The FDA’s decision to more tightly control prescription pain medications surely will save lives. While Thursday’s news came too late to save Steve Rummler, his parents were happy to hear it.
“Wow!” said Judy Rummler who, with husband, Bill, was back east visiting family when she learned of the FDA’s long-awaited decision. “This is the most exciting news we’ve had since we started this effort.”
The Rummlers, of Edina, can be credited with influencing the dramatic policy shift.
Judy and Bill are founders of the Steve Rummler Hope Foundation, named for their son, a gifted musician and financial adviser.
In 1996, Steve, who was once an all-conference soccer player at Edina High School, suffered a severe back injury. Despite many attempts to break free of pain medications for 15 years, he died of an accidental overdose at age 43.
At the time, Judy Rummler had no idea that her family’s tragedy was playing out with alarming frequency nationwide. She soon learned that 15,000 people die annually from prescription drug overdoses.
She also had no idea how reluctant the FDA would be to recommend stricter controls on popular pain medicines, despite support for tighter oversight from the Drug Enforcement Administration and Centers for Disease Control and Prevention.
The government estimates that more than 130 million prescriptions for hydrocodone-containing medications were written for about 47 million patients in 2011, the year Steve died.
The FDA, taking its cue largely from physicians’ groups, originally argued that tightening controls would create unnecessary hardship for patients. Drug and pharmaceutical lobbyists, not surprisingly, have been doing what they can to derail the process.
So Rummler, joining leaders of other similarly focused organizations, has been pushing back, testifying before congressional committees, speaking to Rotary clubs and attending drug summits. Earlier this year, she met with FDA Commissioner Margaret Hamburg.
“She seemed very compassionate,” Rummler said of Hamburg, “but she has to go by the recommendations of her subordinates.”
The turning point, Rummler believes, occurred on Oct. 1, when 600 people from several states protested on Capitol Hill during their “Fed-Up Rally.” The rally, chaired by Rummler, demanded a federal response to the opioid epidemic.
Families talked about loved ones lost to pain killer addiction, or their own near-death experiences. Medical experts testified and “Amazing Grace” was sung.
“It was very emotional,” Rummler said. “The FDA saw us coming together. I think that led to the action.”
Steve’s fiancée, Lexi Reed Holtum, also was heartened by the news. The Rummler Foundation’s vice president was in Denver Thursday, attending a drug conference to learn how to create stronger public health support for Minnesotans struggling with painkiller addiction.
Holtum said she’s working to bring a good-Samaritan-type law to our state to protect people who call the police when they witness someone overdosing on opioids. She’s also gathering information on Narcan, an opioid antidote, with the hope that law enforcement officials here will consider carrying it.
Administered by nasal spray, Narcan blocks the ability of heroin or opioid painkillers to attach to brain cells. It has been used for years by paramedics and emergency room doctors in other states. One police department in Massachusetts reported a 95 percent success rate in saving patients by using the treatment, “yet, first responders don’t always have it,” Holtum said.
The FDA measures, expected to go into effect in 2014, will reduce by half, to 90 days, the supply of the drug a patient may receive without a new prescription. In addition, patients will be required to take their prescription to a pharmacy instead of having a doctor call it in.
Most heartening for the Rummlers is that Vicodin, the most prescribed drug in America, as well as other hydrocodone-combination products, will be reclassified from Schedule III to Schedule II status, placement that requires increased attention to the potential for abuse.
“This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings,” the FDA stated, “during which we received input from a wide range of stakeholders, including patients, health care providers, outside experts and other government entities.”
They didn’t mention Judy Rummler, but she’s OK with that.
“We’re just relieved there’s been enough pressure put on [the FDA] to do this,” she said. “But we recommended this in 2004,” she noted. “That’s how long it’s taken them to do it.”