New draft guidelines from the Centers for Disease Control and Prevention (CDC) aimed at reducing opioid abuse and addiction have triggered a backlash from pain management experts, many of whom see the guidelines as being nothing short of misguided
In their attempt to mitigate the real risks and dangers of addiction, critics allege that the new guidelines will cause real harm to a significant subset of chronic pain patients for whom opioids do not pose a threat, and who often do not have any other options to treat their pain.
One nonprofit in particular, Physicians for Responsible Opioid Prescribing (PROP), has drawn much of the ire in the ongoing debate, as several key members of PROP are also members of CDC groups that will have a lot of influence over the final guidelines.
Abrogating Patient-Centered Care
At the heart of the criticisms of the draft guidelines lies the charge that they favor the interests of payors over those of patients
“To me, [the draft guidelines] read as a risk mitigation strategy for physicians and providers, and not as a risk mitigation strategy for patients,” Dr. Lewis said. “If they were, we wouldn’t be using an addiction model.”
As Dr. Lewis sees it, the draft guidelines, which include provisions for urine testing and limit the total number of opioids that can be prescribed to a single patient, do not leave room for pain patients to make decisions about their own treatment.
Rather, she said, the guidelines start from the presumption that every chronic pain patient is a potential opioid addict.
“The difference between a patient in chronic pain and a person who is addicted is, with addiction, we expect a cure,” Dr. Lewis said.
“We expect the patient will recover to the point that they can maintain some cured state—even if they’re on methadone; the goal is to integrate them back into society.
“That doesn’t happen with chronic pain,” she continued.
“Chronic pain is progressive. It’s associated with a multisystem injury to the body, and it’s not going to be cured. So what we want to do is give that person the most optimal tools, in spite of what has happened to them. It’s a big difference in approach.”
Dr. Lewis also criticized the “one size fits all approach” toward pain patients taken by the draft guidelines, a criticism that has been echoed by others in the pain management community.
“We have two national crises, and only one is being addressed by the CDC,” Dr. Webster continued. “We need to address the opioid problem, but we cannot ignore the larger problem of people in pain, which affects many more people.”
Dr. Webster also objected strongly to the inclusion of payors in the development of the draft guidelines, calling it the “most egregious error” in their conception.
“That’d be equivalent to having pharmaceutical companies making opioid guidelines,” he said. “It’s all about money.
Regulation Without Representation
Dr. Webster also expressed frustration that the guidelines were developed without significant input from the pain management community or from chronic pain sufferers, a concern shared by Jeffrey Fudin, BS, PharmD.
Dr. Fudin said the pain community is irate at the way in which the CDC has handled the development of these draft guidelines.
“But the problem is, you have all these patients who are indigent,” he continued. “They just don’t have the wherewithal to rise up against a government agency, or a group like PROP, that’s working 24/7 trying to take opioids away from patients in need.
“And the professionals, we’re spending our time taking care of patients,” he added. “So it’s difficult for us to sit down at the end of the day, day after day, and fight this battle.”
Dr. Fudin raised the question of where advocates for the stringent draft guidelines are receiving funding for their efforts, and echoed Dr. Webster’s concerns about conflicts of interest.
“One group that was on the CDC webinar was CVS—they own a huge, huge PBM [pharmacy benefit manager],” he said.
“Don’t you think that’s a conflict of interest? They don’t want to pay for long-term extended-release opioids. It’d cost them a fortune.”
“It was done in a secret way. There was not a panel of experts, [and] it was not fairly balanced,” he said
Giving the chronic pain community only 48 hours to respond to the guidelines, Dr. Fudin said, was “cruel,” adding that people with chronic pain ought to have been given more time to respond, not less
“I’m just disappointed in the CDC,” he concluded. “What they did was ethically, medically, professionally and morally wrong.”
Andrew Kolodny, MD, PROP’s founder and current executive director, dismissed suggestions that PROP has played a behind-the-scenes role in drafting the guidelines
He also rejected the perception that PROP, through its advocacy, seeks to restrict access to opioids.
Dr. Kolodny is adamant that PROP had no direct role in drafting the guidelines, but also said that it’s “not a coincidence” that several PROP members are on CDC panels that helped to develop the guidelines.
However, Dr. Fudin pointed out that Dr. Kolodny himself is not, nor does he claim to be, an expert in chronic pain. Nevertheless,
Dr. Kolodny attributes much of the benefits that patients perceive from opioids in treating chronic pain to opioid addiction
This is the ultimate insult, accusing us of wanting the medications for the “euphoria” abusers feel. He doesn’t know that when a person has pain, the opioids are used up to fight it, leaving none to cause euphoria.
Opioid abusers and addicts pursue the high, but
pain patients generally don’t feel a high, just relief,
“When you have a hammer, everything looks like a nail,” Dr. Lewis said.
Dr. Kolodny pointed out that many experts in pain management are opposed to using opioids to treat chronic pain, including Richard Rosenquist, MD, chairman of pain management at Cleveland Clinic. Dr. Rosenquist has published his stance on the Cleveland Clinic’s website (http://consultqd.clevelandclinic.org/2015/02/opioids-for-chronic-pain-2/#.VghfzURGR_8.twitter),
Dr. Webster agreed that opioids are not ideal, but maintains that until better treatments are developed—an effort that he believes will require something on the scale of the Manhattan Project—depriving patients who need opioids to manage chronic pain is not the solution.
“There are people in pain who benefit from opioids long term,” he said. “There are probably millions of people today in this country who have been on opioid therapy for years, if not decades, without serious adverse effects, who believe it’s made them more functional and increased their quality of life.
Why would we ignore that?”