Impact of Drug labeling on Chronic Opioids – Hearing Updates

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Hearing minutes now posted: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM342700.pdf

The hearing started PROMPTly at 9AM with an introduction by the FDA Deputy Center Director Dr. Douglas Throckmorton, Center for Drug Evaluation and Research.  The first four presenters were from downtrodden PROPagandist  parents that lost loved ones to a drug overdose, in each case due to inappropriate prescribing by a licensed medical doctor, misuse, or a combination of both – but in each case it involved opioid addiction.  I think we can all agree that such tragedies are very sad and our hearts go out to all families that continue to suffer from these losses. 

Multiple practitioners that included medical doctors, pharmacists, social workers, and others presented following these first four; some in favor and some against relabeling of opioids (more specifics to come in a later blog post). 

On 4-5 occasions, PROPagandists likened oxycodone to heroin.  I can allow such a comparison by non-medically or pharmaceutically trained people, but it remains unconscionable that medical people bias this factor in presentations.  For example, not a single one said oxycodone is chemically similar to heroin, but, dextromethorphan (found in Robitussin® Cough Syrup) is also structurally similar.  See paindr.com blog post, Heroin, Hydrocodone, Buprenorphine & PROPaganda comparing heroin to buprenorphine

So here I am after half the day and the questions and comments that loom in my mind are as follows:

  • Many medical presenters started by saying, “I have no conflicts of interest to disclose with any pharmaceutical firms”.  I don’t much care, unless all presenters are required to disclose any and all third party funding whether it is funded by the pharmaceutical industry or not – this would serve to expose who is financially fueling this fire (Worker’s Comp, Health Insurance Industry)?  For the record, I funded my own travel expenses.
  • Many spoke about the maximum daily dose of morphine, and one presenter displayed data suggesting that there are more deaths from patients that are in the category of receiving greater than 100mg of oral morphine or equivalent per day.  That may be true, but could it be because of all patients that fall into that category, there are sicker patients compared to those on lower doses?  That certainly would make sense.
  • During Dr. Kolodny’s presentation, he suggested that third party payers would not deny payment for opioids off-label if the indications were changed, yet another presenter sited evidence that this has already occurred.  Dr. Koldony used an example of how Lyrica® is FDA approved for fibromyalgia, yet many third party payers refuse payment in lieu of Neurontin® because it’s less expensive, even though it does not have the FDA approval.  What he failed to mention is that both of these drugs have an identical pharmacological mechanism of action to uptake the alpha-2-delta subunit receptor that affects intraneuronal voltage-gated calcium channels.  Yes, they both work the same way, so it is understandable that third party payers require failure on Neurontin® before paying for Lyrica®.  When directly questioned if evidence exists to support that third party payers will not deny payments, Dr. Kolodny did not offer a yes or no reply.  For the record, no such evidence exists.
  • Perhaps the most compelling, well-organized, carefully balanced, patient-clinician directed and truthful presentations this morning were from Doctors Amy Abernethy (American Academy of Hospice and Palliative Care), Robert Twillman (American Academy of Pain Management), and Charles Argoff (American Academy of Pain Medicine).  Dr. Abernethy’s perspective was particularly enlightening because she spoke about terminally ill patients or some that have had “terminal” illnesses that are not cancer-related, all of which required chronic opioids beyond 90 days and often exceeding 100mg or oral daily morphine or equivalent for quality of life.   Dr. Twillman discussed three “Logical and Philosophical Considerations in the Use of Opioids for Chronic Pain”, perhaps the most compelling that “The absence of evidence does not constitute evidence of absence”.  Dr. Argoff aptly outlined the physiological differences of various pain syndromes and how and why we might expect to see a response from one agent versus another, but also the importance of appropriately combining various pharmacological agents for a rational polypharmacy approach to pain.
  • Items that were not discussed in detail yet are the following:
  1. Prescription monitoring systems across states and how we might work collaboratively across all states and with the DoD and VA systems to tighten up collaborative monitoring among prescribers and pharmacies.
  2. Who’s data will the FDA use to establish what the oral morphine 100mg conversion should be?  See paindr.com blog post, The Answer is Morphine 100mg Equivalent – Morphine Jeopardy.
  3. When establishing a maximum daily dose, how will one account for patient variability?
  4. When establishing a maximum daily dose, how will one account for the lowering of morphine (or other opioid) serum levels specifically due to drug interactions?  See paindr.com blog post, Rifampin Lowers Oral Morphine Absorption, The Path to Publication in Healthcare.

