ATIP Content

One Opioid Crisis or Many?

 

https://atipusa.org/mdocs-posts/analysis-of-us-opioid-mortality-and-er-visit-data-powerpoint-document/”One Opioid Crisis or Many?” by Richard “Red” Lawhern, Ph.D. was published this morning on the American Council for Science and Health’s Website. This article is extracted from a 2400 word manuscript now in review by our ATIP medical professional associates.  

The heart of the article reviews data extracted from the CDC’s Wonder database, the CDC’s Prescribing Data, the Agency for Healthcare Research Quality and the Organization for Economic Cooperation and Development for non-US data.  A very technical analysis of the data is found by reading a presentation of the data summary.

Based on the current media narrative, we expected to find a correlation between the overdose rates and opioid prescriptions if we analyze the data state-by-state.  Articles such as Vox’s recent article showing how Virginia’s approach has been successful lead you to believe that reducing opioid prescriptions and moving chronic pain patients into rehab is a simple solution to a very complex problem.  The reality couldn’t be further from the truth.  As Red points out in his article, there is absolutely no relationship between the amount of opioids prescribed in a given state and the number of overdoses.  

Opioid Deaths per Opioid Prescriptions
There were major variations but no trends in opioid OD death rates and opioid prescription rates from State to State in 2016

In fact, if we consider Emergency Room visits by state, the picture becomes even murkier:  as states DECREASE opioid prescriptions, emergency room visits INCREASE.

Opioid Prescriptions vs ER visits
         As opioid prescriptions fall, ER visits rise.

Finally, if we look at age variation, a different view of the opioid crisis unfolds.  Opioid deaths in 50-70 year olds have been falling slightly since 2005-2006.  Almost all of the increases in overdose deaths are within the 35 and younger age group.    This fact has not been studied in detail, but goes against the grain of forcing stable patients on opioids off their medication.  The vast majority of these patients are 50 and older, not in the under 35 age group.

Opioid Deaths by Age Group
Opioid deaths among those over the age of 50 have been stable or falling since 1999.

Jacob Sullum picked up Red’s article and published a summary in “Reason”:   http://reason.com/blog/2018/05/14/opioid-death-rates-are-not-correlated-with-prescription-rates

Efforts to reduce opioid-related deaths by restricting access to pain medication seem to be backfiring by driving people toward more dangerous drugs. Two analyses published today provide more reason to be skeptical of this approach, showing there is no clear relationship between pain pill prescriptions and drug poisoning.

The full analysis is available in our “Documents” section of the ATIP site:  https://atipusa.org/mdocs-posts/us-opioid-prescribing-vs-overdose-deaths-and-hospital-er-visits-implications-for-public-policy-pdf/

Updated Documents May 15:

US Opioid Prescribing vs. Overdose Deaths and Hospital ER Visits Implications for Public Policy (PDF)

Analysis of US Opioid Mortality and ER Visit Data (PDF)

Opioid Prescribing vs Mortality : Raw Data

ATIP WhitePaper: Principles for a Revised Opioid Prescription Guideline

A CDC Guideline for prescribing opioids to adults in chronic non-cancer pain was published in March 2016.  It has since become clear that this Guideline is generating horrendously negative outcomes for chronic pain patients and their doctors.  Many doctors are choosing to leave pain management rather than face possible prosecution by State authorities or the US Drug Enforcement Agency, for “over-prescription” of pain relieving opioids.  Tens (if not hundreds) of thousands of patients are being summarily discharged without referral and sometimes without management of opioid withdrawal. There are increasing reports of patient suicides.

Many medical professionals have published sharply critical reviews of the problems of the CDC Guideline.  Also of deep concern are proposed 2019 rule changes by the US Centers for Medicare and Medicaid, which make the Guideline a mandatory standard for insurance reimbursement and place sharp limits on the duration of opioid treatment for acute pain.

