I would have none, I hope none of you ever suffer like I do and so many others do but if you could spend a day in my body you would never subject a human being to endure this kind of suffering. Isn’t it in our Bill of Rights that we can have happiness and not a life of torture and pain. I thought you doctors cared about our well being and quality of life? The surgeons were so nice to me when they were telling me they could fix my problem and what a great life I would have, I,saw their 60,000 car. I worked for a surgeon for five years and I got it. But when I came back and said I am worse, he said well this does happen in very few cases. Yet almost everyone I know that had a cervical fusion Is now disabled.
You are picking on the weak and the sick we have suffered enough, please don’t take away the only thing that gives us some days with less pain. Don’t make us have to choice suicide I don’t want to leave my grandkids. But I am not going to live a live that Hilter would inflict on the Jews. My doctor went to school an extra 8 years to know how to treat people with chronic pain. We have urine tests and blood to make sure our liver is not harmed, I don’t drink, smoke, I am a,vegetarian I do everything I can to treat my body with respect. But don’t take away what little pleasure I have. Please show some mercy as we are not drug addicts we are people who by no fault of ours have diseases that cause us to suffer with chronic pain. I know so many who have already taken their lives, is this what you want? Join our groups get to know us and then maybe you will understand that we are just unfortunate human beings who don’t want to suffer anymore than we have to. I will pray you think about what you are trying to do.
Sincerely,
Nancy Marie Lucky
Good luck on the presentation. As a persecuted physician now looking at life in prison for doing everything right, I wish those of you still fighting for the patient the best. I as a Diplomat in the American Academy of Pain Management, and really enjoyed their conferences. Haven’t been able to afford to go to any since my first government attack in 2013. Lucky for me, I am not like Dr. Langley with chronic non-treatable pain. I do have some chronic pain issues, but by using alternatives, they are minimal or healed completely.
I feel for all the chronic pain patients in this country not getting treatment. I guess the only justice this world has to offer is that we, the ones that care and the ones that suffer will someday be in paradise, while the ones that dole out the pain will be spending eternity in everlasting pain.
Once my sentencing occurs October 21, I will be free to speak out more about the evil perpetrated by our government agencies. I can’t right now, because it only gets the accused in more trouble. But watch my website and blog after sentencing and pass the information on to everyone. It will be a real eye opener as to the tactics used to prevent healing and proper treatment of a population of people the government wants to get rid of.
Thank you for standing up for chronic pain patients. I was one of those caught in the web of persecution, after trying to practice in scientific manner. The articles and information I received from my readings, keeping up with proper chronic pain care, was very influenced by Dr Russel Portnoy, at SUNY. I learned that continuing my self education, through reading, and, actually, attending the pain meetings, only got me into trouble. I tried to be compassionate, but selective, in choosing the patients I would treat. Even playing “cop doctoring” did not keep me safe.
Thing is, no one can tell the liars from the true pain patients 100% of the time. I am sure there were a few in my practice. But, do we stop treating 90%, or more, of the, deserving, patients , because of these criminals?!
Ironically, I fell when a deer stand broke about two and one half years ago, resulting in cauda equina syndrome. Without the opiates and Tramadol, I would be unable to continue living. The severe burning and tingling in the left foot would be unbearable to the point of suicide! I get , barely, enough to keep me from suffering. I control my present meds so I don’t suffer pain, at night, so I can sleep longer. I sometimes suffer with the painful parasthesias in the evenings because I am taking my meds in a fashion that will allow me to function, eight hours a day. Having been a fellow of the American Academy of Pain Management, and attending many of their yearly meetings did nothing to save me from the sharks.
But, now that I am disabled, at least I get enough money to survive. (It’s my,only, income, because I was destitute, after the medical board and the lawyers got through with me!) My next venture is moving back to the state I was “evicted” from. Hopefully, there is a doctor, there, not afraid to treat my chronic pain. Otherwise the results could be deadly.
My wife has six different chronic pain conditions. The last time she visited the urologist for her interstitial cystitis, he took her off her pain meds, refused to sign her certificate for application for disability and told her that she should go to college, so she could get a better job. This, all knowing, physician, did not consider the fact that she has had a learning disability, all of her life. She only graduated high school because she was young, pretty, popular, and came from a well to do family. (She was in special education classes! I believe it was untreated ADHD!) Now, she suffers from some new, strange, overheating, conditions that she had only during cheer-leading camp, when she was young. She has never, since I have known her, had a bad reaction from her pain medication.(although Prozac made her homicidal!) All of her pain comes from the interstitial cystitis, irritable bowel syndrome, dysmenorrhea associated with endometriosis, and menstrual migraines. Strange thing with her is that she only has good bowel function, while taking the opiates!
