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.
The 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 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.
National Pain Report welcomes other opinions.
The information in this column is not intended to be considered as professional medical advice, diagnosis or treatment. Only your doctor can do that! It is for informational purposes only and represent the author’s personal experiences and opinions alone. It does not inherently or expressly reflect the views, opinions and/or positions of National Pain Report or Microcast Media.