Hooray for the FDA: Opioid Relabeling Decision is Spot On!

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Highlights include…

  • Denied change to maximum 100mg daily morphine equivalent (MEQ) dose
  • Denied 90 day limit for noncancer pain
  • Denied differentiation between cancer and noncancer pain
  • Ingenious wording on the issue of “moderate to severe” v. “severe” pain.  As one colleague aptly put it, “To say pain that is ‘severe enough to warrant around-the-clock opioids’ in fact is even more of a bow to the patient’s experience and the judgment of the prescriber than to say moderate to severe pain and tie it to a number.”   This is aptly attached to extended release and long-acting opioids only.
  • Immediate Release (IR) opioid labeling remains untouched pending further new evidence.
  • Issued FDA ER/LA-Opioid Prescribing Changes (as posted on Pain-topics.org)

This is a victory for pain patients nationwide.

After more than a year of deliberation, the FDA has made their decision on a Citizen’s petition submitted by Physicians for Responsible Opioid Prescribing (PROP).  It turns out that after careful consideration; perhaps the request was in fact “irresponsible”, at least in some ways.  While the FDA and all of their staffers deserve kudos for all the deliberation, dedication, aggravation, and hard work, they finally came to a scholarly decision based on evidence or lack thereof that cost taxpayers probably tens of thousands of dollars in time, effort, brainpower, venue costs, and more.

In a response letter from the FDA to Dr. Andrew Kolodny (President, Physicians for Responsible Opioid Prescribing), the FDA clearly outlined the flaws of their petition.  This was not a flippant decision.  The FDA painstakingly reviewed hundreds of documents as outlined in their letter, including over 2500 written comments from the Hearing and petition documents combined. 

According to the FDA response…

“FDA also received over 600 comments to the Part 15 Hearing docket. The majority were from patients voicing concerns that labeling changes could make legitimate patient access to opioid analgesics more difficult.  The remainder reflected the same diversity of viewpoints and concerns presented during the hearing itself.  FDA also received more than 1900 comments on the PROP Petition. Many public health agencies and organizations supported the requests in the Petition, citing concerns about increased opioid use and abuse.  However, the majority of comments opposed PROP’s requests. Many professional societies (e.g., the American Academy of Pain Medicine, the American Medical Association, the American Society of Anesthesiologists, the American Pain Society) did not support the Petition and stated that the data cited by PROP did not support PROP’s requests (particularly those requests for limits on dose and duration of use of opioids). Professional societies also expressed concern that the labeling changes requested by PROP were not supported by scientific evidence, and that a ‘one-size-fits-all’ approach to a maximum dose or duration of treatment would be problematic and inconsistent with the need for individualized treatment and the variability among patient responses to opioids.”

As our followers know, shortly after the PROP petition was filed, a group known as Professionals for Rational Opioid Monitoring and Pharmacotherapy (PROMPT) surfaced that was manifested from dedicated pain peers nationwide.  Interestingly, the FDA response aligns squarely with PROMPT’s Mission Statement.  In fact, the FDA letter states, “Pursuant to section 505( o )(3) of the FD&C Act, FDA is therefore requiring all new drug application (NDA) sponsors of ER/LA opioids to conduct post approval studies and clinical trials (post-marketing requirements, or PMRs) to assess certain known serious risks of ER/LA opioid use: misuse, abuse, hyperalgesia, addiction, overdose, and death.” 

PROMPT embraces this sort of careful study and post-marketing surveillance and the pharmaceutical industry will likely pay for it.  Interestingly, nobody is criticizing big pharma for supporting such studies or developing innovative pharmaceutical dosage forms, abuse-deterrent technology in the form of prodrugs, nanotechnology, and more.

