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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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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FDA Restricting Opioids, Patients Lose – NIH Does Not Fund Pain Research – No Access to Nonopioid Treatment


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The War on Drugs Sold so Well That Persons With Pain

Often Cannot Get Pain Medication or Treatment

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Don’t read this. It will upset you.

The federal government has always been more interested in addicts than in persons who are disabled with intractable pain. Billions are spent to imprison addicts rather than pay for addiction programs which would be far less expensive.

Only 3% of medical schools have a course in pain management, Yale announced in 2008. According to the International Association for the Study of Pain, the IASP, education on pain is poor at either the preclinical or clinical levels and information is poorly integrated.” Fewer than 3% of recent graduates have had a few hours of training. This means that unless your doctor is among that small 3% that has recently graduated, they have had no training in pain control. None. And the FDA ignores the extensive training of pain specialists when approving limitations on new medications.

Worst of all, NIH spends 0.67% of its budget on pain research – less than 1% – though 10 to 20% of the population in the US suffers from chronic pain, an estimated 60 million Americans, and the conditions are more prevalent among the elderly. Addiction funding is the only reason neuroscientists in the early 1970’s were able to identify opioid receptors and then to clone them, which legitimized pain in cancer patients and led to use of opioids for cancer pain in the 1970’s and for noncancer pain in the 1990’s.

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Pain Epidemic:

Does Pain Management Have a Place in American Healthcare?

Today, there is too much reliance on opioids for pain because there is little or no NIH research on alternatives. Or maybe because your doctor does not know any other treatment than to prescribe an opioid. Or because Medicare will not pay for the amount of physical therapy you need. Opioids are overprescribed. This increases the risk of opioids being diverted and falling into the hands of addicts, leading to deaths and headlines that will no doubt limit your ability to be treated for pain. How many of you know Medicare has been limiting physical therapy for years? If you use all your treatment by mid February, they will not pay for more no matter how often you fracture your hip or herniate a disc. Is it right for them to pay for opioid pain medication and not physical therapy?

Just think of it. Before the early 1970’s, we had no pain societies, no hospices, no use of opioids for cancer patients (unless they happened to be hospitalized), no oral opioids, no oral morphine — why the very thought that oral morphine could work was argued against vehemently by the chief of the pain service at Memorial Sloan Kettering Cancer Center in NYC, in December 1975 at the first meeting of the IASP. The first meeting. 1975. Think of it. He argued that oral morphine would be metabolized so rapidly that it would pass out of the body and not be there to help.

William Lamers, Jr., MD

William M. Lamers, Jr., MD

In the early 1970’s if you had pain, you were not legitimate because we simply did not know there were such things as opioid receptors nor did we have oral opioid medication.

Now re-imagine that vehement argument in 1975 again, knowing that my dear friend William M. Lamers, Jr., MD, was the first in the world to use oral morphine when he founded home hospice in America 5 or 6 years before that date. He invited Dr. Cicely Saunders to California to teach her how to use oral morphine at her hospice, and following that, St. Christopher’s Hospice in London stopped using the ineffective Brompton’s Cocktail that caused so many side effects with so much less pain relief. Their research a few years later enabled Dr. Robert Twycross from St. Christopher’s Hospice to stride to the stage in 1975 at the IASP meeting, and report their work with oral morphine, to the applause of the Brits.

Let me be clear, I am gravely concerned that the use of opioids for nonmalignant pain will lead to a dire problem with opioid induced hyperalgesia in our large population of pain patients. If not hyperalgesia, the benefit of relief is undercut by the pain they create as shown by recent research on glia. Opioids create pain at the same time they relieve pain.

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We Are Not Getting Access to Effective Nonopioid Treatments

Worst of all, unless opioids are low cost, your insurance – PPO, Medicare, Medicaid – will not authorize several profoundly important nonopioid medications that help and/or relieve intractable disabling pain in many of my patients:

