February 23, 2016
Food and Drug Administration
Bldg. 1 Rm. 3309, 10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting on March 1, 2016. The Science Board will hear about and discuss: (1) The role of opioids in pain management; (2) scientific challenges facing FDA in supporting the development of pain medications, including opioids, that have reduced risks of being abused; (3) scientific challenges facing FDA in seeking to understand the real-world use of opioids to treat pain, including the impact of opioids with potentially less risk for abuse; (4) the role that FDA plays as a part of a larger Federal, State, and local response to the challenges of providing appropriate pain treatment while reducing opioid abuse; and (5) postmarket surveillance activities related to opioids. The Science Board will also receive a final report from the Centers of Excellence in Regulatory Science and Innovation Program Evaluation Subcommittee.
After much consideration about how to address the five discussion points for the meeting on March 1, 2016, I decided to write a “just the facts, ma’am” patient perspective letter and attach the important article, “An Online Survey of Patients’ Experiences Since the Rescheduling of Hydrocodone: The First 100 Days” reflecting the consequences to chronic pain patients to this major policy change. (http://painmedicine.oxfordjournals.org/content/early/2015/12/25/pm.pnv064 Pain Medicine.)
It’s hard to choose which kind of chronic pain to comment on first—searing, stabbing, electrifying, deep, aching, tingling, throbbing, shooting, burning, dull, stinging, pulsing, constant, tightening, local, widespread, pressured, or cramping. Sometimes five or six pains (or more) strike at once or build one upon another. Most chronic pain patients report that unmanaged or untreated chronic pain increases in severity.
Living with a chronic pain condition is breathtaking and brain seizing. Literally. With sharp pain, people grab their back or stomach or head or neck, and suck in a breath of air when a cutting pain stabs into their awareness and seizes their brain. They can think of nothing else then. All of their attention is on that pain: how to stop it, prevent it from increasing, and fear of it getting worse. (Suicidal ideation occurs in 27.2% of this population.) Then they immediately compensate their bodies by dropping a shoulder, turning a hip, laying on the floor, etc. to avoid more pain. If the pain eases, their shallow breathing gradually ceases, blood pressure normalizes, but they remain motionless and afraid to move because it may cause the pain may to return. Their lives are centered around how to survive with serious chronic pain and finding courage to face a lifetime of chronic pain.
What happens when that breath-taking pain occurs regularly, frequently, and unexpectedly? Or when widespread, serious flu-like body pain increases with sensory input? People inhibit their movements, become less active, and refrain from social engagement. Functionality decreases, fatigue sets in, mental well-being diminishes, and empathy from others is worn out. People suffer pain in silence and are shamed into not speaking publicly about their pain. People become chronic pain patients in a medical system that does not support them. In this current political climate, pain patients are stigmatized by being treated like criminals when they seek pain relief. Many chronic pain patients are unkindly questioned and challenged at every turn about their pain levels and chronic pain longevity by medical providers in clinics and emergency departments, pharmacists, and insurance companies.
State legislatures, governors, attorney generals, medical societies, Congress, policy makers, insurance companies, and other controlling entities are showing concern about only one of two serious, and directly related, national health crises: substance use disorder while ignoring chronic pain. It’s pretty simple to understand: Prescription opioid medications exist because pain exists. If America had better treatments for pain, patients would be less reliant on opioids for pain relief. Major pain research in America to discover new treatments and the efficacy of current integrative treatments not covered by insurance is necessary and logical.
In the torturous times of existing (please notice I didn’t say living) with serious chronic pain, chronic pain patients are offended when told that if they learned better life coping skills, or gained biofeedback tools, their suffering would be lessened or relieved. Applying pain is used as torture to extract information or actions from someone who is imprisoned against their will. How can there ever be an acceptable excuse or reason to legally cause people to live in torturous pain by withholding pain relief such as a prescription pain medication? Addiction and illegal use of opioids, whether heroin or a prescription drug, are not caused by people suffering with chronic pain. Chronic pain is a disease, and people with chronic pain deserve to be treated with as much dignity and concern as any other medical condition.
The recent comments by loud and ardent voices questioning whether treating pain levels is the point of pain management are ludicrous. This is inhumane and laying groundwork for legalizing torture. The leaders of pain relief advocacy chose not to compare statistics of people who contemplate or complete suicide because of chronic pain against the number of people who die from an opioid-related death. Those loud voices should be joined with the leaders of pain relief advocacy to focus on treating and researching both diseases: opioid addiction and chronic pain. The leaders of pain relief advocacy organizations support research for addiction (opioids, including heroin) and do not understand why chronic pain is not researched as a major public health crisis.
The media rarely interviews chronic pain patients who are suffering; they don’t pick up on our national surveys that show 27.2% of people with chronic pain have suicidal ideation. How can that be ignored? Few federal officials in the U.S. Department of Health and Human Services, nor its leadership, ask the patient advocates or chronic pain patients why such high suicidal ideation occurs, even though we’ve brought it to their attention. Our national surveys tell us why: for people with serious chronic pain, they question the quality of their pain-filled lives.
As a patient advocate, I’ve advocated hard and for a long time to advance abuse deterrent formulations for all opioid prescriptions. Insurance lobbyists drown out the voices of patient advocates and patients who are constituents of elected officials, claiming that the increased cost per person would drive up health care. Is the cost of addiction to society and to insurance companies more than the increased insurance costs of abuse deterrent formulations? If only abuse deterrent formulations were available, the prescription opioids wouldn’t be attractive to abusers.