Many knowledgeable professionals and informed patients believe that the CDC Guidelines were deeply influenced by anti-opioid bias on the part of writers on the CDC Working Group which authored it. Even more damaging have been revelations that medical evidence assembled in support of the work was manipulated to discredit opioid reliability and to over-magnify opioid risks.  As one group of medical professionals aptly phrased the issues, the CDC Guidelines are “neat, plausible, and generally wrong.”  Inarguably, so also is most of the dominant public narrative on opioids and chronic pain. As phrased in a widely viewed TED Talk on U-Tube, “Everything You Think You Know About Addiction is Wrong.”

Read and download the rest of the White Paper.

References and Further Reading

Dowell D, Haegerich TM, Chou R., “CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016.” JAMA. 2016;65. doi:10.1001/ jama.2016.1464.
https://jamanetwork.com/journals/jama/fullarticle/2503508

Stefan J Kertesz and Adam J Gordon, “Strict limits on opiod prescribing risk the ‘inhumane treatment’ of pain patients.” Stat News, February 24, 2017 [see reader comments] https://www.statnews.com/2017/02/24/opioids-prescribing-limits-pain-patients/

Jacob Sullum, “America’s War on Pain Pills is Killing Addicts and Leaving Patients in Agony,” Reason Magazine, April 2018 edition.

Bob Tedeschi, “A ‘civil war’ over painkillers rips apart the medical community — and leaves patients in fearSTAT News, January 17, 2017.
https://www.statnews.com/2017/01/17/chronic-pain-management-opioids/

Geralyn Datz, “Chronic Pain – A Suicide Story”, National Pain Report, February 26, 2018, http://nationalpainreport.com/chronic-pain-a-suicide-story-8835614.html

Thomas Kline, MD, Ph.D. “Pain Related Suicides”, February 2018. Medium. https://medium.com/@ThomasKlineMD/suicides-associated-with-non-consented-opioid-pain-medication-reductions-356b4ef7e02a

Jeffrey A. Singer, MD. “Let’s Stop The Hysterical Rhetoric About the Opioid Crisis,” Cato Institute – Commentary, August 31, 2017,
https://www.cato.org/publications/commentary/lets-stop-hysterical-rhetoric-about-opioid-crisis

Carl L. Hart, Ph.D., “People Are Dying of Ignorance, Not Because of Opioids” Scientific American, November 1, 2017
https://www.scientificamerican.com/article/people-are-dying-because-of-ignorance-not-because-of-opioids/

US Health and Human Services Centers for Medicare and Medicaid, “Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter.”   https://www.regulations.gov/docket?D=CMS-2017-0163

Baraa O. Tayeb, Ana E. Barreiro, Ylsabyth S Bradshaw, Kenneth K H Chui, Daniel B Carr, “Durations of Opioid, Nonopioid Drug, and Behavioral Clinical Trials for Chronic Pain: Adequate or Inadequate?” Pain Medicine, Volume 17, Issue 11, 1 November 2016, Pages 2036–2046.
https://academic.oup.com/painmedicine/article/17/11/2036/2447887

Stephen A. Martin, MD, EdM;  Ruth A. Potee, MD, DABAM; and  Andrew Lazris, MD, “Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use”, Medium Corporation, September 7, 2016
https://medium.com/@stmartin/neat-plausible-and-generally-wrong-a-response-to-the-cdc-recommendations-for-chronic-opioid-use-5c9d9d319f71

Johann Hari, “Everything You Think You Know About Addiction is Wrong”, TED Talks, June 2015, https://www.ted.com/talks/johann_hari_everything_you_think_you_know_about_addiction_is_wrong

ATIP responds to the recent announcement from CDC representatives regarding overstating prescription opioid deaths

The Alliance for the Treatment of Intractable Pain (ATIP) releases the following response to the recent announcement by the CDC concerning their estimates of annual overdoses tied to prescribed opioids. The American Journal of Public Health published an article in the April 2018 issue which states that an error in an algorithm which the CDC used caused the number of deaths involving prescribed opioids to be “significantly inflated” going back as far as 2006.

