(Note: The endnotes which provide the references for this critique have been collected into the final part of this document.)
The CDC’s peer review panel includes PROP’s vice-president for state regulatory affairs, who is one of the authors of a guideline partially sponsored, and largely authored, by that organization and is the sole author of another guideline. He is chair of the Washington State Agency Medical Directors Group, which sets standards for opioid prescribing. He calls accidental opioid overdoses “one of the worst manmade epidemics in history,” for which he believes regulation is the solution. He promotes “public advocacy” and “professional advocacy” to restrict opioid analgesics, advocates “aggressively” curbing opioid prescribing and credits the PROP guidelines with reducing mortality from opioid overdoses, even though similar reductions were seen elsewhere, prior to the existence of these guidelines[46, 47]. He is one of the seven contributors to the CDC’s guidelines who is also a signatory to the logically, scientifically, and ethically questionable PROP letter to the FDA, demanding that opioid analgesics for “non-cancer pain” be limited to low doses for “severe pain” for a maximum of ninety days.
The CDC’s Stakeholder Review Group includes the co-founder and executive director of PROP. Along with at least two of the core experts from PROP, he equates physical dependence (unpleasant physical symptoms upon abrupt discontinuation) with addiction (compulsive use in spite of evidence of harm). Perhaps, then, physical dependence should be understood in place of “The increased prevalence of opioid addiction,” which he says, in a paper of which he is first author, is “caused by overprescribing of OPRs [opioid pain relievers].” He is a “committee member” of FED Up! Coalition,[89 which is a “legislation and advocacy” group claiming that “the root cause of the problem is overprescribing,”[90, 91] that all physicians overprescribe, that “action from the federal government” can “bring this public health crisis to an end” (FED Up! sponsorship by his own Phoenix House, PROP, and ARPO unambiguously positions them as political organizations, as well.). He promotes “public advocacy” and “professional advocacy” to restrict opioid analgesics and says “the effects that hydrocodone and oxycodone produce are indistinguishable from heroin.” In case of doubt as to his intent, he told the FDA, “what we’re really talking about are heroin
pills,” and he is one of five medical advisors to Advocates for the Reform of Prescription Opioids (ARPO), which claims that “legally prescribed opioid narcotics are pharmaceutical-grade heroin produced in a laboratory.” ARPO is another advocacy group “with the goal of ending the epidemic of death and addiction caused by prescription opioid drugs”[98, 99] through regulation. He is another of the seven contributors to the CDC’s guidelines who is a signatory to the logically, scientifically, and ethically questionable PROP letter demanding that the FDA limit opioid analgesics for “non-cancer pain” to low doses for “severe pain” for a maximum of ninety days. He, too, was one of the authors of the guideline partially sponsored, and largely authored, by PROP. Hypocritically presuming to tell everyone else what to do, as the chief medical officer of Phoenix House, he cannot keep his own House in order: Its more than one-hundred thirty “drug and alcohol addiction treatment” programs have come under fire for “emphasizing business considerations,” “’rampant’ drug use,” altering medical records, “insufficient, inadequately trained or abusive staff; dirty premises; and lax security, with residents coming and going as they wished,” “insufficient clinical and mental health services, strip searches conducted without consent, and failure to file incident reports.” He is also first author of a review that presented data showing an approximately 30% decline in the number of new opioid users over the same interval that opioid prescriptions increased approximately 250%, as proving “the increased prevalence of opioid addiction caused by overprescribing of OPRs [opioid pain relievers].” Not only is dishonest representation of data an ethical breach, but his claiming that temporal sequence proves causation puts him in the scientific company of the barnyard rooster of a well-known fable.
Another of the Stakeholder Review Group is a member of the boards of the political advocacy organizations, PROP and ARPO. As a member of ARPO’s board, he apparently endorses its position that “legally prescribed opioid narcotics are pharmaceutical-grade heroin produced in a laboratory.” Noting that “overdose deaths have risen and addiction rates and demand for treatment have skyrocketed,” he claims, “This happened because doctors began prescribing opioids more liberally for patients with chronic pain.” (Apparently, other possibilities are not even worthy of mention and dismissal.). He is one of the seven contributors to the CDC’s guidelines who also is a signatory to the to the to logically, scientifically, and ethically questionable PROP letter demanding that the FDA limit opioid analgesics for “non-cancer pain” to low doses for “severe pain” for a maximum of ninety days.
