Opioid Intimidation – 29% Decline in Doctors Prescribing by 2017


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The New England Journal of Medicine published a report from Harvard researchers on March 14, 2019, entitled

Initial Opioid Prescriptions among U.S. Commercially Insured Patients, 2012–2017.

They found a “29% reduction in the number of providers who initiated opioid therapy in any patient who had not used opioids, from 114,043 in July 2012 to 80,462 in December 2017.”

Two of my own physicians, both distinguished, outstanding – an internist and a specialty cardiologist who does painful procedures – have said they will never prescribe opioids again. If I ever need an opioid for pain, it is possible I may never be able to get a prescription.

One of my pain management colleagues has defended 6 colleagues in the last 6 months before the Medical Board.

This is just the beginning of Opioid Intimidation perpetuated by government and CDC. It is deeply worrisome and it is getting worse.

We have a shortage of pain management specialists and those that have survived mostly do procedures, delegating prescription writing to PA’s and NP’s because it is time consuming and does not pay. There is a formidable barrier of denials by insurers for nonopioid medications, physical therapy, acupuncture, yoga, Pilates, cognitive behavioral therapy, and all compounded medications. Denials have become voluminous for at least 10 years. The process is not only time consuming, it is expensive, it wears us all down, inflicts horrific cruelty on patients, and to top it all off the appeals system is a joke.

Who would want to go into the pain management field ever again?

Stay tuned for more stories to come.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  

Welcome to my Weblog on Pain Management!

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Senate Hearing on Opioid Prescribing


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HHS Inter-Agency Task Force Urges New Ways to Limit Opioid Use and Addiction

Managing Pain During the Opioid Crisis – A Senate Hearing

In related news, pain patients everywhere rejoiced when Cindy Steinberg, National Director of Policy and Advocacy for the US Pain Foundation, spoke in front of the Senate Committee on Health, Education, Labor, and Pensions (HELP) on February 12, 2019.2 Steinberg, an advocate for the betterment of care for members of the pain community, lives with chronic back pain as a result of a workplace accident.

In her testimony, she urged Congress to restore more balance to opioid prescribing and improve pain care overall by funding and implementing measures outlined in the Pain Management Best Practices draft report released by the above-noted Inter-Agency Task Force, emphasizing the importance of investing in research on safer, more effective treatment options ranging from medical devices to medical cannabis.

In particular, Steinberg, who spoke to the Senators while lying in a cot due to her own chronic pain condition, brought up two points that counteract the current opioid climate, including the fact that:

  • Demographic research on populations has shown that chronic pain sufferers tend to be largely female and over the age of 40 and those with opioid use disorder tend to be largely male and under the age of 30. These are two largely separate groups with very little overlap.
  • Repeated research within the chronic pain population has found the risk of addiction to be small, on average less than 8%; and in patients with no history of abuse or addiction; studies have shown the rate of addiction to be between 0.19% to 3.27%.3-5

She added, “It is essential that treating clinicians be permitted to evaluate individual benefits and risks for each patient and that all appropriate pharmacological, interventional and complementary therapies remain available.” 

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  

Welcome to my Weblog on Pain Management!

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CMS Criteria Do Not Accurately Identify Patients at Risk for Opioid Use Disorder, Overdose


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CMS criteria do not accurately identify patients at risk for opioid use disorder, overdose

Wei Y, et al. JAMA. 2019;doi:10.1001/jama.2018.20404.

February 15, 2019

 

The CMS opioid overutilization criteria may not accurately identify patients at risk for opioid use disorder or overdose, according to a research letter published in JAMA.

“Based on the CMS opioid overutilization criteria, the majority of the Medicare Part D patients diagnosed with opioid use disorder or overdose were not identified as ‘opioid overutilizers,’ and more than half of ‘opioid overutilizers’ did not develop opioid use disorder or overdose during the study period,” Yu-Jung Jenny Wei, PhD, Msc, assistant professor of pharmaceutical outcomes and policy at the College of Pharmacy, University of Florida, told Healio Primary Care Today. “The CMS criteria seem not to be a good clinical marker for identifying patients at risk for opioid-related adverse events.”

To estimate the predictive value of the CMS opioid overutilization criteria in correctly identifying prescription opioid users at risk for opioid use disorder or overdose, researchers used the 5% Medicare sample from 2011 through 2014 from which they identified between 142,036 and 190,320 beneficiaries who had at least one opioid prescription filled every 6 months, were continuously enrolled in Parts A, B and D and who met the CMS criteria as opioid overutilizers. Opioid utilization was defined as receiving prescription opioids with a mean daily morphine equivalent dose 90 mg from more than three prescribers and pharmacists or receiving a mean daily morphine equivalent dose of 90 mg by more than four prescribers.

Breaking the study period into three 6-month cycles, researchers examined the performance measures over time to assess if accuracy changed with increasing efforts to combat the opioid crisis. 

During any 6-month cycle, the proportion of beneficiaries who met CMS overutilization criteria ranged from 0.37% to 0.58%.

Throughout the entire 18-month follow-up, researchers found that the proportion of patients who had a diagnosis of opioid use disorder or overdose increased from 3.91% in the first cycle to 7.55% in the last.

In addition, researchers observed low sensitivity of the criteria which ranged from 4.96% (95% CI, 4.42-5.58) at the beginning of the study period to 2.52% (95% CI, 2.26-2.81) at the end (< .001).

 The CMS opioid overutilization criteria may not accurately identify patients at risk for opioid use disorder or overdose.Source: Adobe Stock

Positive predictive values ranged from 35.2% (95% CI, 32.14-38.38) to 50.95% (95% CI, 47-54.86) and specificity was greater than 99% in all cycles. 

“CMS has required their Medicare Part D plans to implement the criteria,” Wei said. “It’s unclear the effectiveness of such criteria in stopping our national opioid epidemic and whether there are unintended consequences of such implementation. As we are developing solutions to the opioid crisis, it’s important for policymakers, health care providers, hospitals and health insurance companies to be aware that solely relying on opioid prescription data is likely to be ineffective in identifying the high-risk populations for interventions.” – by Melissa J. Webb

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Pain Patients to Congress: CDC’s Opioid Guideline Is Hurting Us, 2% NIH budget for Pain


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Pain Patients to Congress: CDC’s Opioid Guidelines is Hurting Us. Has stoked “climate of fear” leading to inadequate treatment of chronic pain

CLIMATE OF FEAR

WASHINGTON — Patients with chronic pain are suffering from ham-handed efforts to curb opioid overdoses, a series of witnesses told the Senate Health, Education, Labor and Pensions (HELP) Committee on Tuesday.

  • by Shannon Firth, Washington Correspondent, MedPage Today February 13, 2019 

In particular, the CDC’s 2016 guidelines for opioid prescribing came under heavy fire, as even a self-described supporter of its recommendations admitted the evidence base was weak.

In 2018, Congress passed the SUPPORT for Patients and Communities Act, which included billions of dollars in funding aimed at curbing the overdose epidemic and expanding access to treatment for those with substance use disorders.

About 50 million Americans suffer from chronic pain and almost 20 million have high-impact chronic pain. At the same time, more than 70,000 people died from drug overdoses in 2018, often involving opioids, said HELP Committee Chairman Lamar Alexander (R-Tenn.) at the start of Monday’s hearing.

Even as Congress tries to dramatically curb the supply and the use of opioids, “we want to make sure … that we keep in mind those people who are hurting,” said Alexander.

Cindy Steinberg, national director of policy and advocacy for the U.S. Pain Foundation, argued that well-intentioned efforts to address the epidemic — particularly strategies to tamp down overprescribing — have stoked a “climate of fear” among doctors.

Thousands of patients with chronic pain have been forcibly tapered off their medications or dropped from care by their physicians, said Steinberg. (Physicians in California, under threat of medical-board sanction if patients die from overdoses, have reported similar reactions.)

Such decisions are “inhumane and morally reprehensible,” she said.

Steinberg, herself a pain patient, said she takes opioids in order to function. Eighteen years ago, Steinberg was injured when a set of cabinets fell on her. Since her accident, she experiences constant pain, she said, and throughout the hearing she took breaks from testifying to recline on a cot and pillow.

She was especially critical of the CDC’s opioid guidelines, which included recommendations regarding the number of days and dosage limits for certain pain patients.

“When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed,” notes a CDC fact sheet.

These recommendations have been “taken as law,” she said.

In 2016, Massachusetts set a 7-day limit on first-time opioid prescriptions, according to the National Conference of State Legislatures, which counted 33 states with laws limiting opioid scripts as of October 2018.

Steinberg said the guidelines should be rewritten.

Because of the CDC’s reputation, “people think that those [guidelines] are based on strong science and they’re not,” Steinberg said. Pain consultants were not involved in the development of the guidelines, she said.

(Voicing similar concerns in November, the American Medical Association passed a resolution opposing blanket limits on the amount and dosage of opioids that physicians can prescribe.)

Steinberg pointed instead to the Pain Management Best Practices Inter-Agency Task Force, a group appointed by Congress of which she is a member, which issued its own draft recommendations in December.

Alternatively, the NIH (which she noted has an office dedicated to pain policy) could be asked to make recommendations, she suggested.

Halena Gazelka, MD, chair of the Mayo Clinic Opioid Stewardship Program in Rochester, Minnesota, pointed out that the guidelines were “intended to advise primary care providers” and not to provide “hard and fast rules.”

“I actually like the CDC guidelines,” Gazelka said. Mayo’s own guidelines are based on the CDC’s. However, “the doses that are mentioned, probably are not scientifically-based, as we would prefer that they would be,” she acknowledged.

Another challenge for some pain patients are situations that pit prescribers against pharmacists, said Sen. Lisa Murkowski (R-Alaska).

“It’s the pharmacists that are refusing to fill the prescription the doctor has prescribed,” she said, blaming the CDC guidance. Pharmacists are following it out of “an abundance of caution,” including in cases where abuse is not suspected, she suggested.

Steinberg said, “I think we need public education about pain and the fact that pain is a disease itself. … Pharmacists are not getting proper training in that, I don’t think anyone is getting proper training in pain.” She asserted that veterinarians get nearly 10 times as many hours of pain management training as do medical students.

Andrew Coop, PhD, of the University of Maryland School of Pharmacy in Baltimore, returned to the CDC guideline. “I think those guidances on the quotas, I think they’ve been taken too far and that needs to be rolled back.”

Improving Care

In exploring other ways to improve care for patients with chronic pain, Gazelka recalled the pain clinics that existed 30 years ago, which included a physician, a psychologist, and a physical therapist.

