Critique of the CDC’s Draft Guidelines on the Use of Opioid Analgesics for Chronic Pain Part Two

 

(Note: The endnotes which provide the references for this critique have been collected into the final part of this document.)

We now know the names of the seventeen members of the Core Expert Group.[18, 19] Among these core experts is the president of Physicians for Responsible Opioid Prescribing (PROP), which her own biographical sketch calls “an advocacy group that lobbies government agencies concerning regulation for medical use of opioids.”[20] PROP is a political advocacy[21] program of Phoenix House[22] Foundation, Inc., which, in turn, runs more than one-hundred thirty “drug and alcohol addiction treatment” programs.[23] She is an author of at least two other guidelines on the use of opioid analgesics for chronic pain,[24, 25] including guidelines which were not only partially sponsored by PROP, but largely authored by persons associated with it.[25] In the past, she recognized that opioid therapy “can relieve pain and improve mood and level of functioning in many” of those “patients with chronic pain not associated with terminal disease,”[26] but her current position has been characterized as a “former believer turned crusading reformer.”[27] She, along with another core expert from PROP and with one of the stakeholder reviewers from PROP, equates physical dependence (unpleasant physical symptoms upon abrupt discontinuation) with addiction (compulsive use in spite of evidence of harm).[28] She shares the CDC’s[13] and other of its “core experts’” peculiar concern with fractures due to opioid analgesics.[29, 30] She has received personal income from a pharmaceutical company as an “Expert Panel/Advisory” for an opioid analgesic,[24] and her pain unit was the recipient of a $1.5 million dollar educational and research grant for another pharmaceutical company’s opioid analgesic. She is a paid consultant to Cohen Milstein Sellers & Toll,[19] which brings lawsuits against pharmaceutical companies for their opioid marketing,[31, 32] has been criticized for accepting cases from states’ attorney generals to whose campaigns it had contributed,[32] as well as for other ethically suspect practices,[32, 33] and which stands to gain, in the form of more cases from states’ attorney generals and enhanced lawsuits against pharmaceutical companies, from guidelines for opioid analgesics. She advocates education by regulation and more opioid controls.[34] She is one among seven contributors to the CDC’s guidelines who is also a signatory to a letter, on PROP stationary, demanding that the FDA discriminate against “non-cancer pain” according to the degree of pain and the dose and duration of therapy. In particular, that letter demands that opioid-therapy of “non-cancer pain” be limited to low doses for “severe pain” for a maximum of ninety days, because there are no long-term efficacy and safety studies.[35] Of course, not only have such studies never been done, but they can never be done, as she, herself, has recognized.[36] (Apart from the insurmountable ethical and logistical barriers to conducting long-term studies comparing opioid analgesics to “dummy” treatments in patients with “severe” pain, who would ever pay the multiple billions of dollars to conduct such studies? Certainly not the anti-opioid activists who insist that they are necessary.)

Another of the core experts[37] who contributed to the CDC guidelines gave the Food and Drug Administration (FDA) this advice for opioid analgesics: “We need to think about how we would construct a REMS [risk evaluation and mitigation strategy] if we were going to be marketing heroin.”[38] Lest his implication be missed, he is also coauthor, with one of the CDC guidelines‘ outside reviewers,[39] of a paper equating prescribers with illegal “drug cartels and street dealers,”[40] thus implying that the prescribing of opioid analgesics should be prohibited. He is also a signatory of 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.[35]

Another core expert[40] shares the CDC’s,[13] and some of its other core experts‘, peculiar preoccupation with fractures associated with opioid analgesics.[34, 41] As a member of the Washington State Interagency Guideline on Opioid Dosing Panel[41] and a signatory to PROP’s logically, scientifically, and ethically questionable 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,[35] he clearly has predefined views on the use opioid analgesics for chronic pain. He is among the seven contributors to the CDC guideline who is also an author of a guideline partially sponsored, and largely authored, by PROP[25]. He along with at least one other core expert from PROP and one stakeholder reviewers from PROP, equates physical dependence (unpleasant physical symptoms upon abrupt discontinuation) with addiction (compulsive use in spite of evidence of harm).[28]

While not as overtly hostile to opioid analgesics as most of the other authors of those PROP guidelines[25], another core expert[42] seems biased against them. Interestingly, she multiplied 0.00148 overdoses per person per year of opioid treatment by one hundred-thousand, in order to graph as much larger numbers and to present them as overdoses per one hundred-thousand person-years[43]—a minuscule unit that sounds huge.

