NFMCPA Public Letter to FDA REMS Meeting 2016

April 18, 2016  


Drug Safety and Risk Management Advisory Committee
Anesthetic and Analgesic Drug Products Advisory Committee
U.S. Food and Drug Administration
% Stephanie L. Begansky
10903 New Hampshire Avenue WO31-2417
Silver Spring, MD 20993-0002

Sent via http://www.regulations.gov

RE:  Docket FDA-2016-N-0820

Dear Committee Member,


Thank you for your service to the U.S. Food and Drug Administration in an advisory capacity.  America is depending on you to balance the two issues of pain and addiction in your recommendations to them.


Why are we being forced to look at pain and addiction as a major crossroads in our nation?  Why are they not parallel roads?  Opioid medications exist because pain exists:  If there were more and better treatments for pain, there would be less need for opioid medications.  The major reason people seek healthcare is because of pain – they need pain relief to work, parent, contribute to society and maintain a quality of life worth living.


Who should have been at the helm of the research ship guiding our nation towards scientific discoveries about pain over the last two decades?  Congress designated 2000-2010 as the decade of pain with the goal of addressing this major national problem.  Recognizing the impending catastrophe, The National Pain Care Policy Act was introduced annually in Congressional sessions beginning in 2003.  Provisions from the National Pain Care Policy Act 2009 were incorporated into the Health Care Reform Bill (which resulted in the Affordable Care Act), but a pain research agenda was not advanced!


Pain care advocates stayed the course and continued their efforts to raise the importance of pain research with Congress, resulting in the June 2011 IOM Report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.  The report recognized that 100 million American adults have life-altering, chronic pain.  However, despite the stark fact that opioid prescribing for pain was increasing, until pressured to do so, the Department of Health and Human Services chose not to engage with the IOM Report and its strong recommendations until  late in 2013.  DHHS called upon the Interagency Pain Research Coordinating Committee, a Federal advisory committee created from the Patient Protection and Affordable Care Act, to develop a National Pain Strategy (http://www.iprcc.nih.gov/National_Pain_Strategy/NPS_Main.htm).  The prompt action by the IPRCC culminated in a National Pain Strategy (NPS) that was delivered to DHHS in September 2014.  The NPS was released for 48-days of public comment in April 2015 following several public and Congressional requests.  The final NPS was released in March 2016, several days after the CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016.  After the public comment period closed, several significant changes to the NPS were made by DHHS which are supportive of the CDC Guidelines.   


To date, there still is no Federal agency, department, nor champion in DHHS who is responsible for implementing the National Pain Strategy.  There is no Congressional funding specifically for the National Pain Strategy nor major research.  What is wrong with this unbalanced picture?  Who can justify the promulgation of “unintentional policy/recommendation/laws/legislation consequences” to chronic pain patients of increased suffering, suicidal ideation, and consumption of alcohol and street drugs, etc. for pain relief?  The lack of leadership and responsibility by America’s trusted Federal health agencies and elected officials to implement a National Pain Strategy is mystifying and morally wrong.


Of major importance to pain patients and advocates is the elephant in the room:  Pain still exists.  It doesn’t disappear when accessibility to opioid medications is decreased.  One-third of America is (un)intentionally being harmed, marginalized, and de-moralized.  When laws, acts, policies, and recommendations are put into place restricting opioid pain treatments without offering effective alternative options, they are tatamount to legalizing torture.  People with serious pain are the reason opioid medications exist in the first place!  The appalling lack of concern by our elected and appointed Federal officials for the people with chronic pain is increasing their suffering and stigmatization, not to mention their diminishing livelihoods, quality of life, and health.  


Balance.  It’s a pretty simple proposition. To address the two sides of the same coin of pain and opioid addiction, implementing and funding the National Pain Strategy on par with opioid addiction efforts only makes sense.  The root problem, pain, must be addressed.  Just like a thorn deep in the flesh, it will continue to fester and affect the whole body, which is to say American society.


It is a disgrace that our nation’s most important resources are not protected:  hard working American citizens like you and I who are made vulnerable to the tentacles of inappropriately treated pain by the dearth of accessible, appropriate pain relief treatments and prevention.  Addictions occur to several substances:  tobacco, alcohol, and psychotropic drugs, and opioids.  All of these substances, except tobacco, are used to relieve pain.  Chronic pain is a disease.  Addiction is a disease.     

Being dependent on an opioid medication is villainized while dependence on thyroid medication is considered mainstream.  It is morally wrong to encourage stigmatizations about patients who are dependent on a strong pain medication as somehow being weak or inferior for needing these strong medications to relieve serious pain.  Dependence is not addiction.


Health insurance companies are for-profit entities.  No incentive exists for them to improve the coverage they provide for pain treatments.  While new opioid formularies are touted to be more effective, they often are not available due to tiered co-pays or unmet high deductibles.  From a patient perspective they are not safer than current opioid medications unless they are an abuse deterrent formulation.  Medical doctors infrequently guide pain patients to integrative treatment arrangements mostly because health insurance doesn’t cover those services.  Supportive chiropractic care compared to physical therapy, for example, has little coverage, and has become a health service for wealthier citizens.  With too few nonpharmacological tools to help their patients, physicians often turn to pain medications.   


Patients are consumers and purchasers of healthcare services.  All patients should be treated with respect and dignity.  Any changes to REMS or other documents and programs that are created should reflect that.  The current REMS Patient Counseling Document does not contain enough information for the patient to recall the many conversational points with the prescribing physician.  In the current REMS Patient Counseling Document, please incorporate the following:

  • “Talk to your healthcare provider: If the dose you are taking does not control your pain” to read:  “… if the medication you are taking does not control your pain.”
  • Opioid medications are part of an integrative treatment plan that includes physical activity, pain management goal setting, coaching, nutrition, prevention and education programs, and symptom tracking to understand causes of breakthrough pain or causal factors of increased pain.
  • Periodic evaluations of pain relief, pain control, functional goals for therapy, functional outcomes, side-effect frequency and intensity, and health-related quality of life will occur.  Use an app or a notebook to track your progress.  This will help you and your doctor have more productive medical visits.
  • How to properly dispose of unused opioids, and medications in general, should include where (i.e., toilet, drug take back locations).

A patient education training covering all REMS elements should be required for all patients receiving an opioid medication.   


All opioids should be an abuse deterrent formulation, even methadone.   


Study using a personalized medicine approach (i.e., genetic testing by PROOVE).  If more precise prescribing by matching patients with the right medication and dosages results in better pain relief and management, this could lead to a requirement that all patients have a genetic test before receiving an opioid so a prescriber knows the potential effectiveness before prescribing.


Physicians should be encouraged to prescribe opioids as part of an integrative treatment plan and not as a stand-alone intervention.


Thank you, again, for your time and service on these weighty issues.  We are depending on you to balance the two issues of pain and addiction in your recommendations.   


Sincerely yours,  


Jan Favero Chambers, President and Founder
National Fibromyalgia & Chronic Pain Association

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