Living with Pain: FDA Ruling a Victory for Pain Patients and PROP

Living with Pain: FDA Ruling a Victory for Pain Patients and PROP

The Food and Drug Administration has announced new guidelines on the labeling and prescribing of opioid pain medicines. Much of this was in response to a petition submitted to the agency by the Physicians for Responsible Opioid Prescribing (PROP).

In the FDA’s letter to PROP, they explained that they were implementing some, but by no means, all of PROP’s demands.

fda-logo4The FDA rightfully strengthened the warnings on opioid medicine labels. They will warn of the possibility of misuse, abuse, tolerance, addiction, damage to unborn babies when women take opioids during their pregnancies, and the risk of respiratory failure and death in patients taking the medicines.

While the weight of these statements may scare off patients who could benefit from opioids, they are, in my estimation, both reasonable and useful. These statements may stimulate educational conversations between providers and patients. In that, they are a welcome addition to patient information.

The FDA is also requiring drug manufacturers to conduct further studies on the safety of opioids, acknowledging that we don’t yet have enough research on their side effects, particularly on the long-term use of these medicines.

Another area in which PROP succeeded in winning is a label change stating that the opioids should not be prescribed for people in moderate pain — but only for patients in severe pain who have not responded to other treatment.

While these new rules are important and a clear “win” for PROP and in many ways for patients, the more draconian measures PROP asked for were rebuffed by the FDA.

PROP wanted the FDA to limit the amount of an opioid a patient could take in one day to the equivalent of 100 milligrams of morphine.

PROP also wanted to limit the person in “severe” pain to only 90 days of opioid treatment. For example, a young mother suffering with severe pain from rheumatoid arthritis would be limited to the possible salutary effects of an opioid medicine for 90 days.

The patient, after a few months of relief in which she could more easily interact with her children, would be doomed to losing that relief in a short period of time. Imagine her panic at the reality of sinking back into that bleak miasma, knowing that the medicine could relieve her.

The cruelty of that is staggering.

Fortunately for that young mother, and the rest of us, the FDA shot down that proposal. But the fact that it was even made is telling. Even though the FDA rightfully said no to that, it doesn’t mean that this proposal is dead.

PROP’s reliance on questionable research in making these proposals doesn’t augur well for the future of pain treatment. The FDA is mandating that drug manufacturers conduct research, but not all research is valid and reliable. I am quite concerned that PROP will monitor the upcoming studies and seize upon those, whether good research or not, that fit with their program in an attempt to revive the agenda that the FDA has just rebuffed.

I am still of the opinion that PROP is taking the long view, with an eye not only on reviving these proposals but also their ultimate goal of making all opioid medicine completely unavailable to pain patients. Though PROP will protest that this isn’t true, one only has to look to their petition to see it.

An example might clarify this. Once they submitted their petition to the FDA, PROP founder Dr. Andrew Kolodny has repeatedly stated that prescribers could still write prescriptions “off label.” By this he meant that if the FDA declared that opioids could be used for “severe” pain, doctors could still prescribe the medicines for those with moderate pain.

Over the last 18 months, starting in Florida and spreading west to California, there is a growing number of primary care physicians and even pain care providers who are not only refusing new pain patients, but also no longer writing opioid prescriptions for established patients already being treated with opioids.

Recently I wrote about a young mother in southern California who suffered from a brain tumor but could not find a doctor to work with her pain. I have also written about another woman in Florida who, after being fired again from a provider’s practice, committed suicide in despair.

There is also growing evidence that people in pain who cannot obtain this treatment legitimately have turned to drug pushers in increasing numbers to medicate themselves with heroin.

What is disingenuous about off label prescribing can be seen in these trends. As more and more providers are harassed by state and federal regulators and the DEA, the more that threat looms for all physicians. An increasing number of them are walking away from their pain patients that could subject them to more scrutiny.

The tightening of the language on who should be treated with opioid medicine to those only with severe pain will become the escape hatch for many worried providers. They will, even though they know they can prescribe off label, use this new language in service of their fears. It will become easier to stop writing prescriptions for patients they see as suffering from moderate pain and provide them with a new rationale to reject new pain patients.

