Response to the Request for Comment by the Food and Drug Administration (FDA) on
Patient Focused Drug Development for Chronic Pain[1]
Docket No. FDA-2018-N-1621
September 4, 2018
Not Dead Yet is a national grassroots disability rights organization, and some of us are living with chronic pain ourselves. Thank you for the opportunity to comment on the impacts of chronic pain, treatment approaches for chronic pain, and challenges or barriers to accessing treatments.
Perspectives of People With Chronic Pain
Based on our knowledge of the disability community through personal experience and through our work, we have rarely, if ever, seen disabled people with chronic pain experiencing opioid use disorder. What we are seeing is many disabled people who are suffering due to the lack of access to opioid medication[2] previously available as part of comprehensive strategies and approaches to address chronic pain. They are experiencing an increase in chronic pain and other symptoms associated with that pain. Disabled people and others with chronic pain are rarely the ones who are abusing opioids,[3] but they are the ones who are having to deal with chronic pain symptoms without access to medications that made this pain more tolerable. To put it simply, use of prescribed opioids may enhance the ability of some individuals to better manage their lives.
That is not to say that some disabled people will not have opioid use disorder. However, from our observation, chronic pain is not a causal factor[4] in who has abused opioids. Instead, opioids are a mitigating factor in how independent those with chronic pain are able to be. Having to deal with chronic pain with no relief, when opioid medication prevented such pain, can greatly affect the quality of life[5] disabled people with chronic pain have. It can affect their ability to perform activities of daily living. It can affect their ability to sleep. It can affect their mood. It can affect their productivity. Those with chronic pain that is untreated or mistreated are more likely to be depressed,[6] and depression itself can also be linked[7] to physical pain. Being depressed and in pain can also make disabled people more susceptible to suicidal ideation,[8] especially when there is seemingly no relief to the long-term pain they experience.
For some disabled people, opioids are the only medication or treatment that can help their pain. Now those who have chronic pain are treated with suspicion,[9] as though they are abusing opioids, especially by medical personnel at doctors’ offices and hospitals. This is an even greater problem for people of color who have chronic pain, whom studies show already experience serious disparities in pain treatment.[10] Doctors are increasingly afraid and unwilling[11] to prescribe opioids, so instead of continuing effective treatment for those who have seen significant documented benefits from using these medications, too often doctors are essentially abandoning those who truly need access to opioids.
Perspectives of Medical and Health Professionals
Opioid abuse is a problem, but it is not a problem for the overwhelming majority[12] of the disability community or others with chronic pain. It’s a problem for those who have already been abusing these medications. Those are typically not people who need these medications to handle long-term chronic pain.
In response to a recent Oregon Medicaid proposal to severely limit opioid prescribing, a group of respected pain specialists and policy experts sent a letter shared in the National Pain Report (“Schatman letter”). The letter’s authors included the Editor-in-Chief of the Journal of Pain Research at Tufts University School of Medicine; past President of the American Academy of Pain Medicine; Executive Director of the Academy of Integrative Pain Management; and ten other medical, legal and public policy experts. [13] They stated:
Concerns regarding a Center for Medicare and Medicaid Services (CMS) proposal to permit denial of coverage of long-term opioid therapy above 90 MME [morphine milligram equivalents] . . . prompted strong objection from architects of the 2016 CDC guidelines and leading experts in addiction and pain medicine. Among their objections was the lack of evidence of benefit from compelled tapering and considerable anecdotal evidence of harm, ranging from medical decline to suicide. . . . Recognizing these potential harms, CMS declined to go ahead with a hard edit at 90 MME. [Citations omitted.]