Prescribing methadone as a pain medication without abuse deterrent formulation through Medicaid should be stopped. This is a gateway drug to more addicting opioids and heroin. Lawmakers and policy makers should be honest with their constituents and tell them why they don’t vote for abuse deterrent formulations.
On tonight’s PBS News Hour, Governor Charlie Baker of Massachusetts paraphrased President Barrack Obama by saying “states are laboratories and should try different approaches to driving down opioid abuse. Maybe the federal government will adopt one of those state strategies.” Governor Baker seemed to like the idea. Frankly, that’s terrifying – encouraging state legislatures, attorney generals, and governors who are not medically trained to make arbitrary and capricious, and moreover “experimental,” laws about access to pain relief and opioid treatments on the whim of “let’s see what happens.” Policymakers lacking personal experience with serious chronic pain are making hasty and scientifically unsupported policies about access to care for people with chronic pain.
Please stop harming people suffering with chronic pain by making policies with “unintended consequences” in the effort to curb all of the problems with opioids. Why isn’t HHS monitoring the significantly negative consequences of policy on the people with chronic pain?
Chronic pain is not a lifestyle choice. Addiction is not a lifestyle choice. They must both be addressed at the same time with major research.
Jan Favero Chambers, President/Founder
National Fibromyalgia & Chronic Pain Association
attachment: PDF “An Online Survey of Patients’ Experiences Since the Rescheduling of Hydrocodone: The First 100 Days”
March 1, 2016
Public Comments by Jan Chambers to the Science Board to the U.S. Food and Drug Administration Meeting on Opioids in Pain Management
White Oaks Campus, Silver Spring, Maryland
"I have no conflicts of interest.
Hello. Thank you for the opportunity to make a public comment today.
My name is Jan Chambers. I am the president and founder of the National Fibromyalgia & Chronic Pain Association. Our mission is to unite patients, policy makers, and healthcare, medical and scientific communities to transform lives through visionary support, advocacy, research and education of fibromyalgia and chronic pain illnesses.
Pain is felt as searing, stabbing, electrifying, deep, aching, tingling, throbbing, sharp, shooting, burning, dull, stinging, pulsing, constant, tightening, local, widespread, pressured, cutting, cramping, and more. Often several pains strike at once or build one upon another. Pain disturbs restorative sleep and can be 24/7. Unmanaged or untreated chronic pain often increases in severity. Living with a chronic pain condition is brain seizing. Literally. When in serious pain, people think of nothing but how to stop it. They cease working, studying, parenting, and contributing. Pain is exhausting and weakens the immune system, bringing on additional health problems. Unmanaged chronic pain feels like torture.
Applying pain is used as torture to extract information or actions from someone who is imprisoned against their will. How can there ever be an acceptable reason to legally cause people to live in torturous pain by withholding pain relief such as a prescription pain medication? Addiction is not caused by people who suffer with chronic pain.
Our current dual problem is pretty simple to understand: Prescription opioid medications exist because pain exists. Policy makers are currently concerned about only one of two serious, and directly related, national health crises: substance abuse disorder while ignoring chronic pain. Chronic pain and addiction are both diseases; they are not lifestyle choices. Both are major public health issues and must be addressed as such. Public policy and our healthcare system have failed both populations. 100 million American adults suffer with chronic pain conditions. That is more people than heart disease, diabetes, and cancer combined.
We sponsored a large survey published recently in Pain Medicine about the “unintended consequences” from the rescheduling of hydrocodones. The majority of more than 6,000 survey responders experienced problems and barriers to pain management.
Of those who could no longer get hydrocodone, 18% borrowed pain medications, 17% turned to marijuana, 13% added alcohol, 2% added illicit drugs. 64% had more visits to their healthcare provider, 30% had some type of issue interacting with their pharmacy, and most felt that the rescheduling was neither a fair nor an appropriate solution to the abuse of hydrocodone. For those still working, 46% missed work because of the stricter regulations. And the sickening part is that 27.2% reported having thoughts of suicide. Rescheduling has harmed legitimate chronic pain patients. We need serious monitoring of policy consequences intended to curb opioid abuse.
Pain patients want safe pain relief medications and treatments. Doctors and others caring for them need education, appropriate reimbursement for providing comprehensive care and a policy environment that allows them to act as professionals and use their knowledge and experience to improve the lives of their patients. Abuse deterrent formulations should be mandatory on all opioid medications. Americans struggling to live with these diseases need comprehensive care that often includes medication, behavioral health, complementary therapies, compassion and respect.
There would be less reliance on prescription opioids for pain relief if better pain treatments were accessible. We need major research in bench science of pain AND comparative research of integrative, holistic therapies, including chiropractic, yoga, and nutrition.
As a chronic pain patient and speaking on behalf of millions of others, I say strongly, “Please stop harming people suffering with chronic pain by making policies with “unintended consequences” in the effort to curb all of the problems with opioids. State legislators, governors, attorney generals and insurance companies look to the federal agencies for guidance. Policies, recommendations, and laws must not be laboratories trying different approaches to drive down opioid abuse and addiction at the expense of people with pain.
Supportive policies, research, and education are needed jointly for addiction and chronic pain.
Working together, we can
- make a difference,
- find solutions,
- advocate for better access to care for chronic pain and addiction
- encourage and fund research that leads to better treatments."