To read the full article, please follow this link:  https://atipusa.org/?mdocs-file=2393

To read the article by the CDC, please follow this link:  https://ajph.aphapublications.org/doi/10.2105/AJPH.2017.304265

ATIP White Paper on Prescription Opioids and Chronic Pain

Richard “Red” Lawhern, Ph.D. has published  a major White Paper on prescription opioids and chronic pain, from the Alliance for the Treatment of Intractable Pain.  The paper is just under 5,000 words with 46 references from medical literature and online media. It has been reviewed by multiple medical professionals, healthcare writers, knowledgeable patients and caregivers.  It debunks much of the prevailing narrative on addiction which falsely attributes the causes of our public health problem to  medically managed prescription opioids and proposes to “fix” the epidemic by restricting availability of pain relievers and persecuting doctors who prescribe them.

Read the full White Paper here:

ATIP White Paper on Prescription Opioids and Chronic Pain (PDF)
ATIP White Paper on Prescription Opioids and Chronic Pain (DOCX)

Our central messages are these:

          The March 2016 “CDC Guidelines for Prescribing Opioids for Chronic Pain” for adult, non-cancer chronic pain must be withdrawn and rewritten to correct multiple biases, errors and omissions that are driving doctors out of pain management practice and needlessly destroying the lives of hundreds of thousands of people in pain.  

          CDC and all government agencies must recognize both the indispensable role that opioids play in pain management, and the central role of physicians in assessing and prescribing medications that patients need.

           Legislation must direct the CDC to accomplish a vital reconsideration and revision of a document that has already disabled thousands and killed hundreds of people by denying them effective treatment for pain.  Likewise needed is direction to the HHS Centers for Medicare and Medicaid, and the Department of Veterans Affairs to stand down from their draconian efforts to remove opioid analgesics from pain management practice. US State legislators and regulators must halt efforts to restrict medically managed opioid analgesics, pending republication of patient-centered CDC guidelines.  

The Alliance for Treatment of Intractable Pain

ATIP includes professionals who have written widely for publication concerning America’s so-called opioid crisis.  We hope to participate in legislative hearings or to submit point papers to your Senators or Representatives. The present war on drugs has turned into a war against pain patients.  It is time to reverse the tide of misinformation and seek balance in public policy between concerns for addiction and concerns for pain treatment.

ATIP Leader Featured in New York Times

Mark Zobrosky, ATIP Director of Operations, was interviewed by reporter Jan Hoffman for a major article in the New York Times.  Also mentioned and referenced was our associate, Stefan Kertesz, MD, who submitted a letter signed by 220 medical professionals, protesting the pending Medicare rule change that will deny effective pain therapy to millions of patients.

Read article by following the link below. 

Mark Zobrosky

Medicare is Cracking Down on Opioids.  Doctors Fear Pain Patients Will Suffer.

Officials are close to limiting doses of the painkillers, but doctors say doing so could put older patients into withdrawal or lead them to buy deadly street drugs.

Palliative Care Certification

ATIP Palliative Care Exemption – Working Description

Andrea Anderson, Executive Director ATIP
In the 2016 CDC Guidelines for the Treatment of Chronic Pain, the CDC included a specific exemption to arbitrary dose limits through a Palliative Care Exemption. Other exemptions included active and post-cancer care, end-of-life pain management, and hospice care.
However, the CDC did not provide an accurate or reliable definition of how “Palliative Care,” could function as an Exemption, and thus, it is undefined and unused. Practitioners do not have a clear definition under which to implement a legitimate Palliative Care Exemption for qualified patients, and thus it languishes, and neither providers nor pharmacists nor patients are receiving the protections it offers.  Palliative Care Exemption is a critical exemption, as it would give providers the ability to certify and treat patients with the individualized, specific authority their training and licensing grants, allowing them to properly treat and manage their patients with long-term, chronic, intractable pain syndromes. 
Since this very important exemption has not been implemented in any meaningful way, and is often blurred with hospice care, it has not provided the CDC’s intended benefit to patients or providers. ATIP has developed a working model of the Palliative Care Exemption to provide a legal and prudent way for providers to care for the over 5 million patients in the United States who suffer from over 200 illnesses or injuries that have incurable pain as a symptom. 
On the subject of Palliative Care, first it is important to define the terms and help us understand it.  There are many definitions of palliative care, several developed by different government agencies. Here are a few:

“Palliative care is a specialized medical care for people with serious illnesses. This type of care is focused on providing relief from the symptoms and stress of a serious illness or injury…the goal is to improve quality of life for both the patient and family. It is appropriate at any age and any stage, and can be provided along with curative therapies.”

https://getpalliativecare.org

“Since there are no time limits on when you can receive palliative care, it is able to fill the gap for patients who want and need comfort at any stage of their disease, whether terminal or chronic.” (Hospice versus palliative care, from Educational Broadcasting  Corporation/Public Affairs Television)
“Palliative care is defined in a manner consistent with that of the Institute of Medicine as care that provides relief from pain and other symptoms, supports quality-of-life, and is focused on patients with serious advanced illnesses (or injuries-added). Palliative care can begin early in the course of treatment for any serious illness that requires excellent management of pain or other distressing symptoms. This is separate from cancer patients and end-of-life care.” (CDC Guidelines for Prescribing Opioids for Chronic Pain, 2016.)
“Palliative Care is a free-standing method of patient care. Palliative care is an approach that improves the quality of life of patients due to the prevention and relief of suffering and treatment of pain or other problems, physical, psychosocial, and spiritual. These guidelines are not intended only for cancer patients or end of life patients. They are for all patients with serious chronic illness, especially where other therapies have failed.“ (World Health Organization.)
For the sake of the ATIP Palliative Care Exemption, intractable pain is considered an illness in and of itself.
“Intractable Pain has numerous, severe complications which shorten lifespan and incapacitate the patient unless bold measures are taken to control intractable pain. Some common causes of Intractable Pain are spine degeneration, neuropathies of any sort such as Reflex Sympathetic Dystrophy (RSD)or Complex Regional Pain Syndrome (CRPS), Fibromyalgia, Adhesions, Pelvic Neuropathies, Interstitial Cystitis, Chronic Migraine, joint degeneration in any joint, or Systemic Lupus Erythematosus…” (Forest Tennant, MD The Intractable Pain Patient’s Handbook for Survival
ATIP has developed a Palliative Care Exemption certificate. If adopted, either by state medical boards or state and federal legislation, this Palliative Care Exemption certificate would allow providers the discretion to treat patients requiring long-term pain management without arbitrary dosage limits or restrictions on medical or pharmaceutical therapies. Ideally, it would provide a framework for medical care that would grant protections for providers, pharmacists, and patients, and protect against unwarranted disciplinary actions by regulatory agencies.
ATIP’S intention is to thoroughly define the Palliative Care Exemption and oversee it’s adoption and use as the CDC intended. In addition, the ATIP Palliative Care Exemption does not disrupt any anti-addiction initiatives or policies.
Key Provisions:
1.  Much like a handicapped placard, the Palliative Care Exemption could either be a temporary or permanent designation, depending upon the patient’s diagnosis, and a treatment plan would be developed and documented. Recertification could occur every year, or at the provider’s discretion. 
2. A copy of the signed palliative Care Exemption certificate, along with the patient’s diagnosis, treatment plan, and schedule for recertification, would be be entered into the patient’s permanent EHR.
3. Another copy of the Palliative Care Exemption certificate would be given to the exclusive pharmacy as determined by the patient and Provider. This would ensure continuity of care between all members of the patient’s medical team and prevent disruptions in medication management.
4. The Palliative Care Exemption certification would allow pharmacists and dispensers to be aware of the patient’s legal exemption for treatment under the Palliative Care Exemption, and thus release them from any liability from dispensing medications in prescribed amounts that may supersede other existing guidelines.
5.  The Palliative Care Exemption could assign disciplinary action to pharmacists who arbitrarily refuse to fill a legitimate prescription if covered under this Palliative Care  exemption.
6. Ideally, a new ICD-10 code would be generated to compensate providers with a higher reimbursement than that of a standard office visit. Providers who prescribe opioids are often required to obtain additional CME‘s and are also tasked with a significant amount of administrative work.  As these additional requirements are quite  burdensome, additional reimbursement would provide an incentive to treat patients requiring long-term chronic pain treatment, and would more adequately reimburse providers who care for patients with intractable pain syndromes.
7. Palliative care would be recognized as distinct and separate from hospice care, and would not be subject to the rules of hospice treatment, such as imminent mortality or forsaking curative therapies. Patients treated under the Palliative Care Exemption would be treated on an outpatient basis, actively pursue curative therapies, and be supported in their goals to achieve the highest quality of life possible.
We hope to build alliances with all Palliative Care providers and associations, and draft legislation and policies to ensure adequate treatment of chronic, intractable pain.  Our hope is that patients, once certified as exempt by the Palliative Care Exemption, will avoid disruption or abandonment; protect providers, pharmacists, and insurers, and allow providers – whose training and discretion directs the prudent use of opioids, anti-seizure, anti-depressants, and other pain management medications to provide dignity and patient-oriented care without fear of reprisal. 
We welcome input to help craft the language of this exemption, and we welcome partnerships in implementing the CDC Palliative Care Exemption in a truly meaningful way.

