Scientists seek ways to finally take a real measure of pain

http://www.tribtown.com/2019/01/10/us-med-measuring-pain/

WASHINGTON — Is the pain stabbing or burning? On a scale from 1 to 10, is it a 6 or an 8?

Over and over, 17-year-old Sarah Taylor struggled to make doctors understand her sometimes debilitating levels of pain, first from joint-damaging childhood arthritis and then from fibromyalgia.

“It’s really hard when people can’t see how much pain you’re in, because they have to take your word on it and sometimes, they don’t quite believe you,” she said.

Now scientists are peeking into Sarah’s eyes to track how her pupils react when she’s hurting and when she’s not — part of a quest to develop the first objective way to measure pain.

“If we can’t measure pain, we can’t fix it,” said Dr. Julia Finkel, a pediatric anesthesiologist at Children’s National Medical Center in Washington, who invented the experimental eye-tracking device.

At just about every doctor’s visit you’ll get your temperature, heart rate and blood pressure measured. But there’s no stethoscope for pain. Patients must convey how bad it is using that 10-point scale or emoji-style charts that show faces turning from smiles to frowns.

That’s problematic for lots of reasons. Doctors and nurses have to guess at babies’ pain by their cries and squirms, for example. The aching that one person rates a 7 might be a 4 to someone who’s more used to serious pain or genetically more tolerant. Patient-to-patient variability makes it hard to test if potential new painkillers really work.

Nor do self-ratings determine what kind of pain someone has — one reason for trial-and-error treatment. Are opioids necessary? Or is the pain, like Sarah’s, better suited to nerve-targeting medicines?

“It’s very frustrating to be in pain and you have to wait like six weeks, two months, to see if the drug’s working,” said Sarah, who uses a combination of medications, acupuncture and lots of exercise to counter her pain.

The National Institutes of Health is pushing for development of what its director, Dr. Francis Collins, has called a “pain-o-meter.” Spurred by the opioid crisis, the goal isn’t just to signal how much pain someone’s in. It’s also to determine what kind it is and what drug might be the most effective.

“We’re not creating a lie detector for pain,” stressed David Thomas of NIH’s National Institute on Drug Abuse, who oversees the research. “We do not want to lose the patient voice.”

Around the country, NIH-funded scientists have begun studies of brain scans, pupil reactions and other possible markers of pain in hopes of finally “seeing” the ouch so they can better treat it. It’s early-stage research, and it’s not clear how soon any of the attempts might pan out.

“There won’t be a single signature of pain,” Thomas predicted. “My vision is that someday we’ll pull these different metrics together for something of a fingerprint of pain.”

NIH estimates 25 million people in the U.S. experience daily pain. Most days Sarah Taylor is one of them. Now living in Potomac, Maryland, she was a toddler in her native Australia when the swollen, aching joints of juvenile arthritis appeared. She’s had migraines and spinal inflammation. Then two years ago, the body-wide pain of fibromyalgia struck; a flare-up last winter hospitalized her for two weeks.

One recent morning, Sarah climbed onto an acupuncture table at Children’s National, rated that day’s pain a not-too-bad 3, and opened her eyes wide for the experimental pain test.

“There’ll be a flash of light for 10 seconds. All you have to do is try not to blink,” researcher Kevin Jackson told Sarah as he lined up the pupil-tracking device, mounted on a smartphone.

The eyes offer a window to pain centers in the brain, said Finkel, who directs pain research at Children’s Sheikh Zayed Institute for Pediatric Surgical Innovation.

How? Some pain-sensing nerves transmit “ouch” signals to the brain along pathways that also alter muscles of the pupils as they react to different stimuli. Finkel’s device tracks pupillary reactions to light or to non-painful stimulation of certain nerve fibers, aiming to link different patterns to different intensities and types of pain.

Consider the shooting hip and leg pain of sciatica: “Everyone knows someone who’s been started on oxycodone for their sciatic nerve pain. And they’ll tell you that they feel it — it still hurts — and they just don’t care,” Finkel said.

What’s going on? An opioid like oxycodone brings some relief by dulling the perception of pain but not its transmission — while a different kind of drug might block the pain by targeting the culprit nerve fiber, she said.

Certain medications also can be detected by other changes in a resting pupil, she said. Last month the Food and Drug Administration announced it would help AlgometRx, a biotech company Finkel founded, speed development of the device as a rapid drug screen.

