The U.S. Centers for Disease Control and Prevention recently came out with controversial proposed guidelines for opioid prescribing through a process that critics say may harm pain patients and is based on relatively low-grade evidence.
One of those critics is Cindy Steinberg, national director of policy and advocacy for the U.S. Pain Foundation, a patient advocacy group which receives funding from opioid manufacturers. Steinberg said in an interview and in emails that she’s worried the guidelines may negatively impact patients suffering with severe pain. “I am concerned that if these guidelines go forward as they are now written, they will lead to further restrictions on access to opioids for people with unremitting pain who truly need them and take them responsibly,” she said.
Dr. Jane Ballantyne, president of the non-profit Physicians for Responsible Opioid Prescribing (PROP), which is part of a larger group involved in the guidelines process, said in a telephone interview that the worry about limited access to opioids for chronic pain patients is a “very legitimate fear.” But, she added: “We don’t want to reduce access for people already dependent on opioids. The guidelines are designed to not have so many people dependent on opioids in the future…”
Ballantyne said that the new guidelines are similar to previous guidelines with two key exceptions: lower dose limitations and the recommendation that, for acute pain not related to major surgery or trauma, opioids should be prescribed for only three days.
The month-long period for public comment on the proposed guidelines will be over Jan. 13.
A major concern of some critics is the lack of solid evidence backing up the guidelines, which give recommendations on prescribing practices; they include when to start opioids, how to establish treatment goals, how to discuss risks and benefits, recommended limitations on drug doses, duration of treatment and other issues.
For instance, the fifth of the 12 recommendations says that physicians should generally avoid increasing dosage to more than 90 “morphine equivalents” per day. (Opioids differ in potency. One opioid may be three times as potent as another, so doctors use morphine equivalency tables to compare doses.)
But the quality of the evidence backing up this recommendation is rated only “3,” a low rating, acknowledged by the CDC itself. In addition, calibrating morphine equivalents is an inherently tricky process, with multiple, potentially conflicting formulas available. (Moreover, some patients in severe pain may need higher doses.)
The CDC guidelines are aimed at adults with chronic pain “outside of active cancer treatment, palliative care, and end-of-life care.” The guidelines are advisory, not mandatory, but are nonetheless likely to be a powerful influence on physicians, insurers and other government agencies.
The potential problems with the new guidelines are serious enough that on Dec. 18, the U.S. House Committee on Oversight and Government Reform sent a letter to Dr. Thomas Frieden, the CDC director, sharply questioning why the CDC recruited a so-called “core expert group” to write the guidelines instead of complying with standard government (FACA) regulations for establishing advisory groups. (FACA is the Federal Advisory Committee Act.)
On its website, the CDC says it did use a transparent process to create the guidelines.
Among the groups opposing the new guidelines is the American Cancer Society Cancer Action Network, (an advocacy group which lists major drug companies on its corporate member list) which has called for the CDC to withdraw the guidelines, stressing that they were based on “limited” and “low quality” evidence. In a letter to Frieden in October, the cancer group wrote: “We have concerns about the lack of evidence on which the guidelines were based, the methodology used to develop the guidelines and the transparency of the entire process.”
Seven of the 12 recommendations were “very low quality evidence” and five of the 12 were based on “low quality evidence,” according to the cancer group’s letter, which also noted that the CDC’s attempt to solicit public input on the guidelines was “cursory and did not allow adequate opportunity for thoughtful responses.”
I asked the CDC to respond. In an email, a spokesperson said: “Clinical guidelines are always based on best available evidence, including low quality evidence. This does not mean ‘bad’ evidence, it means that not enough randomized control trials were conducted.”
Ballantyne, PROP’s president, acknowledged the lack of good randomized controlled trials on long-term safety and efficacy. But doing such trials is impractical, she said. From clinical experience, she added, “if you use opioids long term, they don’t give you good enough pain relief to warrant the risk.”
(The non-profit PROP “has received financial support from some of its members and from a few individual donors who have been personally impacted by the opioid crisis. We have never accepted corporate support,” according to its executive director, Dr. Andrew Kolodny.
The American Medical Association, on December 17, stated its concern that the guidelines lack “a patient-centered view and any real acknowledgement of the problems chronic pain patients may face.”
In other letters to the CDC (that I obtained) a number of industry-backed organizations expressed concerns, including the American Academy of Pain Management, the Oncology Nursing Society, the Interstitial Cystitis Association and the U.S. Pain Foundation.
The CDC guidelines note that prescription opioid sales have increased by 300 percent since 1999, but also say that “there has not been an overall change in the amount of pain Americans report.” But in 2011, the Institute of Medicine documented the growing chronic pain problem, noting that more than 100 million American adults now live with chronic pain, an increase over previous estimates. The IOM report said the incidence of chronic pain is growing and is likely to continue to do so.