As an attendee at the April FDA Hearings and being caught directly in the crossfire, it is of particular interest to me that the pharmaceutical industry took a hard hit, at least verbally and on social media from PROP supporters.  Day after day and week after week social media including some mainstream newspapers slammed honest patient-centered clinicians and the pharmaceutical industry for promoting use of opioids in patients for which they weren’t indicated for mere financial reward.  But, just last week a major convention took place, PainWeek 2013, with over 2000 attendees that included prescribers and non-prescribers alike.  Attendees included all sorts of scientists and professionals other than “responsible physicians”, including among them, pharmacists, physical therapists, nurse practitioners, physician assistants, pharmacologists, biologists, chemists, and many more.  The pharmaceutical industry clearly has taken bold steps financially and scientifically to develop unusual dosage forms to deter abuse, side effects, and the like in order to make the world better for patients and to mitigate risks to patients and enhance public safety.  True enough industry is in it to make money, but let’s not be naïve; you need to make money to support research, education, and advanced technology.  Who do these PROPagandists think will pay for such advances? 

I feel sorry for the many patients nationwide that anguished day after day and sent thousands of anxiety stricken e-mails to politicians, the FDA, and to me.  But they all owe this country and the FDA a debt of gratitude for spending the time, energy, and money to review each and every document submitted and all the relevant literature to arrive at their resolution. 

So in closing this chapter of the Great Opioid Divide between PROP and PROMPT, and in keeping with the good sense of humour to our north most brethren, perhaps our Canadian clinicians and families that aligned at the FDA Hearing and submitted docket comments now understand FDA to mean, “Final Decision, Aye?”  

Related articles:

PROP Versus PROMPT: FDA Speaks. Practical Pain Management. 2013 October; 13 (9): 13-14.

The Last Word on FDA Opioid Labeling? PROP, PROMPT still disagree; REMS revisions next. Pharmacy Practice News. October 2013, Volume 40.

 

40 thoughts on “Hooray for the FDA: Opioid Relabeling Decision is Spot On!

    1. Denis,

      Obviously the NY Times chose not to tell the whole story. And in fact, regarding the correction statement at the end, I suppose we could add…

      More deaths are caused each year by tobacco use than by all deaths from human immunodeficiency virus (HIV), illegal drug use, alcohol use, motor vehicle injuries, suicides, and murders combined. (Centers for Disease Control and Prevention. Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses—United States, 2000–2004. Morbidity and Mortality Weekly Report 2008;57(45):1226–8. AND McGinnis J, Foege WH. Actual Causes of Death in the United States. Journal of American Medical Association 1993;270:2207–12.

      1. Thank you so much for the quick reply.

        I was just not aware that the NY Times, as the newspaper of record for people who want the whole truth, had the option to tell only half of an important story and to hugely distort the half it does report. This NY Times version of the truth was carried almost verbatim in “lesser” newspapers across the US.

        And in case anybody did not get the ideological messages built into the “news” story, the Times followed up 2 days later with this editorial:

        http://nytimes.com/2013/09/14/opinion/a-step-to-curb-painkiller-abuses.html

        Neither the report nor the editorial carried a comment space, so I emailed a few basic questions to the reporter, who has not replied. I’ve Googled all over the place looking for reactions to the Times treatment of this story, but found nothing.

        I realize I’m late to the party here, but I’m just a retired guy who loses track of things that don’t involve eating, sleeping or dancing. — Denis Murphy

  1. I was very happy to see the FDA make a very, responsible decision on this topic. They are here to protect the public, and I am very Thankful that they they still do their job! Thanks to all of you who fought against PROP, I agree fully with Dr. Fudin on PROP’s proposal, it was way out there!. One day, Karma, will get them..lol
    They will feel pretty guilty if one of them or a family member suddenly needs these Opioids daily, god forbid..
    Thank So Much,
    Becky

