www.healthrising.org/blog/2018/04/20/pain-drugs-genes-fibromyalgia/

From Dr. Trescott’s lecture given to the Physician Partners of America: “Your Genes, Your Pain Drugs and You Or “Why Every Pain Physician Should be Testing Your Genes“

When the patient says, “This doesn’t work,” or, “I’ve been too sensitive,” or, “My mother had a terrible time with medicine X and I’ve had a terrible time with medicine X”, that should really tell you there’s likely to be a genetic problem there. Trescott

We know that many people with fibromyalgia and chronic fatigue syndrome respond very differently to drugs. A drug that works great for one person might have no effect in another person or even make another ill.

Why such variability? I’ve long assumed this meant that many people diagnosed with ME/CFS and FM actually have a different illness, but a recent lecture presented by the Physician Partners of America suggested that’s not necessarily true.  It’s possible that underlying genetics or epigenetic changes which affect how our metabolism breaks down substances could play a role.

The Genes

How you respond to a drug partly comes down to your genes. The human race is very variable genetically. A lot of that variability lies in small genetic variations called gene polymorphisms which can alter how effectively that gene works. These polymorphisms can have no effect or cause the gene to work less or more effectively.

Most people are normal – they have two “good” copies of a gene which allows them to metabolize substances properly. A significant number of people, however, have “good” and “bad” copies of a gene which can inhibit their ability to break down drugs. A smaller number of people (poor metabolizers) have two bad copies of a gene – they hardly break down some drugs at all.

Others with multiple copies of good genes (ultra-metabolizers) can find that even normal amounts of a drug can make them sick as they metabolize the drug into substances that cause harm.  Rapid metabolizers of oxycodone, for instance, will produce high levels of oxymorphone, which causes nausea, sedation and other symptoms.

The pain field is a perfect place to look for genetic anomalies in drug metabolism because responses to pain drugs are all over the map. In fact, the process of producing a pain sensation is so complex that some despair of ever producing really effective pain drugs. Part of that complexity lies in the genes that produce the enzymes that break down pain drugs.

The lecturer, Andrea Trescott, MD, a well known pain researcher and doctor, provided a dramatic personal example of the effects a gene polymorphism can have. Her first clue that she might have some hidden genetic vulnerabilities came during a surgical procedure as she was giving birth when she was given Percocet. It had absolutely no effect on her pain.

 

That process repeated itself during an emergency dental procedure when she was given Percocet, once, twice, three times – and received no relief at all (nor experienced any side effects). She might as well have been eating sugar cubes.

A week later, she went back for another procedure and asked to be given Darvocet which knocked her pain levels out. Subsequently, she found out that genetic polymorphisms in her CYPD26 (or 2D6) gene left her unable to metabolize Percocet. (Ten percent of Caucasians are 2D6 deficient).

Years later, her son, who was also 2D6 deficient, was scheduled to have his wisdom teeth removed. Requesting that hydrocodone, which his genetic status suggested that he metabolized poorly, not be used, didn’t work.  Stating that, “of course, he (the surgeon) blew me off”, her son got little relief from the hydrocodone, went back to the surgeon complaining of pain, and was labeled a drug seeker.

Take codeine. Codeine is inert – by itself it has no effects on pain – and has, like many opioid pain relievers, to be metabolized to morphine by the CYP2D6 enzyme to work. Morphine is then metabolized by another enzyme called UGT2B7 to M6G (morphine-6-glucuronide), which has pain-relieving properties. During that metabolic process, though, two other factors are released which can actually increase pain levels.

If you are not metabolizing codeine, you will get little relief from it. If you’re a super metabolizer taking large amounts of codeine, this could actually make your pain worse. Trescott relayed the story of a child with testicular cancer, in terrible pain on 1,000 mg of morphine, but whose pain was under control on just 30 mg. At 1,000 mg, the child’s system was being flooded with pain-enhancing metabolites.  At 30 mg, his system was getting morphine and it was working.

Hydrocodone is similar; by itself, it has very little effect, but when metabolized by CYP2D6 to hydromorphone or Dilaudid, it relieves pain.  If you find that hydrocodone doesn’t work for you, but Diluadid – which doesn’t get metabolized by CYPD26 –  does, you may be genetically designed not to be able to break down many opioid painkillers.

Tramadol – a weak opioid commonly used in FM – is also metabolized by CYP2D6, but in a twist, the same enzyme also controls tramadol’s excretion. If you’re not so hot at metabolizing tramadol, you may end up with poor pain relief plus lots of side effects due to poor excretion.

For the past five years, codeine prescriptions for children have been restricted because of the effects CYPD26 polymorphisms can have on children. The same concerns have lead the FDA to recently release a boxed warning for the use of Tramadol in children. (The problem is probably only relevant for children with a certain genetic makeup, but in them the effects can be severe. Trescott relayed the  story of a child with rapid Tramadol metabolism who ended up in a coma in the hospital.)

