Opiod abuse has become a serious issue in America. Both heroin and opioid pharmaceutical abuse have risen sharply.
In 2013, the FDA, Food and Drug Administration, released a document that defined properties of abuse-resistance, outlined the types of studies needed to test tamper-resistant technology, and described how the FDA would evaluate the results of those studies. Douglas Throckmorton, MD, deputy director for regulatory programs at FDA’s Center for Drug Evaluation and Research (CDER), told reporters that the science of tamper-resistant technology is “relatively new,” so the FDA is feeling its way slowly.
At that time, several companies with well known opioid brands had already introduced abuse-resistant versions of their drugs, including Purdue’s OxyContin (oxycodone) and Endo’s Opana (oxymorphone). Both of those companies had been actively trying to deter generic versions of their drugs that lack tamper-resistant technology.
Fast forward to 2017, FDA Pulling Pain Medication Opana ER from Market, Is This the Beginning of the End for Chronic Pain Sufferers? Now, I have had firsthand experience in this process. My wife is a chronic pain sufferer, having been diagnosed with RSD/CRPS (Reflex Sympathetic Dystrophy/Complex Regional Pain Syndrome) over 20 years ago. There is no cure for RSD/CRPS, only pain management, and the pain levels associated with it have been described as equivalent to full blown labor pains during childbirth that are constant, 24 hours a day, 7 days a week, 365 days a year.
In her 20+ years of dealing with this condition, my wife has been to specialists including having been a case study at Johns Hopkins. In short, every possible treatment for her condition has been explored. #BeenThereDoneThat
Let me put the FDA’s crusade to save junkies into perspective. In an effort to save those who are self-destructing, the FDA is willing to sacrifice those who are trying to live with some level of quality of life. It’s not just the FDA who are willing to sacrifice the true chronic pain sufferers, state governments and insurance companies have jumped on the crusade bandwagon as well. Case in point, January 2017, the nations largest health insurance provider, United Healthcare, announced it would no longer cover OxyContin (oxycodone) despite its tamper resistant reformulation. This forced doctors to switch their patients to other, newer tamper resistant opioid drugs like Xtampza or Opana ER.
Those not familiar with how insurance works should know that such prescription changes typically require a pre-authorization from the insurance company. A medieval torture process that requires extensive time and effort on the part of the doctor and staff, as well as extensive documentation and hoops to jump through. *and people wonder why healthcare is so expensive.
Now the states get involved, like my home state of Texas, have added guidelines and restrictions such as a one-strike rule on pre-authorizations. When United Healthcare forced my wife to be removed from OxyContin, the doctor prescribed Xtampza. Due to the torturous pre-authorization process, it was denied initially then granted temporary approval to allow the doctor to pre-authorize another new prescription. State law prevented them from attempting to pre-authorize the Xtampza again. Long story short, my wife is now on Opana ER, which the FDA is now pulling from the market.
Now, if your eyes haven’t glazed over yet and you haven’t left this article to go watch cat videos. This is just a tiny glimpse into the life of a chronic pain sufferer dealing with the FDA, insurance companies and state regulations. In the first 6 months of 2017, the FDA crusade to save junkies has resulted in my wife’s pain medication being changed multiple times and her dosage cut in half. Another medication, Valium (diazepam), prescribed for muscle spasms and anxiety which exacerbate her pain levels, was discontinued due to an FDA recommendation not to prescribe it with opioids.
WHY are my wife and millions of chronic pain patients suffering through all of this? Because junkies overdose and are spreading diseases such as HIV or Hepatitis by sharing needles. Because the FDA, states and insurance companies want to save the self-destructive junkies and avoid lawsuits. Because people who don’t deal with these issues on a daily basis haven’t got a clue. We are being bombarded by news of overdoses and rampant drug abuse. Few ever see the toll it takes on the people that these medications are actually created and designed for, those suffering daily with severe chronic pain.