W

ASHINGTON — With pressure building on the the Drug Enforcement Administration to stem the supply of prescription drugs, a new proposal aims to empower the agency to more aggressively limit manufacturing levels and to put hundreds of drug makers on notice.

It’s not yet clear whether the proposal will achieve either goal.

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  • For pain patients and care givers who are following this thread: National Pain Report has published an article outlining how patients can be most effective in lobbying DEA to stand down from their effort to further limit production of vitally needed opioid pain relievers.

    “The DEA Draws a Firestorm of Criticism, on National Pain Report.” As of 0800 Monday April 30, DEA had received 670 comments. Let’s make it 1000, and let’s carefully target the next 400 on the issues which destroy DEA’s entire concept. What they are proposing won’t work because opioid related deaths and hospital admissions have almost no relationship to opioid prescribing rates at all!

    Watch for further information alerts. I have a major analysis of CDC data coming out that will demonstrate beyond any contradiction that limiting medically managed opioid therapy will in no way “solve” America’s opioid crisis.

    See http://nationalpainreport.com/opinion-the-dea-draws-a-firestorm-of-criticism-8836146.html

  • I have registered the following comments with the DEA docket allowing public comments for a measly two weeks, on their proposed rule changes.
    ==============

    I write as a non-physician subject matter expert on chronic pain and prescription opioid policy. I co-lead the Alliance for the Treatment of Intractable Pain, an organization of over 250 medical professionals, healthcare writers, knowledgeable patients and caregivers, with an outreach in social media of about 80,000 daily.

    Our unified message to DEA is “cease, halt and desist”.

    The proposed DEA measures to restrict supplies of scheduled drugs based on “diversion” can aptly be compared to an effort to reduce America’s “obesity epidemic” by reducing food supplies. This is simple foolishness on a grand scale. Proposed DEA regulation changes have potential to further damage health and quality of life for millions of chronic pain patients who have already been harmed by biases, errors and omissions of the 2016 CDC opioid guidelines, mandated refusal of opioid therapy to millions of US Veterans, and imposition of arbitrary and scientifically unsupported restrictions on so-called “high dose” prescribing by HHS/CMS.

    DEA has no reliable measures for diversion at the individual medical practice level, given a wide range of “normal” prescribing practices between individual doctors acting in good faith to serve different patient populations. Prescribing levels as such are not a viable basis for restricting medical supply, absent a detailed knowledge of the patients and conditions serviced by the medical practice. Likewise, restriction of medical opioid supply has already been tried and failed. Prescriptions are now at a 10 year low, while overdose deaths continue to climb.

    By contrast, DEA has clearly failed in its public duty of oversight on major corporate drug distribution companies, notably McKesson. DEA representatives in effect refused to testify before the Senate Judiciary Committee when asked to explain how DEA missed the distribution of huge volumes of opioid medications into zip codes which lacked any credible medical markets for such distribution. DEA investigators have publicly complained of refusals by DEA and DOJ prosecutors to take aggressive action against McKesson, with the clear implication that corporations bought the compliance of DEA officials with promises of later lucrative jobs on leaving government service. It would appear that DEA is unwilling to prosecute the knowing suppliers of major pill mills, but quite willing to harm millions of patients who have never abused a medication.

    The urgency invested in the so-called “opioid crisis” has long been distorted by CDC false attribution of overdose-related deaths to “prescription opioids” which were in fact caused by illegally manufactured fentanyl. CDC analysts have admitted publicly that CDC inflated prescription opioid deaths nearly 100% for years. The dominant causes of the current opioid crisis are illegally manufactured Fentanyl and Heroin – with prescription opioids a distant fifth in overdose statistics.

    DEA is straining at gnats and swallowing camels.

    Diversion is an issue, but not in the context suggested by DEA. According to the National Survey on Drug Use and Health, 75 percent of all opioid misuse starts with people using medication that wasn’t prescribed for them — obtained from a friend, family member or dealer. However, there are no data to support the idea that further restriction of supply will change this dynamic. We are already seeing widespread reports of hospital shortages of analgesics needed in surgery. The proposed DEA action will only exacerbate these shortages while doing nothing to moderate the real public health problems of addiction and overdose death.

    It is known from NIDA reports that addiction among medically managed patients is rare. Likewise, risk of opioid abuse or chronic opioid prescription is less than 0.6% among patients prescribed opioids after surgery. Fewer than 1% extend a prescription beyond 13 weeks. Many extended prescriptions reflect emergence of chronic pain due to failed surgery.

    We also challenge the often heard hype that so many prescriptions are written that every American adult could receive a bottle of pills. Such statements are dangerously over-simplified anti-opioid propaganda. When prescribing patterns are analyzed among millions of chronic and intractable pain patients, it is found that volumes are insufficient to adequately medicate people for whom no other therapies work. There is emerging evidence that refusal of pain management is driving patients into unsafe street markets.

    Thus, our message to the DEA is to stand down. You are chasing phantoms with supply restrictions which will harm millions of people while helping none.

  • “GOP members appear unlikely to provide her with a legislative win.” Politics before the good of the people. Typical.

  • Doctors and pharmacists must stand up for what is right, caring for those who suffer in pain. Pain medicine prohibition is right around the corner, or it is here! Those with the power will not listen for a second to somebody who actually needs the medications who isn’t powerful or privileged. As a “nobody,” all I can say is to encourage your doctors to be truthful and write an email to the powers-that-be. The situation is a nightmare for those who deal with daily pain that infringes upon quality of life. Perhaps a national petition would work. The problem, of course, is that patients are frightened of speaking out for fear of criminals who might want to steal their medications or misguided, overly zealous police who make money from taking medications away from people! This is one crazy world. My heart goes out to everyone who is suffering daily.

    • It won’t happen. Physicians and pharmacists are licensed agents of the states, so their survival depends on compliance. Patients are the least important elements in the medical system. Physician pain associations have been lamenting the undertreatment of pain since at least as far back as the 1980s, and it has only gotten worse. When Thomas Szasz wrote “Our Right To Drugs” he referred to it as the “pain non-treatment industry.” Americans suffered a huge loss when their right to self-medicate was taken away in the early 1900s.

  • The DEA officials who are trying to stem the supposed ” opiate epidemic” must a group of fortunate people who don’t suffer from chronic pain, one of the most underdiagnosed and undertreated medical problems in the United States. Narcotic analgesics can be and must be and are used appropriately by many people. Removing this life line will put people out of work and there will be a lot of very dirty houses. Bone deterioration, ruptured and herniated discs along with nerve damage are very real and very debilitating. I would wish these conditions on the Arrogant legislators who are proposing this damaging idea but instead, I wish it on one of their children ( sorry kids) because I think that that would hurt the idiots more than having to suffer from these conditions themselves. Removing these medications will leave a lot of people in the position of having to decide whether they want to sit in the chair or lay in the bed in order to more effectively watch the dirt pile up around them. Since so many people will be unable to work the government better get ready to Pony up with that disability money. Oh, I forgot to mention the suicide rate. I hope you break your arms patting yourselves On The Backs fellas

    • The DEA no more cares about the plight of people in pain than the Inquisition cared about the well-being of “witches.”

    • With tougher prohibition there will be more heroin deaths and more prostitutes on the streets. Especially since they have also clamped down on the sites where ads were placed.

    • I believe it was plenty clear without further explanation. But then I’m one of “them there folk” who can understand the context without perfect grammar.

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