The FDA announces a public meeting and open call to chronic pain patients to share their thoughts on symptoms, life-impact and approaches to treatment.
Since the release of the CDC Guidelines for Prescribing Opioids for Chronic Pain in 2016 many chronic pain patients have suffered from excessive cutbacks to their pain management. Numerous articles and scientific papers have been published shining a light on the failure to consider the needs of the chronic pain community.
An article from Clinical Pharmacology & Therapeutics titled “The CDC Opioid Guideline: Proponent Interpretation Has Led to Misinformation”(Wegrzyn et al. 2018) concludes:
“Chronic opioid therapy should be considered as one tool for providers along with other pharmacologicals and non-pharmacologicals. When used properly, opioids have proven to be an excellent tool for millions of people experiencing chronic pain.”
Another from the same journal, “Critiquing the CDC Opioid Guideline: Some Light from the Heat”(Juurlink 2018) points out that:
“Misapplication of the CDC’s dosing guidance has spawned an untold number of rapid, forced dose reductions, precipitating withdrawal and its attendant suffering. This is inexcusable.”
An article in the Journal of Pain Research titled “Pain Management, Prescription Opioid Mortality, and the CDC: is the devil in the data?”(Schatman and Ziegler 2017) points at the failure to clearly distinguish between licit and illicit opioid statistics:
“While there is clear evidence that (the increase in unintentional overdose) is driven by the use of illicit opioids such as heroin or illicitly manufactured fentanyl derivatives, this particular fact continues to get lost in the shuffle and results in knee-jerk reactions calling for the reduction of both the supply and use of prescription opioids. People who are not adequately treated for their pain will seek out alternatives, often harmful alternatives that can lead to addiction, unintentional overdose, or even suicide.”
Furthermore, the CDC’s recommendations have often been interpreted as inflexible federal mandates by legislators and health professionals rather than thoughtful suggestions they are. This overreaction has led to reductions in, or complete discontinuation of, effective pain management for the 100 million chronic pain sufferers in America. The situation is desperate, even leading to an increased rate of suicides in the chronic pain community. One wonders how different the climate would be if the CDC had invited comment from those they intended to help.
The FDA is now taking a step to include and focus on the opinions of chronic pain patients in their “Patient Focused Drug Development for Chronic Pain”. According to the FDA:
“The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting and an opportunity for public comment on “Patient-Focused Drug Development for Chronic Pain.” The public meeting will provide patients (including adult and pediatric patients) with an opportunity to present to FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments. FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies.”
This public forum was announced by the FDA on May 15, 2018. The FDA will hold a public meeting on July 9, 2018 from 10 a.m. to 4 p.m. FDA is accepting electronic and/or written comments up until September 10, 2018.
If you wish to comment confidentially you should submit by paper. All the details you need to do that are on the FDA announcement page, here.
The deadline for accepting comments is September 10th. The public meeting will happen in Washington D.C. on July 9th. Find out how you can attend the live event by clicking here.
People with chronic pain have gone unheard by policy makers. If you are a patient or caregiver, seize this chance! We at Patients Rising will help in any way we can to get the word out and make this process easier. Nothing is as important as YOU SHARING YOUR VOICE WITH THE FDA DIRECTLY using the links above.
SHARE THIS ARTICLE WITH YOUR FACEBOOK GROUPS, INSPIRE.COM COMMUNITY, CAREGIVERS AND ANYONE YOU CAN THINK OF WHO NEEDS TO BE HEARD. THIS IS OUR CHANCE!
Juurlink, David N. 2018. “Critiquing the CDC Opioid Guideline: Some Light From the Heat.” Clinical Pharmacology & Therapeutics 103 (6): 966–68. https://doi.org/10.1002/cpt.1061.
Schatman, Michael E, and Stephen J Ziegler. 2017. “Pain Management, Prescription Opioid Mortality, and the CDC: Is the Devil in the Data?” Journal of Pain Research 10 (October): 2489–95. https://doi.org/10.2147/JPR.S153322.
Wegrzyn, Erica L., Ausim M. Chaghtai, Charles E. Argoff, and Jeffrey Fudin. 2018. “The CDC Opioid Guideline: Proponent Interpretation Has Led to Misinformation.” Clinical Pharmacology and Therapeutics, April. https://doi.org/10.1002/cpt.1062.
Jim Sliney Jr. is a Registered Medical Assistant and a Columbia University trained Writer/Editor who creates education and advocacy materials for patient support groups. He has worked closely with several rare disease communities. Jim also coordinates the patient content for PatientsRising and collaborates with other writers to hone their craft. He’s a native New Yorker where he lives with his wife and all their cats. Connections: Twitter Quora Email