My cauda equina syndrome is only partial, so I am able to walk. But, the down side of it , compared to a spinal cord laceration, is that I suffer with neuropathic pain. It has not passed in two and a half years, and I don’t expect it to pass, any time soon! I had MRSA, after my operation, so I am not open to invasive procedures (the injections) that, at best, have a 33% effectiveness rate. They, also, have to be repeated, regularly. I am not a fan of inadequate care, which this represents!
Anyway, thanks for your support of us chronic pain patients.
As a patient with chronic pain I do not want a committee to decide what medications will be available to me. I pass numerous kidney stones every month. No one who has had a kidney stone would ever expect Tylenol to make any difference in their pain. I want to have a life, not spend days in the hospital for pain, nausea and dehydration as I did before I had adequate pain management. Thank you for advocating for us. It’s too bad the conference lost two panelists, but I’m sure the information that is shared will be useful and very interesting.
Dr. Fudin,
I suffer from MSK, ptsd, hemohytrosphy, I apparently wanted to be special. I know how it is over and over to be cast out for being a drug fiend, nuisance patient, and the ever popular group of I can’t help you party.
I do not want my pharmacist involved in the decision on if i can get my meds or not. I feel it is really a basic invasion of privacy, and as far as i know every pharmacist in the world is not a specialist in every field of medicine to be qualified to make this decision.
I also come from a ingrained fear of taking to much medication because my mother ( a RN) ran the whole gambit of pill addiction. The last thing I want to do with my pain meds is get high. The choice i am left with everyday is does this hurt enough to take my meds, or should i save them in case they decide i can’t have them any more.
I will forever and a day give a urine sample in full view of 20 people so there’s no contamination issue, and please test me for all kinds of other drugs three times a week if that’s what it take to have a simple bit of dignity to be able to walk to the bathroom alone if i have my pain meds. I am 47 years old, this disease is one of hundreds no one is educated about and of the 600 people i recently started to converse with everyone, from 21 to 87 have been told they are faking for drugs.
I know the average consumer i.q. is considered to be a 4th grade mentality, but if they went case by case, patient to doctor decision implying we can’t be trusted with medication isn’t really the issue. if the doctor is not trained well enough or responsible enough to look for the signs of abuse vs just me actually being sick, doesn’t that say something about the level of quality care we are getting?
There’s never going to be a perfect match, there will always be someone slipping through the cracks on either side. There’s no glamor in being 47 beaten by chronic disease, begging for help so she can walk to her son’s room to wake him up for school. My actual dream is to be able to one day be pain free enough that i can wash dishes, or vacuum my floor to contribute to my house hold.
it would be very easy to require doctors to take a course to be educated, but you can’t make anyone invest enough thought or time in a patient to determine what is really going on. We’d be forced to drive hours to find a doctor who did get educated, which to me would be worth it if i could have a lil bit of dignity or acknowledgement I am not drug user by choice,
Thank you for even trying to get a discussion going, and being serious, but maybe next year have 4 people talk about their daily life and experiences with and with out relief. It might remind people they chose to be a doctor to heal.
Dianne
MSK savant at large.
Thank you, Dr. Fudin for your helping the people with chronic pain. I really am dumb founded in what’s happening now in the pain management industry. I find it down right cruel that I have to suffer 24/7/365. I have had pain for 25 yrs. now and it gets worse every year (I am now 63). take my medication as prescribed and am honest with all of the doctors I have seen. It seems that only the Doctors who have chronic pain themselves have understood and actually were able to treat me way that I needed. Being in pain for 25 years I have tried practically all the alternative methods even going to a Natural Doctor along with trying thousands and thousands of different medications. (Okay maybe not thousands and thousands lol). It’s been a whole lot. Please help us be able to change this atmosphere of opioid phoebia. At the same time providing the services that folks who are addicted need. Addiction is a disease too that needs compassionate treatment. One has to have the gene to be an addict. Most people in chronic pain are NOT addicts. Thanks for listening and your help. God bless
Dr. Fudin,
Thank you so much for all that you are doing. It’s getting scary for some of us patients.
