Is the Opioid Epidemic Leaving Chronic Pain Patients Out in the Cold?

WTTW of Chicago talks with chronic pain patients in the area that have had their pain medications cut due to regulatory and legal changes regarding opioids.

One of the patient’s story is heartbreaking:

But Urbanek says she feels hopeless and dreads seeing her doctor because she fears her opioids will be further reduced. “I tried everything before the opioids because I didn’t want to be on them,” she said. “There’s nowhere to go. There’s nothing to take.” Her fears, she says, have led her to a nonprofit called Final Exit Network, which supports the human right to die with dignity. “When the time comes, they’re going to help me take my life,” she said. “Without the opioids, my pain here isn’t going to be livable.”

Read the full article:  https://chicagotonight.wttw.com/2018/05/11/opioid-epidemic-leaving-chronic-pain-patients-out-cold

The real numbers behind Nevada’s opioid overdose deaths!

George Knapp continues his excellent television series in opposition to the 2016 CDC “guidelines”. Supported by Dan Laird, MD, and retired pharmacist Rick Martin, the program offers a devastating expose of misreporting by the CDC and local law enforcement authorities who engage in the hysterical hype that puffs up public perceptions of a crisis.

99.98% of opioid prescriptions do NOT result in overdose deaths. Of all deaths reported by the Las Vegas County Medical Examiner, only about one in 40 lists a single prescription opioid as a “cause”. The other 39 involve multiple illegal or legal opioids, alcohol, and unrelated medical disorders. But ALL are reported as “opioid deaths.”

See http://www.lasvegasnow.com/news/i-team-exclusive-the-real-numbers-behind-nevadas-opioid-deaths/1172341496

ATIP member Red Lawhern, PhD is supporting Mr Knapp, Dr Dan Laird, and Rick Martin, with behind-the-scenes data research and interpretation for this latest article.

Opioid deaths barely slowed by prescription monitoring, study suggests

Prescription Monitoring – the tool that will stop doctor shopping – has been hailed as a key tool in helping to slow down number of opioid deaths.  However, a new study shows that prescription monitoring is only “marginally effective.”

At ATIP we are already aware that doctor shopping was not the widespread problem politicians and the media claimed.  We have invested millions of dollars into monitoring programs that did not slow the number of overdose deaths from heroin and illicit fentanyl.  All of those funds could have been spent on research into better pain care.

https://www.cnn.com/2018/05/07/health/prescription-drug-monitoring-programs-opioid-study/index.html

Study: Despite decline in prescriptions, opioid deaths skyrocketing due to heroin and synthetic drugs

The Washington Post highlights a problem that ATIP has been talking about for some time:  as opioid prescriptions decline, deaths continue to rise.  The question arises, are we chasing the wrong problem?

https://www.washingtonpost.com/amphtml/news/post-nation/wp/2018/04/10/study-despite-decline-in-prescriptions-opioid-deaths-skyrocketing-due-to-heroin-and-synthetic-drugs/?noredirect=on&tid=ss_tw-amp&__twitter_impression=true

ATIP submits comments against the DEA’s request to set quotas for the opioid manufactures

I write as a non-physician subject matter expert on chronic pain and prescription opioid policy.  I co-lead the Alliance for the Treatment of Intractable Pain, an organization of over 250 medical professionals, healthcare writers, knowledgeable patients and caregivers, with an outreach in social media of about 80,000 daily.

Our unified message to DEA is “cease, halt and desist”.

The proposed DEA measures to restrict supplies of scheduled drugs based on “diversion” can aptly be compared to an effort to reduce America’s “obesity epidemic” by reducing food supplies.  This is simple foolishness on a grand scale.  Proposed DEA regulation changes have potential to further damage health and quality of life for millions of chronic pain patients who have already been harmed by biases, errors and omissions of the 2016 CDC opioid guidelines, mandated refusal of opioid therapy to millions of US Veterans, and imposition of arbitrary and scientifically unsupported restrictions on so-called “high dose” prescribing by HHS/CMS.

DEA has no reliable measures for diversion at the individual medical practice level, given a wide range of “normal” prescribing practices between individual doctors acting in good faith to serve different patient populations.  Prescribing levels as such are not a viable basis for restricting medical supply, absent a detailed knowledge of the patients and conditions serviced by the medical practice.  Likewise, restriction of medical opioid supply has already been tried and failed.  Prescriptions are now at a 10 year low, while overdose deaths continue to climb (see attachments).

