A drug maker claims that the US Food and Drug Administration (FDA) is responsible for helping to trigger the epidemic of opioids.
Edwin Thompson, a drug maker over 40 years old, said that the very agency that is supposed to approve and regulate powerful painkillers was responsible for handing over more and more OxyContin, a powerful narcotic.
He told 60 Minutes that a label change in the early 2000s had allowed the drug to be widely marketed in patients with chronic pain, which allowed them to sell more pills.
More than 47,000 people died of an opioid overdose in 2017, and according to Thompson, that number will only continue to increase if the FDA stops authorizing and marketing opioids for long-term use.
A drug maker claims that the FDA is responsible for the opioid epidemic after starting to widely market OxyContin for long-term chronic pain treatment patients (image of the file)
The fingers were pointed in all directions to blame the opioid crisis in the United States.
Although Thompson has strongly criticized the role of the FDA, he feels that it is not perfectly faultless.
"I would have liked to be smart enough to have seen this outbreak before – before I started three or four years ago," he told 60 Minutes. "But once you discover 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 of opioid oxycodone, came onto the market.
Purdue Pharma, a private pharmaceutical company, has developed OxyContin. It was approved by the FDA in 1995 and made available in 1996.
At the time, it was thought that there would be less risk of abuse with OxyContin as it is absorbed slowly and does not give users an immediate "high".
Thompson said at 60 minutes that when the FDA had approved the drug, it was based on research showing that it was effective for "short-term" use.
But in July 2001, the FDA changed the label and expanded the use of OxyContin in patients with more moderate and long-lasting pain, such as arthritis.
The leaflet clearly states that the drug is used to relieve severe enough pain to require 24-hour daily treatment … when other pain treatments … do not sufficiently treat your pain or you can not the supporter. & # 39;
Thompson, president of a Pennsylvania-based pharmaceutical company, said it allowed drug manufacturers to sell more pills at higher doses than before.
"The label of a drug … determines if someone can earn $ 10 million or a billion dollars bBecause it then allows you to promote the drug on the basis of labeling, "he told 60 Minutes.
Dr. David Kessler, former Commissioner of the FDA, left before the etiquette changes – and said it was a serious mistake.
"There are no studies on the safety or efficacy of opioids for long-term use," he told 60 Minutes. "The rigorous scientific evidence that the agency should be able to rely on is not there.
According to a 2005 study by the University of Washington's Faculty of Medicine, OxyContin has become the most widely used prescription opioid.
The National Institute for Drug Abuse says that the use of oxycodone has decreased slightly in the United States, but not much.
Dr. Andrew Kolodny, a drug addiction specialist at Brandeis University and a FDA critic, says that since the beginning, opioids like OxyContin should have been marketed for short-term uses or for the treatment of pain at the end of life.
"If you take them day and night every day, quickly, you will become tolerant to the pain relieving effect," he told 60 Minutes.
"To continue to relieve pain, you will need ever higher doses. As doses increase, treatment becomes more dangerous and the risk of death increases.
However, new court documents show that Richard Sackler, former leader of Purdue Pharma and a member of the family to which the company belongs, has worked to ensure that OxyContin is not perceived as a drug at the end of life like morphine. anticancer drug, reported the Wall Street Journal.
The 2015 statement, regarding a case in Kentucky that has since been resolved, shows that Sackler was worried that the drug would be stigmatized and cause a drop in sales.
It appears, however, that the FDA is taking steps to rectify past "mistakes".
FDA Commissioner Scott Gottlieb announced Monday that the agency was asking pharmaceutical 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 asking for years: is your efficiency decreasing and can this loss of efficiency lead to dependency? ", Gottlieb told the newspaper.