Long List of Flaws with CDC Guidelines

National Pain Strategy 0; Drug Wars 1 | Terri A. Lewis, Assistant Professor, Rehabilitation Counseling & Intern’l Prgms Cnsltnt at National Changhua University of Education | Mar 20, 2016

Ms. Lewis has organized the salient points of the current denigration (assault) of pain patients. Her bullet points help my frazzled mind understand what has happened between the National Pain Strategy and the awful CDC guidelines.

“People with disabilities have unique insights about their disability and situation but have been excluded from the decision making process about issues that directly affect their lives.

Persons with disabilities through their representative organizations should be fully consulted and actively involved in all stages of formulating and implementing policies, laws, and services that relate to them Article 4 Convention of the Rights of Persons with Disabilities.”

Findings and recommendations from the IOM report (Institute of Medicine, 2011| Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research) guided the development of the National Pain Strategy (NPS) released to the public March 18, 2016. These included:

• The public at large and people with pain would benefit from a better understanding of pain and its treatment in order to encourage timely care, improve medical management, and combat stigmatization.
• Increased scientific knowledge regarding the pathophysiology of pain has led to the conclusion that chronic pain can be a disease in itself that requires adequate treatment and a research commitment.
• Chronic pain is a pathology that arises from more that 200 known causes, which requires evidence based, integrated, multimodal, and interdisciplinary treatment to address it in all of its expressed forms.
• Data are lacking on the prevalence, onset, course, impact, and outcomes of most common chronic pain conditions. The greatest individual and societal benefit would accrue from a focus on chronic pain.
• Every effort should be made to prevent illnesses and injuries that lead to pain, the progression of acute pain to a chronic condition, and the development of high-impact chronic pain.
• Significant improvements are needed to ensure that pain assessment techniques and practices are high-quality and comprehensive.

To summarize, chronic pain is theorized to be a disease in and of itself that requires preventive and adequate treatment derived from evidence based approaches, with a focus on individual and social benefit.

The long awaited and recently released National Pain Strategy, without a Congressionally allocated budget line, long on rhetoric and badly in need of actionable implementations, calls for:

• Developing methods and metrics to monitor and improve the prevention and management of pain.
• Supporting the development of a system of patient-centered integrated pain management practices based on a biopsychosocial model of care that enables providers and patients to access the full spectrum of pain treatment options.
• Taking steps to reduce barriers to pain care and improve the quality of pain care for vulnerable, stigmatized and underserved populations.
• Increasing public awareness of pain, increasing patient knowledge of treatment options and risks, and helping to develop a better-informed health care workforce with regard to pain management.

The NPS emphasizes an evidence-based practice approach focused on public health.

The hallmark of evidence-based practice of medicine is built on three pillars:

• Valid science and testable theory
• Reliable clinical judgment with reproducible results
• Patient values and data supported by the user experience

The recently published opioid prescribing guidelines (CDC, March 16, 2016) offers guidance to primary care physicians who are gatekeepers for persons with acute and chronic pain needs.

Among the criticisms of this body of work are those associated with ignoring the very tenets of evidence-based practice [as listed above].experience.

Initiated under less than transparent circumstances, the issued opioid prescribing guidelines rely on