(Tramadol is metabolized by several enzymes, and because it’s an SNRI, is good for neuropathic pain. The lecturer said it was one of her favorite drugs for pain.)

(Genetic polymorphisms or mutations could even be responsible for the removal of drugs from the market that could have been helpful for many but which harmed people who were unable to metabolize them properly.)

There there’s methadone, which the doctor called her “desert island” drug. At its best, it knocks neuropathic pain out, often causing no side effects at all – a rarity with painkillers.  Breaking down methadone is a complicated process, however, and her patients have varying responses to it. When it works, though, it really works.

If your CPYD26 status means you’re not going to get much relief from the “odone’s” (hydrocodone, oxycodone), Tramadol or codeine, there’s still hope. You might do just fine on morphine which is metabolized differently.

Antidepressants

The same process occurring in pain drugs applies to antidepressants and other drugs. The CYP2D6 enzyme metabolizes about a quarter of commonly used drugs including many antidepressants. Genetic polymorphisms have so impacted the response to antidepressant drugs that a 2013 Consortium has produced guidelines for antidepressant drug dosing (amytriptyline and nortriptyline), depending on what genetic variations are present in two genes (CYP2D6; CYP2C19).

Its low cost has made Amytriptyline a popular drug, but Trescott called it a “dirty drug” with a lot of potential side effects, in part because of problems some people have metabolizing it.

Drug Interactions

Drug interactions are another really good way to affect drug metabolism. Trescott relayed the result of a study which found that if you’re taking six pharmaceutical drugs you have a 94% chance of a drug interaction occurring; i.e. one of those drugs is going to impact how at least one other is functioning.

Because Paxil, Prozac and Duloxetine inhibit the CYPD26 enzyme, taking them could make your pain drugs less effective.  Taking those drugs together could effectively turn a normal CYP2D6 metabolizer into a poor one.  (Celexa and Lexapro, on the other hand, do not inhibit opioid painkiller metabolism).

If you happen to be taking benzodiazepines, tricyclic antidepressants, naloxone or diclofenac — and morphine or its derivatives — watch out because each of these drugs enhances the breakdown of morphine to metabolites which enhance pain levels!  (If you’re taking opioids, getting off benzodiazepines might help them work better.)

Note that St. John’s Wort – a herb sometimes used for depression – is a potent CYPD26 inhibitor. If you’re taking St. John’s Wort and your pain, antidepressant or other medications stop working as well, St. John’s Wort may be the reason.

Even something as innocuous as cinnamon can be a problem. Cinnamon can cause oxycodone to metabolize into a substance which doesn’t have strong pain-killing properties.

All over-the-counter stomach medications are not cut from the same cloth. Taking methadone and Rantidine together is fine, but if you take Cimetidine and methadone you could end up in the hospital because Cimetidine inhibits the metabolism of an enzyme called 34A which breaks down methadone.

Because cannabinoids are probably significant inhibitors of the CYP2C19 enzyme, which breaks down Valium, Soma and several antidepressants, people taking cannabanoids may notice changes in the effectiveness of those drugs.

COMT, Fibromyalgia and ME/CFS

Dr. Trescott’s last story involved a gene called COMT whose polymporphisms have been associated with an increased risk for fibromyalgia and chronic fatigue syndrome (ME/CFS). The research on COMT and FM is pretty extensive with the latest study coming just this year.

A 48-year-old male with attention deficit disorder, obstructive sleep apnea, polymyalgia, post-traumatic stress disorder, and chronic low back pain stated he was not responding well to his antidepressants or his ADD medication (methylphenidate) which blocks norepinephrine and epinephrine uptake.  An SSRI gave him terrible headaches.

Genetic testing revealed he had reduced COMT activity. Because COMT breaks down serotonin, norepinephrine and epinephrine, his high pain levels were understandable.

Testing also revealed that he had reduced activity of the enzyme that converts methylenetetrahydrofolate to folate, and reduced folate levels, it turns out, are associated with reduced responses to antidepressants and pain medications.

Giving him a folate booster (leucovorin 10 mgs/ morning) and zinc sulfate resulted in a rapid decrease in his pain scores from 9-10 to 2-3 in a week. Plus, his depression and ADD improved.

Hypersensitivity Reactions in ME/CFS

Other scenarios in which genetic testing may be useful include patients who have shown a poor response to medications in the past, those with a family history of drug sensitivity…Argarwal et. Al.

One wonders if the hypersensitivity to drugs and strange drug reactions that some ME/CFS patients experience could be due to a genetic issue or to an epigenetically induced alteration of D26 or other metabolizing genes which occurred when the patient fell ill.

