CHARLESTON – An expert epidemiologist who analyzed Cabell County and West Virginia overdose data to show opioid trends in death rates soared from 2001 to 2017.
During the landmark federal opioid trial in Charleston, Gordon Smith, a public health epidemiologist with West Virginia University School of Public Health, took the stand June 10. He began studying the opioid epidemic when he started at WVU in 2016
Smith has 35 years of experience with a specialty is in public health data, causes of death and factors in death with relation to injury. During questioning by attorney Anne Kearse, who represents the City of Huntington, Smith said drug overdoses are categorized as injuries – poisoning and drug overdoses and helped develop the drug classification system differentiating between prescription and nonprescription with the World Health Organization.
Smith
Smith said epidemiology is the difference between one treating an individual patient and someone who treats/studies the community.
In 2017, Cabell County and the City of Huntington sued the three largest pharmaceutical distribution companies – AmerisourceBergen, Cardinal Health and McKesson Corp. – claiming the companies were largely responsible for the opioid crisis after the companies shipped more than 81 million hydrocodone and oxycodone pills to the county of just 100,000 residents between 2006 and 2014.
Smith worked with state and national data and prepared slides to ensure accuracy, he said. Smith was also surprised by the depth of the problem in West Virginia, including Cabell County.
“I couldn’t believe the drug problem in West Virginia,” Smith said. “We actually have data going right down to the county.”
Smith said he went back in time as far as the data, 1979, would allow in order to fully understand the development.
“Look at the best evidence, the best data I could find on the overdoes in West Virginia and narrow it down to Cabell County,” Smith said. “To me, the trends were the most important part of this. How we basically start off in an area with very little drug problem and now we have what we have.”
When the state noticed the rising trend in drug overdosed in 2001, Smith said a state database was created to monitor trends. He looked at the numbers from this data from 2001 to 2018. When looking at the data, Smith said numbers started so low, a category was unavailable. Five or less deaths are grouped into the next closest group.
“I thought it was important to see what was going on just as the epidemic was beginning,” Smith said. “[There were] so few overdoes from opioids, I had to go to the next grouping—accidental drug poisoning”
Between 2001 and 2018 there were 1,151 overdose deaths nationwide, with about 87 percent being opioid-related. Between 1979 and 2000 there were only 77 drug poisoning deaths. Cabell County had 16 overdose deaths in 2001 with 14 being opioid-related.
The curve started to increased dramatically at this point.
Smith said the determination of death is a global standard analysis. First the medical examiner investigates, blood is sampled, autopsy and toxicology report are completed, medical examiner records cause of death and then sent to vital statistics, it is then coded and recorded by State of West Virginia and sent to the national database.
Smith was questioned on the use of heroin in the overdose, specifically the fact that heroine metabolizes into morphine and could potentially be miscategorized.
“We really started to see the [heroin] increase in 2011,” Smith said. “Up until 2001, heroin was not much of a problem. You will see a very dramatic [increase in] prescription opioids over this time. There’s clearly a very general trend here, of this increasing involved.
“Rate of fatal overdoses, this is Cabell county, increased sharply over that time,” Smith said. “16.6 to 213.9 per 100,000 from 2009 to 2017 which is a very large increase.”
Smith said the CDC informed of an influx of fentanyl that came in to the country from overseas and became what is considered illicit fentanyl. Prior to 2013, the drug was considered to be a prescription opioid.
A 2008 study published in the Journal of American Medical Association was presented and noted that West Virginia had the largest overdose mortality rate in the country between 1999 and 2004. During that time there was a 550 percent increase un unintentional poisoning moralities that continued to increase.
In 2016, the state Department of Health and Human Resources published a study on overdose mortalities to identify opportunities for intervention. The method used was the same as the 2008 study.
Out of 830 overdoses in West Virginia during 2016, 91 percent had a prescription record.
Illicit fentanyl played a large role in overdoses.
“Many are buying pills, they look like prescription pills but they contain fentanyl so the drugs were big mixed together,” Smith said.
