Opioid manufacturer must answer for choosing profits over our people

Published 9:28 am Tuesday, November 21, 2017

By ANDY BESHEAR

Attorney General

In the height of our battle against the abuse of OxyContin, an irresponsible drug company introduced an equally if not more dangerous drug to the market — Opana IR and Opana ER (both oxymorphone).

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By 2012, the abuse of Opana ER (extended release) nationally surpassed the abuse of OxyContin, and over the following years, there were four times as many incidents of intentional abuse of Opana ER than OxyContin.

In 2016, more than 190 Kentuckians died from a drug overdose caused by Opana ER — the powerful prescription opioid three times stronger than morphine.

Many, including my office, voiced concerns to the federal government in 2017 about the potential for abuse of a reformulated Opana ER, encouraging the FDA to take a hard look at the safety of this powerful drug.

Citing concern that Opana ER’s risks outweighed its benefits, the FDA requested that the manufacturer, Endo Pharmaceuticals, remove the drug from the market. The FDA based its decision on data that demonstrated a shift in abuse and an association with outbreaks of HIV and hepatitis C.

The company announced it was pulling the drug from the market July 6.

Sadly, the damage to Kentucky was already done.

Our opioid epidemic is the challenge of our times, and I am seeking to hold Endo Pharmaceuticals accountable for allowing Kentuckians to die, overdose or face a public health crisis while being abundantly aware of the risks of its drug.

Part of our battle is the ever-evolving public health crisis this epidemic presents to every neighborhood, college campus, business and household.

This is particularly true with Opana ER.

When abused by injecting intravenously, Opana ER’s active pharmaceutical ingredients increase in a person by 43 percent. And when people inject a drug, there is always a risk of HIV or hepatitis C.

The risk became a reality in 2015 when the abuse of Opana ER led to a surge of HIV cases in Scott County, Indiana, located just 30 miles north of Jefferson County, Kentucky.

The Centers for Disease Control and Prevention tied the 2015 outbreak specifically to the injection of Opana ER. The federal health agency identified 220 counties across the country at the greatest risk for similar outbreaks.

Fifty-four of those counties — roughly 25 percent — are in Kentucky.

Thirteen of our counties, virtually all in the eastern region, are in the top 20 most vulnerable listed in the CDC scientists’ report, because Endo and other opioid manufacturers and distributors were selling and marketing these highly addictive drugs to our people, especially our veterans and seniors.

Wolfe (the number one county on the list), Breathitt, Perry, Clay, Bell, Leslie, Knox, Floyd, Clinton, Owsley, Whitley, Powell, Knott, Pike, Magoffin and Estill counties are in the top 25.

Yet counties in every region of our state appear on the CDC’s list for potential outbreaks — Boyle, Breckinridge, Campbell, Carroll, Edmonson, Green, Grayson, Hickman, Mercer and Monroe.

I believe the makers of this drug knew all along the dangers it posed to Kentuckians, but chose to look the other way in the name of increasing corporate profits.

My office refuses to sit back and watch families be torn apart while opioid manufacturers like Endo line their pockets at the expense of our communities and our future.

As part of my multifaceted strategy to combat the opioid crisis, in September, my office awarded a contract to the legal team we will partner with in the investigation and prospective litigation against opioid drug manufacturers, distributors and retailers.

My plan seeks compensation on behalf of the Commonwealth where there is evidence that bad actors contributed to the opioid epidemic by illegally marketing, distributing and selling opioids to Kentuckians.

I know I’m not alone in the outrage felt for the total disregard by Endo and the other rogue pharmaceutical companies focused on money at the expense of our families’ health.

For their actions, these companies must pay for what they have intentionally done to Kentucky, and I give you my word that I will work hard every day to hold these folks accountable.