Living with Pain: PROP’s Misleading Petition

Living with Pain: PROP’s Misleading Petition

Last week the Physicians for Responsible Opioid Prescribing, along with a group of doctors and public health officials, sent a petition to the Food and Drug Administration requesting changes in labeling for opioid analgesics.

For over a decade pharmaceutical companies that manufacture opioid analgesics have said that their products are safe and effective when taken under the supervision of a physician. The petition states that those claims are flawed at best and that the increase in prescriptions for these medicines has led to a corresponding rise in addiction, overdose and accidental death.

All of this sounds compelling until one scratches the surface of PROP’s claims. In their petition they cite several research studies to buttress the proposed elimination of “moderate” pain from opioid medicines labels. They contend that opioid analgesics should only be prescribed for “severe” pain and this change would result in fewer accidental deaths.

The problem with this is that people suffering from moderate pain can still suffer horribly. If these patients try other forms of treatment for pain with no good result, they should still have the option of using opioid analgesics. But if PROP campaign succeeds, these patients would have no choice at all and would be left to suffer needlessly.

PROP also wants the daily maximum dose of opioids to be limited to an equivalent morphine dose of 100 milligrams. And patients receiving this maximum dose would only be able to take the analgesic for a maximum of 90 consecutive days.

Leaving aside for the moment how this provision can be easily circumvented, let’s suppose this change would be adopted. What would happen to a patient who suffers from horrendous pain, but who only gets relief from opioids prescribed above the 100 mg limit?

What happens when their 90 days are up?

What does PROP suggest be done to help this patient and the millions of others who suffer with chronic pain?

PROP cites research that “suggests” people who take an opiod analgesic for 90 days are more likely to still be taking the drug after five years. This implies that the only reason they are taking the drug is that they are addicted or dependent.

I will, for the sake of argument, agree that there may be something to this for a certain type of patient who should able to live without opioids. But what about my hypothetical patient in moderate pain? Is this patient simply taking the drug after five years because he or she took the analgesic for 90 days? Should this person be taken off the opioid because he or she has been taking a high dose?

I asked a pain care policy analyst, Robert Twillman, PhD, about the petition and its claims.

“A number of others have pointed out the lack of overwhelming evidence in support of their points,” Twillman told me in an email. “Not only are those points supported by small amounts of research, but many of those studies have significant flaws that make them less than convincing.”

This is not to say that current treatment methods for pain should not be regularly reviewed as all healthcare providers need to know best evidence based practices. I, like millions of other people living with pain, would like to see research into the treatment of pain that would free all of us from using opioid analgesics.

But right now, science hasn’t gotten us there, and opioids are, when used with properly screened patients and under careful medical supervision, one of the useful arrows in the medical quiver.

I now return to the legal circumvention of PROP’s proposed changes. Dr. Twillman says there’s an easy way around them.

“Prescribers can legally use anything off-label, with only a tiny bit of an increase in risk if someone calls their practices into question,” said Twillman. “Because it (relabeling) does absolutely nothing to mandate limits on prescribing, but in reality, only imposes limits on how the meds are marketed. And some insurance companies actually have step therapy protocols that mandate the use of off-label prescribing before they will pay for medications that are indicated for the disorder in question.”

Additionally, the FDA recently published a Risk Evaluation and Mitigation (REM) strategy for extended release opioids that calls for educational programs for both providers and patients. The FDA is also in the process of testing a proposed provider/patient opioid agreement that will go some distance in educating both on the safe use and storage of these medicines.

PROP’s proposed changes will not go far in protecting either patients or the public. In my opinion, and in the opinion of others in pain care advocacy, PROP is committed to a long-term campaign to eliminate opioid analgesics, with the possible exception of Suboxone and Subutex, from the medical quiver for treatment of pain. I hope I’m mistaken and that PROP will join in a genuine balanced approach to the treatment of pain and protecting the public.

Mark Maginn

Mark Maginn lives in the east bay of San Francisco where he is a poet, writer and social justice activist. Mark suffers from chronic pain and was a longtime volunteer with the American Pain Foundation. His blog can be found here

The views, opinions and positions expressed in this column are the author’s alone. They do not inherently or expressly reflect the views, opinions and/or positions of American News Report, Microcast Media Group or any of its employees, directors, owners, contractors or affiliate organizations. American News Report makes no representations as to the accuracy, completeness, currentness, suitability, or validity of any information in this column, and is not responsible or liable for any errors, omissions, or delays (intentional or not) in this information; or any losses, injuries, and or damages arising from its display, publication, dissemination, interpretation or use.

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There are 11 comments for this article
  1. dave at 1:41 pm

    DOc for thepeople- Its medicnes neglect and prejudice toward people in pain that has lead to the opioid crises. Blame your colleagues for refusing to take peoples pain seriously, blame your colleagues who refuse to have education in pain care, blame your colleagues for overusing and misusing opioids and failing to make intelligent use of all available treatments to help people in pain. And blame your colleagues for calling people in pain catastrophizers and letting them eat opioids instead of finding lasting solutions to pain.

  2. Renee Mobley at 7:31 pm

    I have tried everything to help my pain. Everything from surgeries, rehab., injections and a styms unit and nothing has worked. I don’t want to take the pain medicines but without them I’d be stuck in bed and using a wheelchair because of the pain. I’m still in pain with the medicines but at least it takes the edge off enough so that I can walk with my walker or even on my own.

    Please don’t take the only relief I get away from me.

