CDC’s new opioid guidelines will be used by plaintiffs bar, WLF says
WASHINGTON (Legal Newsline) – A Washington, D.C.-based public-interest law firm that has been outspoken about the Centers for Disease Control and Prevention’s handling of an opioid guideline development team argues the agency’s new guidelines, which were issued this month, will “no doubt” have an effect on future litigation.
Richard Samp, chief counsel for the Washington Legal Foundation, argues plaintiffs law firms, including Cohen Milstein Sellers & Toll PLLC, will use the CDC’s approval and release of the guidelines to their advantage.
“Will the plaintiffs bar use these guidelines in their pending litigation? I have no doubt that, yes, they will,” Samp told Legal Newsline.
The CDC released its new guidelines regarding prescriptions for opioid painkillers, such as Vicodin and OxyContin, March 15. The guidelines, which are voluntary, recommend primary care physicians:
* Use non-opioid therapy for chronic pain management, outside of active cancer, palliative and end-of-life care;
* Prescribe the lowest possible dosage when opioids are needed; and
* Always exercise caution when prescribing opioids, monitoring patients closely.
“Overprescribing opioids — largely for chronic pain — is a key driver of America’s drug-overdose epidemic,” CDC Director Tom Frieden said in a statement. “The guidelines will give physicians and patients the information they need to make more informed decisions about treatment.”
Samp says WLF takes no issue with the guidelines themselves, but the agency’s procedures used to develop the guidelines.
“We’re not medical experts,” he said. “We take no issue on whether guidelines should be issued, or what they should say.
“But we do recognize there is a broad spectrum of views as to what could be done, and the process used by the CDC did not provide a fair opportunity for everyone to participate.”
For one, Samp argues the CDC did not follow the Federal Advisory Committee Act.
FACA, which became law in 1972, governs the behavior of federal advisory committees.
Under the law, an advisory committee is defined as “any committee, board, commission, council, conference, panel, task force, or other similar group” that dispenses “advice or recommendations” to an agency or government official.
Committees composed of full-time officers or employees of the federal government do not count as advisory committees under FACA.
The CDC has argued that its Core Expert Group, or CEG, didn’t qualify as an advisory committee under the federal law.
WLF, in a 13-page letter sent to Frieden in November, countered that the CEG indeed fell under the definition and was required to comply with each of the law’s “numerous obligations,” including opening all meetings to the public; publicly releasing all documents that the CDC made available to the CEG; and preparing and publicly releasing minutes of all CEG meetings.
Instead, the CDC complied with none of the requirements, Samp and General Counsel Mark Chenoweth wrote in their letter for WLF.
“(The CDC) nominated this advisory group to help come up with these guidelines, but the group met totally in secret,” Samp said.
“Only after the initial draft guidelines were released did they say who was on the advisory group.”
A complete list of the Core Expert Group members and other internal documents surrounding the prescribing guidelines surfaced in September.
The names on the list included Jane Ballantyne, a paid consultant for Cohen Milstein.
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 in 2014 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.”
WLF, in its letter, pointed out that Ballantyne was one of “numerous” members of the CEG who were on record — well before joining the committee — as “strongly supporting the need to tighten opioid prescribing standards.”
“Conspicuously absent from the CEG, however, were physicians and others with experience in treating patients suffering from chronic pain,” Samp and Chenoweth wrote.
The foundation called Ballantyne’s inclusion the “most egregious.”
Ballantyne disclosed her services as a paid consultant for Cohen Milstein to the CDC, but didn’t recuse herself. The plaintiffs law firm 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.
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, and another by the California counties of Orange and Santa Clara.
It also is trying to assist the New Hampshire Attorney General’s Office in a similar investigation over drug makers’ marketing of the powerful prescriptions. However, a state judge recently struck down the contingency fee agreement between the attorney general and Cohen Milstein.
“Clearly, if the CDC issues guidelines that essentially urge states to change prescribers’ practices and to implicitly criticize past prescribing practices, that’s something you would expect Cohen Milstein in its lawsuits around the country against drug companies to tout,” Samp explained. “It’s in the direct financial interest of plaintiffs lawyers to have these CDC guidelines adopted.
“That’s why we think it was a terrible mistake to include people like Jane Ballantyne on its advisory group, when she clearly has an interest in the outcome.”
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, has countered that Ballantyne is “one of the most respected pain specialists in the country,” which is why the CDC asked her to join its expert group.
No doubt in response to the public outcry over the development of its guidelines, the CDC announced in December it planned 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.
The public comment period ended Jan. 13, pushing back the agency’s original release date. The CDC had hoped to release the opioid guidelines in January.
Also in December, the CDC said it would convene the National Center for Injury Prevention and Control’s Board of Scientific Counselors, a federal advisory committee, to review the draft guidelines.