Diederik Lohman, Director of Health and Human Rights for the widely respected non-profit Human Rights Watch has stated “the right balance needs to be found between keeping opioids off the street and making sure medications are still available to legitimate patients.” In many third world countries, opioid medications like morphine are nearly impossible to obtain. Lohman, in describing how Human Rights Watch came to view untreated pain as a human right in this country, has said, “…we started hearing more and more stories of chronic pain patients in the U.S. who had been on opioids, who were being told by their physicians that ‘We have to take you off.’ And we started hearing stories of patients who were having a lot of trouble finding a doctor who’s willing to accept them as a patient.”[14]
The Real Causes of Opioid Overdoses and Deaths
The public and many policy makers tend to want very complicated, multi-faceted social issues to be simplified. Crucial distinctions are blurred. Nuances are overlooked. For example, fentanyl has been seen as a prescription opioid, i.e. a doctor can prescribe it under appropriate circumstances. In recent years, though, deadly knock offs of fentanyl have become increasingly available from dealers. Thus, an editorial in the American Journal of Public Health recently argued that the death rate from prescription opioids is inflated by including deaths where synthetic opioids like illicitly manufactured fentanyl (IMF) play a role, as the Centers for the Disease Control and Prevention has traditionally done. When death related to synthetic opioids (most of which involves IMF) is excluded from the calculation, the number of deaths from prescription opioids in 2016 decreases from 32,445 to 17,087.[15]
A recent article in the Boston Globe provides additional data on the role of illicit fentanyl:
Fatal overdoses continued to decline in Massachusetts in the second quarter of 2018, but a new challenge has surfaced as deadly fentanyl gets mixed with cocaine, a drug now found in more overdose deaths than heroin, authorities said Friday.
The devastating and growing prevalence of fentanyl was the dominant message in the state’s latest quarterly report on opioid-related deaths, released Friday. Fentanyl — the illicit synthetic, not the drug doctors prescribe — was present in nearly 90 percent of overdose deaths.[16]
As the Schatman letter documents:
[C]urtailed opioid prescribing has not correlated with a reduction in drug-overdose deaths. Although prescribing has dropped every year since 2012, drug overdose deaths during the same period have skyrocketed as the crisis has evolved to feature heroin and illicitly manufactured fentanyl and its analogs. Even most deaths that involve a prescription opioid are polypharmacy – often including illicit drugs, benzodiazepines and other CNS depressants, and alcohol – and most misuse is non-medical. [Citations omitted.]
And finally, as the Pain News Network has written, “To be clear, one overdose is too many. But if we are ever going to find real solutions to the overdose crisis, we need to find accurate numbers to reflect what is causing so many drug deaths. Pinning the blame on prescription opioids, pain patients and prescribers has only led to a growing catastrophe in pain care…”[17]
Misguided Approaches To Addressing the Opioid Crisis
Understandably, legitimate pain patients and prescribers are easier to target than illicit drug traffickers but, as both pain patients and medical experts tell us, this misguided approach will not solve the overdose crisis and is already causing unacceptable harm to real people and their families. As these misguided approaches are hastily undertaken across the country, the very individuals who benefit greatly in terms of health and productivity from continued opioid use as part of a comprehensive pain management strategy are now the people who face the most scrutiny and harm by not having access to medically necessary and appropriate medication.
Despite the stiff opposition of chronic pain and disability advocates, as well as many in the medical community, Oregon is considering a first-in-the-nation proposal that would end coverage of opioids for chronic pain patients enrolled in Oregon’s Medicaid program unless a specific exception was granted for an individual. Patients would be forced to have their opioid doses tapered to zero over a twelve month period regardless of whether or not they were showing signs of addiction or other negative health consequences. The proposal would not apply to people with pain from cancer or a few other diseases, however, most persons with chronic pain with disabling conditions would be affected.[18] Patients would be able to get therapies like yoga and acupuncture but that may be scant comfort to a person with an upper level spinal cord injury whose pain from muscle spasms can only be managed by prescription opioids.