Yet another core expert[44] is an author, along with two other core experts, of a paper crediting the guidelines partially sponsored by PROP, and largely authored by persons associated with it,[25] as having reduced mortality from opioid overdoses 50%[45] (Maybe so, but similar reductions have been seen elsewhere, prior to the existence of those guidelines.[46, 47]). She is among the seven contributors to the CDC’s guidelines who is also a signatory to the logically, scientifically, and ethically questionable PROP letter which demanded that the FDA limit opioid analgesics for “non-cancer pain” to low doses for “severe pain” for a maximum of ninety days.[35]

One core expert[48] was an unspecified “leader”[49] in developing Ohio’s Emergency and Acute Care Facility Opioids and Other Controlled Substances Prescribing Guidelines (Emergency Guidelines).[50] However, the development that she led was merely a modification, based upon “feedback from Ohio emergency departments,”[51] of the same guidelines[25] that have previously been noted as partially sponsored by PROP and largely authored by persons associated with it.

Another core expert‘s[52] bias may be seen from the fact that she is the first author of a paper (whose senior author is a PROP member and signatory to the PROP letter to the FDA[53]) illogically condemning physicians for not performing “risk reduction strategies”[54] for which she had already published that there is “lack of evidence”[55] to justify their use.

The only connection that I can find between one core expert[56] and opioid analgesics is his conclusion that opioid prescriptions for those 65 and older have increased[57]—which reveals nothing about how—or whether—they ought to be prescribed. Tellingly, however, he has a history of manifest hostility toward the pharmaceutical industry, as an expert witness,[58] as co-creator of a database to be used against pharmaceutical companies,[59] and as author of many of articles attacking the pharmaceutical industry.[58]

Yet another’s[60] relevant experience seems to be limited to having chaired a position statement on prescription drug abuse. It said little more than that the American College of Physicians was against such abuse, perhaps because, ironically, it was authored by a lawyer and two other non-physicians.[61]

Another core expert’s[62] interest in opioids seems to be limited to naloxone treatment of overdoses[63] and to social, sexual, and racial “disparities” in overdose deaths[64]—as if we should be ensuring social, sexual, and racial equality in overdose deaths, too.

So far as I can tell, another core expert‘s[65] expertise is solely based upon being unspecified “staff” for the Oklahoma Injury Prevention Advisory Committee, from the Oklahoma State Department of Health, Prevention & Preparedness Administration.[66] One would expect the CDC to supply its own “staff” and not to rely upon them for its “Core Expert Group.”

Another[67] was an author of Arizona’s guidelines, which were developed by the department for which she is Deputy Medical Director.[68] These appear to be independent of the PROP guidelines[25].

One core expert[69] was a member of the steering committee[70] that developed the Tennessee Clinical Practice Guidelines For Management of Chronic Pain.[71] It is clearly independent of the PROP guidelines[25] and is noteworthy for requiring documentation in the medical record that the patient was “counseled that the goal of chronic opioid therapy is to increase function and reduce pain, not to eliminate pain.”[71]

Another core expert[72] who offers an alternative to CDC Director Tom Frieden’s views chaired the American Association of Family Practitioners’ (AAFP) guidelines, which stress that the AAFP “opposes any actions that limit patient access to physician-prescribed drugs.”[73] Rather than targeting prescribers, as do Frieden and almost all of the other contributors, he promotes Project Lazarus, which he says successfully reduced “overdose deaths down to basically zero,”[74] while broadening “awareness of the extent and seriousness” of chronic pain.[75]

Another[76] core expert whose views may be an alternative to Frieden’s is an author for a paper which finds that the increase in deaths from prescription opioids was primarily due to just one drug, methadone.[46] It also showed not only that “Opioid drugs…can be used safely with only 0.64% of opioid prescriptions associated with a fatality,” but that the rate declined “dramatically” from 2002 through 2010.[46] This occurred prior to the guidelines to which three other core experts credit[45] reductions in overdose deaths. However, she has been partially funded by the CDC,[47] and so has a financial conflict of interests in helping to develop CDC guidelines.

In spite of the widespread preoccupation with overdoses from “prescription painkillers,” another of the core experts[77] has shown that overdose deaths from prescribed opioids are actually rare[78] and that nonmedical opioid overdoses are strongly correlated with pain and apparent self-medication.[79]

(Continued)