  • Namenda an NMDA antagonist that was shown in European research in 2001 to be effective for severe pain at a dose of 55 mg per day; in the US it is approved only for dementia at a dose of 20 mg per day. Insurance will not cover the dose needed; patients cannot afford it.
  • Compounded capsules and ointments may be the only thing that helps others, but are often not approved.
  • Naltrexone and other morphinans – see my post on naltrexone –  may relieve disabling pain, but compounded medications are often not approved
  • Medical marijuana research has been forbidden by the federal government despite active research and use of approved compounds in Canada and UK for severe intractable pain. Marijuana is in a class of chemicals called cannabinoids. Our brain makes cannabinoids and has receptors where they act. A synthetic cannabinoid  is FDA approved in the US for chemotherapy induced vomiting. The cost of one mg capsules is $400 for 20 – who can afford that?  In Canada, it is used for pain patients at bedtime to relieve severe pain that prevents sleep. Yet in California where inexpensive medical marijuana is legal, the Obama Department of Justice has continued the prosecution of Charles Lynch, a legitimate marijuana dispensary owner.  He was convicted on federal drug charges despite carefully following state and local law in setting up and running his business and being fully licensed by the state. He had the full support of the mayor and city council, yet he was sentenced to a year and a day in jail last week – the Obama DOJ pushed for a mandatory 5 years jail. Federal law prevented him from testimony in his own defense, presumably because federal law excludes states rights and the issue that marijuana sales may interfere with interstate commerce. For discussion of this and the bill introduced Thursday by Rep. Barney Frank, HR 2835, to legalize medical marijuana, see here. There was a time in the recent past when hospice doctors in the US made marijuana suppositories to relieve severe pain and nausea in dying cancer patients. In Mexico, marijuana is used in ointments by the elderly to relieve arthritis pain. 100 years ago, it was mentioned in some medical textbooks in America. And U.S. Rep. Mark Kirk calls for 25 years in prison for first time trafficking offense.
  • Marijuana: Effective for severe pain, safe, nontoxic, inexpensive and illegal.
  • The legal status of prescribing as well as the legal status of using marijuana is needlessly complicated. The Federal Government is clear… prescribing and use are both criminal offenses. Nothing is for certain except that the legal status is a mess.
  • Unrelieved suffering leads to an intensification of pain that may result in depression, withdrawal, irritability, anger and sometimes even hostility to caregivers.

NSAID –  nonsteroidal anti-inflammatory drug – use is discouraged in the elderly.  NSAIDs pose severe risk to the elderly and cannot be used in others due to heart disease, gastric intolerance, ulcers, GERD, anemia, bleeding, kidney disease, asthma, and those who are on various medications such as Plavix or Coumadin. Further, heavy NSAID use leads to higher dementia risk (see my post on this).

Some nonopioid alternatives cannot be used in those with liver or kidney conditions, men over 50 who still have a prostate, persons who wish to avoid suddenly becoming obese (Lyrica), those with allergies or intolerance to their side effects because the drug makes the fall backwards or suppresses their bone marrow.

Worse than those issues, we have only a few opioids which work on specific opioid receptors, some are more specific for neuropathic pain or for allodynia, yet since September 2008, the FDA has removed several of the older opioids from the shelf with no reason given to pharmacists or MD’s. I have spent hours calling pharmacies to see if they stock a medication I wrote for a patient hours before they left the office holding their specialized prescription. You know very well that if a patient called asking about opioids in stock they’d be looked upon as an addict, and many pharmacies will not stock opioids with the excuse they would be robbed. No matter you are in severe pain, you must wait 72 hours until they stock it. 

Even with insurance, your PPO will not authorize many if not most of the medications I prescribe and the cost of medication is surely the #1 reason.  That is true for opioids and nonopioid medication I use for pain control. Many are off label for pain, others are off label for anyone  who does not have cancer despite severe disabling pain, therefore not covered. If you are wealthy, you can purchase any medication prescribed.

Opioids are a distinct issue and outrageously expensive compared to the pennies cost of the raw drug. There is never a discussion of reducing costs of new drugs. Imagine $45 per unit, used 12 or 20 times per day in extreme, rare cases. Then imagine your PPO allowed prior authorization for 1 year, but then it was 6 months, then 2 months. What will happen next month? Hours and hours of non-reimbursed physician time is spent on these.  They could just save us all time if they published a list telling us what they will never ever ever reimburse no matter what. No wonder a radiologist or cardiologist or a doctor who does procedures makes millions every year. They don’t have to deal with the deafening “no.” The California law is never enforced that guarantees continuation of medication that is being used and that has been approved in the past for years. Requesting an independent appeal is a sham, the fox guarding the henhouse, paid by the same company that refused authorization.

The FDA has limited use of short acting fentanyl to cancer pain, thus PPO’s will often not authorize it without a cancer diagnosis.  News flash: there is no such thing as cancer pain. Patients without cancer have the same categories of pain that you do: involving abberent signals from nerve, viscera or other tissues. At the American Pain Society’s annual meeting in San Diego, May 2009, an FDA official admitted there were only 3 pain specialists on a panel of 11 MD’s that reviewed short acting fentanyl. It is likely the other 8 had no training in use of opioids.  Fewer than 3% of medical schools spend less than 30 hours over 4 years teaching pain management to medical students, and that is only in recent years, which means almost all physicians in practice today have had no training in use of opioids. Oncologists included. Do they think that pain specialists who have spent decades in the field have no understanding of opioids? If so, then why do they not limit all strong opioids to persons with cancer? or is this coming? Politicians do not like headlines about addicts who overdose themselves.