  2. Dr. Fudin and all of your colleagues who have worked tirelessly , I would like to express my heart felt THANKS to each and every one of you. With each of of your efforts, patience and level headed approach regarding the PROP’s agenda. This is a very big Victory for many Chronic Pain patients !! I have lived in both Florida and in Kentucky and I can not tell you how many people are suffering. In Florida as you know there is the “Pharmacy Crawl” in Kentucky doctors are out and out refusing to even see patients who take or NEED pain medication. We have people who have had to move to Hospice just to receive them and then if they do NOT decline quickly enough hospice is taken away. Kentucky is in a state of desperation right now.. The Heroin use here has tripled since House Bill 1 aka ‘Pill Mill Bill” was introduced !! I can only hope and pray this will make it easier for people in the state of Kentucky to receive the pain medication they so desperately need. We have patients here from woman with eroding vaginal mesh who have had to endure countless surgeries and only given 7 days worth of pain medication but still have mesh in them cutting them to be told TAKE ADVIL. We have HIV/Aids patients being denied all medication until they went into hospice, 60 + year old men with prostate cancer denied pain medication, yes Cancer patients are being denied !!! The list is endless Dr. Fudin, I was so hoping the story you did with Dr. Tallio and the Media attention I was able to receive (story was done by 3 member’s in my group) for the state of KY by WKYT wold have help shed light on this to law makers but it had no effect other than create criminals as those in Chronic pain are turning else where and to street drugs for relief again Kentucky is in a state of DESPERATION !! I only hope that relief is in sight for all those suffering and that this VICTORY will open the door for this to happen. Thank you again Dr. Jeff, the Pain Patients of Kentucky and Florida as well as around the US also Thank you !!

  3. Dr. Fudin, Thanks so much for your efforts! Now, just get prescribing physicians write scripts for us for opioid medications!
    I’ve been in moderate- severe pain from FM for 13 years. Prior to the FDA’s recommendations, I was able to get oxycodone from my PCP. Since, however, I get Tylenol#3, which is useless to my pain.
    I’ve never had a dependence problem in my life, and I only take them as needed. Now I’m crying in pain every day, can’t walk, and spend most of my time lying down.
    I don’t know what to do!

  4. Dr. Fudin,

    I am very appreciative of your efforts to speak up for chronic pain patients. I have had a hard time keeping the faith that this would work out in favor of those of us already dealing with so much, and I think you said I was bitter. I have every reason to be, but this time, we came out on the winning side and it’s in no small way due to your efforts.

    Thank you, Doctor, and have a great day. You are our hero!

  5. Common sense like this is all that is needed. Just old fashioned horse sense. How refreshing! Why have mental anguish AND severe pain? It’s so unnecessary! It’s time for those who want to fight to grow up and open their eyes to the facts! People in severe chronic pain are suffering enough already. Thank you.

  6. Dr. Jeff, I cannot thank you enough for your tireless efforts and hard work to be a voice for those of us that don’t seem to have one. The fear and anxiety that pain patients and doctors have been under has been enormous and I cannot express how grateful I am for people like you that have been fighting the good fight. Your immediate response to create PROMPT is appreciated that words cannot express. The tireless hours you and your PROMPT group has spent to fight this battle is so appreciated. The fact that the FDA and groups like yours have restored some of my faith in human caring as what PROP was suggesting was preposterous and inhumane. It chills me to the bone that groups like PROP exist at all. I know this battle is not over as I have seen such a high percentage in our advocacy group, FFCAN, of patients that are still having to battle with the pharmacy crawl. It is my hope that with the FDA taking non cancer chronic pain seriously and not being willing to lump us in a “one fits all approach” and their being unwilling to see a clinical difference in pain from cancer pain to non cancer chronic pain will help us in the next step, which is to make sure chronic pain sufferers have access to these life saving medicines again. Hopefully with some more work to create more solutions in the future in regards to safety we can create a win win solution. Having come to realize there are millions of chronic pain patients in the US, I thank you AGAIN for standing up for those of us that only desire to have a better quality of life. You are my hero!

  7. Thank you FDA, you have renewed my faith in government to make a rational decision, based on facts. Dr. Fudin, you have reinforced my faith in our medical system. Enduring unending pain is difficult. Having to convey the point, that there are unfortunate non cancer patients who cannot think or function through the pain without the help of opioid medication is impossible, for the patient alone. You saw that and gave a forum and a voice to those that suffer everyday with intractable pain. Dr. Fudin you are my hero. Thank you for PROMPT

  8. Thank you to everyone involved for taking the time to properly research and review this petition and realize that its approval would negatively affect many people. We are upstanding citizens and contribute to society. That contribution would have been taken from many of us, who would have ended up a prisoner to our homes or even our beds. I can still get up and go to school (Saint Leo University) and spend time with my family, especially my very active grandchildren. This was a hard fight and winning is great, but it is still sad that something as normal as getting our prescriptions filled has to be such a big deal, when it should be a normal part of life. Thanks again to all who helped.

