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


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Two Novel Opioids

Win Tepid Backing From FDA Panel

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

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

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

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

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

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

diagnosis or treatment provided by a qualified health care provider.

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

If you wish an appointment, please telephone my office.

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

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Pain is Worse Than Dying – Insurer Sues to Recover Payment for Opioids


 

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Pain Is Worse Than Dying

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Humana Is Obscene

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Humana Seeks

Repayment of Hundreds of Thousands of Dollars

 From Pharmacy

For Pain Medication of Years Ago.

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Reversal and Recovery

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In 2013, I was privileged to meet an angel, a wonderful soul, a 28 year old woman who was furious that she had permitted her doctor to replace a catheter in the vein (PICC line) that kept her alive for six years with feedings. She was frail, skeletal, vomiting frequently, starving, with no body fat, and had to carry a vomit bag because of involuntary vomiting day and night. She had a mitochondrial disorder that caused many abnormalities and many kinds of pain – acute pancreatitis, Guillain Barre-like nerve pain, hepatic pain, enlarged cervical and lumbar nerve roots, demyelinating polyneuropathy, ICU stays for episodic sepsis. Her stomach was elongated, reaching deep down into the lower abdomen and pelvis. She had extreme pain, was suicidal, deeply spiritual and would never take her own life, but she knew if the catheter had to be removed, she would never give permission for it to be replaced and she would soon die without fluids. 

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“I just want to die. I’m done trying to get well. I did that for 10 years”

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Her entire digestive system was not working.

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She had been hospitalized months at a time, at many hospitals in the country in search of a diagnosis that was finally made by the foremost specialist in mitochondrial disorders. She had been part of an NIH study in Texas for two years, was hospitalized for months at Mayo Clinic, at Columbia University, and wanted to be on hospice the year before she saw me.

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All night long, she would make the most beautiful hand crafted cards— pain and vomiting made it impossible to sleep. I prescribed Subsys, a rapid onset fentanyl to spray under tongue with onset in 10 minutes. The only opioid suited for her pain. She could not take medicine by mouth and had no body fat needed for pain patches.

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Subsys was never enough. She required IV opioids for intractable pain, soon transferred to hospice, refused replacement of the feeding IV PICC line and died surrounded by her loving family.

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Thank goodness mom is an RN, she was able to be at home all those years. Humana saved years of hospital care, saved for a few months with Subsys.

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Humana now wants to recover hundreds of thousands of dollars in payments to the pharmacy for medications for her and others.

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A few years before mom and patient met me, Humana cut her off from her pain meds – cold turkey, forcing mom to take her to the ER. She ended up in the acute care hospital for 6 MONTHS while mom fought with Humana.

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Each time she got turned down, mom appealed.  The case made its way to the Department of Health and Human Services, Office of Medicare Hearings and Appeals after three levels of appeals and a hearing before the Administrative Law Judge. 

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[The case did not reach the Supreme Court as I originally posted – see corrections below photo.]

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Mom won – by herself – no attorney – just organized with good documentation. Mom did have the director of pain management pharmacy from a local hospital on her side as a witness, though. Mom is an RN “Erin Brockovich” and will do whatever she can to fight this egregious action by Humana, the suicidal curse of pain, and all the patients who legitimately suffer with pain.

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Subsys is unique. There is no comparison. Among all the rapid onset fentanyl pain relievers, it is the fastest, with good levels in 10 minutes. When pain spikes rapidly, from low to severe in minutes, it is ideal to use a rapid onset opioid that may begin in 10 minutes rather than a pill that takes 1 or 2 hours to peak effect. Like many rapid onset fentanyl products, Subsys costs perhaps $100 each depending on dosage or $3,000 for 30. If you need 6 per day, that may be $18,000 per month. The raw powder costs pennies. The delivery device is a small spray of 0.1 mL (2 tiny drops) in a fine mist.

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Not all patients are able to use all forms of opioids for pain, yet the FDA approval for rapid onset fentanyl that excluded her. It is approved only for cancer pain – now CDC wishes to allow rapid fentanyl only for actively treated cancer. Your pain does not matter.

