A drug manufacturer says the US Food and Drug Administration (FDA) is responsible for helping to spark the opioid epidemic.
Edwin Thompson, a drug manufacturer of more than 40 years, says the very agency that is supposed to approve and regulate powerful painkillers was responsible for more people getting their hands on OxyContin, a powerful narcotic.
He told 60 Minutes a label change in the early 2000s allowed the drug to be broadly marketed for patients experiencing chronic pain, which allowed more pills to be sold.
More than 47,000 people died from overdoses involving opioids in 2017, and Thompson says that number will only continue to rise unless the FDA stops approving and marketing opioids for long-term use.
A drug manufacturer says the FDA is responsible for the opioid epidemic after it began broadly marketing OxyContin for those with long-term chronic pain management (file image)
Fingers have been pointed in all directions when it comes to placing the blame for the US opioid crisis.
Although Thompson has been a vocal critic of what he says is the FDA’s role, he feels he’s not completely faultless.
‘I wish I was smart enough to have seen this epidemic before – before I got three or four years into it,’ he told 60 Minutes. ‘But once you find out that it’s not correct, you have to do the right thing.’
He says the root of the problem began in the 1990s when OxyContin, the brand name for the opioid oxycodone, first hit the market.
Purdue Pharma, a privately-held pharmaceutical company, developed OxyContin. It was approved by the FDA in 1995 and made available in 1996.
At the time, it was believed there would be less potential for abuse with OxyContin because it’s absorbed slowly and does not give users an immediate ‘high’.
Thompson told 60 Minutes that when the FDA approved the drug, it was based on research that showed it was effective for ‘short-term’ use.
But, in July 2001, the FDA changed the label and broadened OxyContin use for those with more moderate and long-term pain such as arthritis.
The insert clearly states the the drug ‘is used to manage pain severe enough to require daily around-the-clock, long-term treatment…when other pain treatments…do not treat your pain well enough or you cannot tolerate them.’
Thompson, the president of a Pennsylvania pharmaceutical company, said this allowed drug manufacturers to sell more pills at higher doses than they were before.
‘A drug’s label…determines whether somebody can make $10 million or a billion dollars because it allows you to then promote the drug based on the labeling,’ he told 60 Minutes.
Dr David Kessler, the former FDA commissioner, left before the label change – and says it was a huge mistake.
‘There are no studies on the safety or efficacy of opioids for long-term use,’ he told 60 Minutes. ‘The rigorous kind of scientific evidence that the agency should be relying on is not there.
According to a 2005 study from the Washington University School of Medicine, by 2004, OxyContin became the most prevalent abused prescription opioid.
The National Institute on Drug Abuse says oxycodone abuse has slightly decreased in the US, but not by much.
Dr Andrew Kolodny, an addiction specialist at Brandeis University and FDA critic, says that, from the beginning, opioids like OxyContin should have been marketed for short-term uses or end-of-life pain management
‘If you’re taking them around the clock every day, quickly, you become tolerant to the pain-relieving effect,’ he told 60 Minutes.
‘In order to continue getting pain relief, you’ll need higher and higher doses. As the doses get higher, the treatment becomes more dangerous and the risk of death goes up.’
However, new court documents show that Richard Sackler, a former executive at Purdue Pharma and a member of the family that owns the company, worked to make sure that OxyContin would not be perceived as an end-of-life drug like morphine or as a cancer drug, reported The Wall Street Journal.
The 2015 deposition, from a case in Kentucky that has since been resolved, shows Sackler feared the drug would be stigmatized and cause a decline in sales.
It seems, however, that the FDA may be taking steps to rectify past ‘errors’.
On Monday, FDA Commissioner Scott Gottlieb announced the agency is requiring drug companies to conduct studies on the safety of prescription drugs already on the market, according to The Washington Post.
‘We are going to impose a mandate on existing products…to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction,’ Gottlieb told the newspaper.