My life changed when my Dr. rx’d my first ER opiate. After my initial adjustment period, my spine unclenched. I was able to exercise (down 56 lbs ) and now have a much better quality of life. Can you imagine going from minimal pain relief to being able to have hope again? It’s the best feeling ever.
My screws are never coming out, especially not in 90 days. Neither are my bone spurs, nerve pain or scar tissue. Oh, and the wear between fusions, that’s not moving out of my spine on a 90 day lease. It’s laughable for them to even try to equate the pain with a time cycle.
Thank you for giving us a voice.
Kate Del Rio
12 spinal surgeries including T4-10 fusion (14 pedicle screws, 2 rods and a brace)
4 cervical surgeries
1 Thoracic
4 lumbar surgeries
3 pre-fusion surgeries, trying to save things or lessen symptoms.
It is sad and disappointing that the debate will not go on. I was really looking forward to the debate, but now I am even more excited to attend and listen to PROMPT representing facts!!
PROPs petition is arbitrary and contradictory. It speaks of an epidemic but lacks evidence other than a rise in overdose incidents in emergency rooms. The whole notion limits of 100mg morphine equivalent and 90-day treatment has no basis in fact or research which is the basis of their argument for the change in labeling. Label changes will not STOP or CHANGE abuse of addiction to opioids; there is absolutely no evidence to support that. Label changes will hurt legitimate pain patients, as insurance companies will deny payment for off-label prescribing and opioid therapy will become inconsistent with recognized standards of care. No one who has not experienced the realities of true chronic pain can understand the impact that it has on the lives of those who suffer from it constantly on a daily basis. What is interesting is that PROMPT was not contacted for an opposing view as this petition was put together AND when PROP had the chance to present facts and go in a debate against to educate the public they REFUSED. How ironic…
Thanks Dr. Fudin for all what you do and all the education your provide on a constant daily basis to physicians, pharmacists, healthcare professionals and of your course chronic pain patients. You are wonderful!!!
EA,
It’s interesting what you say about “lacks evidence”. PROP is pretty much hanging their hat on three low evidence studies.
From PROP’s FDA petition: “Three large observational studies published in 2010 and 2011 found dose-related overdose risk in CNCP patients on COT.” 1
These “Three and “observational studies” did not separate substance abusers from legitimate pain patients, and they presumably included overdoses from patients that did not use their medications as prescribed and could have used substances concomitantly that enhanced opioid morbidity and mortality. For example, in the Dunn study cited, the author’s admit “Increased overdose risk among patients receiving higher dose regimens may be due to confounding by patient differences and by use of opioids in ways not intended by prescribing physicians. The small number of overdoses in the study cohort is also a limitation.2
Even if the data from these three studies was perfect, “observational studies” would never meet the rigorous criteria required for scientifically based decisions of peer reviewed prescribing guidelines. This is evident in the APS-AAPM COT-CNCP (chronic opioid therapy for chronic non-cancer pain) guidelines that separated out studies by quality of evidence, so designated as low, moderate, or high quality.3 It is curious then that several epidemiologists signed the PROP petition, including the lead author on COT-CNCP guidelines that labeled the very same evidence type as “low-quality”. Epidemiologists customarily regard observational study conclusions to be among the weakest of quality because they draw extrapolations about possible treatment effects in studies that are not controlled by the investigator.4 Even more disturbing is that a Medscape-PROP commentary is basing this statement on three (3) observational studies, while the COT-CNCP guidelines reviewed eight thousand and thirty-four (8034)3
Perhaps the best contemporary example of how study beyond 90 days may not prevent a poor outcome is consideration of the Vioxx® story. Clinical data was available for 5435 patients treated with active drug over a 22 month span and did not suggest any adverse cardiovascular outcomes from thromboembolic disease; based on this data, Vioxx® was approved by the FDA for chronic use as a COX-2 specific NSAID in 1999.5 It has since been removed from the market due to increased morbidity and mortality resulting from enhanced thromboembolic risk and resultant increased morbidity and mortality.
References:
1. Physicians for Responsible Opioid Prescribing (PROP). Petition submitted to Food and Drug Administration July 25, 2012. http://www.citizen.org/documents/2048.pdf. Accessed October 8, 2012.
2. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Annals of Internal Medicine 2010;152:85-92.
3. Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P,6 Donovan MI, Fishbain DA, Foley KM, Fudin J, Gilson AM, Kelter A, Mauskop A, O’Connor PG,Passik SD, Pasternak GW, Portenoy RK, Rich BA, Roberts RG, Todd KH, Miaskowski C. FOR THE AMERICAN PAIN SOCIETY–AMERICAN ACADEMY OF PAIN MEDICINE OPIOIDS GUIDELINES PANEL Opioid Treatment Guidelines, Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. The Journal of Pain, Vol 10, No 2 (February), 2009: pp 113-130.
4. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Annals of Internal Medicine 2010;152:85-92.
Dr. Fudin
I have a question regarding your comment:
“Even if the data from these three studies was perfect, “observational studies” would never meet the rigorous criteria required for scientifically based decisions of peer reviewed prescribing guidelines.”
Which randomized trials provide evidence supporting the use of opioids for long-term management of chronic non-cancer pain?
Thank you.
David Juurlink
Dr. Juurlink,
Thank you very much for corresponding on this forum! As I’m sure you and the PROP folks know, high-quality, randomized trials of opioids for CNCP are lacking. And some might argue that high-quality observational trials do indeed have much merit. Notwithstanding, this is no excuse for PROPagandists to debase legitimate pain patients, the FDA, or PROMPT’s call for more research so that we have high-quality, randomized trials of CNCP opioids before implementing draconian and unsubstantiated random limits. Dr. Stewart Leavitt posted a nice review on long-term opioids at http://updates.pain-topics.org/2013/02/opioids-on-trial-part-2.html.
I still would very much like to see a civil forum in which PROP supporters and PROMPT supporters could discuss this in an open forum for the benefit of everyone. The bottom line is that we all want what is best for patients (I think). I believe if we all worked together the outcomes would be most favorable for all involved.
Dr Fudin,
Thanks for your reply. I suspect the PROP and PROMPT folks agree on more things than they disagree on.
With regard to the lack of longterm RCTs, I think these haven’t been done because manufacturers are not obliged to do them, and experts in the field of pain (including some members of PROMPT) have not pushed for them. The same is not true for some NSAIDs, where we have longer-term data on safety and efficacy from RCTs,
Would you agree that the companies that manufacture opioids, such as Purdue, Endo and others, should (voluntarily or otherwise) sponsor large-scale studies of the safety and efficacy (using meaningful clinical outcomes rather than, say, pain scores) of opioids vs. other medications in chronic pain? (I asked a similar question of Dr. Leavitt some time ago and he declined to answer.)
If you do agree, would PROMPT petition them to do so, or have they perhaps already done that? I ask because you mention PROMPT’s call for more research, which I agree is a good thing.
Thanks
David Juurlink
Dr. Juurlink,
You certainly raise some very interesting points. I agree with you that PROP and PROMPT folks probably do “agree on more things than they disagree on”. Yes, I agree that someone, somebody, some agency, and/or some manufacturers in collaboration should sponsor large-scale studies of the safety and efficacy using meaningful DSM-4 criteria outcomes and clinical outcomes. I think this should happen with many drug classes, not just opioids. For instance, I’d love to see this with Statins (or HMG-CoA reductase inhibitors). Generally I am not in favor of pain scores such as 0-10, but a more precise measurement such as the SPID (summed pain intensity difference). The SPID, as you know, and other pain measurement scales are probably more accurate and some allow for the patients to serve as their own control [See, Defining the clinically important difference in pain outcome measures (http://www.ncbi.nlm.nih.gov/pubmed/11068116)]. But, I wouldn’t necessarily measure opioids against “other medications in chronic pain” because it would be like comparing apples to oranges. As a pharmacologist, I’m sure you know that.
I think instead that a bunch of us should put our heads together (PROP, PROMPT, and others) to devise some studies that will tell us the things we need to learn. I suspect the reluctance so far has been the span of time required, the large numbers, and high expense. Notwithstanding, it is an important endeavor that is most probably worth every penny considering the predicament we all face now. So, yes, I “MOSTLY” agree. I would encourage PROMPT to “petition them (manufacturers) to do so” if PROP worked with us so that we get it right the first time with opinions from both camps. PROMPT has not approached manufacturers to support such studies as a group, nor do I believe that industry should bare the entire burden. This would be a great study for NIH with support from many sources, including whoever is currently funding travel and other expenses for the PROP group.
