THE OPIOID CRISIS THAT has driven drug abuse and fatal overdoses to record highs in America unfolded in three distinct waves over the last two decades, tracing a chalk outline that likely marks a deadly new normal and won't be erased anytime soon, a new U.S. News analysis shows.
Despite myriad attempts to combat the crisis at the federal, state and local levels — including a White House declaration of a public health emergency, followed by an administration pronouncement that America is "beginning to turn the tide" — the analysis shows the nation's opioid death rate is five times higher than it was in 1999, and is likely to remain there or climb even higher in years to come.
The U.S. News analysis examines opioid death rates for nearly two decades, far longer than short-term data regularly cited by policymakers when assessing the epidemic and the effectiveness of the public health response. Viewing the data over time offers a clearer view of how the crisis has progressed, and what to expect as it continues to unfold.
(TORI SMITH FOR USN&WR)
"Things are now worse – much worse – than they've been in the past 20 years," says Rocco Perla, co-founder of the new nonprofit The Health Initiative. Perla carried out the analysis at U.S. News' request with the assistance of Lloyd Provost, a statistician with the consulting firm Associates in Process Improvement.
The epidemic's three waves – driven by a procession of legal and illicit opioids alike – have ricocheted across the country, creating a scenario in which Americans now are more likely to die from an opioid overdose than a car crash. By slicing the epidemic into phases, the analysis offers a glimpse into how America's ever-changing drug habit morphed into an all-consuming crisis:
From 1999 through 2006, the death rate rose steadily with the expanded use of prescription opioids, which exacerbated a long-smoldering heroin problem.Starting in 2007, the death toll rose at a slower pace as knowledge about prescription-fueled addiction grew and legal action targeted the pharmaceutical industry.In 2014 and the years since, as more lethal opioids – particularly the synthetic substance fentanyl – became increasingly accessible, the death toll began soaring to tragic new heights. In 2017, the age-adjusted opioid death rate reached 14.9 per 100,000 people, up from 2.9 in 1999.
Failures to detect the leveling off of the death toll more than a decade ago or to quickly recognize the subsequent surge in deaths were costly, translating to more lives lost, Perla says.
(TORI SMITH FOR USN&WR)
"We lost an opportunity to learn what was happening and make decisions that might have sustained that (leveling-off) trend," he says.
The advent of the epidemic can be traced to OxyContin, the first formulation of opioid painkiller oxycodone that allowed for the medication's 12-hour release. Manufactured by Purdue Pharma, OxyContin was approved by the Food and Drug Administration in 1995 and is used to aid patients in moderate to severe pain, such as those recovering from operations or suffering from cancer.
Purdue Pharma's OxyContin marketing campaign was led by a sales force armed with research that downplayed the risks of addiction. Doctors and dentists, buoyed by the prospect of an effective, low-risk painkiller, began writing millions of prescriptions for the narcotic.
A focus on the importance of improving pain control contributed to the flood of prescriptions. The American Pain Society in 1996 endorsed more aggressive treatment by introducing the concept of pain as "the fifth vital sign," while The Joint Commission several years later introduced standards for pain control as part of its health care accreditation procedures.
Even a decade later in 2011, The Institute of Medicine published a more than 350-page report on pain relief in America that — not counting appendices and citations — mentioned "addiction" just a handful of times.
"The old notion was that if you were using opioids for a legitimate purpose, you couldn't become addicted," FDA Commissioner Dr. Scott Gottlieb says. "We now know that's not true. You can become addicted, even if the purpose of the prescription is appropriate."
As opioid prescriptions began to soar, oversight authorities – including the FDA and Drug Enforcement Administration – and pharmaceutical distributors failed to recognize or raise red flags about potential abuse, experts say. In 2006 and 2007, for example, McKesson Corp., one of the largest drug distributors in the country, shipped more than 5.66 million opioid pills to a single pharmacy in a tiny town in rural West Virginia, according to a scathing congressional report released last month.
McKesson's "due diligence" file for the pharmacy – tied to a process required by federal authorities to mitigate the risk a controlled substance will be misused – contained just one document: a November 2007 declaration from the pharmacy's owner that it only sold legitimate prescriptions, the report said.
"Those pills were distributed to places that there's no possible way folks can use millions of pills in a little town of 2,000 or 3,000 people," says former Mississippi Attorney General Mike Moore, who helmed the legal fight that led to a multibillion-dollar settlement between states and tobacco companies in the 1990s, and is now leading legal efforts targeting the pharmaceutical sector for its role in the opioid epidemic. Distributors, he alleges, "were negligent."
In recent years, more than two dozen states and hundreds of cities and counties have filed lawsuits against opioid distributors and manufacturers – including Purdue Pharma – claiming enthusiastic overprescribing based on aggressive and misleading marketing has helped fuel the deadliest drug crisis in U.S. history. Moore is representing Mississippi, Arkansas, Louisiana and Ohio, and is working with attorneys representing about a dozen other states in several opioid lawsuits.
