FDA Enters Opioid Controversy – Where’s The Patient?

FDA Enters Opioid Controversy – Where’s The Patient?

By Ed Coghlan

The U.S. Food and Drug Administration wants to create an action plan that can “reassess the agency’s approach to opioid medications.

According to the email the FDA distributed Thursday night, “the plan will focus on policies aimed at reversing the (opioid) epidemic, while still providing patients in pain access to effective relief.”

Already, chronic pain advocates are asking one question.

“What is the patient’s role in this action plan?”

Terri Lewis, Ph.D., who studies how the U.S. health care system treats chronic illness like chronic pain, was characteristically blunt.

“What’s missing? Once again, no patient voice,” she told the National Pain Report.

What caught Dr. Lewis’ attention was that declaration by the FDA that it will convene a panel of experts, without any reference to the patient point of view. Here’s how the release described the FDA efforts:

“As one of the cornerstones of this plan, the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. For example, the FDA has already asked the National Academy of Medicine to help develop a framework for opioid review, approval and monitoring that balances individual need for pain control with considerations of the broader public health consequences of opioid misuse and abuse.

In addition, the FDA will convene independent advisory committees made up of physicians and other experts when considering for approval any new opioid drugs that do not contain abuse-deterrent properties. The FDA will also convene a meeting of its standing Pediatric Advisory Committee to make recommendations regarding a framework for pediatric opioid labeling and use of opioid pain medications in the pediatric population.”  

Dr. Lewis, who is a daughter and mother of people who have suffered or currently suffer from chronic pain, believes that the patient’s voice needs to be heard.

“When FDA accepts direct patient reports of serious adverse events, we have something to talk about,” she said. “When FDA penalizes health providers for NOT REPORTING information, we have something to talk about. Until then we have no real time reporting and will never be able to connect the dots.”

According to the FDA it will:

  • Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects
  • Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;
  • Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;
  • Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;
  • Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;
  • Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;
  • Improve access to naloxone and medication-assisted treatment options for patients with opioid use disorders; and
  • Support better pain management options, including alternative treatments.

The FDA also claims that strengthening the requirements for drug companies to generate post-market data on the long-term impact of using ER/LA opioids. The agency says it expects this to result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder.

What’s missing?

Dr. Lewis says the FDA doesn’t appear to care what the patient thinks.

“FDA does not incorporate reports filed into the system from consumers because they consider them to unreliable,” she said. “That’s bunk.”

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Authored by: Ed Coghlan

There are 19 comments for this article
  1. Donna at 10:10 pm

    Hi BL,
    Thanks for the posting. How do I go about finding that information specifically? Google “opioid prescribing laws”? I used to be good at figuring things out, but my mind no longer works as well as it used to. Very frustrating! Any specific info you can give me on exactly where to look will be greatly appreciated!

  2. BL at 6:37 pm

    HOWARD H HEROLD, Donna, unfortunately drs lie to patients about no longer being able to prescribe opiates. It is important that every chronic pain patient stay up to date on the laws that govern the prescribing on chronic pain medications. This can be be done online by reading the federal and state laws. You can also find out what your states Board Of Medical Examiners position is regarding the prescriving on opiates and other issues by going to your states Board Of Medical Examiners website. If a dr tells you that they can no longer prescribe opiates, it may be because they have a problem and not a new law. Whatever the reasons are, you need to find out if what your dr is saying is true.

  3. Donna at 10:53 am

    I’ve had a doctor tell me that he thinks primary care doctors can no longer prescribe opioid for chronic pain. I don’t know if there is or not, or AMA or other calling for this action. I hate to think or say it, but yes, I think we will be expected to do without. We MUST figure out how to come together and do battle to win.

