September 24, 2015 at 5:00 am ET
The CDC’s been exceedingly secretive during the drafting of its controversial opioid prescribing guidelines for physicians, refusing to disclose its outside advisors. The panel of advisors is known within the CDC as the Core Expert Group. (The proposed guidelines, which were released this week, have angered many pain patients who think they could lead to sharp reductions in the prescribing of opioids for both acute and chronic pain.)
The only thing the CDC would say is that, “The Core Expert Group includes a limited number of CDC scientific staff, primary care professional society representatives, state agency representatives, experts in guideline development methodology, and other subject experts.” What’s missing? How about pain experts?
But when a federal agency tries to hide what should be an open and transparent process, sunshine has a way of breaking though the curtains. Here for the first time (and from inside the belly of the beast) is the CDC’s confidential document, “CDC Guideline for Prescribing Opioids for Chronic Pain.” It includes a complete list of the Core Expert Group. That group for the first time is now public knowledge:
Core Expert Group
According to the document, the CDC, “aimed to minimize conflict of interest, enhance objective assessment of the evidence, and reduce bias.” Well, they may have aimed – but they missed badly. The members of this group do not represent a broad spectrum of thought on opioids. To put it nicely, the issue of normative bias needs to discussed –loudly and openly.
Consider Jane Ballantyne.
Ballantyne last year was named President of Physicians for Responsible Opioid Prescribing (PROP), a controversial organization that has lobbied Congress and criticized the Food and Drug Administration for not doing more to limit opioid prescribing. And in her conflict disclosure (see page 39 of the CDC document), she discloses her services as a paid consultant to Cohen Milstein Sellers & Toll – the same law firm referenced by the New York Times as shopping around opioid litigation – and having guidelines from the CDC that recommend restrictions in opioid prescribing could certainly be advantageous to such an endeavor.
As Pain News Network has reported, “The CDC and PROP appear to have a close working relationship — a link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found — unedited — on the CDC’s website.
According to Bob Twillman, Executive Director of the American Academy of Pain Management (one of the stakeholder groups that will be consulted by the CDC):
Clearly, this is PROP’s way of getting what FDA didn’t give them when they advocated for an ER/LA opioid label change. I don’t think it’s a coincidence that this sets a 90 mg MED dose limit, when PROP advocated for a 100 mg MED dose limit in their Citizen Petition to the FDA. That PROP’s president and one vice-president are part of the core expert group; their executive director and a board member are part of the stakeholder review group; and another board member is one of the three who will help edit the guidelines after the stakeholders report, all is not a coincidence, and clearly puts their fingerprints all over this guideline. But, of course, no one is supposed to know that.
And where is the FDA? According to the CDC, “FDA has been involved in the review process of the guidelines and we will continue to work with them on this prescription drug overdose epidemic.” If that’s true, why wasn’t an FDA expert included in the Core Group?
Per Twillman, In assessing the validity of the guidelines there are two factors that make up that validity assessment: the quality of the underlying evidence and the qualifications of the person making the recommendation. In the best case, of course, you want someone who is highly qualified making recommendations on the basis of high-quality evidence. That isn’t the case here, because CDC itself, in the review document, rates 8 of its 13 recommendations as having “very low quality of evidence” and 5 as having “low quality of evidence”. They also note that 12 of their 13 recommendations are “strong recommendations”, and only one (on UDT) is “weak.” In the absence of even moderate quality evidence, though, any recommendation really constitutes an opinion, creating an “eminence-based guideline,” not one that is “evidence-based.” In that case, the qualifications of the person issuing the unsupported opinion are VITAL to assessing the validity of the recommendation. If we are talking about a guideline that SHOULD be about how to use opioids to treat chronic pain, then shouldn’t we have more than one person in the core expert group who has extensive experience doing just that?
And that’s a question worth asking in open public debate.