“It would be ideal to return to a situation where people could have all of that care in one place,” Gazelka told MedPage Today after the hearing. But most small practices and even institutions may not have the same blend of clinicians, and the cost could be “prohibitive,” she said.

Access to specialists also poses a problem, noted witnesses as well as senators.

In her own pain group, it takes patients more than a year to get an appointment with pain specialists, Steinberg said. She encouraged Congress to “incentivize” pain management as a specialty.

Gazelka agreed and suggested leveraging telemedicine and electronic health records to extend the reach of existing specialists.

Telemedicine can allow primary care physicians to consult with pain management specialists, she said. Also, in Mayo’s own controlled substances advisory group, she and other specialists review cases submitted by primary care clinicians and provide advice directly into the patient’s medical record. However, Gazelka noted that privacy protections in some states might disallow that.

Gazelka noted that insurance coverage can be a barrier to non-opioid alternatives. For example, the Mayo Clinic has a Pain Rehabilitation Center staffed by specialists in pain medicine, physical therapy, occupational therapy, biofeedback, and nursing that aims to treat pain without opioids. But Medicaid won’t pay for it, she testified.

Witnesses also spoke of efforts to develop non-addictive painkillers, such as NIH’s Helping to End Addiction Long-term program.

Steinberg called these efforts “a great start” but noted that only 2% of the NIH’s budget is directed towards pain research. Funding should be “commensurate with the burden of pain,” she said.

Finally, Coop pressed the committee to take seriously the potential of medical marijuana.

Acknowledging that it’s a controversial area, he stressed the need for “good consistent, well-designed clinical studies with good consistent material,” referring to the type of marijuana used.

But speaking to reporters after the hearing, Alexander was cautious. “I’ve supported giving states the right to make decisions about medical marijuana. That’s about as far as I’m willing to go right now.”

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Ketamine’s effects tied to opioid system in brain


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Stanford announces:

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Ketamine’s antidepressive effects

tied to opioid system in brain

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“Ketamine’s antidepressive effects require activation of opioid receptors in the brain, a new Stanford study shows. The surprising finding may alter how new antidepressants are developed and administered in order to mitigate the risk of opioid dependence.”

 

 

…”The study enrolled adults with treatment-resistant depression, meaning their condition had not improved after multiple treatment efforts. Twelve participants received infusions of ketamine twice — once preceded by naltrexone, an opioid-receptor blocker, and once with placebo. Neither the study participants nor the researchers were told whether active drug or placebo was administered during each test. The researchers found that ketamine reduced depressive symptoms by about 90 percent for three days in more than half of the participants when administered with a placebo, but had virtually no effect on depressive symptoms when it was preceded by naltrexone.”

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Opioids increase risk of chronic pain – potentiate pain – faster, stronger, longer. Activate TLR4 receptor on microglia, blocked by low dose naltrexone (LDN)


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Professor Linda Watkins was the distinguished keynote speaker at the May 2015 American Pain Society annual meeting and gave the NIH 2015 Kreshover Lecture:

“Targeting Glia to Treat Chronic Pain: Moving from Concept to Clinical Trials.”

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The University of Colorado at Boulder describes her work

She has authored or co-authored over 190 book chapters, review articles and journal articles.

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Dr. Watkins’ research focuses on 3 inter-related areas. Her primary research interest is understanding how to control clinically relevant pathological pain states. Her group’s research points to a novel reason that clinical pain has been impossible to successfully control. That is, pathological pain is being created and maintained by a surprising cell type, namely glia. These cells, upon activation, dysregulate normal pain processing by the spinal cord neurons.

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Medical News Today published news of her recent study April 19, 2018

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“Opioids may increase risk of chronic pain.” They potentiate pain “faster, stronger, longer” and activate the TLR4 receptor on microglia. That receptor is blocked by low dose naltrexone (LDN).

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Opioids trigger inflammation in the brain and spinal cord. This is an elegant study by renowned Prof. Linda Watkins at the University of Colorado Boulder, with Peter Grace. His early work on LDN brought him from Australia to postdoc at her lab and now research at MD Anderson Cancer Center.

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“Having been used in one form or another for millennia, opioids beat pain into submission, quickly making the patient more comfortable. The latest study, which was carried out at the University of Colorado Boulder, turns this firmly held notion on its head.

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Senior author Prof. Linda Watkins, from the Department of Psychology and Neuroscience, says, ominously, “[…] there is another dark side of opiates that many people don’t suspect.”

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In this case, it is not addiciton issues that Prof. Watkins is referring to. Paradoxically, opioids may actually prolong pain following surgery. The results were published recently in the journal Anesthesia and Analgesia.

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Postsurgical pain and opioids examined

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For the study, Prof. Watkins and colleague Peter Grace, of MD Anderson Cancer Center in Houston, TX, carried out laparotomies on male mice. This procedure involves making an incision through the abdominal wall to access the interior of the abdomen, and it is done on tens of thousands of U.S. individuals each year.

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“Opiates are really effective for acute pain relief. There is no drug that works better. But very little research has been done to look at what it is doing in the weeks to months after it’s withdrawn.”

Peter Grace

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Following surgery, one group of rats received the equivalent of a moderate dose of morphine for the next 7 days, while another group received morphine for 8 days, and the dosage was tapered off by day 10.

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Another group was given morphine for 10 days, after which point treatment stopped abruptly. A final group was given saline injections rather than morphine as a control.

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And, in another experiment, a group of rats received a 7-day course of morphine that ended 1 week before surgery was carried out.

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Before the morphine regimes commenced, and after they had been completed, the rats’ sensitivity to touch was measured, as was the activity of genes related to inflammation in the spinal cord.

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Compared with rats given saline, those that received morphine endured postoperative pain for over 3 additional weeks. Also, the longer the morphine was provided, the longer the rats’ pain lasted.

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The study also revealed that tapering of morphine dosage makes no difference. As Grace explains, “This tells us that this is not a phenomenon related to opioid withdrawal, which we know can cause pain. Something else is going on here.”

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How can morphine raise postoperative pain?

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The next question to ask, of course, is what drives this counterintuitive effect. Prof. Watkins calls it the result of a “one-two hit” on glial cells.

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In the brain, glial cells are more numerous than neurons. They protect and support nerve cells and, as part of their role as protector, they direct the brain’s immune response, including inflammation.

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The first “hit” occurs when surgery activates glial cells’ toll-like receptor 4 (TLR4). Prof. Watkins calls these “not me, not right, not O.K.” receptors; they help to orchestrate the inflammatory response. This first hit primes them for action when the second hit occurs.

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The second hit is morphine, which also stimulates TLR4. As Prof. Watkins explains:

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“With that second hit, the primed glial cells respond faster, stronger, and longer than before, creating a much more enduring state of inflammation and sometimes local tissue damage.”

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Although the study is in an animal model and will need replicating in humans, it does line up with previous findings.

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For instance, in 2016, the same scientists published another animal study, which found that a few days of opiate treatment for peripheral nerve pain exacerbated and prolonged pain. In that study, the activation of inflammatory pathways was also implicated.

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“An unusually high number of people end up with postoperative chronic pain,” explains Prof. Watkins. In fact, millions of U.S. individualssuffer with chronic pain. “This new study lends insight into one explanation for that.”

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Interestingly, the rats that received a course of morphine that ended a week before surgery did not experience prolonged postsurgical pain, leading the study authors to conclude that there is “a critical window for morphine potentiation of pain.”

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Because opioids are currently considered the best course of action to deal with postoperative pain, if these results are replicated in humans, it leaves medical science in a difficult situation.

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This is why Prof. Watkins is focusing much of her energy on designing drugs that could be given alongside opioids to dampen down the inflammatory response. She is also exploring alternative painkillers, such as cannabinoids.”

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Families Refusing Opioids for Pain in Dying Loved Ones


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Refusal of care in the palliative care setting, lack of cooperation in treating pain. Fear the pain medicine will kill. Addicts dying of overdoses. Fear the dying grandmother will be addicted or die from the pain medicine. Fear of addiction in the family, unsafe to keep opioid for the patient. So many fears, myths and misunderstandings.

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Fear has taken over in so many levels of our consciousness. That is why we all need to educate ourselves so that we are prepared to safely help those we love when the time arises.

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Death and dying need not mean agonizing pain. Strong pain may require strong opioids for relief, and strong opioids can be safely adjusted to allow good mental function so you and your loved ones can be present in the last days. Not, not in shock and anguish from screaming pain going on for weeks.

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Yes, I have been called to help a family whose mother was in her last days, on palliative care. Her only communication for weeks was loudly moaning with grimacing and wincing the muscles of her face. They were refusing to give even the tiniest drops of morphine under her tongue, as recommended weeks ago by the palliative care physician.

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Refusal of care will only get worse, not just for the dying but millions with chronic pain. Physicians refusing to treat pain or being firmly uncooperative with family or pain team recommendations. This is a huge issue in cancer hospitals and cancer wards. The old way was never to give opioids for cancer. The standards in medicine are set by the old guys who pass it on and control all coming up the ranks. Don’t step out of line. Fear is in control.

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Dispel that fear. Inform yourself in proper care recommendations by leaders in the field or you will live with regret when your loved ones died screaming in pain and you refused care. I have seen many oncologists refuse pain care and threaten patients, families and staff.

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Read some of the myths and issues that are too frequently encountered by caregivers all across the country – click here.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Medicare & Insurers Crack Down on Opioids – Patients Suffer


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Individualized pain management does not exist.

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Correction from reader: 

“Individualized treatment does exist, but insurance companies are not paying for it. This has to change.” 

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The New York Times reports “Medicare is Cracking Down on Opioids” (link below).

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Last year an insurer denied 10 mg daily Oxycontin for one of my seniors who had been safely taking this for many years. That is less than 1 mg per hour for 12 hour relief. Pharmacy refused to fill unless insurer approved. That’s one way to reduce healthcare costs without an uprising. There is little tolerance for someone with pain. Are they viewing patients as addicts? Would they do this for cancer? 

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

~~

Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Editorial from PAIN: Hijacking the endogenous opioid system


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Neuropathic pain responds poorly to opioids, often not at all, and may become worse with treatment.

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I have seen pain improve in many after tapering off.

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Then you must treat pain without opioid; it doesn’t just disappear, but it will not be as intense. This editorial explains some of the reasons opioids become a problem.

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Excerpted from an editorial in the current issue of PAIN

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[emphasis mine]

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[COT = chronic opioid therapy]

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…..This review highlights why we may see some of the more insidious problems that occur with COT, which are summarized below.