Palliative Care Certificate – Word Format
Palliative Care Certificate – PDF Format

Opioids and Chronic Pain

There are over 100 million chronic pain patients in the US
(according to the US Institutes for Medicine).

Chronic pain is defined as lasting longer than 90 days or otherwise exceeding medically expected recovery times.   Once diagnosed, many chronic pain patients will have debilitating severe pain for the rest of their lives. For many, pain is resistant (refractory) to a wide range of therapies.

For millions of people, management of severe pain has in recent years included prescription opioid medications as a key element. Opioid medication frequently makes a life-or-death difference in quality of life. However at present these people are being made scapegoats for a perceived – and largely false — “epidemic” of opioid addiction and overdose deaths misattributed to prescription analgesics.  [i] [ii] [iii] [iv]

There are presently no reliable replacements for opioids.[v] Due to under-funding of research, there are no prospects for improvement in these conditions for years to come.

Richard “Red” Lawhern, Ph.D. covers this issue in great detail in his white paper “Prescription Opioids and Chronic Pain.”

Please visit Red’s Corner and download his latest publication along with prior publications covering this important topic.

 

References:

[i]   Mark Edmund Rose, “Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts”, Pain Medicine, December 17, 2017 https://doi.org/10.1093/pm/pnx048

[ii] Carl L. Hart, Ph.D., “People Are Dying of Ignorance, Not Because of Opioids” Scientific American, November 1, 2017
https://www.scientificamerican.com/article/people-are-dying-because-of-ignorance-not-because-of-opioids/

[iii]  Stefan J Kertesz and Adam J Gordon, “Strict limits on opiod prescribing risk the ‘inhumane treatment’ of pain patients.” Stat News, February 24, 2017 [see reader comments] https://www.statnews.com/2017/02/24/opioids-prescribing-limits-pain-patients/

[iv] Jacob Sullum, “Opioid Commission Mistakenly Blames Pain Treatment for Drug Deaths” Reason Magazinem November 2, 2017,

[v] Agency for Healthcare Research and Quality, “Noninvasive, Nonpharmacological Treatment for Chronic Pain: A Systematic Review”, Draft circulated December 2017, pp vii, 270

Comments on proposed opioid restrictions by CMS (impacting Medicare, Medicaid, and Insurance Policy)

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

After review and comments by medical professionals associated with ATIP, I have submitted the following commentary in the Federal Register Docket concerning Centers for Medicare and Medicaid efforts to impose hard limits on opioid prescribing. We urge all pain community members to submit their own stories and concerns by March 5th

https://www.regulations.gov/docket?D=CMS-2017-0163

My response to the CMS Opioid Policies:

I am a technically trained non-physician subject matter expert on public policy for treatment of chronic pain, backed by ~200 medical professionals, healthcare writers, knowledgeable patients and caregivers in the Alliance for the Treatment of Intractable Pain.

