CHARLESTON — McKesson Corp. made its sales force the company’s “eyes and ears” against illegal drug diversion, all while giving them a chance to double their salaries for making sales, attorneys pointed out in federal court Tuesday in Charleston.
Cabell County and the city of Huntington are arguing that the “Big Three” drug distributors — AmerisourceBergen Drug Co., Cardinal Health Inc. and McKesson — flooded the area with excessive amounts of opioid doses over eight years before a reduction in the pills shipped made addicted users turn to illicit drugs.
The defendants point to the Drug Enforcement Administration, doctors and West Virginians’ poor health as the culprits.
Tuesday began with defense attorney Paul Schmidt’s cross-examination of Michael Oriente, director of regulatory affairs for McKesson, who said McKesson was fully transparent with the DEA, although the agency accused the company of violating the Controlled Substances Act at least twice, on one occasion finding 4,600 violations.
In the afternoon, Tim Ashworth, a McKesson salesperson, testified on practices in which McKesson’s sales force was on the front line of diversion control by helping gather information from customers who hit their monthly pill order ceilings, all while having a chance to double their salaries through sales.
Oriente said prescriptions are FDA approved and manufactured by other companies, which issue alerts or warnings on the drugs. A doctor’s prescription is needed to obtain them individually in the closed system, he said. The DEA kept increasing the quota for the amount of pills that could be shipped each year to keep up with an increase in prescriptions.
He said a pharmacy simply ordering low quantities of opioids does not mean diversion is not occurring, nor would large quantities indicate diversion. A pharmacy might order a high number of pills because the pharmacist in charge of ordering might be taking a vacation and need to order in advance, he said.
The DEA guidance has not always been clear, Oriente said. In 2006 and 2007, the administration sent letters to distributors outlining changes of what was expected of wholesalers.
One of those expectations was having pill order limits or thresholds for each pharmacy. Oriente said it was a project in itself to figure those out, and that thresholds reflected prescriptions.
“As prescribing has gone down, pharmacies have ordered less. Because pharmacies have ordered less, we were able to reduce those thresholds,” he said.
If an order hit a threshold, it would go through a three-level review. The first level involved a questionnaire asking the pharmacy why it needed the threshold increase, requesting sales information.
Cabell County attorney Eric Kennedy said, according to McKesson protocol, reviews were supposed to be handled by management, but it was Ashworth and other sales members who would be the ones to help pharmacies fill out those questionnaires. Kennedy questioned the ethics behind the practice, because if the pharmacies could not buy pills, then the sales members would lose money.
Some of the questionnaires were incomplete, Kennedy said, pointing to 26 from Cabell County over a two-year period that said an increase was needed, but gave no explanation why.
The defense pointed to one fully filled out in October 2010 when the Custom Script, located in the 2400 block of U.S. 60 in Barboursville, sought 7,000 more oxycodone doses a month in its limit. It said they had been “aggressively marketing to practices” to increase business. The marketing included the practice of former doctor Philip Fisher, a physician who is serving a criminal sentence in Florida for a murder-for-hire plot against his sister.
Kennedy claimed McKesson put its sales force in the middle of diversion control. Ashworth said salespeople played a role in collecting information, but it was his bosses who made the ultimate decision. Kennedy pointed to a previous deposition taken from Ashworth in which he had agreed he played a key role in preventing diversion.
From 2008-13, McKesson’s practice was to warn its customers when they were near their threshold and ask if they wanted it to be increased, Kennedy said. Oriente said customers were not told their thresholds.
“There was a period that we were giving that information to let the customer know they were approaching their threshold, because it was all new and it required some explanation,” Ashworth said.
An order would not be labeled as suspicious and reported to the DEA until it reached the third level, Oriente said. Sometimes threshold reviews required a site visit and paperwork review, to check for red flags. Oriente said he would go on site visits weekly.
The directors would also research the Office of Inspector General and newspaper articles to see if any DEA activity had been occurring at the facilities.
The majority of increase requests would come in the last week of the month, which caused frustration among Oriente’s peers, whose emails showed complaining of heavy workloads. They also said it was not possible to be diligent with their case volume.
Oriente said he felt he could still do his job, but that it took longer.
Dave Gustin, a fellow director of regulatory affairs, sent an email in 2011 to his peers stating areas needed to be tightened up because the distributor’s customers showed large gaps between their purchases and their sales. Schmidt, the defense attorney, said the communication showed in 2011 distributors were trying to tighten thresholds and were doing extra due diligence.
Gustin also emailed the sales force, stating they were the “eyes and ears” for the directors.
