Caught in the Crossfire: PROMPT vs. PROP

Caught in the Crossfire: PROMPT vs. PROP

When a group of doctors, public health officials and members of Physicians for Responsible Opioid Prescribing (PROP) submitted a petition to the FDA to restrict the approved uses of opioid medications, the shockwave that rocked the chronic pain patient community was overwhelming.

The petition asks the FDA to limit the approved use of opioids to severe non-cancer pain; to limit the dosage to the equivalent of 100 mg of morphine a day; and to limit the length of prescriptions to 90 days. The current approved use of opioids to treat moderate pain would end under the petition.

Patients were outraged, with many claiming that they had tried numerous treatment options for pain, and opioid medications were the only thing that allowed them to function.  Some patients already face extreme difficulties in obtaining their pain medications due to the government crackdown and their stress levels have gone through the roof. For them, this petition from PROP couldn’t have come at a worse time.

The FDA has asked for public comments on PROP’s petition, and the response has been continuous from both patients and the medical community. Health care providers across the country are divided on the issue, with some in complete agreement with the limitations that PROP is proposing, while others are vehemently against it, saying there is no legitimate scientific evidence to support the claims of the petition.

As a direct result of this controversy, a new organization of medical professionals was formed, called the Professionals for Rational Opioid Monitoring & Pharmaco-Therapy ( PROMPT) and quickly set out to draft a response in rebuttal to PROP’s petition.

PROMPT’s Chairman is Jeffrey Fudin, a doctor of pharmacy who has been treating and advocating for chronic pain patients for many years. He currently works in a hospital-based pain clinic in Albany, NY and says when he first read the PROP petition, he was “appalled to say the least.” Dr. Fudin worked quickly to contact other medical professionals to get their take on the situation, and upon finding many were in agreement with him, PROMPT was formed.

According to Dr. Fudin’s blog, PROMPT members include clinicians, researchers and academicians from various fields of pain management. PROMPT states that they have “serious concerns about the safety of chronic opioid use; we are therefore in favor of mitigating these risks by employing reasonable and validated interventions intended to benefit patient care and public safety.  We advocate for clinician education, proactive risk stratification, and appropriate therapeutic monitoring.”

The first order of business for PROMPT was to draft a letter supporting the one that the American Academy of Pain Medicine submitted to the FDA opposing PROP’s petition. According to Dr. Fudin, PROMPT is building momentum and professionals are rapidly coming on board in support of their efforts.

The next step was to open up commentary to chronic pain patients, which shows PROMPT’s commitment to the patients they provide care and advocate for. There has been a positive response from the patient community, and PROMPT is asking patients to keep the comments coming by posting their comments here.

“I want to get as many patient stories as possible so that a group of professional people can advocate for the patients,” Dr. Fudin wrote to me in an email.

PROMPT also encourages chronic pain patients to contact the FDA directly in regards to PROP’s petition and how if implemented, it would affect their level of care and way of life. Patients can do this by going to the FDA’s website.

Dr. Fudin has also engaged PROP’s president, Dr. Andrew Kolodny directly in conversation, in an attempt to get PROP to withdraw the petition and work with PROMPT in finding a more balanced, scientific approach to opioid prescribing that won’t leave patients without cancer out in the cold. So far, no compromises have been made.

In the end, it is the patients that have the most to lose in this debate. It is the sincere hope of the chronic pain patient community that these medical professionals can come together with a willingness to cooperate, and work towards a solution that keeps their patients’ best interests and physical health in mind.

Mary Maston

Editor’s Note: Mary Maston suffers from a rare, congenital kidney disease called Medullary Sponge Kidney or MSK. She is an advocate for MSK patients and others in chronic pain, and writes from the perspective of a patient who has been “caught in the crossfire” of the War on Drugs.

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There are 18 comments for this article
  1. mark maginn at 11:29 am

    Nicely done, Mary.

    To say as some have that the PROP petition will not limit doctors in their prescribing of opioids is quite slippery. For prescribers to use these medicines off label is to place them squarely in the cross hairs of the DEA. Would that happen right away? Probably not, but with PROPs continuing assault on pain patients it wouldn’t be long before they started agitating to sanction off label prescribing. I remain convinced that this and other groups want to make these medicines impossible for pain patients to obtain.
    I imagine that this is just one step in a carefully calibrated plan to do just that.

