From the Alliance for Patient Access, a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
The Centers for Disease Control and Prevention has drafted new guidelines on prescribing opioids for chronic pain—and they could be bad news for patients living with pain. Released via webinar last week, the CDC’s guidelines have unsettled patients and incited controversy for a number of reasons
1. CDC guidelines overlook the legitimate medical need of patients with chronic pain.
The guidelines focus almost solely on reducing abuse—identifying non-pharmacological treatment as “preferred” and advising reduced dosages for patients who rely on opioid pain medications to manage chronic pain.
In a joint letter from patient advocacy organizations to CDC leadership, signers explained that, “By addressing only how to limit or avoid opioids, the new guidelines will inevitably result in fewer prescriptions overall – including those needed by patients with legitimate medical needs. Chronic pain advocacy organizations hear daily from increasing numbers of constituents who are not being able to access the opioid medications they’ve relied on to live with their chronic painful conditions.”
2. CDC’s development process lacked transparency.
Slides used in the CDC’s webinar did not provide the names and affiliations of those who worked to promulgate the guidelines. As the aforementioned letter described, “The [webinar] presenters refused to provide any information other than to read exactly what was written on the slides even when asked directly by audience members to disclose the processes and people who had developed these prescribing guidelines.”
The CDC has not provided the public a list of the Core Expert Group members who assembled the guidelines.
3. CDC guidelines do not acknowledge FDA process and guidance.
The Food and Drug Administration requires safety and efficacy data for all medications, including the opioid pain medications it has approved. The FDA also approves an information insert to guide physicians in prescribing approved medications. By creating its own recommended daily maximum doses, the CDC effectively disparages FDA’s expertise.
4. CDC guidelines advise on minimizing the risk of abuse, but offer physicians little direction on helping patients manage their pain.
As patient advocates explained, “We need CDC to provide some context around the incidence and prevalence of undertreated pain and the related adverse consequences of undertreated chronic pain on all body systems. With these insights it may actually be possible to improve pain care rather than restricting one treatment based on perceived, not quantified, harms to legitimate patients.”
CDC’s complete guidelines are not available publicly, but a summary can be accessed on CDC’s website.