The special case of Subutex and Suboxone which is buprenorphine alone or with naloxone. Buprenorphine is an old drug, a long acting opioid that has unique effect at kappa opioid receptors and it is said it may help allodynia better than other opioids. PPO insurance will not authorize Subutex (buprenorphine) for my patients with pain, or if they do, they will authorize only one of the two, Subutex, but not the other, even though the one they will pay for causes intractable migraine but not the other. In Europe, both are approved for pain or for addiction, just like we use methadone here.  But our FDA has limited use to addicts, though it is an important opioid that we might use for pain. This means PPO insurance will not pay for it. This new formulation of Suboxone or Subutex in a sublingual tablet means it is very expensive, and I have patients in pain, weeping that they cannot afford it and must go back on their Oxycontin that works less well.

Unique issues for oral short acting fentanyl and Subutex or Suboxone: both will absorb directly in the mouth which is important for some persons with colitis, abdominal surgery, bariatric surgery, other conditions with poor GI absorption of tablets such as celiac disease, and those who are unable to use fentanyl patches due to skin allergies.

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Need for Balance between Risk of Substance Abuse

vs  Suffering and Disability Caused by Untreated Pain?

The FDA and Congress voice concern about addiction, but how much do they care about pain? Actions speak louder than words and the lack of NIH funding for pain research is shocking. Pain does not make newspaper headlines though pain is the #1 reason people seek medical help, more so as the population ages.

Here are more policy and headline issues that will make it harder for people with pain to get the care they need:

FDA, Pain Docs Look to Cut Abuse of Pain Killers“FDA said it was working on a plan to make it tougher for people to abuse certain prescription painkillers….” From the comments: “Regardless of great efforts to reverse this trend, physicians who legitimately prescribe opioids for pain may still feel ‘damned if they do and damned if they don’t.’ It seems as though we have simultaneously raised consciousness of the need for pain control and increased the risks to physicians of being part of the solution. If this dilemma is not resolved, advancing the cause of pain management as a fundamental human right may, in part, serve to polarize the medical community.”

F.D.A. to Place New Limits on Prescriptions of Narcotics “This is going to be a massive program,” according to Dr. John K. Jenkins, director of the F.D.A.’s new drug center.”  “…a law passed in 2007 gave the agency a new, intermediate weapon — Risk Evaluation and Mitigation Strategies. Known as REMS, these programs allow the agency to place strong restrictions on the distribution of certain drugs.”

Increased Scrutiny of Opioids Could Alter Prescribing Practice “If a formal risk reduction plan for opioid painkillers increases the regulatory burden on physicians, they may simply stop prescribing such drugs, to the detriment of patients in severe pain, the FDA was told Thursday.” Most physicians have no training in pain management, yet instead of requiring more education, regulation of doctors makes it harder to treat persons with legitimate pain and may have no effect on addicts and illegal diversion that they are really trying to regulate. Suggestions were made at a public hearing, quoted here:

  • If a REMS does end up imposing requirements on physicians, positive incentives should be put in place to fund and support training in pain management, such as waiving or reducing the fee clinicians now must pay to the DEA for the privilege of prescribing Schedule II drugs
  • But clinicians do not currently have the tools to enforce proper distribution and use of narcotics, and need more support and training, said Jennifer Bolen, founder of the Legal Side of Pain and the Pain Law Institute. “It’s dangerous and irresponsible to use physicians to teach the law,” Bolen said. She said state medical licensing boards, health insurance plans, and law enforcement officials must play a big role in enforcing the REMS.
  • But the FDA is not a criminal enforcement agency, said John Jenkins, M.D., director of the Office of New Drugs at the FDA.
  • One suggestion from a number of speakers is that the FDA require opioid manufacturers to put serial numbers or microchips in opioid tablets, linked to the prescription that released them to a patient. That way, if law enforcement officials seize pills, the prescriber and patient can be easily traced.
  • The FDA is already considering serial numbers on some classes of medication for a different reason — to confirm the integrity of the supply chain.
  • Other speakers suggested creating opioid medications that are “less abusable” such as crush-proof pills. However, formulations intended to thwart abuse have been tried before. That was the original intent behind Oxycontin, the brand of extended-release oxycodone that ended up widely abused.While it’s up to the FDA to decide what a REMS will look like, it’s the responsibility of drug companies to enforce the new regulations.
  • the two-day hearing was peppered with emotional testimonies from people whose family members overdosed on opioid drugs that they obtained illegally.
  • the FDA might convene an advisory committee before any REMS is finalized.

