Cannabis risk, death from fungal infection, demanding peer reviewed science. Not even billions can buy CBD if it is classed as Schedule I


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“IMPROVING MICROBIAL DETECTION STANDARDS FOR CANNABIS”

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The full article in O’Shaunessy’s is recommended. I’ve extracted a few parts.

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“If the government is going to tax us, in return they’ve got to provide us with needed services. And that means well-equipped analytic test labs run by disinterested technicians.” [emphasis mine]

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“Let’s make measured changes before another patient is harmed while demanding peer reviewed science is used to guide the regulatory process. In an era of fake news, science by press release with “beliefs” derived from companies that have a vested interest in seeing more cannabis safety testing should be hyper scrutinized.”

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“I think the cannabis-testing labs should be operated by the Department of Public Health, overseen by Commissioner Raber (and equally proficient chemists in every city and state) and staffed by well trained and well paid technicians whose pensions are secure.”

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The importance is that many patients who are immunosuppressed use medical marijuana, and need to use it safely because nothing else helps as well, including those who are immunosuppressed and don’t know it. For example, many do not know that diabetics are immunosuppressed. Those with autoimmune diseases, chronic renal disease, may be using medical cannabis and should demand testing be done with their taxed dollars as should we all. This has been one of the most useful herbs in history, for thousands of years, and can give balm and relief even to shattered nerves, especially now that healthcare insurers are denying to pay for pharma’s gobsmacking overnight billious costs.

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gobsmacking billious costs

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getting up to speed on legal cannabis &

 research on endocannabinoid systems

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This is a timely issue. Discuss with your doctor, get your representatives to help to legalize it nationwide. It may be the only thing that can help, or the only one that doesn’t constipate or cause erectile dysfunction or interact with other drugs. We don’t want our medication infected, even if we want to use cannabis for relaxation and pleasure. The Xanax’s and Ativan’s could be improved upon if only the right science is funded.

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“On February 7, the Daily Mail reported a cancer patient in northern California died from a fungal infection that authorities suspect was caused by the inhalation of contaminated medical cannabis.”

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snip

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“Furthermore, molecular techniques can be used to assess whether this cancer patient’s infection was actually cannabis derived. This is possible by using PCR and sequencing as performed by Remington et al. on the cannabis material and on the patient to confirm such an event.”

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“Rather than jumping to conclusions from a news story about cannabis contamination (which may in fact be the case), officials should confirm, via molecular methods, that a fatal infection occurred from the consumption of contaminated Cannabis or from another source, such as a hospital acquired infection. Once confirmed, the scientific data can help drive the appropriate regulations forward to ensure patient safety.  Unfortunately, most regulations passed to date for microbial detection do not appropriately address patient safety and often suggest the use of antiquated, inaccurate technologies.  For instance, we have peer-reviewed evidence that the currently accepted 48-hour Petrifilm-based method currently in use fails to detect some of the most harmful microbes found on cannabis. The State of Colorado has recently come to similar conclusions and has moved their Petrifilm detection times from 48 hours to 60-72 hours while referencing a paper suggesting 120 hours may be required.  And even with these adjustments to the regulations, Petrifilms will never give as accurate results as PCR.” [emphasis mine]

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“All technologies used to ensure product quality and patient safety should be peer reviewed. DNA-based methods are imperative to patient safety, as they are accepted, peer reviewed, and have been used for decades in other industries for similar purposes.”

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Kits to perform qPCR-based microbial testing on cannabis are commercially available at medicinalgenomics.com. We hold the largest sequence database of microbes found on cannabis and have kits that perform these tests in hours as opposed to days.”
[emphasis mine]

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“The technology exists to ensure safer cannabis for patients. Let’s make measured changes before another patient is harmed while demanding peer reviewed science is used to guide the regulatory process. In an era of fake news, science by press release with “beliefs” derived from companies that have a vested interest in seeing more cannabis safety testing should be hyper scrutinized. This extends to our own work at Medicinal Genomics and underscores our publication history in this space.”

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snip

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O’Shaughnessy’s retro message:

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Medicinal Genomics’s qPCR technology is undoubtedly superior and would have picked up the aspergillus that may have been fatal to the California  patient. But how widespread is the danger, really? In San Francisco in the ’90s, many thousands of AIDS patients whose immune systems were beyond “compromised” smoked untested crude herb, and I only heard of one rumored instance in which aspergillus may have been involved in a death. Donald Abrams, MD, might be able to confirm or correct my reassuring recollection.”

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“That said, of course the labs testing cannabis should employ the best available technology. The question, is who should pick up the tab?” [emphasis mine]

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“When I was working for the San Francisco District Attorney in ’01 or ’02 I called on Josh Bamberger at the city health department on Grove Street and asked if their lab would take on the testing of cannabis being sold at dispensaries. He said he didn’t have the budget or the personnel.  In the years ahead I was surprised that nobody from the movement/industry ever made the demand —not even the request— that a government agency take responsibility for testing medical cannabis. No patient advocate declared, “If the government is going to tax us, in return they’ve got to provide us with needed services. And that means well-equipped analytic test labs run by disinterested technicians.” [emphasis mine]

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“All around the world, PRIVATIZATION is the overwhelming socioeconomic trend of our time.  The Power Elite have done such a thorough job of selling off the commons and undermining the public sector that everybody now simply assumes that for-profit labs can and should take on the responsibility of protecting public health. “

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“I think the cannabis-testing labs should be operated by the Department of Public Health, overseen by Commissioner Raber (and equally proficient chemists in every city and state) and staffed by well trained and well paid technicians whose pensions are secure. And while we’re at it, how about free public education and single-payer medical care?”

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I keep getting the suspicion billions are being funneled rapidly down new rabbit holes using fear to prevent science. We must be able to do more than just prescribe  opioids for severe pain. Opioids cause inflammation which causes more pain. Cannabis is anti-inflammatory, analgesic, etc etc etc, and not allowed in hospitals, SNFs, or in facilities that seniors can only dream of retiring to when they can no longer manage at home. We need medical better choices.