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Individuals on COT may continue to “need” opioids to replicate the functions of endogenous opioids that are no longer being released (or are in competition with the exogenous opioids). As the review by Ballantyne and Sullivan states, “a new homeostasis is reached that can only be maintained by continued drug taking”.1 Individuals on COT lose the ability to endogenously improve mood, decrease stress, and socially engage because the endogenous opioid system becomes inherently less responsive. In pain management, we know of this need for increasing opioid dose over time to maintain analgesia as opioid tolerance. But a similar physiological phenomenon likely occurs with any endogenous opioid function. Although we have mainly anecdotal reports from individuals who have been weaned off of opioids, the change in personality, social engagement, motivation, fatigue, and mood is often profound when individuals on COT successfully taper to lower doses or off opioids. These insidious side effects of COT would all be expected to inhibit individuals from maximally engaging in the patient-centric, disease management strategies that are now recommended for all chronic pain states.

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This may also explain why it is often very difficult to taper individuals on COT completely off opioids and underscores the importance of a slow, structured weaning protocol with appropriate psychological support. It may take months or years for endogenous opioid function to return to normal after cessation of opioids, or perhaps this system never returns to normal in some patients (as seems to occur in heroin addicts).5

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This paralysis of the endogenous opioid system by COT could render ineffective many other treatments that are recommended for chronic pain and that work in part via the endogenous opioid system. Many if not most nonpharmacological therapies for pain, such as exercise, acupuncture, and many other mind-body therapies are believed to work in part by engaging endogenous analgesic pathways that are partly opioid dependent.

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Opioids have acute antistress and antidepressant effects, and many of our patients with chronic pain are taking opioids chronically to medicate their co-morbid depression, despair or distress more so than to treat pain. Brain imaging studies indicate that many brain regions typically involved in pain and sensory processing are also involved in affective regulation. Patients having chronic pain who show higher degrees of psychological comorbidity or stress might therefore desire opioids because of their temporary salutary effects on these domains, rather than for their intended analgesic effects. We need to develop better cognitive-behavioral and psychosocial interventions that target the needs of the many patients with pain experiencing more harm than benefit from opioids, but still seek these drugs to reduce their affective symptoms.

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The endogenous opioid system may actually participate in the pathogenesis of some chronic pain conditions making this class of drugs particularly problematic for some patients. Many lines of evidence suggest that individuals with more centralized pain conditions such as fibromyalgia are particularly unresponsive to opioids, and the endogenous opioid system may be participating in the pathogenesis of these conditions.2,7 This has tremendous clinical implications because it means that we may actually make these patients’ pain worse by administering opioids. These same individuals may also be those at highest risk for prolonged use of opioids initially given for acute pain, both because they need higher doses for longer durations, and they are more likely to have the psychological comorbidities that drive unintended use and misuse.

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We clearly need to re-think the focus of opioid education and screening programs in light of some of these observations. After any exposure to an opioid, especially following the very common use in the United States for treating acute pain, patients can become addicted or can misuse these drugs to treat concomitant despair, depression, or pain elsewhere in the body that would not be expected to be responsive to an opioid. As we contemplate risk evaluation and mitigation strategies to curb further opioid misuse and addiction, we need to better appreciate these common alternate paths to unintended uses of opioids.

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We are not the first field to underappreciate the consequences of hijacking a critical endogenous system for one purpose, only to eventually find that there are significant consequences. Following the discovery of the endogenous corticosteroid system, Hench and others found that cortisone was an extremely effective treatment for rheumatoid arthritis, and this revolutionized our treatment of inflammatory processes. But it took several decades to fully appreciate all of the intermediate and long-term side effects of chronic corticosteroid use.4 Nearly all of these under-recognized issues were due to off target effects of exogenous corticosteroids on critical endogenous functions of these hormones. Although the short-term effects of opioids have been understood for centuries, long-term, high-dose opioids have only been advocated for a few decades. It is likely that we are now witnessing a similar clinical phenomenon, and as we increasingly appreciate the off-target effects of repurposing a critical endogenous system, the pendulum needs to rapidly swing back towards caution with prescribing a class of drugs that have a plethora of serious side effects other than addiction and death from overdose.

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Best wishes to all!


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Companies out of the pain business, NOT a hotbed of innovation, NOT COVERED by insurers


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Bloomberg news published this analysis below that explains much of the dead end in pain medication:

  • companies got out of the pain business.
  • there is no hope in sight for effective analgesics
  • insurers refuse coverage for more and more pain medications
  • insurers refuse coverage for modalities except opioids

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What kind of medical system:

  • forces patients to seek street drugs for pain relief because they are cheaper?
  • fails to treat addicts?
  • fails to allow cannabis (medical marijuana) one of the safest drugs ever discovered for pain and symptom management?

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The whole field is a sham ruled by politicians through CDC fiat and the justice department, subject to radical changes:

  •  a threat to your care
  • a threat to the field of pain management
  • a brick wall to any professional contemplating entering the field
    • pain management is complex & time consuming
    • most chronic pain patients have 3 or more pains
    • each pain requires assessment
    • risks patient addiction and/or suicide
    • risks loss of license
  • constant change
    • prior authorizations from insurers refused on appeal
    • disability refused for disabling pain
    • onerous computerized opioid database that is not nationwide, not fully completed by pharmacists
    • threats from patients, addicts, DEA, attorney general
    • highly politicized
    • good specialists thrown in jail despite expert testimony of foremost pain specialists – after testimony of addicts who reduced their sentence with lies
    • poor coverage of modalities if any for P.T., acupuncture, massage, integrative pain management, psychology, biofeedback, psychiatry, cannabis, compounded medications
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Here’s the article, click title to read in full.
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For the drug industry, building a better pain pill is a problem.

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Pharmaceutical companies have introduced new medicines to treat dependence, reverse overdoses, and deal with opioids’ side effects. But few effective and economically viable alternatives to addictive painkillers have emerged from the laboratory.

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That’s because of broken incentives, according to economists and industry experts. The payment policies of insurers and government health programs, along with pressure from investors, have encouraged drugmakers to treat the symptoms of the opioid epidemic but discouraged innovations that might get to the root of the problem.

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New therapies for pain have generally been too expensive, too cumbersome to use, or targeted at too small a group of patients….

 

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Different Incentives

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The incentives to develop a better pain pill differ sharply from those in other areas of research, such as Alzheimer’s disease.

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Drugmakers have spent billions on more than 100 failed medicines for Alzheimer’s, but a breakthrough would potentially reach a large and lucrative population of elderly patients on Medicare. Any new pain drug would be fighting it out with inexpensive, proven rivals in a politically fraught environment.

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The White House Council of Economic Advisers estimated this week that abuse of opioids cost the economy about $504 billion in 2015, or nearly three percent of that year’s overall economic output in the U.S. Those costs include health-care expenses, spending on criminal justice and first responders, and lost worker productivity.

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“There’s currently a lot more costs of addiction that are being borne by society in a more diffuse way,” said Kosali Simon, a health economist at Indiana University….

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Effort and Expense

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Most opioids are cheap generic drugs that have been prescribed for decades, making the effort and expense of developing new painkillers hard to justify.

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“They’re off-patent, they can be produced by companies that aren’t the original inventors,” said Bertha Madras, a professor of psychobiology at Harvard Medical School and a member of President Donald Trump’s opioid commission. “It becomes a much more expensive proposition to develop and get the approval for an opioid.”

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Drugmakers have instead invested in developing complex medicines for cancer and rare diseases, which can fetch six-figure price tags.

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“Companies got out of the pain business,” said Pratap Khedkar of ZS Associates, a sales and marketing consultant who studies the pharmaceutical industry. “It’s not the hotbed of innovation.”…..

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Wary Payers

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Drug plans have been reluctant to pay for abuse-resistant pain medicines, which often cost more and can be more difficult to administer. A recent report from The Institute for Clinical and Economic Review, a nonprofit that evaluates the value of prescription drugs, found that abuse-deterrent opioids weren’t cost-effective for insurers.

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At the same time, payers are limiting patients’ access to older pain drugsCigna Corp.took OxyContin off its list of preferred drugs for 2018, though it still covers other opioids. CVS Health Corp. said its pharmacy-benefits management arm will limit prescriptions to a seven-day supply, and Express Scripts Holding Co. also said it wouldcurb prescriptions.

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That leaves patients with a difficult choice. Abuse-deterrent painkillers might cost as much as $250 out of pocket. But generic opioids cost as little as $2, according to Denis Patterson, a pain specialist in Reno, Nevada.

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Abuse-resistant drugs get “denied 90 percent of the time. But the pain pills will get approved every single time,” said Patterson.

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“Shouldn’t it be flipped,” he said, “in that the things which can get people better should have better coverage?”…..

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Insurers Deny Opioids, CVS Refuses to Fill Unless Authorized


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Always something new in this amazing field of pain management where treatment is decided by politicians and insurers.

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Patients and physicians alike have suffered denial of medications without prior authorization for the last 10 years or more. Prior authorization takes enormous time, at times more than one hour for each medication.  Try to picture a full day of seeing patients and an unexpected full day just for prior authorizations that must be fitted into the hours the insurer is open – remember, examiners often leave early, central time, hours ahead of PST. 

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Insurers deny the usual opioid because there is no proof that opioids have ever been proven to help chronic pain and side effects may include constipation, cognitive impairment, overdose and/or death.  

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Insurers routinely deny opioid at lower dosages when I try to taper: giving less is not allowed without prior authorization. Remember, we don’t find out until the patient goes to the pharmacy to fill, and they may wait to fill, then may need the medication that very night to continue their medication. Who is open after hours? 

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One independent 94 year old senior for years has been on fentanyl 12 mcg/hr patch and Oxycontin 10 mg in AM (not PM) for frozen shoulders and arthritis in knees. These are small doses. Denied for 3 or 4 years, so she paid out of pocket, in her 90’s. 

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She walks with a rollator, and wins at bridge games that she plays several times a week. Under my care since 2003, physical therapy has been unsuccessful. With her orthopedist, she receives injections every three months that help arthritis in knees. We had tried appeals including sending entire chart to insurer that included physical therapy note, but insurer insisted on physical therapy again. I asked them to show me one, simply ONE publication that showed physical therapy helpful for severe frozen shoulders present for decades. 

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Now pharmacy refuses to fill her 10 mg Oxycontin and her patch unless insurer authorizes. Her oxygen saturation is 98% which is excellent. Cognitive function is unchanged since 2003. I cannot imagine how she gets dressed as even a few degrees of motion of either shoulder elicits screams of pain. Her daytime caregiver must be dressing her. 

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That’s how we treat our injured, our disabled and our elderly.