The proposal unreasonably interferes with the patient-doctor relationship and is counter to pain management principles. It comes close to implying that Medicaid patients on prescribed opioid medication for chronic pain are trumping up their pain and perhaps their disabilities. It would do nothing to address the crisis created by street drugs. As the Schatman letter stated:
The Oregon proposal is the most restrictive in the country and is unsupported by current treatment guidelines related to opioid prescribing, including those issued by the Centers for Medicare and Medicaid Services (CDC) in 2016, Canada in 2017, the U.S. Veteran’s Administration, and professional medical associations. . . . According to Tamara Haegerich of the CDC, the guideline does not provide “support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources.” Under both guidelines, for patients with managed risks who experience a loss of function or an escalation in pain, tapering should cease. . . . The denial of coverage to the Medicaid population, in particular, is likely to have a disproportionate impact on individuals with disabilities, on the sickest patients and those with multiple chronic conditions.
The proposal must not be implemented and no state must implement anything like it.
Apart from the Oregon proposal, it should also be noted that alternative therapies to treat pain are often not covered by insurance and may be unavailable to people with chronic pain for geographic or other reasons. Providers of alternative therapies may also be inaccessible to people with disabilities. And even people who can access the alternatives may find that they are either not helpful, or that they are most helpful when combined with opioids as part of a comprehensive/multi-faceted pain management plan. As the Academy of Integrative Pain Medicine has stated “For some patients, access to opioid medications to manage their daily pain is necessary; for others, nonpharmacological methods alone provide sufficient relief; and, for many, it’s a combination of both.”[19] These realities must not be ignored in formulating policies to address the opioid issue.
Recommendations Concerning Proposed Federal Legislation
H.R. 6 (“The Support for Patients and Communities Act”) is now before the United States Congress. [20] We are unable to do a full scale analysis as to how the act would impact people on prescription pain medication for chronic pain but we would like to point out a few things. We encourage the development of effective non-opioid drugs for chronic pain (Section 6032) and think that this portion of the act should be clarified and elaborated on. We are also in favor of providing funds to support education and outreach to prescribers of opioids about best practices for prescribing opioids, although Section 6052 should be broadened to apply to doctors in general and not just to “outlier prescribers”. The goal should be that all relevant providers learn that prescription opioids can be a valid part of a pain management program and what constitute best practices, just as providers learn best practices in other areas of medicine. Groups representing chronic pain patients as well pain management experts should be involved in identifying and developing best practices.
We do have concerns about the requirement in Section 2003 that new Medicare patients who have opioid prescriptions be screened for opioid use disorder. Section 2003 taken by itself renders suspect people who take prescription opioids in the proper dosage as part of a medically supervised pain control plan, placing the burden on these individuals to show they are not abusing drugs. This is unacceptable. At a minimum, Section 2003 must be counterbalanced by adding new provisions that fully acknowledge the legitimate role that prescription opioids can play in alleviating chronic pain.
We note that under Section 3004, the FDA is required to provide “high-quality, evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain.” This requirement should be broadened to include guidelines for indication-specific treatment of chronic pain as well.
Apart from H.R. 6, we encourage the FDA to promote the development and delivery of better, safer and more effective pain medications.
Certainly, the public must be educated about the dangers of illicitly manufactured opioids and the toll they are taking on the country. However, the FDA along with other federal agencies must recognize the harmful effects of a misguided crackdown on the legitimate use of opioids for chronic pain, educate state governments and providers about research on this issue, and discourage federal, state and local programs that do more harm than good in addressing the opioid crisis.
Thank you for your time and consideration.