  9. A small victory in an ongoing and arduous battle as the pendulum of change swings another direction. I recognize and appreciate the voices of reason and the hands of “responsible change”.

    The power of those who, if they had their way, would kill the opportunity for pain medication for non-terminal / non-cancerous patients is enormous. It is critical to be responsible on all ends…the FDA, the Pharmaceutical Companies, the State Boards, The Doctor and The patient. The pendulum of change, however; should not be used as a wrecking ball of destruction.

    There are so many professional studies available on prescription drug abuse and death yet, very few qualified studies on the positive aspects of long term pain medication use for patients. There are also studies that show women, children and the elderly are often under medicated, under validated and left to live in painful conditions–Cruelty beyond words.

    The victory here though does nothing for those of us suffering in chronic pain. It is becoming exceedingly difficult to find a prescribing clinician because of the “addict” culture or fear of potential lawsuit and accountability to the boards/FDA. We are required to complete dockets of paperwork with questions like, “have you ever been raped?”; “were you a victim of sexual abuse?”; “Do you like yourself?”. The invasive and abrasive manner in which we are treated for seeking help is without foundation. This culture has to change!

    Long gone are the days when your medical doctor was kind, knew your children’s names, asked about your garden. Long gone are the days when it was rare to be subjected to and fearful of the implied power a medical professional has. While there are still some good ones out there, it is the more common experience to be shuffled in, the doctor has to look at the chart to address you by name. The small talk and general niceties are replaced with commands and demands. I cannot tell you the last time I heard of an appointment where the doctor actually explained what he/she was going to do or why they were doing it. At the end of your ten minute time allotment, you are shuffled out.

    If you are a chronic pain patient…the above seems like a trip to Disneyland! The witch hunt for addicts, pill poppers and doctor shoppers has relegated that “all are guilty”. The Pharmacist, the Nurse, The Doctor, The Emergency Room…their culture is to assume the worst. The chronic pain patient is already debilitated physically. The bio-psycho-social-spiritual wealth of a chronic pain patient is often at bankruptcy levels. Many times, I have heard one of them say, “I’m so scared, I have an appointment with a new doctor tomorrow…” or, “I’m super sick, I have to go the emergency room and I’m terrified–I wonder if I can just make it?” What a sad, sad thing it is that we, as a population, are terrified to go to the doctors office or emergency room.

    So, I am grateful that there were some victories made on our behalf with PROMPT and the FDA. I am grateful that a population of medical professionals have come together as advocates for responsibility AND for the chronic pain patient. I thank you, Dr. Fudin, for your work and efforts.

    I will be grateful and thankful though, with shallow breaths, as the pendulum continues to swing.

  10. 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.

  11. First, thank you to the FDA for making the relabeling changes to opioids based on the available evidence and not just on a knee jerk response. I believe all the controversy regarding the labeling changes has allowed a more open discussion regarding what studies and information is available vs lacking for opioid prescribing and abuse and has brought to light what needs to be further researched or done in the future. Hopefully the needed research and open discussion will continue in the future amongst states, healthcare providers, and the science community so opioid prescriber education can continue to grow and better methods to combat opioid abuse will become available.

    Also a huge thank you to Dr. Jeff Fudin for developing PROMPT, offering a platform for pain patients to voice their concerns, and being a leader in pain management education. Your expertise and willingness to fight for what is right has been remarkable over this past year.

    Lastly, thank you to everyone that has spoken up and given a voice to concerns over PROP’s suggested labeling changes to opioids. I believe the outcome of the FDA’s decision shows that enough noise can get them to listen and look at both sides of an issue. In a world where we often feel we don’t have control over many huge decisions, it is inspiring to see what happened here.