According to a 2020 federal court plea in Kentucky, this was around the time Gustin approved the shipping of 300,000 pills into a rural Kentucky pharmacy, a charge for which he pleaded guilty to a misdemeanor.
The DEA has said McKesson continuously ignored its warnings to tighten its suspicious order monitoring.
A 2008 civil settlement reached between the DEA and McKesson had the company agree to pay $13.25 million in civil penalties to settle allegations it violated the Controlled Substances Act by failing to report suspicious orders of prescription medications.
Oriente said in 2008, the DEA was aware McKesson’s standard for setting thresholds was taking the average of the customer’s monthly purchasing for a year-long period and adding 10%. The DEA also knew distributors treated their independent stores differently than the national accounts, such as Rite Aid, because they had their own regulatory staff. The DEA was also told of its three-level review system for large monthly orders, but it did not complain.
Schmidt pointed to a handful of documents that he said showed the company had been doing its due diligence and attempting to follow what the DEA wanted.
A second, separate settlement was reached in 2017 in which McKesson agreed to pay $150 million for similar allegations.
As part of the 2017 settlement, McKesson acknowledged from 2009-18, at various times, it did not report or identify to the DEA some suspicious orders, but Oriente said the admission did not apply to any Cabell County pharmacy.
HUNTINGTON — Local kids will soon be able to cool off this summer with a new splash pad.
The all-inclusive splash pad at St. Cloud Commons in Huntington will open Saturday, May 29. A ribbon-cutting ceremony was held in October. An all-inclusive playground at the park opened a couple of years ago.
Greater Huntington Park and Recreation District interim executive director Kathy McKenna said the district will have a community event to mark the occasion from noon to 2 p.m. Saturday.
The splash pad will be open from 10 a.m. to 8 p.m. Monday through Saturday and from noon to 8 p.m. Sunday, McKenna said.
“It’s beneficial to the whole community because all children with all skills of abilities can come and use that facility and experience the water play,” McKenna said.
The term “all-inclusive” has to do with the different experiences the play areas can give, McKenna said.
The splash pad will have activities that activate different senses, McKenna said. Water splashing and some features that make noise, such as frogs that will croak, will stimulate auditory senses. Vestibular senses can be activated through balancing activities at the site. McKenna said there will also be tactile, or touch, experiences.
“That end of town has not had a water feature in a lot of years, so I know that that community is very much looking forward to having this water activity in their neighborhood,” McKenna said of the splash pad at St. Cloud Commons, which is located at 1701 Jackson Ave.
Funding for the splash pad is provided by a $250,000 Building Better Communities grant from the American Water Charitable Foundation. McKenna said the district also received help on the project from National Recreation and Parks Association and West Virginia American Water.
Sarah Nibert, of Barboursville, brought her kids for their first visit to the St. Cloud Commons playground last week. While the splash pad wasn’t open just yet, it didn’t stop the family from playing with the equipment. Nibert said she will probably bring her kids back after that area opens.
A friend recommended the park to her, she said. The St. Cloud Commons playground seemed nice, she said, adding that it is safe and clean. She said she could easily keep an eye on her kids as they had their fun.
“I think it’s good to keep them active and find different things and opportunities for them to meet other kids and play. It’s just good for them,” Nibert said.
McKenna said the park district does not have plans to add another all-inclusive area to other parks, but Ritter Park’s playground is all-inclusive.
CHARLESTON — West Virginia Gov. Jim Justice opened his Tuesday press briefing noticeably solemn.
“We’ve lost 13 people since the last time we were together (on Thursday),” Justice said. “From the standpoint of progress, it’s hard to imagine that that’s real progress, but it is from the standpoint that the number of folks that we’ve lost has surely decreased significantly.”
The sorrow quickly turned to positivity. As the state attempts to achieve as many vaccinations as possible, progress has become evident. Justice said the state is “on track” to lift the mask mandate on West Virginia Day, reaching the benchmark of 65% Justice announced earlier this month.
As of Tuesday morning, the number of West Virginians who had received at least one dose of the vaccine was at 57%, meaning the state is hoping for a growth of eight percentage points between now and June 20.
The Centers for Disease Control and Prevention announced on May 13 that people who are fully vaccinated no longer need to wear a mask or physically distance in most places, while recommending those who are not vaccinated should continue using face coverings in order to limit the spread of the virus. Still, Justice plans to do away with face coverings next month no matter what.
“We’re on track, and you just wait and see,” Justice said. “The numbers will prove me right on this one. At the end of the day, we’re going to get rid of these masks on June 20 — period.”
