Legislative Alerts and Updates

This section contains timely and important news of new, proposed, pending, or changing laws concerning any aspect of being a long-term chronic pain patient. Currently, these have been aimed at reducing the availability of several drugs upon which millions of us and others rely to get through each day. Unfortunately, as RSD/CRPS patients and/or their caregivers, we are part of the controlled substances (CS)-using population, and the laws concerning CS use often change. These changes are seldom good for us or our physicians, as the DEA continues to meddle in the business of pain medicine.

These items are listed in the order of importance for citizen activism (that means YOU!!),
i.e., writing letters, making a few calls, etc., to try to influence congresspeople to vote the right way.
PLEASE do these things - it's the ONLY WAY to make our voices heard and count!!!

Currently, all important issues concern the availability of opioids for patients with chronic, non-cancer pain (like us). The issues are listed in the order of the importance of citizen action in affecting their outcome, where #1 is the most important.


      1. Survey on Pain Medication Availability - ACTION NEEDED!!!

A survey on the availability of pain medications is being done by the National Fibromyalgia and Chronic Pain Association. It's only about a half dozen, single-answer questions, and I really urge everyone who reads this to fill out the survey. It's not often that our voices about the availability of the pain medications we need can be heard in a large group! Here's the link:

http://www.rsdhope.org/crps-awareness-events--fundraisers.html


      2. Petition on Abuse-Deterrent Opioids - ACTION NEEDED!!!

A consortium of four groups has petitioned the U.S. FDA to reject non-abuse-deterrent opioid analgesics and, separately, to end the abstinence-only stance regarding approval of medications used for addiction treatment. Obviously, the first item would impact us and our community in very negative ways. Here's the petition, and here are the three main requests in the document:

  1. reject applications for new and generic opioid medications lacking abuse-deterrent features;
  2. acknowledge that patients tend to benefit from medication-assisted treatment (MAT) for substance abuse in various ways aside from staying drug-abstinent for prolonged durations; and
  3. provide additional guidance to the pharmaceutical industry that explains the requirements necessary for obtaining FDA approval and recognition as an abuse-deterrent opioid.

There are many ways that the public can express their reaction to these proposals. The best source, as it is so often, is a Pain-Topics.org article. In this case, it was authored by a guest author Stacey L. Sklaver, Esq., an attorney specializing in health issues. PLEASE read this article and take some of the suggested actions. We CRPS patients often feel helpless when the "powers that be" abuse us - well, here's your opportunity to fight back - please do it!!!


3. Relabeling of Opioid Medications

The FDA scheduled a public hearing on the use of opioids for February 7-8, 2013 from 9:00 a.m. to 4:00 p.m. (here's the Federal Register announcement (PDF; HTML). This action was prompted by the infamous PROP petition. It is too late to register for a personal appearance, but written and electronic comments were accepted until April 8, 2013.

I hope everyone who read this prior to the deadline took some action. It's hard to complain about the way upcoming legislation treats us if we don't take any action to prevent it when it's possible. To keep track of this issue, it's Docket No. FDA–2012–N–1172.


4. The PROP Petition updated graphic

Since the original publication of the PROP petition, professional organizations like the American Academy of Pain Management and the American Academy of Pain Medicine, have come out strongly against it. Now, the heavyweight American Medical Association (AMA) has weighed in, and are as against it as everyone else. This is an excellent development, as the AMA has huge political power (for better or worse), and the adoption of the PROP petition just got much less likely.

The "Physicians For Responsible Opioid Prescribing" is a group of physicians from many specialties (their head is a psychiatrist) that is proposing serious restrictions on the use of opioids for chronic, noncancer pain. Here are their three specific requested actions:

  • Strike the term “moderate” from the indication for non-cancer pain. (Instead of "moderate-to-severe", just "severe".)
  • Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.
  • Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain.

In my opinion, these are listed in order of increasing stupidity or danger, depending on how your mind works.

#1 - Dropping a subjective term (moderate) from another one (severe) isn't going to change a physician's mind on what to use in a given situation.

#2 - Setting an arbitrary limit (actually, any limit) on the maximum daily dose of opioids ignores the mountain of evidence that as tolerance grows, so does the dose needed to achieve the same effect as it did months or years before. Also, everyone reacts to opioids differently, including the dose needed for a particular response, usually based on genetic factors which are just now becoming clear. Would anyone support an upper daily limit on the amount of insulin that a diabetic is allowed to use every day?

#3 - This one is so much worse than #2 it's hard to believe that it was actually proposed. What it codifies is that if you have CRPS, diabetic neuropathy, get cluster headaches, suffer from a serious spinal cord injury, or suffer great pain from any source at all except cancer, you'd better hope it goes away after 90 days. There is so much scientific literature supporting the use of opioids for chronic pain that isn't caused by cancer, it seems that serious education is needed by the PROP crowd.

This is a knee-jerk response to the rise in accidental overdoses of prescription opioids, with the predictable idea of restricting access to the evil compound. The debate about cancer vs. noncancer pain has raged for decades, with the idea that cancer pain is always the worst finally starting to fade. CRPS was shown decades ago to be considerably more painful than the painful cancers, yet its sufferers are to receive a 90-day supply of pain relievers?

Predictably, many professional groups have come out against this proposal, the most visible being "Professionals for Rational Opioid Monitoring and Pharmacotherapy" (PROMPT), which was founded by Dr. Jeffrey Fudin. Others include the American Academy of Pain Medicine and the American Society of Anesthesiologists. A petition to the President against PROP is circulating, and sympathetic organizations are forming, such as the Advocates for the Reform of Prescription Opioids (ARPO). The controversy has also been highlighted in news sites like Pharmacy Practice News and Pain Medicine News, and individual physicians have begun publishing opinion pieces against the rescheduling proposal.

The Centers for Disease Control (CDC), unfortunately, has been a cheerleader for PROP's suggestions, and have published several slide presentations that present their case. The tenor of the presentations is not exactly unbiased - the positive effects of long-term opioid therapy for noncancer pain is not acknowledged at all. The "Educational Module" is called "Balancing Pain Management and Prescription Opioid Abuse", and features three sections. Check these out; it's important to know what the opposition is up to:


5. Rescheduling Hydrocodone Medications

For about a decade, the DEA has been trying to get hydrocodone products re-classified into Schedule 2 (C-II) from Schedule 3 (C-III). For a brief review, see this Medpage article. Their latest effort, begun last Fall, resulted in a two-day FDA hearing on the pros and cons of such a move. After the hearings, the panel voted 19-10 to endorse the DEA's recommendation.

However, the panel's vote is not binding, and the FDA has a history of denying this specific change to the DEA. In fact, last October, they published a short paper on their policies concerning hydrocodone, in which they wrote "There's insufficient evidence to support the Drug Enforcement Administration's (DEA) finding that hydrocodone-containing products have a similar abuse potential as Schedule II drugs and should be regulated as such." In fact, the ongoing disagreements between the DEA and FDA have been characterized as an "interagency war". This issue, unfortunately, has passed the point where citizen activism is possible.

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