OxyContin Maker Bows out of Meeting on Harder-to-Abuse Drug

Americans are becoming “primed” for heroin addiction through the growing use and abuse of prescribed opioid painkillers, the Centers for Disease Control and Prevention reported Tuesday.

Heroin use has increased across the US among men and women, most age groups, and all income levels.

Some of the greatest increases occurred in demographic groups with historically low rates of heroin use: women, the privately insured, and people with higher incomes.

Not only are people using heroin, they are also abusing multiple other substances, especially cocaine and prescription opioid painkillers.

As heroin use has increased, so have heroin-related overdose deaths. Between 2002 and 2013, the rate of heroin-related overdose deaths nearly quadrupled, and more than 8,200 people died in 2013.

In the meantime, pharmaceutical giant Purdue Pharma continues to not be held truly accountable.

For those who didn’t know, Purdue is the manufacturer of legalized heroin, known by the tradename OxyContin.

As far back as 2001, Connecticut Attorney General Richard Blumenthal issued a statement urging Purdue to take action regarding abuse of OxyContin; he did note that, while Purdue seemed sincere, there was little action being taken beyond “cosmetic and symbolic steps.”

After Purdue announced plans to reformulate the drug, Blumenthal noted that this would take time, and that “Purdue Pharma has a moral, if not legal, obligation to take effective steps now that address addiction and abuse even as it works to reformulate the drug.”

OxyContin was “re-formulated” only as recently as 2010 to discourage patients from crushing the tablets for snorting or injection. Purdue Pharma discontinued the older version of its blockbuster drug, due to its association with addiction, overdose and death.

But nothing has really changed.

In fact, just this week, Perdue was scheduled to meet with the FDA in long-planned two-day meeting to evaluate whether the abuse-deterrent features Purdue said they put into their newer version of their drugs actually translated into reduced rates of abuse by pain patients.

Previously, the FDA required Purdue Pharma to conduct long-term, follow-up studies tracking rates of abuse, addiction, overdose and death with the updated drug.

In fact, the FDA has been urging (but not requiring) companies to design new painkillers with tamper-resistant features to make them more difficult to abuse.

Deaths linked to opioid pain medications like OxyContin and Vicodin have quadrupled since 1999 to an estimated 16,000 in 2013, the most recent year for which the Centers for Disease Control and Prevention reports figures, which data demonstrates, according the verbiage from the CDC itself, that these painkillers are essentially the worst drug epidemic in US history.

In late 2013, the FDA tried to make it significantly harder for doctors to prescribe Vicodin, Lortab, and other highly addictive painkillers that have killed tens of thousands of Americans over the past decade.

While lawmakers praised the agency’s move, the very next day, over the objections of its medical advisory board, the FDA approved Zohydro, a new drug that has 5 to 10 times more of the heroin-like opioid hydrocodone than Vicodin!

“If you approve this pill, you surely will be signing a death sentence for thousands of people, especially young kids,” Avi Israel, a father whose 20-year-old son committed suicide after becoming addicted to doctor-prescribed hydrocodone, told FDA officials at the December 2013 hearing.

Meanwhile, just last week, Purdue unsurprisingly pulled out of that federal meeting to review the company’s “harder-to-abuse version” of its much-debated drug.

An executive for Purdue Pharma says the company “wants more time to review and analyze its data.” As a result, the company has withdrawn its application that was slated to be reviewed before a Food and Drug Administration committee this past week.

The excuse provided: “Given the complexity of epidemiological research and the unprecedented nature of this exercise, we’ve made the decision to complete additional analyses,” said Dr. Richard Fanelli, the company’s head of regulatory affairs, in an emailed statement. Blah, blah, blah.

[Note: FDA meetings are typically planned months in advance and cancellations are highly unusual. The agency must present detailed evaluations of the company’s application and coordinate travel for outside experts who advise the federal government.]

Let’s be abundantly clear and speak in plain English: Doctors prescribe de-facto heroin for a wide range of ailments, from post-surgical pain to arthritis and migraines. However, medical experts state that the only ethically and morally appropriate role of these drugs should be used for the most severe cases, such as cancer pain or end-of-life care.

So, quite simply, we are allowing the guys and girls in the white lab coats to be licensed drug dealers promulgating the worst drug epidemic in U.S. history.

And then, when our loved ones become unsurprisingly addicted, they are left to fend for themselves in our communities, which localities historically demonize and stigmatize the addicted; our states and federal government underfund treatment; and regulators do not give us the tools to separate the good from the bad providers.

But we continue to march on. Keep the faith.

Read more here.

About Jeffrey Lynne

Jeffrey C. Lynne is a South Florida native, representing individuals and business entities relating to licensing, accreditation, regulatory compliance, business structure, marketing, real estate, zoning and litigation pertaining to substance abuse treatment facilities and sober living residences. Mr. Lynne has been recognized across the region as a leader in progressive public dialogue about the role that substance abuse treatment has within our communities and the fundamental need and right to provide safe and affordable housing for those who are both in treatment for addiction and alcoholism as well as those who are established in their recovery.