I’m glad I could provide this quick update during lunchtime.  More to come!

18 thoughts on “Impact of Drug labeling on Chronic Opioids – Hearing Updates

  1. Hello. Close to 10 MM Americans use Chronic Opioid Therapy (COT), as part of their pain management strategy, to improve their health and have some quality of life. Morphine, Hydrocodone, Oxycodone and others are not evil medicines, they are required to treat chronic pain. In the IOM 2011 Study on Blueprint for Transforming, Prevention, Education on Chronic Pain determined that chronic pain is a disease affecting 116 MM Americans.
    As such, chronic pain disease should be treated by Doctors to prescribe COT to their patients who suffer chronic pain. Denying patients the opportunity to utilize COT is similar to denying insulin to diabetics who are ill due to their obesity.
    A good site to learn more about COT is http://www.livingingpain.org. Please continue to write the Senate H.E.L.P. Committee to instruct the FDA to disregard changing the labels for Opioid medicines. You can contact them at http://www.regulation.gov.

  2. The FDA videos are now available for viewing on the FDA website. I started watching part one which included Avi Israel’s first testimony. It is interesting because he talks about his son,Michael, taking Cymbalta and Xanax as well as hydrocodone. It is interesting because he refers to Cymbalta, a non-narcotic medicine, as being addictive (kind of strange) and because anti-depressants, like Cymbalta, come with increased risk of suicide warnings. I don’t understand why Avi Israel is blaming the opioid, when it is far more likely that the Cymbalta had some role to play.

    This actually brings up another question that PROP needs to answer. Why are medicines that effect neurotransmitters like anti-depressants and anti-convulsants fine to use, but other medicines that do the same, like opioids, are not? Seems like some very arbitrary rules to me.

    1. Andy,

      It’s really probably a combination of all his medications. And, I don’t know if he was taking Cymbalta for pain or neuropathy, or both, although in either case in increases risk of suicidality. Also for the record, SNRIs (like Cymbalta) and SSRIs can cause “physical dependence” which is often times incorrectly labeled as addiction.

      1. At the hearing, he said his son was taking all those medicines for Crohn’s disease. Either way, it is not the first time someone was taking multiple medicines and then passed away and had their family blame only the opioid medicine.

    2. I agree this makes no sense and the anti depressant med have such horrible side affects, they don’t work, seems like another cop out to me.

  3. Thanks for the update & continued advocacy, Dr. Fudin!

    I was just thinking….. I would have so much more respect for Dr. K , if he stuck to increasing education & treatment for opioid addiction. He could make a real impact by focusing on making treatment for opioid addiction more accessible to people who are committed to recovery. I have read that patients often have to wait months to see doctors who can prescribe Suboxone for opioid addiction. It is insane to tell an addict who is finally ready to stop, “you will be put on a waiting list, so keep using until we call you”.

    He is focusing so much effort & energy on decreasing access to opioids for EVERYONE, including those who benefit from them, that he is creating immeasurable pain & misery for an entire population of innocent people. There is NO evidence than any of these proposed label changes will prevent addiction.

    As Dr. Sachy mentioned (above), doesn’t he have PATIENTS to see?

  4. I just don’t think the FDA is hearing what they need or want to hear. All of these families telling the story about how they lost a loved one is tragic but not enough to make the changes Dr. K. wants. It is bad it came down to this for all that lost loved ones to overdose deaths but must all that suffer from chronic pain pay for the mistakes of those that didn’t follow the directions of their prescription bottle. We never hear all of the story, if there was alcohol involved or not.

    I’m going to put myself out there and say Dr. Kolodny will not get his way, he doesn’t have enough professional medical proof provided by those who talked for PROP. And that’s all I have to say about that, it seems that Dr.Kolodny is really bent on getting his way and when he doesn’t then that will be it on his attack on all that suffer from chronic pain.

    Mark S. Barletta

  5. Thank you Dr. Fudin for providing a snapshot of the morning’s proceedings. I’d like to think that the FDA board members have read chronic pain patients family and friend’s emails and letters and will conclude that the vast majority of chronic pain patients take their medication as prescribed. …and that this hearing is unnecessary.