These topics David, are the very things that we could have discussed at a PROP vs. PROMPT debate in Las Vegas at PainWeek. Such dialogue would have served the medical and pharmacy community well and could have helped to dispel myths that any of the pain doctors, psychiatrists, addictionologists, etc. are monsters. As you said, “I suspect the PROP and PROMPT folks agree on more things than they disagree on”.
Again, many thanks for your comments and participation here!
Best,
Jeff
I think RCTs are have serious limitations for long-term studies (e.g., 6 moths+) efficacy studies on generalized disorders. The expected drop-out rate is expected to be high and the results will inherently be biased. If you have more active follow-up (and therefore retention in treatment), you threaten generalizability because the setting is further from routine clinical practice.
I would be curious to hear what a trial might look like. How do you analyze the data when you know you can’t hold people on one single form of opioid therapy for 12 months if the pain isn’t controlled? What is the endpoint? What do you randomize to as the control arm(s)? Is placebo ethical?
It’s a bit tedious, I think, to trot out the old “rigorous criteria” thing. On top of that the patient-reported outcome side has some well-known issues in pain. In short, I don’t think a simple RCT for efficacy will really give us additional information that’s worth the expense.
That said, I do like this study design, as one of the few that blend RCT and clinical practice long-term in a meaningful way, but it was a safety trial (they weren’t assessing efficacy):
http://www.ncbi.nlm.nih.gov/pubmed/16716877
Nabarun,
All excellent points from an exert in he field. It is useful excellent dialogue like this that make blogs worthwhile.
Just a few thoughts on the clinical trial issue:
1. We do in fact have long-term studies of statins looking at hard clinical outcomes. In fact, we value those studies more than studies that look at surrogates such as LDL.
2. I do think a longer-term RCT of opioids vs. nonopioids has merit. Will people drop out? Yes, from both arms. That’s what happens in real life. But the prospect of dropout it is not a reason not to do a trial. In many trials, persistence with therapy is actually an outcome of interest. And it should be.
3. Most of the RCT data we have now derives from short-term studies (3 to 4 months long) vs. placebo. (So, to answer Dr. Dasgupta’s question, it appears that placebo IS ethical, even if it’s not something a clinician would normally consider.) These are efficacy trials to determine if a drug CAN work in an ideal or quasi-ideal setting, not how a drug compares to alternatives.
4. Perhaps most importantly, if we do not do proper studies, we’ll never advance from where we are, which is relying on short-term studies to guide what is often a long-term intervention. Doctors who have patients on opioids for a year or more are effectively “flying blind”, exposing people to drugs that undoubtedly help some but also harm many. That would never be accepted in the fields of cardiology or in oncology. Why is it accepted in the management of chronic pain, which is such an important public health problem?
Dr Fudin, what a great thing you are doing to help put an end to this debate…The recent comments made public by many high ranking appointed officials calling on the FDA to accept PROP’s petition is very shameful..How so many people involved with the DEA and the CDC could actually believe that the petition is in the best interest of Pain patients is absurd! The tone of their request may have changed, specifically the distinction between cancer and noncancer pain, but i think that just shows that it is not going well for PROp and that The FDA is not so easily fooled, However the fact remains that any attempt to control abuse must be tempered with the real best interest of legitimate pain patients… These Doctors that want to get rich of suboxone, or force more people to undergo Epidural steroid injections, really need a dose of the very harm they dish out…. Thank you for taking a stand and giving the patient community another loud voice……Keep rockin!
Thank you Walt…I plan to keep “rockin” at least for now. 🙂
I really hope the representatives from PROP reconsider attending the discussion. I will have an open mind when listening, and very much want to hear both sides of this issue, as I want to believe everyone has, at the very least, good intentions for their respective positions.
Dr. Fudin, thanks so much for bringing this news that the prop folks really don’t have a leg to stand on.(Or a chair to sit in).
Long-Term Opioid Prescribing for Chronic Noncancer Pain. I have been down for three days. I’m a moderator for “COFWA”. I have a responsibility to these wonderful, and educated people. The pain is so incapacitating that I have just laid in bed. Pitiful. I was such an athlete 13 years ago.