    Renee Mobley

  3. Walt at 2:06 pm

    As a patient advocate and patient of Adhesive arachnoiditis caused by a unethical surgeon, I can assure you of this! Arachnoiditis is as painful as end stage cancer without the benefit of death! being in working contact with hundreds of other People butchered by doctors they trusted that the suicide rate of arachnoiditis patients is actually high. if you take the only option to control the horrific pain away, I can assure you that the rate will increase greatly. The exit network is already a common topic discussed in our support groups. If this proposal succeeds and the suicide rate increases due to doctors fearing prescribing off label for fear of persecution from the DEA , Would the creators of this absurd petition be able to live with the deaths of hundreds? Would Dr.Andrew Klodony be able to bear those demons? It is a rather sad state that no one ever asks the people these laws effect! well those days are over. Pain patients are fighting this with very organized campaigns along with their own petition to the FDA. We are a party to this problem and we will have our say!

  4. Doc ForthePeople at 5:45 am

    The fact is that the media AND stte and federal regulators are routinely using FDA guides for marketing as the “standard” for assessing the quality of a doctors practice. The restrictions recommended by PROP would have a devastating effect on treatment of chronic pain as a disease. The fact is that too many doctor are AFRAID to treat chronic pain because of the relaity based fear of consequences for doing so.

    Second, there is a dearth of information and scientific studies about chronic pain. The lack of evidence proves the fact that the medical profession is avoiding giving chronic pain the attention it deserves. It is interesting that PROP would limit marketing of opioids to no more than 90 days. The fact is that, by definition, chronic pain does not begin until AT LEAST 90 days AFTER the pain begins. PROP would simply ban marketing, and publicly ACCEPTABLE use of opioids for any and all treatment of chronic pain.

    Displacing the blame for the current escalating overdose deaths among addicts onto the reliable chronically suffering chronic pain patient will not solve the problem of addiction and overdose! It will simply sweep both problems further under the rug!

  5. Sally at 11:30 am

    Carly, I’m so sorry about your husband’s horrible pain, and the way our society has abused people with seroious pain conditions. As long as there are people like “DocG”, who are ignorant, cruel, and angry……we will continue to hear that people like your husband, are just “addicts” seeking drugs. I’m not sure what “spins confusion” means, but that’s just more ignorance rearing it’s ugly head. Until you, or someone you love, has lived with daily debilitating, intractable pain, you just don’t have a clue. Denying adequate pain relief to human beings, simply because of political rhetoric & knee jerk emotional responses, IS cruel and unusual, you’re right. The only ones hurt by this ridiculous petition, are the people that these medications are intended for. The irony is almost funny, if it weren’t so terribly sad…..

  6. Carly Gayle at 9:15 pm

    This is horrible. My husband has had 2 spinal fusion surgeries, the last one leaving him with permanent spinal cord and nerve pain. He can hardly stand to be in his own skin and has cried EVERY morning when he wakes up for TWELVE years now. He was an extremely active, hard working man, that now can hardly walk to the bathroom. He has tried many medications and combinations of medications over the years, and was finally getting comfortable enough where he was going to start taking the water exersizing classes here in Florida to try and build a little muscle and strength…. untill this horrible medication nightmare started. Now he is back to bed 24/7, his quality of life down the drain, and I am sure he will kill himself if the medication shortage continues. Having sick, disabled people drive around from pharmacy to pharmacy begging for the medication that can help them is CRUEL and UNUSUAL punishment! WHY in the world would you do this to these poor people? This is actually sickening!

  7. Erika at 5:20 pm

    PROPs proposal is too radical. Label changes will be counterproductive. Let physicians use their best clinical judgment. Another excellent article by Mark Maginn!

  8. DocG at 8:47 pm

    Here in the postings lies a prime example of how the addict spins confusion.
    Thanks for the biology lesson Ms. Sally.

  9. Pat Anson at 5:59 pm

    Editor’s Note: Dr. Andrew Kolodny, one of the founders of Physicians for Responsible Opioid Prescribing, strongly disputes Mark Maginn’s statement that “PROP is committed to a long-term campaign to eliminate opioid analgesics.” PROP’s petition to the FDA, if adopted, would prohibit drug companies from promoting opioids for moderate, non-cancer pain. However, doctors would still be able prescribe them “off label” for that purpose.

    American News Report welcomes all points of view on the complex issue of pain management.

  10. Sally at 7:27 pm

    Talk about “Irresponsible” Physicians! The dose maximum is a joke. What works for one person, doesn’t work for another. Apparently, some of these doctors missed the lecture about genetic metabolic enzyme abnormalities found in many pain patients, most notably Cytochrome P450; which can involve 3 different defects, and they directly relate to the way in which people metabolize opioids. Some patients REQUIRE higher doses of opioids to achieve any significant pain control. To deny that, is bad science, bad medicine, and simply dishonest. When are people going to realize that the patients who legitimately need this medication to survive, aren’t the ones abusing it, overdosing, and diverting it. Regardless of whether or not doctors would chose to prescribe “off label”, i think most would be uncomfortable doing it. They would fear (as most do NOW), regulatory scrutiny. Including scrutiny by LAW ENFORCEMENT agencies that have NO business, education, or understanding of MEDICAL decisions about PAIN. OH…. And 90 days? So, after the three months is up, do we just kill ourselves? This proposal is BARBARIC, and people need to start confronting these maniacs. First do no HARM.