Kolodny responded quickly to Chou’s email, urging Ballantyne and the other PROP members to sign up as speakers. Although a public notice about the CDC hearing was not officially published in the Federal Register until January 11 -- three days later – the notice was put on “public display” in the Federal Register on Jan. 8, along with a link that allowed speakers to sign up early.
“We need to register ASAP if we hope to get a spot to give oral remarks (which can be done over the phone). I think it’s best for Jane to give remarks for PROP,” Kolodny wrote in an email of his own. “You don’t need to include a full written statement, just mention that you intend to speak in favor of the draft guideline and the need for promoting more cautious opioid use.”
Although the public notice asked that “each organization register one speaker to represent their organization,” PROP wound up having four speakers at the Jan. 28 hearing: Kolodny, Ballantyne, Franklin and Dr. David Juurlink. Franklin registered on Jan. 8, identifying himself as a representative of “Washington State public agencies.” Juurlink signed up as a representative of the “University of Toronto and American College of Medical Toxicology” and Kolodny identified himself as “Chief Medical Officer, Phoenix House Foundation.” Only Ballantyne signed up as representative of PROP.
The four PROP members were joined by over two dozen other guideline supporters, including Gary Mendell, Judy Rummler, Pete Jackson and other anti-opioid activists who have lost children to opioid overdoses. They urged CDC not to change the guideline by “watering it down” or removing dose limits.
“The CDC guideline is urgently needed. The guideline was very carefully crafted using the best available evidence, expert opinion from a group of individuals with extensive experience of writing practice guidelines, and stakeholder input from a broad and balanced group of stakeholders,” Ballantyne said in her written comments.
“Primary care needs guidance on opioid prescribing that is free of industry bias. The CDC guideline accomplishes this. Evidence shows that the widespread use of opioids for chronic pain is harming more people than it is helping,” said Kolodny, according to minutes of the hearing.
Only four people spoke in opposition to the guideline. One was Howard Techau, a pain patient who pointed out that most overdoses were caused by illicit fentanyl, not pain medication. “Many chronic pain patients are suffering more now due to the (opioid) restrictions that are already in place,” said Techau, according to the hearing minutes.
The hearing ended with BSC chair Dr. Stephen Hargarten thanking the participants for their “extraordinary discussion and input from a variety of perspectives.”
‘Stacking the Deck’
A pain patient who registered for the hearing but was not given a chance to speak was Anne Fuqua. She encouraged dozens of other patients to attend and register as speakers, helping some to fill out their online registration forms. When the hearing ended and none of them were called upon to speak, she remembers feeling the hearing was rigged and stacked against patients
“The whole process felt like such a concerted effort to railroad patients,” Fuqua told PNN. “I remember at the time us saying we felt like it was beyond the realm of chance that they randomly selected the speakers.
“Aside from the 4 PROPers, it just doesn’t seem possible that supporters would have been this successful in flooding the sign-in ahead of everyone else.”
The CDC disputes the notion that anyone at the hearing who was pre-registered was denied an opportunity to speak.
“A total of 37 individuals pre-registered for the meeting and, of those, 30 requested to give oral public comment. During the 90 minutes allotted for public comment, participants were called on in the order that they registered. After individuals that had pre-registered were given the opportunity for public comment, public comment was opened to others for the remaining time. One additional person provided public comment at that time,” Courtney Leland, a CDC spokesperson, said in a statement to PNN.
“I don’t understand how they could possibly say only 30 registered to provide public comments. There were so many patients who told me they registered at the time and I registered way more than 30 people myself,” says Fuqua, who provided dozens of donated cell phones to nursing home residents so they could call in.
Others questioned the “first come, first served” process used by CDC to sign-up speakers, which could be easily manipulated by anyone given advance notice.
“The first come-first served method necessarily gives advantages to groups that hire lobbyists to track Federal Register postings, and, apparently, groups that have an inside connection who can alert them to the opportunity,” said Bob Twillman, PhD, former Executive Director of the American Academy of Pain Management. “Individual patients and even patient advocacy organizations are not going to have the resources to find out about these opportunities until the very limited number of slots are filled. CDC needs to seriously re-think this method of filling spots if they do anything like this in the future.”
‘Forward This Announcement to Others’
At least five PROP board members were involved in advising the CDC during the guideline’s development, so it is not clear why they were given yet another chance to express their opinions. Ballantyne and Franklin were members of a key guideline advisory panel known as the Core Expert Group; Dr. David Tauben was on the guideline’s peer review panel; and Kolodny and Juurlink were on a stakeholder review group.
Kolodny has tried to downplay PROP’s role in drafting the opioid guideline, but Chou’s email is direct evidence that there was some degree of collusion.
When asked why he contacted PROP and other organizations to give them an early heads-up about the hearing, Chou said he did so at the request of the CDC. A CDC staffer emailed Chou and other “Partners” involved in the guideline process, urging them to “forward this announcement to others who may be interested in commenting.”
“The information I forwarded to those folks and others was from an email that I received from CDC on January 8 that had been sent out widely to partners/stakeholders. Not sure why there would be any prohibition on sharing that information, which was public,” Chou wrote in an email to PNN.
But the information was not yet public, at least not widely. CDC never sent out a press release about the hearing and the public notice that was in the Federal Register probably wasn’t seen by many people outside of lobbyists.
“Chou can say all he wants that this justified his efforts to stack the deck, but it also shows CDC was complicit,” says Fuqua.
“The fact that CDC would encourage people to publicize the availability of this speaking opportunity prior to publication in the Federal Register, especially when they were using a first come-first served selection method, is problematic,” said Twillman.
“It is shameless that Roger Chou gave PROP a head start to prepare. It’s like an author writing their own book reviews,” said Julie Killingworth, a pain patient and independent researcher who helped PNN track the 2016 emails, which were obtained by another journalist through the Freedom of Information Act.
“PROP members and their cohorts like Chou have proven beyond doubt they will always resort to cheating and lying to promote and profiteer their destructive scientifically faulty agenda. The CDC has unapologetically shacked up with a shadowy lobbying group, endangering the health and well-being of all citizens.”
As for Chou’s warning that pharma was “gearing up to take as many slots as they can” at the hearing -- not a single representative from the pharmaceutical industry spoke. Pharma did not “dominate” the hearing as Chou predicted, PROP and other guideline supporters did.
Outspoken Critic of Opioids
All of this happened six years ago and may seem like “inside baseball” trivia to people unfamiliar with the CDC and its opioid guideline. But for this reporter and others who have followed the issue for years, it has a familiar ring.