He says the cases pose "kind of a simple question."
"Should taxpayers pay to clean up the mess caused by multibillion-dollar companies who lied to sell their products, or should the companies who profited pay?" he says.
Purdue Pharma, meanwhile, is vigorously defending itself against the lawsuits targeting it and has taken steps to buff its tarnished image and curb the epidemic.
The company's chief medical officer, Dr. Marcelo Bigal, declined to comment on its past behavior. But he says Purdue Pharma has eliminated its OxyContin sales force and has stopped promoting opioids. Purdue also is encouraging insurers to reimburse for non-opioid pain treatments – including physical therapy and other alternatives – so physicians aren't prescribing opioids simply because they're covered by health plans. The company is taking steps to expand access to the overdose-reversing drug naloxone as well, and is working to develop new, non-opioid analgesics – potentially the next blockbuster painkillers.
The realization in the early to mid-2000s that patients were becoming addicted prompted many physicians to offer fewer prescriptions, says Dr. Robert Trestman, senior vice president and chairman of psychiatry for Roanoke-based Carilion Clinic, a major health care system in southwest Virginia. Those concerns, along with increased oversight and industry efforts to reduce excess prescribing, may account for the slump in overdose deaths that began in 2007.
"Lots of physicians have experienced real guilt over this," Trestman says. "Many of them have seen their patients suffer and die from unexpected addiction."
The epidemic has particularly ravaged New England, Appalachia and parts of the Midwest, where social and economic decay in some states resulted in an explosion of so-called deaths of despair from drugs, alcohol and suicide.
On average, higher rates of these deaths cut into a community's average life expectancy more than high violent crime rates or low rates of health insurance coverage, according to data drawn from U.S. News' Healthiest Communities rankings, a project assessing these and other measures of health and well-being in nearly 3,000 communities nationwide.
Starting in 2014, the opioid death rate began to soar, thanks in large part to the prevalence of synthetic substances like illegal fentanyl, added to heroin to increase its potency. Today, drugs like meth and cocaine are laced with fentanyl as well, marking a twist on the deadly threat.
In Detroit and surrounding Wayne County, Michigan, for example, a spike in opioid deaths between July 2016 and February 2017 appears to have been tied to illicit carfentanil, an ultrapotent cousin of fentanyl, which itself is already significantly cheaper and 50 times more potent than heroin. Cocaine was detected in 29 percent of the carfentanil-related deaths.
Communities across the country have reported similar trends, though it's unclear how many users are purposely mixing such drugs themselves. Dealers or those higher up the supply chain are typically thought to be the ones cutting heroin with fentanyl.
"Stimulants often come into play in the late cycle of (a localized) heroin epidemic," says Dr. Daniel Ciccarone, a heroin researcher and professor at the University of California–San Francisco. "What is surprising … is this contamination of those products with fentanyl. We simply don't know whether it's purposeful contamination, accidental contamination or for co-use."
Counterfeit prescription drugs also have created additional hurdles for policymakers, as people who purchase mail-order drugs online may not realize they can be laced with – or almost entirely made of – contraband fentanyl sourced from foreign countries like China, which recently said it would take steps to further clamp down on fentanyl and related substances.
"Even when the consumers (think they) are buying Percocet or Vicodin online, in many cases what they're getting is pressed fentanyl … in doses that are unreliable, where there's a high variability from pill to pill and there's a risk they're going to get a lethal dose," Gottlieb says.
In fiscal 2017, about 275 million packages flowed through international mail facilities in U.S. states or territories, the FDA says, and an estimated 9 percent of those contained drugs of some kind. The agency has said it hopes to ratchet up its inspection program from 10,000 packages per year, on average, to 100,000.
The latest opioid concern carries echoes of the OxyContin spark that helped ignite the crisis in the 1990s. In November, the FDA gave approval to a new formulation of the fentanyl analogue sufentanil. Sold as Dsuvia, the painkiller is five to 10 times more potent than ordinary fentanyl.
Gottlieb says his agency approved Dsuvia to be used in small doses and only under highly controlled conditions. It's intended for people who need immediate pain relief, such as soldiers with battlefield injuries, and for those for whom other painkillers haven't worked.
Gottlieb acknowledges that drug diversion for illicit use occurs, but says it's uncommon. An analysis of publicly reported drug diversion incidents found that more than 20 million pills or medication dosages had been "diverted" by health care workers to an illicit use in 2017. More than 90 percent of incidents for which data on drug type were available involved an opioid.
Critics worry controls will fail and Dsuvia will hit the streets, much like OxyContin did two decades ago.
"It's a scary drug," says Theodore Cicero, a psychiatrist at Washington University in St. Louis with expertise in drug abuse surveillance. "If it has a high abuse potential, it will leak out into the public.
"I see no end in sight now for opioid overdoses," Cicero adds. "It seems like an elusive goal to me."
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