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Medicinal cannabis is a healing plant with cannabinoids like ones that your body makes that helps you feel healthy and somehow influences the immune system more than any other system, while also lifting mood. Wouldn’t it be nice to know? It has 400 chemicals, not just two synthetic ones pharma makes. An exciting new cosmos in the body’s realm of more than just neuroscience. We have more cannabinoid receptors than any other kind in our body. We need to learn.
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Stop this Schedule I nonsense. Legalize cannabis. Privatize and regulate it like big alcohol, but keep it apart from big pharma, and endow strong university ties. For pete’s sake, fund the research immediately. We need it. The immune system needs it. The pain matrix needs it. Why should we allow euthanasia when we can treat pain and symptoms. Grandmothers used to know how. We are living in the dark ages with cannabinoid systems science. It is in starving infancy, Israel’s Mechoulam lab pioneering this blossoming for decades.
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Don’t forget to tell your representatives that you hear you may benefit from medical marijuana. Cannabis, marijuana, just may help, as it helped so many little children having hundreds of seizures each day, helped by just one of the cannabinoids in the plant: CBD.  It has been reported to almost completely stop the hundreds of daily seizures in possibly 50% —wouldn’t it be important to do research on it?

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CBD  has no psychoactive power. There is no high, no hallucinations. It actually blocks the psychoactive power of THC. It should be legal. The plant should be legal. It helps many medical conditions. I have posted an astonishing case months ago 100% relief with CBD. Instead it, just the other day, CBD got clearly classified as Schedule I. This must go to the courts. This insanity about a healing plant can be sanely managed, just like alcohol is managed. Without privatized prison systems that waste taxpayer dollars.

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We see new funnels of big money going down the rabbit hole. The urgency to privatize. We have a lot of people who cannot afford the American medical system, cannot afford doctors, who may get some relief even as a muscle relaxant or for sleep or anxiety.

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How can anyone respect a legal system that does not even allow research on a healing plant so important to the immune system?

 

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No amount of billions can buy CBD if it is classed as Schedule I.

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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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PEA in US (palmitoylethanolamide), PeaPure in Netherlands – DO NOT BUY OTHER SOURCES


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PEA in US is palmitoylethanolamide from Vitalitus

PeaPure in  Netherlands

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DO NOT BUY OTHER SOURCES

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PEA is thankfully available in the US since Spring 2016 from ONE company: Vitalitus. It is a trusted source. Buy PEA only from Vitalitus in the US, others are fraudulent sources.

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I strongly recommend that you AVOID any product with a “PEA-type” name trying to sell elsewhere in the US or on the web.

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One such fraudulent source is a foreign entity pretending to be in the US, and they are now listing a US address on Brickell Avenue, Miami, FL 33131 United States. But that is a virtual office address which is still listed for rent at $60/month.

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It looks like they’ve morphed the website and their product label. Very professional looking but AVOID THEM LIKE POISON. They keep trying to post comments on my website. They may even be buying advertising on my free site – anyone can advertise but I do not endorse products with this one exception, PEA, because it is unique.

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I have also seen “PEA-type” powder available on the web. Do not buy powders claiming they are pure palmitoylethanolamide. They are not trustworthy sources.

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Make sure your PEA comes only from a trustworthy source. In the US, that is Vitalitus. PEA works on the innate immune system, mast cells, and much more. There are more than 400 scientific publications on palmitoylethanolamide since it was rediscovered by a Nobel Prize Winner in 1993. Vitalitus’ PEA capsules are 100% palmitoylethanolamide. Pain relief is one of its immune functions. Your body makes it, plants make it, it has no toxicity, but follow directions or capsules will not fully absorb.

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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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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.

 

NFL – Prevent &Treat Chronic Traumatic Encephalopathy, CTE – Opioids Blamed Wrongly


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Crowdfunding Needed

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Prevent and Treat

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Chronic Traumatic Encephalopathy

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C.T.E.

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Opioids Wrongly Blamed

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Leagues may have known about this technology since 2002 publications

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Football players have demonstrated ability to influence others

and raise money for important medical causes.

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This is not about class action law suits.

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This can be imaged early and likely treated.

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It’s about science and bringing medicine into the 21st century.

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A paradigm shift began with the discovery

of the innate immune system by internationally recognized scientists in 1991.

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The clock has been turned off.

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We can change this now.

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Funding is needed for internationally recognized leaders to continue this work.

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The tragic deaths of former NFL football players from repeated concussions has led to brain damage and death from Chronic Traumatic Encephalopathy (CTE). Suicide profoundly shocks us when many players like Junior Seau at age 43 and now Tyler Sash, die at age 27. He is the youngest found to have such extensive brain damage, as bad as that seen in Junior Seau. So much can be done with state of the art science now that has been ignored.

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Disclosure: I was asked by a research institute if I would evaluate retired NFL players. I chose not to do that so that I might be free to post unbiased information that is not subject to being manipulated by either side in the ongoing appeals for compensation that must be going on with the NFL for $70 million. Tragic that this is such a fight. Even more tragic, this may be diagnosed early and treated.

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Pearls

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Fear of compensation claims after concussion injury prevents imaging of football players and veterans early, while still treatable, before severe changes and death.

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Fear of compensation claims has prevented decades of research funding by internationally recognized scientists. Could politics at NIH & the VA have turned off funding for veterans with pain and with concussion blast injuries? Does cancer and heart disease forever lock up all the research money and now it shifts to stem cells?

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It is inaccurate to say that CTE cannot be diagnosed except after death at autopsy.

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PET scan imaging of glia can show changes early, while alive.

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The ligand PK1195 must be used for PET scan to image glia, available for years in Australia, not yet in America.

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FDA approval must be obtained for the ligand PK1195 before it is used to  image glia in the United States.

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CTE can be diagnosed early.