By contrast,  DEA has clearly failed in its public duty of oversight on major corporate drug distribution companies, notably McKesson.  DEA representatives in effect refused to testify before the Senate Judiciary Committee when asked to explain how DEA missed the distribution of huge volumes of opioid medications into zip codes which lacked any credible medical markets for such distribution.  DEA investigators have publicly complained of refusals by DEA and DOJ prosecutors to take aggressive action against McKesson, with the clear implication that corporations bought the compliance of DEA officials with promises of later lucrative jobs on leaving government service. It would appear that DEA is unwilling to prosecute the knowing suppliers of major pill mills, but quite willing to harm millions of patients who have never abused a medication.

The urgency invested in the so-called “opioid crisis” has long been distorted by CDC false attribution of overdose-related  deaths to “prescription opioids” which were in fact caused by illegally manufactured fentanyl. CDC analysts have admitted publicly that CDC inflated prescription opioid deaths nearly 100% for years.  The dominant causes of the current opioid crisis are illegally manufactured Fentanyl and Heroin – with prescription opioids a distant fifth in overdose statistics.

DEA is straining at gnats and swallowing camels.

Diversion is an issue, but not in the context suggested by DEA.  According to the National Survey on Drug Use and Health, 75 percent of all opioid misuse starts with people using medication that wasn’t prescribed for them — obtained from a friend, family member or dealer. However, there are no data to support the idea that further restriction of supply will change this dynamic.  We are already seeing widespread reports of hospital shortages of analgesics needed in surgery.  The proposed DEA action will only exacerbate these shortages while doing nothing to moderate the real public health problems of addiction and overdose death.

It is known from NIDA reports that addiction among medically managed patients is rare.  Likewise, risk of opioid abuse or chronic opioid prescription is less than 0.6% among patients prescribed opioids after surgery. Fewer than 1% extend a prescription beyond 13 weeks.  Many extended prescriptions reflect emergence of chronic pain due to failed surgery.

We also challenge the often heard hype that so many prescriptions are written that every American adult could receive a bottle of pills.  Such statements are dangerously over-simplified anti-opioid propaganda.  When prescribing patterns are analyzed among millions of chronic and intractable pain patients, it is found that volumes are insufficient to adequately medicate people for whom no other therapies work. There is emerging evidence that refusal of pain management is driving patients into unsafe street markets.

Thus, our message to the DEA is to stand down.  You are chasing phantoms with supply restrictions which will harm millions of people while helping none.

Regards and well wishes,

Richard A. “Red” Lawhern, Ph.D.

Co-Founder and Corresponding Secretary, Alliance for the Treatment of Intractable Pain

“Has the opioid pendulum swung too far? Finding the balance between pain and addiction”

Red responds the article “Has the opioid pendulum swung too far? Finding the balance between pain and addiction” in the Morning Call:

You have offered a rare balance in our on-going public conversation concerning opioid medications, chronic pain, and the so-called “opioid crisis”.  Too often, US policy debates on drug abuse are dominated by hype and nonsense.  We seem to collectively suffer from a “drunk under the lamp post” syndrome, as government regulators look for cheap or easy solutions for the wrong “epidemic”, ignoring the magnitude and measures of the real ones.  They propose to “solve” the opioid crisis by denying medically managed pain relief to millions of people in agony — thereby creating a second hidden crisis in disability and death.

If I may, I would offer your reporting staff a recent “White Paper on Prescription Opioids and Chronic Pain“.  This paper isn’t small.  It’s heavily referenced to both medical and popular literature.  And it reveals what may be the first steps toward correcting the avalanche of hype and misinformation which substitutes for effective public policy on opioids and addiction. This paper received ~5,000 downloads in the first week of its availability.  It has been distributed to over 400 Senate and House staff whose jobs are concerned with healthcare policy.

I invite any of you to follow up by email and phone, to explore opportunities for further discussion of these issues in your round table discussions.  The Alliance which I co-lead includes multiple well-spoken medical professionals, informed patients and care-givers.  I have myself interviewed with award-winning journalist George Knapp on Coast to Coast AM radio concerning “The Other Side of Opioids”.  I also presented on January 30th in public hearings before the FDA Opioid Policy Steering Group.

