It was curious that the CDC decided to tackle prescription safety or efficacy issues in any capacity, which is clearly the FDA’s responsibility. It was even more curious that the CDC produced these guidelines completely in secret until forced – by threat of lawsuit, and a congressional inquiry – to disclose just who it was that they consulted for expert advice on opioids and pain. Who was it? A selection of qualified pain specialists and/or anesthesiologists, those who most often prescribe opioid analgesics?
It was our anti-opioid friends over at PROP, as it turns out. The Physicians for Responsible Opioid Prescribing (or PROP) is considered the most biased anti-opioid advocacy group in the county. PROP and its members have repeatedly tried different tactics to limit access to pharmaceutical opioid analgesics all under the banner of reducing addiction and overdose deaths. What could be more effective than infiltrating the CDC from within and helping them to author opioid prescribing guidelines? To give them credit, their efforts worked beautifully (as long as one doesn’t care that countless pain patients and their medical providers were harmed in the process).
Just how many members of the PROP advocacy group were included in the ‘Core Expert Group’ (or CEG), or on the peer review panel, or in the “Stakeholder Review Group”? Out of the 17 members of the CEG plus the other groups we count five members of team PROP, including 3 of the 4 members of the PROP Board of Directors. Wouldn’t the inclusion of so very many biased, anti-opioid voices raise concerns about the legitimacy and appropriateness of the resulting guidelines?
In fact, it would. A number of concerns were raised by MANY groups at the time including the American Cancer Society Network, among many others.
The National Fibromyalgia & Chronic Pain Association, Hospice and Palliative Nurses Association, American Chronic Pain Association, and a wide range of other patient advocacy groups and healthcare professional organizations have also come forward to denounce the lack of scientific evidence behind the proposed rules and the lack of transparency in writing them.https://www.insidesources.com/dysfunction-lobbying-and-conflict-of-interest-in-the-debate-over-opioids/
Which members of PROP participated in the Core Expert Group? When the names were finally disclosed we learned, starting at the top: the President of PROP, Dr. Jane Ballantyne. Vice President of State Regulatory Affairs, Dr. Gary Franklin. Both heavily affiliated with the University of Washington.
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.https://morningconsult.com/opinions/opioids-and-sunshine-at-the-cdc/
The list of peer reviewers for the CDC Opioid Guidelines is brief; only 3 names appear. One of those is Dr. David Tauben, PROP Board Member and another University of Washington professor. The Stakeholder Review Group (see Appendix C for the list) contains Dr. David Juurlink (PROP Board Member) and Dr. (Psychiatrist-not-pain-specialist) Andrew Kolodny, PROP co-founder and Executive Director. That makes up our famous five.
Did they heavily influence the CDC’s guidelines? Hard to imagine how they couldn’t. Here are some of the key concerns which were raised almost immediately:
- CEG members Ballantyne and Franklin did not disclose they were PROP office holders or indicate they had a conflict of interest as members of PROP.
- Ballantyne did disclose that she served as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies. Ballanytne also disclosed that she serves on a special advisory committee reviewing opioid abuse deterrence for the Food and Drug Administration.
- Franklin did not disclose any conflicts, although he played a significant role in the development of opioid prescribing regulations in Washington state, which has some of the toughest prescribing laws in the nation. For that, Franklin was honored by the workers compensation industry for “his pioneering research and outspokenness on the overprescribing of opioid pain medications.”
- Ballantyne, Franklin and Tauben all have ties to the University of Washington; where Ballantyne is a professor of Anesthesiology and Pain Medicine at the UW School of Medicine, Franklin is a research professor at the UW School of Public Health, and Tauben is the Chief of Pain Medicine at the UW School of Medicine. All three were involved in the development of opioid prescribing regulations in Washington state, which has some of the toughest prescribing laws in the nation.
The CDC placed a number of outspoken anti-opioid activists on a panel with only a few moderate members and no pain experts. While vigorous debate can lead to good policy decisions, the Core Expert Group lacked opposing arguments, and a drive to conformity can lead all members to reach conclusions inconsistent with the evidence.https://www.insidesources.com/dysfunction-lobbying-and-conflict-of-interest-in-the-debate-over-opioids/
Quality of the Evidence/Strength of the Guideline Recommendations: In the best case you want someone who is highly qualified making recommendations on the basis of high-quality evidence.
- 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”.
- CDC also notes that 12 of their 13 recommendations are “strong recommendations”, and only one (on UDT) is “weak.”
PROP’s Agenda Continues, unchecked:
“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.”Bob Twillman, Executive Director of the American Academy of Pain Management at https://morningconsult.com/opinions/opioids-and-sunshine-at-the-cdc/
Finally, 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.
The level of evidence cited to support the guidelines, which are non-binding on physicians, “is low to very low and that’s a problem,” said Sharon Hertz, FDA’s director of the Division of Anesthesia, Analgesia and Addiction Products.http://drugwonks.com/blog/cdc-feels-the-pain
AHRQ health scientist Richard Ricciardi called the recommendations “ridiculous” and “an embarrassment to the government.”
To recap: PROP tried to get the FDA to limit access to pain medication. When that failed, their board members infiltrated the CDC and apparently heavily influenced the CDC opioid prescribing “strongly recommended” guidelines even though the quality of evidence is low to very low. Yet here we are with PROP calling the shots on pain care in America. Do we think that they will stop now that they’ve influenced national policy and impacted the lives of millions? Nope.