By Pat Anson, Editor
A pro-business legal foundation with a history of taking government agencies to court is asking the Centers for Disease Control and Prevention (CDC) to withdraw plans to release new guidelines for the prescribing of opioid pain medications.
In a letter to CDC Director Tom Frieden, the Washington Legal Foundation accused the agency of “blatant violations” of the Federal Advisory Committee Act (FACA), which requires federal agencies to identify members of advisory committees and hold committee meetings in public. As Pain News Network has reported, the CDC has refused to publicly disclose the identities of the “Core Expert Group” that initially drafted the guidelines.
“The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers,” wrote Washington Legal Foundation (WLF) chief counsel Richard Samp in his letter to Frieden.
“More importantly, CDC’s repeated violations of the Federal Advisory Committee Act call into question the viability of the entire enterprise and dictate that any guidelines adopted as a result of the current administration process could not withstand judicial scrutiny. We call on CDC to withdraw the Draft Guideline and to generate reliable data on ways to ensure adequate treatment of patients while preventing opioid abuse before renewing efforts to write a guideline.”
The CDC’s draft guidelines for primary care physicians recommend “non-pharmacological therapy” as the preferred treatment for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended when the drugs are prescribed for acute or chronic pain. Many pain sufferers fear they will lose access to opioids when the CDC plans to adopt the guidelines in January 2016. A complete list of the guidelines can be found here.
The identities of the CDC’s Core Expert Group (CEG) were leaked soon after the draft guidelines were released in September. The group includes Jane Ballantyne, MD, President of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to end the overprescribing of opioids. PROP Vice President Gary Franklin, MD, is also part of CEG. Critics say Ballantyne, Franklin and several others who advised the CDC have a conflict of interest and never should have served as consultants on the guidelines.
The CDC says it withheld the identities of the Core Expert Group so its members could “provide honest and independent comment and feedback.” The agency also maintains that CEG does not qualify as a FACA advisory committee.
“CDC’s secrecy, and its apparent indifference to conflicts of interest by those likely to support news restrictions on opioids, have led many to conclude that CDC is uninterested in conducting administrative proceedings that give all interested stakeholders an equal opportunity to attempt to influence the agency’s decision making. If CDC is to overcome its tarnished image, it must immediately eliminate its culture of secrecy and apply its conflict-of-interest rules in an even handed manner,” Ramp wrote in his letter to Frieden and Debra Houry, director of the CDC’s National Center for Injury Prevention and Control, which oversaw development of the guidelines.
A spokesman for the Washington Legal Foundation told Pain News Network the CDC had not yet responded to the group’s complaint. He also declined to say how the foundation would respond if the guidelines were not withdrawn.
WLF describes itself as a public interest law firm “that regularly litigates to ensure that federal administrative agencies comply with statutes designed to ensure procedural fairness.” The non-profit foundation generally supports business groups and companies in litigation against government agencies, and has represented or acted in behalf of pharmaceutical companies such as Johnson & Johnson and Purdue Pharma, the maker of OxyContin.
"We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants," a spokesman for Purdue Pharma told Pain News Network.
WLF does not disclose the names of its donors. According to Greenpeace, WLF has accepted over $1 million in donations from foundations representing Charles and David Koch, two billionaire brothers who actively support conservative causes.
Senators Support CDC
With the CDC under fire from pain patients and advocacy groups, eight U.S. Senators have written a letter to Frieden expressing their support for the CDC’s guidelines.
“We are committed to doing everything in our power to bring this (opioid) epidemic under control because our communities are hurting. The problem will only grow worse if we fail to act,” the letter says. “We applaud the CDC for developing prescribing guidelines and for your efforts in the fight to end prescription drug abuse. We strongly urge you to maintain this commonsense approach when you release the final guidelines early next year.”
The letter is signed by Sens. Joe Manchin (WVa), Ed Markey (Mass), Tammy Baldwin (Wisc), Dianne Feinstein (Calif), Jeanne Shaheen (NH), Bill Nelson (Fla), Richard Blumenthal (Conn) and Angus King (Maine).