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There is no such thing as cancer pain.

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All people including cancer patients may have pain of nerves (neuropathic), organs (visceral) or other tissues (nociceptive). There is no such thing as cancer pain.

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The agony a physician feels when faced with a patient who is suicidal from severe pain and insurers that refuse to pay for needed medication is beyond words. Refusals like this have been happening for years, now far more often with egregious denials and futile “prior authorizations” – just yesterday refusing 20 mg morphine in a patient with many forms of severe pain. Medical ethics is not a business model. Insurers answer to stock holders, not those who buy their policy.

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Americans do not view pain as worthy of attention. Billions of dollars more for cancer. Almost nothing for pain research.

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Unlike most pain specialists, I have spent the last 15 years on alternatives for severe intractable pain, better than opioids, documented on these pages. I am the least opioid apologist, but I do prescribe opioids and taught cancer pain at one of the finest cancer hospitals in the world making me more “fluent” with opioids than most anesthesiologists who, after all, do mostly procedures. I could study for a year or two to take a special test, to be “certified” as a pain specialist – studying things I will never use in my practice, instead I refer to proceduralists when indicated.

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Oral analgesics are more cost effective and usually better than short lasting expensive procedures for chronic pain. Don’t get me started on the lack of research for spinal cord stimulators – use the tiny search box top left above my photo. Their $100,000 cost was effectively lobbied to insurers. Is it effective for more than two years? And the harms?

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Most people with chronic pain have no access to anything as effective as opioid medication. Well, that will be gone soon. You too will someday need help.

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Today FDA announces a sweeping review of agency opioid policy

to CUT access.

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Prepare for an avalanche of denials for your pain medicine. There’s been a storm of denials for years, denials for nonopioid treatment of pain, even more denials in the last few weeks since CDC’s offensive experiment I posted 11 times since late October. The avalanche is coming to bury us.

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It’s really a thankless job treating pain. Pain is devalued by Americans. Patients seem to accuse me of not doing my job when their medication is denied. They are treated like addicts. Doctors, families and pharmacists are suspicious of patients and of us.

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But this is happening for all medications, not just for pain, even generic asthma medicine, low dose estrogen that costs $12. Insurers know congress doesn’t care. Pharma knows congress doesn’t care. It’s a war on patients who are caught in the middle.

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CDC and FDA now want to take opioids away,

before we have an effective alternative.

Anti-opioidists have no science to back their stand.

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There is absolutely no reason any analgesic

should be limited to people with “actively treated” cancer –

CDC only allowed for that one partial change among a long list of changes sought by the American Pain Society.

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Politics has no place in the treatment of pain.

Pain policy in this country is sickening those with chronic pain.

Catering to the deaths of addicts –

politically expedient to deny you pain relief.

Treatment of pain doesn’t fit the American paradigm –  too weak.

War on drugs and addiction is more macho.

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Give us a better alternative.

Better for pain relief.

Better for addiction treatment.

For Pete’s sake look at addiction treatment

in countries who proved prohibition fails to work.

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Better treatment for addiction is not cured by denying pain relief to

116 million Americans with severe chronic pain.

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Or else start studying suicide in pain patients, not addicts.

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War on drugs is war on people with pain.

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My dearest friend who started home hospice in America

changed federal policy and the paradigm to treat cancer pain.

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Doctors threw food at him when he

spoke about treating pain in dying people.

Senior professors, the experts, rushed onstage, frantically

waving their arms in front of him saying:

“Don’t listen to this man, he’s crazy.”

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How much has changed?

Do the ghouls take your medication away?

Do insurance profits own government policy?

Do they destroy neighborhood pharmacies by

retracting hundreds of thousands of dollars years later?

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Bill

William M. Lamers, Jr., MD

December 24, 1931 – February 2, 2012

They are still inadequately treating cancer pain.

We miss you Bill

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Correction February 5, 2016:

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Mom writes to advise the case did not reach the Supreme Court. It went all the way up to the Department of Health and Human Services, Office of Medicare Hearings and Appeals after three levels of appeals and a hearing before the Administrative Law Judge. After 9 months of this process, the judge ruled in favor of having Humana cover Fentora buccal tablets for M – even though she didn’t have cancer. Fentora is another rapid acting fentanyl but not as fast as Subsys that was not yet on market in 2011. Humana APPROVED Fentora on 1/6/11 and then Humana DENIED it on 8/24/11, causing the patient to be hospitalized for several months.