“I would like to think that the CDC’s decision in December to slow things down might have been based, in part, on our complaints,” Samp said. “But they never really corrected the problem.
“It again displays their misunderstanding of what is required by FACA.”
From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.
Filed under: General Problems
The CDC also refused to look at any state data, in states where they applied these guidelines before the CDC did. My state enacted draconian opiate restrictions, and a PDMP in 2011. The rates of overdose, new heroin addictions, and suicides all went up. The physicians on the Opiate Board, used their positions to advertise all kind of products, amplify useless and biased research, and tailor the narrative for corporate funding.
A self described “Pain Researcher” who is on the Opiate Board, used her position to get funding for her “research.”
https://www.abqjournal.com/1045059/kinesio-offers-unm-300k-for-new-center.html
https://medium.com/@anthonyroberts/kinseio-tape-sued-in-consumer-fraud-class-action-2a6f9927dbb4
This is just one example of how they peddled everything but the kitchen sink, to fight the so called opioid epidemic. They turned their positions on state boards into lucrative marketing careers. They marketed all kinds of gimmicks as if they would protect people from heroin addiction. They cut a deal with Walmart too, https://www.dea.gov/events/2019/03/06/new-mexico-youth-summit-opioid-awareness The Walmart parking lot can give anyone and education on “Opiate Awareness.” In this state a lot of the illegal drug activity goes on in Walmart’s parking lot. Walmart profited from the selling of millions of doses of opiates, and attacked pain patients, instead of their suppliers.
Nobody questioned providing free corporate advertising to address a serious public health problem, that the very same corporation contributed to. Walmart was instrumental in cutting public health services. Their owners and shareholders did not have a problem with our states destruction of their behavioral health system, in order to enrich a few political donors. https://nonprofitquarterly.org/former-provider-sues-in-new-mexico-mental-health-dispute/ Walmart’s employees were relying on food banks, food stamps and Medicaid. While the owners, lobbied for less Medicare, and cutting taxpayer funding for behavioral health and addiction services.
The CDC, FDA, and even the FTC were supposed to protect us all. Instead they turned a public health issue, into a marketing scheme. 22 years out, they are no closer to a solution than they were then. These agencies have been undermined and rendered ineffective by corporate lobbyists. At the root of the problem is money in politics. These agencies were instrumental in protecting the corporations that are still profiting. The corporations even undermined CMS data collection, to protect their interests.
This state is still complicit with the corporations that brought us here. They proudly announce their “public private” partnerships. No one looked at the Fact that half of this state can’t even afford healthcare. Years ago, a job at Walmart was required in order to get Medicaid. Walmart has been getting millions in taxpayer subsidies for “Job Training” a deal our politicians made secretly, in return for corporate money. They took educational funding meant to fund education and funneled it to Walmart. 20 years out we can see how this destroyed small business and undermined democracy.
Every single on of our federal agencies were strategically underfunded, as industry insiders were put in charge. This is how unregulated capitalism operates. Everyone knew that opioids were addictive, but they were profitable!
https://www.theguardian.com/us-news/2019/jul/24/opioids-crisis-big-pharma-drugs-carnage
Jane Ballantyne tried to hold herself out as the pain expert. Anesthesiology and a actual pain management physician are very different specialties. Anesthesiologist’s mainly control patients pain during surgery or procedures, In Vaginal delivery they frequently place epidurals or spirals for c/section. They are not responsible for other pain management, especially chronic pain. She is NOT board certified in pain management, although she was deceitful by trying to hold herself out as the pain expert. The wasn’t a single physician who was a pain management expert. The CDC has blood on their hands considering they knowingly wrote these guidelines in secret with out a single pain management expert!!! That’s the minimum complaints. How many patients are suffering, dead or committed suicide?? Kolodny is an addiction specialist and doesn’t treat pain at all. He’s the worst anti-opioid zealot in this country. He takes no responsibility for the suffering patients with chronic pain have endured. He’s a liar just lining his pockets with $$$!!!
That’s all good and well, but looks like it was from 3 years ago. What’s happened since? Did they bring a suit against them? That’s what needs to happen!
I think that many -falsely believed – that the entire CDC guidelines would be followed … not just a particular sentence, paragraph or page out of 90+ pages and the fact that they stated that it was just guidelines and didn’t bear the weight of law.. IMO.. there is a much higher chance of some sort of lawsuits starting in the not to distant future. Some believe that the CDC did not have the statutory authority to publish those guidelines and now this legal opinion suggests that they did not follow the existing laws… even if they did have statutory authority.. Some are calling for them to be revised.. IMO… BAD IDEA.. just have them declared unconstitutional and and tossed out..