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Congressional opioid investigation targets drug wholesaler Miami-Luken


Charleston Gazette-Mail

CHARLESTON, W.Va. — A congressional committee investigating West Virginia’s opioid epidemic has directed prescription drug distributor Miami-Luken to turn over documents amid allegations that the firm shipped massive amounts of powerful painkillers to the state’s southern counties and failed to report “suspicious” orders from local pharmacies.

On Monday, the U.S. House Committee on Energy and Commerce requested Miami-Luken provide copies of personnel records related the Ohio company’s former top executive, who was stripped of duties to flag suspect pain-pill orders.

The panel also wants files that detail Miami-Luken’s painkiller shipments to four Southern West Virginia drugstores: Westside Pharmacy, in Oceana; Colony Drug, in Beckley; Tug Valley Pharmacy, in Williamson; and the former Sav-Rite Pharmacy, in Kermit.

Miami-Luken sold prescription drugs valued at more than $3 million a year to the Kermit pharmacy over six consecutive years, bankruptcy records show. Kermit, a town in Mingo County, along the Kentucky border, has fewer than 400 residents.

The Drug Enforcement Administration cited Miami-Luken’s questionable drug shipments in a “show-cause” order that’s part of a separate ongoing federal investigation, according to a letter the House committee sent to the company Monday. Miami-Luken, headquartered in Dayton, Ohio, is fighting the DEA’s effort to revoke the wholesaler’s license to distribute opioids and other controlled substances.

“As we have continued our investigation, it became increasingly clear that we needed to extend our oversight into Miami-Luken, a significant opioid distributor that we know has been active with West Virginia’s pharmacies,” said committee Chairman Greg Walden, R-Ore., and Ranking Member Frank Pallone Jr., D-N.J., in a joint statement. “West Virginia is among the hardest hit states by this epidemic and it’s critical we get to the bottom of how such large quantities of opioids were readily available in such small towns.”

The DEA order discloses that a Miami-Luken sales representative reported to his superiors in 2008 that Tug Valley Pharmacy’s painkiller sales were unusually “high,” noting that the pharmacy filled prescriptions from nearby pain clinics. But his superiors at the company failed to investigate whether the prescriptions were legitimate, according to the committee’s letter.

Miami-Luken shipped 27 orders of hydrocodone — a total of 258,000 doses of the prescription painkiller that’s better known under brand names like Lortab and Vicodin — to Tug Valley Pharmacy in just one month in 2009, according to the DEA. That’s more than 10 times what a typical retail pharmacy in rural West Virginia receives each month, the committee’s letter says.

Miami-Luken also was a major supplier to the Sav-Rite Pharmacy, according to bankruptcy records and the committee’s letter. The DEA alleges that Miami-Luken “failed to maintain effective controls against diversion” of hydrocodone between 2008 and 2011, when the Mingo County pharmacy purchased 10.8 million doses of the painkiller.

For years, Miami-Luken did the bulk of its West Virginia business in Mingo County, which has about 27,000 people.

Between 2007 and 2012, 63 percent of the distributor’s hydrocodone shipments in West Virginia went to Mingo County, DEA records show. The company sold 14.7 million doses of hydrocodone to Mingo over six years.

Elsewhere, Westside Pharmacy, in Wyoming County, had been limited to buying 6,000 doses of oxycodone (sold under brand names like OxyContin) per month. But Miami-Luken’s shipments exceeded that limit every month from September 2008 to December 2015. The company only reported that it received one suspicious order from Westside, according to the DEA’s order.

The DEA also cites Miami-Luken’s questionable shipments to Colony Drug, in Raleigh County. In March 2008, for instance, the company shipped 16,400 doses of oxycodone to the Beckley pharmacy. The next month, Miami-Luken sent 37,200 oxycodone doses to Colony — a 127 percent jump. The distributor never investigated the increase, according to the DEA.

The congressional panel’s letter mentions a Washington Post report about court records that show Miami-Luken board Chairman Joseph Mastandrea intends to testify that he stripped former CEO Anthony Rattini of his duties supervising the company’s efforts to comply with federal drug regulations “as DEA inquiries increased.”

The committee requested documents that detail Rattini’s removal and the reasons behind it, along with a list of other Miami-Luken employees who lost their positions after the DEA started to investigate.

Rattini has retired.

Between 2007 and 2012, Miami-Luken was the fourth-largest distributor of pain pills in West Virginia, according to DEA data. The company shipped 20.4 million hydrocodone doses and 8.2 million oxycodone doses to West Virginia pharmacies during those years.

Committee members have said the reported “possible oversupply” of powerful painkillers suggests “such practices may have exacerbated the opioid problem in the state” as many addicts have switched from prescription pain pills to street drugs like heroin and fentanyl.

West Virginia has the highest drug overdose death rate in the nation — and the deaths are rising. At last count, 879 people fatally overdosed on drugs in 2016 — a record number.

The House panel gave Miami-Luken until Oct. 6 to turn over the documents. Rep. David McKinley, R-W.Va.,who serves on the committee, signed the letter, along with Reps. Tim Murphy, R-Pa., and Diana DeGette, D-Colo.

The DEA also is investigating Miami-Luken’s shipments to five other pharmacies, in Southern Ohio and Eastern Kentucky, according to the committee’s letter.

In February 2016, West Virginia Attorney General Patrick Morrisey ended a state lawsuit against Miami-Luken, after the company agreed to pay $2.5 million to settle allegations that it flooded the state with painkillers. Morrisey, a former lobbyist for a trade group that represents Miami-Luken and other drug distributors, inherited the lawsuit in 2013 after ousting longtime Attorney General Darrell McGraw.

Miami-Luken’s Charleston-based lawyer would not comment Monday. Company executives in Ohio did not respond to emails and phone calls.

Miami-Luken took the DEA to court last year, asking a judge to force the feds to release agency documents that the company would presumably use to fight the DEA’s effort to take the firm’s license. Last month, a judge rejected the DEA’s arguments for keeping the agency’s documents under wraps and out of Miami-Luken’s hands, Reuters reported.

The company distributes drugs in Ohio, Indiana, Kentucky, Tennessee, West Virginia, Western Pennsylvania and Southern Michigan. Most of its shipments go to independent pharmacies, not chain drugstores.

Miami-Luken has mostly flown under the radar amid growing national scrutiny over the role of prescription drug distributors in the opioid epidemic. The nation’s largest wholesalers — McKesson, AmerisourceBergen and Cardinal Health — have shouldered most of the criticism and a barrage of lawsuits filed against them by cities, counties and states. The “Big Three,” as they’re collectively known, are big targets with big pockets. Their combined revenue totaled $460 billion last year.

The House committee started investigating McKesson, AmerisourceBergen and Cardinal Health in May. The companies were asked to disclose their shipment records by June 8. The distributors also had to disclose the locations of their warehouses.

The committee also is investigating the DEA’s decline in enforcement action against drug wholesalers, following reports by The Washington Post.

“Considering that this reported decline in enforcement action occurred in the midst of the opioid epidemic — with the number of opioid prescriptions in the U.S. increasing from 112 million in 1992 to 249 million in 2015 — it is imperative that the committee gather the facts about DEA’s actions,” House lawmakers wrote in May.

The committee directed the DEA to turn over all documents related to blocked or delayed enforcement against prescription drug distributors during the past six years.

Reach Eric Eyre at [email protected], 304-348-4869 or follow @ericeyre on Twitter.

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