Junkies Control FDA Opioid Drug Policy

Image Source: fda.gov

Opiod abuse has become a serious issue in America. Both heroin and opioid pharmaceutical abuse have risen sharply.

The Opioid Epidemic in the U.S.

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.

 

Author, Advocate, Blogger & Zombie Aficionado. Air Force veteran and jack of all trades, with a wide range of experience with many different cultures around the world as well as working alongside both CEOs and average Joes. “Writing was never a goal or even vaguely contemplated as a career choice, it just happened, an accidental discovery of a talent and a passion.” A passion that has taken him in many directions from history to zombies to advocacy to News especially in this day and age of “Fake News” and “Alternative Facts.” The Truth Is Out There!

About the Author

Jon Britton
Author, Advocate, Blogger & Zombie Aficionado. Air Force veteran and jack of all trades, with a wide range of experience with many different cultures around the world as well as working alongside both CEOs and average Joes. "Writing was never a goal or even vaguely contemplated as a career choice, it just happened, an accidental discovery of a talent and a passion." A passion that has taken him in many directions from history to zombies to advocacy to News especially in this day and age of "Fake News" and "Alternative Facts." The Truth Is Out There!

7 Comments on "Junkies Control FDA Opioid Drug Policy"

  1. I have also been on Opana for a MRSA infection from knee surgery..It was the only th that touched the pain levels…Have been on hydrocodone for years due to multiple issues with my back..My PCP used to prescribe my pain medication but due to all the illegal activities, I now have to go to a specialist for Pain Management…I got one drug test that cost $17,000 dollars to prove I wasn’t taking illegal drugs so I could get my pain medication…This is a giant ripoff !!

  2. My wife and I have been going through the same thing over the last few years here in Washington State. What I told our Representatives then was A) stay out of our healthcare as that is between us and our doctor. (Yeah, still hear the laughter.) And B) if this keeps up people will hit the street for relief, as heroin is easier and cheaper to get, (albeit far more dangerous). Something has to be done, but so many people believe the hype as they think the gov’t is always the answer to the problem. They don’t seem to realize the gov’t is the problem.

  3. This angers me to no end. I’ve worked my whole life in hard labor and have the broken bones, severed digits and worn out joints to prove it. Now pushing 60 with a second spinal fusion it is getting harder and harder to get the medication that allows me to stay active. All because others abuse the drugs.

  4. This is all total bs.somewhere and someone is making a lot of money on doing this people that really need the Medes are now suffering.If the junkies want to kill them selves then so be it but the person that just wants to have a pain fre day and a reasonable life should not have to suffer for it.I still say money is behind it all.we need to find out where it is going and then go after them to leave the true suffer along

  5. Before long all of us who suffer chronic pain, myself for about 6 yrs, WILL be turning to herion. Believe me living with chronic pain is not a cauilty of life. There are days I pray good says” youve had enough its time to come home”. I have NEVER abused my pain meds or xanax. Plz stay out of my business.

  6. The drug cartels are dancing in the streets of Mexico at the new influx of chronic pain patients needing Heroin to replace the pain medicines doctors are cutting them off from. This makes the FDA the biggest drug dealer around with new customers waiting in the wings. Our government is STUPID and overpaid.

  7. Cartels are now making fentynal to sell to gringo’s left in chronic pain also. This is just the beginning of what will be available on the streets of our towns and cities in the near future. Overdoses due to ignorance about these drugs will lead to even more deaths. Time to get serious about finding replacement and ileagel drugs. Go south suffers go south. Thank you FDA and DEA you are now ruining the lives the pain sufferers were trying to live !

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