ATIP’s Response to “Three things to understand about America’s opioid crisis”

Red’s response to Three things to understand about America’s opioid crisis and pain pill addiction

Dr Gupta states “A new study shows that over time, opioids don’t provide any more relief for people suffering from chronic pain than other pain relievers that don’t come with so much risk of addiction.”.  If he is referring to the work published by Dr Krebs and her colleagues in the Journal of the AMA, then he is seriously mistaken.  The “study” they performed was fundamentally flawed in multiple ways, invalidating the conclusion that Dr Gupta claims for it.

Likewise, Dr Gupta would do well to deep-dive the draft “Systematic Review” on non-opioid alternative therapies circulated in December 2017 by the Agency for Healthcare Research Quality.  AHRQ recovered ~4500 published trials of non-prescription, non-invasive therapies for five broad categories of chronic pain, and subjected them to a rigorous quality review.  A mere 205 survived the review, and in over a hundred of those, the Agency applied the term “medical evidence weak” to describe outcomes of the trial.  It is arguable that the quality of research on non-opioid therapies is so poor that we do not know with any confidence if they work any better than placebos.  They may help some people some of the time as supportive therapies administered with analgesic pain management.  But they are not a replacement for analgesics and anti-inflammatory medications.

Unmentioned in his article is the reality that many medical interventions in chronic pain are not only ineffective but frequently cause worse pain.  About half of all back surgeries fail.  Corticosteroid injections into the spine are also increasingly associated with development of adhesive arachnoiditis or complex regional pain syndrome.  Likewise, the reason why analgesics are the present standard of practice is precisely because we cannot yet identify the underlying medical causes of many forms of pain, and thus have no proven “cures”.

It is fair to suggest that many painful disorders are a consequence of unhealthy life styles.  American diets are too rich in fats and sugar, producing an “epidemic” of overweight.  We do not get enough exercise or enough sleep in our deeply over-stressed days.  Smoking is still a major cause of avoidable death in heart disease and lung cancer.  Alcoholism is wide spread and possibly getting worse for the same reasons that opioid overdose deaths are rising:  economic and social disintegration are causing people to become hopeless and vulnerable to distraction.  But to scapegoat people in pain for causing their own distress is simply unacceptable.  Dr Gupta is talking about cultural changes that take generations.  The pain is right now!

Variables that determine opioid efficacy

Studies of the type summarized here are frequently problematic. Academics pontificate about philosophy and the categorization of people, but it is not always clear that medicine in either its pharmaceutical or behavioral dimensions does some individuals much good.  We might go so far as to suggest that a powerful mythology is acting in both dimensions.  Let’s call it the mythology of generalizations.

In the current practice of both psychiatry and mainstream pharmaceutical therapy, the “holy grail” (the much sought-after “magic bullet”) is a therapy which reliably cures or improves function in large numbers of people affected by a discrete disease or disorder, while causing no fatal or disabling side effects.  At every step in this search for goodness, dragons await us with unsheathed claws.

As Norbert Wiener (the inventor of the engineering practice of modern operations research) informed us many decades ago, “All truly interesting human behaviors are over-determined.”  What he was telling us is that any defined human behavior can result from more than one cause or combination of causes.  This variability in cause and effect can make the first step in modern medical practice — diagnosis — very difficult.

It is generally recognized by scientists that the central basis of generalization is the ability to measure and replicate (repeat) previously claimed results.  Measurement is another of the dragons, particularly when we have only the patient’s reports to characterize outcomes, as is largely the present case with pain disorders. If clinicians ask overly simplistic questions, they get overly simplistic answers.  Clinicians often forget that patients are individuals — with all of the potential for misunderstanding such  forgetfulness entails.  Outcomes of the same procedural steps can vary between individuals, often for reasons we do not understand.  The numerical pain scale seems very attractive as a measure of outcomes.  But clinicians forget to ask an important question of their patients:  what is the natural variation in their pain levels from hour to hour or day to day? If we don’t ask about variability, then a 1-point-in-10 change in NPS outcomes can indeed be meaningless.