Submitted by:
Diane Coleman, JD, President and CEO
Dominick Evans, Member, Board of Directors
Lisa Blumberg, JD, Consultant
[1] https://www.regulations.gov/document?D=FDA-2018-N-1621-0001
[2] Andrew Rosenblum, et al., Opioids and the Treatment of Chronic Pain: Controversies, Current Status, and Future Directions (2008) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2711509/
[3] Maia Szalavitz, Opioid Addiction Is a Huge Problem, but Pain Prescriptions Are Not the Cause (Scientific American, May 10, 2016) https://blogs.scientificamerican.com/mind-guest-blog/opioid-addiction-is-a-huge-problem-but-pain-prescriptions-are-not-the-cause/
[4] Michael A, Yokell, et al., Presentation of Prescription and Nonprescription Opioid Overdoses to US Emergency Departments (Jama Intern Med, Dec 2014) https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1918924
[5] McCarberg BH, et al., The impact of pain on quality of life and the unmet needs of pain management: results from pain sufferers and physicians participating in an Internet survey (Am J Ther 2008) https://www.ncbi.nlm.nih.gov/pubmed/18645331
[6] Bair MJ, et al., Depression and pain comorbidity: a literature review, (Arch Intern Med, Nov 2003) https://www.ncbi.nlm.nih.gov/pubmed/14609780
[7] Madhukar H. Trivedi, M.D., The Link Between Depression and Physical Symptoms (Prim Care Companion J Clin Psychiatry, 2004) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC486942/
[8] Beverly Kleiber, et al., Depression and Pain (Psychiatry, May 2005) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3000181/
[9] Chronic pain patients say opioid crackdown is hurting them (Chicago Tribune, June 5, 2017) http://www.chicagotribune.com/lifestyles/health/ct-opioid-patients-backlash-met-20170603-story.html
[10] “Study Links Disparities In Pain Management To Racial Bias,” UVA Today, April 4, 2016, https://news.virginia.edu/content/study-links-disparities-pain-management-racial-bias; “Black patients half as likely to receive pain medication as white patients, study finds,” The Guardian, August 10, 2016, https://www.theguardian.com/science/2016/aug/10/black-patients-bias-prescriptions-pain-management-medicine-opioids
[11] Kelly K. Daneen, et al., Between a Rock and a Hard Place: Can Physicians Prescribe Opioids to Treat Pain Adequately While Avoiding Legal Sanction? (Am J Law Med 2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494184/
[12] Nobel M, et al., Opioids for long-term treatment of noncancer pain (Cochrane, Jan 2010) http://www.cochrane.org/CD006605/SYMPT_opioids-long-term-treatment-noncancer-pain
[13] Schatman, M. et al., U.S. Chronic Pain Practitioners and Scientists Comment on Oregon Forced Taper Proposal (National Pain Report, July 31, 2018) http://nationalpainreport.com/u-s-chronic-pain-practitioners-and-scientists-comment-on-oregon-forced-taper-proposal-8836865.html
[14] Anson, P. Human Rights Watch Investigating US Pain Treatment, Pain News Network. March 15, 2018 https://www.painnewsnetwork.org/stories/2018/3/15/human-rights-watch-investigating-treatment-of-pain-patients
[15]Seth, P. et al., Quantifying the Epidemic of Prescription Opioid Overdose Deaths, American Journal of Public Health, March 2018 https://ajph.aphapublications.org/doi/10.2105/AJPH.2017.304265
[16] The scourge of fentanyl is more clear in the battle against opioid use, Boston Globe, August 24, 2018 https://www.bostonglobe.com/metro/2018/08/24/with-fentanyl-flooding-illicit-market-all-drug-users-now-danger/GCYjSAKx0Q6m4hOL3T3eGJ/story.html
[17]Anson, P., CDC Admits Rx Opioid Deaths “Significantly Inflated”, Pain News Network. March 21, 2018 https://www.painnewsnetwork.org/stories/2018/3/21/cdc-admits-rx-opioid-deaths-significantly-inflated
[18] Facher, Lev., Tapered to Zero: In a Radical Move, Oregon’s Medicaid Program Weighs Cutting Off Chronic Pain Patients from Opioids, August 15, 2018 https://www.statnews.com/2018/08/15/oregon-medicaid-tapering-opioids/
[19] Schatman, M. et al., U.S. Chronic Pain Practitioners and Scientists Comment on Oregon Forced Taper Proposal (National Pain Report,July 31, 2018) http://nationalpainreport.com/u-s-chronic-pain-practitioners-and-scientists-comment-on-oregon-forced-taper-proposal-8836865.html
[20] https://www.congress.gov/bill/115th-congress/house-bill/6/text#toc-H6AF5290276BF4FB38596EDBFDD234601