I, for instance, have become extremely sensitive to caffeine. Just a few sips of coffee or tea can send me flying. That didn’t happen prior to ME/CFS. Polymorphisms in two genes (CYP1A2, N-acetyltransferase 2) mainly regulate caffeine metabolism. Could an epigenetic shift have turned me into a super caffeine metabolizer?

Testing

Pharmacogenetics is a relatively new field which uses genetic tests to assess a patient’s risk of having an adverse reaction to a drug or their likelihood of responding very well to it.  It’s too new for most primary care doctors to be aware of pharmacogenetics, but a primer was recently published that could help guide their use of opioid painkillers. It’s been estimated that over 25% of common drugs have some sort of genetic information which could prove useful.

Genetic testing can provide some answers, but unfortunately is usually not covered by insurance – a mistake, Dr. Trescott thinks, given the 2.2 million adverse drug reactions in the US that cause 100,000 deaths and cost the medical system billions of dollars every year.  A variety of genetic panels (CYP2C9, CYP2C19, CYP2D6, and VKOR1, OPRM1, COMT, and ABCB1, as well as dopamine receptors and transporters, serotonin receptors and transporters) are available, however, and more are on their way. Trescott mentioned that Generex [SP] has a program which combines genetic test results with drug intake to determine which drugs are more likely to help.

A group of largely U.S. researchers has created a “Genetic Addiction Risk Score (GARS)”,  which uses variations (polymorphisms/mutations) in ten genes to determine one’s risk of having pain problems and/or increased drug or alcohol use. They’ve warned about commercial enterprises which offer bogus gene testing, claiming to be able to predict addiction. See the strange case of Proove Biosciences.

As costs of genetic testing continue to decline, genetic tests at a reasonable price should become more available.

Bottom Line – Doctors Should Listen to Their Patients!

“When they say they’re not getting relief from their medicine, they’re not getting relief from their medicine. Okay?”

The bottom line for Dr. Trescott is that doctors should listen to their patients.  If a patient is not responding well to pain or other drugs – if they feel they need more drug to get relief (low metabolizers), they’re not necessarily drug seekers. Or if they’re getting lots of side effects (rapid metabolizers), they are not necessarily complainers or hypochrondriacs.

Pharmacogenetics is being used in cardiovascular disease, and extensively in cancer, but not so much in pain yet.  As the research proceeds, though, and the data builds up, it will play a key role in the personalized type of medicine that our medical system is slowly moving to.

Filed under: General Problems | 1 Comment »

Filed under: General Problems | 1 Comment »

An Open Letter To All Who Hold Public Office In America From Painful Disease Patients

View at Medium.com

www.medium.com/@heatherzamm/an-open-letter-to-all-who-hold-public-office-in-america-from-painful-disease-patients-e1afebaca945

We are crying out to you today as intractable pain patients who are citizens of the United States and registered voters. We believe any measures considered to reduce the amount of pain medication permitted to intractable pain patients, or any measures that try to regulate the way a physician can practice medicine to be a mistake and will fully explain with cited scientific and social references why.

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There is an agenda in America to delegitimize pain, to reduce pain to a mere annoyance that is manageable by Tylenol or other OTC medications, and to paint persons who require more intervention as “addicts” or medication “seekers” when this is the furthest from the truth. Painful disease patients with lifelong chronic illness are suffering persecution and backlash unheard of since the days of the Holocaust.

To fully understand the machinations behind this campaign against prescribed opioid pain medication, all Politicians or political figures must consider all the following facts.

In 2005, the magazine Wired (1) released an article entitled, “The Bitter Pill” , about a promising new addiction treatment drug making the rounds in New York City called buprenorphine. It featured a 36-year-old New York health department psychiatrist named Andrew Kolodny. Dr. Kolodny allowed the reporter to shadow him as he attempted to convince reluctant physicians to prescribe “bupe” instead of methadone to people suffering from substance abuse disorder. It also featured stories from those who proclaimed that buprenorphine had given them somewhat of a normal life back. The reporter also spoke of Dr. Kolodny’s appeals to prison physicians to switch prisoners from methadone to bupe.

In 2018, Dr. Andrew Kolodny is the co-director of Opioid Policy Research at the Heller School of Brandeis University. He is also the co-founder of Physicians for Responsible Opioid Prescribing (PROP). He achieved these positions without returning to hallowed halls to receive any further higher learning in opioids, pharmacology, or intractable pain and its effects on the body. He achieved this status without treating a single patient with intractable pain, and he has never written a single prescription for an opioid drug (well, outside of buprenorphine, a very powerful opioid -which the government allows to be prescribed without consideration of that fact). He achieved this status without continuing to prescribe buprenorphine for more than a few months in 2005. He is a psychiatrist who has no patients or couch. It is difficult indeed to address him as “Dr. Kolodny” when he has done little in the way of true patient care, yet has titles and accolades heaped upon him for what appears to many to be keen sales acumen and cunning abilities of persuasion.

