How To Represent

Last month, I had my first chance to serve on an FDA Advisory Committee as a Patient Representative. I had a lot to learn about the drug under consideration, but I also learned how to use my individual perspective to represent a large group of people. As more researchers in ME try to engage with patients as partners, I have five lessons to help you use your personal ME experience to speak for us.

I have been a member of FDA’s Patient Representative program since May of 2013. FDA recognizes that patient perspectives are critical to evaluating new drugs and products, and includes patients on its advisory committees. The Patient Representative program trains the representatives and matches them with committees. Despite being in the program for more than five years, this was the first time my experience matched an Advisory Committee topic.

The Advisory Committee met on June 26, 2018 to consider a new opioid product called Remoxy. Remoxy is a new form of extended release oxycodone in a sticky, viscous gel in a sealed capsule. Pain Therapeutics (the drug sponsor) was seeking FDA approval of Remoxy with a label stating that the drug had abuse-deterrent properties for injection, snorting, and smoking routes of abuse. Since extended release oxycodone is already marketed, the Advisory Committee’s focus was primarily on the abuse deterrence claims, as opposed to the efficacy and safety of the drug itself. I was selected to be the patient representative because I have chronic pain (from ME) and have been on long-term opioid treatment.

Representation Lesson #1: Invest in preparation

Committee members received more than 300 pages of briefing materials a few weeks prior to the meeting, so I spent most of June in a crash course on abuse-deterrent properties in opioids. There was technical information about testing for abuse deterrence in the lab and clinical trials. FDA included data on the opioid abuse problem from multiple sources, which helped me understand the landscape of opioid misuse and abuse. I also did my own research on the opioid abuse crisis.

Despite the fact that I have been taking an opioid for more than ten years, I discovered that I knew very little about the crisis or abuse deterrence. I thought more than 40,000 people were dying from prescription opioid overdoses a year. I also thought abuse-deterrent opioids were proven to deter abuse. I learned that I was wrong on both counts.

The reality is that while more than 40,000 deaths a year are attributed to opioids, less than 15,000 involved prescription opioids. That is still awful, but this changed my perception of the problem and solutions. Both heroin and synthetic opioids (like fentanyl) were involved in more than 15,000 deaths apiece. Solving the opioid crisis will require solutions to the heroin and fentanyl problem, not just prescription drugs.

I was very surprised to learn that there is little evidence that “abuse-deterrent” opioids actually deter abuse. One reason for the lack of evidence is that drug companies have not submitted data to FDA from postmarketing epidemiology studies to see if there is meaningful reduction in abuse, despite being required by the FDA to conduct the studies. Another problem is that everyone (including FDA) acknowledges that there is no way to deter the most common route of abuse: swallowing pills.

Taking the time to prepare the briefing materials and do additional reading was essential. I needed to correct some of my misconceptions of the opioid abuse crisis. I also needed to understand the specific details about Remoxy and what proof there was (or wasn’t) of abuse deterrence. If I had not put in the effort, I would have been much less effective as a representative of the people for whom the drug was intended.

Representation Lesson #2: Think outside your personal box

I have my own personal experience of chronic pain and opioid treatment. After all, this is what qualified me to serve on this committee. But my personal experience is just that: individual. I needed to think beyond that.

Given my proximity to major medical centers, I have had little difficulty in accessing a pain management program. But this is not the norm. The vast majority of people with severe chronic pain are never referred to pain specialists and never receive comprehensive care.

I have also had minimal difficulty in obtaining my pain medication. We’ve made numerous changes to my medications over the last fifteen years (at least), including the permanent addition of a relatively mild opioid more than ten years ago. I don’t like taking the frequent drug tests as required by my doctor, but it’s more of a hassle than a true barrier. Again, this is not the norm.

A huge piece of the government’s response to the opioid crisis has been to crack down on the prescription of opioids. People with chronic pain are paying the price. I have read many stories of people who were told that they could no longer have the opioids they need. Even people with terminal cancer have difficulty getting adequate pain management, in part because attitudes and prescription controls have swung so far against the use of opioids.

Reading about treatment of chronic pain and the barriers people face helped me think about the value of adding another prescription opioid to the system. I came into the committee meeting thinking about balancing the needs of people with chronic pain and the needs of people who misuse or abuse pain medications. If I just thought about my own experience, I would have unintentionally introduced a great deal of bias into my perspective.

Representation Lesson #3: Identify questions in advance

When I was in law school (a long time ago!), the true challenge in preparing for an exam was the task of synthesizing all the information in order to answer questions about it. I found the same to be true in preparing for the committee meeting. Once I finished reading the briefing materials and the additional articles I found, the true challenge was identifying the questions that would help me decide whether I thought Remoxy should be approved. I knew that I had more questions than I would ever have a chance to ask in the meeting, but coming up with the list helped me synthesize everything I had read.

In the Patient Representative program training, we were encouraged to think about questions that people using a product might have. This goes beyond side effects to questions like the experience of using the product or other considerations people might have. FDA told us that we are included in meetings for the purpose of bring these kinds of concerns to the table, and that other experts might not even think to raise such questions.

In this case, I thought about how people with chronic pain make decisions about medications. Since so many of us have comorbid medical conditions and take additional medications, I had a lot of questions about the extent to which this was studied by the drug sponsor.