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Hospitalized for months vs use of fentanyl at home for years.

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She had a very rare disease. These are the numbers from 2012.  They may be higher by now (or lower with deaths): It is estimated that 2,500 people throughout the world have Mito.  MNGIE is a rare form of Mito. There are only 70 people in the world known to be diagnosed with it. Twelve of them are in the U.S.  She was one of them.

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The material on this site is for informational purposes only.

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

provided by a qualified health care provider.

Relevant comments are welcome.

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

This site is not for email.

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

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Please be aware any advertising on this free educational website is

NOT advocated by me and NOT approved by me.

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Insurers Refusing to Cover Pain Medication – Morphine 100 mg per Day Maximum – Opioid Wake up Call – New Nationwide Standard? DEA Mandate


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The FDA mandated 22 manufacturers of long acting opioids

to fund a program on opioid prescribing.

FDA dictated the content.

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I attended the SCOPE of PAIN program Friday November 6, from 8 to 12:30, taught by an Addictionologist from Portland with our local Southern California DEA. Continuing education credit was given by Boston University. The first grant recipient was in 2012.  

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My take:

I think we will rapidly see a 100 mg per day

maximum morphine equivalent allowed

Could I be interpreting this wrong?

Insurers simply deny paying for high doses. They have begun already.

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I am exhausted from ICD10 diagnosis coding – complex patients !!! – that has taken away any possibility I could leave my desk until 4 AM for the last four weeks, in midst of moving office to much better place, and midst the only two computer crashes I have ever had in my pursuit of efficient tech, plus dental fracture, so much more….perfect storm. The paragraphs could be edited and rearranged, so they would be in sequence but they’re not.

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I hope others will give me their take on this. It has been getting worse since almost all university interdisciplinary pain clinics were closed in 1991. Insurers, i.e. managed care clerks, are practicing medicine mandates set forth by anonymous committees looking at spreadsheets not at our complex care. Insurers could save many billions if they invested a few billions in education. Insurers wrote Obamacare. They could write it better. Congress wants all of us to do our part. Surely business too?

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Based on this series of opioid conferences, my guess is their first step is to chop opioid prescribing down to 100 mg morphine equivalents. But what about untreated pain at the heart of the epidemic of suicide? I see it among all classes of people, because we’ve focused on opioids too long to the exclusion of research and exclusion of a whole world of medications now generic, no longer on patent therefore inexpensive, FDA approved medications. The biggest shock: Valuable compounded medications are no longer on formularies of insurers! Our most affordable FDA approved medicines are no longer covered by insurance.

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Where is the data that we must limit the dose to 100 mg per day morphine equivalent?

Is it too much pain medicine or is it untreated pain?

Is it lack of medical care?

or is it lack of affordable medical care?

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My comments arise from grave concern the Insurers and FDA are overlooking the needs of my pain patients. I must speak up now despite need to recover in the next few days.

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Where is the concern for the pain patient

in this multimillion dollar pharmaceutical-company-funded opioid conference?

FDA mandated that manufacturers of extended release opioids fund the conferences.

Where are the millions that need to be spent on

rational interdisciplinary pain management,

rather than just opioid management?

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We need more than just studies of suicides and opioid changes.

We need hospitals and insurance systems

to recognize legitimate therapies that work for real people.

Would the epidemic of addiction

go down if people could get treatment for their pain?

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I posted this week on a new study, an epidemic of suicide in Caucasian middle aged Americans. The results were a shock to Case and Deacon, the Princeton Economists who did the research that merited two articles in the New York Times.

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Epidemic of suicide

deaths as high as in the AIDS epidemic,

driven by pain, disability, loss of job, drug abuse, other.

By too many opioids or by untreated pain?