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CTE is likely to be treatable.

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Internationally distinguished scientists have shown reversal of complete paralysis in rat models of multiple sclerosis in 2010, a so called “degenerative” neurological disease.

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Intractable pain and treatment resistant depression can be put into remission with glial modulators. Surely CTE and other neurological diseases can be approached with scientifically recognized mechanisms and treatments – even if doctors are not aware of the paradigm shift and how to modulate neuro-inflammation. See years of posting on this site since 2009 based on the most important finds in the field of neuroscience for more than 100 years: the innate immune system, glia, neuro-inflammation, and ability to use glial modulators, to modulate intractable conditions that are known to lead to suicide and/or death.

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Paradigm shifts in all fields including medicine, fail to be recognized.

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CTE gives opioids a bad name and misled Taylor Sash and likely others from the diagnosis of CTE that caused years of severe forgetfulness and behavior changes. He may have chosen suicide by opioid.

 

 

 

FACT:

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Trauma such as concussion or infection or stroke triggers inflammation in the brain:  “cytokine storm”

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Inflammation kills brain cells

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Inflammatory cytokines (inflammation) are produced by glia that has been activated by trauma or other causes such as infection, stroke, etc.

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Activated glia produce neuroinflammation and cell death.

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Inflammatory cytokines produce pain and “degenerative” neurological and psychiatric disorders including dementia, depression, anxiety, delirium and death.

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Neuro-inflammation in brain has been found in teens with early signs of schizophrenia, in rats made depressed, and rodents with chronic pain.

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Glia have been detected in life, in vivo, with PET scan imaging, by internationally-recognised radiologist working at Imperial College London, now based in Australia.

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PET scans require a ligand, PK1195, approved for years in Australia – must be approved by FDA in the United States before it can be used here.

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There is good clinical data and publications in animal models to show that damage in brain and spinal cord produced by activated glia can be reversed.

E.g., In 2010, total paralysis has been completely reversed in a rat model of multiple sclerosis by internationally-recognised glial researcher who, in 1991, transformed the understanding of glia that comprise 85% of the brain, since then known to be the innate immune system.

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Publications have shown that patients with major depressive disorder and patients with chronic low back pain have memory loss and brain atrophy.

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Opioids cause pain by stimulating production of inflammatory cytokines that are known to damage neurons in brain and spinal cord – and must be tapered off. We have better treatment for pain.

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Insurance carriers routinely deny payment for recognized medications and procedures to relieve pain.

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CDC is planning a nationwide experiment to radically limit opioids.

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Treatment with glial modulators that reduce neuroinflammation has been shown clinically to relieve treatment resistant major depressive disorder, PTSD, bipolar depression and intractable pain. They are neuroprotective.

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We need to be able to flag players off the field early and intervene with treatment such as glial modulators either before, during or after repeated injury.

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GOALS

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1.  PK1195, a ligand for PET scans, must be tested and approved by FDA. Approval is mandatory for all medications or substances injected into vein or body.

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It simply “tags” the PET scanner to image glia, the cells of the innate immune system that are activated by trauma, infection, stroke, etc.

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2. Do serial PET scans using PK1195 to image glia in NFL players and veterans after blast injury.

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Trauma from concussion is causing cytokine storm, killing brain cells –> ultimately end stage dementia, anxiety, depression, suicide

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3. Flag that player off the field. Follow glial changes during treatment to determine if able to return or if permanent, but prior to end stage damage.

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4.  Treat with glial modulators preventively, early, middle, and/or late

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This subject will be continued. My apologies for lack of time to delete and edit. Days pass by quickly to post brief comments. Time is limited. Please send comments, below.

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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.

If any questions, please call the office to schedule an appointment.

This site is not email for personal questions.

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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 website is

NOT advocated by me and NOT approved by me.

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Be the change you wish to see – or walk away. Money at NIH


 

 

A Turning Point

 

$$$$$ MONEY $$$$$

 

at NIH

 

May not come this way again

 

NIH developing

5-year NIH-wide Strategic Plan

 

 

 

Donate to organizations, below

They can provide feedback to NIH via the

RFI Submission site


 

 

 

John C. Liebeskind, 1935 – 1997, distinguished scholar and researcher, past president of the American Pain Society, had the radical idea that pain can affect your health.

 

Research decades ago by an Israeli team at UCLA and others had shown “that pain can accelerate the growth of tumors and increase mortality after tumor challenge.” Decades ago Professor Liebeskind lectured all over the country: Pain kills.

 

He wrote an editorial in 1991, summarizing a life’s work:

 

“Pain and stress can inhibit immune function.”

 

 

Quoting John Bonica, the father of modern pain management, he wrote:

 

“Bonica has long argued that the term ‘chronic benign pain’ (used in distinction to pain associated with cancer) is seriously misleading.  Chronic pain is never benign, he contends; “it is a ‘malefic force’ that can devastate its victims’ lives and even lead to suicide.”

 

 

Liebeskind continues, “It appears that the dictum ‘pain does not kill,’ sometimes invoked to justify ignoring pain complaints, may be dangerously wrong.”

 

Pain mediates immune function

 

Importantly

 

  Opioids mediate the suppressive effect of stress on natural killer cells,

 

 published in 1984, immune system.

 

Alcohol increases tumor progression, 1992, immune system.

 

It used to be news.

He did not live to see change.

 

People just want to go on doing what they’re doing.

They want business as usual.

 

 

After 1991, we saw the great discoveries of neuroinflammation, pioneered by Linda Watkins, PhD, the early understanding of the innate immune system, its involvement in chronic pain and depression, and a few weeks ago, a British team showed neuroinflammation in teens with early signs of schizophrenia and DNA markers.

 

 

Major Depression has the same neuro-inflammation found in chronic pain, often responding to same medications, in particular glial modulators – immune modulators. Now, perhaps early schizophrenia will respond to glial modulators, reducing inflammation seen on scan in teens, before they become homeless and burned out by antipsychotic drugs

 

Inflammation out of control destroys neurons

 

Fire on the brain

 

 

We must be the change we wish to see

 

It’s not just the Bern. It’s been starting. Forces are finally coming together. We want change. It’s been too much. Too long.

