By Pat Anson, Editor
A key government panel that oversees pain research will file a formal objection to proposed opioid prescribing guidelines being drafted by the Centers for Disease Control and Prevention (CDC). Those guidelines, which are set to be released next month, would discourage primary care physicians from prescribing opioid pain medications.
The National Institute of Health’s Interagency Pain Research Coordinating Committee believes there is little or no evidence to support many of the prescribing guidelines, according to Politico. Some committee members reportedly called the agency’s recommendations “ridiculous” and “an embarrassment to the government” during a meeting Thursday.
The pain research committee includes representatives from the Food and Drug Administration, Agency for Healthcare Research and Quality, Department of Veterans Affairs, Department of Defense, and the CDC itself.
Evidence cited to support the guidelines "is low to very low and that's a problem," said Sharon Hertz, the FDA's director of the Division of Anesthesia, Analgesia and Addiction Products.
The CDC unveiled the draft guidelines in September to a select online audience and then allowed only 48 hours for public comment. The guidelines, a list of which can be found here, recommend “non-pharmacological therapy” as the “preferred” treatment for non-cancer pain, and state that limited quantities and doses of opioids should be prescribed for both acute and chronic pain.
Complaints immediately arose from physician organizations and patient advocacy groups that the guidelines were developed in secret, with too much input from special interest groups, addiction control specialists, and Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. Five PROP board members, including its President, Vice-President and founder, are on committees that helped the CDC draft the guidelines.
The CDC developed the guidelines to combat what is often called an epidemic of prescription drug abuse and overdoses, but the agency’s own documents acknowledge there is “low quality of evidence” or “very low quality” to support many of its recommendations. For example, one guideline would greatly expand access to addiction treatment drugs such as buprenorphine and encourages physicians to refer patients to addiction treatment programs. Although "strongly recommended" by the CDC, the quality of evidence for that guideline is considered low.
The agency also admitted it rushed through the process, apparently to meet a January deadline.
“CDC conducted ‘rapid reviews’ of the contextual evidence on alternative treatments, benefits and harms, values and preferences, and resource implications. Rapid reviews are used when there is a need to streamline the systematic review process to obtain evidence in a short time frame. Methods used to streamline the process include limiting searches by databases, years, and languages considered, and truncating quality assessment and data abstraction protocols. Given the public health urgency of developing opioid prescribing recommendations, a rapid review was required for the current guideline,” the agency said in briefing documents obtained by Pain News Network.
A top official in the Department of Health and Human Services told the NIH research committee the CDC’s guidelines were “shortsighted” and there was a rush to judgement.
"You know, damn the torpedoes. Full speed ahead," said Wanda Jones, principal deputy assistant secretary for health at HHS, according to Politico.
Pain patients agree the CDC guidelines are shortsighted and could have a disastrous impact on the pain community. In a survey of over 2,000 patients by Pain News Network and the Power of Pain Foundation, over 90% said the guidelines were discriminatory and would be more harmful than helpful to pain patients. Most said they had already tried non-opioid treatments, such as massage, acupuncture and cognitive behavioral therapy, and found that they didn’t work. Many predicted the guidelines would lead to more suicides in the pain community, and cause more addiction and overdoses, not less.
Last month the Washington Legal Foundation (WLF) accused the CDC of “blatant violations” of federal law for not holding public hearings and refusing to publicly identify members of its advisory committees.
“The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers,” wrote WLF chief counsel Richard Samp to CDC director Tom Frieden.
The WLF has a lengthy history of taking government agencies to court to overturn regulations and policies it considers unfriendly to business.
Additional reporting for this story can be found in DrugWonks.