Moving toward that goal requires the continued administration of vaccines across the state. Justice, leaning on current numbers, made a plea for people to continue turning out to receive their doses, encouraging them to not fall into a worst-case scenario.
“Now we’ve got 232 people that are hospitalized, and 85 of them are in the ICU units. We know that the overwhelming majority of those folks, if not every single one, is not vaccinated,” Justice said. “I don’t know what to tell you. I don’t know what to do and what to tell you anymore than just the fact that the vaccines are so safe it’s unbelievable. The vaccines are incredibly effective.”
Justice also discussed the state’s $100 incentive being offered to West Virginians aged 16-35 who received the vaccine, estimating Tuesday morning that “18,000 or something like that” had registered “over the last couple days.”
Yet he expressed frustration with the process, saying the FBI is warning about a new scam targeting vaccinated individuals. According to Justice, scammers are attempting to contact vaccinated individuals over the phone, then trying to enroll those vaccinated into a fraudulent lottery process.
“Once they get that information, they’re going to try to invade you and absolutely extract things from you,” Justice said. “You cannot give them that information; it’s nothing but a scam.”
As of Tuesday morning, the state had totaled 5,341 active cases and a cumulative percent positivity of 5.11%.
There were 233 new cases of COVID-19 reported, for a total of 160,587, and seven new deaths, for a total of 2,782.
Among the deaths reported was a 60-year-old woman from Cabell County and a 61-year-old woman from Lincoln County.
Total cases per county are: Barbour (1,476), Berkeley (12,602), Boone (2,117), Braxton (970), Brooke (2,218), Cabell (8,780), Calhoun (366), Clay (536), Doddridge (616), Fayette (3,497), Gilmer (873), Grant (1,280), Greenbrier (2,848), Hampshire (1,891), Hancock (2,831), Hardy (1,553), Harrison (5,944), Jackson (2,175), Jefferson (4,671), Kanawha (15,221), Lewis (1,254), Lincoln (1,527), Logan (3,194), Marion (4,535), Marshall (3,503), Mason (2,025), McDowell (1,586), Mercer (5,015), Mineral (2,909), Mingo (2,648), Monongalia (9,303), Monroe (1,158), Morgan (1,210), Nicholas (1,818), Ohio (4,263), Pendleton (705), Pleasants (946), Pocahontas (668), Preston (2,924), Putnam (5,267), Raleigh (6,928), Randolph (2,731), Ritchie (733), Roane (646), Summers (832), Taylor (1,248), Tucker (538), Tyler (736), Upshur (1,907), Wayne (3,151), Webster (510), Wetzel (1,372), Wirt (444), Wood (7,868) and Wyoming (2,020).
In Kentucky, another COVID-19 vaccination milestone was surpassed with more than 2 million residents receiving at least their first shot, Gov. Andy Beshear said Tuesday.
Vaccinations rose significantly last week as youngsters 12 to 15 joined other Kentuckians in rolling up their sleeves for the shots, the governor said.
So far, more than 23,000 Kentuckians ages 12 to 15 have received the vaccine, he said.
“When you think about it, it is just a miracle,” Beshear said in announcing the inoculation milestone. “Fifteen months after the first case here in Kentucky, not only do we have effective vaccines, but 2 million Kentuckians already being vaccinated is really exciting.”
The virus’s incidence rates are much higher among younger Kentuckians, and “it’s directly associated with whether you’re vaccinated,” he said at a news conference.
With the state’s pandemic-related capacity restrictions easing in coming days and largely ending next month, the governor urged the unvaccinated to take their turn in getting the shots.
“If you are not vaccinated, that comes with a heightened risk for you,” he warned.
Starting this Friday, capacity will be allowed at 75% for businesses and events in Kentucky. The state’s coronavirus-related capacity restrictions will end June 11.
Stressing the importance of vaccinations, Beshear noted that 97.5% of Kentucky’s virus cases in March and April, and 94% of virus-related deaths, were among unvaccinated people.
“These things work,” he said of the inoculations.
Slightly more than 80% of people ages 65 and older in Kentucky have been vaccinated, while more than 60% of people ages 50 to 64 have gotten the shots, according to state statistics. The vaccination rate dropped to 31% among Kentuckians ages 18 to 29.
“Again, we need to do better, especially in our younger age groups,” the governor said.
Meanwhile, the governor reported 580 new coronavirus cases, the state’s lowest number for a Tuesday in three months. He reported five more virus-related deaths, raising Kentucky’s death toll to at least 6,725 since the pandemic began. The statewide rate of positive cases was 2.52%.
In Ohio, more than 700 new cases of COVID-19 were reported, for a total of 1,098,593, with 19,748 deaths.