  6. I can’t believe Pete Jackson and Avi Israel were allowed to speak. Both of their children abused pain medicines. Emily Jackson was not even prescribed the medicine she overdosed on. In fact, Emily Jackson had no prescription for any opioid nor did she have any painful condition that might have required their use. As for Michael Israel, many pain patients take their opioids as prescribed and live full healthy lives. It is neither the doctors fault nor the pharmaceutical companies fault that he began to abuse his prescription ( it was admitted in one article that he would crush and snort his medicine). Why should we ruin the lives of millions of law abiding chronic pain patients because a handful illegally obtain pain medicines or abuse their prescribed medicines? Doctors are not infallible omnipotent beings. They can’t monitor patients 24/7/365. Doctors have to rely on their patients word when it comes to chronic pain. I’m so sick and tired of these parents blaming everyone else for the tragic mistakes their children made.

    I also can’t believe Ada Giudice-Tompson was allowed to testify since she is not an American citizen ( she lives in Ontario and is a Canadian citizen). What if was her testimony that persuaded the FDA panel to follow PROP’s prescribing guidelines? How would that be fair to American citizens with chronic pain?

    1. Also, I completely forgot to mention that Avi Israel’s son , Michael, did not die from opioids. Michael Israel was abusing his pain medicines, but he did not die from an overdose or pain medicine abuse. Michael Israel committed suicide ( with a shotgun, not pills). So, while his parents and others (groups like PROP and ARPO) blame opioid pain medicines and classify it as an “opioid related” death, it very well could have been caused by other issues or factors. His parents were quick to blame the opioids and to rally against them with PROP, but the truth is nobody knows why he did it. Maybe he had other problems like depression unrelated to his use of opioid pain medicines. Maybe he was taking other medicines associated with a suicide risk like anticonvulsants or antidepressants.

      It is just another example of a person blaming opioid pain medicines for a tragic incident with absolutely no evidence to prove opioids had any part ( yet, they testify in front of the FDA that opioids caused this tragedy and need to be banned). I just wanted to post this, so that my fellow chronic pain patients are informed about the people who are trying to ban medicines that help us live our lives as best we can. I really believe it would be devastating and ruin millions of lives if the FDA actually passed these proposals. I think it would be even more horrific if it happened because they listened to people who should have never been allowed to testify in the first place.

      Basically, the FDA panel was allowed to hear testimony in favor of passing the label changes proposed by PROP by a non-American citizen and a person whose son committed suicide with a gun.Why should the FDA listen to them? Last time I checked, the FDA regulates medicines inside America, not Canada. Last time I checked, the FDA regulates medicines,not shotguns ( Maybe they should talk with the ATF instead). I think that allowing them to testify was unfair and that their testimonies should not be considered at all in any decision.

  7. Maybe it is just me, but it didn’t seem like the FDA was too pleased with supporters of PROP. They provided very little if any solid data and facts. They did provide a lot of emotional reasoning and opinions which the panel seemed to pick up on. I have to say I think the more balanced presenters seemed more appealing to the FDA panel. I just wish that there were more balanced presenters. It is not fair to hold a hearing on opioids and then to have over 50% of those speaking have extreme personal bias against them. Personal bias and anecdotes are not science and do not constitute good evidence, which is what the FDA is looking for.

      1. Yes, I was aware of him and his crusade against opioids as well. It is weird,bizarre, and unfair to have non-American citizens advocating for changes in American regulatory policies. However, David Juurlink did not appear before the FDA to plead his case. I suppose non-Americans have a right to support groups online whose cause they believe in. However, it is fundamentally unfair for them to appear before American officials and politicians and personally beg for laws that will only effect American citizens and not them. It doesn’t really matter if a non-American citizen tweets articles in support of PROP all day long. It does matter and is entirely different if they appear before American committees and try to persuade them to change policies.

  8. The video of the hearing should be online later today. I watched it streaming live online. I can post the link if you want. I have many questions about the hearing, but the biggest one I think is why was Ada Giudice-Tompson allowed to speak? Isn’t she a citizen of Canada? The FDA only regulates medicine inside of America, so why would she speak? I don’t think non-American citizens should be allowed to testify for regulations in America. They don’t have to live with them like American citizens do.

    1. Andy, I thought the same thing about those Canadians, what do they have any business talking at this meeting? They have their own guidelines as far as opioids..I was very confused about this.
      Becky

  9. I am thankful for those that have spoken so far in favor of chronic pain patients, and I sincerely hope that you are provided an opportunity to speak as well, Dr. Fudin. Thank you for the update.

  10. Sounds like a typical Court Room – full of theatrics, spin, prejudice and axes to grind – bereft of scientific fact and plain old REASON. But thank goodness for Drs. Abernethy, Twillman and Argoff…

    Doesn’t Dr. Kolodny have patients to see to?

    I do!

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