The only thing that Andrew Kolodny has achieved since Wired made him known in 2005 is sales of buprenorphine and demonization of traditional opioids with exaggerated stories, backed by his credentials. He managed to travel the United States throughout the end of the 2000’s, convincing prison physicians and hospitals to switch prisoners and patients from generic methadone to name brand bupe, sold under trade name Suboxone, raking in untold fortunes for its maker. As you know, prisons operate on state and federal contract, and with the contracts now locked into Suboxone, Dr. Kolodny had scored an unheard-of victory for the Suboxone maker Reckitt-Benckiser, an unlikely pharmaceutical contender, as they are manufacturers of Durex Condoms and Lysol spray.

Surely, Dr. Kolodny did this all out of the kindness of his psychiatrist heart and received zero compensation. A real champion of the people.

In 2010, a faint alarm sounded. Esteemed science journals began to realize that intractable pain patients were soon to be damaged if hysteria being whipped up by Dr. Kolodny and his esteemed friends in the pharmaceutical industry, who had much stake in the rise of buprenorphine (enough to keep tweaking its formulation to keep the patent), were to be taken seriously.

The esteemed scientific journal Cochrane published a study entitled, “Opioids for Treatment of Long-term Noncancer Pain” (2). The authors arrived at the conclusion “proper management of a type of strong painkiller (opioids) in well-selected patients with no history of substance addiction or abuse can lead to long-term pain relief for some patients with a very small (though not zero) risk of developing addiction, abuse, or other serious side effects”. The authors added a caveat that their study had the parameters of a shorter window of time than other medication review studies, simply due to humanity. Plainly put, a control group of intractable pain patients can only be asked to go so long without pain relief in a civilized society for the purposes of medical research. This is a particularly sad and astonishing fact to ponder, as medical professionals are daily force tapering and abruptly cutting off intractable pain patients prescribed opioid medications and anxiety medications that they have taken for many years at stable doses, as directed, with no signs of substance abuse. Yet, the research community feels this is too inhumane to do for study purposes!

In addition, the National Institutes of Health also published a paper supported by the nonprofit group Human Rights Watch, entitled “Access to pain treatment as a human right” (3), in which the authors argue, “According to international human rights law, countries have to provide pain treatment medications as part of their core obligations under the right to health; failure to take reasonable steps to ensure that people who suffer pain have access to adequate pain treatment may result in the violation of the obligation to protect against cruel, inhuman and degrading treatment.”

State Legislators began to implement tracking programs in their states, called the Physician Drug Monitoring Program or PDMP- in some states known as the PDMD-the Prescription Drug Monitoring Database. This program was slipped into states without a single patient voting. Many had no idea it was even in place! No consent was given. It is a controlled substance tracking system, which pharmacies use to see where a patient gets controlled medications, and how much each patient receives. Supposedly to control “double dipping”, this program has become a Gestapo type program with the boot squarely on the throat of chronic pain patients. In some states rampant abuse of this system occurs, with no punishment. Veterinary offices have full access to the state PDMP, though they treat animals and not people, and HIPAA does not apply remotely to veterinarians. There is absolutely no way on earth to legally justify this. Law enforcement also has access to the PDMP system in some states. Additionally, in some states as well as in some pharmacy chains nationwide, there is an added program named Appriss NarxCare(4), in which the physician can enter a patient’s name and date of birth, and the computer will use an algorithm to decide whether or not that patient “deserves” to receive prescribed pain medication according to the “score” received by the algorithm. The algorithm searches the state database and decides this “score” based on how many prescriptions have been filled of what medications and in what amounts.

These algorithms are very secret and proprietary, so little is known of their formula, however what IS known is that they do not take into consideration diagnosis, scans, labs, genetics, surgeries, length or time of conditions, doctor patient relationships or any other variable outside the medication and amount. What kind of medicine is this being practiced and how is this allowed? What is the point of a $100,000 + medical education if a physician is going to push a button to decide care instead of using an education? Why are algorithms being used to determine worth of human suffering, a very personal and partisan experience that a machine cannot possible determine the worth of?

Enter Gary Mendell, a billionaire hotel tycoon who decided that he wanted to channel all his rage and frustration over the loss of his son into making opioids inaccessible to 99.9% of America. Brian Mendell died in 2011 of suicide after years of substance abuse disorder, starting with early teenage marijuana experimentation(5) . Mr. Mendell claims his son “had been clean for over a year and had committed suicide over shame of his addiction.” To date, little else has been released publicly regarding Brian Mendell’s SUD and no one knows what drugs Brian was abusing after marijuana. Mr. Mendell was exactly who Dr. Kolodny had been waiting for. Angry with very deep pockets. Mr. Mendell founded Shatterproof(6) , an organization that spreads fear and lies about opioids on a daily basis through their paid media sources. A recent example reads:

“Opioid Addiction can begin in just three days exposure”.