 

We won’t take it anymore.

 

I figure if I tell you about it, you might just mention it to someone to pass it on. That is all. One small action may lead to change. Activate inputs to the NIH strategic plan.

 

 

~ Action needed ~

 

Prices of drugs becoming unaffordable

No new drugs for pain or major depression

Research to repurpose existing drugs

Expose the politics destroying our compounding pharmacies

 

Above all

The #1

Major Priority:

Request NIH to solicit priority call for research on

Glial modulators of the

Innate immune system

 

 

Why?

 

Glia modulate

chronic pain, major depression

and almost every known disease

 

Glia are your innate immune system

 

Inflammation kills

 

 

 

 Stress kills. Inflammation kills.

 

 

Pain kills

 

In the 1970’s, Professor Liebeskind and an Israeli team at UCLA injected cancer cells to two groups of rats that had sham surgery. Cancer spread much faster and killed far sooner in the group with poor treatment of surgical pain.

 

 

~ Pain kills ~

 

He lectured all over the country

 

Forty five years ago

 

 

I’m gonna be dead before I see this country do anything but unaffordable opioids and the magical ineffective trio of gabapentin, Lyrica, Cymbalta to treat chronic pain. The devastating, blind, nationwide emphasis does nothing to address the cause: inflammation, the innate immune system gone wild.


 

 

Innate immune system in action

 

Untreated pain suppresses the hormone systems too.

 

Untreated depression – same inflammation kills lives.

 

Where’s the money?

 

We are the change we wish to see. It’s pitiful I am so lazy. Suddenly, too late, we may need something, but, aha, no new drugs in the pipeline.

 

 

 

~ Make a joyful cry to NIH ~

 

They are soliciting input from professional societies

 

If your condition has failed all known drugs for pain or major depression, then make a joyful cry to NIH, now, before they give away all that nice new $$$$$money$$$$$.

 

 

Follow and join

 

American Pain Society

 

 

International Association for Pain

celebrating 40 years of pain research

 

 

Reflex Sympathetic Dystrophy Syndrome Association

help for CRPS/RSD  

 

 

 

The key to CRPS/RSD pain will apply to all forms of chronic pain, in particular the most difficult form, neuropathic pain. RSDSA funds research into all forms of chronic pain, not only Complex Regional Pain Syndrome (CRPS/RSD). Their scientific board members are not funded by opioid money.

 

 

 

Exactly

what is the annual cost of care

as fraction of GDP

for the growing population of Americans on opioids

for one year, for lifetime?

 

 

People are dying from prescription opioids and those who need them find they don’t work well enough. Prescriptions opioid costs must be a huge fraction of the medical costs in the United States GDP. You are required  to see a doctor every single month each year, often lifelong, just for one opioid, 12 months a year x 30 years x tens of millions of people and increasing – a growth industry. Not even counting $600 a day for the opioid, what the cost of monthly visits for 30 years? Not counting the army of DEA, FDA, CDC agents watching the opioids like a hawk. We all have to be sharp, addiction is growing. Addiction aside, deaths from prescription opioids are shaking up the CDC forcing urgent change this coming month.

 

 

 

Opioids do not work well for chronic pain

We need better

It’s not just the $600/day price

They just don’t work

 

 

donate

 

 

Raise a joyful noise at NIH now or write back at us readers with comments and better suggestions. Tell others what you’d like to see. Which politicians do you know would be most interested in this at national levels and organizations?

 

You may never see this change unless you do it now. Other forces will get this new money.

 

 

Turning point now

May not return

 

 

We are at a turning point and we will fail to catch the sail that’s coming fast to carry all research money in their shiny big stem cell direction. They never look back.

 

 

There is so many medications we can use today, FDA approved drugs that can be re-purposed and applied to recent cutting edge science. Someone must pay to do the work to study this.

 

 

Re-purpose old drugs

 

 

Stanford just showed a popular generic drug improved recovery of stroke paralysis in mice to begin at 3 days rather than 30. Old drug, new purpose, of course more years of testing to confirm in humans. Brilliant team applying new science.

 

 

Request
NIH to solicit a

Special Invitation

for 30 good protocols to

repurpose old drugs

 

 

Hundreds of old drugs, already approved, could be involved in mechanisms we have recently learned about. Speak up or money will go to shiny new stem cells. None for chronic pain or major depression. No company will find this profitable – it must be funded by NIH. A popular generic sleeping pill can bring astonishing return from stroke paralysis.

 

 

Congress has not opened this new money to NIH in many long years. How often will there be extra money?

 

 

donate

 

 

Lawrence A. Tabak, D.D.S., Ph.D.
Principal Deputy Director, NIH, solicits you to

Review the NIH Strategic Initiative Plan and their

Request for Information (RFI) and the NIH website

and provide your feedback via the RFI Submission site

 

 

This is for “stakeholder organizations (e.g., patient advocacy groups, professional societies) to submit a single response reflective of the views of the organization/membership as a whole. We also will be hosting webinars to gather additional input. These webinars will be held in early to mid-August.

 

 

 

Be the change you wish to see

Donate to those organizations

to solicit the change you wish to be

 

 

 

Happy New Year

Rejoice!

There’s money at NIH

 

 

 

 

 

 

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.