While most of the overdose deaths included more than one drug, prescription opioids, in particular, were seen to play a significant role in West Virginia.
Attorney Lora Wu, representing McKesson led the cross-examination.
Wu asked Smith if he looked at the origin if the prescription drugs involved in the overdose deaths from his data. Between 2005 and 2017, poly-overdoses began to rise.
“[We’re] just looking at molecules [the] toxicologist finds,” Smith said. “I’m just describing the drugs that are involved in the death, that’s all I can say."
Wu argued there is no way to determine the drug poisonings are from diverted opioids and it can be difficult to determine the exact cause of death with overdoses.
“It’s in their opinion, all of these drugs contributed to the death,” Smith said. “You cannot selected which one or any one didn’t but also believe each of them made a significant contribution, otherwise he would not be listed”
Wu questioned Smith about the risks doctors should take into consideration, including chance of dependency. She asked if those patient risks were the responsibility of distribution and manufacturer companies.
“They do not get involved, they’re like epidemiologists, they do not get involved [with patients],” Smith said
Wu questioned the ability to determine if the prescription drugs involved in overdoses were illegal and the assurance of which drugs caused the deaths.
“I rely on experts all the way along the way that I work with,” Smith said. “You don’t check with the farmer on the chicken [you’re about to eat.] We rely on experts to do their jobs.”
Smith said there is a lot of time spent by the medical examiner’s office to determine whether the death was morphine or heroin.
Wu wanted to admit a death certificate and toxicology report from an overdose to discuss the drug causing the overdose.
Attorney Paul Farrell Jr., representing Cabell County immediately objected to both due to the personal information and ease of locating listed person and the fact the plaintiffs have been prohibited from sharing stories that resulted in the death certificates.
“We could tell stories of individual overdose cases in Huntington/Cabell County West Virginia using death certificate and autopsies for the next year and a half,” Farrell said.
The judge allowed questioning, but did not admit.
Wu argued several other illegal drugs were responsible for a large number of overdoses.
Attorney Steve Ruby, representing Cardinal Health, questioned Smith on a large number of drugs in the data being opioids or not during a quick cross-examination.
AmerisourceBergen declined cross.
Farrell led the redirect trying to show the exchange of opioid and heroin deaths over time.
He also showed the toxicology report from earlier in the day with hydrocodone and codeine being contributing drugs.
Attorney David Ackerman, representing Huntington, then called Jakki Mohr, professor of marketing with University of Montana as an expert witness.
Time allowed for questioning of Mohr’s credentials and knowledge on the subject at hand.
Mohr gave her opinion the distribution companies engaged in marketing opioid prescriptions and played a role between pharmaceutical companies and downstream customers.
Mohr’s examination will continue Friday.
Earlier in the day, cross-examination of Joe Rannazzisi, the former director of the DEA’s Office of Diversion Control, concluded. By the time re-direct examination was finished, Rannazzisi spent nearly three full days on the witness stand.
The pattern of questions were in reference to Rannazzisi’s knowledge of the changes drug distribution companies made after specific meetings with the DEA, as well as customer terminations and policies presented.
Huntington is represented by Anne Kearse, Joseph Rice, Linda Singer and David Ackerman of Motley Rice and Rusty Webb of Webb Law Centre. Cabell County is represented by Paul Farrell Jr. of Farrell Law, Anthony Majestro of Powell & Majestro and Michael Woelfel of Woelfel & Woelfel.
AmerisourceBergen is represented by Gretchen Callas of Jackson Kelly and Robert Nicholas and Shannon McClure of Reed Smith. Cardinal Health is represented by Enu Mainigi, F. Lane Heard III and Ashley Hardin of Williams & Connolly. McKesson is represented by Mark Lynch, Christian Pistilli, Laura Wu and Megan Crowley of Covington & Burling.
U.S. District Court for the Southern District of West Virginia case numbers 3:17-cv-01362 (Huntington) and 3:17-cv-01665 (Cabell)