Green Eyed Angel

@DrMakaryFDA, why take away the one medication that brings relief BEFORE finding an effective substitute? The FDA’s new draft guidance on “Development of Non-Opioid Analgesics for Chronic Pain” is a guide for drug companies to make safer non-opioid pain meds faster. Thank you for fast-tracking these meds to help the chronic pain community and acknowledging the failure of present options available to us—but why restrict opioids now, before these fixes are ready? You read that right! The FDA finally admits—what we’ve screamed for years—that today’s options fall short for many, leaving pain untreated. Yet they’re unhappy this failure of non-opioids requires people to take opioids for relief—proving we need those opioids until real alternatives arrive. Their words: “Despite the availability of these treatments, a substantial proportion of patients with chronic pain have pain that is inadequately treated with non-opioid analgesics, with some requiring initiation of opioids.” The guidance goes on to infer the urgency for new medications is because opioids carry “risks of abuse, misuse, addiction, overdose, and death.” Since this guidance is focused on chronic pain patients, this is a smear and flat-out lie that pain patients are becoming addicted and OD’ing on their prescription opioids—especially when you’re restricting access before safer options exist. It’s alarming that the FDA is either unaware of the true data on chronic pain patients or purposefully continuing to slander pain patients and opioid medications. Truth: • Prescribed opioids aren’t the cause of addictions or ODs. • Unprescribed Tylenol has far more ODs per year (~500 deaths, 56K-78K ER visits). • Opioid ODs come from illicit fentanyl, not us. • Pain patients already comply with urine tests, pill counts, etc., to verify we’re taking meds properly without abusing. While adding non-opioid options is great—it’s not “saving” us from addiction or ODs because chronic pain patients use opioid prescriptions safely and get relief not a buzz—so why pull them before substitutes are here? These potential “future” fixes are years off? So, why do we have opioid medication restrictions hitting now: shortages, forced cuts, doctors arrested, and patients abandoned, while other available options fail? In your own FDA guidelines you verify that present options are not good enough but have already taken away the one reliable relief medication. How does that make any sense? It’s a punishment to pain patients. We’re not addicts—we’re patients who need effective relief NOW! Remove restrictions on opioid medications for chronic pain patients. Chronic Pain Warriors: Submit your comments on this guidance by Nov 10 here: regulations.gov/document/FDA-2…. Let’s demand better! #ChronicPain #PainManagement #Opioids #TLChronicPain💜