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That is why, a few days ago I posted on that epic study by Princeton economists: the suicides in middle aged Caucasians now comparable to deaths during the AIDS epidemic. I posted how that can change. In that article and for years with this blog, I post about medications that work more effectively than opioids, i.e. glial modulators, and the need for compounded and herbal medications from approved highly reputable small local pharmacies need to be covered by insurers and allowed on hospital formularies.

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Epidemic of suicide – could it be due to lack of pain treatment

not due to an epidemic of opioids?

Is it too much pain medicine or is it untreated pain?

Is it lack of medical care?

Or is it lack of affordable medical care?

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The key figure from the Case-Deaton study on epidemic of suicides in white middle-aged Americans –  bigger than deaths at the height of the AIDS epidemic. The question is why?

Andrew Gelman, statistician at Columbia University and writer for the Washington Post, argues in his blog against the rate being higher at all. His conclusion: “…death rates among middle-aged non-Hispanic whites in the U.S. slightly increased, even while corresponding death rates in other countries declined by about 30%.”

Screen Shot 2015-11-05 at 7.53.11 PM

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Regardless of the argument, untreated pain is a big problem. It causes suffering and joblessness, and can lead to addiction and suicide.

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Does it matter which side of the argument is right?

Pain management is being taught in only 3% of American medical schools.

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births.

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Where is the data that we must limit the dose to 100 mg per day morphine equivalent?

Is it too much pain medicine or is it untreated pain?

Is it lack of medical care?

Or is it lack of affordable medical care?

Insurers are not willing to pay for larger doses of opioids

and deny prior authorization.

Does this lead to suicide?

Money is the root of some of this.

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The cure for suicide is not just to take a sword and slice off the top doses of morphine, and treat everyone with the same low doses, whether you have herniated discs or sprained ankle or RSD.  Sprained ankles may be already getting too much.

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Why blame it all on over-prescribing? How about suicide due to under-prescribing, or suicide from not treating pain at all because healthcare insurance and unemployment don’t mix?   

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Are they blaming high doses as cause of suicide? How about when high dose opioids fail, when all drugs fail, we see no new drugs on the horizon for pain control. That does not fill those patients with hope.

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Of course it is important to acknowledge, as the New York Time health section has followed that epidemic research with How Doctors Helped Drive the Addiction Crisis.

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Where is the data that we must limit the dose to 100 mg per day morphine equivalent?

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Someone must advocate for change. It’s not just pills, it’s not just opioids.

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We are all at risk from disabling pain, loss of jobs and suicide

—yes, doctors too become disabled—

because of substandard education in pain management in this country

focused almost universally

on opioid treatment of pain.

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Lack of funding killed the university interdisciplinary pain management centers in 1991

 

AND we need access to compounded drugs, herbs & supplements in our hospitals.

If Memorial Sloan Kettering Cancer Center can do it, why can’t my hospital?  

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Expect 100 mg oral morphine or equivalent maximum dose per day to rapidly become the standard nationwide. Insurers are refusing to cover the cost of higher doses. Even if you can afford $17,000 out of pocket each month for pain relief, your doctor will be shouldering liability if outside these rapidly evolving guidelines. Insurers rule – and they deny coverage of inexpensive compounded drugs that work better than opioids for my patients who have failed all known treatment. That’s why we need better education and more clinically focused research.

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Those who blame Obamacare for high insurance costs and business-wide practices need look no further than the price of medications, especially opioids.

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It seems everyone breezes over where Washington State came up with a maximum of 100 mg morphine (or equivalent) as a maximum daily dose of opioid. 

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This 100 mg maximum daily morphine dose became law in Washington State many years ago, initially for Workers Compensation, and will soon be adopted by Oregon.

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Of course we are all concerned about the shocking rise in deaths from prescription opioids that are occurring since opioids began to be used after Russell Portnoy published its use for chronic pain in 1991. We just didn’t know that they work for cancer pain that is usually acute pain, not for what is now tens of millions with chronic pain who are on opioids

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But opioids are still necessary for some. Those of my patients who take opioids will have a very hard time with the 100 mg morphine (or equivalent) maximum daily guideline. Informed consent is out the window. We all recognize the practice of medicine has been done by insurance companies since the late 1980’s when managed care took over. This will not change. Now insurers require the ICD10 diagnosis code before they will allow the pharmacist to refill an antidepressant that the patient has been taking for one year with much needed relief. This will give them more tools to deny paying.