Looking deeper than the eyes, scientists at Harvard and Massachusetts General Hospital found MRI scans revealed patterns of inflammation in the brain that identified either fibromyalgia or chronic back pain.

Other researchers have found changes in brain activity — where different areas “light up” on scans — that signal certain types of pain. Still others are using electrodes on the scalp to measure pain through brain waves.

Ultimately, NIH wants to uncover biological markers that explain why some people recover from acute pain while others develop hard-to-treat chronic pain.

“Your brain changes with pain,” Thomas explained. “A zero-to-10 scale or a happy-face scale doesn’t capture anywhere near the totality of the pain experience.”

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Attention Missouri Pain Patients

www.medium.com/@marycremer/attention-missouri-pain-patients-fc398bc34c8a

We are in need of YOUR personal story. Please email to…

mopainadv@gmail.com

What’s needed? We need to know what is happening in your pain control lives. These are some ideas.

• Are you still receiving pain meds?

• Have your pain meds been cut or threatened? If so, why?

• Has your original dr retired, quit prescribing, referred you to pain management or expressed concern or fear from government and/or employers?

• Did you sign a Pain contract?

• Are you periodically drug tested? Any problems with this?

• Has your insurance or pharmacy given you problems?

• Have you lost quality of your life?

• Have you contacted your elected officials?

• Do you have a loved one that also has problems with pain control?

• Have you had problems post surgery or injury?

• Have you been flagged as a dr shopper? Has this caused you problems?

• Has anyone you know taken their life, or have you thought about it? And why?

• Describe your pain and what pain control does for you?

• Include any additional information.

Please include your name, address and phone number.

If you want to remain anonymous, you may, just please provide what district in MO you reside (and the email should state that you want to remain anonymous). You can look up your district and state Representative and state Senator at the bottom of the page. Please try NOT to be anonymous, if possible. Elected officials need to understand we are REAL and problems are happening in MO.

Please share this with other people from Missouri because we want as many true stories to come in so that our elected officials hear our voices.

This is a pivotal time in this state and country. Currently, MO is the last state to not have a fully functioning PDMP (prescription drug monitoring program). But, it is being added to many counties. A flagging system is in place too. Also, elected officials are saying they are NOT hearing from us. So, they do not think the changes they are making are affecting us. So, now is your time to make a difference.

https://house.mo.gov/FrontPageMobile.aspx

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CVS Health and Aetna officially merged at the end of 2018.

https://www.businessinsider.com/cvs-health-reveals-plans-for-health-hub-stores-2019-1

The $70 billion merger combines a chain of nearly 10,000 pharmacies that also owns a drug benefits business with one of the biggest US health insurers. The result is an entirely new healthcare company that can wield a tremendous amount of power over how healthcare gets paid for and provided to patients.

In a presentation on Tuesday at the JPMorgan Healthcare Conference in San Francisco, CVS CEO Larry Merlo outlined for the first time how the combined company will provide healthcare differently. The main goals are: keeping patients healthier and out of the hospital, caring for patients at less-costly locations (such as CVS’s clinics instead of emergency rooms), and pioneering new methods of caring for devastating chronic diseases like cancer and heart failure.

Achieving those goals will help CVS boost its profits. Since it now owns is a health insurer, the company will spend less on medical care if it can keep customers healthier, or care for them at clinics instead of hospitals.

Read more of Business Insider’s coverage from the J.P. Morgan Healthcare Conference here

A big component of the strategy is providing more healthcare in CVS stores, both at the pharmacy counter and via the company’s MinuteClinics. To make space, CVS is removing some products from the front of the stores where it’s piloting the new approach.

“We can open a new front door to health that is both easier to use and less expensive, while at the same time, providing convenient access to high-quality health care,” Merlo said during the presentation.

The strategy also helps CVS find new use for the floor space in its 9,800 locations, as customers increasingly shop for everyday goods on Amazon. And providing more care in stores can help CVS counter forays by rivals like Amazon into healthcare. Amazon, for its part, acquired the pharmacy startup PillPack last year, marking its entry into the drug-delivery business.

To start, CVS is opening up its first “health hub” in a redesigned store in Houston in February. On Tuesday, the company revealed what that store will look like. You can see that there’s a lot more store space devoted to providing healthcare, including at the clinic and pharmacy.

