Former FDA Commissioner: Pharmaceutical companies have promoted opioids as safe and effective



Pharmaceutical companies hoping to increase the sale of opioids began promoting the drugs as safe and effective for migraines, back pain, and other chronic conditions during the 1990s, even though their products were more potent than the drugs. previous drugs, said the former Food and Drug Administration commissioner. Thursday at Central Islip.

Sales rose – as did drug abuse and fatal overdoses, said David Kessler as an expert witness from Nassau, Suffolk and New York State, which sued seven manufacturers and distributors of drugs for allegedly causing the opioid epidemic that ended thousands on Long Island. lives in recent years.

“The more drugs prescribed, the more abuse,” Kessler said in a video review recorded in January that was presented to the jury in a landmark opinion dispute in Suffolk.

Prior to the 1990s, Kessler said, doctors were wary of opioid pain relievers because of the high risk of addiction, abuse, and overdose. Doctors have limited the use of opioids to cancer patients and others with severe pain.

That all changed in the ’90s, when pharmaceutical companies – including defendants Teva Pharmaceuticals, Endo Pharmaceuticals and Allergan Finance and their subsidiaries – began to claim that they had developed new products with minimal risk of addiction or dependence. abuse. These products could be used to safely treat headaches, arthritis and other ailments, Kessler said.

These claims, Kessler said, violated FDA regulations because they were neither true nor accurate.

Kessler, now the head of President Joe Biden’s task force to develop and distribute COVID-19 vaccines, served as FDA commissioner from 1990 to 1997. He is best known for his efforts to streamline the process. ‘approval or rejection of AIDS drugs and to regulate the tobacco and dietary supplement industries.

State and county officials say they hope to hold the defendants accountable for the death and misery caused by the opioid epidemic and recover millions of dollars for treatment, recovery and prevention.

Lawyers for drug manufacturers and distributors have said their customers are not responsible for the opioid epidemic, saying they have followed all regulations and have become the scapegoats for health regulators who have encouraged opioid use, doctors who over-prescribed pain relievers and other forces beyond control.

Suffolk County attorney Jayne Conroy released a video for Kessler that showed Endo chief executive Carol Ammon explaining how the company was targeting “thought leaders” – influential doctors and researchers – to do so. pressure for changes in pain management to drive sales.

“It was one of the key elements that led to the epidemic,” said Kessler, who said the pharmaceutical industry’s campaign to erode opioid mistrust “has changed the practice of medicine.”

Endo and other companies have also paid third parties millions of dollars to minimize the risk of addiction and promote their products as safe and effective, Kessler said. The literature accompanying Kadian, an opioid drug manufactured by Allergan, described doctors’ mistrust of opioids as an “opioid phobia” and “an irrational fear of using opioids.”

Drug companies also created a condition they called “pseudo-addiction” to appease doctors who feared their patients would become addicted to drugs, Kessler said. The pseudo-addiction happened because doctors mismanaged the treatment of pain, the companies said. The solution was more painkillers.

“That’s what got us in trouble,” Kessler said.

Allergan’s attorney, Jennifer Levy, during cross-examination attempted to portray Kessler as a highly paid gun that has benefited greatly not only as an expert witness, but the opioid trade as well.

She pointed out in the January video that Kessler won $ 1.6 million as an expert witness in a federal opioid case in Ohio. He had also served for 13 years as a senior advisor for TPG, an investment firm whose holdings included an opioid firm. Kessler said he resigned from this and other posts in January after being invited to join the White House COVID-19 task force.

“Have you ever gone to TPG and said, ‘We shouldn’t be holding companies that market opioids? “Levy asked Kessler. He admitted that he had never raised his concerns about opioids to the investment firm.

The trial before state Supreme Court Judge Jerry Garguilo is being held at Touro College in Central Islip to accommodate the large number of lawyers involved in the case.

This is the first opioid lawsuit in the country to go to a jury, which is expected to hear from hundreds of witnesses. Testimonies will continue on Monday morning.



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