The FDA has published its “Opioids Action Plan”. Here is the link: http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm

drugsIn their “plan”, they state “The FDA is deeply concerned about the growing epidemic of opioid abuse, dependence and overdose in the United States. In response to this crisis, the agency has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities.”

But their focus is still on their misconception that opiates cause addiction. Their only “plan” involves labeling opiates with warning labels, creating more hurdles for new opioid approvals, and pushing abuse-deterrent formulations.

In trying to persuade physicians from prescribing opiates for pain, they are using the current government position that there is no evidence that long-term use of opioids is effective. Excuse me? Opiates have been used for centuries for pain. But they are basing their statement on the absence of “controlled studies”. Well, we don’t have controlled studies on the effectiveness of Aspirin on fever either, but we know it works. Hopefully their requiring companies to do the studies will show that opiates work the best for chronic pain with the least risk. The problem is that controlled studies basically prove whatever the designer sets out to prove. Since the money will be in studies that prove lies about opiates, that is probably what we will see—lies.

The following breakdown of the points of the plan are copied and discussed.

FDA’s actions also include:

  • Expand use of advisory committees with the expected outcome of reviewing any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling.

  • Develop warnings and safety information for immediate-release (IR) opioid labeling similar to the extended-release/long-acting (ER/LA) opioids now in effect. The expected outcome is information for doctors about the risks and how to prescribe safely.

Potential for more attacks on doctors for prescribing “outside the usual course of practice”.

  • Strengthen postmarket requirements, requiring drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. Outcome: Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.

Here they are being quite obvious in what they want these studies to show, and so they will.

  • Update Risk Evaluation and Mitigation Strategy (REMS) Program. ER/LA opioids are currently subject to a REMS program that requires sponsors to fund continuing medical education (CME) providers to offer, at low or no cost, CME courses on the appropriate use of these products. The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements. Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing.

Again, another potential way to attack doctors. Either they haven’t taken these courses, putting them at risk for charges, or they have, and the government can charge them with not following the protocols.

  • Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. The pharmaceutical industry has shown significant interest in developing ADFs and the technology is progressing rapidly. ADFs hold promise as their abuse-deterrent qualities continue to improve and as they become more widely available. The FDA will issue draft guidance with its recommendations for the approval standards for generic abuse-deterrent formulations. Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs. Outcome: Spur innovation and generic ADF product development.

This provision shows the best promise for actually doing something good. If we can provide opiates that are actually impossible to abuse, then switching to these for real medical issues can decrease the use of prescription drugs for illegal purposes and at the same time, provide legitimate patients with real treatment. But the key here is cost. If these drugs are not made available to the poor, government insured and uninsured at reasonable cost, they will still not affect the majority of the population.

  • Support better treatment. The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone.

The government seems to think that the answer to drug abuse is simply to give everyone the antidote. This is really backwards thinking at its prime.

“The agency actively supports the Centers for Disease Control and Prevention guidelines for prescribing opioids for the treatment of pain and will facilitate the development of evidence and improved treatments.”

In my opinion, this is a lie. The government isn’t really interested in the development of improved treatments. There have been improved treatments for pain for decades now, and the government won’t pay for them. Prolotherapy for example.

  • Reassess the risk-benefit approval framework for opioid use. The FDA will seek advice from the agency’s Science Board in March 2016 and is already engaging the National Academies of Sciences, Engineering, and Medicine on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them.

This is the real danger of this entire plan. We already know the government’s stand on the use of opioids. It is my opinion that the purpose of this plan is to pave the way to completely outlaw the use of opioids entirely for chronic pain. We will be forced into the old “live with it” treatment plan. Time will tell.

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