Manchin, Braun Introduce The FDA Opioid Labeling Accuracy Act

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July 11, 2019 saw U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN), introduced the FDA Opioid Labeling Accuracy Act, which would prohibit the Food and Drug Administration (FDA) from allowing opioids to be labeled for intended use of “around-the clock, long-term opioid treatment” until a study can be completed on the long-term usage of opioids.

There is little if anything that is rational in this proposal, so let’s look at the facts.

  • The bill claims it will help eliminate opioid overdose and abuse, yet the CDC, DOJ, Substance Abuse and Mental Health Services Administration (SAMHSA), National Institute on Drug Abuse and AMA have all published data showing that despite a reduction in prescription opioids, the overdose rate continues to climb and there is no direct correlation between prescribed opioids and the risk for addiction. In fact CDC data shows that less than 1%, 0.62% of individuals prescribed opioids become addicted, compared to 6.5% of individual who develop alcohol addiction. These rates for both opioids and alcohol have remained constant since 1996.
  • It’s well known that the misuse of the 2016 CDC Guidelines on Opioids for Chronic Pain Management by Primary Care Providers resulted in increased suicide deaths and individuals turning to street sources once forced tapered or terminated. A current survey conducted on this site is showing that primary care providers have forced tapered or terminated prescription opioids for 67% of their patients and when that was done, 65% report that medication was cut off suddenly without tapering or offering any medical assistance when doing so, of those, 25% considered suicide seriously enough to write a letter or leave a message behind for family.
  • Considering the monumental failure of the CDC in publishing recommendations based on acute pain management using data from opioid naïve patients and failing to use experts on its panel skilled in chronic pain management, the Federal Government created a new group, the Pain Management Best Practices Inter-Agency Task Force. They estimate that 50 million Americans suffer from daily chronic pain with 20 million receiving opioids to manage that pain. Their recommendations are not for cutting off these patients, but for better management as can be verified in the excerpts of their findings.
  • The NIH has stated publically that over prescribing opioids as a cause for the opioid crisis is just a theory. The NIH has an annual budget of around $30 Billion for medical research but to date, spends less than $200 Million annually on research for chronic pain and none of that is spent on identifying the long term benefits or problems associated with opioid use in medical conditions, most is directed towards finding non-opioid alternatives for pain management. Considering the fact that the NIH is resistant to funding research for the benefits and complications of long term opioid treatments, passing the bill by Manchin and Braun would be the equivalent of cutting off insulin for diabetics without first considering the potential harmful effects.
  • The FDA has a rigorous and disciplined scientific approach to labeling guidelines for pharmaceuticals and it’s a separate agency for doing so to prevent political interventions of this sort. So clearly these legislators are attempting to disrupt a proven process which has worked for decades to protect the health and wellbeing of the public, something our political officials are not qualified to do.
  • Ironically, giving the bill a title of the FDA Opioid Labeling Accuracy Act is in fact an oxymoron considering the fact that it can’t be accurate without scientific data to back up both the benefits and harmful effects of taking such actions.

I believe the Manchin/Braun bill will fail, but this should not stop us from speaking out. I believe that when the bill is debated, some legislator with common sense will make this point. If the bill passes, we will suddenly have 20 million people thrown into a crisis, going through withdrawal, suffering other medical complications because of other preexisting conditions, the suicide rate will spike, and some will turn to the street to get what they need. If even half this number were pushed onto the healthcare system over a 30 day period, it would collapse the system, and seriously burden the insurance industry, Medicare primarily since 60% of chronic pain patients are elderly individuals with multiple medical problems. Is this what we’re willing to risk by passing this bill? We have to respond to opioid abuse and addiction with rational common sense and consider all the angles, not rush blindly, hither and nether with knee jerk responses while wearing a blindfold to the collateral damage which can occur.

We are approaching an election, and we’ve already seen some legislators come out with irrational proposals which have fallen flat on their face for the shear irrationality they advocate, this proposal is no different. Take for example Kirsten Gillibrand proposal to limit opioids for first time use which did not take into consideration the myriad of medical conditions it would impact in a negative way.

As is typical with all politicians running for office, they pander to their political base, tossing around wild accusations and offering extreme promises which have no chance of ever becoming law because they don’t address the whole of our nation, only a small group. Such rhetoric is designed for reelection purpose only and we must keep this in mind, resisting the inclination to panic.


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