Addiction is a very important issue. Families are best in a position to see what is happening to members who have addiction problems, but addiction programs are poorly funded and many Americans are uninsured, especially the young who are most vulnerable to chemical dependency. Can families help someone who does not want to be helped?

I want to make it very clear that all of us, myself included, are responsible for reducing addiction, misuse of prescription drugs, and diversion in this country. Yes, that means anyone who gives someone else a pill from their prescribed medication, no matter how harmless it may seem. If that is a pain drug, your pain specialist can go to jail for 30 years even if he or she did not know about it. Never give one of your prescription pills to anyone else.

Designing high tech remedies to prevent opioid tablets from being injected or inhaled by addicts will increase the cost of your pain medication.  It is already difficult to afford without new technology, and why is it so expensive since many are now old drugs and the raw material costs pennies?

If we become disabled or develop chronic pain, there is often no money for the multidisciplinary approach to pain management that is essential for treatment: extreme limits on physical therapy, no cognitive behavioral therapy, no coverage at all for many medications that I prescribe. Some of my patients who are still working are afraid they will be laid off at work if they limp, are slow or show they have pain. This is not unlike my cancer patients who fear public knowledge they have cancer. But the rising insurance cost to their employer is Darwinian evolution at its cruelest, untouched by the human mind and heart. Free for the rich, for profiteering off the most vulnerable.

Cost of high tech pills to deter addicts. We thank the FDA for their guidance in requiring opioid manufacturers to make it more difficult for addicts to abuse these drugs, but does the cost of that new technology make these medications unaffordable for the average person, especially the disabled and elderly who may need them more than others. Is the FDA pulling older and more affordable opioids off the shelf because they do not have this new technology? Is the cost of medical care and denial of coverage being driven by the 5% of addicts in this country, by expensive prison empires to house them, by headlines and politicians?

Cost is the issue that limits care. When Medicare & PPO coverage is cut for all of us, will the cost of drugs be one of the major reasons? Answer: it already is.

Remember, the FDA does not have a majority of pain specialists on pain-related advisory committees, only 3 out of 11 MD’s sat on the FDA committee that limited use of short acting fentanyl medication for cancer pain. Opioids may be an essential option for some of my patients yet their PPO will not pay for it — it’s restricted to cancer patients. PPO’s will not pay for many nonopioids used for pain either.

Does the FDA think oncologists know more about treating pain than a pain specialist? The answer is definitely no! Oncologists do not, and some abuse their power to prevent pain relief. Research has shown severe untreated pain in 34% of cancer patients among oncology specialists in the Northeastern US, and likely far more in other areas. There are many untold stories about oncologists who do not treat pain or who use poor practice treating pain, even at major cancer centers. Pain is not their priority and most spend no time learning the needed expertise.

So no coverage for PT, for off label medication, for compounded medication, for opioids restricted to cancer pain, for expensive medication, and increasing regulation for older and more affordable opioids if they have not been pulled off the shelf by the FDA.

Cost cuts imposed major losses in pain management. PPO cuts were severe at least as far back as the mid 1980’s. In 1990, UCLA closed its Anesthesiology Interdisciplinary Pain Center, only 15 years after the first international pain society meeting. Laid off with two weeks notice was the President of the American Pain Society and distinguished researchers in the field. Soon after that, in the hallways of the annual pain society meeting, whispered rumors spread that almost all university centers had closed their interdisciplinary pain centers. Only a few remained, but there was silence on the subject from the platforms and leadership and media. UCLA paved over the only therapeutic swimming pool in the greater Los Angeles area in order to build yet another radiology center.

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The Era for Procedures

There has been a rapid increase in interventional procedures with almost all pain specialists shifting to high reimbursement and easily funded techniques, but where’s the science? Read the practice guidelines of the Academy of Neurology and American Pain Society on epidurals and nerve blocks. Where are the studies that show their benefit? Are they suitable as the best choice?

Pain management requires individualized care that involves analysis and specific treatment based upon many factors. Medicare and PPO’s will pay for procedures which are inversely proportional to the time needed for analysis. There is no single evidence based protocol that can be applied to every one such as there is for chest pain.

With so little research funding and so little training going into pain management,  politics may make the treatment of pain subject to more and more irrational or unaffordable choices.

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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.

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

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