Their 90 MMED nonsense has widely been interpreted as a statutory limit on opioid prescribing. My presentation responded with a “not only no, but HELL no.” The CDC and Veterans Administration have already killed hundreds of patients with their scientifically unsupported risk threshold. If a REMS were to specify threshold drug amounts for opioid analgesic prescriptions above which prescribers would be required to provide additional documentation of medical necessity, what should the amounts be and how should they be determined for various clinical indications? What data are there to support such amounts? What additional data would be useful?”.
#One hand clapping feature film 2018 professional
I was particularly pleased by professional responses to the first question posed by the Steering Committee: Don’t deny treatment to patients for whom opioids are the only therapy that works.”ĭespite disconnects between these narratives, several important insights emerged. The message was “don’t make a horrible situation worse by further over-regulating doctors.
Patients are lapsing into agony and death by medical collapse and suicide.
Patients and their advocates were unanimous in telling the FDA that policies of the US Center for Disease Control are already driving physicians out of practice in droves. These presentations were dominated by strong emotions – and regrettably few facts. Anti-opioid partisans implied that nobody should ever need an opioid pain reliever and that those who are prescribed such medications are instantly at risk of opioid dependence and addiction. One surprise was that a substantial amount of integration and data sharing has already occurred in multiple over-lapping programs funded under Federal grants. Corporate players want a “piece of the pie” of government contracts for integrating patient treatment data that now resides in 50 separate State Prescription Drug Monitoring Programs (PDMPs). Some speakers offered specific ideas concerning how FDA might better regulate medical access to opioids. Professional associations want to be consulted and to participate in shaping the REMS. The Committee itself was carefully non-committal. Although the audience was discouraged from applause, some of the speakers also seemed not to connect hands – or ideas. FDA is considering steps to more tightly regulate standards of physician and pharmacist practice in prescribing and reporting opioid analgesic use.Īt times during the day, I found myself shaking my head. The FDA had previously announced eight questions relating to the implementation of an FDA “Risk Evaluation and Mitigation Strategy (REMS)” responding to the so-called “opioid crisis” in America. The hearings were convened (the presiding officer told us) as a “listening session” to receive public input concerning eight questions. For once, pain patients were allowed to participate, along with medical professional societies, healthcare technology corporations, and a few partisans intent on obstructing all access to opioid pain relievers. The Committee is composed of eight FDA senior department heads and Center directors. On January 30, 2018, I was one of about forty speakers before an audience of over two hundred, in public hearings of the US FDA Opioid Policy Steering Committee, at Silver Spring, MD. 
One might be that the sound of one hand clapping is silence…unless met by another hand. “What is the sound of one hand clapping?” can have many answers. Many years ago, a stand-up comic named Shelly Berman helped to immortalize a riddle told by Zen masters. What Was Said or Missed in the FDA Opioid Policy Steering Committee Hearings?īy Richard A Lawhern, Ph.D., as published in National Pain Report.
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