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

This site is not for email.

~~~~~

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

 

 

 

 

Proposal: A 5-Year Study of Best Methods to Treat Intractable Pain


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PROPOSAL

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A controlled trial to improve care for chronic pain:

The study to understand prognoses and preferences for

outcomes and risks of treatments

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Model after Joanne Lynn’s 1995 SUPPORT Study

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A controlled trial to improve care for seriously ill hospitalized patients:

The study to understand prognoses and preferences for

outcomes and risks of treatments (SUPPORT)

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Proposal

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A controlled five-year trial to improve care for outpatients with chronic pain. The study will be designed to understand prognoses and preferences related to the outcomes and risks of various treatments.

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The focus:

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Intractable pain, those who have failed pain medications and procedures or those with moderate to severe pain who only partially respond.

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Study polypharmacy, compare medications that may show synergy or that additively improve relief.

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Study and search for glial modulators – medications that reduce proinflammatory cytokines.

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Problem

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Research is needed to give persons with intractable pain the data and the confidence that they can affordably use to choose the best treatment needed to get their lives back again. They have already spent tens of thousands. They may be unable to work. We all need these options.

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There are a few small islands in this country doing a radical experiment in managing pain without opioids [narcotics, the police term] as discussed in the New York Times in May 2014, and the 2008 Mayo Clinic study. Efforts such as these need to be supported with data as soon as possible in order to reduce the burden of disability and pain in our society, especially our youth, our children, our veterans, our aging seniors, well everyone. We can be productive and we want to be.

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I have seen remarkable outcomes, pain that failed to respond to all known pain medications, going into partial and even total remission, lives restored after weaning off opioids and appropriate treatment given.

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We cannot expect any medication to work every time. How often can we achieve better results after opioids are tapered off? Opioids may prolong pain in Complex Regional Pain Syndrome where remission seems possible only after they are stopped, yet opioids may be essential in many forms of chronic pain. We need data on the radical experiment to manage pain without opioids, and determine how best to manage chronic pain with them.

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Opioids have a long history of being the drug of choice to treat chronic intractable pain by doctors who lack information and training about other exciting options now coming to the fore. Compounding the problem is the fact that physicians do not know how to diagnose musculoskeletal pain and do not know how that good physical therapy is actually effective.

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Healthcare providers need data about all the options to begin to address the toll that chronic intractable pain exacts and government worldwide need to know what is cost effective and possible. Many countries cannot obtain opioids.

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We must not be insensitive to the financial burden that frustrates patients when they spend tens of thousands of dollars for drugs that provide little if any benefit.

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Investment in developing nonopioid treatments for pain does not even begin to compare to the investment in opioids for pain. The few medication choices we have are not enough. Often they fail to help. Expensive drugs are not the best choice if they are not affordable or they are limited to diabetic neuropathy when more than 100 types of peripheral neuropathy have been identified, plus many more types of even more severe neuropathic pain not classified as neuropathy. Shall we continue to ignore all those because FDA has classed these few new drugs for diabetic neuropathy exclusively?

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Let me be clear, prescription of opioids is justified and they are valuable. Opioids are on the World Health Organization list of ten essential drugs. BUT there is little or no research on treatment of intractable pain without opioids.

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Neuropathic pain, nerve pain, is the most difficult to treat. Neuropathy, radiculopathy, transverse myelitis, adhesive arachnoiditis, central pain, RSD, Guillain-Barre, trigeminal neuralgia, Tic Douloureaux, post herpetic neuralgia, to name a few. It is not enough to limit research of neuropathic pain to diabetic neuropathy when it fails to address all other causes. When FDA approves a drug only for diabetic neuropathy, insurers deny the drug for the other 95% of you without diabetes. Insurers may choose to read guidelines as mandates, fiats,  marching orders.

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Neuropathic pain is not the only concern. Physicians do not know how to diagnose musculoskeletal pain. How can they if only 3% of medical schools teach pain management and when doctors do not know how to assess ineffective physical therapy when they have never seen better.

A patient dislocated her hip 7 times, manually repositioned each time in ER. The 6th surgeon impinged a wide band of muscle in the joint causing muscle all down the thigh to bulge 5 to 7 mm high, of rock hard spasm with intense relentless pain. The 7th surgeon had the gentle ability to restore position and release the entrapment. A light touch across the thigh even through clothing can detect the cause. Would a surgeon have discovered to release the entrapment unless she had dislocated a 7th time? Simple muscle strain, undiagnosed by a surgeon who deals with muscle all the time, was not even noticed and he ignored the acute pain it caused. She has now learned how to avoid dislocating that new hip. Had the muscle not been appropriately identified as cause, she would not be able to move by now. But the surgeon should have had the skills to notice instantly before those muscles became chronically strangled. She was referred for manual physical therapy and thankfully, before all else could occur, she dislocated and was repositioned by the 7th surgeon. A wonderful teaching case for a teaching hospital that should be every hospital. Grand Rounds for pain cases.

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MAJOR FUNDING DECLINE IN PAIN RESEARCH

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 BEFORE 2008

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 BEFORE CONGRESS CUT NIH BUDGET BY UNTHINKABLE 30% IN 2010

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Perhaps the biggest impediment to gathering data about pain management is the lack of government funding for pain research and lack of a Pain Institute at NIH. If not, funding will continue to be fragmented and split elsewhere, not to learn about one of the most costly problems in every society.

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In 2008, before the worldwide depression, pain research was in major decline. The AAAS, the American Association for Advancement of Science told us then:

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“Federal funding for pain research is declining sharply, more than 9 percent a year since 2003, according to a new study published in The Journal of Pain. Pain research, as a result, now accounts for only 0.6 percent of all grants awarded by the National Institutes of Health (NIH), despite the high prevalence of chronic pain in the U.S.

