DEFEATING PROPS FDA PETITION LIMITING OPIOIDS FOR PAIN
Two months ago I wrote a column for the American News Report (LIVING WITH PAIN: PROPS MISLEADING PETITION) critical of the Physicians for Responsible Opioid Prescribing’s (PROP) petition to the Food and Drug Administration (FDA) asking the agency to make changes to the labeling of opioid analgesics. Many have written that these proposed changes would lead to the drastic reduction of opioids available to pain patients.
I’m returning to this subject as a person in a position of knowledge at Health and Human Services has stated to some members of the pain action community that the public comments to the FDA docket regarding this petition are running 3 to 1 in favor of PROPS proposal.
It seems obvious to those who’ve seen the comments in support of PROPS petition that a great many of them are single sentences that repeat the same information leading to the tentative conclusion that PROP or another supporter of the petition has organized a group of individuals to send in the same, or very similar comments to pressure the FDA to adopt it’s radical, oppressive changes to opioid labeling.
The two most egregious changes PROP proposes are to limit the use of opioids to people suffering only from extreme pain, not those who suffer from moderate non-cancer pain. This would leave millions of people with chronic “moderate” pain out in the cold with little or no relief. Exacerbating this is the proposal that opioids be limited to those with extreme pain, but for only 90 days. These two proposals, as I stated in my last column, would lead to the reduction of medicines to pain patients and ultimately lead to the withdrawal of treatment as patients will either be considered to have moderate pain, or they would max out at the ninety day limit.
Andrew Kolodny, the addictions psychiatrist who is PROPS leader says that these changes will not lead to the complete withdrawal of these medicines as physicians will simply prescribe opioids off-label. Off-label simply means that the prescriber cites a diagnosis other than pain for which the medicine is to be used. Kolodny’s reasoning is disingenuous at best. Insurance companies are increasingly unwilling to cover prescriptions for drugs prescribed off-label and what physician doesn’t know this. It seems that most of PROPs goal is to separate pain patients from the opioids that make life bearable.
Kolodny denies this, but nowhere that I have seen he or PROP engaged in a balanced strategy that works to protect the public from diversion, illegal use, addiction and deaths while protecting the rights of people with pain not to live with torture. The International Declaration of Human Rights states that everyone should be free of torture. However, if PROP’s petition results in the labeling changes that they have proposed to the FDA it would lead to millions of people being forced into torture at the hands of those who have a moral duty to set a balanced approach to opioid care and by those morally charged to treat us, to mitigate the torture that has invaded our bodies.
Untreated moderate to severe pain leads to depression, isolation, and ultimately, suicide among the least powerful among us who can no longer deal with the desperation of invidious, unremitting pain. When a productive member of our society is felled by moderate to severe pain they most often lose their employment as they are longer able to work. If they are lucky, they can fall back on the financial support of their partner. This financial reliance is a chimera of sorts as the couple is now living on reduced income which subjects this family to being one paycheck from no health care and possible homelessness. And in this economy I imagine this happens far more than we want to believe.
I think that PROP’S initial motivation was solely linked to the scourge of opioid addictions and deaths that they spent their days and nights working on. They saw a serious public health issue and they responded. Yet as their campaign progresses their proposals have become more radical. PROP’s proposal is oppressive with human rights implications. If these proposals become FDA rules we could well be treated to, on a national level, the horrors of trying to find adequate treatment that now oppresses thousands of people with pain in Florida and Washington state. PROP is silent on this oppression.
People living with pain can fight back. The Docket is still open on PROPS petition with the FDA. Every person with pain, every spouse, child and caregiver needs to write a personal note to be published in the FDAs docket. You can go to the FDA at http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-00… This will take you to a page called regulations.gov.under which you’ll find a box titled Document Details. Go to the right corner of that box and click on Comment Now which will take you to a box called Submit a Comment. Enter your contact information on the left in the appropriate places then click on the Comments box on the right and write in your own words your story. When finished drop down to Submit Comment and click on the blue Submit button. You’ll be notified later that your comment has been submitted to the docket.
In my opinion, PROPs petition unmasks their true goal. Given the effect of these changes it is only logical to conclude that PROP and their supporters want to make these life-saving medicines rare if not illegal.
Defeating PROPs petition with our comments cannot be overstated. The proposed changes to manufacturer’s labels of opioid analgesics will be far reaching as it will be devastating.