A patently false, outrageous claim that no one in the media questioned before they ran with it, pulling quotes from the air. A simple logic check, without having to consult medical journals, reveals this lie. If this were true, most of the United States would be addicted to opiates. This kind of fear mongering only causes people to go through unnecessary pain when they could be comfortable, because they are “afraid” of addiction after a painful surgery or dental procedure. Unmitigated spreading of these lies helps no one in America.

The ship of fools gathered steam and courage, bolstered by the a few dishonest doctors and fake patients they uncovered, exposed and shut down in the early 2010’s, the “pill mill years”, and then the magnum opus, the CDC guidelines for chronic pain management, were issued in April 2016, after a premature attempt by Kolodny was rejected soundly by the FDA in 2012(7). However, at least Dr. Kolodny finally received somewhat of an education in what an opioid actually is. Dr. Janet Woodcock gave him a very good education on the subject while telling him to get stuffed in the most scientific way possible, to the immense enjoyment of all who think the paper the letter was written on has more substance than Kolodny himself. Alas, the 2016 guidelines were rushed through. However, the guidelines were never given proper vetting by a peer group, they were convened by a secret panel led by Dr. Kolodny and Ms. Deb Houry, another wrongly invested CDC point person with a past tragedy fueling her rage against opioids. Also, the CDC guidelines were never meant to apply to existing intractable pain patients. Nor were they supposed to read as a standard- they were guides, not laws. However, the media, led by Mendell, soon shook the guide at physicians who dared to prescribe over 90 MME per day, labeled patients as addicts who required pain control over 90 MME per day and doctors were soon threatened with license revocation for daring to prescribe AT 90 MME per day.

All we will say further about the CDC guidelines are they are presently destroying people’s lives. Intractable pain patients are committing suicide daily in large numbers due to the cut off their life-giving medicine because of the imposition of these guidelines(8) . How could any state consider ending coverage of prescribed pain medication? Especially considering the revealed truth about present CDC director Dr. Redfield? One more person in this scheme against intractable pain patients who has a personal score to settle. His son suffers from substance abuse disorder and overdosed on cocaine laced with illegal Chinese fentanyl analog . Dr. Redfield responded by vowing to take away intractable pain patient’s abilities to obtain legal prescriptions of opiates in amounts needed to relieve their pain(9). How does cocaine overdose by a person who purchased an illegal street drug even compare to prescribed pain medication that is carefully vetted by a physician before being given to a patient who faithfully attends regularly scheduled appointments? Furthermore, prescriptions have sharply decreased in the past decade and RX opioid addiction treatment has declined as a result, nearly flatlining as the lowest population in addiction treatment centers according to the Substance Abuse and Mental Health Services Administration (SAMHSA). This graph supplied by that administration shows the incredible truth of addiction in America, with illegal heroin leading the way, followed by alcohol, marijuana, and lastly prescribed opioids. Yet, incredibly, recreational marijuana is being legalized in states across the country! How does this make any rational sense?

When is someone finally going to stand up for intractable pain patients? There are voices in the medical community who have tried to speak out for us and they get shouted down! Dr. Michael Schatman wrote a lengthy peer reviewed piece (10) pointing out that the CDC’s own data collection mechanisms were flawed and inflated . He showed that in OD’s, almost every time, there were multiple drugs present, usually 5 or more illicit ones. Overdoses were not happening in the chronically ill patient population, but in the recreational user population. Exactly what happened with Eric Bolling’s son(11) , what happened to Dr. Redfield’s son, Deb Houry’s loved one, and almost all others who have exacted their vengeance on prescribed opioids. Millions of intractable pain patients are paying the price for this revenge play! How can this be happening in the United States of America in 2018?

Please, we beg the you to review the links footnoted and to understand that this “opioid crisis” is not a crisis that involves prescribed drugs to intractable pain patients. This is/always has been an illicit drug problem that involves heroin and illicit Chinese fentanyl analogs that are deadly, analogs the DEA didn’t even attempt to begin to control until late 2017(12) . It is also could be fairly called a manufactured “addiction crisis” to help the sales of Suboxone(13)!You must use logic and dispassion.

Strike any bill that would take away medication that restores life and function to millions of people who need it every day. Would you force taper and cut off insulin to diabetics? Our carefully prescribed pain medication is no less vital to our health. We should not be held hostage to those who are suffering from substance abuse disorder, or those who have stolen pills and gotten off scot free due to “who they know” in your ranks(14)!