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“This startling finding shows the government’s meager investment in pain research is seriously out of proportion with the widespread chronic pain incidence in our society, which is estimated at one in four Americans and accounts for more than 20 percent of all physician office visits,” said Charles E. Inturrisi, president of the American Pain Society and professor of pharmacology at Weill Cornell Medical College, New York. “And this disparity is not attributable to years of budget cuts at NIH because the Journal of Pain study clearly shows pain research has a higher percentage decline than the overall NIH budget. So the drop in agency funding has not affected all research areas equally.”

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[emphasis mine.]

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Research in pain was sharply declining prior to 2008. Then a 30% cut across the board in 2010. Thank the American Pain Society for those ancient 2008 figures. No one had ever asked – which is why we need a Pain Institute at NIH.

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Frustration is compounded the last few years by insurers no longer willing to authorize many opioids and non-opioid medications, even generics.

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As for the cost of opioids,  a single opioid for one patient may exceed $80,000 per month when the patient is required to use with another long acting opioid, and often several nonopioid adjuncts just to bring pain down from 9 on scale of 10, to a slightly more bearable 7 or 8 which is severe, relentless and prevents sleep and ability to concentrate. One drug that costs pennies to make, sells for $80,000 a month to allow 4 a day when at least 6 a day are needed and it is only one of many for pain every day.

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Prescription of opioids is justified and may be invaluable.

but there is little or no research on

 treatment of intractable pain without opioids.

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We need national consensus guidelines based on data

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We must do a better job treating intractable pain. We need guidelines that have more to offer than the few opioids and few adjuvants we now have, so few in number, so great the need. Can we know when is it true that opioids are indicated? Our use is many times more than all the other First World countries?

 

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Treatment must be individualized

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Data is needed to guide choice

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Compounded Medications are among the

most useful drugs we have for treatment of intractable pain

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Compounded medications may be the only ones that help, and can reduce pain to zero. We can re-purpose the delivery of any medication, as long as it has been FDA approved. But the last few years insurers have been discontinuing coverage for compounded medications and Medicare has never covered them.

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This must change. Who is funding that political blockade that denies coverage for compounded medicine? The cost may be $120 for one compounded medication vs $80,000 for one opioid. Either way, the person with intractable pain likely needs 3 or 4 or 5 or 6 medications, compounded or not. Who can afford $400 per month out of pocket for compounded medications that work, when insurance will not cover the affordable drugs. Who can afford that out-of-pocket expense if insurers cover nothing for your pain, neither the bright shiny opioid or the compounded sprays, capsules, suspensions, creams, troches, as well as the essential solutions instilled into the bladder for interstitial cystitis?

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This must change. Lawmakers must be called to account for allowing and perpetuating the inhumane taking advantage of those who suffer intractable pain.

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A first step in getting lawmakers to pay attention is to amass a body of compelling data.

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BALANCE IS NEEDED

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The United States as a society cannot afford for pain research to die and go bankrupt and leave only opioids as the standard treatment for hundreds of types of pain. Someone has to begin the needed studies. It does not just bankrupt the patient, it leaves us all bankrupt, the country most importantly. It ends marriages, tears apart families. To be struck down as a child with intractable nerve pain the rest of your life, or be struck in your prime, is devastating. And disability gets routinely denied for pain. Why? Perhaps because pain is taught in only 3% of university medical schools. How are doctors to imagine that pain can end lives when they have no experience seeing how disabling it can be?

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 If doctors cannot see the devastating toll that pain takes,

how can we expect accountants to see it?

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The Study We Need

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Solution

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 To gain a comprehensive and compelling picture of how pain impacts the population and how to effectively treat it we need a large-scale study:

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  • Five years in duration

  • 10,000 outpatients – statistically this must be adjusted to obtain multiple outcomes

  • At five major university teaching hospitals for regional differences

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 Outcomes

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The study will yield important information about the following:

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  • Efficacy

  • Pain Numeric Rating Scores, Percent Improvement

  • Functional Improvement, etc

  • Compounded medications

  • Racial and Gender Disparities

  • Addicts who have chronic pain

  • Top notch manual physical therapy* [see below], not for what passes in most places. This must change ASAP. United States is far behind other countries. Even if the condition is neuropathic, it often becomes musculoskeletal after splinting for months, years

  • Interventional procedures

  • Meditation

    How you brain can heal your body and your body heal your brain.

  • Pain changes DNA, neurotransmitters. Have we permanently changed them with opioids?

  • Polypharmacy. When employing one drug alone is unlikely to lead to a successful outcome.

  • Stem cells for joint pain – autologous lipid derived mesenchymal stem cells

  • rTMS, experimental after 20 years, is it still better for acute than for chronic pain?
    Who will benefit, for how long? How many weeks of relief for that $15,000 investment?

  • Glia, the Innate Immune System

Opioids create pro-inflammatory cytokines that create pain and opioid tolerance.

Restore cytokine balance, reduce inflammation and pain.

Which of our existing medications either trigger or reduce inflammatory cytokines in the CNS?

  • Pain in the person with Alzheimers dementia

  • Danger of combining opioids with benzodiazepines

  • Danger of long term use of opioids (regardless if short or long acting)

  • Appropriateness of using opioids as a first choice in acute pain (loss of a milk tooth, sore throat in a teenager, acute back pain, ankle strain, etc.)

  • Appropriateness of opioid holidays.

  • Post op pain can be avoided completely with combined use of oral low dose naltrexone and ketamine IV anesthesia. Patients discharged directly from recovery room with no need for pain medication for months or years

  • Cost Benefit Analysis

 

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Five Conditions Will Be Studied

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Strong emphasis must be placed on neuropathic pain that so often fails to respond to any intervention

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1. Complex Regional Pain Syndrome

The Netherlands invested €25 million over 5 years to study this one devastating pain condition, far out of proportion to the incidence in that small country. There are pain specialists who cannot recognize it and/or doctors who routinely deny disability for this devastating pain, like death in life.

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2. Low Back Pain

Define criteria for surgery.

If we wait too long before surgery is done, will we ever reverse the chronic pain that has set in?

Have we condemned that patient to monthly visits for opioid the remaining 50 years of their life?

