While there’s early evidence that the explosive rate of opioid deaths has started to slow, opioids killed more than 49,000 people in the United States in 2017.
A bold “60 Minutes” story on Feb. 24, placed the blame for the widespread scourge on the Food and Drug Administration.
Here are some excerpts from the devastating story:
“60 Minutes” reported: “We have not had a high-ranking executive from the pharmaceutical industry sit before our cameras, until now. Tonight, Ed Thompson, a drug manufacturer who spent decades managing and producing opioids for Big Pharma, breaks ranks to denounce his industry and the federal regulator, the Food and Drug administration, which he says opened the floodgates on the crisis with a few little changes to a label.”
Ed Thompson: “The root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain.”
Reporter Bill Whitaker, “The FDA ignited this opioid crisis?”
Ed Thompson, “Without question, they started the fire.”
“Ed Thompson told us when the top selling opioid, Oxycontin, was first approved in 1995, it was based on science that only showed it safe and effective when used ‘short-term.’ But in 2001, pressured by Big Pharma and pain sufferers, the FDA made a fateful decision and, with no new science to back it up, expanded the use of Oxycontin to just about anyone with chronic ailments like arthritis and back pain.”
Thompson: “So this is what a package insert looks like.”
“The FDA did it by simply changing a few words on the label, that lengthy insert no one ever reads. Today the label says the powerful pain pills are effective for ‘daily, around-the-clock, long-term … treatment.’ And that small label change made a big change in the way drug companies would market all opioids, allowing them to sell more and more pills at higher and higher doses.”
Thompson: ‘A drug’s label is the single-most important document for that product. It determines whether somebody can make $10 million or a billion dollars.”
“Ed Thompson owns PMRS, a successful Pennsylvania pharmaceutical company that manufactures drugs for Big Pharma. It’s made him a rich man. But now he’s putting his livelihood at risk. He’s doing what no other drug maker has ever done, he’s suing the FDA in federal court to force it to follow the science and limit the opioid label to short term use.”
If he wins the suit and the FDA changes the label other manufacturers would be forced to change their labels and limit their marketing. Thompson said that change would take $7 to $10 billion out of the market.
And thousands of lives would be saved.