We are not addicts. We do not suffer the ridiculous notion of “buprenorphine deficiency” that has been suggested by unscrupulous, incentive driven ER physicians trying to score points with a pharmaceutical company. We do not deserve the outrageous violations of civil rights and constitutional benefits enjoyed by our fellow citizens who take their freedom for granted, without a second thought about being tracked or judged, without worrying about denied treatment due to a computer algorithm that has no idea of human characteristics or charted information.

If you can read through this plea and continue your course to reduce and discontinue prescribed pain medication after reading all these facts, then you are either in league with these soulless people or have antisocial personality disorder. If you can stand by, wringing your hands while we send our letters and call your offices, and reply with silence or your pithy form letters, you are no better than those who went before you while wholesale slaughter went on and did nothing to stop it, back to the days of Herod.

They will be judged harshly, and you no less. Will it be worth it?

Sincerely,

The Chronic Pain Patients of America

_____________________________________

(1)-https://www.wired.com/2005/04/bupe/

(2)-https://www.cochrane.org/CD006605/SYMPT_opioids-long-term-treatment-noncancer-pain

(3)-https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2823656/

(4)http://www.modernhealthcare.com/article/20171009/TRANSFORMATION03/171009954

(5)-https://www.cnbc.com/2017/11/17/opioid-abuse-should-be-treated-as-a-disease-not-moral-failing-ceo.html

(6)-https://www.shatterproof.org/about/history

(7)-http://paindr.com/wp-content/uploads/2013/09/FDA_CDER_Response_to_Physicians_for_Responsible_Opioid_Prescribing_Partial_Petition_Approval_and_Denial.pdf

(8)-https://tonic.vice.com/en_us/article/8x5m7g/opioid-crackdown-chronic-pain-patients-suicide

(9)-https://www.livescience.com/63088-cdc-chief-son-fentanyl.html

(10)-https://www.dovepress.com/pain-management-prescription-opioid-mortality-and-the-cdc-is-the-devil-peer-reviewed-article-JPR

(11)-https://people.com/tv/eric-bolling-son-death-ruled-accidental-overdose-included-opioids/

(12)-https://www.dea.gov/divisions/hq/2017/hq110917.shtml

(13)-https://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html

(14)-https://www.salon.com/1999/10/18/drugs_3/

Filed under: General Problems | 3 Comments »

https://drive.google.com/file/d/19MvQ9vz25lGt-NbAUK4Cyw_JzK16Wz_Z/view

PLEASE FAMILY AND FRIENDS – PLEASE PASS THIS AROUND IN YOUR STATE AND SHARE TO EVERYONE ON FACE BOOK! THIS MAN IS TRUST WORTHY IN MY OBSERVATION OVER THE LAST 2 TO 3 YEARS OF KNOWING AND WATCHING HIM! HE IS A CHRISTIAN MAN WILLING TO HELP FOR FREE ALL THE POOR PEOPLE IN PAIN AND SUFFERING! GOOD PERSON I DO BELIEVE! I TRUST HIM!

Filed under: General Problems | 4 Comments »

CDC Guidelines Refuted with Scientific Evidence

CDC Guidelines Refuted with Scientific Evidence

Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use – Medium
Stephen A. Martin, MD, EdM; Ruth A. Potee, MD, DABAM ; and Andrew Lazris, MD

Finally, someone is standing up for the truth about opioids and pain patients. These three courageous M.D.s expose the CDC guidelines for the fraud they are.

They’ve written a well-researched paper that refutes the basis of these unscientific and biased guidelines piece by piece with real evidence from scientific studies to back their claims.

I admire these three authors for having the ethics-based courage not to let this gross misinterpretation of science and be accepted without question.

They show how the CDC cherry-picked data with obvious bias (much as they did people). Repeatedly, the CDC interpreted studies with such a slanted view as to assure the outcome they wanted. 

When interpreting them without bias, the same studies actually refute the CDC’s arguments.

Recommendations from the Centers for Disease Control and Prevention (CDC) for chronic opioid use, move away from evidence, describing widespread hazards that are not supported by current literature.

These recommendations are in conflict with other independent appraisals of the evidence — or lack thereof — and conflate public health goals with individual medical care

The CDC frames the recommendations as being for primary care clinicians and their individual patients. Yet the threat of addiction largely comes from diverted prescription opioids, not from long-term use with a skilled prescriber in a longitudinal clinical relationship  

By not acknowledging the role of diversion — and instead focusing on individuals who report functional and pain benefit for their severe chronic pain — the CDC misses the target.

We provide here a review of the evidence regarding long-term opioid use for chronic pain in order to

a) better point public health efforts, and

b) reduce harm from consequent restriction of these medications for patients who have substantial benefit in their use.

With these new recommendations concerning the use of opioids, the CDC has taken available data and developed a narrative that H.L. Mencken would generally have described as “neat, plausible, and wrong.”

