Opioid pulled from shelves

*Originally published in the Appalachian News-Express*

By Buddy Forbes
Staff Writer

“Strong pills lead to strong addiction. Strong pills lead to crime. Strong pills lead to a lot of very severe health effects.”
A statement from Pikeville Commonwealth Attorney Rick Bartley mirrors the decision made last week by Endo Pharmaceuticals, the makers of the drug Opana ER, to halt the sale of its product.
Opana ER, also known as oxymorphone, is a strong pain medication that has been used by opioid-addicted users to get a strong high.
“Opana is a relatively new drug. It is yet another extremely powerful pain reliever in the opioid class. It’s similar to oxycodone, but it’s my understanding that it’s probably oxycodone and morphine,” said Bartley. “It’s supposedly for people who have serious, prolonged pain. They’ve now come up with an extended release version.”
This extended release version is a stronger dose, which is meant to take the place of multiple pills by employing a time-release composition to send smaller doses throughout a specific timespan as opposed to a large dose all at once.
According to Bartley, with most drugs, alcohol included, there’s a time immediately when you take it that you get no effect at all. But as it’s absorbed into the bloodstream, it “goes up like a mountain.” Bartley said once the drug reaches its “peak,” or maximum effect, it begins coming back down.
“At that point, you need another pill. What you get are periods of no relief and periods when you get more relief than you really need,” said Bartley.
According to Bartley, the idea is a time-released pill that will only go up a smaller amount and then it will plateau across and keep relief in a constant amount for a longer period.
“So, in theory, it makes a lot of sense. But it’s the exact same thing we were told by Purdue Pharma about oxycodone … but we know that was 100 percent a lie,” Bartley said.
The drug, when crushed, releases all of its medicine at once, defeating the purpose of the time-released composition.
“One of two things happened with this extended-release Opana. The manufacturer did not do due diligence in its testing, and if so that’s a crime. Or they knew it, but they were going to sell it as long as they could,” said Bartley.
According to a statement from Attorney General Andy Beshear, this decision by the company to pull its product is a move in the right direction for a suffering state like Kentucky. Beshear said this is the “first step” in combatting the Commonwealth opioid epidemic.
Beshear voiced his concerns about the product to the Food and Drug Administration (FDA) in February.
“The previously determined the reformulated Opana ER can still be readily prepared for injection and can be crushed with common items for snorting,” Beshear said. “Snort-able or injectable drugs have crippled Kentucky, ranging from the widespread abuse of Oxycontin to the return of heroin.”
According to the statement, on June 8, the FDA requested that Endo Pharmaceuticals remove Opana ER from the market.
The statement also said Beshear’s office intends to file multiple lawsuits against drug manufacturers, distributors, and retailers where there is evidence of known contribution to the opioid epidemic. Such evidence would prove that these parties illegally marketed and sold opioids to Kentuckians. According to the statement, Beshear is requesting that legal services not be paid for with taxpayer dollars.
According to Bartley, Kentucky isn’t the only state cracking down on this issue.
“Multiple states are now filing, or contemplating filing, lawsuits against manufacturers of opioids to try to get back some of the money that it’s costing the state, the government and the people to treat these addicts,” he said.
Bartley said in many cases, in the eyes of the pharmaceutical companies, it’s about the bottom dollar, not those who have hit rock bottom.
“So, if experience is any teacher, experience says this is another drug that’s going to cause death and destruction along this impossible pain relief,” he said. “Yet, it continues. So, what do we see? More and stronger drugs being pushed on the public so drug manufacturers can make more money, with little regard to the health and safety of addicts and people whose lives are being destroyed.”
This was echoed by Beshear, who is currently joined in a multi-state lawsuit against the maker of Suboxone, and working with law enforcement and local leaders in an effort to host substance abuse awareness forums across the state.
“The abuse and diversion of Opana and other strong opioids is devastating the health of many of our Commonwealth’s citizens. They, as well as our Medicaid and corrections departments, pay an enormous financial price in the attempt to treat this epidemic,” Beshear said.
According to the statement, Beshear will continue to fight for an end to the opioid crisis in Kentucky.
“Opana ER has already taken the lives of Kentuckians,” Beshear said. “Emily Walden (Louisville), whose son, T.J., died of an Opana ER overdose in 2012, has led the charge to have the reformulated drug removed from the market. By working hand-in-hand with dedicated Kentuckians like Emily, we can and will end our opioid epidemic.”


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