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Insurers have authorized $50,000 spinal cord stimulators for years without a single study showing long term proof of efficacy. The potential for permanent damage to spinal cord and potential for accelerated pain syndromes is frightening. See the many comments on this site from patients who have suffered serious medical injury. 

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NIH has failed to adequately fund pain research for decades. But congress has accepted millions from opioid manufacturers and for years FDA approved one new opioid after another, as often as 4 new ones each year. FDA previously approved a nonopioid medication such as Lyrica for neuropathic pain, but in the last few years, a nonopioid Horizant has been approved only for postherpetic neuralgia pain — nerve pain, but only ONE type of nerve pain. Remember, insurers mandate first trying gabapentin for nerve pain, though it was never FDA approved for pain at all. Try to get an off-label non-opioid medication approved for pain. hah!

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Now I have an RN in her 40’s who has severe nerve pain from CRPS in both upper limbs after carpal tunnel surgery. Gabapentin caused severe cognitive dysfunction, improved on Horizant but insurers refused to approve Horizant. The cost for one daily is at least $750, but pain is better using twice daily.

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This week comes a letter from insurer that Revia, naltrexone 50 mg tablet FDA approved for addiction to opioids and alcohol, is no longer covered.

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Psychiatry colleagues tell me the same story. Antidepressants that also help anxiety are not covered but better than taking Xanax that causes memory loss and can be used to overdose.

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Vote for better politicians, not for lies. Insist on NIH research funding for chronic pain management to represent the vast population with chronic pain, not the pittance they allow. 

 

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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Comments are welcome.

This site is not for email, not for medical questions, and not for appointments.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Cannabis Overwhelmingly Preferred over Opioids for Pain – UC Berkeley / HelloMD Opioid Study


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Congratulations and thanks to HelloMD’s email, posted below, that describes a new study. They are doing important work for people who can be helped by cannabis. We need help in the treatment of chronic pain.

I’ve seen pharma pressure pain specialists to refuse to treat patients who also use cannabis. For Pete’s sake it helps relax deep muscle like nothing else, helps anorexia, can bring up extremely low energy a tiny bit, helps depression, and pain. Shock and awe. What an awful thing to pressure doctors to do just to punish the plant based industry and extinguish the competition. I’m sure TV ads brainwash even more. Professionals in healthcare and politics need our help to know good studies already exist and even without that rigorous proof, our dispensaries can recreate what the world has safely used for thousands of years.

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HelloMD is a trusted source of information. 

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The HelloMD Advisor

Opinions from Industry Experts


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Hi Nancy,

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Yesterday we announced the results of our landmark study examining the use of cannabis as a substitute for opioid and non-opioid based pain medication. Performed in collaboration with University of California Berkeley, HelloMD surveyed 3,000 participants from our patient database….[– click on below link to article]

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[They showed the]

overwhelming majority of cannabis patients (92%) prefer using cannabis to opioids when managing their chronic pain.”

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Your participation in HelloMD studies is invaluable as it takes us one big step closer to showing healthcare professionals, elected officials and the public at large the potential for cannabis to alleviate the opioid crisis our nation is experiencing.

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HelloMD also recently launched in New York state offering patients the ability to get their medical marijuana certification online. This week we highlight PharmaCannis, a shining example of the eastern US cannabis scene, with five dispensaries statewide, professionals from the pharmaceutical industry, and an eye towards making cannabis a part of the future of healthcare.

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Finally, we highlight Dr. Gary Richter, the ‘Cannabis Pet Vet’, who has made it his mission to help animals and their owners lead happy, healthy lives.

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Be happy & healthy,

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Pamela Hadfield – Co Founder

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This is an important study for people to learn about and to help our legislators understand we need help to use this plant for billions who are needlessly suffering. We all need help. And simple is best. This medication has been safely used by grandmothers for thousands of years. Silly to think we cannot begin. Silly to deny millennia of use. We need help:

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  1. Low cost medication is essential.

  2. Healthcare insurers must reimburse patients for the cost of medical marijuana. This is done in New Mexico and should be in every state.

  3. We must all stop weaponizing a simple healing plant that can be effective. Truth beats fear. Every study helps to open minds.

  4. Support the work of good groups like HelloMD, NORML

  5. Get politics out of science and healthcare

  6. Teach our doctors – require 1 hour CME for all who see patients.

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I have so many senior patients terrified to try cannabis, and one who just had a once-in-a-lifetime result with a few cannabis drops under the tongue. She worked with a dispensary that mixed a personalized ratio of THC:CBD. It Worked! Nothing else had, her life spent in years of constant headache. It’s gone! yet she is still terrified of cannabis.

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Such has been the insanity about the American gung-ho opioid boosters vs the shoot ’em dead plant loving criminals and addicts – that’s what these little old ladies think they have become. Criminals and addicts. This sweet woman’s intractable migraine has taken her life every day for years, failing to respond to the best care in the nation, is now gone with cannabis! Yet she’s going to have a heart attack because for decades the GOP has trained her to think she’s a criminal addict. She was referred by one of the foremost migraine experts whose final suggestion was to try cannabis. A few weeks later when she came to her first visit with me, she was headache free.

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Had her family doctor been able to recommend someone who works with cannabis patients many years ago, she would not have wasted her life and fortune. It can be simple and life-saving to try, and always nice to have a helpful hand from the dispensary to show you how.  Again HelloMD helps with that.

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I am very grateful for HelloMD. For their great organization, a smoothly developed, simple, cost effective model that is affordable and convenient for my patients who are too ill to travel or simply too uncomfortable at the thought of hanging with a waiting room crowd so far from their better healed comfort zone.

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After all, they don’t look disabled, but I see disabled kids as young as 8 through 90’s.

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Do not judge disability by how someone looks. Young disabled veterans wearing artificial legs, have been attacked for not looking disabled when they park in disability spaces.

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Bring peace and healing to all whenever you can. Learn to use the plant and to enjoy the plant too. To be able to let off the weight of the world…. that alone is healing. Nothing is working right. Well, so what? Let go. We have to let go, let peace, breathe. You know you do the best you can as always, so now do the best and let go. Bring peace.

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Cannabis is a sacred plant. Treat it with respect. Fear is ignorance. Teach the truth. 

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“Democracy dies in darkness.”

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Bring peace and healing

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The material on this site is for informational purposes only.

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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Avoid opioid use in surgery to reduce postop pain


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Science for years has confirmed that opioids trigger inflammation and that creates pain. Trauma and surgery also create inflammation that leads to pain. How logical is it then to continue use of sufentanil for anesthesia when it is the most highly potent opioid 500 to 1,000 times stronger than morphine. Where is the logic in creating pain by using sufentanil as the anesthetic? A new one on the market will be 10,000 times stronger than morphine. Inflammation is not always easy to reset after you strafe the innate immune system with an opioid.

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Why is ketamine not used more often for surgical anesthesia when we know ketamine profoundly lowers the inflammatory response thus reducing pain more than ever. Studies for years have shown that even a small dose of ketamine reduces postop pain. This is not new.

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A study needs to be done comparing patients who receive no opioids. At least this study showed that when fewer opioids are used, pain scores are 37% lower than if more had been given. Patients given higher doses of opioid, had higher analgesic requirements postop. That increases the risk of persistent chronic pain and the tragic risk of addiction.

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Opioids inflict known lasting harm, pain and suffering, perhaps disability and addiction.

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Reduced opioid use in surgery linked to improved pain scores
Written by Brian Zimmerman

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After anesthesiologists at the University of Virginia Health System in Charlottesville began administering fewer opioids to patients during surgeries, patients’ self-reported pain levels dropped, according to a study led by three UVA anesthesiologists.
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For the study, the team examined 101,484 surgeries that took place in the UVA Health System from March 2011 to November 2015. During this time period, the amount of opioids administered via general anesthesia at the system was reduced by 37 percent.
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For the same time period, self-assessed patient pain scores recorded in post-op recovery units dropped from an average of 5.5 on a 10-point scale to an average of 3.8, marking a 31 percent improvement.

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One of the study’s leaders, UVA anesthesiologist Marcel Durieux, MD, PhD, said the impetus behind the pain score improvements is likely attributable to several factors. One, previous research has indicated opioids can ultimately make people more sensitive to pain. And two, the increased use of non-opioid painkillers like lidocaine and acetaminophen during surgeries at UVA was likely effective.

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….”There is very clear evidence that people can become opioid-dependent because of the drugs they get during and after surgery,” said Dr. Durieux. “I think that by substantially limiting opioids during surgery, we’ve made an important step in addressing that problem.”

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Opioids: a think tank to expose the deep-rooted failures and injustices in our health care system


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STAT is “a new national publication focused on finding and telling compelling stories about health, medicine, and scientific discovery” in partnership with the Lown Institute.

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“The Lown Institute is a think tank dedicated to research and public communication to expose the deep-rooted failures and injustices in our health care system, and to helping clinicians, patients, and communities develop a shared vision for a better health system.”

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.“Since 2012, the Lown Institute has been a leading voice in the movement to recognize the harms of overuse of medical care, and in pointing out the clear connection between wasteful medical treatment and our system’s failure to deliver needed care.”

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This article from STAT, excerpted below, beautifully and painfully describes the opposing sides of the deep divide in our country about treatment with opioid analgesics for chronic pain. It is a divide deeper than the growing upheaval of politics in America, and it is unique to us. The United States, with 5% of the world’s population, consumes 80% of the global opioid supply, and an estimated 99% of hydrocodone. “Pain drugs are the second-largest pharmaceutical class globally, after cancer medicines.”

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I have seen both sides, those who cannot live or function without opioids and those whose pain improves radically once they taper off. The war on patients plays out many times daily, while patients and doctors alike are deeply concerned at the lack of research in this volatile unpredictable field, where patients are subjected to whack-a-dose prescriptions since the March 2016 CDC fiat that dictated slashed opioid dosages, a dictate that now entitles insurers to deny all medication overnight —saving them tremendous costs. All denied, no matter how small the dose, nor how intense the diagnoses and pain.

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This irrational, inhumane, and unpredictable disease of change has become a constant, destroying lives of patients and caregivers while addicts continue to overdose evermore and prisons are filled with low level street corner dealers —never the rich who buy their way out of prison. Cheating is a way of life for corporations, condoned by congress.

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A ‘civil war’ over painkillers rips apart the medical community — and leaves patients in fear

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PALO ALTO, Calif. — For Thomas P. Yacoe, the word is “terrifying.”

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Leah Hemberry describes it as “constant fear.”

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For Michael Tausig Jr., the terror is “beyond description.”

