Drug overdose is the leading cause of accidental death in the US, with 47,055 lethal drug overdoses in 2014. Opioid addiction is driving this epidemic, with 18,893 overdose deaths related to prescription pain relievers and 10,574 overdose deaths related to heroin in 2014.
From 1999 to 2008, overdose death rates, sales and substance use disorder treatment admissions related to prescription pain relievers increased in parallel. The overdose death rate in 2008 was nearly four times the 1999 rate; sales of prescription pain relievers in 2010 were four times those in 1999; and the substance use disorder treatment admission rate in 2009 was six times the 1999 rate.
From the American Society of Addictive Medicine, ASAM
OxyContin, a trade name for oxycodone, is a time-release painkiller that can be highly addictive. From 1996 to 2001, the number of oxycodone-related deaths nationwide increased 400 percent. The annual number of OxyContin prescriptions increased nearly 20-fold, according to a report by the U.S. Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to another 318.
OxyContin Marketing and Promotion
“OxyContin’s commercial success did not depend on the merits of the drug compared with other available opioid preparations. The ‘Medical Letter on Drugs and Therapeutics’ concluded in 2001 that oxycodone offered no advantage over appropriate doses of other potent opioids.3 Randomized double-blind studies comparing OxyContin given every 12 hours with immediate-release oxycodone given 4 times daily showed comparable efficacy and safety for use with chronic back pain4 and cancer-related pain.5,6 Randomized double-blind studies that compared OxyContin with controlled-release morphine for cancer-related pain also found comparable efficacy and safety.7–9
The FDA’s medical review officer, in evaluating the efficacy of OxyContin in Purdue’s 1995 new drug application, concluded that OxyContin had not been shown to have a significant advantage over conventional, immediate-release oxycodone taken 4 times daily other than a reduction in frequency of dosing.10 In a review of the medical literature, Chou et al. made similar conclusions.11“
OxyContin Legal Troubles
Patients began filing lawsuits against Purdue in the early 2000s, but the company has been effective in either smoothing over the claims or settling the suits on confidential terms. Purdue experienced a serious blow at the hands of the U.S. Department of Justice when it launched a criminal investigation in 2002.
When he took office in 2001, according to U.S. Attorney John Brownlee, his office was handling a number of cases related to OxyContin abuse. Including crimes by addicts seeking to support their habits and arrests of street dealers and even pharmacists and physicians.
“But it always seemed I think to me and to the investigators that there was more,” Brownlee told a news conference. Investigators from a number of state and federal agencies worked together on an investigation of the Purdue and began to subpoena company records in 2002, Brownlee said.
The Department of Justice investigated marketing claims that OxyContin was less addictive than other painkillers. Three top executives pleaded guilty to fraud charges, and in 2007, Purdue was ordered to pay $635 million.
Purdue Paid $634.5 Million Fines
In 2007, Purdue Pharma L.P., its president, top lawyer and former chief medical officer paid $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said.
“With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public,” U.S. Attorney Brownlee said. “For these misrepresentations and crimes, Purdue and its executives have been brought to justice.”
The plea agreement settled a national case and came two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to over-prescribe OxyContin.
12-hour Dose Claims Not Accurate
A 2013 investigation by the FDA featured testimony from Brown University professor Dr. David Egilman, an expert on warning labels, who claimed that Purdue had willfully ignored the science that proved OxyContin was ineffective as a 12-hour dose. And, that it had created an “addiction producing machine.” Purdue lawyers barred him from revealing confidential information and sealed testimony from company executives.
Egilman, an expert in warning labels, had worked on hundreds of product liability cases ranging from asbestos to microwave popcorn. He had developed a reputation as a plaintiff’s advocate driven to expose corporate wrongdoing. He submitted a PowerPoint presentation to be played in his absence. In the five-minute presentation, Egilman accused Purdue of ignoring its own science for financial reasons and sending patients on a dangerous roller coaster of withdrawal and relief.
“In other words,” he said, “the Q12 dosing schedule is an addiction producing machine.” Neither Purdue nor the agency ever responded to Egilman’s presentation.
Purdue Company OxyContin Official Response
In response to an LA Times’ article, Purdue submitted a one-page response similar to the FDA assessment of OxyContin as a 12-hour drug.
“Scientific evidence amassed over more than 20 years, including more than a dozen controlled clinical studies, supports FDA’s approval of 12-hour dosing for OxyContin,” wrote Purdue’s chief medical officer, Dr. Gail Cawkwell. Purdue officials added in the same statement that “Purdue [has] dedicated [itself] to helping address our nation’s opioid epidemic.”
According to Purdue: “Only 12-hour dosing has been proven safe.”
Increasing Deaths Related to Higher Doses of OxyContin
From the American Society of Addictive Medicine, ASAM
National Opioid Overdose Epidemic
In 2012, 259 million prescriptions were written for opioids, which is more than enough to give every American adult their own bottle of pills.
Four in five new heroin users started out misusing prescription painkillers. As a consequence, the rate of heroin overdose deaths nearly quadrupled from 2000 to 2013. During this 14 year period, the rate of heroin overdose showed an average increase of 6% per year from 2000 to 2010, followed by a larger average increase of 37% per year from 2010 to 2013.
94% of respondents in a 2014 survey of people in treatment for opioid addiction said they chose to use heroin because prescription opioids were “far more expensive and harder to obtain.”
Need Opioid Addiction Treatment and Recovery?
Arrowhead Lodge Recovery: Men’s Rehab
Arrowhead Lodge Recovery is a gender-specific addiction treatment center for men over 30; located in Prescott, AZ. We treat opioid painkiller addiction on two fronts: addiction and chronic pain. Our physician is board certified in pain and addiction medicine.
This means we are able to treat both addiction and chronic pain symptoms. Our program requires a 12-week residential stay that may be covered by medical insurance plans. We also work with workers compensation companies for those whose injury was work related.
OxyContin’s 12-hour problem http://static.latimes.com/oxycontin-part1
The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774
This article, written by Kenneth Chance, originally appeared here on the Arrowhead Lodge site Kenneth Chance is the founder and CEO/President of Arrowhead Lodge Recovery.Share ...
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