CMS proposes “all sponsors to implement hard formulary-level cumulative opioid safety edits at point-of-sale (POS) at the pharmacy (which can only be overridden by the sponsor) at 90 morphine milligram equivalent (MME), with a 7 days supply allowance.”

Under 42 US Code ~1395, US government agencies are legally restricted from controlling the practice of medicine. Proposed regulation changes are an attempt to subvert that law by injecting financially self-interested insurance companies into control of medical practice as proxies for direct government interference. CMS proposals mandate a dangerous, unfounded and medically unethical intrusion into medical practice by third parties operating without face to face knowledge of the patient. These draconian changes will damage and deny care to large numbers of the 1.6 million patients whom CMS estimates are presently treated with opioids above 90 morphine milligram equivalent dose per day.

It is widely known that CDC Guidelines on which these changes are based are factually in error and biased in their reading of evidence on risks of opioid analgesics. Very few pain patients ever display DSM-5 markers for opioid use disorder. Managed medical exposure to opioids contributes almost nothing to the widely hyped “opioid crisis”. Drug-related overdoses have risen steadily in the past ten years despite restriction of medical supply — a death toll entirely associated with nonprescription drugs.

Over-regulation of prescribing is already harming hundreds of thousands of stable patients coerced to reduce doses below therapeutic levels. Mandated VHA restrictions on opioid prescribing are directly responsible for hundreds of deaths among Veterans.

A major study in the January 2018 British Medical Journal illustrates the foolishness of the CMS proposal. Diagnoses of opioid abuse disorder were tracked for 565,000 opioid-naïve post-surgical patients followed an average of 2.6 years. Only 0.6% were later diagnosed with OAD. Less than 1% renewed prescriptions up to 13 weeks. OAD incidence was only weakly sensitive to dose level from <20 MME to >120 MME per day. OAD diagnoses were likely made by physicians with little expertise in chronic pain and without reference to formal criteria (DSM). A second large cohort study in JAMA Internal Medicine (Sep 2016) shows incidence of extended post-surgical opioid prescriptions at 0.135%.

CMS is trying to “solve” a non-problem by means guaranteed to create far worse problems.

CDC Guidelines ignore genetic polymorphism in the expression of liver enzymes governing opioid metabolism. Imposing hard limits on MMED in “safety” audits will cause therapy failure in hundreds of thousands of patients who can benefit from opioids, but only at significantly higher doses than entertained by CDC and this regulation change.

In January 30 public hearings before the FDA Opioid Policy Steering Committee, the American Academy of Pain Management recommended against hard limits on opioid analgesics. Other speakers advocated for leaving practice standards to medical professional associations which guide doctors in each specialty.

There is no one-size-fits-all patient or treatment plan.

Forcing pain patients to go through an “exceptions” process before extending prescriptions beyond 7 days is inappropriate and dangerous nonsense. Prevailing practice allows for prescription duration sufficient to treat anticipated pain levels. The alternative is to drown doctors in useless paperwork and to prompt patients to defer needed surgery because they fear being left without pain control.

Proposals for restricting co-prescription of so-called “potentiating” drugs like Benzodiazepines, Lyrica or Gabapentin are also problematic. Conclusions regarding adverse effects of combined opioid-benzodiazepine treatment derive entirely from poorly controlled, retrospective case-control studies. Prospective studies of the combination show trivial effects on arterial oxygen saturation. However, under-treatment of anxiety and depression in pain patients are major factors in overdose deaths. Lyrica and Gabapentin are also widely used in seizures, fibromyalgia and neuropathy – conditions which produce disabling pain and mortality risk. There are presently no published data to establish a single reliable threshold criterion for safe use of combinations of these medications. But denial of this option will disable many patients and kill some by iatrogenic suicide.

