Dr. Bob Twillman Critiques FDA Opioid Hearing

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Bob Twillman, PhD, FAPM is the Director of Policy and Advocacy for the American Academy of Pain Management.  A complete biosketh appears beneath this post.

Dr. Twillman writes…

The US Food and Drug Administration’s (FDA’s) February 7th and 8th hearing on opioid labeling produced a predictable outcome and at least one important admonishment to everyone involved in the ongoing discussions about what to do with opioid analgesics. In the end, I am more certain about what I think to be the proper regulatory response, and perhaps a bit more hopeful that the opposing sides of this debate can come together to produce useful guidance for clinicians trying to do the best for their patients with pain.

Aside from a handful of people who apparently thought the FDA had solved time travel, and could thus transport them back two weeks in time so they could comment on hydrocodone rescheduling, presenters focused on a number of relevant discussion areas. There were, of course, those presenting data about both the benefits and the risks of high-dose/long-term opioid treatment of pain, but there also were a few who talked about the philosophy involved with regulatory change, both in general and specifically with respect to those changes suggested in the PROP citizen petition.

If the data presentations had been a duel, it would have been one fought with Nerf swords, and clearly would have ended in a draw. While I was quoted as telling the committee that “the absence of evidence is not evidence of absence”, I think I might have been just as accurate if I had told them that “the presence of evidence is not necessarily evidence of presence”. Both those who focused on opioid therapy risks and those who focused on opioid therapy benefits were able to present data suggesting that there may be some truth to their respective assertions, but the nature of the existing studies is such that it really leaves you wanting more—more studies, more rigorous methods, more controls on subject selection, more simultaneous assessment of risks and benefits, etc. It reminds me of one of those chic restaurants where the portion sizes are so tiny that, after eating your entrée, you say, “Wow—that was really good. When’s dinner?”

One example of this was a slide summarizing several open-label extension studies of opioid treatment for “chronic non-cancer pain”. The presenter, who was clearly trying to make the point that long-term opioid treatment causes significant adverse effects, pointed out that, in all of the studies, roughly half the subjects terminated their participation prior to the end of the study. This strikes me as asking the age-old question about whether the glass is half-full or half-empty: clearly, a lot of people judged that the adverse effects were greater than the benefit they gained, but just as clearly, a substantial number also judged that the benefits outweighed the adverse effects. There are a lot of things we don’t know here that could influence the interpretation of these results. How heterogeneous were the subjects and the etiologies of their pain (which can vary substantially even among those with a single diagnosis, especially if it is as non-specific as “low back pain”)? What were the specific adverse effects, and if efforts had been made to address those, how many would have stayed in the studies? How many subjects dropped out of these studies but found better results when rotated to another opioid treatment? How many would have done just as well, had they been given non-pharmacological and/or non-opioid treatment?

For me, the bottom line in this whole debate is that I still firmly believe that opioid analgesics are frequently over-prescribed and mis-prescribed, and that we need to do something about this. One of the time travelers who presented on hydrocodone was a representative from the American Academy of Oral and Maxillofacial Surgeons, who seemed pleased with the restraint demonstrated by the fact that the most common number of hydrocodone/acetaminophen tablets prescribed by his residents following wisdom tooth extraction is 12. My own informal survey on the topic of analgesic requirements following such extractions shows that the average number of opioid dosage units used by most people is around 2. I think the problems with overprescribing are not confined to acute pain, but also are evident in chronic pain treatment, likely owing to a combination of poor pain management education for providers; patient demand for medications, especially opioids, in lieu of non-pharmacological and non-opioid interventions; a paucity of non-pharmacological therapy providers; lack of evidence for some non-pharmacological interventions; and poor reimbursement for interventions other than medications and procedures. Clearly, opioid labeling has little to do with this array of concerns.

Proponents of label changes seem to have a lot of faith in the ability of such a change to foster more judicious prescribing. Frankly, I think that label changes such as those requested in the citizen petition are likely to go virtually unnoticed by many and ignored by most of those who do notice. The only effective means of reducing opioid prescribing that I see arising from such a label change would result from insurance companies imposing strict upper limits or prior authorization requirements that match the proposed new labeling. While proponents of label change denied the likelihood of such a move, asserting during the hearing that such reimbursement restrictions are almost always done when the medication is very costly on a per-dose basis, I think the truth is that the restrictions are typically imposed when it is the therapy that is costly—i.e., if you have a very inexpensive medication, but you give a lot of doses over a long period of time, it still costs a lot to provide the therapy. And, without any significant prior experience with this type of label change to predict the outcome, my fear is that this would suppress prescribing across the board, rather than suppressing only the injudicious prescribing.