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All three are patients struggling with chronic pain, but what they are describing is not physical agony but a war inside the medical community that is threatening their access to painkillers — and, by extension, their work, their relationships, and their sanity.

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Two years after the United States saw a record 27,000 deaths involving prescription opioid medications and heroin, doctors and regulators are sharply restricting access to drugs like Oxycontin and Vicodin. But as the pendulum swings in the other direction, many patients who genuinely need drugs to manage their pain say they are being left behind.

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Doctors can’t agree on how to help them.

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There’s a civil war in the pain community [my emphasis],” said Dr. Daniel B. Carr, president of the American Academy of Pain Medicine. “One group believes the primary goal of pain treatment is curtailing opioid prescribing. The other group looks at the disability, the human suffering, the expense of chronic pain.”

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Pain specialists say there is little civil about this war.

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“There’s almost a McCarthyism on this, that’s silencing so many people who are simply scared,” said Dr. Sean Mackey, who oversees Stanford University’s pain management program.

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“The thing is, we all want black and white. We don’t do well with nuance. And this is an incredibly nuanced issue.”

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Stanford’s Mackey said those risks are important to recognize. But, he said, nearly 15,000 people die a year from anti-inflammatory medications like ibuprofen. “People aren’t talking about that,” he said….

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…Dr. Anna Lembke, who practices alongside Mackey at Stanford’s pain clinic and is chief of the Stanford Addiction Medicine Dual Diagnosis Clinic, published a book about the opioid crisis last year. It was titled: “Drug Dealer, MD: How Doctors Were Duped, Patients Got Hooked, and Why It’s So Hard to Stop.

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Lembke believes that long-term opioid use can cause patients to perceive pain even after the original cause of pain has cleared. Some patients, she said, find themselves free of pain only once they have endured the often agonizing effects of opioid withdrawal.

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“That’s what we’re seeing again and again,” she said.

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…. a single father of two teens, said that every month he needs to fill a prescription, he’s fearful it will be denied.

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Mackey says doctors being trained at Stanford’s pain center have grown increasingly fearful about prescribing opioids...

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[Dr. Mackey describes a practicing 81 year old physician who cycled to work until recent back surgery. His life is now complicated by severe back pain and he requires opioids to continue to function.]

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“If you’re 81 and you stop getting out of bed, it’s a slippery slope,” he said.

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Heroin Addiction absent or rare in UK prescribing


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Diamorphine (heroin) is prescribed for pain in the UK . Yesterday’s LA Times Op-Ed

What’s really causing the prescription drug crisis?

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Studies show addiction to opioids of any kind, even heroin, is rare in the UK. Not what we see in the US. They have more socialized care for housing, medical care, medications including for the jobless. They do not have the hopelessness that leads to desperation and addiction. Desperation is why all patients with chronic pain must work with a psychologist. Pain is not in your head, but desperation is, and a psychologist can help you learn tools to deal with desperation. If you don’t, pain will go up, up, up and that’s what’s in your head. Unless you use those tools, I promise you will suffer because it will get worse and worse and worse.

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“Doctors in many parts of the world — including Canada and some European countries — prescribe more powerful opiates than their peers in the United States. In England, if, say, you get hit by a car, you may be given diamorphine (the medical name for heroin) to manage your pain. Some people take it for long periods. If what we’ve been told is right, they should become addicted in huge numbers.

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But this doesn’t occur. The Canadian physician Gabor Maté argues in his book “In the Realm of Hungry Ghosts” that studies examining the medicinal use of narcotics for pain relief find no significant risk of addiction. I’ve talked with doctors in Canada and Europe about this very issue. They say it’s vanishingly rare for a patient given diamorphine or a comparably strong painkiller in a hospital setting to develop an addiction.

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Given that really powerful opiates do not appear to systematically cause addiction when administered by doctors, we should doubt that milder ones do. In fact only 1 in 130 prescriptions for an opiate such as Oxycontin or Percocet in the United States results in addiction, according to the National Survey on Drug Use and Heath.

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So what’s really happening? The second, clashing story goes, again, crudely, like this: Opiate use is climbing because people feel more distressed and disconnected, and are turning to anesthetics to cope with their psychological pain.

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Addiction rates are not spread evenly across the United States, as you would expect if chemical hooks were the primary cause. On the contrary, addiction is soaring in areas such as the Rust Belt, the South Bronx and the forgotten towns of New England, where people there say they are lonelier and more insecure than they have been in living memory.”

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Healthcare costs in the US are a very serious problem. Opioids require monthly visits. Patients on opioids are forced to see a pain specialist, many for decades when pain is chronic. That’s bad enough, but the cost of opioid medications are outrageous. I know some whose opioids cost $17,000 per month or more. And some doctors in my area have mandated urine drug tests every single month, $750 per test, to prove you are not taking street drugs. High risk patients and nonaddicts alike, every month, just to pee in a cup and get your prescription opioid. 

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Now congress is getting rid of the ACA, to make it better. I can only imagine how helpful they have been. Privatize social security, privatize medicare, privatize everything. Of course that will be better for them. Will it help anyone else? 

 

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The material on this site is for informational purposes only.
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It is not legal for me to provide medical advice without an examination.

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It is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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This site is not for email and not for appointments.

