The Morning Journal (Lorain, OH)
Has marketing created an epidemic?
Authorities: Tactics by makers of OxyContin have created a crisis
“I think if all my friends had never tried OxyContins it would have never led to the heroin, never. Everybody (that I know who uses heroin) started out with OxyContins.”
That’s what an 18-year-old Dayton woman told a Wright State University researcher in 2002. OxyContin had been on the market for just six years by that point but was already bringing in more than $1 billion a year.
Half a decade after that report was published, the makers of OxyContin would admit to misbranding the drug in one of the largest court settlements in U.S. history.
OxyContin was introduced to the market in 1996 by Connecticut-based Purdue Pharma. What made OxyContin stand out from other opioid-based prescription painkillers like Vicodin is the claim of longer-lasting pain relief through what it called “controlled release.”
A 1996 news release from Purdue Pharma stated “unlike short-acting pain-relievers, which must be taken every three to six hours — often on an ‘as needed basis’ — OxyContin Tablets are taken every 12 hours, providing smooth and sustained pain control all day and all night. Dosing with OxyContin Tablets on a regular schedule spares patients from anxious ‘clock-watching’ when pain must be controlled over long periods of time.”
Using the FDA’s own words, an “aggressive marketing campaign” accompanied OxyContin’s release.
Between 1996 and 2000, Purdue Pharma increased its internal sales force from 318 sales representatives to 671, according to a 2009 article released in the American Journal of Public Health called “The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy.”
The article adds that during the first five years of the drug’s availability, Purdue Pharma held more than more than 40 national pain-management and speaker-training conferences at resorts in Florida, Arizona, and California. There were 5,000-some physicians, pharmacists, and nurses who attended these all-expenses-paid symposia, where they were recruited and trained for Purdue’s national speaker bureau.
“It is well documented that this type of pharmaceutical company symposium influences physicians’ prescribing, even though the physicians who attend such symposia believe that such enticements do not alter their prescribing patterns,” the article by Dr. Art Van Zee of Virginia states.
Purdue Pharma also had a “starter coupon” program, where the company provided patients with a free limitedtime prescription for a sevento 30-day supply of OxyContin. That program would end in 2001, but not before 34,000 coupons were redeemed.
In a more unique approach to pharmaceutical marketing, Purdue Pharma distributed OxyContin-branded promotional items like fishing hats and stuffed plush toys. There was even a CD called “Swing in the Right Direction with OxyContin.”
By 2001, OxyContin was the most prescribed brandname narcotic medication for treating moderate to severe pain, according to the United State General Accounting Office.
GAO released a report in 2003 looking into OxyContin abuse and diversion. By that year, half of OxyContin’s prescribers were primary care physicians, GAO’s report states. The Drug Enforcement Agency had expressed concerns that the drug was being promoted to “treat a wide range of conditions to physicians who may not have been adequately trained in pain management.”
From its 1996 release to a label change in 2001, OxyContin used two key promotional messages according to the GAO report.
The first was that “Physicians should prescribe OxyContin for their pain patients both as the drug ‘to start with and to stay with.’ ”
The second “contrasted dosing with other opioid pain relievers with OxyContin dosing as ‘the hard way versus the easy way’ to dose because OxyContin’s twice-a-day dosing was more convenient for patients.”
Noncancer prescriptions of OxyContin grew from 670,000 in 1997 to 6.2 million by 2002.
The FDA originally approved OxyContin in December 1995. At the time of its approval, the FDA stated there was “increasing recognition that many patients with pain are inadequately treated.” At the same time, diversion and abuse of prescription drugs was increasing. OxyContin is a type of oxycodone, which had become common targets for “both drug abusers and drug addicts,” but OxyContin’s original labeling stated its tablets’ “delayed absorption” was believed to reduce its abuse liability.
According to the “The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy” article, Purdue Pharma trained its sales message the risk of addiction was “less than one percent.”
As OxyContin abuse and diversion grew, the FDA determined that the label suggesting that OxyContin may have lower abuse potential “may have affected product use or prescribing.” In July 2001, the suggestion that the controlled-release nature of OxyContin reduced abuse liability was removed from the labeling.
An expensive settlement
In 2007, Purdue Pharma pleaded guilty to “misbranding” OxyContin. The company agreed to pay more than $600 million in fines.
According to a New York Times article on the settlement, federal officials said internal Purdue Pharma documents showed that company officials “recognized even before the drug was marketed that they would face stiff resistance from doctors who were concerned about the potential of a high-powered narcotic like OxyContin to be abused by patients or cause addiction.” That resulted in the company developing a “fraudulent marketing campaign” promoting OxyContin as a time-released drug less prone to abuse and addiction.
In a statement issued by Purdue Pharma on Feb. 16, it stated: “This company accepted full responsibility for the actions some of its employees took prior to 2002. Although our products represent less than two percent of all opioid prescriptions, we’ve led the industry in developing medications with abuse-deterrent properties, and we’ve long supported the use of prescription drug monitoring programs, which are important components of our nation’s strategy toward combating prescription drug abuse.”
A 2016 Los Angeles Times investigation found that the supposed “12 hours of relief” OxyContin was said to provide wore off early in many users. Even before the drug was released, clinical trials showed many patients were not getting those full 12 hours.
Theodore J. Cicero, a neuropharmacologist at the Washington University School of Medicine in St. Louis, told the Los Angeles Times that the 12-hour intervals could be the “perfect recipe for addiction.”
Users who had the effects of OxyContin can have both their underlying pain return and the “beginning states of acute withdrawal,” Cicero told the Los Angeles Times.
“That becomes a very powerful motivator for people to take more drugs,” he said.
In the 20-plus years OxyContin has been on the market, more than 7 million people have abused the drug, according to a National Survey on Drug Use and Health report.
Cracking down
Appalachia was the first area to see the grip of OxyContin’s addiction, with rural communities in Ohio, Kentucky, Pennsylvania, Virginia and West Virginia among the hardest hit, according to the GAO report.
Those states have increased efforts in the past few years to combat prescription drug addiction. According to a Pittsburgh Post-Gazette investigation, those five states, along with Maryland and Tennessee, had 608 doctors disciplined by state medical boards for overprescribing narcotics.
In Ohio, both the number of pills dispensed and the number prescriptions for opioids written have declined by 20 percent since 2012.
Despite the crackdowns, overdose deaths continue to rise. In Ohio, the number of heroin overdose deaths surpassed the number of natural/semisynthetic (oxycodone, hydrocodone) opioid overdose deaths in 2012 it has remained that way since. Heroin provided those addicted to prescription drugs a cheaper and increasingly easier-to-obtain alternative.
Ohio passed legislation cracking down on pill mills — doctor’s offices, clinics and pharmacies prescribing and dispensing pills inappropriately or for nonmedical reasons — in 2011, the year a record 582 people died of natural/semisynthetic opioid overdoses. The state saw those overdose deaths decrease to 499 in 2012, but the numbers started creeping back up to 518 in 2013 to a new record of 618 in 2014. The record was broken again the next year with 690 natural/semisynthetic opioid overdoses according to the Centers for Disease Control.
The evolution of the opioid epidemic, of course, didn’t stop with heroin. Fentanyl, a synthetic opioid, has risen to prominence in the past few years. There were 75 Ohio deaths attributed to the drug in 2012, but by 2015 that number rose to 1,155.
While the opioid epidemic is hitting Ohio the hardest, it’s a national problem. According to the U.S. Department of Health and Human Services, 78 people are dying from opioid overdoses in the U.S. every day. Prescription opioid abuse is creating $55 billion in health and social costs in the United States each year.