Since Remoxy is an opioid with potentially abuse-deterrent properties, I also wanted to know more about how a potential opioid abuser might approach the drug. How would they try to hack abuse-deterrent properties? The drug sponsor said that in addition to experts in the abuse field, they had also relied on information from abusers in designing the studies but I was disappointed to hear that they gleaned it from internet forums. Several committee members who interact extensively with opioid abusers were able to contribute important perspectives on this point.

Identifying questions in advance also helped me to be a more active listener during discussion. I reviewed my list a few times to confirm if I thought the issues had been addressed, and this helped me discern which of my remaining questions were most important to actually ask.

Representation Lesson #4: Have confidence in your knowledge and experience

It is very easy to feel intimidated when we step outside our familiar comfort zone. I am primarily housebound by ME, so it was a little disorienting to be in public, sitting at a large table while microphones and cameras recorded everything. And I knew that everyone else at the table was a doctor and/or scientist and/or advocate with professional expertise in the topic of the meeting. I also knew that I have expertise that is unique. I have relied on opioids as part of my pain management program for more than a decade, and I was sitting at the table for that very reason.

No one who spoke at the meeting (including public comment) self-identified as having chronic pain. I was surprised by this, and I felt obligated to make sure that perspective was heard. I pointed out that there are two public health crises that deserve attention: chronic pain and opioid abuse. I said there were many voices that needed to be heard at the meeting. I shared a little bit of my experience with pain management and how my healthcare is being criminalized through new restrictions. (I’ll update this post with my exact comments when the transcript is available in a few weeks)

Our society awards advanced degrees for academic work, not life experience. But if you are successfully living with a chronic disease or disability, then you have the life equivalent of a Ph.D., and it is every bit as valuable as the academic version. Being a doctor doesn’t mean understanding what it is like to be a patient. Only we can do that.

Representation Lesson #5: Be honest

Serving as a patient representative in any context requires many forms of honesty. Be honest in sharing your own personal experiences (including whether it is your experience or someone else’s). Be intellectually honest in considering other points of view. Be honest about whether you understand something. Be honest in your decision-making.

Participating on a federal advisory committee requires an open mind, especially when there are regulatory and business interests at stake. It’s a bit like serving on a jury: you need to listen to both sides before making up your mind.

The committee voted on whether the drug should be approved. This was not a secret ballot; I knew my personal vote was a matter of public record. Sharing the reasons for the vote was optional, although everyone on the committee did offer remarks. Ultimately, my vote came down to weighing all the information and making the best decision that I could.

Being honest is essential as a patient representative in every context. We have to speak honestly about the diverse experiences of people with ME, and we need to listen with an honest ear as well. I don’t think we can contribute positively without both forms of honesty.

To recap, there are five lessons from my Patient Representative experience that can help you to better represent your group:

  • Invest time in preparing the material
  • Think outside your personal box
  • Identify questions in advance, and review during the meeting
  • Have confidence in your knowledge and experience
  • Be honest in speaking and in listening

Doing those five things will help you speak on behalf of the diverse experiences of people with ME or any other group you may represent.

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13 Responses to How To Represent

  1. cort says:

    You are a great representative Jennie – the type every committee hopes for 🙂 Thanks

  2. Janet Dafoe says:

    This is just so fabulous, Jennie! This should be given to every representative on every committee everywhere! It should be published. You are so thorough, smart, and helpful. Your analysis is stunning. I’m in awe of this piece. I’m printing it out. Can I share it?
    Thank you so much for your unending commitment.

    • Jennie Spotila says:

      Thank you, Janet!!!! Yes, please share it. I think it could help in many contexts.

  3. Janelle says:

    Great article, as always, Jennie.

  4. I see how important it is to have patient representation. You have my admiration.

    I also know there is no way in hell I could have survived any of what you just described. ANY. Sitting in a room with a bunch of people on a committee just isn’t in my skillset, because by the time I got there, all I’d want would be to leave, lie down, shut it all out.

    Thanks for your very real service to our community, and I’m sure it was at great personal cost.

    I live with chronic pain, manage it with no opioids because I will not spend the additional energy visiting the pain specialist monthly, etc., etc., would cost. I tried a stimulant years ago – same effect: whatever small benefit there was didn’t equate to the mindless sitting in a doctor’s office to keep getting the prescriptions – which were only good for a month.

  5. Denise says:

    You became part of the FDA Patient Rep program in 2013, did the requisite training, but weren’t selected for a committee until 2018. I am sure the time between training and selection wasn’t idle on your part.
    Thanks for laying out these lessons.

    Time and again your advocacy reminds me that we have to be in this for the long haul. (I wish things were quicker, but the reality is that this is a long haul.) And we need to cultivate a diverse set of skills and training to get us to our goal(s).

  6. Andrew Kewley says:

    Thanks Jennie, this looks like excellent advice.

    One piece of advice that stuck with me from another advocate was remember what hat you are wearing – remember who you are representing. People have complex backgrounds, beliefs, professional experiences that can sometimes cloud our view.

  7. Kathy D. says:

    Thank you so much, Jennie, for doing all of this work, representing the ME/CFS community so well — and then explaining the process and what works.
    Great job, as always!

  8. Pingback: M.E. Too or Why I am No Longer NOT Speaking to Doctors about Chronic Illness | Africa Clockwise

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