The narrative is as follows:

People in chronic, severe pain are readily provided unproven opioids in ever-increasing doses, get easily addicted and die of overdose either from the opioids prescribed to them or from a switch to lethal heroin.

Neat? Yes. Plausible? Yes. Wrong? Unfortunately, yes.

In addition, the exception “palliative care” is notable.

In defining people to be served by palliative care, the National Consensus Project notes that

“serious or life-threatening illness is assumed to encompass populations of patients at all ages within the broad range of diagnostic categories, living with a persistent or recurring medical condition that adversely affects their daily functioning or will predictably reduce life expectancy.” [7]

Chronic pain, when controlled for sociodemographic factors, has been found to reduce life expectancy by ten years. [8]

It doubles rates of suicidal ideation, attempts, and completion [9]

while quadrupling rates of depression and anxiety. [10]

When people look for some relief of chronic suffering, they are doing so relative to a situation of misery. Given the impact of chronic severe pain, it appears to meet the definition for palliative care itself.

Can people in chronic pain expect meaningful relief from long-term opioid use? Not according to the CDC. The recommendations state there is no evidence for such use and only evidence of harm.

Absence of evidence is not evidence of absence, and the CDC’s claim is also belied by direct reports from patients using long-term opioid treatment who report substantial pain and functional improvements.

The CDC, in telling patients that “the benefits are transient and generally unproven,” [12] is essentially telling patients they are wrong about their pain and function.

When conventional evidence is limited and suffering is high, use of clinical ethics for individual patients has been proposed as a worthwhile decision-making model. [13]

the 2014 National Institutes of Health “Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain” concluded that:

Patients, providers, and advocates all agree that there is a subset of patients for whom opioids are an effective treatment method for their chronic pain, and that limiting or denying access to opioids for these patients can be harmful.

Our consensus was that management of chronic pain should be individualized and should be based on a comprehensive clinical assessment that is conducted with dignity and respect and without value judgments or stigmatization of the patient. [15]

… Biased media reports on opioids also affect patients. Stories that focus on opioid misuse and fatalities related to opioid overdose may increase anxiety and fear among some stable, treated patients that their medications could be tapered or discontinued to “prevent addiction.” [16]

The CDC, in contrast, highlights that prescription opioids are “really dangerous medications which carry the risk of addiction and death.”

Much has been made of opioid-induced hyperalgesia. But even the most recent reviews of this phenomenon are unable to determine its prevalence, and studies have generally been experimental in nature or with unusual administration of opioids (e.g., intrathecal). [22,23]

Whether it is clinically important for patients with chronic pain on standard opioid medication is unclear. [24] As to concern for dose escalation, a recent cohort study found it occurred in fewer than one in ten opioid-naïve patients. [25]

First-line interventions advised by the CDC are limited in their effectiveness

Acetaminophen was recently found to have no impact on osteoarthritis pain. [26]

NSAIDs had their FDA warning strengthened in 2015 regarding heart attacks or strokes [27] and their risks of kidney injury and gastrointestinal bleeding have long been recognized. [28,29]

Anticonvulsants or tricyclic medications for neuropathic pain have a number needed to treat of 5, meaning 4 patients do not have a benefit. [30]

Perhaps “multidisciplinary biopsychosocial care with a prominent component of self-management, generally accepted as the gold standard of care for chronic pain”? According to a pain specialist, its availability has “all but disappeared in the United States.” [31]

the choice to use opioids is not made in a vacuum. The decision is made in comparison with the status quo of chronic, intractable pain despite other medical interventions.

As a comparison, chemotherapy for cancer treatment also has severe side effects, even toxicity. People make the choice to use such treatments because they are choosing against the alternative.

The CDC states that “prescription opioids are just as addictive as heroin.” [32] Others call them “heroin pills.” [33] But a full year after after major surgery, only “0.4% of older opioid-naive patients continued to receive ongoing opioid therapy.”

Unfortunately, recent publications have included “pooled studies with widely differing definitions, outcome variables, and populations,” which detract from their conclusions. [35] Concerns about such misleading data and definitions come from a wide variety of sources. [36–38]

The term “prescription opioids” itself is problematic as the adjective does not distinguish how the drug was actually obtained by the user.

Among those who take opioids long-term for chronic pain, the CDC highlights the potential for overdose (“overdose” is mentioned 144 times in the recommendations) and death

The study cited in the CDC’s own telebriefing [12], however, found “opiate-related” death to occur in 59 of 32,449 (0.2%) patients taking opioids for more than three months. [39] The context of these deaths was unknown

In its review of a Citizen’s Petition to limit doses of chronic opioids, the FDA found that “the scientific literature does not support establishing a maximum recommended daily dose of 100 mg MED [morphine equivalent dose].”[42]

Opioid overdose deaths are generally the result of diverted medications (“diversion” is mentioned 2 times in the recommendations)

heroin, fentanyl, or a combination of these. Diversion is most often from prescriptions for acute, not chronic, pain.[43]

94% of people in treatment for opioid addiction said they chose to use heroin because prescription opioids were “far more expensive and harder to obtain.”

