By Elizabeth Brico
On April 9, 2019, the FDA released a drug safety communication in which the regulatory body unequivocally stated that patients who are dependent on opioids should not have their medication abruptly discontinued.
WHY YOU SHOULD CARE
The war on opioids led to many pain patients suffering from an abrupt termination of their medication. Now regulators are correcting course.
Lelena has struggled with pain for most of her adult life. She’s been diagnosed with fibromyalgia, a condition affecting upwards of 12 million Americans marked by chronic pain without any definitive cause, and for several years she depended on opioid-based medicines as painkillers. But in March 2019, her urine tested positive for heroin, and Lelena was unceremoniously dismissed from the clinic where she used to receive medicines. Within a month, hair test results would confirm the heroin positive had been false — a rare occurrence in patients like Lelena who use both morphine and over-the-counter pain relievers. But it was too late.
With no final script, taper schedule or even a referral for addiction treatment services, she was forced through excruciating, acute withdrawal, which included intense flu-like symptoms as well as increased pain. Lelena — her name on social media platforms, which she requested we use — is among several thousands of pain patients who have had to deal with forced dose tapers or total discontinuation since the start of America’s war on opioids in 2016. Now, America’s health regulatory authorities are correcting course, amid growing evidence that their earlier guidelines against opioid abuse were interpreted by far too many doctors as a license to suddenly stop crucial pain relief medication, hurting the very people the policies were meant to help.
On April 9, 2019, the Food and Drug Administration released a drug safety communication in which the regulatory body unequivocally stated that patients like Lelena who are dependent on opioids should not have their medication abruptly discontinued. It also says that patients who require discontinuation of opioid medication should receive individualized tapers designed to minimize withdrawal.
The Centers for Disease Control and Prevention has been quick to follow suit. In 2016 guidelines, it had directed prescribers to attempt non-opioid interventions for pain before resorting to prescription opioids and suggested dosing limits for new patients to prevent potentially fatal respiratory depression. Pain patients and advocates have long criticized those guidelines as responsible for the sudden discontinuation of opioid medication. In April, it clarified that “sudden opioid discontinuation or dismissal of patients from a physician’s practice” was in fact against its recommendations — and had been all along.
“IT WAS HARD IN SOME WAYS TO GET THE CDC TO CHANGE
KATE NICHOLSON, CIVIL RIGHTS ATTORNEY”
The American Medical Association and the American Journal of Clinical Oncology — representing many of the nation’s top physicians — have publicly supported the CDC shift. The change was needed, suggests Laura Mills from Human Rights Watch, which also has been advocating against the sudden discontinuation of opioids for pain patients.
“We always emphasize that the risk for harm [from suddenly stopping opioid medication] is huge, given that an approximate 13 million Americans are still on opioids long-term,” says Mills.
There are no hard numbers of the total patients who have had opioid medication stopped abruptly since 2016, say medical experts and analysts, because doctors and medical researchers simply haven’t kept track. But studies have shown the extent of suffering that patients such as Lelena have had to endure. In a nationwide study of 3,000 pain patients by researcher and pain specialist Terri Lewis in 2018, half reported disruption or abandonment of care. In a Boston Globe survey in 2017, nearly 10 percent of doctors said they had completely stopped prescribing opioids. According to a Veterans Health Administration study in 2017, almost 12 percent of sampled veterans who had their long-term opioid treatment discontinued subsequently demonstrated suicidal tendencies.
It isn’t only pain patients who suffered, say experts. Opioid agonist medicines like methadone and buprenorphine — designed to reduce cravings and withdrawal in patients addicted to opioids without producing euphoria — have also suffered from a similar stigma as addiction-inducing opioids.
Many Alcoholics Anonymous and Narcotics Anonymous fellowships, for example, deride patients on these medications as still being in active addiction. Psychiatric patients who are hospitalized with multiple disorders have in some cases reported that their addiction medications have been withheld or the doses rapidly decreased. The FDA label change stands to remedy that, making a clear statement that opioid-dependent patients can face serious medical harm if their medications are abruptly withdrawn.
It’s an argument that has been brewing within the addiction community for some time. Lawsuits have been springing up around the country demanding access to methadone and buprenorphine in jails and other restrictive facilities. Sally Friedman, the legal director of the Legal Action Center, a New York-based nonprofit that helps clients combat medication discrimination, says that inequity against patients taking opioid agonist therapies remains rampant. “The biggest setting is the criminal justice system. It’s systemic,” she says, before detailing a litany of venues in which this type of forced withdrawal is also common. Included on her list are employers, child services and even addiction recovery homes. In 2018, she helped a client stay on his medicine after a Clinton County judge ordered him off of the buprenorphine that he had been taking for 13 years. But not all patients have access to such legal help.
The explicit FDA announcement could eventually mean incarcerated people will not require lawsuits in order to obtain appropriate medication. Since the announcement, a federal court of appeals ruled in favor of a woman suing to continue her buprenorphine treatment while incarcerated, and Whatcom County, Washington, agreed to provide medication-assisted treatment in its jails as part of a settlement with the American Civil Liberties Union of Washington.
The change in approach from America’s medical regulators didn’t come about overnight. Groups like the American Medical Association and the Chronic Pain/Opioids Task Force have been pressuring the CDC for the past year. Prior to the agency’s announcement, Kate Nicholson, a Colorado-based civil rights attorney formerly with the Department of Justice, and Stefan Kertesz, an addiction medicine physician and professor with the University of Alabama at Birmingham, met with CDC leadership to seek a public statement clarifying their position on the 2016 guidelines.
To be sure, some doctors worry that the changed approach from the CDC and FDA could encourage some doctors to once again issue opioid prescriptions without adequate restraint. And not all doctors believe the CDC was at fault in its 2016 guidance. Andrew Kolodny, the co-director of the Opioid Policy Research Collaborative at the Heller School for Social Policy and Management at Brandeis University, says that in many cases — such as Lelena’s — opioids were wrongly prescribed in the first place. “There’s no debate: You don’t give opioids for fibromyalgia,” says Kolodny. “It’s the fault of this campaign that encourages people to prescribe opioids, a highly addictive drug you become easily dependent on.”
But supporters of the new shift argue that it’s precisely by ensuring access to opioid-based medication for those who need it that America can sustainably address its drug abuse problem. Multiple lawsuits against doctors who facilitated or encouraged opioid abuse — 31 were charged by federal prosecutors in April — will also serve as a deterrent in the future, they argue.
And even Kolodny agrees that once someone is on pain medication, it is “exceptionally cruel to abruptly withdraw a patient from opioids.” For advocates like Nicholson and patients like Lelena, the shift from America’s medical regulators represents renewed hope. Yet, they say, the work to ensure that the approach advised by the FDA and CDC is actually followed by doctors remains. “It was hard in some ways to get the CDC to change,” says Nicholson. “And in some ways, it was the easiest first step.”
- Elizabeth Brico, OZY Author
______________________________________________________________________________TAGS: Elizabeth Brico, OZY, Opioid Policy Research Collaborative, Heller School for Social Policy and Management, Brandeis University, Andrew Kolodny, FDA, CDC, Stefan Kertesz, American Medical Association, Chronic Pain/Opioids Task Force
LINK TO ORIGINAL ARTICLE: https://www.ozy.com/fast-forward/why-americas-latest-turn-on-opioids-is-bringing-hope-to-pain-patients/94624?fbclid=IwAR34E4vLzQqH56AFhSVh-MPzLAjbG2TkAX9viNH7o6fd6bzNdmsO0IReU-Q