So, where does this leave us? I think it’s pretty clear that nothing said at this hearing is conclusive enough to warrant a change in the indications for opioid analgesics. However, I think there might be enough suggestive evidence that a black box warning might be warranted. I think a warning that looks something like this might convey what we know:

“The efficacy and safety of long-term and/or high-dose opioid analgesic therapy has not been proven by well-controlled studies. Epidemiological and observational studies suggest that such therapy may be associated with effective pain relief for some patients, but that it also may be associated with the development of serious adverse effects, including addiction and overdose death. Caution is advised in opioid analgesic prescribing, and providers are strongly urged to thoroughly screen their patients for potentially serious drug-drug interactions, personal or family history of substance use and psychiatric disorders, complicating concomitant medical conditions, and willingness and ability to adhere to treatment as prescribed. Patients should be educated on safe storage of dispensed medications and proper disposal of excess quantities of medication, and should be monitored very closely for both effectiveness of treatment and the development of adverse effects.”

It would require a fairly big box, but there is a lot of important information to convey.

One of the more philosophically-oriented presentations was that given by Rebecca Kirch, representing the American Cancer Society. Rebecca presented information about how concerted efforts by a number of cooperating entities have produced sharp declines in tobacco use, with a resulting sharp decline in cancer deaths. She urged all parties in the opioid therapy debate to find areas of agreement, especially with respect to what healthcare providers need to know, and to build upon those to produce the kind of constructive behaviorally-specific guidance needed to improve practice. I think it is likely that there really is a great deal of content on which we all agree, perhaps much more so than the content on which we disagree. I agree with Rebecca that it is time to lay down the flamethrowers, and either literally or figuratively sit down at a table together to define those areas of agreement. Reasonable people can disagree without being disagreeable, and it’s time we all demonstrate that we really do have the same goal and can work together to reach it. After all, is anyone really in favor of irresponsible opioid prescribing? I sense a greater willingness among the parties to move in this direction, and I just hope we can leverage that to produce some real progress.


TwillmanDr. Bob Twillman is the Director of Policy and Advocacy for the American Academy of Pain Management.  In that capacity, Dr. Twillman is responsible for overseeing federal and state pain policy developments and advocating for those supporting an integrative approach to managing pain.  He also serves as Chair of the Prescription Monitoring Program Advisory Committee for the Kansas Board of Pharmacy.  Dr. Twillman received his Ph.D. in Clinical Psychology at the University of California in Los Angeles, and maintains a volunteer faculty appointment as Clinical Associate Professor of Psychiatry and Behavioral Sciences at the University Of Kansas School Of Medicine in Kansas City, KS.  Prior to taking his current position, Dr. Twillman was a full-time faculty member at the University of Kansas Medical Center, where he founded and directed the inpatient pain management program and was a co-founder of the hospital’s Palliative Care Team.  He has been actively involved in pain policy through his work with the Alliance of State Pain Initiatives and the American Pain Society for many years.

16 thoughts on “Dr. Bob Twillman Critiques FDA Opioid Hearing

  1. Quote:

    Governments have an obligation to take measures to protect people under their jurisdiction from inhuman and degrading treatment. Failure of governments to take reasonable measures to ensure accessibility of pain treatment, which leaves millions of people to suffer needlessly from severe and often prolonged pain, raises questions whether they have adequately discharged this obligation.

  2. What is wrong with coming up with a treatment to make you not want these drugs anymore. I know there is suboxan but it is addicting. You could also do a thorough research on patients that you suspect isn’t in pain and just wants the drugs to sell. I have a disable son that would rather be working, but that is impossible. He has severe nerve pain. He has had 2 fusions in his neck. He is in constant pain if he doesn’t have his pain medicine. He also has degenerative arthritis. He has problems from a botch appendectomy. His appendix had ruptured when they did his surgery. He shouldn’t have to suffer because others are abusing their pain medicines. Please reconsider your decision to make all people pay for others that take advantage!!

  3. We all need medicine. Whether its vitamis, NSAIDS, or the happy drugs. The problem is, there is enough irresponsibilty to go around. You got the Dr who over prescribes, the patient that is noncompliant, and the pharmaceutical company that keeps pushing more and more for the dollar and at the same time, pushing drugs that can kill you without proper research. Oh yes and the FDA who approved it.