In keeping with the CDC’s focus on harms, to the exclusion of benefits, the first author of its draft guidelines is its own “Team Lead for the Prescription Drug Overdose Team,” from its Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, which is behind the “#RxProblem” social media campaign. She is featured as a speaker for a National Rx Drug Abuse & Heroin Summit, believes that opioids are simply “risky drugs,” falsely claims that the most important risk factor for addiction and overdose is any prescription of any duration for opioid analgesics, and helped author New York City’s opioid prescribing guidelines.” Of course, having a boss who claims that “just a few doses” can lead to addiction, “injection drug use,” and heroin also poses a significant financial conflict of interests to an author of the opioid guidelines written for him.
Apparently, one was not enough, because the second author was also from the CDC’s Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control. She is first author of a paper that, like the review for these guidelines, focuses on harm from opioid analgesics and ignores benefits, claiming that there is “a critical need” for information “about policies and practices that will improve prescribing,” where “policies” are political solutions and “improve,” in context, means “reduce.” Apart from her own biases, writing opioid guidelines for a boss with reckless antagonism toward opioid analgesics poses a significant financial conflict of interests.
The third author of this guideline was an author of a guideline partially sponsored, and largely authored, by PROP and was first author of another opioid prescribing guideline. He is one of the seven contributors to the CDC’s guidelines who is also a signatory to the logically, scientifically, and ethically questionable PROP letter demanding that the FDA limit opioid analgesics for “non-cancer pain” to low doses for “severe pain” for a maximum of ninety days.
The CDC guidelines had three outside reviewers. One of these is director of a division of medical toxicology in a department of emergency medicine, whose objectivity and credibility may be judged by her published blame of “all doctors” for “causing the problem” of opioid overdoses, and by a paper she coauthored with one of the core experts from PROP. In that paper, they equated opioid prescribers with illegal “drug cartels and street dealers,” implying that the prescribing of opioid analgesics should be prohibited, as well. Another outside reviewer’s focus is on the mental health of patients with chronic pain, the sexism and racism of those treating it, and such scientifically rigorous “pain self-management” research as “Positive thinking” and “Positive attitude and using positive thinking/affirmations.” The other outside reviewer was a “Professional Education and Training” member for the National Institutes of Health Interagency Pain Research Coordinating Committee’s draft National Pain Strategy, is one of the authors of the guideline partially sponsored, and largely authored, by PROP, is a board member of that organization, and was co-chair of the Washington State Agency Medical Directors’ Group opioid treatment guideline, the preface of which declares that “preventing the next group of Washington residents from developing chronic disability due to unnecessary, ineffective, and potentially harmful COAT [chronic opioid analgesic therapy] is a key objective of this guideline.” Clearly, this group of three fails the test of IOM standard 7.1: “External reviewers should comprise a full spectrum of relevant stakeholders, including scientific and clinical experts, organizations (e.g., health care, specialty societies), agencies (e.g., federal government), patients, and representatives of the public,” (published with emphasis on the CDC’s own site: “a full spectrum of relevant stakeholders.”[124; emphasis in original])
The CDC’s choice of a toxicology-emergency medicine outside reviewer for its guidelines on opioid analgesics for chronic pain is, by itself, a telling preoccupation with harms and disregard for either chronic pain or the benefits of opioid analgesics, especially when she has already announced that opioid overdoses are to be blamed on “all doctors.” Its choice of an outside reviewer whose work in chronic pain has been limited to mental health, such scientifically nebulous treatments as positive thinking, positive attitudes, and positive affirmations, and to sexism and racism in opioid therapy, demonstrates its own disregard for scientific rigor and its politicization of chronic pain. Its choice of a co-chair of an existing guideline and member of an advocacy group opposing opioid analgesics demonstrates its own prejudices, especially when the guideline over which that person co-chaired describes chronic opioid analgesic therapy as “unnecessary, ineffective, and potentially harmful.”
The president, the vice-president, and the executive director and co-founder of PROP and chief medical officer of Phoenix House (members of the CDC guidelines’ Core Expert Group, peer review group, and Stakeholder Review Group, respectively) actually equate physical dependence following medical opioid therapy with addiction. While they note that sudden nonavailability of opioids, tolerance, and attempts to taper can trigger cravings and addictive behaviors, the predictable consequences of medically abandoning patients who have used opioid analgesics for any length of time would benefit the “business considerations” of the Phoenix House chain, for which PROP is a front.