  4. HOWARD H HEROLD at 2:33 pm

    I have been taking Opiods for over 10 years, my Doctor has inform me a law is comeing out where she wont be able to prescribe Opiods, Im not addicted Ive had two failed back surgeries, a Laminectony and a Fusion, Im in constant pain so if Opiods wont be available for Chronic Pain, what do i have to do suffer the rest of my Life? Im 63 yo my pain Meds are locked up, because of a theif !!! My Meds are given to me by my wife everyday, because we dont want them stolen again.
    RESPECTFULLY

  5. Sickandtired at 2:53 pm

    HJ, they don’t really care about us pain patients, that little blurb is just smokescreen, the truth is in the comment that they are not looking for patient input because it is too “unreliable.” What a crock. Do not fall under any assumption that they are looking out for OUR rights or OUR care. There is zero empathy for those of us in pain. Many of us are looking into legal actions, whether this is a violation of our rights and/or civil liberties, I advise you do the same. Look for groups on Facebook or internet and join in. The only way we’ll be heard is if enough of us raise our voices loudly enough – apparently they think we are too “unreliable” to fight back too!!

  6. Terri Lewis at 11:55 am

    We need to understand the patient experience LONG BEFORE they end up in the morgue.

  7. Crystal Murphy at 11:04 am

    No, I believe it is painfully (pun intended) that the FDA, CDC or any government agency could care less about the practicality, or logistics of chronic pain patients.
    These rules will do nothing but further discourage medical professionals from prescribing needed opioid to clients that genuinely need them to survive.
    Sudden Death Syndrome is a real diagnosis for Chronic Pain Patients. Pain can kill.
    It is a disease in and of itself.
    So many problems exists with these proposed measures.
    First of all, these were all done in secrecy and were supposed to be implemented this past January, until some very acute pain patients and advocates started protesting.
    The hearings that just occurred only allowed physicians and so-called professionals to speak at the public hearing.
    Patients are not only not being heard, we are being IGNORED.
    Many of us lost jobs, insurance, homes due to diseases we did not CHOOSE to have.
    We worked for decades, paying into a system that was to be there when and if the day comes where you were disabled.
    Then, they make it a stressful, agonizing event to even apply for what we paid into.
    Years go by… Many appeals to be filed, poor excuses for why one isn’t eligible and it my case, three separate letters with three separate excuses.
    Along with job loss usually comes loss of insurances. In my state, you cannot even apply for Medicaid UNLESS the government has deemed you DISABLED.
    That alone, denies many people without an income to access to a physician, no medications, even for insulins, asthmatic inhalers… You know, those inconvenient LIFE SAVING MEDICATIONS.
    Pain is not recognized as the disease itself. Physicians are afraid to prescribe what they know is the appropriate treatment or medications for these conditions, for fear of repercussions from The FDA on their licenses.
    The alternative treatments they are wording so wonderfully, have major flaws.
    How can a patient with no income, or no insurance pay for those? What if it is not appropriate therapy for them?
    Many, dare I say MOST insurances would not cover said treatments.
    Also, the time-released medications and the abuse-preventative ones that they speak of… VERY expensive.
    Won’t be covered under most plans, even the best of them.
    Time-released medications are not the answer. People have different genetic makeups, and things such as how acid the digestive fluids in the stomach are.
    People who’ve had gastric bypass and the like are unable to even use time-released medications of any kind.
    With a decent pain management physician, those that are on time-released dosing are usually prescribed an immediate or quicker acting pain medication, in addition to the time-released. This us for what is commonly know as “Breakthrough Pain”.
    One won’t be able to get that, and pain levels will increase. Insurance companies will buck paying for TWO medications.
    So, indeed the patients in pain are victimized by the medical profession, as a whole, the public in general and now, by tour Government. You know, the ones that didn’t bother to listen to our voices.
    Keep advocating, in any way that you can. Let your voice be heard.
    Chronic, intractable pain patients often commit suicide.
    How much blood they will have on their hands… How many do we have to lose when common sense pain management techniques between the patient and the doctor is the best way to succeed?
    The government, with their Big Pharmaceutical Buddies, needs to get out of bed with one another. Let Doctors and patients decide between themselves appropriate therapy.
    Keep Government Out Of Healthcare!

  8. Tim Mason at 5:32 am

    HJ’s comments reflected my feelings about this article and his/her analogy was spot on.

  9. Tootie Welker at 2:25 am

    The goal of the CDC guidelines is obstensibly to make sure pain patients still have access. The Montana Know Your Dose website is supposed to ensure patients still have access, yet the unintended consequence is the opposite. I have no illusion it will be different with FDA.