  12. Hooray! Thank you, PROMPT members, professionals, and the FDA for coming to this decision. I have voiced my thanks for your diligent efforts to keep us informed and “fight the good fight.” Thank you FDA for listening to the many voices of non-cancer pain patients everywhere. I can only hope that the DEA and other agencies will stop penalizing chain pharmacies who have lost my business after 20 years because of shortages in Florida where I live. To wake up in the middle of the night with pain, only to see this email, was such a wonderful surprise, it will help me sleep a little easier. I do hope that PROMPT and Dr. Fudin will continue to remain a powerful voice against future irresponsible groups like PROP. I also hope the FDA will receive our thanks for a responsible decision–handing the reins back to responsible and caring physicians who treat pain. I’ve heard many doctors say they “don’t do pain and wouldn’t want to be in a pain doctor’s shoes” in this climate. Perhaps the stigma of being a pain management physician and patient will go the way of the dinosaur. Dr. Fudin, I so appreciate your tireless efforts on behalf of responsible prescribing; you were our voice and the FDA heard you loud and clear.

  13. Thank you Dr. Fudin, and PROMPT for everything. My biggest fear though still remains, for PROP had done much damage to the chronic pain community. The doctors, pharmacists, and drug distributors are still being harassed by the DEA, with no end in site. Now with new regulations, we must rely on a doctor to decide if we are in severe v. moderate pain. Can you see how that can hurt us? I still am woefully under medicated, living in very severe pain every day of my life, and yet finally the answer has been written, has anything really changed since PROP opened this unnecessary Pandora’s Box? Also, what is Dr. Kolodny planning next, for he seems to be quit vindictive, and loves his 15 minutes of fame. I only wish for him a body such as mine, that has been ruined by medical science, and for which I am paying for, because I trusted doctors, such as “Dr” Kolodny. Let us hope that the DEA will lay off of pain patients now.

  14. Fellow Blogger Participants; It is indeed heartwarming to see all of the positive comments (finally) on this victorious outcome for patients! It is also especially nice to see that the FDA has received so many positive statements from the people they are charged to serve. This is a true case of how the government can protect its people. As a reminder, below is the 2013 updated FDA Mission Statement. Hats off to FDA staff and administrators for serving the public well!

    Statement of FDA Mission

    FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

    FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

    FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

  15. Thank you, Dr. Fudin and all associated with PROMPT for all you have done for chronic pain patients everywhere. Thanks, also, to the FDA for their wise decision in denying Andrew Kolodny and PROP’s misguided attempts that would have made it so much more difficult for those with non-cancer related chronic pain to be able to function. Thank you, Donna Ratliff and those who worked so very hard in social media groups to fight for the rights of legitimate chronic pain patients. And thanks to all the pain patients who signed petitions, wrote letters or comments about the need for help and to raise awareness. Their sacrifice, and it is often a sacrifice to even type an email when one is feeling pain, truly helped make this possible. It is, indeed, a sweet victory. Now, let’s work so that all people can be free from pain, be able to receive adequate pain care when they need it and be able to have their pain prescriptions filled upon request with dignity and without delay.

  16. It’s not bad enough that every pain clinic you go to makes you feel like a junkie looking for a fix, but lately being treated like a second rate human forced to go to eight different pharmacies looking for my medication. Listen up world, I didn’t choose to wind up with a body racked with pain every day. I worked my rear end off in trenches all year long in Wisconsin doing work that nobody else would do. I’ve been through enough and now can’t do ANYTHING that I used to love to do. Making it possible for me to get the medication that I need to survive is a no brainier. Why penalize chronic pain patients? Because gangsters and junkies are dying? Good! Call it natural selection. My Doctor knows what and how much of it I need to be able to exist, about time the other people sticking their noses in back off.

  17. As a future pharmacist, I am very thrilled that the FDA made the responsible and correct decision based off of science and not biased opinions. It makes me very happy that all the efforts of the members of PROMPT, patients, and even pharmacy students finally paid off in the end. After participating and submitting a small project to the FDA through Dr. Fudin’s pain management course, which demonstrated the huge discrepancy in the idea of morphine equivalency, I hope the project was able to help the FDA in understanding how preposterous the suggestions of PROPS were. I am very proud of everybody in being part of something bigger than themselves and fighting for our patients. This just goes to show that science/truth will always prevail over the misleading and biased opinions. In closing, I’d like to say a big thank you to members of PROMPT, patients, pharmacy students, and the FDA!

