Editor’s Note: Terri Lewis is an expert on Rehabilitation Medicine who has been very critical of the Center for Disease Control Guidelines on opioid prescription which is another government offensive designed to slow down opioid prescriptions. Dr. Lewis is a frequent contributor to the National Pain Report.
The development of guidelines is based on a consensus building process. In developing guidelines, one considers all of the evidence and obtains input from the stakeholders who will be most affected by the guidelines. As a generally held principle, a guideline is neither a Standard of practice nor a regulation. It carries no legal weight, it is nonbinding, and is unenforceable. Guidelines cannot bind personal behavior. In healthcare, guidelines are intended to provide a consensus about the general direction for patient care after the patient is appropriately identified and selected into treatment.
Guidelines promulgated by government agencies have clearly identified work processes associated with their development that are differentiated by whether or not they are intended to bind the behavior of the agency. Responsibilities and authorities are clearly elaborated. The Supreme court has ruled that agencies cannot use guidance development in the absence of existing rules as a substitute for rulemaking, and may not issue guidance beyond the scope of existing agency authority (GAO-15-834T, September 23). Guidelines may be developed in advance of rulemaking to assist with preparation for implementation.
The Office of Management and Budget (OMB) has established requirements for the issuance of guidance documents that are of any significance when it comes to public policy (GAO-14-704G). Standard elements that must be included in significant guidance documents and directs agencies to (1) develop written procedures for the approval of significant guidance, (2) maintain a website to assist the public in locating significant guidance documents, and (3) provide a means for the public to submit comments on significant guidance through their websites. In 2011, the GAO recommended that the Secretaries of a number of agencies, including Health and Human Services (HHS), strengthen their application of internal controls by adopting practices to assess risk to the public that may be inherent in the issuance of a guideline; written procedures and tools to promote the consistent implementation and communication of management directives; and ongoing monitoring efforts to ensure that guidance is being issued appropriately and has the intended effect. HHS (which includes FDA, CDC, CMS and others) agreed to comply with these internal control recommendations.
In 1991, the GAO reviewed the practice of guideline development by medical organizations and could find no consistent means of work practices. By definition, the practice of medicine falls under accepted ethical practices of ‘research’ which has clearly defined rules, and guidelines for practice contained within 45 CFR 46. Every patient, every problem, and every solution is unique, an “N of 1.” Clinical judgment requires that each person be granted specific protections as clinicians sort out the patient’s presenting problems and the available resources that can be applied to a healthcare solution. Each patient is an ‘experiment’ processed in less than controlled conditions of care. Results cannot be generalized beyond the individual to the population at large. Hypothesis testing requires that the clinician apply the rules of research to the experimental conditions of patient care. These rules have strong prohibitions against actions that might harm patients as a result of treatment. These patient protections include assurance of the right to self-select treatment (autonomy) and one’s treating providers, informed consent (veracity), education about risks and benefits (beneficence) and ethical practice (fidelity).
Treatment guidelines are applied after patients are appropriately selected into treatment based on the characteristics and needs associated with their unique problems. We don’t use treatment guidelines to recruit patients into treatment, nor do we use treatment guidelines to coerce patients into treatments not suited for their characteristics, needs or values. Guidelines may not be used to reject a patient for treatment or to coerce them into accepting treatment. The application of guidelines to patient selection encourages wrong diagnosis, increases potential for patient harms and injurious outcomes, and doesn’t address their unique needs. The application of guidelines to patient selection before the needs of the patient are understood encourages a model whereby the patient is coerced into adherence and conformance to an untested protocol that potentially addresses the wrong theory of their problem. Adherence and conformance to the wrong protocol may produce no positive outcome for the patient, and may well place the patient in an adversarial relationship with the treating provider as treatment outcomes fail to materialize. This leads to blaming the patient for treatment failure, an all too common outcome for chronically ill consumers. When treatment fails, the risk of loss is transferred by the process to the patient who has no recourse for treatments provided under nonbinding guidelines.
