In 1995, the Food and Drug Administration approved OxyContin for prescription use. Its active ingredient, oxycodone, has been deemed highly addictive since the 1960s.
The drug hit the market at a time of increasing recognition by the U.S. medical community that many patients in pain were being inadequately treated.
In 1996, the American Pain Society argued for medical providers to view pain as a “fifth vital sign.” The organization urged medical providers to routinely assess and respond to pain levels in their patients in the same way they monitored blood pressure, heart rate, respiratory rate and temperature.
“We know in the ’90s there was a sort of a shift in that pain was the fifth vital sign and that we really need to be paying attention to patients’ pain because it wasn’t being treated well at that time,” said Dr. Jenna Walters, director of medical student and resident education at the Vanderbilt Pain Management Center and assistant professor of anesthesiology and pain medicine.
With the introduction of OxyContin came an aggressive marketing campaign aimed at doctors by drug manufacturer Purdue Pharma. The pharmaceutical company took out ads in medical journals, hosted conferences and deployed pharmaceutical representatives to physician offices and clinics across the country.
In 1999, 5 percent of people who received publicly funded addiction treatment in Tennessee were abusing prescription pain relievers and 342 people died from overdoses.
By 2000, prescription opioids had become the top drug abused by those receiving publicly funded treatment at detox facilities and halfway houses for recovering addicts, according to the Tennessee Department of Mental Health and Substance Abuse Services.
In 2003, the FDA issued a “warning letter” to Purdue Pharma for misleading advertisements that said:
“The combination in these advertisements of suggesting such a broad use of this drug to treat pain without disclosing the potential for abuse with the drug and the serious, potentially fatal risks associated with its use, is especially egregious and alarming in its potential impact on the public health.”
As the number of opioid-related emergency room visits and deaths continued to climb around the country, the FDA in 2008 began holding a series of meetings to discuss opioid risks, misuse and abuse.