  18. Hey Dr. Jeff, thanks so much for what you have done. I know this is a short and sweet letter, but dealing with something other than Arachnoiditis today. I have a parotid gland infection. So, off to an oral surgeon in the morning.
    I have seen been sent all of the letters, downloads, regarding the recent FDA decisions. I was wondering for months, “What if?” What if they listen to this Dr. Kolodney and his heartless attempts to drag down the pain patient any further? I am a W/C patient as you know, I think you know. Heck, this has been going on so long i forget. It was trickleing down to us. The Doc that I see was questioning what was going to be done in the future. Worker’s Comp was getting a little weird. The med questions he was asking were getting different. He even discussed with me the changes that could happen. Well, looks like it’s gonna get better, not worse. I think of the thousands, tens of thousands of people that would suffer……….Well, thanks to you, and others for this tireless work and big KUDOS to the FDA,,,,,,,,,,,,,,,God bless Dr. Jeff, and again, thanks so much,,,,,,,,herb “doc” Neeland

  19. This is a nice concise overview of yesterday’s FDA announcement. Thanks, Jeff! I think the takeaway phrase is “bow to the patient’s experience” — what a lovely concept.

  20. I want to thank the FDA for making the decisions they did. This took patients and a lot of work by the FDA, lots of reading comments on their website. Getting phone calls and reading emails from chronic pain sufferers scared to death their going to lose the main thing that helps them be somewhat pain free so we can exercise, go grocery shopping for our self and be able to get out of bed and look forward to a day with less chronic pain. I thank the FDA for taking their time and not rushing to judgment like PROP did. Even though this whole thing caused me great stress and anxiety as it did others like me along with our doctors in the end the FDA made the correct decision . I want to thank the FDA for their time and patients and having compassion for all chronic pain sufferers of the U.S. And also thanks to the FDA for working closely with our doctors that have the compassion to help us be as pain free as possible.

    Regards,
    Mark S Barletta

  21. Everyone should read the FDA’s comprehensive response to the PROP petition PDF here. In a very polite way, the agency told the petitioners that they could not get away with distortions and biased interpretations of evidence in order to foist their own agenda on the public. This is not a time to gloat, but the FDA essentially agreed with past critiques of the evidence by PROMPT and Pain-Topics.org. It is good that science and reason won out over demagoguery. Kudos to the smart folks at the FDA.

  22. Without Jeff Fudin’s diligence, this might have had a much different outcome. As I sat in Medical Grand Rounds this morning listenening to “Harm Reduction: A Novel Approach to Drug Use and Users” (naloxone prescribed for home use if on opioids, clean syringe programs, opioid maintenance etc), I realized how real the potential unintended consequence of limiting opioids would be: obtaining pain relief illegally and dangerously!

  23. Thanks to all the people for talking for all of us that have to deal with Pain. Some doctors have made me feel like a drug addict. I know I am not the only one out there in Pain just don’t know how to get the Dr. to give my medicine without having to go to a Pain Dr specialist. We need help.

  24. Dr. Fudin and all of your colleagues, THANK YOU, for all of your efforts, patience and level headed approach regarding PROP’s agenda. I am sure we all know this “war” has not been won, but for now, this particular battle has been decided.

    I did share on your last blog, the continued reality many patients are still dealing with. I can only hope that with this decision, it will give some doctors, perhaps even some pharmacists some breathing room when it comes to making medical decisions, when it comes to what is best and appropriate for their patients.

    Again thank you. Oh, if by chance (and I am sorry if I have missed it in a previous blog/comment), this PROP rally on Oct. 1st, in Washington D.C., “FED UP! RALLY FOR A FEDERAL RESPONSE TO THE OPIOID EPIDEMIC”, sponsored of course by PROP; their agenda according to a website: “Immediate action from our federal agencies is needed to prevent new cases of opioid addiction, to prevent more overdose deaths and to ensure access to effective treatment for millions who have become addicted”…..what other avenues or doors are they trying to push through at this point?

    Sincerely
    Elevan

    1. Elevan,
      Thank you for your comments. I can’t predict what PROP will do next, but they haven’t pulled the wool over anybody’s eyes that have taken a scientific look at their proposed FDA label changes. I would say that if you want to know what’s next on their agenda, go to their website, send an email, and ask. No better way then right from the horses mouth as they say.

