FDA needs to follow existing FDA protocols and stop being driven by the prevailing winds from political forces. FDA is the final authority on regulation of drugs and should not be second guessed people who do not understand medicine and science, much less attempt to superimpose layer upon layer of regulations on top of existing FDA prescribing guidelines tailored to each pain medication.
CDC is trying to drive policy based on their poorly written and poorly understood 2016 Opioid prescribing guidelines, proving themselves incompetent and not grounded in the best interests of the US public, especially not in best interests of chronic pain patients who depend on analgesics for quality of life. CDC has castigated the US chronic pain community and destroyed the lives of millions of honest, law-abiding victims in hospice, with cancer, with sickle cell anemia, with auto-immune disorders, the disabled, the elderly, and the most unfortunate citizens in our nation. These are the people the government is supposed to stand up for and help, not drive to suicide or street drugs, which is in fact what is happening now and consequently overdoses are going HIGHER. If you keep cranking down on regulations and the problem gets worse, isn’t that a sign you are fundamentally taking the wrong approach? Is it not a sign of insanity to keep doing the same thing and expecting a different result? Why not insist that the CDC revoke the 2016 guideline that has not served the public interest in any way, shape or form?
FDA alone is the authority, yet we now have the CDC, PROP, 50 state governments, US Congress, US Senate, President of the United States, and even certain members of the media all trying to force additional, overlapping, burdensome, contradictory, politically motivated and unscientific regulations on opioids. The US government needs to get out of the doctor’s office and leave it 100% up to the FDA to regulate and approve what medicines are on the market. FDA’s full prescribing information already contains limits and conditions and guidelines tailored to all drugs, and that is all that is needed. All other parties need to frankly butt out, because not only are they misinformed of the facts, their politicized guidelines have caused death and misery for chronic pain patients while not helping addicts whatsoever. Sheriffs routinely report they are not seeing prescription drugs found on deceased overdose victims, but instead see illicit fentanyl, heroin, and other illegal drugs such as methamphetamines for at least 8 years now.
Can’t CDC and others outside FDA see their own data doesn’t add up? A recent study concluded that 1.3% of overdose fatalities were caused by patients taking their own prescribed opioids. So 98.7% are due to illicit drugs or illegal activities. Pounding that 1.3% down to 0% is more likely to kill hundreds or thousands of times more as disabled and elderly patients who are suddenly thrust onto the street buying heroin for pain relief and getting God knows what in their Cartel provided medicine. How about we do something right for a change, instead of driving good people to end their lives via suicide or become criminals?
If that is what our society has decided to become, perhaps our nation needs to dissolve and let each state become independent, because our federal system is not helping people who need help the most, it is in fact crucifying, torturing, and driving people who worked their entire lives to support this nation into a state of insanity because everyone proposes regulation du jour. Such gross ignorance and negligence has caused the greatest atrocities in the United States since the Civil Rights movement. Is that the kind of nation we want our children to inherit? And while this is going on, the illegal drug trade is growing stronger, and Mexican importers and Chinese producers are laughing all the way to the bank while standing back and watching as America burns.
For the Love of God, please stop this perpetual going in circles and pushing the federal government to “JUST DO SOMETHING” whether it makes sense or does not. FDA has held enough meetings, task forces, written reports, etc. Doctors are more confused than ever, due to the hundred or so organizations trying to influence prescribing policy. How about say, NO MORE? We have enough guidance in existing drug literature and enough is enough. The 2016 CDC guidelines were based on zero long term studies and the 2019 report added only 1 narrowly scoped “long term” study, based on a 600 mostly male veterans with osteoarthritis. No reasonable scientist would dare mandate policy on such limited, narrowly scoped study, where one group was provided low dose opioids without titration (<40 MME) and the other received NSAIDs and it is well understood both can improve arthritis. Then throw in the fact that tramadol was not even considered an opioid in this study, so how could anyone attempt to use this one study to define opioid regulations that apply regardless of disease, body size, age, degree of pain, gender, duration on analgesics, drug metabolisms, comorbidities, that all vary individual by individual?