NOW, the question is, why would kolodney want to show up at something he really know’s nothing about? Well, I would just like to see “Dr. Jeff” put him in his place. Again, thanks Dr. Jeff. BTW, I just ran an errand, by my old truck. I could barley get back in the house, I guess this flair is not gone yet. Does Kolodney even know the meaning of the word? I mean him no disrespect , really, but why would the guy show up anyway……….doc,,,,,,(Herb Neeland)
Thanks Herb. I hope all is well with you. Keep up the fight against your pain! Best, Dr. Jeff Fudin
Thank you Dr. Fudin for making us aware of this conference. It is disappointing that PROP won’t be there to discuss all this but I am very glad that PROMPT will be. That tells me that Andrew Kolondy doesn’t want to be involved in the deep conversation about his citizens petition. I think he knows he can’t win with his ideas because there are too many people suffering non cancer chronic pain in this country and most of them successfully find relief with opioids. Without opiate medication available, many patients would not have any kind of a life at all. I also feel that the FDA knows this too and that is why they haven’t accepted that petition. We all know that some people will abuse the medications but everyone shouldn’t have to suffer because some people have addiction problems. Perhaps, that is where Suboxone could help addicts that have chronic pain so they too could have some relief. Every human being should have access to pain relief and also choices of medication that works the best for them or pain type.
Thank you so very much for everything you do, including creating PROMPT to support pain patients against PROP. I’m sure this conference will be a great success! I also would like very much to hear the conference at some point. If there is anyway this will be on podcast, please let us know.
Thank you for your comments regarding the “debate” of PROMPT versus PROP. Be well Donna.
Thank you Dr.Fudin for defending chronic pain patients and the science that supports the judicious use of opioid pain medications for chronic pain. Will the debate be filmed and placed online for all to see? I would be very interested to watch the debate. Will the health professionals against the use of opioids for chronic pain be representing a particular group or organization, or are they independent?
Despite advances over the past several years, the medical community and society at large still need more awareness, discussion, and education regarding pain management. This event had the potential to create a lively discussion and bring attention to an issue that needs to be addressed and I hope that PROP reconsiders for future events.
Nevertheless, I think this event will still present the issues in a way that allows those present to draw their own conclusions about the best way to solve the problems we face. Thanks Dr. Fudin for keeping this issue on the “front burner” and keeping the discussion rationale and evidence based!
Thank you Dr. Costantino. I agree with you; I hope that “PROP reconsiders for future events” to participate in an educational forum so that attendees can listen to the discussion and take away the best from both sides so that we have a balanced solution to the issues surrounding opioids. It doesn’t necessarily need to be a debate of PROP versus PROMPT; an educational candid discussion would be wonderful too. The world is only in trouble when there is s zealot in one camp or another without compromise or consideration of the outcomes for everyone involved. You are also correct that “this event will still present the issues in a way that allows those present to draw their own conclusions”.
Also, best of luck in your endeavor to serve the United States Army…you should be very proud and I’m honored to know that you are taking this huge step to protect our freedom. It is because of people like you that I have been fortunate to spend my life caring for veterans. I’m hopeful of course, that I never see you in my Pain Clinic except for a friendly visit. Whether the Marines say Semper-Fi, or “oo-rah!”, the Army says “hoo-ah!”. Whatever the saying, GOOD LUCK!
There must be a way to find a balance between pain mangmt. and opiate abuse. As a responsible pain patient & a mother, it’s easy for me to see both sides of this coin.
The availability of prescription drugs on the streets is a problem, but nobody should have to suffer daily pain because their meds are abused by others. Especially since these drug addicts would be abusing some other drug if prescription drugs became scarce.
Thank you for keeping this issue in the spot light. It really is a matter of life or death to many.
Katt Morris
Citrus County, FL
Thank you Dr. Fudin for keeping us up to date on these topics and issues. I am still mystified why and how PROP is able to warrant the opportunities to present their so called theories, when it appears that the majority, if not all, even have any actual experience treating patients with long term chronic pain , cancer or otherwise. Honestly I believe some of them saw an opportunity to ride the media hype, and in their efforts for their name to be known, even of it is perpetuating false information and literally hurting so many people. Thank you
Jennifer/E11
Jennifer,
Thank you for your thoughts. It is quite mystifying.
I thank PROMPT for taking reasonable, scientific positions on pain control issues. It is a refreshing change as opioids are the Drug Demon Du Jour in the popular imagination. In reality, opioids are very useful medications and very safe for people who take them as prescribed and do not abuse them. PROMPT provides an excellent counterweight to hysterical, strident organizations like PROP that are agenda-driven. Follow the money.