  4. Dear Dr Twillman

    I am wondering if you can help me with both giving me your own opinion as well as suggesting where I can get other authoritative opinions for the following:

    In trying to obtain credits for having Nurse Practitioner students rotate through my clinic I am of the understanding that:
    1) because Nurse Practitioners are already a nurse
    2) because they are learning to do things that are beyond the scope of a nurse such as a) suturing b) writing prescriptions c) ordering diagnostic tests d)doing well exams e) seeing, examining ,forming a differential diagnosis and writing prescriptions etc for patients

    That the training of a nurse practitioner is classified as “medical training”.
    That is not to say that they are not medical students but they definitely are not being thought the things that they have already learned as a nursing student.

    I do not understand how this training is not ” medical training”

    I would appreciate any help in resolving this question.

  5. So, Dr Sachy and fudinj, who is deciding what is irresponsible prescribing—-who wants to be judge? Because right now we have Senators that want to decide and because of 2, Ms. Feinstein and Mr. Grassley and their war on opioids, there are innocent physicians being accused of crimes that are beyond their control. If you prescribe correctly, do everything that is BECOMING the standard of practice in pain, follow up with random drug testing and the patient decides not to follow the directions given on how to take the drugs and winds up overdosing, who is responsible then? Who decides that the doc should have seen this coming. Unfortunately patients lie, scam and do everything in their power to get around all of the necessary hurdles that physicians set up to catch the drug users, the abusers. So now, my husband, and many like him are accused of manslaughter, murder and overprescribing. Is it ignorance or a witch hunt to satisfy our government? If you’re successful then you better run! Doing the right thing doesn’t always keep you safe. Practices ruined, families torn apart, lives lost. Who would want irresponsible opioid prescribing?

  6. I am a chronic pain patient with arachnoiditis. Yesterday after spending my birthday with my Daughter and her BF, after this I went to Walmart. When I got home, a friend of mine stopped by to visit, by the time she left I was in so much pain from my somewhat busy day. Or at least for me it was busy. I had to take my opioids and lay down, about an hour later I started to feel better. I know for a fact that these medicines help my pain, just from the example I gave. I get a sufficient amount of medicine for my pain. I am responsible and have been taking the same dose for 8 yrs. I have had no problems, other then mild constipation which there are many OTC items you can take for this.
    Some months I don’t even take all of them, I don’t want to get myself used to no pain, b/c I know I will have to take these drugs the rest of my life. I try to take the least amount. But some days I have to take the dose prescribed. You just never know when the pain will be worse or better. I go day to day every day like this. I hate it, I hate having to take all these meds, b/c some Doctor missed my epidural space and hit my Dura. Why should patients like us suffer from these opioid fights? I sure did not ask for this pain.
    If opioids are under prescribed to patients that need them, it will only hurt these people. I wish they could come up with a way to measure pain..that would solve a bunch of issues with Opioids.
    Even if they keep it off the streets they will come up with something else..Druggies always do!
    Right now there is a new drug on the streets called MOLLY, it has cocaine, crack, bath salts and excatsy.It weakens your immune system and destroys your organs..Where in the H are they getting this kind of crap, who is making this stuff???? This is what government and Police need to be tracking..Just awful!

  7. My chronically painful and fatal genetic disease will not be considered worthy of opioids because it is VEDS instead of cancer, and I have already suffered the loss of 2 pain doctors in the same practice who refused to continue prescribing opioids. They literally turned away every chronic patient in their huge practice. The threat of PROP getting their way caused this knee-jerk reaction. I turned to a pain specialist based at a hospital who feels sure PROP will not succeed in their quest. I hope he’s correct, but just in case, I reduced my meds and decided it would be better to live with pain at level 4 than be on higher doses and suddenly be forced to go through withdrawal because of drug unavailability. Thanks, Dr. Fudin and all the other medical professionals who are trying to be the voice of reason in an uncertain climate of fear. I do hope my final days will be pain-free and knowing people like you are fighting for people like me is heartwarming and appreciated.

  8. I’m not the enemy here Anon, I’m only trying to inspire and lift up the already broken people down and out suffering from chronic pain.
    It dawned on me that this Petition started by PROP was a TACTIC trap to scare Pain Specialist in to lowering the dosage they would normally prescribe their pain patients. This petition also got under the skin of many pain patients making them just a little bit more stressed and increasing their chronic pain. This TACTIC PROP started has worked even though the FDA has not voted on any of the Opioid Label changes. Reporters sensationalizing their stories can make the public think negative about the very pain medications that give back the life of people that suffer from chronic pain. I think we have fallen in to this Tactic trap set by PROP and they never expected any opioid label changes to begin with.

