"We have found an alarming use of these products in patients who should never have received them," said G. Caleb Alexander, lead author of the study and director of the School of Health. public Johns Hopkins Bloomberg. "The prescription of this medicine was supposed to be closely monitored and contained, but was not.
"What we found was that several years after the program was launched, alarming deficiencies had been identified, yet the FDA and the drug companies have done little to effectively address these issues."
The study was based on a review of 4,877 pages of FDA reports and other documents obtained under the Freedom of Information Act from 2012 to 2017. It dealt with a class fentanyl called immediate release fentanyl or transmucosal FTI for cancer patients. opioids already present 24 hours a day with acute pain.
This type of fentanyl – usually administered by lozenges, sprays and tablets – gets into the bloodstream in seconds. The FDA created the program in 2011 to monitor prescriptions because of its effectiveness.
The goal of the program was to reduce the risk of adverse effects, abuse, abuse, addiction and overdoses by strictly monitoring who was prescribed and limiting it to a minimum. small subgroup of cancer patients.
The study quotes the FDA in the documents stating that the program "was not meeting its overall goal or most goals".
This type of fentanyl is "one of the most powerful and fastest opioids on the market," said Alexander, adding that he presented "an unacceptable risk for a fatal overdose" in patients other than those for which it was intended.
But the study found that thousands of patients received the drug, which should not have been done. In fact, more than half of those who used restricted fentanyl should never have received it.
Over a four-year period, 12,916 out of 25,322 (51%) of the patients who had been prescribed fentanyl were "opioid and non-tolerant", which means that they should not have been prescribed. . The FDA asked for more data for a five-year report, which found that between 34.6% and 55.4% of patients with prescriptions were opioid-non-tolerant, according to the study.
"These drugs are dangerous enough, they should never be used in patients who are not already on opioids 24 hours a day," said Alexander.
Alexander stated that the study was not designed to be able to say what harm could have been caused to patients who took fentanyl. But he added that everyone should be worried about the lack of supervision of the program meant to restrict its use because "there is a real risk of fatal overdose".
"The FDA and the opioid manufacturers share responsibility for these failures," he said.
Andrew Kolodny, co-director of the opioid policy research group at Brandeis University, found the study results "very troubling".
"This document shows a total failure on the part of the FDA in protecting the public," said Kolodny, who did not participate in this research. "Despite overwhelming evidence of TIRF issues, the FDA has done nothing to change and is maintaining the status quo.
"The majority of FRBR patients do not have cancer and do not tolerate opioids, so it's very disturbing."
FDA spokesman Michael Felberbaum said the agency shared the concerns expressed in the study as to whether the program was "working as intended".
"The agency is actively evaluating the recommendations of our advisory committee on the effectiveness of the [program] and necessary changes, "he wrote in an email. The FDA will soon be announcing next steps, including planned changes to the current TIRF REMS system, to ensure that the program is working to reduce the risks associated with these drugs prescribed only to tolerant patients. opioids, and that these patients understand the risks and how to use FRBR drugs safely. "
In August, the agency convened a meeting of a public advisory committee to review the latest data on the fentanyl program and discuss trends and adverse effects associated with drugs. At the time, Dr. Scott Gottlieb, a member of the Commission, had tweeted that the agency knew "that there is still much to be done. to mitigate the risks associated with these medicines and that their prescription is a top priority ".
Mr. Gottlieb pointed out that "gaps in the data on the use of these products and adverse effects" had been presented to the FDA at the meeting and that he was determined to make improvements and to "align our approach to find a better balance between access and security".
Raeford Brown, an anesthesiologist at the University of Kentucky who attended the FDA meeting in August, said the new study "faithfully reflects what we found".
"The TIRF [program] was ineffective enough to ensure the safety of this class of opioids, "said Brown, who was appointed to serve on the FDA Advisory Board in 2015.
He said that the advisory committee had found that more than 50% of the time, this class of fentanyl was "prescribed for everything except cancer pain".
"Arithrite – really all you can think of," he says.
Five top executives of Insys – one of the fentanyl makers called Subsys, which is part of the federal program – also accuse of bribing doctors in exchange for a prescription drug for cancer patients. This is the first criminal trial of opioid manufacturers' executives, highlighting their tactics and their contributions to the opioid epidemic in the country. The five executives denied any wrongdoing.
According to media reports, last week, jurors watched a video of Insys employees dancing and hitting the product.
"I have new patients, and I have a lot of them," they recount.
At one point, a person dressed in a bottle of purple and white Subsys joins her as employees dance around the bottle. "If you want to be great, listen to my voice, you can be great, but that's your choice."
Towards the end of the video, two employees sit in a top-five coffee shop. "It will kill, man," said one of them.
Kolodny said that the power of these fentanyls was nothing funny: "These are extremely dangerous drugs."
Brown added, "This is not a joke that goes beyond the imagination because these drugs can kill.In no way should people laugh and joke about it."