CHARLESTON – A director of the Food & Drug Administration says physicians in the 1990s lost their fear of prescribing opioids, leading to higher rates of addiction.
Before that, opioids had been more conservatively used, mostly for end-of-life and cancer treatments.
“Doctors said okay, I can do back pain (use opioid drugs), or for osteoarthritis,” Dr. Peter Marks said April 13 during the eighth day of the West Virginia state trial of four suppliers of opioid prescription pills accused of causing an epidemic. “When you do that, you end up exposing a larger group of people (to drugs). You’re shipping more (pills). More people become addicted. You say you can open up use and more prescriptions correlates into more addictions.”
The trial, which began April 4 in Kanawha Circuit Court, is being streamed live courtesy of Courtroom View Network.
Janssen, the drug arm of Johnson & Johnson, and opioid suppliers Teva, Cephalon and Allergen, are accused of causing an epidemic in West Virginia.
West Virginia Attorney General Patrick Morrisey initially filed lawsuits against the drug manufacturers in late 2019 in the Boone Circuit Court. The case, which began last week, is being heard in the 13th Judicial District Kanawha Court by a state's Mass Litigation Panel in a bench trial. Judge Derek Swope will render a verdict after what is expected to be a two-month trial.
Other state-conducted lawsuits including in Washington and Florida are being held against opioid distributors and manufacturers.
Plaintiffs’ attorneys in West Virginia are seeking to prove the companies ignored the addictive dangers of the drugs for profits, endangering the public by creating a public nuisance and violating the West Virginia Consumer Protection and Control Act. State attorneys argue that the companies recklessly promoted opioid drugs while instituting ineffective anti-drug diversion programs.
West Virginia will seek millions in damages from the defendants to fund addiction treatment programs.
Defense attorneys argue the epidemic was caused by illegal drug abuse including heroin and fentanyl, and not by manufacturing companies legally supplying doctors and hospitals with the pain pills they prescribed.
One of the original defendants was another company Endo, but Morrisey announced last month the company had settled with West Virginia for $26 million.
Marks, an oncologist and director of the FDA Center for Biologic Evaluation and Research, in a deposition taped in January of 2021, said drug labeling needed to be truthful and accurate.
“It is the manufacturer who has the responsibility,” he said, “to make sure a drug is used safely. The drug label has information on what’s agreed to (between FDA and the maker).”
Marks conceded the ability of FDA officials to oversee everything a drug manufacturer does is not absolute.
“You can’t be everywhere,” he said. “The FDA has only glimpses of the world. The sheer volume ... you can't see everything.”
Marks was asked by a state’s attorney if the FDA and a manufacturer work together in taking a drug to market.
“Both have responsibilities,” he said. “To make sure the (drug) label is truthful. The FDA has to oversee and catch violations.”
“You (FDA) did not look at individual prescriber (doctor) habits?”
“That would be a fair statement,” Marks said. “It is up to the doctor to use their judgement (make a prescription).”
Asked how the marketing of opioids had changed in the past 30 years, Marks said both the dose of the drugs and the availability.
“Two reasons,” he said. “There were very strong opioids on the market in the 1990s, stronger opioids, and more of them. The real change occurred in the practice of medicine. Opioids (before) were used sparingly, for cancer pain. There was a fear of opioids because of their addictive properties. Marketing efforts changed that.”
Marks said the medical community came to believe the drugs were not as addictive as previously thought, and could be used for other types of (non-cancer) pain.
He indicated that opioids do alleviate suffering and play an important role, but balance and common sense are needed.
“You can change things in negative ways,” he said. “There’s no question they (opioids) work on acute pain, but how the drug should be used should be spelled out on the label."
“Does the FDA have control of the label?”
“At the time of drug approval,” Marks answered. “Afterward, the manufacturer has the responsibility to make sure the label is updated.”
Marks said it is possible for a label to tout the benefits of a drug while not spelling out the risks. He also agreed that a third party could be hired by a drug manufacturer to promote a drug and be less than truthful.
“Have you seen a drug that was overstated (benefits and not risks)?” Marks was asked.
“Regrettably, yes,” he answered. “You can broaden it to use for less severe pain.”
“What’s wrong about broadening a market?”
“When you go beyond (over-prescribe), you put patients at risk,” Marks said. “Drugs can be diverted. It has a ripple effect.”
Marks was asked about the difference between a branded drug and a generic version.
“Branded is made by the manufacturer,” he said. “It’s first on the market. It gets a term (of use). After its patents expire, other companies can come in and sell it with the same ingredients. These are called generic.”
Marks said a manufacturer should not promote a drug (touting benefits) beyond its label.
“When an industry manufacturer adopts a behavior, it’s observed by other manufacturers,” Marks said. “They can ride the coattails in changing the practice of medicine.”