The ‘Cone of Silence’ Returns to CDC
/By Pat Anson, Editor
The Centers for Disease Control and Prevention drew a lot of criticism last year for its secrecy and lack of transparency while drafting its controversial opioid prescribing guidelines.
Closed-door meetings were held by the “Core Expert Group” and other CDC advisory panels, which included hardly any experts in pain management, but did have several addiction treatment doctors and longtime critics of opioid prescribing.
The CDC’s penchant for secrecy on such an important public health issue was mockingly compared by Stephen Ziegler to Get Smart’s “Cone of Silence.”
But it was only when the agency was accused of bias, blatant violations of federal law, and a Congressional investigation was launched that CDC appointed a new expert panel to review the guidelines -- which were released in March essentially unchanged from the draft version.
The CDC apparently didn’t learn much from the experience.
This summer the agency has been holding a series of training webinars to educate healthcare providers about the guidelines -- and it invited as speakers some of the very same people who were removed from the first expert panel because they were perceived as being too biased.
For example, this week’s webinar on the benefits and harms of opioid therapy was led by Jane Ballantyne, MD, who is president of Physicians for Responsible Opioid Prescribing (PROP), and Mark Sullivan, MD, who is a PROP board member. PROP has lobbied the federal government for years to reduce opioid prescribing.
MARK SULLIVAN, MD
“We really don’t have good evidence of long term benefit from opioid therapy, but we do know it creates serious problems,” Sullivan advised the physicians and pharmacists listening to the webinar.
“We don’t want to be giving patients a month or multiple refills of opioids for acute pain problems, because that’s where long-term opioid therapy gets started and is difficult to discontinue.”
Last year Sullivan and Ballantyne co-authored a controversial article in the New England Journal of Medicine that claimed reducing pain intensity should not be the primary goal of doctors when treating chronic pain. They believe that other quality of life issues, such as better sleep, mood and physical function, are more important.
“It’s so easy for someone who’s been on opiates for a long time to believe they need the opiate, because if they stop taking it the pain gets worse,” said Ballantyne, who maintains that long-term opioid patients should be slowly tapered to lower doses or off opioids entirely.
“A successful taper makes a patient much better able to function. And generally their experience is the pain level either doesn’t change or is actually improved,” she said.
Both Sullivan and Ballantyne are employed as professors at the University of Washington School of Medicine, which according to a webinar disclaimer “received a contract payment” from the CDC.
Another professor at the University of Washington who participated in the webinars, David Tauben, MD, is also a PROP board member and served on the CDC's peer review panel for the guidelines.
Ballantyne, Sullivan and Tauben’s involvement with PROP are not disclosed in the disclaimer and some of their conflict of interest statements also appear incomplete.
JANE BALLANTYNE, MD
Sullivan’s disclaimer states he is “consulting with Chrono Therapeutics concerning development and testing of an opioid taper device,” but it fails to mention over $15,000 in consulting fees and travel expenses Sullivan received in 2015 from Pfizer, Janssen, Purdue Pharma, Roxane Laboratories or Teva Pharmaceuticals, according to a Medicare database.
No outside income from drug and medical device makers was reported for Tauben or Ballantyne in 2015, although Ballantyne did serve a few years ago as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies over their opioid marketing practices.
The CDC disclaimer also fails to mention that the University of Washington Medical Center received over $17.2 million last year for research, consulting, and grants from dozens of drug and medical device companies, many of which are involved in the field of pain management and are directly impacted by the CDC guidelines. Ballantyne, Sullivan and other professors at the university played key roles in the development of opioid regulations in the state of Washington, which has some of the toughest prescribing laws in the nation.
Still, the CDC maintains that its planners reviewed the webinar content “to ensure there is no bias.”
Unanswered Questions
How much is the CDC paying the University of Washington and PROP activists to participate in its opioid webinars? Why is only one side of the opioid debate being offered by a federal health agency? We posed those questions to the CDC and have yet to get an answer.
We’ve also been unable to learn from CDC how much the agency is paying a Seattle-based marketing firm called PRR, which is conducting a research and communications analysis about the impact of the prescribing guidelines. PRR handles marketing, research and public relations for dozens of government agencies.
“Yes, the CDC hired us to conduct this research but unfortunately that is all I can tell you at this time. If you want to know more about the specifics of the study, it is best that you contact the CDC directly and they can answer your questions,” Katherine Schomer, a Research Group Account Director at PRR said in an email.
A source at PRR told Pain News Network that what the CDC really wants to know is why its opioid guidelines were so poorly received by the pain community and to find out "where they’ve gone wrong.”
“They’ve heard a lot of outrage about this, specifically from Pain News Network’s survey asking people with chronic pain how they felt about this. That in particular was something the CDC picked up on,” the source said. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”
That survey by PNN and the International Pain Foundation was conducted last fall, months before the CDC guidelines were finalized and released. Even then, many pain patients realized how disastrous the guidelines would be for them.
Nearly 90% of the 2,200 respondents said they were worried or very worried that they would be unable to obtain opioid pain medication if the guidelines were implemented. Large majorities also predicted the guidelines would have a chilling effect on physicians; that doctors would prescribe fewer opioids or none at all; that use of heroin and other illegal drugs would increase; and that there would be more suicides in the pain community.
Virtually all of those predictions have come true, with many patients complaining they are being weaned or taken off opioids, despite years of taking the medications safely. Hundreds of thousands of counterfeit pain medications laced with fentanyl have appeared on the black market, enough to kill dozens of people and for the DEA to warn the nation is in the midst of a “fentanyl crisis.”
Most disturbing of all are anecdotal reports of patients committing suicide because they are unable to obtain pain medication.
All of this is happening in plain sight, as the CDC conducts biased webinars and pays for marketing studies to figure out “where they’ve gone wrong” -- and while the agency refuses to acknowledge publicly that its guidelines have been harmful to patients and are being implemented far too widely.
The Cone of Silence indeed.
