It’s called the FED UP! Coalition, and its leader—Andrew Kolodny, MD—is one of the best known names in the movement to reduce the availability of prescription opioids. Kolodny, who also serves as chief medical officer of New York City-based Phoenix House and president of Physicians for Responsible Opioid Prescribing (PROP), says this coalition, which will hold a rally Sept. 28 in Washington, D.C., is unique in that it includes small groups of people who have lost loved ones to opioid overdoses.
The coalition, which also organized a rally in 2013, also includes PROP and Phoenix House. PROP describes its mission as seeking “to reduce morbidity and mortality resulting from prescribing of opioids and to promote cautious, safe and responsible opioid prescribing practices.”
The idea behind FED UP! was to harness the grief of the hundreds of people across the country who “want to have something meaningful come from their losses,” says Kolodny. “This is a way of coping with the tragedy.”
FED UP! is similar in some ways to Mothers Against Drunk Driving (MADD)—people can mobilize to effect change—but it’s very different in terms of stigma. Kolodny says stigma poses one of the biggest barriers to creating a coalition of people who have lost friends and family members to overdose, whereas no stigma is attached to being run over by a drunk driver.
“The overwhelming majority of people who lost a loved one to a drug overdose don’t tell anyone,” Kolodny says. More than 125,000 people have died from a prescription opioid overdose in the past 10 years. With FED UP! “What you have is a few brave souls who say, ‘To hell with the stigma,’” he says.
Kolodny hopes the groups that make up the coalition will find that they can become more influential in the policy arena. “When we are small and scattered, it’s more difficult,” he says.
Taking aim at the FDA
The coalition's primary focus is on the federal government, says Kolodny. “There’s a lot of frustration with the failure of the federal government to coordinate a response to this crisis,” he says. Instead of working together, agencies such as the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) work at cross-purposes, he says.
“The main problem is the FDA,” Kolodny says.
The regulatory history around hydrocodone offers a good example, he says. In 2004, the DEA tried to put hydrocodone-acetaminophen combination products such as Vicodin on the stricter Schedule II of the Controlled Substances Act, instead of on Schedule III. By 2004, “It was clear we had a serious problem on our hands,” Kolodny says in reference to hydrocodone overdoses.
A popular medication for pain, Vicodin was aggravating the growing opioid epidemic. “The DEA tried to fix that,” Kolodny says. But the way the Controlled Substances Act is written, the FDA needs to approve of a rescheduling. Last fall, the FDA did recommend rescheduling hydrocodone combination products to Schedule II; a decision by the DEA is pending.
The FDA has said in general that it is concerned about patients in pain not being able to access medication as a result of regulatory actions the agency might take. But Kolodny says 92% of the people who died from opioid overdoses were actually taking the medications that had been prescribed to them for chronic pain. “I believe they have become addicted,” he says.
Kolodny also credits the Centers for Disease Control and Prevention (CDC) for “showing that what’s causing this epidemic is the overprescribing of painkillers.” The CDC has connected the dots, showing that as prescribing began to take off, addiction and overdose deaths increased.
“To turn this epidemic around, we need the medical community to prescribe more cautiously,” he says.
While the vast majority of overdose deaths are occurring in people who are taking medications that were prescribed to them, according to Kolodny, the group of young people who got into trouble with opioids and overdose but not on their own prescriptions is represented by the small coalitions that form FED UP!. Many of these groups have as leaders the parents of children who overdosed, he says.
In addition, some of the young people who originally got into trouble with prescription opioids are now turning to heroin, because their physicians no longer are prescribing for them, says Kolodny. They also are overdosing in increasing numbers, but on heroin rather than prescription drugs.