  2. kathy at 6:05 am

    This is unbelievable that any group would form to stop opiods from being prescribed for chronic pain patients. This is an outrage. We suffer enough and now have to deal with this. It is a disgrace. Our healthcare system is in shambles and this is what they are concentrating on. Wake up people!!!….Stop them…..I am trying to figure out where all the money is to be made. Oh, don’t tell me the makers of cymbalta may have a stake in this as well??? All involved in this need investigated.

  3. Dan Troutman at 3:11 pm

    Anyone or any Dr that wants or thinks Opiods should not be subscribed or have the dosage dropped should see a Psychiatrist & then turn in their Md lic.! If anyone wants to advocate for pain meds to be restricted from patients with chronic pain or set lower restrictions I can only hope you end up with severe chronic pain so you can see what it’s like! I have been dealing with severe chronic pain for over 20 years & have been prescribed Opiods of some type for the past 10 years with great success! I had tried everything else prior to starting Opioid therapy including an internal stim! You had better think twice before trying to make changes because for many of us it has been the ONLY way to lead a somewhat normal life!! It disgusts me when I hear some Doc’s that think chronic pain patients are just users! Any of you folks that would like to debate me please feel free to email me ! Us folks with severe chronic pain deserve some sort of normalcy as well even though some of you think it would be better for us to suffer & recommend more injections that last a little over a week!!

  4. Lynda Clearman at 2:00 pm

    I could never live with the pain I have without these patches! I have degenerative disc disease, had 2 back surgeries and just last week found out I have 5 more discs bulging. What do they want us to do.?
    If they suffered my pain just 24 hrs they would change their mind instantly! This is more than rediculious!
    NO ONE SHOUKD SUFFER LIKE I HAVE, EVER!

  5. Joni at 11:22 am

    If PROP doesn’t want the suicides of hundreds, maybe thousands of chronic, severe pain patients on their heads, they should withdraw this petition NOW. Who are they to say that just because we don’t have cancer, we don’t HURT every bit as much as some people who DO? This petition is wrong, wrong, wrong and potentially dangerous. Shame on everyone involved with this!

  6. Nancy at 8:54 pm

    Poor Dave….you seem to be confused about who and what Dr. Fudin stands for. Just because he doesn’t agree with PROP’s FDA petition (which has NOTHING to do with scientific evidence, is completely out of touch with reality), doesn’t mean he is “pro-opioid” and doesn’t advocate for safe, responsible, monitored, opioid prescribing. Unlike Dr. Kolodny, Dr. fudin is an expert in opioids from a Pharmacological, educational, and clinical standpoint. Dr.Fudin has been involved with the Pain Management field for many years. He doesn’t just advocate for risk reduction and education associated with opioid prescribing, he also advocates for ensuring ACCESS to opioid medications for patients in pain. That is because he has been on the front lines, and he understands that chronic pain is complex and diverse, and to lump all “chronic non-cancer pain” conditions into ONE category is not just ignorant and “MISGUIDED”, but it is irresponsible, and even dangerous. While I respect Dr. Kolodny’s dedication to treating patients with opioid addiction, he is NOT an expert in pain care. Believe it or not, there are some patients who BENEFIT from the proper use of opioids for chronic non-cancer pain, and they don’t become drug addicts. PROP has removed patients from the discussion, and Dr. Fudin has enough respect and compassion for them, to at least include them in this discussion. You know….almost as if chronic non-cancer pain patients are HUMAN BEINGS who deserve to be heard. Imagine that! We THANK YOU, Dr.Fudin.

  7. dave at 2:50 pm

    Mr Fudin is misguided in believing that education and montoring-the leave us alone well deal with it approach- can work. First physicians dont have and dont wish to have needed education in pain care. For Mr Fudin or his colleagues to talk about the importance off education in pain care has not been effectve. Only laws requiring doctors to have adequate education not just in opioids but in diagnosing and managing pain care is needed- and Mr Fudin knows doctors arent volunteering to have education in pain care. Second voluntary monitoring has not been adequate with regard to opioid use-and i say foxes shouldnt be guarding hen houses. It has been easy and quick and profitable to prescribe an opioid rather then take the time to properly diagnose and treat peoples pain. Mr Fudin you may fool people who dont know much about pain care but your plan doesnt convince someone serious about improving pain care. Youve only convinced me that you wish pain care to largely remain unchanged.