From the standpoint of modern business models, human variability is anathema because it creates expense and uncertainty.  And make no mistake:  medical insurance is a business.  Arguably, it is a business which has transformed much of medical training into a cookbook process.  If the patient has symptoms A, B, and C and lab tests X and Y are positive, then they “have” Disorder so-and-so, for which treatment options are thus-and-such.  And all of this is supposed to be confirmed in not more than 45 minutes of doctor time for extended appointments. Or in 10 minutes of face time in a typical appointment, during which data entry into an automated record system competes for the doctor’s attention.

Just as metrics are a problem for modern practice, so too is replication of results.  A bit over two years ago, a group of academics undertook studies to duplicate the outcomes of 100 important studies of long-accepted principles and outcomes in clinical and social psychology.  In over 60 of these replication experiments, the claimed outcome could not be duplicated.  In the remaining 40,  the magnitude or strength of outcomes was often significantly less than originally claimed.

As humorist Will Rogers told us 100 years ago, “It ain’t the things that a man don’t know that get him into trouble.  It’s the things he knows for certain that ain’t so.”  By this criterion, practically all of modern psychology and psychiatry is “in trouble. ”  Modern pharmacology is in the same kind of trouble, largely because of corporate meddling and cherry picking in trials outcomes.

If either of these “replication crises” is ever to be resolved, then it seems to me that we would all do well to respect a fundamental reality:  the human brain and physiology are the most complex biological machine that we know of.  We should not expect one-size-fits-all answers for serious medical problems, including the problems of acute or chronic pain.  What we should expect instead is a range of outcomes from any human experiment on treatment or cure.  We can assess the median outcomes, but we must also document the range of variability around that median, and shape medical practice to address the variations between individual patients.

ATIP Reply to “CMS tweaks opioid proposal after backlash” in The Hill

ATIP member Richard “Red” Lawhern posted the comment below to “The Hill.”

http://thehill.com/policy/healthcare/381493-cms-tweaks-opioid-proposal-after-sparking-backlash#.WsQgOGoSYFo.twitter

As one of the subject matter experts who signed Stefan Kertesz’ letter, I would add a couple of footnotes to an otherwise informative article.

(1) As written, the CMS rule change does change the wording of the rule to transform a “hard edit” at 90 MMED to a “safety review” to document the prescribing physician’s rationale for higher doses.

(2) However, the rule leaves in place an option for insurance companies to impose a hard edit *on their own authority* at 200 MMED. If implemented, the 200 MMED threshold will plunge hundreds of thousands of chronic pain patients into agony and disability.

(3) The new rules also impose a 7-day limit on initial prescriptions for acute pain — a duration known to be highly inadequate in some post-surgical situations, particularly hip or knee replacement and spinal fusion surgery. This rule may force patients who have limited mobility to return to a doctors’ office while they are STILL in pain, for renewal of prescriptions.

There is a central reality in all of the issues surrounding the CMS rule making process and the CDC guidelines around which they are built. CDC royally screwed up by proposing an arbitrary and scientifically unsupported threshold of opioid abuse risk at the dose level of 90 MMED. This is actually NOT a “high” dose and there is very little evidence that it actually represents anything real . Over 1.6 million medicare patients are presently treated at levels exceeding the threshold, and there is no evidence that any significant number of them are becoming addicts.

Due to variability of individual human metabolism, there is no one-size-fits-all maximum safe opioid analgesic dose. NONE. There are published case reports of patients maintained for years safely and without symptoms of opioid use disorder at dose levels exceeding 2000 MMED.

There is no medical, scientific, or ethical justification for coerced tapering of patients who are otherwise stable and whose quality of life has been supported by opioid pain relievers. Moreover, we now know beyond any reasonable possibility of contradiction that fewer than 0.7% of properly profiled surgical patients will later require ongoing opioid prescriptions or be diagnosed with opioid use disorder. And many of the diagnoses of OUD represent physician error, not a real risk of addiction.

CMS proposes to restrict pain relief to 99% of all patients who are managed on opioid analgesics above 200 MMED for severe pain — in order to “save” 1% from addiction? What is wrong with this picture? Just about everything!


Richard A. “Red” Lawhern, Ph.D.
Co-Founder and Corresponding Secretary,
Alliance for the Treatment of Intractable Pain