In summary, these new regulations are a victory for pain patients even though there is room for continued concern. The pain community needs to stay involved in this process and be aware of PROP’s continued activity. One hopes with these new regulations, PROP will fade from the scene. That, I’m afraid, is a pipe dream.

Mark Maginn

Mark Maginn

Mark Maginn lives in Chicago 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 “Left Eye Blind” can be found here

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There are 5 comments for this article
  1. Anita C. Spero at 9:17 am

    What really scares me is the question I need to ask.
    What happens to people like me? Some of my pain is in the non-specific area and comes from a brutal rape years ago. The pain in my pelvic area is “severe” . But nothing shows up on film. I avoid restaurants, weddings, church, any type of schooling. I can’t sit in a chair properly. My need to change positions is constant including sleep (a rare act for me these days). Because they can’t see it will I be put into the “moderate” group? I can’t help but to feel some guilt. Because of people like ME, in the non-specific pain group….am I making it harder for people to receive pain relief? Not all is non-specific, but some. I hope my question makes sense.

  2. LKnight at 7:38 am

    I had never even heard of PROP before. I checked out their website, and it is just plain scary the stuff they are working on getting passed. Others things are just plain wrong. The one that caught me eye was about addiction NOT being rare in pain patients. I ran across a few doctors that thought that. It is a failed logic though. They assume that a pain patient gets a “high” off of the meds we take. We don’t. It doesn’t matter to them though. No matter how much you tell them that they are wrong, and explain why, they have made up their minds.

    I went almost 2 years untreated on any type of medication for chronic pain, which I fairly recently found out is small fiber fibro. That time was hell. I wasn’t able to function properly. I was in and out of ERs and, my memory problems were worse. At times causing complete black outs. I don’t want to be on opioid pain meds just as much as PROP doesn’t want me to be on them. I fear what they are doing to my system in the long run. However, I have no choice. We know so little overall about the human body and how, specifically, chronic pain works. I don’t see effective, non opioid, pain medicine hitting the market until we understand that. Even when that does happen, what happens to people that it doesn’t work on? What happens to people that may be allergic to the medicine prescribed? It seems that PROP is that mob outside yelling “She’s a witch, BURN HER.” Yet they have no idea what a witch is.

  3. Elly Raborn at 1:21 am

    I suffer from chronic pain since mid 90’s, I waited 1 year until the pain became so bad after I broke my neck, had 2 failed cervical fusions with titanium plate that caused the 2nd surgery due to pressure from it caused me severe choking, pain from a anterior plate and limited ROM and herniated the last cervical disc! I could not live without pain medicine, nor meds for muscular spasms & peripheral neuropathy in my legs plus severe fluid retention, which I must use Lasix occasionally.c3-5 fused with plate & 6 screws, then in 02 removed plate & screws, removed herniated disc & donated bone placed in and secured. All went well, but my chronic pain didn’t . I can’t imagine not having my medication to control myself or kept it in a level I can focus on life, otherwise I don’t know what I would do. I have pain mgt. MD which is very strict requiring a monthly UA to test for the level of my med. & a signed contract too. This is in Hou.Tx., I use same pharmacy and they know me so I get my meds. I hope the USA does not get between the pt.& Dr.or many will seek underground methods like THC in food or some manner! Works wonders on many other pts. Where allowed, if I could move and get on edible form I would. Well, that’s my thoughts, thank you from a Nurse-BSN!

  4. Rainey at 11:28 pm

    The FDA should not have changed prescribing guidelines. Sorry. I feel like it is giving in. PROP’s agenda (90 day supply for severe pain, cancer pain only) is unrealistic and will leave a lot of chronic pain patients without treatment. Heavier regulation will not address addiction either. If people want these drugs, they are going to get them. These guidelines will go far in spurring black market demand, while putting physicians who prescribe long acting/ extended release opiates under additional unnecessary scrutiny.