Scott Gottlieb, commissioner of the Food and Drug Administration, told the Washington Post this week his agency will require drug companies to study whether opioids already on the market actually work for chronic pain. Although these drugs often have been prescribed for patients with chronic pain, particularly in the past, there is controversy about how much good they do beyond the first few weeks after an injury. Efforts to reduce the amount of prescription opioids in circulation have ramped up in recent years as the country has struggled to combat the growing opioid addiction problem. That is primarily fueled now by heroin and fentanyl, but prescription drugs also find their way to the street and may give future addicts their first exposure to opioids.
Gottlieb also told the Post that he will require drug companies to determine whether the drugs can paradoxically make patients more sensitive to pain. That, along with tolerance to the drugs, can lead to higher doses and dependence. Patients experiencing withdrawal may also have increased pain.
A statement from Gottlieb on opioid policy posted Tuesday by the FDA did not address whether companies would be required to study their drugs in chronic pain patients. It did say the agency will promote development of nonaddictive pain drugs, and that it will support drug packaging that allows appropriate acute pain patients to get prescriptions that contain only enough medication for a day or two. It also will step up enforcement efforts against illicit opioids.
It could lead to changes in labeling and prescribing rules. There’s growing recognition that authorities and physicians underestimated the addictive potential of the drugs, which were once used primarily for acute pain, severe cancer pain, or pain at the end of life. The FDA allowed long-term use of OxyContin in 2001. A local pharmaceutical executive has been outspoken in arguing that that was a mistake.
The Centers for Disease Control and Prevention found no studies of long-term use of opioids that compared them to other treatments. A 2017 report from the National Academies of Sciences, Engineering, and Medicine concluded that the current evidence does not support long-term use for chronic pain.
Gottlieb is seeking more rigorous studies.
In a 2018 study, Erin Krebs, a researcher at the Minneapolis VA Health Care System, compared two groups of patients with serious and chronic back, hip, and knee pain. The group not on opioids tried an average of four pain medications, requiring careful trial and error under close medical supervision. Compared with the second group, who took opioids, those who had other therapies scored the same on measures of function, but reported less severe pain and many fewer side effects.
Surgeons have begun using opioids more sparingly during their patients’ hospitalization and recovery. That has reduced the number of people who felt they needed the drugs long-term. Pre-surgical education can also reduce use of pain medication afterwards.
New Medicare rules went into effect this year, adding extra oversight if doctors exceeded certain opioid dosages. Although the new rules do not prohibit higher doses, they add to physician and pharmacist workloads. Many private insurers already had such rules. Many chronic pain patients said doctors have required them to taper to lower doses or have referred them to pain experts.
Many chronic pain patients have been vocal in their opposition to greater restrictions on medications they say have been life-altering in a positive way. Many said they were nearly incapacitated by pain before opioids allowed them to participate more fully in life. Some experts who have worked with such patients believe that people who are on high doses and are doing well should be treated differently than new patients. Cutting their doses too fast could lead to greater disability, depression, suicide, and illicit drug use.