Very true Anon, “…opioids are very useful medications and very safe for people who take them as prescribed and do not abuse them…” Perhaps some of the tamper resistant products of the future will help push us in that direction.
Thank you Dr. Fudin for your continued support. It is important for chronic pain patients to be heard. For me it is a matter of getting out of bed and living a “normal” life. I am a junior at Saint Leo University, but without my pain medication I would not be able to go to school. Recently, I have seen a heard a lot of talk about legalizing medical marijuana in Florida. I can’t help but think this is in response to trying to take our pain medication away. For some that is good, I guess. But for me, I don’t want to get HIGH. I simply want to have my pain controlled to a liveable level. I was a patient of Walgreens, who it seems in light of their “bad behavior of warehouse employees” worked out a deal with the DEA to only fill pain medicine for people that are “dying.” These were the exact words of the pharacist as she politely advised me that she would not longer be filling my prescriptions. She went on to advise me that I would be better helped with physical therapy, and said, “these medicines are for people who are dying and you are not dying.” When did pharmacists become able to make the decisions of doctors?So I was thrown back out to crawl. Fortunately, I found a small business pharmacist who was williing to fill my prescriptions. However, there are countless others out there crawling month after month. Again, I thank you for you continued support.
Rhonda,
Thank you for your comments. It’s always good to add real live persepctive to the issues at hand. Best of luck at Saint Leo University. I wish you all the best successes.
PROP: Physicians Refusing to Obtain Proof:
physicians, pharmacist, clinicians, researchers and educators of all type should have one thing in common. a true desire to obtain knowledge, to share experiences, to open their eyes to all facts and to be willing to share their thoughts as well as be receptive to others. We have all learned in school this is how advancements are made in the world of patient care. Medicine is truly a field where it is a “practice”, meaning that this opportunity we have to enhance patient care expands from experience and education. I find it meaningful and sincere that PROMPT members are hoping to share their thoughts with others and are willing to hear different opinions. Unfortunately, when one group refuses to interact with others, when minds are closed to other facts and experiences, ignorance and bias grow. I don’t think that anyone from PROP or PROMPT would probably change their views, however when more knowledge is exchanged between different groups, it allows for a better way to enhance patient care and understanding reduces bias and prejudice. I am sorrowed that any group would refuse to sit down and feel comfortable about expressing their opinion and listening to others, regardless of the topic.
I have always told my boys they could have any opinion they wanted, but must be able to defend it and share it. They are both lawyers.
when one group refuses to meet with the other, it shows a sign of weakness in thought, lack of commitment to ideals, fear of being overwhelmed with facts you cannot logically refute.Basically, you’re afraid of being proved the fool you are.
The whole theory of medical advancements comes through trial and error, sharing experiences, communication of success and failures. PROMPT will grow and change as we acquire more knowledge, find better medical, clinical and psychological ways of dealing with patients who suffer. we are not afraid to hear other opinions and when applicable, modify our thoughts. That’s called growth through knowledge and experience. PROP’s failure to be willing to communicate is more problematic than their stand. As with abortion, I respect everybody who is willing to stand up and express their opinions based upon facts, even if i disagree, i can understand WHY they have their point of view. I have loss all respect for PROP. they could have a potential nationwide and with the internet, a world wide audience to share their view; to educate the world.
Perhaps their PROP is a good anacronym Physicians Refusing to Obtain Proof.
Dr. Tarr,
Thank you for, your comments. I’ve had some pretty wild e-mails about that comment related to the acronym. Perhaps one of the most though-provoking is that the images aren’t real…they are just PROPs.
It is really too bad that this event could not come to fruition. Regardless, the real debate carries on. Everyone with a nervous system and emotions has a stake in this.
I look forward to the next opportunity for experts from both points of view to defend their positions in close proximity and on the record. I hope it happens sooner than later.
Thank you Jeffrey and thank you PROMPT
James Patrick Murphy, MD, MMM
Louisville, Kentucky
Thank you for your comments Dr. Murphy and thank your for your unyielding dedication and commitment to education, patient care, and safe opioid prescribing! If every practitioner practiced like you, we would be certain to have less deaths from prescribed opioids. I too hope that PROMPT and PROP can come together in an educational debate or some type of discussion forum.