• The utilization of a definition for chronic pain that values and weights chronic pain differently than pain associated with cancer even though most research indicates there is no objective evidence for us to make such a distinction or to operate from such a position;
• GRADE analytics imposed on limited scientific studies and admittedly low-quality research;
• Biases that result from the reflected personal beliefs of a work group oriented toward addiction theory rather than incorporating the experience of experts who treat the disease of chronic pain and its more than 200 comorbidities, or persons who consume services associated with treatment of conditions associated with chronic pain;
• Recommendations that are practitioner-centered rather than patient centered;
• The absence of valid, accessible, and evidence-based methods and metrics to manage chronic pain even as some recommendations are associated with known patient harms when utilized by vulnerable populations;
• The biopsychosocial model is referenced without address of specific steps primary care physicians may incorporate to be sure than patients have access to what are now largely inaccessible and unachievable services for most consumers with progressive chronic pain syndromes and comorbidities;
• Recommendations that are by themselves stigmatizing, rely on consumer acceptance of negative labeling practices as a condition for treatment, and demand adherence and conformance to practices that by themselves add little or no value to symptom management or contribute much to understanding of disease processes or the collection of evidence to guide treatment;
• Non-address of the complexity of chronic pain care and the comorbidities and risks imposed by polypharmacy which may potentiate opioid risks or the management of multiple complex conditions from which variants of chronic pain arise;
• Metrics associated with reduction of overdose deaths as the primary outcome measure instead of measures of improved personal or community function;
• Installation of a systematic bias by failing to conduct an equitable review of the patient experience and to properly stratify comments and incorporate real data from patient experiences.

The resultant recommendations for implementation give rise to recommendations that infer:

• Patients need protection from their own behaviors and are incapable of objectively managing their personal user experience or providing valid and reliable reflections because of their status as chronic pain patients and dependence on opiates dispensed in a variety of forms
• Prevention of harm to patients demands reduction of the use of opioids and that access must be rationed to prevent ‘dependence’ for the public and individual good, a hypothesis without evidence metrics;
• Acceptance of the notion that dependence is the inevitable precursor to addiction, a hypothesis without evidence metrics;
• Acceptance of the notion that for long term users with progressive diseases associated with chronic pain, dependence on opioids is the equivalence of addiction and controlled dispensing to an arbitrary dispensing level will reduce potential harms, a hypothesis without evidence;
• Only chronic pain patients with progressive disease should be considered for long term opiate based interventions, which presumes that only nonopiate methodologies (which are admittedly inaccessible, unavailable, and in some cases unsafe) have preventive value as a risk mitigation strategy for those whose disease can be stabilized, a hypothesis without evidence;
• That opioids prescribed to persons who have chronic pain, are by themselves largely to blame for causing widespread deaths among users – which, given the variable legal and illegal contexts in which opioids are obtained is an untested theory which has the potential to subject chronic pain patients to widespread experimentation;
• At all costs, deaths by overdose must be reduced even though premature deaths among some user populations (e,g, chronic pain patients with progressive disease) are inevitable given contextual conditions unassociated with prescribing practices.

Ms. Lewis then elaborates on how the CDC guidelines were created in subterfuge and have destructive consequences.

Opting to favor measures derived from death data and the illegal use of street drugs by those not party to a treating physician-patient relationship is hardly a measure for effective population based health outcomes for treatment of persons with chronic pain

What we have instead is an improperly framed hypothesis which represents no testable theory as of yet, is not reproducible, and has been wildly overgeneralized.

has resulted in the generation of policy and regulations based on the ‘spread’ of faulty beliefs built on widely disseminated data of questionable origin.

If we assume that all users of opioids with chronic pain are presumptively vulnerable to addiction and death by overdose, then we will always err on the side of managing risk

(See Only NON-Medical Opioid Use Leads to Heroin Use)

incorporate a systematic error into our analysis, measuring the impact of physician prescribing behaviors and judgments compared to the rate of overdose.

no need to pretend that the opioid prescribing guidelines released on March 16 are designed to improve the lives of patients

Because they won’t and everyone knows it.

The guidelines will make a lot of money for the addiction industry. They will lead to fail first protocols.  They will set vulnerable persons with chronic pain up for further injury and care failure which will go largely undetected because the metrics are wrong.

Insurers are held harmless for their role and conduct in achieving an effective implementation that values reduction of ACO costs for complex care coordination. Let’s don’t even address the the phenomena of capitation that blocks primary physicians from participation in regionalized contracts.

let’s employ evidence based practices instead of acting as representatives of the nanny state who foist fraudulent agents upon patients for “the public good.”