CMS should stand down from attempting to force restrictions on medical practice which have such predictable and horrid consequences.

Opioid Policy Steering Committee – make your voice be heard!

Richard Lawhern and others represented ATIP at a public hearing in Washington DC by the FDA’s Opioid Policy Steering Committee on January 30, 2018.  He was joined by Kristen Ogden, Fred Brown, Megan Wilson and Al Knowles.

Richard summarized the session:

“My presentation begins about 15 minutes into the first segment, following Amanda Proctor.  I ran over my allotted time but made my take away points.  Kristen Ogden’s session begins about 25 minutes into the segment.  Fred Brown speaks a bit later in the session.  The last presentation in Segment 4 is by Al Knowles’,  and I consider it the highlight of the day.  It was the only patient-centered presentation that FDA Commissioner Scott Gottlieb heard after joining the hearings in the late afternoon.  Al’s speech was impassioned, well-paced, authoritative and well organized. His theme was You were once our heroes… and you can be again.  He spoke to the fact that FDA has a Federal charter for establishing medical best practice standards, whereas the CDC, for the most part, does not.  He urged FDA to take back that role and to lobby for a rewrite of the CDC opioid prescription guidelines. “

Listen to the full session on the FDA’s website.

You can download Richard’s Presentation from our “Documents” page.

We need everyone to reach out to the FDA and leave comments.

AHRQ Labors Mightily to Produce a Mouse

Richard A. Lawhern, Ph.D.
December 4, 2017

Largely unknown to many Americans, many medical “best practices” are strongly influenced by the Agency for Healthcare Research and Quality (AHRQ), an organization of the US Government. AHRQ provides grants and monitors research intended to improve the safety and quality of US healthcare. Sometimes they make real contributions – and sometimes not so much.

Over a year ago, AHRQ issued a public call for comment on a series of questions intended as a basis for analyzing available medical evidence pertaining to “noninvasive, non-pharmacological treatment” of five types of pain in adults. I commented on this data call at length, pointing out a number of serious weaknesses in the logic and definitions proposed. On January 15, 2017, the Journal of Medicine of the US National College of Physicians published my comments under the title “The CDC’s Fictitious Opioid Epidemic, Part I” [see https://www.ncnp.org/journal-of-medicine/1929-doctors-fleeing-pain-management-dumping-patients.html]

It is now almost a year later, and AHRQ has circulated a for-comment draft of their systematic review report. I read this 300+ page monster and sighed. The following is an extract from comments I returned to AHRQ


 

As noted in the report abstract, the conditions studied and the key questions were as follows:

Scope and Key Questions

This comparative effectiveness review focused on noninvasive, nonpharmacological therapy, with a Key Question (KQ) for each of five common chronic pain conditions:

KQ 1: Chronic low back pain
KQ 2: Chronic neck pain
KQ 3: Osteoarthritis (knee, hip, hand)
KQ 4: Fibromyalgia
KQ 5: Chronic tension headache

For each condition, [AHRQ] addressed the following subquestions:

a. What are the benefits and harms of noninvasive nonpharmacological therapies compared with sham treatment, no treatment, waitlist, attention control, or usual care?

b. What are the benefits and harms of noninvasive nonpharmacological therapies compared with pharmacological therapy (e.g., opioids, NSAIDs, acetaminophen, antiseizure medications, antidepressants)?

c. What are the benefits and harms of noninvasive nonpharmacological therapies compared with exercise or (for a headache) biofeedback?


 

As noted in my comments to AHRQ, a key failing of their effort is that the published studies reviewed by their panels frequently lacked explanations for what “usual care” actually comprised of the alternatives studied.  From page 268-269 of the draft report, we learn:

“Some of the limitations described in the review process reflect limitations of the evidence base, including those related to heterogeneity within and across interventions and heterogeneity within a given condition. Details of concurrent interventions and components of usual care were generally not reported or poorly reported. Additionally, it is assumed that most patients with chronic pain likely continued medications and other therapies or practices during the trials. These factors likely resulted in the substantial mixing of effects, so that the effects of the intervention studied could not be separated out based on information presented in the trials. These factors possibly attenuated observed effects.”