Maybe the reason PROP backed out is they have nothing to offer and nobody wants to hear from a group of doctors who do more harm than good. I’ve heard nothing but negativity coming from PROP from day one with their Citizens Petition. Lets face the facts that Petition from PROP made many people very annoyed, frustrated and everyone thought what are these doctors thinking . How cold could PROP be to send such a one sided Citizens Petition to the FDA.
PROP does not want anymore people dying from opioid overdoses, everyone wishes for this same thing. Unfortunately that’s just not going to happen because opiates will always be abused by people who don’t take them for all the right reasons. The reason I take them is to reduce my chronic pain and increase function. Everything that doctors use to say about the percentage of people that take opiates for chronic pain becoming addicted was wrong , so they say from what they know now from back then. People have lost sight of the fact that opiates can be dangerous if not prescribed properly and selectively. These type medications are not for everyone that have ongoing chronic pain. But if you’re a person that has tried everything and everything failed you and you suffer as a result what is a suffering person to do.
Risk come with ever new prescription a person takes prescribed to them by their doctor. We must see to it the benefits outweigh the risk when prescribing opiates. Doctors must be more careful who they prescribe opiates to and how much. Opiates for chronic pain should be the last option when everything else has failed a person suffering from ongoing chronic pain.
Thank you Dr. Fudin for taking on such a important subject, you seem to be one of many Pain Specialist holding on to your beliefs. Not many doctors would start such a debate in fear of brining attention to themselves. I appreciate you and I’m sure other pain sufferers look up to you for taking on such a touchy subject . Over the past 13 years I’ve watched things change in the field of pain management.
Mark S Barletta
I have been treating pain in complex patients with and without a history of substance abuse for many years. It always boils down to the individual patient, benefits and risks, and careful selection and monitoring. I was looking forward to the original agenda but will be there just the same. I thank both groups for their conviction, but am disappointed that PROP pulled out of the debate. I missed the original press release ” the initial press release, which nicely outlined the original intent and title of the program”, but heard a lot of buzzing about the PROP – PROMPT debate.
Pain&AddictionDoc,
I’m glad you’ll be at the conference, which of course has many great programs all week. You are in luck, because a simple Google search yielded the following active links to the original press release…
PAINWeek to Host PROP vs PROMPT Debate at Opioid Safety Day
http://www.bioportfolio.com/news/article/1550930/PAINWeek-to-Host-PROP-vs-PROMPT-Debate-at-Opioid-Safety-Day.html
http://www.streetinsider.com/Press+Releases/PAINWeek+to+Host+PROP+vs+PROMPT+Debate+at+Opioid+Safety+Day/8467143.html
http://www.redorbit.com/news/health/1112889943/painweek-to-host-prop-vs-prompt-debate-at-opioid-safety/
Dr. Fudin,
While I don’t know everything that has happened behind the scenes, I want to personally thank you for your willingness to go ahead and participate in PainWeek, and for deciding to represent chronic pain patients, as well as actual science, at this forum. I find it ironic that those who have been the “squeaky wheel” for so long now against chronic pain patients, and the medications that help them to function, decline to participate in a rational discussion on what would be most beneficial for those who have the most to lose. Especially after they had already committed to sit down and discuss things. Why is that? Perhaps it’s because they know they are doing more harm than good with their suggestions to begin with, and are unwilling to compromise on the issue. At any rate, thank you again for your unwavering support of those of us who are at the mercies of the “powers that be.” Without you and the members of PROMPT, we wouldn’t stand a chance.
Sincerely,
Mary Maston
MSK Advocate
Mary,
Nice to hear from yo and thank you for your kind comments and support. We anticipate hundreds of professionals to be at the “discussions” between PROP’s position and PROMPT’s position in the opioid labeling request as originally submitted last July. I think that considering the time that has passed, any momentum with the FDA to follow PROP’s lead has all but fizzled out. I believe the the FDA panel has carefully considered all of the risks and benefits, they will continue to watch, and likely will take steps to encourage the safest prescribing possible though development of more REMs initiatives and other similar strategies. That coupled with Prescription Monitoring Programs throughout the U.S. will hopefully help to direct prescribing in a more safe direction. Please encourage all of your contacts to comment here, as PROMPT believes that the bottom line is that any decisions made are based on patient safety, adequate pain control, and education.
Very disappointing. I was truly looking forward to this session in its original format.
Disappointing indeed, but it should still be great!