The MinuteClinics in the pilot stores will offer more services, including disease screenings and blood draws. CVS already has about 1,100 MinuteClinics across its stores. They’re usually staffed by nurse practitioners or physicians’ assistants, and now provide basic checkups and care for minor illnesses and ailments.

The stores will also have a “care concierge,” who might help individuals understand how their health insurance works, or help them use health and wellness devices and technology.

CVS is also testing several other initiatives to improve how its customers get healthcare, using the resources of the combined company.

In one program, CVS pharmacists will call Aetna members who the company thinks could be at high risk of a negative health event, and counsel them on how to improve their health. A second outreach program will focus specifically on Aetna members with heart disease.

Another focuses on Aetna customers who’ve been in the hospital. To make sure they get the care they need after leaving the hospital and prevent them from having to go back, Aetna care managers will schedule followup visits for them at MinuteClinics, if they can’t get in to see their usual doctor.

At the MinuteClinic, healthcare providers can make sure the patients understand their disease and how to manage it. They’ll also check that patients have the right prescription drugs and know how to take them.

“Helping people on their path to better health has been a cornerstone of our purpose at CVS,” Merlo said. “As we zoom out and look at the broader health care market and the savings that can be achieved by more effectively managing chronic conditions, the opportunity here is massive”

If CVS uses the same format that they use for the Silver Scripts Part D prescription program… they will put financial incentives/disincentives on copays and deductibles to “encourage” pts to use only CVS’ array of care thru one of their programs.  I have seen statements from they  – in regards to the Aetna merger – that they would not “force” Aetna policy holders to use CVS services.

Will CVS’ Minute Clinics become the triage for Aetna policy holders before they will be “allowed” to go to a ER ?  There are numerous ways that CVS can put financial incentives/disincentives in place that will very persuasive to pts to go down that path… Hopefully, none of these pts will be more ill than they believe they are and there “condition” is much more severe and life threatening than the pt believed it to be and “waste” critical time getting treatment in a ER because they were trying to take the “less expensive route” ?

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Hy-Vee implements controlled substance prescription policy

https://www.drugstorenews.com/retail-news/hy-vee-implements-controlled-substance-prescription-policy/

In an effort to assist in combatting the national opioid epidemic, Hy-Vee has implemented a new controlled substance prescription policy.

As of Jan. 1, 2019, Hy-Vee pharmacies will no longer allow a subsequent fill of a Schedule II controlled substance, or a refill of a Schedule III or Scheduled IV controlled substance more than 72 hours early without authorization from the prescriber.

Hy-Vee pharmacies also no longer accept GoodRx coupons for controlled substance prescriptions.

“The opioid epidemic in the United States claims the lives of more than 100 people every day, and Hy-Vee is continually working to assist in the fight,” Kristin Williams, Hy-Vee senior vice president and chief health officer, said. “Implementing this 72-hour policy is one more step toward combatting the opioid epidemic in communities throughout the eight states we serve.”

Hy-Vee already offers naloxone without a prescription in all eight states where it operates pharmacies: Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska, South Dakota and Wisconsin.

Naloxone is available at Hy-Vee pharmacies in a nasal spray and injection forms (upon request), although, the nasal spray is the most commonly used form. The drug is stored behind the counter and cost varies, depending on the form and whether a customer goes through his or her insurance, or pays cash.

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OHIO RESIDENTS ONLY. PLEASE HELP!!!!

URGENT CALL TO ACTION:

Call the Ohio Board of Pharmacy
Ask them to Keep Kratom Legal

Dear Kratom Warriors:

We were notified earlier that the Ohio Board of Pharmacy will be voting tomorrow morning on whether or not to ban kratom, making it illegal in the state of Ohio.

We have a short window to make our final push.

Please take a minute and call the Ohio Board of Pharmacy and ask them to keep kratom legal and listen to the findings of scientists who have concluded kratom is safe to consume.

You can contact the Board of Pharmacy at (614) 466-4143 or email them at exec@pharmacy.ohio.gov.

PLEASE BE RESPECTFUL WHEN CALLING.

Make no mistake, what happens in Ohio will reverberate across the country.

Thank you for your support and willingness to help in the fight to protect kratom.

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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.

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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.

---

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/

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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!

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