    As for the hydrocodone change making this medication a schedule II script that PROP proposed this is just another Tactic trap set by PROP to further their cause . Dentist and primary care physicians need a medication they can call in until the patient can be seen . All of the changes PROP has proposed has been ridiculous and unheard of. This was all a Tactic trap set by PROP so changes would start even with no FDA rulings.

    PROPaganda – ideas, facts, or allegations spread deliberately to further one’s cause or to damage an opposing cause;

    Mark S. Barletta

  9. It will be impossible to find common ground when the proponents of PROP are making emotion based arguments and decisions instead of evidence based arguments. Good luck striking a compromise with PROP members. Their speeches made it clear that they will do whatever it takes to effectively ban opioids for CNCP. Hell, there were quite a few that who knowingly lied to the FDA. There was one PROP supporter there, who told lies the entire time speaking ( and I can prove this too). It made me sick and ill to watch the FDA listen and consider anecdotes (not evidence) which were full of lies and omissions of important factors. PROP always tries to push their version of “evidenced based prescribing,” yet had only lies and very little evidence to present to the FDA.

  10. Mark Barletta writes, “When all is said and done I think all that suffer from chronic pain will get the treatment they need.” Why would they, under potentially more onerous conditions, if so many patients aren’t even getting relief from chronic pain right now?” It should also be noted that there is no legal “right” to opioids, even for the most extreme pain imaginable. Doctors are NOT “legally obligated” to prescribe anything if it is against their best clinical judgment. If you stand by these statements, please refer us to the specific laws that you think “legally obligates” physicians to prescribe opioids. I do believe this should change, so we are on the same side. People in pain deserve adequate pain treatment and they should have a legal right to it. As of today, the patient’s recourse is to find a different provider. As for the calls for a rational discussion, I agree that one is needed but good luck with that. The problem is that the PROPagandists at these hearings are too extreme to compromise with the more reasonable voices. PROPagandists believe that the loss of a foolish, reckless, drug-abusing loved one overrides the rights of legitimate, responsible patients to access their needed opioid medications. No amount of label changes or other repressive measures will can ever protect the foolish from themselves. Can’t fix stupid! I wish it weren’t so, as I would have liked to join in with more optimistic and encouraging comments.

  11. I’ve seen and heard of a lot of suffering while advocating for those in chronic pain. I hope we can all come to a reasonable conclusion with the petition PROP has proposed.
    We need to take steps to overcome the obstacles to adequate pain treatment . When all is said and done I think all that suffer from chronic pain will get the treatment they need. We must have opioid analgesics as part of essential medicines as it is a legal obligation under the right of health to protect people from suffering.

  12. “Reasonable people can disagree without being disagreeable, and it’s time we all demonstrate that we really do have the same goal and can work together to reach it. After all, is anyone really in favor of irresponsible opioid prescribing?”

    These statements are correct.

    Then we must finally once and for all, publicly expose those who prescribe irresponsibly [without reasonable scientific or medical rationale] along with those who are simply…unreasonable.

    1. Touché Dr. Sachy! Touché
      Nobody wants irresponsible opioid prescribing…

      PROP (physicians for RESPONSIBLE opioid prescribing
      PROMPT (professionals for RATIONAL opioid MONITORING and pharmacotherapy)

      Really, wouldn’t it be better to accomplish our common goals instead of “Duking it Out!?!”

      1. The problem is that what is reasonable for one person is not for the next. Sentencing people to a lifetime of pain is unreasonable. It’s my life I should be able to decide what compromises I’m willing to make, not anyone else. When my pain is controlled by narcotics I’m a much nicer person. when I’m in pain I’m not. I’m sick of being treated like an addict because I have chronic pain caused by my service to my country. I want to see our country start treating pain as the serious problem it is. I’m sick of the government/DEA trying to “save” addicts. There is no way to save anyone unless THEY want to be saved. It seems funny that Portugal WON their war on drugs by legalizing them. Let’s do the same. Legalize the stuff, ensure that there is not rat poisoning in it and let us act as adults. I worked as a drug education specialist and I believe that addicts will do whatever in order to get high. I heard one guy shot up peanut butter to get high. I’ve heard of addicts shooting ice water, urine, cooking oil (the list goes on) trying to find their high. Just look on the net at all the energy they use trying to circumvent the system. For every new safeguard there is an addict “breaking” to “lock”. Why can’t we simply allow people to live as they want as long as they don’t infringe on the rights of others. Wouldn’t that be a refreshing change in the USA?

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