If you wish an appointment, please telephone the office to schedule.

~~~~~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please IGNORE THE ADS BELOW. They are not from me.

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Pain News: “Reckitt Benckiser sued by 35 US states for ‘profiteering’ from opioid treatment”


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Headlines today from the Guardian:

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“Reckitt Benckiser sued by 35 US states for ‘profiteering’ from opioid treatment”

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There really is no financial advantage for pharmaceutical companies to create medication that helps pain because opioids are for life, and are so valuable some of them can charge each patient $20,000 a month. For life. Explains why every year 2 or 3 new opioids come on the market, year after year after year, more new opioids.

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Opioid profiteering.

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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The advertising below is not recommended by me.

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Abuse & Misuse Risk Assessment Tools from FDA – for Opioids, Ketamine, Adderall, Xanax, Ativan, Valium, Any Drugs of Abuse


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Risk Assessment Tools Examples from FDA.gov

page 11  (pdf)

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We must always remember, all of us, families, friends and physicians alike, the possibility of opioid use disorder (OUD) in anyone on chronic opioid therapy (COT) and those who are prescribed any drugs of abuse such as Ketamine, Adderall and benzodiazepines such as Valium, Ativan, Xanax. None of us should be taking medications that interfere with our ability to think and function. None of us should be taking more than we need. Many of us do not realize that less is more.

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Details of many tools for risk assessment are reviewed previously here.

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Keep this in mind:

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  • “Assessing risk of abuse and OUD in patients receiving COT is a dynamic, ongoing process.

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  •  Diagnosing misuse, abuse and OUD in patients with pain is complex

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  • Current screening tools do not diagnose abuse or OUD but only misuse and not intent”

     

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Tools

# of Items

 Administered

Patients considered for long-term opioid therapy:

ORT Opioid Risk Tool

5

By patient

SOAPP® Screener & Opioid Assessment for Patients w/ Pain

24, 14, & 5

By patient

DIRE Diagnosis, Intractability, Risk, & Efficacy Score

7

By clinician

Characterize misuse once opioid treatments begins:

PMQ Pain Medication Questionnaire

26

By patient

COMM Current Opioid Misuse Measure

17

By patient

PDUQ Prescription Drug Use Questionnaire

40

By clinician

Not specific to pain populations:

CAGE-AID Cut Down, Annoyed, Guilty, Eye-Opener Tool, Adjusted to Include Drugs

4

By clinician

RAFFT Relax, Alone, Friends, Family, Trouble

5

By patient

DAST Drug Abuse Screening Test

28

By patient

SBIRT Screening, Brief Intervention, & Referral to Treatment

Varies

By clinician

 

Opioid Production in US Cut 25% by DEA in 2017


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The DEA regulates how much opioid is allowed to be made each year. Production will be cut by 25% in 2017. Some will be cut by more than 25%, for example hydrocodone will be cut 34%.

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The reasons given are that demand is falling and the opioid epidemic is not. Congress of course could think about funding addiction treatment and offering clean injection sites for addicts such as Vancouver’s.

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The order will be published tomorrow in the Federal Register.

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In June 2016, Senator Richard Durbin interrogated Chuck Rosenberg, acting administrator of the Drug Enforcement Administration (DEA), during a Senate Judiciary Hearing.

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Durbin has introduced legislation to fight opioid abuse. One section of the bill would require DEA to consider opioid addiction when setting production quotas. If annual quotas increase, DEA would be required to justify that in writing, explaining why the bump outweighs the risk of having more addictive drugs available.

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Opioid death stats demonstrate the ravages of the epidemic.
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About 47,000 people died from overdoses in 2014, Rosenberg said. That’s 129 every day. About 61 percent were due to prescription opioid and heroin.

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me to give medical advice without a consultation.

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Opioid taper – please comment. Your story matters


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Opioids

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Americans use 80% of prescription opioids in the world.

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If you have voluntarily tapered off opioids, please comment

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In 1991, America was not even among the top 10% prescribing opioids for cancer pain. Now look where opioid induced pain has led the way medicine is practiced. We have created disability like throwing gasoline on fire. It is costing lives.

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Patients with intractable pain who have failed all  procedures, nerve blocks, injections and opioids, why are they still taking them if pain is still severe, if they are not able to function? They do worse than nothing.

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Opioids create pain: They trigger the brain to produce pro-inflammatory cytokines that cause pain. It is drowning in a universe of delusion to ignore the data. Clinging to fear.

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Data: Here’s an old Stanford study from 2005 Journal of Pain:

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Opioid Tolerance and Hyperalgesia in Chronic Pain Patients After One Month of Oral Morphine Therapy: A Preliminary Prospective Study

 

Abstract

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There is accumulating evidence that opioid therapy might not only be associated with the development of tolerance but also with an increased sensitivity to pain, a condition referred to as opioid-induced hyperalgesia (OIH). However, there are no prospective studies documenting the development of opioid tolerance or OIH in patients with chronic pain. This preliminary study in 6 patients with chronic low back pain prospectively evaluated the development of tolerance and OIH. Patients were assessed before and 1 month after initiating oral morphine therapy. The cold pressor test and experimental heat pain were used to measure pain sensitivity before and during a target-controlled infusion with the short-acting μ opioid agonist remifentanil. In the cold pressor test, all patients became hyperalgesic as well as tolerant after 1 month of oral morphine therapy. In a model of heat pain, patients exhibited no hyperalgesia, although tolerance could not be evaluated. These results provide the first prospective evidence for the development of analgesic tolerance and OIH by using experimental pain in patients with chronic back pain [my emphasis]. This study also validated methodology for prospectively studying these phenomena in larger populations of pain patients.

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Perspective

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Experimental evidence suggests that opioid tolerance and opioid-induced hyperalgesia might limit the clinical utility of opioids in controlling chronic pain. This study validates a pharmacologic approach to study these phenomena prospectively in chronic pain patients and suggests that both conditions do occur within 1 month of initiating opioid therapy.

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Of course when you stop the opioid, the system rebounds like wild, stronger pain. It’s one thing to publish this important study, but how to offer better relief than the adjuvants that failed?

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How has opioid’s overwhelming inflammatory imbalance in brain affected the ability to recover? ever. The brain is maxed out. Is it permanent? How long does this last? There are those who think, I won’t taper off, I’ll wait till the very last minute, do rapid detox and expect instant change. Do not allow brain recovery. Opioids are still in system for weeks after stopped.

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People more likely to remain on disability if opioids are even once started. Doctors then prescribe tramadol, Nucynta, buprenorphine in patches or film for sublingual use. Those are still opioids.

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And one week ago, two more opioids approved. They make billions, guaranteed lifelong. Why should pharma try something that will actually relieve pain without causing inflammation centrally in brain?

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The problem is that patients who taper off have been offered nothing adequate to replace the opioid.

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The question is, if FDA refuses to approve any more opioids, will pharma do anything to relieve pain?

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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Opioids “Two Novel Opioids Win Tepid Backing From FDA Panel” – really? 2 more opioids?


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Two Novel Opioids

Win Tepid Backing From FDA Panel

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Two more opioids . . . . . . . . oh boy! more opioids

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The only class of pain drugs that rakes in $40,000 per month or more for a single patient. We’d see pharma thinking about something better than opioids if they were blocked from charging more than gabapentin. Opioids cost pennies yet these formulations can cost more than $1,000 a day and they are poorly effective for chronic pain.

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“Both committees — the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety Risk Management Advisory Committee (DSaRM) — were asked to consider a proposed indication of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.”

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“Many of the committee members said their “yes” votes on approval came with some hesitation — while Teva’s product may be an incremental step in the right direction, there needs to be better outcome measures for reductions in abuse resulting from reformulations, as well as improved outcomes for the treatment of pain, they said.
Meeting a second day, the same panel also voted 9-6 to “recommend” approval of a different abuse-deterrent product, this one combining extended release oxycodone with naltrexone (Troxyca). The slim margin is often seen a null recommendation.”

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Don’t get excited about naltrexone in these formulations. When injected into vein, it will block the effect of the opioid.

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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~

 

Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Neuropathic Pain Medications – review & metanalysis of 229 studies


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This review was done by many of the best pain specialists from all over the world. You will not find answers in that large review if neuropathic pain has already failed tricyclic antidepressants (Elavil, amitriptyline, Norpramin desipramine, others), gabapentin (Neurontin), pregabalin (Lyrica), lidocaine, capsaicin, or opioids. That is the current paradigm. A new paradigm – glial modulators  – that I discuss on this site, may or may not give relief.

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A member of the International Association for Study of Pain, IASP, published a brief critique of that comprehensive review of 229 trials of medications for neuropathic pain published in Lancet Neurology February 2015. The critique is posted below, done by a member of the Neuropathic Pain Special Interest Group, NeuPSIG.

 

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To understand the metanalysis of these 229 trials, you need to understand the simple concept of number needed to treat, NNT.

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NNT is an estimate of “the number of patients that need to be treated in order to have an impact on one person.”

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The smaller the number, the more effective the drug. Example, NNT of 7.2 for gabapentin means you need to treat  7.2 people before a response. If 3, need to treat 3 before a response.

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Barsook (Harvard, ref. below) reviewed ketamine studies in 2009:  “they did show a level of efficacy (of ketamine) based on NNT that equals or betters most drug trials for this condition.”

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“NeuPSIG has just published an up to date systematic review on the effectiveness of pharmacotherapy in Lancet Neurology. They have negotiated with the journal to make it available beautifully open access. You can download it for free here.”

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Neil O’Connell, Brunel University London

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“This is a comprehensive review, containing 229 trials of the full range of pharmacological agents using robust methods, to synthesize, summarise and make value judgements about the quality of the available evidence. So what are the take home messages?”

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“Using a primary outcome of achieving at least 50% pain relief trial outcomes were described as “generally modest”. The number of patients needed to treat with the drug compared to a placebo for one more person to achieve this outcome ranged from a relatively rosy 3.6 (95% confidence interval 3 to 4.4) for tricyclic antidepressants such as amitryptiline, 4.3 (95%CI 3.4 to 5.80 for strong opioids to a less impressive 7.2 (95%CI 5.9 to 9.21) for gabapentin, and 7.7 (6.5 to 9.4) for pregabalin (often sold under the brand-name Lyrica). It’s interesting, at least to me, how much better the older more traditional agents seem to have fared compared on effectiveness to the more modern (and commonly more expensive) agents although the safety and tolerability of gabapentin seems superior.”

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“The spectre of publication bias also raises its head. The reviewers carefully took a number of routes to try to unpick this notoriously difficult issue and estimate that there has been overall a 10% overstatement of treatment effects. Published studies reported larger effect sizes than did unpublished studies. This is not a problem restricted to the field of pain trials. It is a burning issue across the world of clinical trials. It is very important because if we fail to base our clinical recommendations on the totality of relevant evidence (because some data are hidden from us) we are in danger of mis-estimating the benefits and the harms and as a result patients are put at risk. If you think that is pretty important then there are ways that you can help. Check out the All-Trials campaign.”

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“Overall what does this mean? Many drugs are effective but not as effective as we would wish them to be. No pharmacological agent really impresses and for any drug the most probable outcome is failure to produce 50% pain relief. There are various potential reasons for this. The first is that the drugs may only be moderately or marginally effective, another is that neuropathic pain includes quite a mixed bag and our ability to accurately diagnose and to target drugs to specific mechanisms in the clinic is currently fairly poor.”

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“The NeuPSIG review team formulate a number of recommendations for revision of their clinical guideline for managing NP pain, balancing the benefits, harms, costs and strength of the evidence.”

  • a strong recommendation for use and proposal as a first-line treatment in neuropathic pain for tricyclic antidepressants, serotonin-noradrenaline reuptake inhibitors, pregabalin, and gabapentin;

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    • a weak recommendation for use and proposal as a second line treatment for lidocaine patches, capsaicin high-concentration patches, and tramadol; and a weak recommendation for use and proposal as third line for strong opioids and botulinum toxin A. Topical agents and botulinum toxin A are recommended for peripheral neuropathic pain only.

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“This email [from IASP’s NeuPSIG] is also published as a blogpost at www.bodyinmind.org”

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References

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Finnerup NB, Attal N, Haroutounian S et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14:2:162-73.

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Glial modulators – another paradigm

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From my January 2012 brief review of publications on ketamine, only one of a handful of glial modulators, this author says reviews “show a level of efficacy based on NNT that equals or betters most drug trials for this condition.

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Ketamine and chronic pain – Going the distance, David Barsook, Director, P.A.I.N. Group, Massachusetts General, McLean and Children’s Hospitals, Harvard Medical School, Boston, MA;

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This paper covers essential points not mentioned by many, thus quoted at length below:

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Our current therapeutic armamentarium is quite limited in terms of analgesic efficacy in controlled trials. Some would argue that the small efficacy (both at a population level and the magnitude of change in VAS score) this is related to the fact that we need to consider mechanistic approaches to chronic pain subgroups. However, patients and clinicians find themselves in a position of “what to do now”.