  8. Millie Andreasen at 1:30 pm

    As a person in intractable pain this PROP petition scares me. I can’t believe that there are people and professional’s out there that are proposing such restrictions in medications that keep me and thousands of others alive and in my case, walking. Before I started taking narcotic medications, my Doctor and I tried EVERY complimentary therapy known to men; Biofeedback, Reiki, PT, Aqua Therapy, Accupunture, TENS unite, spinal cord stimulator, trigger point massage, trigger point injections, SI joint injections, spinal blocks (several) and nothing worked like my medication does.

    I’ve been through 5 lumbar spinal surgeries and one cervical fusion due to an accident, my pain is intractable and after years of working as a social worker for HIV/AIDS patient’s, I am now left in pain 24/7-365 and walking with a cane. What scares me of PROP is that they have absolutely no evidence that their proposition is going to stop the addicts of getting hold of narcotics. Their proposition is basically going to tie the hands of the Doctor’s that treat us, and make our lives miserable. I will like for Dr. Fudin or any other member of PROP to speak to my family members, they will tell them the story of what I use to be vs. of what I am now, and it is all thanks to my medications. Stop playing with people’s lives, stop trying to play with what works for us. I know that this is a cliche, but walk a mile in my shoes, and tell me if my treatment is dangerous, tell me that is not warranted. Stop playing with my life and the life of thousands of others that depend on this medications to survive. We are not the ones abusing these medications, the ones abusing these medications will keep on doing it no matter what!! They are addicts and addicts will steal, beg and borrow to get their fix, we are NOT the problem, so leave us and our Doctor’s alone!!

  9. Laurel McDonough at 9:12 am

    As a Hospice RN and a pain patient I am aware that research shows it is the rare patient who becomes addicted to opioid medications from legitimate doctor-prescribed use. Research also shows that some 50% of pain patients are under-treated. Addiction occurs when medication is take for recreation or to self-treat emotional distress. Yes, patients who take opioid medications often will require higher dosing as time goes on due to physical dependence, which is NOT the same as addiction. I do not get “high” when I take my pain medication — I feel a reduction in the amount of pain in my body. Perhaps some day when a pain medication comes on the market that relieves pain but does not give the “high” that addicts seek patients will no longer be stigmatized for wanting to lead a life more “normal.” Until that time, do not penalize those of us who suffer with long-term non-cancer pain.

  10. Sue Me at 8:48 am

    Ok, this is my second attempt at posting a comment. My first comment was denied because it was “too insulting.” Even though I used absolutely no curse words or foul language. It is hard to not be insulting when misguided idealists are trying to ruin your life. Especially when those people display a ” I know whats best for you,” attitude. I am an adult and I don’t need other people lecturing me on what is best for me. Especially when those people are healthy and are not held captive by severe chronic pain. And more importantly, when those people have no medical training and no training in pain management.

    Now let us get down to business. I’m going to calmly explain why PROP’s main talking points are very wrong and insincere. The first talking point PROP supporters like to state is ” Opioids have not been shown to be safe for long term use. ” The problem with this is neither has any other medicine that has been released. This is normal. The FDA release a lot of classes of medicines without doing long trials. They release drugs like NSAIDs,antidepressants, and anxiolytics without long term trials. Those medicines can be abused and just as fatal as opioids. But nobody is up in arms about those medicines.

    The second part of PROP’s first claim is ” pharmaceutical companies need to prove that opiates are safe for long term use.” Pharmaceutical companies do not claim that opioids are safe for long term use. Trust me, I have to take them and no where on the packaging or labeling do they claim this. The pharmaceutical companies do not have to prove something that they do not claim to begin with. The part of the claim above that is most insincere is the “prove it,” part. Like I said previously, there is no claim being made, therefore no proof has to be given. Not to mention, how long do these medicines need to be tested for? I’m assuming 10 to 20 years is what a PROP supporter would say. So, I will just assume 15 years for the sake of argument. Where are you going to find people willing to commit 15 years of their life to a clinical trial? How are you going to insure the integrity of a clinical trial that long? How are you going to control all of the variables associated with time or trial duration? How are you going to control the group that receives the placebo? I’m willing to bet that they will quit because they can’t take 15 years of untreated chronic pain. There are so many problems with a long term trial, that it can not be done. The supporters of PROP have to know this. If those trials were feasible, then the pharmaceutical companies would have done them. It it ridiculous to hold opiates to some crazy unattainable standard. You can’t just single out opiates. There are a lot of medicines that should be re-evaluated if opiates are. The FDA has high standards and if the pharmaceutical companies met them, which they did, then they should be left alone.

