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Ex-FDA commissioner: Pharmaceutical companies promoted opioids as safe and effective

Former Food and Drug Administration Commissioner David Kessler,

Former Food and Drug Administration Commissioner David Kessler, seen above in May, testified in a video examination that was presented Thursday to the jury in a landmark opinion litigation in Suffolk. Credit: AP / Jim Lo Scalzo

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

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

"The more drugs prescribed, the more abuse there is," Kessler said in a video examination recorded in January that was presented to the jury in a landmark opinion litigation in Suffolk.

Before the 1990s, Kessler said, physicians were wary of opioid painkillers because of the high risk of addiction, abuse and overdose. Doctors limited the use of opioids to cancer patients and others suffering from severe pain.

That all changed in the '90s, when pharmaceutical companies — including defendants Teva Pharmaceuticals, Endo Pharmaceuticals and Allergan Finance and their subsidiaries — began claiming that they had developed new products that had minimal addiction or abuse risks. Those products could be used to safely treat headaches, arthritis and other ailments, Kessler said the companies said.

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

Kessler, now the head of President Joe Biden’s task force to develop and distribute vaccines for COVID-19, was FDA commissioner from 1990 to 1997. He is best known for his efforts to streamline the process to approve or reject AIDS drugs, and 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 to recoup millions of dollars for treatment, recovery and prevention.

Attorneys for the drugmakers and distributors have said their clients are not responsible for the opioid epidemic, arguing that they followed all regulations and are being made scapegoats for the actions of health regulators who encouraged opioid use, doctors who overprescribed the painkillers and other forces beyond their control.

An attorney for Suffolk County, Jayne Conroy, played a video for Kessler that showed Endo chief executive Carol Ammon talk about how the company targeted "thought leaders" — influential doctors and researchers — to push for changes in pain management to drive up sales.

"That was one of the key elements that led to the epidemic," said Kessler, who said the pharmaceutical industry’s campaign to erode opioid wariness "changed the practice of medicine."

Endo and other companies also paid third parties millions of dollars to minimize the risks of addiction and promote their products as safe and effective, Kessler testified. Literature that accompanied Kadian, an opioid medication manufactured by Allergan, described doctors’ wariness of opioids as "opioid phobia" and "an irrational fear of using opioids."

The drug companies also created a condition they called "pseudoaddiction" to assuage physicians who expressed concerns that their patients were becoming hooked on drugs, Kessler said. Pseudoaddiction occurred because doctors were mismanaging pain treatment, the companies said. The solution was more pain medication.

"That is what got us into trouble," Kessler said.

Allergan attorney Jennifer Levy on cross-examination attempted to portray Kessler as a highly paid gun-for-hire who has profited handsomely not just as an expert witness but also from the opioid trade.

She pointed out in the January video that Kessler had earned $1.6 million as an expert witness for a federal opioid case in Ohio. He had also served for 13 years as a senior adviser for TPG, an investment firm whose holdings included an opioid company. Kessler said he resigned from that position and others in January after he was asked to join the White House COVID-19 task force.

"Did you ever go to TPG and tell TPG, ‘We should not be holding companies that are marketing opioids?’ " Levy asked Kessler.

"I have never had a conversation that stated it that way, no," Kessler replied.

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

It is the first opioid lawsuit in the nation to go before a jury, which is expected to hear from hundreds of witnesses. Testimony will continue on Monday morning.

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