    I’m also all for alternative treatments-have used for 40 years. But now I can’t work and waiting on SSDI appeal. Unless they also make insurance/Medicaid cover massage/chiropractic/cranial sacral/Feldenkrais etc, most people in chronic pain can’t afford them

  10. Nick Wilson at 3:31 pm

    If the FDA believes that their goal is going to “Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects,” they are missing the vital data from the “public.” They do not see the effect because “we the people” are unreliable.

    Nice…

  11. BL at 1:36 pm

    My apologies about the link. It doesn’t deal with California, it is from Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco

  12. Donna at 12:35 pm

    Still yet another government agency wanting to be in control of the doctor-patient relationship when it comes to treating us. Just how many will be in the exam room with us to decide if we are drug-seekers and refused treatment OR we are bona-fide pain patients and still refused treatment? I am too bitter and too distrustful to think the FDA is going to act on our behalf.

  13. BL at 12:10 pm

    Unfortunately, the vast majority of chronic pain patients wouldn’t be able to be objective. You have to do things a certain way when you’re involved in things like this. You can’t just start talking about certain things that aren’t the topic. You also have to remember that since chronic pain patients aren’t consistently vocal and visible that it does not appear that many of them are adversely affected.

  14. HJ at 11:14 am

    Good point. Asthma meds were reformulated to be CFC-free, which meant they were protected under a new patent. They are now available only at brand-level copays, which are prohibitively expensive.

    I can’t manage to have this happen with my pain medications. Asthma can be life-threatening but is not daily torture the way that chronic pain is.

    Given this, those chronic pain patients may not turn up in the ER or morgue for whatever condition is causing their pain… but perhaps for choosing pain relief over diabetes medication or asthma medication or better yet — cholesterol and blood pressure medications (the silent killers).

  15. Sherrie Harris at 10:21 am

    I just hope that this doesn’t make it even harder to get my medications for me just to exist. Every since the DEA stepped in and decided what we can take for our pain my quality of life has went down to a 2. I am in constant pain never a day moment without my friend pain she’s with me 24/7 365 days a year. I use the term friend because it always with me it’s by no means a friend but it’s always there. There is no cure for my diseases only medication that helps to deal with the pain. Even on pain meds at best relief I get is a 4/3 that a great day to only be on a pain scale of 4 or 3 usually it’s a 10 all the time. I remember the day when the government DEA wasn’t telling our Doctors what we can take. It seems like everyday it’s something new that will effect our quality of life. Thank you for letting me express this.

  16. Kristine (Krissy) at 7:43 am

    Am I to understand the FDA considers patients too unreliable to have a stand in this? Or am I confused?

    HJ, the way I read it is that the FDA will consider current patients’ needs, but will want them on the new type of opioid or Nal. Am I right? Or am I confused?

    I would find the new type of opioid just fine if it works but I want to know what they plan to do with older folks who have been on high doses for many years in terms of care for withdrawal. How does this work? Does one get off the opioid first then take the new kind. It almost sounds medically risky for older folks who aren’t very healthy. But, again, I would be all for a less harmful drug. That being said, I don’t believe I’ve been harmed by my meds either.

  17. BN at 7:31 am

    “In addition, the FDA will convene independent advisory committees made up of physicians and other experts when considering for approval any new opioid drugs that do not contain abuse-deterrent properties.”

    Will they force insurers to cover abuse-deterent medications? The prescription opioids most likely to be abused are the only ones with decent formulary coverage on many insurance plans…

  18. HJ at 6:21 am

    I’m confused. This sounded like somewhat hopeful news…

    “According to the email the FDA distributed Thursday night, “the plan will focus on policies aimed at reversing the (opioid) epidemic, while still providing patients in pain access to effective relief.””

    This is the first time I’ve heard ANYONE add that patients in pain should get access to effective pain relief.

    Is the point of the article that it doesn’t go far enough because no patients are included in the panel?

    Point taken. But…

    It still kinda sounds like good news. It seems odd to have the FDA supposedly advocating on our behalf. I guess I’m so used to being bashed. Of course, the FDA isn’t the unbiased regulatory agency some people think it is. Drug manufacturers have a huge influence on the FDA.

    I do kind of feel like I’m standing in the crossfire of a war. Before I felt like I was blindfolded in front of the firing squad.