    The second talking point that PROP supporters like to state is ” You don’t understand our petition. You can still take and buy your medicine as usual. We only want to change the labeling, not the prescribing of pain medicines.” This is very insincere. The second part of PROP’s petition clearly states that patients can only take the equivalent of 100mg of morphine a day and only for 90 days. How is limiting doctors to an arbitrary dose limit of 100mg not restrictive? How is limiting doctors to prescribing opiates for a patient for only 90 days not restrictive? Forcing doctors to prescribe medicines “off label,” will harm chronic pain patients. Many insurance companies and insurance programs like Medicaid and Medicare will not pay for “off label,” use. The members of PROP have to know this as well. It is incredibly deceptive and insincere to tell us that “nothing will change, it will still be the same.” If that were the case, then PROP would obviously have more chronic pain patient supporters.

  11. Donna ratliff at 1:10 am

    One size does not fit all, like PROP thinks. Ask the majority of chronic pain patients that have been on opioid therapy for many years if the medications work to keep the pain at bay? There is your proof and long term study. Until you find cures for incurable diseases 100%, then medications are suitable for pain. I have seen and heard of way too many botched surgeries and procedures that do nothing but drive up insurance costs. Plus we have many new painful diseases that were never around before, Lyme disease and Fibromyalgia for example. Lyrica, Cymbalta does not help or cure Fibro, I know I have tried them. Why does doctors think that anti-depressants are a cure all? These cause physical dependancy as well. They also have a high death rate associated with them as well, but those are okay? No.. They are not. They are dangerous drugs as well. They mess with your brain. Now your list is getting longer for diseases with no cure cure. I bet cutting dosages of pain medications will only drive people to combine other things trying to self medicate. Everyone is not going to live forever. People die everyday. Humans have a right to treat their pain the best way they see fit. I believe this is between the doctor and the patient, no else.

  12. Unhinged at 12:38 pm

    PROP’s petition is NOT rooted in scientific evidence. The claim that opioids aren’t safe and effective for chronic non-cancer pain, is a joke. Opioids have been around longer than almost any other group of medicines. When taken as directed, and without other contraindicated substances, they are almost always safe, and ARE effective. As others have stated, no one WANTS to rely on pain medications to survive. For some of us, who have tried and failed at EVERYTHING ELSE to minimize pain, these medications are LIFE SAVING. People are FOOLISH if they think that label changes won’t effect prescribing practices across the board. These changes will also be just the excuse insurance companies need to deny payment. If not for daily opioids, I would be dead. It is nearly impossible to find physicians willing to take patients who require opioids, even ones who have been on them for YEARS, with the only side effect being decreased pain. How dare people think they know what’s best for people who live with debilitating pain conditions. It is a life that, through no fault of our own, we have been forced to live. The decision to begin opioid therapy is not made without being informed, and without having first tried many other therapies. I don’t know where people get off thinking that “they know” what’s best for us. When the alternative to opioid therapy is a death sentence, or a life of torture, the decision is clear. PROP’s agenda is bizarre to say the least….100 mg. Or equivalent (a “made up” dose threshold ?), 90 day amximum (some arbitrary number of days, because what, something magically happens to us on day 91?). Another responder here got it right…. PROP seems to have some ties to the pharmaceutical companies themselves…. SUBOXONE! Thank GOD for Doctors (& other healthcare professionals) like Dr. Fudin, who have some common sense, respect for science, respect and compassion for people who suffer from serious pain, and actually believe that chronic pain patients are HUMAN BEINGS who shouldn’t be sentenced to live a life of torture. We are getting damn tired of being treated like criminals & junkies because we suffer from intractable pain. Walk a mile in our shoes & you would be on your knees everyday, thanking GOD for your health….

  13. E11 at 10:09 am

    Where is the PROFOUND SUPPORT for no long term pain mgmt for intractable pain? In labs and academic settings? Don’t you think, I imagine the the majority, have tried every therapy (most have to anyway prior to getting on a long term pain mgmt therapy) PRIOR to using medications daily? You really think this was or is a first choice for most people? That is so typical for doctors that actually don’t have to look at a patient, in the eye, every month, and discuss what their quality of life has been.