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3. Other neuropathic pain conditions such as adhesive arachnoiditis, trigeminal neuralgia, transverse myelitis, Tic Douloureaux, Post Herpetic Neuralgia, Interstitial Cystitis, Vulvodynia, Proctalgia, Pudendal Neuropathy


4. Painful peripheral neuropathy nondiabetic and Painful Small Fiber Neuropathy  all forms of painful neuropathy

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5. You choose – central pain?

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What We Must Do Now

 

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  • Find a pain advocate like the cancer advocate of the 1950’s that changed attitudes for research

  • Fund the pain SUPPORT study

  • This will spin off enormous research ideas that we must begin separately to implement with research as each develops, the need is beyond urgent. How many more years can we make everyone wait?

  • Write letters, to congress, the White House. Real letters, not email, not signature lists. Congress will not hear us unless we speak in very, very large numbers.

  • Help the topic of intractable pain become a part of the 2016 presidential conversation.

  • Incentivize teaching hospitals to teach pain management and to develop options for nonopioid treatment of chronic intractable pain. Pain is a multidisciplinary field, not limited to Anesthesiology procedures.

  • Create an Institute for Pain Management in addition to the 28 institutes at NIH, three of which are for addiction, none for pain. Pain is the number one reason people seek medical help.

  • Require that pain specialists sit on the FDA advisory committees for pain medication – none recently.

  • Require insurance coverage for compounded medications.

  • Prevent FDA from limiting medication to cancer pain.
    Cancer pain does not exist.

    There are basic types of pain that occur in persons who have cancer, neuropathic pain being worse than other forms of “cancer pain.” It has the same medication response or failure to respond as persons whose pain is not due to cancer.

  • How do we restrict the use of opioids to severe pain when there is nothing else to offer and after everyone is started on opioids by their family doctor years before they see a pain specialist?

  • Novel and ancient methods for treatment of pain should be explored including cannabis and possibly hallucinogens

  • Isolation of pharmacologically important medicine from rainforest and deep seas must be done before they disappear.

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Physical Therapy is the #1 Key to Chronic Pain

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Manual Physical Therapy was introduced to the United States in the late 1970’s but is rarely practiced or not done well. It does not mean “hands on.” It derives from techniques brought to us by British Commonwealth and Scandinavian countries. Our healthcare providers do not know how to differentiate between good and useless practices. Fortunes and lives are wasted hinging on that distinction. Pills never can undo the harm brought about by common musculoskeletal issues – and our providers have no training in recognizing simple muscle trigger points, let alone intractable connective tissue contractures. My patients have been misdiagnosed as histrionic, drug seeking, personality disorders, and worse. It boils down to ignorance and lack of basic training, let alone believing what the patient says and not having the tools to help.

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The trend is for year long residency programs following the 3 year Doctorate of Physical Therapy (DPT).  The year long residency program is a very positive step.  The limitations are that it is a year with a clinical staff that may have a specific perspective.  The push towards evidence based practice is a reasonable step but should not exclude considerations of outside the box treatment options.

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The osteopathic manipulative technique has been a cornerstone of best education for physical therapists.  The craniosacral approach is an offshoot from that tradition.  When we get to visceral mobilization, the evidence is much harder to produce but that does not have me shy away from its application.

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Movement is critical for the hormonal regulation of the body.  Chronic stasis leads to numerous changes that compound an underlying medical diagnosis.  We see that with a 16 y/o female, Lyme’s disease, CRPS diagnosis, bedridden for years.  She is significantly benefiting from stretching dysfunction and improving axial extension.  Another who quit walking had global lower limb connective tissue contracture.  Walking is currently limited by soft tissue contracture through the tarsal tunnel, affecting the plantar nerves and the burning and tingling with walking greater than 5 minutes at a time.  Mobilizing the soft tissues will ultimately restore function. This 20 year old quit college due to pain and one first visit requested motorized wheelchair and Social Security Disability. This young person will walk again.

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There is no end point to this educational process except when we think we know it all.  No certification, no degree, no one course signifies competency.  Ongoing intellectual curiosity is the most important element in preparation.

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Prescription painkiller overdose epidemic in the U.S.

Not in other countries

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Pain Management centers at major universities closed in 1991. They lose money, are time consuming, require team conferences that are not reimbursable. Thus began the era when prescription opioids took off for noncancer pain, and no one was generating nonopioid approaches to chronic pain. Anesthesiologists shifted to procedures – that is their focus after all. Procedures are not applicable to many types of pain.

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“Since 1999, the amount of prescription painkillers prescribed and sold in the U.S. has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.”

from the CDC report of prescription painkiller overdose epidemic

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I feel I have failed when I have to point out to my own patient whose pain is severe, that the high dose opioid I have prescribed is not helping, or is creating pain; when I know there are other options which are not available because the FDA has not approved them or because they are prohibitively expensive. I have failed when so many medications I prescribe are not on the formulary.

 

We need a mandatory formulary available for those with intractable pain.

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There were 16,651 deaths from prescription opioids in the U.S.in 2010, “Starting with 4,030 deaths in 1999….” “…nearly 60 percent of the drug overdose deaths (22,134) involved pharmaceutical drugs. Opioid analgesics, such as oxycodone, hydrocodone, and methadone, were involved in about 3 of every 4 pharmaceutical overdose deaths (16,651).” It’s far higher now. A CDC report stated that one in every 20 U.S. adults has a history of [opioid] use – not abuse, but use.

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Monitor risk, yes, but that should not get all the investment. Many addicts would not be there if there were better treatments for pain, if they had not been given opioids after a minor procedure or injury that is better treated with real therapy, not drugs.

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People with pain do not mention the pain has taken their lives. We may see them as weak. That young child with fractures on the ball field is going to need the best care so pain does not become chronic. Give him or her opioids and opioids cause pain, pain becomes worse, intractable before the 6th grade. That is not an addict, but that child and his or her parents are often treated like addicts, at least with suspicion, drug seeking. What is best for that child with chronic pain when she becomes pregnant? When nursing? Think of our young veterans, some with 3 or 4 different pains, and each type addressed differently. What if either of them was an addict before the pain? If we don’t treat them, they will turn to drugs. What are the best, most efficient, options for treatment of intractable pain? When will we learn? We need to identify and treat before it becomes chronic.

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Chronic pain can be reduced or eliminated in many situations now even possibly without drugs, provided the issue is properly identified – and that will never happen until providers are educated in how to identify first class physical therapy. Further research will help to release persons with intractable pain from the prison that too often makes them feel that life is unbearable and that they can more easily face death. We all need to wake up to this situation.