The trouble with the current activities being promulgated by CDC and their CORE team of experts is that they have either never learned the purpose and distinctions of guideline development, or they have forgotten, or they don’t care. Of concern are four distinct issues: (1) In its current role, the government cannot direct the practice of medicine in the private sector, nor can it bind the selection of patients into research except under controlled experimental IRB-approved conditions. (2) The dose established for medications is controlled through the manufacturers petition to FDA for approval based on clinical trials data - government does not have the authority granted under existing rules to supplant the rights of patients to agree or disagree to treatment protocols. (3) The guidelines as written foster discrimination in the provision and practice of healthcare services across a class of disabled individuals solely by virtue of their healthcare attributes and needs (§1557 of the Affordable Care Act). (4) The proposed guidelines as written are fraught with conflicts of interest, bias, and do not reflect the needs of the multiple populations who rely on and have successfully utilized a wide variety of opioid formulations and delivery systems to ameliorate chronic pain.
We are dealing with a continuum of consumer needs in this discussion from addiction to treatment for intractable lifelong palliative care. There are unique subclasses of patients within this group of persons who rely on the use of controlled medications. By the very nature of their illnesses and injuries, some will die, by inadvertent overdose (even at low levels), their own hands, or natural causes, and some will thrive even at high doses of controlled substances. There are many other social and biological factors that enter into this equation that are not addressed by the proposed guidelines as drafted – an omission of significant import. Suggesting that the use of coercive and stigmatizing practices drafted as guidelines for the purpose of binding patients to contingent treatment is a violation of the Common Rule and provisions of CFR45 and CFR46. Under any circumstances installation of discriminative healthcare practices into the health care services provided to these groups of patients is unlikely to achieve anything more than unintended results and exacerbate the current observable problems we believe to be present in serving these distinct populations.
The question that remains, is exactly what does this foray into guidance development represent? Does CDC, in concert with special interest groups, plan to seek a change to the scope of one or more federal regulations that would advance the agenda of rationing and controlling the delivery of healthcare services for the population of users who suffer from addiction or chronic pain? Has a special interest group filed a petition for rule making? If not, let’s get back to the basics of ethical practice in the development of ethical guidelines conceived in collaboration with the input of the stakeholders who are most affected – persons who rely on opioids to address conditions of chronic and intractable pain. Let’s not confuse the controlled entry of drugs into the population with the treatment of patients who use controlled drugs.
Briss, P.A., Zaza, S, Pappaioanou, M. et al (2000). Developing an Evidence -Based Guide to Community Preventive Services - Methods. American Journal of Preventive Medicine, 18 (1S), 35.
CDC Draft Guidelines Opioid Rx Prescribing Seminar https://www.google.com.tw/url?sa=t&rct=j&q=&esrc=s&source=web&cd=10&cad=rja&uact=8&ved=0CG4QFjAJahUKEwi9_4SHt57IAhUDnJQKHXBlCwg&url=http%3A%2F%2Fwww.aspmn.org%2FDocuments%2FAdvocacy%2FCDC%2520Draft%2520Opioid%2520Rx%2520Guidelines%2520webinar%2520slides%25209-15-2015.pdf&usg=AFQjCNGhQnjVUcExkx7LfCPRA8XFXT7-nA
Code of Federal Regulations 21 Common Rule, retrieved from https://www.hhs.gov/ohrp/humansubjects/commonrule/index.html
Code of Federal Regulations Title 45 Public Welfare and Title 46 Protection of Human Subjects, retrieved from https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
General Accounting Office (2015). Regulatory guidance processes-Agencies could benefit from stronger internal control practices, GAO-15-834T, September 23. Government Printing Office: Washington, DC. Retrieved fromn https://www.gao.gov/assets/680/672687.pdf
General Accounting Office (2015). Regulatory Guidance Processes: Selected Departments Could Strengthen Internal Control and Dissemination Practices, GAO-15-368, Apr. 16, Government Printing Office: Washington, D.C
General Accounting Office (2014). Standards for Internal Control in the Federal Government. GAO-14-204G, September, Government Printing office: Washington DC
Schunemann, H.L., et al (2015, October 6). Guidelines International Network: Principles for Disclosure of interests and principles for management of conflicts in guidelines, Annals of Internal Medicine, 163(7), 548-552.