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It would appear that those who govern our medication use (insurers and DEA) — and who deny coverage of even more useful, inexpensive medication –  feel that 100 mg morphine equivalent is the maximum dose that should be prescribed.   

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100 mg oral morphine is equivalent to:

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66 mg Oxycodone

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25 mg/hr Fentanyl Patch

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25 mg hydromophone (Dilaudid)

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120 mg hydrocodone (12 of the Vicodin, Norco, Lorcet 10 mg tablets)

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30 mg Oxymorphone (Opana) use not recommended

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Morphine               to                Methadone      

30-90 mg                                   One fourth the morphine dose

90-300 mg                                 One eighth (200 mg/day morphine = 25 mg methadone)

300-500 mg                               One twelfth the morphine dose

>500 mg                                    One twentieth the morphine dose

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Methadone conversion is far more complex than this guideline from University of Michigan

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Only 3% of medical schools teach pain management. That ignorance is costing us trillions in insurance and pharmaceutical fees, and right now the latter two are making war on each other by taking it out on you, the patient who is getting substandard care. They’re taking care of their financial needs that show us the symptoms of disease, pain, suffering, disability, loss of job, and the just published this week, the epidemic of suicide. We need to treat the cause, not just the symptoms. Medical education, injury prevention and treatment needs to be taught starting K-12. The cost would pay for itself but the Insurance Industry needs to pay for it there and in University Medical Schools because Congress will not pay for it. It would be a cost saving investment that would pay itself off in care for seniors when grandchildren have to spot mom and dad in the 24 hour, extended family care that strains budgets. We cannot afford not to teach trigger point basics to each kid and each physical therapist and MD. That alone could save tons of opioids and monthly visits for what never works for muscle strain that no one has found.

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I’m tired of seeing how degraded it has become. To fail to treat the cause of disability and suffering is far more in our hands now, it could happen if people were taught basics instead of opioids, K through medical school. Are we teaching only opioids? yes, it seems so. I am advocating for everything I have written about in this blog since 2009. Glial modulators, mechanical approaches, but compounded medications, in particular, are sadly becoming unaffordable because insurers have stopped coverage for them. Then we all lose one of the most important tools, the only tool, that my patients and millions of others have in treating intractable pain or treatment resistant Major Depressive Disorder, Bipolar Depression. Compounded medications often work after everything else has failed. The lives of my patients have usually either returned back to normal or  improved in ability to function. That has never been shown with opioids for chronic pain.

 

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I’m too exhausted to be in a position to edit what I’ve written just now, or write adequately. I am just furious at the direction our country for decades has pushed into opioid treatment rather than pain management. This has reached peak brewing since the DEA conference yesterday, dictated by the FDA funded by opioid manufacturers.

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It is a hope that Insurers could fund an analysis of the billions that could be saved and suicides prevented if they funded pain management. What is there to live for than a life free of pain and disability?

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The analysis could show how much is saved when training begins with the young, how to prevent and treat injury. How helpful a child can be to aging grandparents or parents when illness strikes the family. We always turn to family first, as we should. Why is something of the field of pain management not taught in K-12?

 

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The FDA just authorized two opioids for children this last week. I have a vague memory one was oxycontin in children. I do not argue against opioids, I have given opioids to tiny children when I worked in hospice. Children have crippling arthritis too and other medical needs for opioids.

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I am not arguing against opioids. I am saying that what is taught is zero pain management. The focus on drugs is completely unbalanced.

 

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If Sloan Kettering can teach herbal and supplementary medicine to cancer patients, why not begin the study of herbal medicine at K-12 since a lot of parents are taking it instead of using common sense such as exercise, weight loss, family time, relaxation. And herbal and supplementary medicine is what these young ones will teach their children when they grow up. Hopefully prevent some of the toxicity from swallowing all sorts of useless and dangerous things on the shelves.

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Rational health care must begin young in the schools. .

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