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 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.
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