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If we continue to passively allow nothing to be done, then there may be nothing to help us when we fall into the sudden bind of intractable pain when we wake up one day with shingles or a pinched nerve or when pain of the face prevents us from eating or sleeping or speaking or even wanting to live. It will be too late.

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Sharp like a razor’s edge is the path,
The sages say, difficult to traverse.

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Shall we let those we love hang on the edge while we fail to move this multi-tentacled monster forward? How do we light the fire that enables us to solve this fearful fragmentation of choices?

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See how beautifully it works when the right combinations are brought together?

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Yellow rose blue hibiscus

 

 

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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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Ketamine – small doses work in depression and bipolar disorder


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Everyone is very edgy right now with depression. Media is sensationalizing, which is the worst thing to do. I even hesitate to write this now.

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Ketamine really does work

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Small doses may be all that’s needed. Even large doses are safe.

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Two Cases

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I hate to play on emotion that is strong right now, but Robin Williams might be alive today if his doctors prescribed ketamine nasal spray.

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Every one, doctors and patients alike, worry about ketamine. It sells newspaper headlines and distorted media coverage that then overtakes the life saving stories of its profound safety when used under good medical supervision. Experience helps.

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Two cases from yesterday and today really must be shared. These two patients would not be alive today if they did not have ketamine nasal spray for their depression.

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I don’t mean to say every one will respond to these extremely tiny doses, but it’s always exciting to hear the effective dose is simply so small.

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These details would make good case reports if time permitted, but there is never enough time. I wanted simply to say a few things now because these two patients were seen.

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**1**

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In May 2014, saw a fifty-ish woman who is now responding to 20 mg (4 nasal sprays) given as one dose every 48 hours. She has been treated at well known university psychiatry departments, failed ECT 9 or 10 times – memory loss was so bad she got lost in her own neighborhood. Received IV ketamine once or twice weekly for one year before I saw her.

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Diagnoses:  dysthymia as long as she can remember, and 25 years of Major Depressive Disorder, PTSD, anxiety, etc. Olympic level athlete —

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**2**

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Second patient now in late teens, Juvenile Bipolar Disorder/Fear of Harm phenotype, profound thermoregulatory changes respond in seconds to ketamine, dose of 10 mg nasal spray every 3 days. That’s it! Temperature responds in seconds, and the depression responds in 10 minutes in her case. She was so violent before treatment that she had been hospitalized 7 times in 2-1/2 years. Doing very very well. And the low dose naltrexone, by the way, is involved in thermoregulation.

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I should mention, no side effects whatsoever. I have never seen toxicity. I watch kidney and bladder function meticulously, and patients with massive pain on very high doses have never had any organ toxicity.

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NEURO-INFLAMMATION AND GLIA – brain on fire.

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I mention Olympic athlete because so many people I see with Complex Regional Pain Syndrome – the pain that so often leads to suicide, seems to occur more often in top level athletes, either state or national level, professional or sponsored in their teens. Yes, they occur in others, but there is a striking predominance in athletes for unknown reasons.

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Glia are triggered by trauma, then they become activated and produce pro-inflammatory cytokines. Inflammation is out of balance. Ketamine profoundly reduces the pro-inflammatory cytokines, and so does low dose naltrexone. I write about these mechanisms with more frequency that anything else. This is what we must address – the brain is essentially “on fire.” And this inflammation, these pro-inflammatory cytokines, are involved in almost every known disease: Alzheimer’s disease, Parkinson’s disease, ALS, chronic pain, major depressive disorder, cancer, autoimmune disease, and atheroscloerosis.

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Inflammation kills. Unfortunately this new research on glia and inflammatory diseases, these diseases could be called gliopathies, all based on new research since the turn of the century. We now know glia are your innate immune system in brain and spinal cord. They need a balance the anti-inflammatory cytokines with the pro-inflammatory cytokines. Inflammation may be lifesaving when you have caught a virus, but not as a steady diet. Give the brain a break or it leads to hyperexcitable glutamate that triggers calcium flooding into the neuron, cell death, brain atrophy and memory loss. Seen in people with Major Depression and those with chronic low back pain.

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Do doctors know about the innate immune system? or the receptor that won the Nobel Prize 2 and 1/2 years ago? or glia?

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Answer: no.

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Papolos et al have published Clinical experience using intranasal ketamine in the treatment of pediatric bipolar disorder/fear of harm phenotype

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Ketamine administration was associated with a substantial reduction in measures of mania, fear of harm and aggression. Significant improvement was observed in mood, anxiety and behavioral symptoms, attention/executive functions, insomnia, parasomnias and sleep inertia. Treatment was generally well-tolerated.

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Dr. Papolos’ video on treatment points out, ketamine nasal spray is off-label

for Bipolar Disorder. And I add, ketamine is off-label for pain and for major depression.

He posts this:

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PUBLIC WARNING

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Public Warning: Ketamine is a controlled substance.

Administered improperly, or without the guidance of a qualified doctor,

Ketamine may cause injury or death.

No attempt should be made to use Ketamine

in the absence of counsel from a qualified doctor.

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“Off label” means it is FDA approved for another purpose, but he prescribes it for Juvenile Bipolar Disorder. I would add that in qualified hands, ketamine is one of the safest medications we have in our formulary.

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More later, as time permits.

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PUBLIC WARNING

reprinted with permission of Demitri Papolos, MD
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Ketamine is a controlled substance.
Administered improperly, or without the guidance of a qualified doctor,
Ketamine may cause injury or death.
No attempt should be made to use Ketamine
in the absence of counsel from a qualified doctor..

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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.

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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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