  25. Jeff, and the other members of PROMPT, thank you! your role in this battle was swift and spot on. In the beginning, i had doubts that the FDA would accept this petition, then as time went on and the onslaught of appointed officials at the DEA and CDC urging the FDA to adopt the recommendations along with all the elected officials doing the same, had me very worried! My group ASAP (Arachnoiditis Society for Awareness and Prevention) has been locked in battle with the FDA for a few years now trying to get the damage of epidural Steroid injections stopped. For many years we were losing Faith in the FDA to do the right thing and reduce the epidemic of arachnoiditis happening across this country, and this decision has helped restore some faith that the FDA has the best interest for us in mind. After we filed the petition to stop Prop, Dr Throckmorton reach out to us concerning the PROP petition, and we took that as a great sign and show of faith. After we were able to show the FDA panel the email from Kolodny that expresses his own admitted problem concerning the distinction between cancer and noncancer pain, Dr Throckmorton seemed genuinely concerned for the motives that PROP had. The immediate response from All the Patient Advocate groups, PROMPT, the multitude of professional organizations and patients themselves show that it is still WE THE PEOPLE! Now we can move on in life and career and let this serve as an example that hopefully will help stop the Temperance movement from further tightening almost 100 years of prohibition in this country, and finally serve to establish that Pain is real and address the need for treatment and research to end this Madness we call Chronic pain!

  26. Many thanks to everyone for fighting this battle with us. I am part of a social media group in FL and I know we all appreciate all that you have done Dr. Jeff! I have been a chronic pain patient for 15yrs after an accident at work and in FL over the last 5yrs my month to month fight to get my meds has only gotten worse! Our state has put the DEA on attack towards the pharmacy & doctors so they are afraid to do their jobs and when I do find my meds they are 500 times the cost I used to pay which really hurts because I can not get approved for health insurace and I pay out of pocket for my care. It saddens me to think I may have to relocate to get the medical care I need from a doctor instead of being treated by the politicians in FL.

    Thanks again for all you do!!

    Rebecca

    1. Being in severe chronic pain for over 40 years, I’ve always needed to be on pain medicine to control my pain – and to work until I could no longer. I do not know how anyone can afford pain medicines that have been around forever yet the costs increased exhorbitantly. I understand the R&D of it all but the price never goes down. For those of us who need the medicines have been inhumanely ignored and often it’s a choice whether to eat or get pain medicines. Not only do we have to pay our doctors but then go to a pharmacy and pay there IF they even will fill your prescriptions. I now require a medicine that costs $750 – about half of what my disability check is – it is impossible. I am fortunate that my husband has a good insurance plan which he pays for because I pay annually anywhere from $20,000 on up and it is getting higher. Florida residents seems to be paying another price by being treated like drug criminals even though my drug history and need is well documented. And what they put my doctor through is unspeakable as he is trying to help his patients with BOTH arms tied behind his back. He is one of the remaining few that have been able to continue his ability to practice and help his patients who are suffering and have no choice but to take medications in order to live any kind of life; however, so many good doctors have had to “close shop” as the Federal government made it impossible for them to practice. I’ve recently joined a website of people like me and it is a common thread that we are all facing uncertain futures in knowing we can get the help we need; personally, I am very scared for my future as my pain will inevitably increase. I will sign any petition or sign up any cause to make my voice heard with so many others that suffer unnecessarily because we’ve become part of the targeted group of people who abuse the system. The system has been broken a long time. I always believed in the US but after seeing how other countries “take care of their own” made me take a second look at our Federal government who doesn’t.

  27. Thank you Dr. Fudin and your doctors for creating “PROMPT” to support all chronic pain patients in the U.S. I cant tell you all how this Petition by PROP had me filled with anxiety over the past year increasing my chronic pain. Now I can sit back and let that anxiety go and I hope all chronic pain sufferers along with their physicians that where afraid to let it go. Although much work is ahead of us we got past this part, we cant get past any and all obstacles standing in our way.
    A huge weight has been lifting off my shoulders and I thank God for that.
    We that suffer from chronic pain along with our compassionate doctors that care enough to treat us will prevail.

