fter months of controversy, the Centers for Disease Control and Prevention Tuesday published prescribing guidelines to address the epidemic of deaths and overdoses attributed to opioid painkillers.
The guidelines, which focus on chronic pain except for cancer and end-of-life care, arrive amid intensifying concern over the widely prescribed drugs. Every day, more than 40 Americans die from overdoses of opioid painkillers, according to the CDC. And each year, 2 million people abuse or misuse the drugs.
Many state lawmakers have responded to the crisis by introducing bills to restrict prescribing. And the Food and Drug Administration is pushing drug makers to develop more tamper-resistant products. But the CDC guidelines, while voluntary, arguably represent the most sweeping effort to address the problem.
“Management of chronic pain is an art and a science. The science of opioids for chronic pain is clear — for the vast majority of patients, the known, serious, and too-often fatal risks far outweigh the unproven and transient benefits,” wrote CDC Director Dr. Tom Frieden and Dr. Debra Houry, the director of the CDC’s National Center for Injury Prevention and Control in an essay today in the New England Journal of Medicine.
The guidelines are targeted at primary care physicians, in particular, since family doctors write the vast majority of prescriptions for painkillers. Notably, the agency recommends doctors prescribe opioids only after other therapies have failed and rely on the lowest possible doses.
The CDC also suggests that short-term treatment — typically, just three days, but sometimes seven days — is far more preferable than long-term use. The overriding concern is that patients who take opioids for extended periods are much more likely to become addicted.
“We don’t want people getting more opioids than needed,” said Houry in an interview. “We want people to have a proper course of treatment, but still want patients and health care providers to use caution.”
To what extent the guidelines will be adopted is uncertain. Although the opioid epidemic has received substantial publicity and policy makers are more aggressively trying to combat the problem, the CDC recommendations are just that — recommendations. Another unknown is whether more people will turn to heroin if opioids are harder to obtain, said Alison Insinger, editor of Alcoholism & Drug Abuse Weekly.
Nonetheless, the effort was welcomed by the Physicians for Responsible Opioid Prescribing, an education and advocacy group, whose president was a member of an expert working group that helped draft the guidelines.
“It’s the first time the federal government has clearly communicated to the medical community that widespread and routine practice of treating long-term chronic pain with opioids is inappropriate,” said Dr. Andrew Kolodny, the group’s executive director, who is chief medical officer at Phoenix House, a nonprofit that runs drug abuse treatment and prevention programs.
The opioid epidemic has been fueled by what some say is improper marketing by drug makers.
Nearly a decade ago, Purdue Pharma and three former executives pleaded guilty to fraudulently marketing OxyContin as less addictive than other pain medications and paid $634 million in fines. More recently, Purdue and other drug makers have been sued by some local governments for allegedly misleading consumers about the risks of their opioid painkillers.
The guidelines were more than a year in the making, and the CDC encountered considerable pushback from some patient groups after a preliminary version of the guidelines was leaked online last fall. The groups argued that the agency relied on weak evidence to generate its recommendations. They also feared that some patients would be denied needed pain relief, an issue they continue to press.
“We’re concerned that rather than trying to understand the nuance involved, many clinicians will simply implement suggested dosing and duration recommendations as de facto limits, (instead of) thresholds that trigger additional actions,” said Bob Twillman, who heads the American Academy of Pain Management, which receives financial backing from the pharmaceutical industry.
Some groups voiced considerable opposition to the guidelines at a meeting last December of the Interagency Pain Research Coordinating Committee. However, the meeting itself became controversial because some of the groups also receive financial support from drug makers that sell opioid painkillers. Their involvement prompted US Senator Ron Wyden (D-Ore.) to ask the US Department of Health and Human Services to conduct an inquiry.
The kerfuffle prompted the CDC to ask the National Center for Injury Prevention and Control’s Board of Scientific Counselors to review the guidelines. In the end, the board supported the CDC, and the agency tweaked its initial version of the guidelines. The CDC maintains that its critics are misguided because there simply isn’t sufficient evidence available to evaluate the long-term use of opioids or compare them with other treatments.
Most placebo-controlled, randomized trials of opioids have lasted six weeks or less, and CDC officials are not aware of any study that has compared opioid therapy with other treatments for more than one year and produced outcomes related to pain, function or lifestyle, wrote Frieden and Houry in their essay. “In fact, several studies have showed that use of opioids may actually worsen pain and functioning.”