(Note: The endnotes which provide the references for this critique have been collected into the final part of this document.)
The CDC, itself, has published standards requiring a balanced “guideline development group” and a broad base of reviewers comprising “a full spectrum of relevant stakeholders.”[127; emphasis in original] However, out of twenty-five contributors and reviewers: Seven have highly questionable credentials. Another ten are overtly hostile toward opioid analgesics, while there is indirect evidence for such hostility in three more (thirteen total). Only five have both credentials and points-of-view that are distinct from the public positions of the CDC’s director, Tom Frieden, but one of those five has a financial tie to the CDC, creating a conflict of interests. Two are from the CDC’s Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, which is promoting a social media campaign against prescription opioids, one of the two is “Team Lead” for its “Prescription Drug Overdose Team,” and neither is an independent voice from Tom Frieden. Two are medical advisors to ARPO. One is chief medical officer of Phoenix House. Five are officials of PROP, an agency of Phoenix House, and at least two others are members of it. One is a “committee member” of FED Up!, a political action organization that is sponsored by PROP, Phoenix House, and ARPO. Eight are signatories 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. At least nine are responsible for the PROP guidelines or a modification of it, or else have a public position in favor of it. At least eight were authors of other guidelines. Two of three authors and two of three outside reviewers already had public positions that opioid analgesics are harmful or without benefits. At least five contributors have significant financial conflicts of interests, and the activities or declared positions of nineteen create significant intellectual conflicts of interest.
Furthermore, if authoring guidelines counts as participation in an “advisory board” (as I believe it does), at least fifteen of the twenty-five appointments violate the IOM’s Standard 2.3: “Members of the GDG [Guideline Development Group] should divest themselves of financial investments they or their family members have in, and not participate in marketing activities or advisory boards of, entities whose interests could be affected by CPG [Clinical Practice Guideline] recommendations.” Certainly, the interests of PROP, Phoenix House, ARPO, and FED Up!, the American Association of Family Practitioners, and even funding for the CDC’s Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, “could be affected by” the CDC’s clinical practice guidelines.
Worse, by the definition published by the CDC, itself, the activities of least fifteen (and arguably eighteen) of the twenty-four represent “Intellectual COI [conflicts of interests]: academic activities that create the potential for an attachment to a specific point of view that could unduly affect an individual’s judgment about a specific recommendation….”
By the standards published by the CDC, “Members with COIs [conflicts of interests] should be a minority, but they are the majority of this group. Those same standards note that mere disclosure of conflicts of interest, whether they be financial or intellectual, can actually promote biased advice, because of the phenomena of “Strategic exaggeration” (the “Tendency to provide more biased advice to counteract anticipated discounting”) and “Moral licensing” (“The often unconscious feeling that biased advice is justifiable because the advisee has been warned.”).
Surely the CDC is aware that “what is to be decided is often already decided with the selection of the deciders.” The agency that is vested in its “#RxProblem” campaign against opioid analgesics clearly chose people with prejudged opinions against opioid analgesics for the same reason that it chose to conduct a one-sided (harms) review of the literature on opioid analgesics—to force the outcome, and provide them a chance to get through it what the FDA refused to give them.
Under Frieden, the CDC ignored the IOM’s requirement that guidelines be based upon a systematic review of the world literature, as well as the standards it has published, requiring “thorough and unbiased review of existing knowledge.” Instead, the CDC only conducted systematic reviews for harms. For benefits, the CDC substituted “rapid reviews,” limited to U.S. studies, and incongruously focused on “overdose, cardiovascular events, motor vehicle crashes, and fractures,” and then excluded the information from its strength of evidence analysis. In other words, the CDC’s literature review was designed to find no benefits, but to thoroughly document harms. While the CDC posts that guidelines that are not based upon a thorough and systemic review of the scientific evidence are neither trustworthy nor should be included in the National Guidelines Clearinghouse, it claims that its own guideline irregularities were justified by the need to “streamline.” Streamline for what? Why did this streamlining specifically leave them “informed” neither “by a systematic review of evidence” nor by “an assessment of the benefits and harms of alternative care options,” so that they do not even so much as qualify as “clinical practice guidelines,” under the IOM’s definition.[2; emphasis in original]
The man who preaches “the importance of practicing interventional epidemiology” through political activism, who advocates science with a political agenda, who poses with a congressman to campaign against opioid analgesics, whose appointment and tenure solely depend upon the President of the United States, whose budget is political,[134, 135] and under whom the CDC targets physician prescribing, conducts its “#RxProblem” campaign, openly advocates enforcement as the solution to opioids, and speaks approvingly of Washington State moving “aggressively” to curb opioid prescribing, expects us to believe that the guidelines developed under him were apolitical. If the guidelines were not political, then why, of the twenty five selected to have roles in these guidelines, were at least nineteen politically tainted? Sixteen contributors are known to engage in, or to advocate, political processes to impose upon others their own views about prescribing opioid analgesics, one of whom implies that opioid analgesic prescriptions should be prohibited, and two more at least have close ties with those in the political camp. Of the sixteen that are unambiguously politically active, six are members of the board of directors of an organization which its own president describes as a lobbying group, of which three have leadership roles in two other political action organizations. No politics, indeed. “Pay no attention to that man behind the curtain.”
The question, in the letter from the House of Representatives Committee on Oversight and Government Reform, regarding the “efforts by the CDC to ensure that the composition of the ‘Core Expert Group’ was balanced in terms of points of view,” can be answered by noting that at least ten of the contributors are active in campaigns against the use of opioid analgesics for chronic pain, that two are under CDC Director Tom Frieden, in the CDC‘s own Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, and that at least eleven (and arguably thirteen) are members of the same incestuously interlocking network. If “Guideline panel membership is the main determinant of the trustworthiness of guidelines,” these guidelines cannot be trusted.
This composition, like the one-sided literature review, perfectly reflects CDC Director, Tom Frieden‘s own agenda. Frieden says opioid analgesics should be “reserved for situations like severe cancer pain.” Does Frieden think that pain in patients with cancer is a different kind than it is in those without cancer? Or does he, like PROP (but quite unlike the FDA)—stand logic and ethics on their heads, by saying that pain which will be suffered for the rest of people’s lives should be treated for those people and pains that are expected be short-lived, but not for those people and those pains that are expected to last for years? Apparently so, because Frieden misleadingly refers to opioid analgesics by their legal classification as “dangerous drugs,” sensationally–but falsely—claiming that “just a few doses may lead to a lifelong struggle with addiction” and the “risk of injection drug use including heroin.” In the later, Frieden disregards: (1) the FDA’s counter to PROP, (2) the International Narcotics Control Board‘s opinion that pharmaceuticals are substitutes for illicit drugs with similar effects, and (3) the Institute for Effective Diagnosis‘ observation that “prescription drugs are now being substituted for illegal drugs,” because of a preference for the standardization, purity, and sanitation represented by drugs manufactured under the supervision of the Food and Drug Administration (FDA). Tom Frieden treats the logically incoherent and scientifically untenable “gateway hypothesis” as fact, “connects the startling rise” in heroin use with prescriptions for opioid analgesics by decree, and announces that “people are primed for heroin use because they were addicted to an opioid painkiller.” Frieden’s propaganda against prescriptions also puts him at odds with the United Nations Office on Drugs and Crime, which flatly states, “Health-care professionals should not be blamed for the problem as a whole.”