When Purdue Pharma introduced the opioid painkiller OxyContin in 1995, the Food and Drug Administration allowed the company to claim that the drug was less susceptible to abuse and less likely to cause addiction than other opioids.
It was not true. Executives at Purdue Pharma and the members of the Sackler family who owned and controlled the company knew it was not true. The FDA never should have allowed such a potent drug to be marketed with such a rosily dishonest campaign. But using an army of salesmen and women who wooed thousands of doctors with false talking points, fees, travel and meals, Purdue Pharma turned OxyContin into a cash machine that has generated more than $35 billion in sales.
The combination of pharmaceutical companies willing to do everything to increase sales, and an FDA unwilling to stop them and protect the nation, is an old story.
A database created in 2014 catalogs more than 11 million payments to physicians and hospitals. The division of the FDA responsible for approving opioids gets 75 percent of its budget from the drug industry because in 1992, with the FDA badly underfunded, Congress passed legislation that levies huge fees for new drug approval applications. And Dr. Raeford Brown, the chair of the FDA opioid advisory committee, is apoplectic that the agency continues to approve dangerous opioids over his committee’s objections.
Purdue Pharma is not the only bad actor, and OxyContin is not the FDA’s only misstep. But Purdue Pharma presents a clear case study for how badly our drug companies and our regulatory process need to be reined in.
Until 2007, Purdue Pharma continued to push the false line that less than 1 percent of patients prescribed OxyContin would become addicted. In that year, the company pleaded guilty to a felony charge of “misbranding,” and three top executives pleaded guilty to misdemeanors. The men and the company admitted they had marketed the drug by misrepresenting its potential to cause addiction and be abused, and paid $635 million in fines. But Purdue kept pushing to increase sales of opioids, and the FDA never made the company stop.
More than 200,000 Americans have died from overdoses related to prescription opioids since 1996. Hundreds of thousands more who died from overdoses of heroin or fentanyl were introduced to opioids via prescription painkillers obtained legally or illegally. OxyContin and Purdue Pharma and the Sacklers can’t be blamed for all of that tragedy, but neither can they avoid sharing the blame.
More than 1,600 lawsuits filed against the company for its part in this plague are coming home to roost, although most plaintiffs may never collect. Purdue Pharma last month settled a suit brought by Oklahoma by agreeing to pay $275 million. The company wanted to avoid a trial, and the state wanted to get paid before a possible company bankruptcy.
But new and more powerful opioids continue to be approved over the objections of the FDA’s experts. Salesmen and women push doctors to prescribe the drugs, which are often ineffective and nearly always addictive. FDA commissioners still side with pharmaceutical companies. And opioid addicts still die at the rate of 150 a day.