    Best Regards,
    Mark S Barletta

  28. Thank you so much for all of your time and hard work in getting the PROP petition STOPPED. All of us patients across the country are forever grateful for actions like yours! Thank you!

  29. “:Misuse, abuse, hyperalgesia, addiction, overdose, and death.” Yes, all are possible and real risks.
    But the potential benefits can be miraculous, including but not limited to: the amelioration of chronic, withering, even existential suffering.

    “A one-size-fits-all’ approach to a maximum dose or duration of treatment would be problematic and inconsistent with the need for individualized treatment and the variability among patient responses to opioids.”

    This is a statement surely reflective of scientific principles, practical experience, and REASON!

    And thankfully, ensconced within these laudable principles, are the kernels of compassion and kindness that are the likely basis for the “art” portion of the practice of medicine.

    As such, it must be asked again, what cognitive demons or distortions serve as the motivation for a subset of “healers” who promulgate a healing philosophy that is “inconsistent with the need for individualized treatment”?

    But the real kick in the testicles was the statement to Dr. Kolodny, ” (The) FDA knows of no physiological or pharmacological basis upon which to differentiate the treatment of chronic pain in a cancer setting or patient from the treatment of chronic pain in the absence of cancer, and comments to the Petition docket reflect similar concerns. (The) FDA therefore declines to make a distinction between cancer and non-cancer chronic pain in opioid labeling.”

    Oh thank God for the FDA on this one! So many non-cancer patients will therefore continue to have a chance at pain reduction and thus a modicum of worthwhile living.

    And finally, right this very minute, I can think of one physician who might be in need of some form of long term testicular pain management as he reassesses his medical expertise and overarching belief system that would lead the FDA to question his and his follower’s abilities to “make a distinction between cancer and non-cancer chronic pain” and promulgate a treatment approach that is “inconsistent with the need for individualized treatment.”

  30. Thanks to all who continue to fight for pain patients. For far to long we have been treated with disrespect and suspicion because of the actions of drug addicts and dealers who turn our needed medication into an illegal profiting street business.

    This is a step towards understanding that there is a difference between pain patients who take opiates to lower their physical pain and those who abuse opiates for psychological pain.

    Once again I see a glimmer of hope , until a cure is found for chronic pain, that the younger generation won’t live over half their lives in pain, like I did while learning how to “act” so you’re not labeled as a drug seeker. I hope that pain can be seen as a condition that can be treated with proper attention spent on treatment of the pain, not with suspicion but with the care and understanding that others with chronic conditions receive.

    We, as pain patients, know what we need. With drug testing, pill counts and contracts, we are well documented patients. We only ask for the medication that allows us to get up and make it a day, a medicine that unfortunately is abused by some and a life-saver for others.
    …Peace…

  31. Thank you thank you I have suffered for two years with2 pinched nerves.
    I have been so worried I have thought of suicide rather than live in the pain I have without prescription opioid medication.
    Thank you from bottom of my heart . Joyce Dowling

  32. Thank you! Thank you! Thank you! Living with chronic pain and geeing told that I cannot get relief because of some people in suits think there is a limit makes it so much worse! Next battle will be getting all my drs who have been brainwashed all their careers into thinking we can only have so much to go ahead with our treatments! I breathe a sigh of relief.. Will arm myself with this article when I go to my next dr visit..

    From the bottom of my achy heart, thank you!!

  33. I think everyone on the right side if this issue slept a little better last night after hearing the news. Thanks to everyone that worked so hard to give us this victory! I am forever grateful.

  34. I am so thrilled Dr. Jeff ! I have spread the word about your blog update here and I know that many will be so happy to hear the good news and will reply here. Once again, thank you and your doctors for creating “PROMPT” to support all chronic pain patients in the US. Everyone with chronic pain was very worried about the PROP petition. Many patients that live in (FL) where I do can at least breath a little easier now with all that behind us. We still have a huge fight on our hands down here and we’re going to continue it. The situation is dire and we need to get the DEA off pharmacists and doctors backs. Hopefully, with the FDA’s decision being finished now it will help us to get them to realize that many people do have pain that needs to be treated.
    Once again, thank you so very much!

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