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Ketamine, brain function and therapeutic effect – neuroprotective or neurotoxic

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With the onset of chronic pain (including CRPS) a number of changes in brain function occur in the human brain including but not limited to: (1) central sensitization ; (2) functional plasticity in chronic pain and in CRPS; (3) gray matter volume loss in CRPS ; (4) chemical alterations ; and (5) altered modulatory controls. Such changes are thought to be in part a result of excitatory amino acid release in chronic pain. Excitatory amino acids are present throughout the brain and are normally involved in neural transmission but may contribute to altered function with excessive release producing increased influx of calcium and potentially neural death. Here lies the conundrum the use of an agent that potentially deleteriously affect neurons that may already be compromised but may also have neuroprotective properties by mechanisms that include reducing phosphorylation of glutamate receptors resulting in decreased glutamatergic synaptic transmission and reduced potential excitotoxicity . Alternatively, ketamine may affect glia regulation of glutamate and inhibit glutamate release within glia. However, by whatever mechanism ketamine acts on CRPS pain, there does seem to be a dose/duration effect in that longer doses at levels tolerated by patients seem to prove more effective in terms of the duration of effects.

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So what could be happening in the brain and what is required to alter brain systems and reverse the symptomatic state? Ketamine may diminish glutamate transmission and “resets” brain circuits, but it seems that a minimal dose and/or duration of treatment is required. Alternatively, ketamine may produce neurotoxicity and damage or produce a chemical lesion of affected neurons. These two issues are important to be understood in future trials. Reports from patients who have had anesthetic doses have included prolonged pain relief for many months. While the authors did not address issues such as the effect of dosing duration or repetitive dosing at say 6weeks, they did show a level of efficacy based on NNT that equals or betters most drug trials for this condition.”

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Conclusions

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As a community we have a major opportunity to define the efficacy and use of a drug that may offer more to CRPS (and perhaps other) patients than is currently available. This is clearly an opportunity that needs urgent attention and a number of questions remain to be answered. For example, is ketamine more effective in early stage disease? How does ketamine provide long-term effects? Further controlled trials evaluating dose, duration, anesthetic vs. non-anesthetic dosing are needed. Few of us really understand what it is like to suffer from a chronic pain condition such as CRPS. Ketamine therapy may be a way forward that can be brought into our clinical practice through further controlled studies that will allow for appropriate standards for use in patients.

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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~

Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Opioid Overdoses ~130 every day, the capacity of a Boeing 737 – naloxone $4,500, up from $690 in 2014. You pay


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LA Times reports

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As need grows for painkiller overdose treatment, companies raise prices

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$4,500

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$4,500.

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$4,500 for naloxone manufactured by Kaleo, Richmond Virginia. Naloxone reverses opioid overdose.

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That seems to be their Evzio two-pack, two single-use injectors of naloxone in a hard case handy to carry in a pocket for someone who has an opioid overdose.

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Each has a 0.4 mg injection that last 2 or 3 minutes each, just long enough to call an ambulance.

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A drug that costs pennies, sold as a 2-pack for $690 in 2014, then $900, now $4,500 as of Feb. 1.

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“…Columbus, Ohio, said the city’s firefighters last year used 2,250 naloxone doses, or about 6 doses a day — at a cost of $147,000. Recently, Columbus also stocked the drug in 115 police cruisers….”

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FDA approved Evzio in April 2014 after granting fast-track status. Fast track now means gold mine status. 

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Naloxone was first approved in 1971.

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“In July 2005 its average wholesale price for a vial of the injectible drug was $1.10, according to Truven Health Analytics.

By 2014, the price was almost $19 a vial.” 

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Medical costs are astronomical, insurance premiums are up, insurance deductibles are $5,000 to $10,000 for many. Police, fire department and EMT’s are using naltrexone to save lives and lower ER visits.

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Taxes are high. Where is the initiative and innovation among EMT’s, police, fire? How many hours per day do they get paid full salary to work out at the gym and stay fit while they sit and wait for the next call to rescue an addict who overdosed. Then retire on double pensions if they hold two city jobs. While they wait for next calls, could they not fill syringes from a vial of naloxone? How much do taxpayers pay for these overpriced robotic filled syringes at factories.

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Pharma is raking it in. Pharma’s blood sucking 1% are overdosing on costs. Many of my patients with intractable pain who are on opioids were not able to afford $690. They are not addicts but any dose of opioid can kill. Your tax dollar pays for naloxone for addicts found dead, unresponsive.

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We are all paying a fortune for inexcusable pharma costs. Costs for millions of drug addicts all over the country. Costs for prescription medications. Congress unwilling to address anything that would cut the flow of donations to their coffers from pharma.

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Just remember, in Israel, it is illegal for corporate lobbyists to contact any politician.

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“Late last year, Adapt introduced a naloxone nasal spray named Narcan for a average wholesale price of $150 for two units, according to Truven.”

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That is a BD syringe fitted with a flared BD adapter at the tip to fit the nostril. It requires the user be capable of pushing the 1 mL syringe so the liquid is sprayed into nostril.

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For Pete’s sake. I’ve been prescribing medicine in these BD syringes with nasal adapter for years. Is there no EMT smart enough to make and stock their own supply to use for emergencies?

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“…as the demand for naloxone has risen — overdose deaths now total 130 every day, or roughly the capacity of a Boeing 737 — the drug’s price has soared.
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…Increased access to naloxone is among the measures included in federal legislation that Congress passed last week in response to the painkiller deaths. The White House has said that President Obama plans to sign the bill.
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Last month, U.S. Sens. Susan Collins (R-Maine.) and Claire McCaskill (D-Mo.) wrote to Kaleo, Rancho Cucamonga’s Amphastar Pharmaceuticals and three other drug makers, asking why they had hiked prices for naloxone during a public health crisis.
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“At the same time this epidemic is killing tens of thousands of Americans a year,” said McCaskill, “we’re seeing the price of naloxone go up by 1,000% or more.

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 …Mylan, which sells a vial [how many doses per vial?] for an average wholesale price of $23.70, according to Truven and Adapt Pharma of Dublin, Ireland.”

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment

provided by a qualified health care provider.

Relevant comments are welcome.

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Opioids can make pain worse


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Why taking morphine, oxycodone can sometimes make pain worse
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Article By Kelly Servick, May. 30, 2016

“Peter Grace, a neuroscientist at the University of Colorado (CU), Boulder, and his team has been trying to trace hyperalgesia to the way opioids affect the immune system.”

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“There’s an unfortunate irony for people who rely on morphine, oxycodone, and other opioid painkillers: The drug that’s supposed to offer you relief can actually make you more sensitive to pain over time. . . . A new study in rats—the first to look at the interaction between opioids and nerve injury for months after the pain-killing treatment was stopped—paints an especially grim picture. “

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“Animals given opioids become more sensitive to pain, and people already taking opioids before a surgery tend to report more pain afterward.”

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“Grace says the field badly needs a human study that systematically tests pain thresholds over time in opioid users…. In the meantime, he says, “I hope that it’ll get people to really question what the benefit of long-term opioid therapy might be.””

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© 2016 American Association for the Advancement of Science

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I generally accept only those who have failed most or all known treatments, and only those who I feel I can help.

 

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Opioids: Will We Let Politicians Treat Pain? Need Presidential Debates on Precedent


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Pain kills

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Cutting back my patient’s opioids when they were helping, when there is no better alternative, none better –  it is the most painful thing I’ve ever been asked to do as a doctor. Withdraw necessary medicine. On orders from the federal government forcing me to harm my patient.

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Harm my patient. The thought sickens. Forced by government orders to harm my patient.

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Orders. Cold as a steel gun held by DEA Swat team bursting into my office if I don’t act on government orders. Certain dictatorships treat citizens that way.

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Congress is pushing this opioid bust very hard.

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That is demagoguery

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I am pained and suspicious in several ways.

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Legal nationwide precedent.

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A precedent in government, deciding for each individual person, without good faith history and examination of each, now orders each person’s medical treatment.

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It overrides judgement. I feel my judgement specializing for decades in pain management, with or without use of opioids, using comprehensive multi-specialty approaches has always chosen excellence in the field of pain management, in accord with State and Federal guidelines until this new one, and within the best practices of the American Pain Society.

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Best practices are irrelevant. Choke on that one. The lack of options is impossible to swallow. It is life-changing for the most severely disabled patients across the country.

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It has nothing to do with the subject: pain control.

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Nothing to do with helping to relieve pain.

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It causes grave harm to my patients and their families and sets an astonishing precedent among healthcare insurers to never allow more than the guidelines; the federal CDC-invented, arbitrary, pseudoscience, one-size-fits-all guideline for opioids because:

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the government can’t deal appropriately with the heroin epidemic and the war on drugs. They ignore results from countries that have done more enlightened research to point the way.

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Demogogues order doctors how to treat everyone. This country is has done what China and Russia have done to their citizens. I am in shock. My patients are in shock. Aghast. Feeling forced to bend over and swallow an undemocratic, unscientific piece of

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This used to be a free country with certain rational sets of behavior and one that recognized a need for pain specialists. Only recently did it create specialists in pain management. Specialists who get ignored. Does this happen in every other field? Shouldn’t we all care no matter our expertise because we may all have bad pain if we live long enough? Chronic noncancer pain. What if some federal agency starts ordering you that dialysis will be allowed less often?

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None of us gets away from the grip of the irreligious opioid guidelines. Will we have intractable pain at some time in our lives? Will we allow government to dictate that you or your spouse or gram cannot be given the dose that has safely helped for years? The guidelines were forced on us.

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Insurance will not pay for more.

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This needs to be discussed as a presidential election debate issue.

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Demagogues appear at times of unrest across the country. Politicians may feel forced to bow to the anti-opioid groups, angry because of the heroin epidemic and at how badly addiction treatment is neglected in this country.

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But for pain patients not addicts, to be subjected to directives from federal agencies, CDC and DEA, how do we object to this unscientific, irrational precedent? At least debate it on a presidential level.

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Drug abuse, addiction, pain management and healthcare insurance as it pertains to these new federal opioid guidelines presume to treat pain but force us all into a cage of irrational pseudoscientific dictates. And we are forced to mangle the finely adjusted treatment of your pain, your spouse or your granny’s pain. We’ve slogged through so much to get there. It’s tough to find the right balance with chronic daily pain.

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Those running for president:

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What is the candidate’s position on this unprecedented fiat that dictates your maximum morphine equivalent daily dose (MEDD) you can receive?  It is a dose that is far less than you’ve been on for years that had been helping.

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Is this creating unprecedented pain among 50 million Americans with chronic pain?

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Are we going to let politicians treat our patients with pain?

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This site is not email. Not intended for medical advice.

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This is the start of all sorts of federal dictates

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Pseudoscience, Opioids, Politicians – Oh MY! Whose MEDD? Slashing Dose


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Opioid Guidelines are Pseudoscience

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They do not pretend to treat pain

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CDC Opioid Guidelines limit opioids to

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 90 mg morphine equivalent daily dose, MEDD

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Whose calculations will the DEA use against your doctor?

 

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Chronic pain is life altering. Opioid guidelines are life altering. The introduction of pseudoscience on a nationwide scale is life altering. Actually being the physician to reduce opioid doses to comply with arbitrary guidelines is life altering.

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The guidelines are intended to stop death and misuse from opioid overdose, not intended to relieve pain. About the same as taking drivers off the highway to stop highway deaths. We are just about back in the era of pain management before 1990.

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A nationwide mandate that affects the practice of thousands of doctors and the health and well being of 50 million people whom the authors have never examined, is life altering.

 

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We are all in shock. Guidelines don’t care about pain. CDC does not care. It’s all about death from overdose – tens of thousands of overdoses every year. Even when we calculate some magic pseudo-equivalent dose, just how are we to get from point A to point Z?  It is not discussed. This anonymous treatment limit is an insult to our patients, and fails the standard of practice of medicine in this country that requires a good faith history and examination of the whole person, just to begin. Then to design a treatment plan.

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For example, how do we calculate the morphine equivalent daily dose (MEDD) of oxycodone? That can be tricky. Opioids vary from person to person, drug to drug and the tables used to calculate and convert from one to another all differ. How simple is that? Wouldn’t we rather be talking about opioid splice variants, anything, but this calculated number is based on pseudoscience, as explained in this publication:

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The MEDD myth: the impact of pseudoscience on pain research and prescribing-guideline development

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This critical paper is published by the Journal of Pain Research, which is open access peer reviewed. Why is this important?

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Let’s look at a few points:

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In 2014, Shaw and Fudin conducted a survey comparing various online opioid dose-conversion tools and found a −55% to +242% variation across eight opioid-conversion calculators.16 The standard deviations in these two studies alone exceeded many of the MEDD maximums that several states have employed to trigger consultation from a certified pain expert.8,17–19 These studies alone unequivocally disqualify the validity of embracing MEDD to assess risk in any meaningful statistical way. Outside of MEDD calculations, there are several factors that also require consideration, but that remain largely ignored. These include patient-specific attributes, such as pharmacogenetics, organ dysfunction, overall pain control, drug tolerance, drug–drug interactions, drug–food interactions, patient age, and body surface area.15 The bottom line is that as the scientific concepts upon which prescribing guideline authors depend are flawed and invalid, so are the guidelines themselves. As a result, we posit that these guidelines are disingenuous and highly unethical.

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Opiate overdoses unfortunately can occur at any dose, and patients are at risk on even low-dose opioids.

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Death can occur at any dose. There is no “distinct risk threshold.”

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The guidelines are intended to stop tens of thousands of deaths from opioid overdose, they are not intended to improve pain. Just as chronic pain seizes the brain, the opioid guidelines stop rational thinking and all your reflexes.

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The morphine equivalent daily dose (MEDD) of 90 mg is the maximum dose on the guidelines and affect everyone no matter how different your pain, your age, or your dose needs to be from another person, and regardless of how opioids differ from one another. Pseudoscience creates a huge problem. This is not only not evidence-based. There is no evidence at all.

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I have recently referenced criticism of the opioid guidelines which I recommend for additional details.

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It’s not only opioid guidelines. Medicine is an art, not a science. Real people and medicines have real differences. The New York Times reviews a book about medicine by Abraham Nussbaum, MD, that says it well:

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“He notes that partisans of today’s much promoted evidence-based medicine must determinedly finesse the fact that medicine is riddled with flawed, incomplete evidence. The leaders of genomic revolution trumpet a future that keeps being postponed. Quality-control gurus abound, but their work often fails to yield actual quality.”

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Will the opioid guidelines bring a prohibition like the alcohol prohibition of 1928?

 

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment

provided by a qualified health care provider.

Relevant comments are welcome.

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For My Home Page, click here: 

Welcome to my Weblog on Pain Management!

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CDC Opioid Guidelines – The Criticism in today’s Practical Pain Management


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Criticism of the CDC Opioid Guidelines

from today’s Practical Pain Management

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This excellent journal is edited by the gifted, much loved, and opinionated Forrest Tennant, MD, who we like to count on for not holding back. I missed it in the brief look I did today – this is necessarily sober.

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Following criticism of the CDC Opioid guidelines, please read important information on suicide prevention, below, and how Vancouver has prevented deaths from opioid overdose. At Vancouver’s clean supervised drug injection centers: Over the last 13 years, millions of injections have occurred at Insite and there have been no deaths.

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Two things stand out, on this page of criticism of the CDC Opioid Guidelines. In particular:

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  1.  The heartfelt, pointed comment by Daniel Carr, MD, the President of the American Academy of Pain Medicine(AAPM)

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  2.  Organizations that have criticized the CDC Opioid Guidelines

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Directly quoting, below:

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However, some have not responded to the CDC’s guidelines with unconditional support. A number of criticisms have been expressed by organizations, like the American Medical Association (AMA), the American Academy of Pain Medicine(AAPM), and the American Academy of Pain Management, that question the validity and quality of the guideline’s featured recommendations.

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[Emphasis mine]

The criticisms surround the CDC guideline’s low-quality evidence base, which excludes all data from studies investigating opioid efficacy recorded from 3 months to 1 year duration. This is a concerning omission, according to Daniel B. Carr, MD, President of the AAPM, because the guidelines are intended for treating pain that lasts longer than 3 months. By contrast, associations like the Food and Drug Administration (FDA) do accept studies in this longer range.

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AAPM Response

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In a statement released by AAPM, the association said they cautiously support the efforts of the CDC to address the challenges that often accompany prescribing opioids for chronic non-cancer pain.

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“We know that doctors—primary care and pain medicine specialists—are integral in treating pain wisely and carefully monitoring for signs of substance abuse. Abuse and diversion of prescription opioids must be addressed,” said Dr. Carr, Professor of Public Health and Community Medicine at Tufts University. “Opioids are not the usual first choice for treating chronic non-cancer pain, but they are an important option—as part of a comprehensive multidisciplinary approach— that must remain available to physicians and appropriately selected patients.”

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Dr. Carr said that society needs to address both chronic pain and its treatment as public health challenges. This view is endorsed by the National Academy of Medicine and outlined in the draft National Pain Strategy from the NIH.

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[emphasis mine]

“Public health problems are typically complex; well-meaning, but narrowly targeted, interventions often provoke unanticipated consequences,” he said. “We share concerns voiced by patient and professional groups, and other Federal agencies, that the CDC guideline makes disproportionately strong recommendations based upon a narrowly selected portion of the available clinical evidence. It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately.

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The AMA’s response:

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“While we are largely supportive of the guidelines, we remain concerned about the evidence base informing some of the recommendations, conflicts with existing state laws and product labeling, and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care, and the potential effects of strict dosage and duration limits on patient care,” said Patrice A. Harris, MD, the AMA board chair-elect and chair of the AMA Task Force to Reduce Opioid Abuse.

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“We know this is a difficult issue that doesn’t have easy solutions and if these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable. If they produce unintended consequences, we will need to mitigate them. They are not the final word. More needs to be done, and we plan to continue working at the state and federal level to engage policy makers to take steps that will help end this epidemic.”

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Very sobering issues and too many deaths from opioid overdose. Whether alone, in combination with alcohol or other sedatives and sleeping pills, the focus is on opioid dosages.

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The fear is what the DEA will do in response to the guidelines. The immediate reality is that insurance formularies have changed in strange and unpredictable ways the last few months. As always, we may need to adjust dosing as patients age or illnesses enter into an evolving lifetime of care. Be prepared to change the dose, alert to doses that may be too high for their current medical condition, and always alert to opioid misuse, addiction, misjudgement, and mental health. Be wise and do the right thing.

 

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Suicide prevention

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The New York Times published March 9, 2015 on Blocking the Paths to Suicide, rethinking prevention.

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Sometimes, depression isn’t even in the picture. In one study, 60 percent of college students who said they were thinking about ways to kill themselves tested negative for depression.

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“There are kids for whom it’s very difficult to predict suicide — there doesn’t seem to be that much that is wrong with them.

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 Suicide can be a very impulsive act, especially among the young, and therefore difficult to predict.

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About 90 percent of the people who try suicide and live ultimately never die by suicide. If the people who died had not had easy access to lethal means, researchers like Dr. Miller reason, most would still be alive.

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“People think of suicide in this linear way, as if you get more and more depressed and go on to create a more specific plan,” Ms. Barber said.

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Dr. Igor Galynker, the director of the Family Center for Bipolar Disorder at Mount Sinai Beth Israel, noted that in one study, 60 percent of patients who died by suicide after their discharge from an acute care psychiatric unit were judged to be at low risk.

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“The assessments are not good,” he said. So Dr. Galynker and his colleagues are developing a novel suicide assessment to predict imminent risk, based upon new findings about the acute suicidal state.

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In fact, suicide is often a convergence of factors leading to a sudden, tragic event. In one study of people who survived a suicide attempt, almost half reported that the whole process, from the first suicidal thought to the final act, took 10 minutes or less.

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Among those who thought about it a little longer (say, for about an hour), more than three-quarters acted within 10 minutes once the decision was made.

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. . . growing evidence of suicide’s unpredictability, coupled with studies showing that means restriction can work, may leave public health officials little choice if they wish to reduce suicide rates.

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Ken Baldwin, who jumped from the Golden Gate Bridge and lived, told reporters that he knew as soon as he had jumped that he had made a terrible mistake. He wanted to live. Mr. Baldwin was lucky.

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Ms. Barber tells another story: On a friend’s very first day as an emergency room physician, a patient was wheeled in, a young man who had shot himself in a suicide attempt. “He was begging the doctors to save him,” she said. But they could not.

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Addiction

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Let us never forget the curse of addiction, and the profound misunderstanding our leaders make: it is a medical condition, not a choice. The war on drugs must be transformed from militarization of addiction to medicalization of addiction. Like Canada, Portugal and some of the South American countries.

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The New York Times writes this week of Vancouver’s clean supervised drug injection centers. Over the last 13 years, millions of injections have occurred at Insite and there have been no deaths.

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opioid and heroin overdose deaths are preventable. The drug Naloxone, which blocks the effects of heroin, is a safe, inexpensive antidote when someone is available to administer it, as is the case at Insite.

 

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Coda

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After all this, it feels like we’ve advanced a long way into the 21st century. Old stuff does not work. There sure is a whole bunch of stuff that no longer works. Life happened, and moved along.

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This site is not for email.

If any questions, please schedule an appointment with my office.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment

provided by a qualified health care provider.

Relevant comments are welcome.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Please be aware any advertising on this free educational website is

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NIH Releases a National Pain Strategy


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Today NIH Releases a National Pain Strategy

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Doesn’t look too different from the opioid reduction strategy.

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From an excellent NYT article that covers several sides of the issues, and that I had previously linked two days ago:

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But alternatives are unrealistic for some. Physical therapy is too expensive for Ms. Kubicka-Welander: she can scarcely make the rent on her home in a trailer court. Patients with a compromised liver cannot take high doses of acetaminophen. Those on blood-thinners should not use ibuprofen.

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I would add that the American Pain Society cautions against use of ibuprofen and similar NSAIDS in seniors. The risk of taking these drugs – GI bleed, heart attacks and arrhythmias  – increases with age.

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This site is not for email.

If any questions, please schedule an appointment with my office.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment

provided by a qualified health care provider.

Relevant comments are welcome.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Rectal Suppository Morphine, part 3 – cannabis


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Let’s all now avoid the topic of cannabis.

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How am I and other physicians, without research, supposed to help someone with insomnia caused by pain that takes the blood pressure to 220/110, with intense nausea.

That kind of pain.

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CDC suggests Tylenol and aspirin. That’s it folks.

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There is only one politician discussing cannabis.

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And please, don’t force researchers to use that stale dry brown stuff that NIDA sends to researchers.

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This site is not for email.

If any questions, please schedule an appointment with my office.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment

provided by a qualified health care provider.

Relevant comments are welcome.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Rectal Suppository Morphine, part 2 – link to formulary Blue Shield


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Here is a link to the formulary for long acting opioids for Blue Shield.  You can see the update date on the bottom as 3/3/16.  I could have added that they index rectal suppository Morphine as a Long Acting* Opioid as well:

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Under Notes and Restrictions:

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PA=Prior Authorization

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ST= Step Therapy Required

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NF=Non-formulary

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https://client.formularynavigator.com/Search.aspx?siteCode=1390724043&targetScreen=3&drugBrandListBaseTC=analgesics%7copioid+analgesics%2c+long-acting&drugSortBy=status&drugSortOrder=asc

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*Hint, it’s short acting.

 

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Signed,

Your friendly neighborhood healthcare insurer

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Do they live in your neighborhood?

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It would be unAmerican to publish their names and addresses.

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With the world’s eyes on this nationwide experiment, they allow Rectal suppository morphine. That’s all folks.

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Sweeping effects on the practice of medicine.

Meditate on that.

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Head to my front page if you want

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This site is not for email.

If any questions, please schedule an appointment with my office.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice, diagnosis or treatment

provided by a qualified health care provider.

Relevant comments are welcome.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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