The story of OxyContin

 

This is the story of OxyContin, a schedule II opioid pain reliever introduced in 1996 which was more widely abused after its introduction that any prescription drug in the past 20 years. Sales of the drug, marketed by Purdue Pharma, rose to over $1 billion in less than five years, making it one of the fastest growing and highest grossing pharmaceuticals in recent times. Along with its popularity and rapid growth came widespread abuse, attracting attention from the media, the Food and Drug Administration, the Drug Enforcement Administration, Congress, law enforcement officials, and the medical community. Heralded as a highly effective groundbreaking new medication, OxyContin brought relief to millions of chronic pain patients, but also brought suffering and death to drug abusers. The backlash from this was felt by the manufacturer, the medical community, and legitimate pain patients who suddenly found themselves labeled as addicts and unable to obtain medication. The appropriateness of long-term opioid use was brought to the forefront of debate among medical professionals, and the progress which had been made during the past decade in the aggressive treatment of chronic pain conditions appeared to take a step backwards. To understand OxyContin, one must first know something of the history of opioids, which derive from the opium poppy known botanically as Papaver somniferum first cultivated by humans circa 3400 B.C. From the opium poppy morphine was created, and then in 1898 Bayer released the most famous drug brand of all time, Heroin. A wide variety of opioids were created over the next century, including oxycodone, the active ingredient in OxyContin. All opioids have in common an unrivaled pain relieving efficacy without toxicity to the body, allowing their use in large quantities over long duration. Unfortunately, opioids also bring euphoria and pleasure to many of their users, leading to widespread use and abuse. Modern science is still unable to separate the euphoric and pain-relieving qualities of opioids, making their use controversial and requiring restrictions on their availability. Longer term opioid use leads to tolerance as well, requiring users to take larger quantities over time to achieve the same initial effects. OxyContin was unique in that it was available in slow-release 12 hour high-dose formulations, giving physicians to ability to indefinitely increase patient dosage and maintain continued pain relief. Oxycodone seemed to have a lower number of side effects compared to other opioids, but also seemed to produce a uniquely enjoyable euphoric quality and was easily abused because of the high potency of the pills. The story of OxyContin was in a large part created by the media, which brought national attention to the drug with a wave of sensationalized news stories which began in early 2001. OxyContin was proclaimed a national epidemic and called the ‘New Crack’ with a ‘heroin-like’ high, supposedly claiming hundreds of lives yearly. These claims were not borne out by fact, but the news media was undeterred, and devoted a startling amount of attention to the drug in a 6 month period. This gave the DEA, Congress, the FDA, and the medical community no choice but to respond to these claims. In truth, abuse of prescription drugs had been occurring for decades. An analysis of prescription drug abuse data showed that OxyContin was responsible for less than 1.0 percent of total drug abuse emergency department mentions. It had also contributed to less than 20 percent of all opioid abuse mentions, and was in fact overshadowed by established opioids such as Vicodin, Morphine, and Percocet. A review of the coroner’s toxicology reports also suggested that the death numbers reported by the media may have been dramatically overstated, and that many of the OxyContin overdose victims had consumed alcohol, anti-anxiety drugs such as Valium, and other opioids. The Drug Enforcement Administration had already begun to investigate OxyContin diversion and abuse on a small scale in 1999 and 2000, but as the media coverage hit in 2001 and congressional hearing appeared imminent, the DEA drastically stepped up its rhetoric and its investigation of physicians. Before a congressional subcommittee in August 2001, the director of the DEA made it clear that OxyContin was the agency’s number one priority, characterized as a societal threat unlike any which had been seen for decades. Within six months, the DEA requested a budget allocation of $25 million to combat OxyContin diversion and abuse on top of the $114 million it was already requesting for its Diversion Control department. The diversion of OxyContin was due to its high street price; approximately $1 per milligram, nearly 10 times the pharmacy price. Stories were frequently reported about corrupt doctors making thousands of dollars through liberal prescription practices. Legitimate patients were sometimes selling their medication to supplement their income, and people were importing the drug from Mexico and Canada. Originally only popular in certain rural areas, the drug seemed to spread to urban areas as the intense media coverage brought it to attention, and the DEA predicted that the plague was heading west. Congressional subcommittees were convened to discuss the issue and the company was called on to address the problem. The DEA announced a National Action Plan to combat diversion and abuse through coordination of law enforcement agencies, cooperation with the manufacturer, public education campaigns, and discussions with physician and patient groups. Unsurprisingly, these groups were largely unreceptive because they had been hard at work throughout the decade passing legislation and changing medical opinion to support the increased use of opioids in treating a wider variety of chronic pain conditions. They knew that with increased scrutiny would come a constriction of legitimate use from doctors who feared the threat of DEA investigations. No matter how often the DEA stated that it gave full support to doctors who used opioids appropriately, it was never exactly clear what the DEA’s interpretation of ‘appropriate use’ meant, so physicians were left to look out for their own interests. It began to appear that partial responsibility for the problem lay with Purdue’s aggressive marketing of the drug. Sales grew from $300 million in 1996 to $1.49 billion in 2001 in part because of Purdue’s targeting of physicians who were already liberal prescribers. Some began to suggest the Purdue had downplayed the risks of the drug by claiming that it had reduced addiction liability due its slow-release mechanism. In also may have been marketed for a wider range of conditions than was appropriate. In 2001 Purdue began to make some effort to combat the problem by withdrawing the highest dose formulation and conducting anti-prescription drug abuse advertising campaigns. Under DEA pressure, the warning label and indications were changed in 2001 to convey the risks of the drug and the appropriate patient populations. In the face of rising criticism of its practices and calls to withdraw the drug, Purdue remained defiant, claiming innocence and placing the blame fully on those who chose to manipulate doctors and abuse the drug. While publicly proclaiming support for prescription monitoring programs and giving the state of Florida $2.1 million to establish its own monitoring program in exchange for halting an investigation, Purdue quietly opposed other attempts to create or strengthen monitoring programs. A rising tide of legal cases also began to occupy Purdue as patients filed suit against the company for inappropriate labeling and misleading marketing. As media attention began to subside, OxyContin was still on the radar of the DEA and Congress. After having caught the few corrupt doctors, the DEA settled for frightening the rest into changing their prescribing practices. The doors of clinics began to close and physicians became reluctant to prescribe the drug. It was this change in the medical community’s comfort with opioid use which was perhaps OxyContin’s most tragic legacy. While many doctors simply switched to other possibly less effective opioids, some stopped prescribing altogether. Patients’ advocacy groups found their cause had been set back dramatically, and legitimate chronic pain patients often found themselves unable to obtain treatment.