Ex-FDA Commissioner: Drug companies touted opioids as safe and effective

Drug companies hoping to increase sales of opioids began touting the drugs as safe and effective for migraines, back pain, and other chronic conditions in the 1990s, even though their products were more effective than previous drugs, the former food commissioner said and Drug Administration Administration Thursday in Central Islip.

Sales soared – as did substance abuse and fatal overdoses, said David Kessler, an expert witness for Nassau, Suffolk and New York State, which sued seven drug manufacturers and distributors for allegedly causing the opioid epidemic that hit thousands of Long Island has finished living in recent years.

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

Before the 1990s, Kessler said, doctors were suspicious of opioid pain relievers because of the high risk of addiction, abuse, and overdose. Doctors limited opioid use to cancer patients and others who were in severe pain.

That all changed in the 1990s when pharmaceutical companies – including defendants Teva Pharmaceuticals, Endo Pharmaceuticals, and Allergan Finance and their subsidiaries – claimed they had developed new products that had minimal risk of addiction or abuse. These products could be used to safely treat headaches, arthritis, and other ailments, Kessler said.

Those claims, Kessler said, violated FDA regulations because they were not truthful or accurate.

Kessler, now head of President Joe Biden’s Task Force on Development and Distribution of Vaccines for COVID-19, was FDA commissioner from 1990 to 1997. He is best known for his efforts to streamline the AIDS drug approval or rejection process and the tobacco and dietary supplement industries.

Sign up for the Classroom newsletter.

The pandemic has changed education on Long Island. Find out how.

By clicking on Register, you agree to our privacy policy.

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

Attorneys for drug manufacturers and distributors have stated that their customers are not responsible for the opioid epidemic, arguing that they followed all regulations and were scapegoated for the actions of health officials who promoted opioid use, doctors who did the pain relievers overly prescribed and other forces beyond their own control.

Suffolk County attorney Jayne Conroy played a video for Kessler in which Carol Ammon, CEO of Endo, spoke about how the company was targeting “thought leaders” – influential doctors and researchers – to drive changes in pain management increase sales.

“That was one of the key elements that led to the epidemic,” said Kessler, who said the pharmaceutical industry’s campaign to undermine the opioid warning “changed the practice of medicine.”

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

The drug companies also created a condition they called “pseudo-addiction” to reassure doctors who were raising concerns about their patients becoming addicted to drugs, Kessler said. Pseudo addiction occurred because doctors mishandled pain management, the companies said. The solution was more pain relievers.

“That got us into trouble,” said Kessler.

Allergan attorney Jennifer Levy attempted cross-examination to portray Kessler as a highly paid wage earner who has profited not only as an expert but also from the opioid trade.

She pointed out in the January video that Kessler made $ 1.6 million as an expert witness on a state opioid case in Ohio. He also spent 13 years as a senior advisor for TPG, an investment firm that owned an opioid company. Kessler said he stepped down from that position and others in January after being asked to join the White House COVID-19 task force.

“Have you ever gone to TPG and told TPG, ‘We shouldn’t have companies that market opioids?’ Levy Kessler asked, admitting that he had never raised concerns about opioids with the investment firm.

The trial before the State Supreme Court Justice Jerry Garguilo is being held at Touro College in Central Islip to do justice to the large number of lawyers involved in the case.

It is the first opioid lawsuit in the nation to be brought before a jury set to be heard by hundreds of witnesses. The testimony will continue on Monday morning.

Michael O’Keeffe covers Suffolk County Police and other Long Island law enforcement agencies. He is an award-winning journalist and co-author of two books, “The Card” and “American Icon”.