The National Institute on Drug Abuse estimates that fewer than half of young people injecting heroin report abusing prescription opioids beforehand. These crucial details are unacknowledged in the CDC recommendations

Examining this Narrative

Public health interventions are different than clinical interventions.

• The former are scaled, diffuse and unilateral.
• The latter are individualized and shared.

The CDC recommendations are more focused on public health concerns (such as non-medical use of prescribed drugs) rather than the individual risks and benefits of opioids for actual patients.

The CDC recommendations describe a linear relationship between opioid prescribing and nonmedical use. But data on opioid prescribing [55,56] and nonmedical use [57], state by state, tell a more complicated story

A Different Narrative

Our concern for individual patients is that recommendations and regulatory changes [62] concerning prescribed opioids are increasingly being developed not through evidence, but by a flawed narrative of how addiction develops and overdose occurs. [63,64]

The CDC was provided with descriptions of these flaws in the period of public comment, but chose to make only minor revisions

Our concern for public health is that these recommendations do nothing explicitly to address the major source of prescription opioids used in substance use disorders in the United States: diversion.

The continued use of graphs that track kilograms of prescription opioids and overdose deaths, however, misleads when many of those “prescriptions” are taking place outside of a skilled, longitudinal, patient-clinician relationship. [66,67]

The data we provide here describe a more accurate narrative:

Should other treatments not succeed, people suffering from intractable chronic pain may find that carefully monitored long-term opioids, in combination with other modalities, can help reduce their suffering and improve their function.

The evidence indicates they can do so with a low risk of developing opiate use disorder and an exceedingly low risk of overdose death. As with all treatments, the decision to use and continue long-term opioids should be one of ongoing shared decision-making.

Overall, the new recommendations sacrifice accuracy for a fabricated sense of clarity

But this goal is better addressed by recommendations that consider both individual patient choice and the impact of prescribed opioids on public health through diversion, two very distinct issues.

The outcome might be less neat — yet still plausible — and have the added advantage of being beneficial to the many people struggling with chronic pain  

These three individuals are our true heroes.

There are 87 references provided for this article. The authors have done the hard research and now it’s up to us to use this as a tool and spread the message…  as much as we with our lives limited by chronic pain and illness, can.

 

I’ve never asked for anything before, but this is so important I feel justified.

Please help spread this article to all pain patients

by posting it to your other social media accounts or email lists.

The short link to this post is http://wp.me/p3evjQ-3IN

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https://youtu.be/HppBhlLAnMY

Operation #Starburst is a nationwide effort to end the abuses by the American government against out elderly, cancer patients, disabled, veterans, minorities, etc. This lawsuit is being filed in as many states as possible in an attempt to expose these policies to deny legitimate pain medications as being violations to our Constitution & Bill of Rights. If you would like to join this effort, please contact Robert D. Rose Jr. at sickof.suffering@comcast.net.

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https://www.linkedin.com/pulse/unique-serialized-number-new-california-pharmacy-law-kevin/

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You have changed things. I just got a call from a lady at VA. Someone sent the video to a senator and that senator (she would not give me the senators name) contacted the VA and told them to find a way for me to receive after treatment where ever I want. This is a big deal. However, while this does help me obtain the treatment I need it still doesn’t change the fact that had they done things the way they should have I would not be dying.

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Michael Levine’s Triangle of Death, now out there in eBook format!

Amazon Kindle: http://goo.gl/EM7XVg
iTunes Bookstore (for Apple merchandise): https://goo.gl/Lw39vu
Barnes & Noble NOOK: https://goo.gl/SWbM8r
Kobo (Adobe DRM EPUB): https://goo.gl/0gSyvD
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60 Minutes presses for the reality, and Robert C. Bonner, former federal decide and head of the DEA, calls the CIA “drug smugglers.” This video is devoted to all these lives misplaced within the War on Drugs, whereas the CIA betrayed us.

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Deep Cover is now out there on Kindle right here:http://goo.gl/DrfPM
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THE BIG WHITE LIE can also be out there in eBook format on the hyperlinks under:

Amazon Kindle: http://goo.gl/OKpxl
B&N NOOK: http://goo.gl/OEOYy
iBooks (for iPad, iPhone and iPod Touch): http://goo.gl/fVM5i
Kobo (and different Adobe DRM eReaders): http://goo.gl/5T0ft

http://www.michaellevinebooks.com

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