ATLANTA (Legal Newsline) - The Centers for Disease Control and Prevention continues to catch flak for its handling of an opioid guideline development team -- a member of which served as a paid consultant to a prominent plaintiffs law firm that reportedly has been shopping around opioid litigation and has filed at least two lawsuits on behalf of public officials.
Pain advocacy groups, prominent medical organizations and even some federal agencies have balked at how the CDC developed its guidelines, which are aimed at helping physicians more responsibly prescribe opioids, arguing the process did not include much public input and was done behind closed doors.
Peter Pitts, a former associate commissioner of external affairs at the U.S. Food and Drug Administration and now president and co-founder of the Center for Medicine in the Public Interest, can be counted among those critical of how the panel was put together.
Pitts, who worked for the FDA from 2002 to 2004, was the senior official in charge of advisory committees.
“Obviously, when you put committees like these together, you want the best and brightest,” he said in an interview with Legal Newsline. “But there are also issues of bias you have to consider.”
Biases are especially important when it comes to medical and science issues, Pitts noted.
“Medicine and science are not binary, they’re not black and white,” he said. “There are many shades of gray. So you have to have as open of a mind as possible.”
And that’s exactly where the CDC went wrong, Pitts said, pointing to Jane Ballantyne. Ballantyne served as a member of the CDC’s “Core Expert Group,” which played a key role in developing the agency’s opioid guidelines.
Ballantyne, a retired professor of anesthesiology and pain medicine at the University of Washington, is a member of the International Association for the Study of Pain, or IASP, and last year was named president of the Physicians for Responsible Opioid Prescribing, or PROP.
PROP’s mission, according to its website, is to “reduce opioid-related morbidity and mortality by promoting cautious and responsible prescribing practices.”
“Not only does she have strong opinions, but extra strong opinions -- almost on the lunatic fringe -- on pain medicine issues,” Pitts said.
“For the CDC to say, we’re going to put someone who comes to the discussion with such preconceived notions on such a committee, you have to ask yourself, why? And then why was it hidden from the public?”
Andrew Kolodny, a senior scientist at the Heller School for Social Policy and Management at Brandeis University and PROP’s executive director and co-founder, took issue with Pitts’ characterization of Ballantyne and her work.
“Dr. Jane Ballantyne is one of the most respected pain specialists in the country and internationally, which is the reason the CDC asked her to join their expert group,” he said in a statement to Legal Newsline.
“Mr. Pitts should be ashamed of himself for attempting to smear Dr. Ballantyne’s reputation.”
Pitts noted Ballantyne’s connection to law firm Cohen Milstein Sellers & Toll PLLC -- a plaintiffs law firm that is known for its class action lawsuits and has been hired by a number of state attorneys general in recent years, including some of those to whom it donated.
Ballantyne reportedly disclosed her services as a paid consultant for Cohen Milstein to the CDC. The firm currently is helping to represent the City of Chicago in a lawsuit filed against a group of pharmaceutical companies over the marketing of opioid painkillers.
It is also helping to represent the California counties of Orange and Santa Clara in a similar suit.
But the connection between Ballantyne and Cohen Milstein only came to light after a complete list of its Core Expert Group members and other internal documents surrounding the prescribing guidelines surfaced in September.
“For a guideline to be credible, it is important to eliminate or effectively manage sources of bias. These sources of bias might include financial relationships with industry, intellectual preconceptions, and previously stated public positions,” the CDC said in the internal documents.
“Prior to participation, CDC asked CEG members to reveal potential conflicts of interest. Members could not serve if they held conflicts that could be anticipated to have a direct and predictable effect on the recommendations.”
Still, Ballantyne didn’t recuse herself, Pitts noted.
Instead, the CDC “stacked the deck,” he said.
“I think it’s safe to say they were trying to pull a fast one on the American public and got caught with their hands in the cookie jar,” he said.
When it comes to government agencies and public health, Pitts said transparency is “crucial.”
“Here, they brought together a group of people who all agreed on the same basic premise,” he said of the CDC. “On top of that, they deliberated in secret and then refused to release who helped craft these guidelines until they were forced to.”
Not to mention the CDC “specifically excluded” anyone from the FDA from serving on the committee, Pitts said.
“I think they realized the FDA wasn’t going to go along with their Mickey Mouse-process,” he said.
According to reports, both the FDA and the National Institutes of Health have slammed the prescribing guidelines.
Sharon Hertz -- the FDA’s director of the Division of Anesthesia, Analgesia and Addiction Products -- has said the level of evidence cited to support the CDC’s guidelines “is low to very low and that’s a problem.”
The guidelines are part of the Obama administration’s efforts to combat the country’s growing overdose problem, which has been attributed to prescription painkillers.
According to the CDC, prescription painkillers, or opioids, can be used to treat moderate-to-severe pain and are often prescribed following a surgery, injury or for health conditions such as cancer.
In recent years, there has been a dramatic increase in the acceptance and use of prescription opioids for the treatment of chronic, non-cancer pain, such as back pain or osteoarthritis.
No doubt in response to the public outcry over the development of its guidelines, the CDC now plans to publicly post the guidelines and seek comment.
“We received feedback from our partners that a formal public comment period would be helpful, and we are augmenting our process to incorporate a 30-day public comment period into our guideline development,” the agency said in a statement Monday.
The public comment period opened Monday and closes Jan. 13.
That means the guidelines won’t be released in January, as the agency originally planned.
The CDC said it also will convene the National Center for Injury Prevention and Control’s Board of Scientific Counselors, a federal advisory committee, to review the draft guidelines.
From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.