    Oh yeah, well I spent four days a week getting massages, acupuncture etc (oh and usually, insurance has a small limit of those that they will cover), and I tried those, and MANY MANY MORE, and unless I wanted to spend my quality of time in a office every other day for these procedures (and I did give it a fair shake), WHAT KIND OF LIFE IS THAT?

    A true chronic pain patient does NOT want to be on medication; it is a last resort. I went off all my medications twice to see if I could cope with the pain differently, with different therapies, and by the second month, I was seriously suicidal. And all this crazy hype at making pain patients feel less then human, like a criminal and junkie, we begin to actually feel like society would be better off without us–MAYBE, that is what you all are REALLY TRYING TO ACCOMPLISH? Just let us die off because we are not the contributing members of society we once were. Remember–NONE of us asked for a life like this–it happened in an instant, or genetic lottery–I NEVER THOUGHT my life would be reduced to what it is now. I worked very hard and was very successful prior to my ATTACK BY A STRANGER, shattering my face with many surgeries and complications, here I am. Still disfigured. Still in pain. But gosh, a massage or a shot (tried those too–come at me again with a needle I will put in you)…get off your HIGH HORSES and start treating us like living humans! You wouldn’t allow an animal to suffer, or give them ridiculous procedures that work for about 1-3 hours at a time. Shame on you all thinking you KNOW what we are actually going through. You know nothing about what severe chronic pain can do to a person, over time. If it weren’t for these medications, I would be dead, but I guess that is what you PROP people want, huh?

  14. PROMPT NOT PROP at 9:02 am

    In response to Pete J and Ada, there are issues with making COT for chronic pain patients off-label prescribing. First, insurance companies may decline to pay and second, there are standards of care and anything off-label is bound to fall outside of these standards. PROP can not outright ban these medications for chronic non-cancer pain, so this is their backdoor method of making it even more onerous to prescribe the only medications that work for people in serious pain, and it is plenty onerous already. PROP is fundamentally dishonest about their intentions. I have had several unfortunate contacts with PROP representatives and they are inevitably ugly with PROP members and supporters screaming about how chronic pain patients are nothing but “drug addicts.” These PROP people, of course, have never performed any medical exams or evaluations of the people they are labeling. PROMPT, not PROP, has the reasoned position. (Now go ahead and have your supporters call me names!)

  15. Pete Jackson at 6:01 am

    I wish this was a simple case of doctors being misinformed, however I fear that Dr. Fudin and his accomplices are well aware that science is profoundly lacking to support the use of opioid analgesics for treating chronic noncancer pain. The burden of proof for a drug is that it be shown to be safe and effective before it can be labeled for an indication, and unfortunately this was never done. I challenge Dr. Fudin to provide the medical evidence showing opioids to be safe and effective for long-term use for chronic noncancer pain.

    The second point I wish to raise is that you and other pain patients have a profound misunderstanding of the PROP proposal – it would NOT restrict the ability of a doctor to prescribe opioids for a patient. Nothing is being restricted insofar as doctors PRESCRIBING opioids for their patients. The PROP proposal actually pertains only to the MARKETING of opioid medicatuions. But with the re-labeling proposed by PROP, hopefully doctors and patients alike will begin to understand the serious health implications of taking these medications long-term. It is unfortunate that our government has not done a good job of educating prescribers and patients as to these documented dangers…

  16. Ada at 5:37 am

    PROP’s petition will not prevent a doctor from continuing to prescribe to patients who are already on opioids. Doctors will have the freedom to prescribe “off-label” when it is in the patient’s best interest. The petition is seeking judicious evidence based prescribing and presently there is a lack of evidence demonstrating that COT is safe & effective in the long term. How can anyone argue with the desire to more safely care for all people. The petition does not suggest that patients be cut off in fact many will need to continue to be on opioids for the rest of their lives but we can & should prevent further harm through education and prevention.

  17. Belynda at 12:15 pm

    Thank you, Mary, for advocating for MSK patients and other patients with chronic pain. I do not want government limiting my treatment options, especially without any research to validate their supposed treatment regimes.

  18. PROMPT NOT PROP at 10:58 am

    I support PROMPT and their desire for science-based medical practices. PROP is nothing but an industry group for suboxone.