“There are no studies on the safety or efficacy of opioids for long-term use,” said former FDA commissioner David Kessler in a recent “60 Minutes” interview.
The former Food and Drug Administration commissioner expressed regret that the agency allowed drug companies to promote the idea that opioid painkillers were safe for long-term use in a recent 60 Minutes interview.
Dr. David Kessler was FDA commissioner during the ’90s, when Purdue Pharma’s prescription opioid OxyContin was approved. Shortly after, Purdue began an aggressive marketing campaign to both prescribers and consumers, including chronic pain patients.
In 2001, the FDA changed the indication on the label for prescription opioids to say that it was safe for long-term use, allowing drug companies to market them as such. However, Dr. Kessler now says that there were no studies on the long-term effects of regular, ongoing opioid use at the time.
“There are no studies on the safety or efficacy of opioids for long-term use,” said Kessler in the interview. “The rigorous kind of scientific research the agency should be relying on is not there.”
The former commissioner also appears to regret allowing the methods of the OxyContin marketing campaign, which were unprecedented in the prescription drug market. Soon, companies like Purdue were convincing doctors to prescribe more pills at higher doses — something that experts believe fueled the current epidemic of opioid-related addiction and overdoses.
Dr. Kessler is now on retainer by cities and counties that are suing Perdue Pharma and other drug companies for the damage caused by the opioid crisis. He officially left the FDA before the drugs were proclaimed safe for extended use, but laments that no one stopped it from happening.
“You have a system of pharmaceutical promotion that changed the way medicine practiced and no one, all right, stopped it,” he said. He later blames this on understaffing in the FDA marketing department.
Current FDA Commissioner Dr. Scott Gottlieb declined to be interviewed, instead providing a written statement.
“Many mistakes were made along the way,” it reads. “While the agency followed the law in approving and regulating opioids, we at the FDA include ourselves among those that should have acted sooner.”
On another 60 Minutes segment three days later, drug manufacturer Ed Thompson indicted “his own industry” and agreed with Dr. Kessler’s assessment that the label change was what sparked the opioid epidemic.
“The root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain,” Thompson said. “Without question, they start the fire.”
Thompson himself is now suing the FDA in an attempt to force the administration to change the label on prescription opioids once again to say that it’s only safe for short-term use. As a maker of these drugs, he stands to lose billions if he’s successful. Thompson is going ahead with the suit, however, refusing to sell what he calls “snake oil” to consumers.
“You’re using high-dose, long-duration opioids when they’ve never been designed to do that,” he explained to the 60 Minutes host. “There’s no evidence that they’re effective. There’s extreme evidence of harms and deaths when you use them.”