Prescription painkillers played a major role in fatal overdoses in Huntington and Cabell County over a two-decade period, an epidemiologist said Thursday at the federal opioid trial in Charleston.
The testimony came after the local governments turned the presentment of their case to look at the role prescription pain pills have in the ongoing opioid crisis. The governments hope it will show the connection between prescription pain pills and heroin and other illicit opioids.
Huntington and Cabell County accuse the “Big Three” drug wholesalers — AmerisourceBergen, Cardinal Health and McKesson — of fueling the opioid epidemic by sending excessive shipments of opioids into the area for eight years, before a reduction in the number of pills shipped made users turn to illicit drugs.
The defendants point to the U.S. Drug Enforcement Administration, doctors and West Virginians’ poor health as the culprits.
Gordon Smith, an epidemiologist at the West Virginia University School of Public Health, was the first of his field to take the stand Thursday. Smith has focused his work on studying overdoses and other drug poisonings. He joined WVU in 2016 to study the opioid epidemic.
For this trial, he was asked to review the crisis and its evolution in West Virginia, specifically Cabell County. For his findings, he used two databases: the 2001-18 fatal overdose data from the vital statistics office and the 1979-2018 drug poisoning data from the U.S. Centers for Disease Control and Prevention.
He said he found that the rural drug problem is very different from what is seen on a national level.
In testifying to his findings at the questioning of Huntington attorney Anne McGinness Kearse, Smith said that, from 1979-2000, there were less than 75 drug poisoning deaths, which included opioid deaths, per year. From there it increased dramatically. In 2001, there were 14 opioid-related deaths in Cabell County. From 2001-18, he said, there were 1,002 opioid-related deaths, 87% of the 1,151 drug poisoning deaths.
More than half — 657 — were reported from 2014-18. Heroin accounted for half of the fatal overdoses from 2013-15 and one-third of deaths from 2016-18. Fentanyl accounted for half of the fatal overdoses from 2016-18.
Fatal overdose rates increased from 16.6 to 213.9 per 100,000 from 2000-17.
Based on preliminary data for 2019-20, Smith said it seems the main drivers now are heroin and fentanyl, although most of the deceased are found with multiple drugs in their system.
Data shows prescription opioid deaths exceeded illicit opioid deaths in Cabell County from 2001-17. Prescription opioid deaths exceeded that of illicit opioid deaths until 2013. Prescription opioid overdose deaths did not start to decrease until about 2018, when it took a dramatic dive.
A study looking at 2006 data said pharmaceutical diversion was associated with 186 deaths (63%), while 63 accidents (21%) showed evidence of doctor shopping. Substance abuse indicators were found in 279 deceased people (94%) and multiple substances were found in 234 deaths (80%).
While the defendants have held that West Virginians needed more opioid pills because of a history of bad health and laborious jobs, the study showed that the most illegal diversion of opioids was seen among the 18-24 age range, when residents were at their prime.
McKesson attorney Laura Wu countered that the study Smith used had incomplete data and was not a reliable source. She said the same study did not examine where the opioids had been obtained, but the majority of people using illicit drugs reported receiving the drugs for free from a friend or relative to whom it was prescribed.
The West Virginia Overdose Fatality Analysis released in 2016, 10 years after the aforementioned study, said the West Virginia Board of Pharmacy’s Controlled Substance Monitoring Program showed 91% of all deceased individuals had a prescription history.
Of those, 49% of women and 36% of men had filled a controlled substance prescription in the month prior to their deaths.
Wu said Smith’s analysis did not consider if a prescription had been used as prescribed. It also did not consider the chemical breakdown of heroin, which breaks down to morphine over time. Morphine was counted as a prescription-related death, when it could have been heroin the user had injected.
His report also counted a fentanyl-related overdose as a prescription until 2013, she said. Smith said 2013 is when the CDC reported that illicit fentanyl abuse had exploded across the country, so, prior to that, he counted it as prescribed.
Before the epidemiologists took the stand Thursday, Joe Rannazzisi, head of the Office of Diversion Control for the DEA from 2006-15, finished his testimony. He was asked questions by AmerisourceBergen attorney Robert Nicholas.
Rannazzisi said over three days of testimony that the distributors ignored their duties to report suspicious orders as part of a nationwide systemic problem, which could have guided them in stopping opioid pills being illegally diverted as they flowed into local communities.
The DEA and AmerisourceBergen had a great relationship before Rannazzisi’s era, Nicholas said. From 1998-2005, the company let DEA members train at their facility, he said, but, when Rannazzisi took his position in the DEA, the relationship crumbled as he changed policies and the regulator’s expectation of the distributors.
When the DEA had a conference with distributors showing concern for internet pharmacies, AmerisourceBergen took action to implement new policies and procedures. It led AmerisourceBergen to investigate hundreds of pharmacies, Nicholas said. Rannazzisi said “investigation” was an overstatement.
Nicholas referred to a memo that followed the meetings in which an AmerisourceBergen employee said the DEA gave him information about a pharmacy the company needed to investigate for illegally diverting pills. Rannazzisi said it would have been done in error, because it would violate the due process each registrant has.
“It’s not in line with what the DEA would do,” he said.
Pointing to a 2007 settlement reached with the DEA after it shut down AmerisourceBergen’s Orlando, Florida, facility, Nicholas said AmerisourceBergen had been sending the DEA their sales data within two business days. The DEA also viewed the suspicious-order monitoring programs at five AmerisourceBergen distribution centers but did not find any major issues, Nicholas said.
The defendants argued that the DEA never gave them access to the agency’s pill ARCOS database (Automated Reports and Consolidated Ordering System), but Rannazzisi said the argument was a “smokescreen” and an attempt to shift the blame elsewhere.
DEA presentations to the distributors have said the agency takes its investigative obligations seriously because it takes just one criminal physician to do enormous harm and line the pockets of people with opioid use disorder.