My personal reading of the AHRQ draft report is less optimistic. The so-called “observed effects” of the therapies reviewed in this effort seem to me at best marginal in all of five of the classes of disorder studied.  Compounding weak evidence and protocols, the review encountered most of the problems which I pointed out before nearly a million dollars of taxpayer money was spent.

The following were “Key Messages” of the draft report:

 

  • A number of nonpharmacological interventions may improve function or pain outcomes 1 month to 1 year after the completion of therapy; evidence for some treatments and conditions is limited.
  • Exercise, acupuncture, multidisciplinary rehabilitation, mind-body and mindfulness practices and psychological therapies such as cognitive-behavioral therapy may improve function or pain outcomes for specific chronic pain conditions.
  • There was no evidence suggesting serious harms from any of the interventions studied, although data on harms were limited.
  • Additional comparative evidence with data on the sustainability of effects on function and pain outcomes is particularly needed for chronic tension headache, as well as for osteoarthritis, chronic neck pain, and fibromyalgia.

 

Unfortunately, however, I read the outcomes of this review quite differently than its authors seem to. The term “usual care” was particularly suspect. “Usual care was defined as care that might be provided or recommended by a primary care provider” [Draft Report, Page3]. However, many of the therapies that were studied would more often be employed by specialists than by primary care providers. Moreover, the term “Quality of Evidence – Low” appears over 100 times in the draft report.

In my view, the conclusions of the systematic review might read quite differently than they appear above. I paraphrase from my comments as submitted to AHRQ:

     “Database searches conducted for this comprehensive review identified 4,470 potentially relevant articles. After dual review of abstracts and titles, 1,091 articles were selected for full-text dual review and 205 publications (192 trials) met inclusion criteria. We included 65 trials (69 publication) on chronic low back pain, 23 trials on chronic neck pain, 51 trials (54 publications) on osteoarthritis, 44 trials (50 publications) on fibromyalgia, and 9 trials on chronic tension headache. One-fourth of the trials excluded at full text did not meet our criteria for follow-up duration (i.e., a minimum of 1 month of follow-up after termination of the intervention).

“After a detailed review of the 205 publications, AHRQ essentially found that the quality of documentation for therapy outcomes was severely compromised by investigators’ failure to identify, explain and assess the baseline effects of “usual care” therapies that were likely combined with the techniques studied.  It is plausible and within the range of uncertainty for outcomes that none of the trialed techniques actually generated a positive effect beyond placebo when added to “usual care.” 

“At the present state of medical knowledge, published research has failed to demonstrate a measurable and conclusive positive effect for non-invasive, non-pharmacological treatments for chronic or intractable pain.  To correct this deficiency, most of the research will need to be repeated with much more rigorous attention paid to fully documenting trials protocols and applying methods of factors analysis to assess relative contributions when multiple therapies are applied concurrently.”

 

I would add parenthetically, that I am not surprised by the outcomes reported in this systematic study.  In the 20 years I have supported chronic pain patients and families, I’ve talked with thousands of people about the outcomes of so-called “alternative” therapies.  While a few have reported improvements in their pain or the quality of their lives, the great majority have not. 

 

I also suggest that outcomes of this systematic review seem directly pertinent to best practices in chronic and intractable pain management — and are contradictory to conclusions drawn in the 2016 CDC opioid prescription guidelines.  This review runs seriously counter to the naïve trust placed by the CDC guideline writers in non-invasive, non-pharmacological therapies for severe chronic pain. The AHRQ review can reasonably be said to demonstrate that medical science now lacks any standard of care for chronic pain which reliably improves on the record of opioid analgesics — or which offers realistic hope of replacing opioid therapy in patients who experience severe chronic and intractable pain.