CHARLESTON — An opioid researcher testified that dangerously powerful drugs such as OxyContin were promoted by manufacturers and distributors in what amounted to a step-by-step distortion campaign undertaken for profits — resulting in an epidemic.
“The manufacturers put their finger on the scale,” Dr. Andrew Kolodny said April 14 during the state opioid trial. “It led to the benefit side (of drugs) and minimized the risks. Doctors had difficulty weighing it (information). It led to a massive increase (prescribed drugs) and was harmful to patients.”
Johnson and Johnson and its drug subsidiary Janssen were referred to as the drug “kingpin.” Circuit Judge Derek Swope agreed with a defense objection and ordered the reference stricken from the record.
The trial is being streamed live courtesy of Courtroom View Network.
Janssen and suppliers Teva, Cephalon and Allergen are accused of causing an opioid epidemic in West Virginia. The charges include the creation of a public nuisance and violations of the state's Consumer Credit & Protection Act. If the state wins the case it will ask the companies to pay millions to establish drug treatment programs.
Attorneys have estimated it could take 30 years to undo the human damage from the epidemic.
West Virginia Attorney General Patrick Morrisey filed lawsuits against the companies in late 2019 in the Boone Circuit Court. The case is now being heard by a state Mass Litigation Panel in a bench trial with no jury. Swope will decide the outcome.
The case is the latest of several state-conducted lawsuits including in Washington State and Florida against opioid distributors and manufacturers.
Plaintiff attorneys in West Virginia will seek to prove the companies ignored the addictive dangers of the drugs so they could profit by promoting them, and maintained ineffective anti-drug diversion programs.
Originally included as a defendant was Endo, but Morrisey announced last month that company settled with West Virginia for $26 million.
West Virginia’s is considered a landmark case because the state has one of the country’s highest addiction rates (three times the national average). Native American tribal reservations across the country also have high rates.
Defense attorneys argue that societal problems and illegal misuse of drugs including heroin resulted in the epidemic. That distributors and manufacturers are innocent, only doing their jobs supplying drugs needed by pain patients that were legally prescribed by doctors.
Called as an expert witness by the state, Kolodny portrayed a pro-opioid movement in the 1980s that began with only a few proponents, but eventually grew to become a national industry campaign—one of disinformation and false exaggerations.
“The reality is that even after only five days of (opioid) use, with dis-use there are (withdrawal) symptoms,” Kolodny said. “A patient can be on opioids for six months in exactly the way the doctor prescribed, and wants to come off the drug. You have to go slowly. Acute withdrawal is likely, insomnia, irritability, fatigue. All she (patient) has to do to feel better is to put one pill in her mouth, because of physiological dependence.”
Kolodny said misleading and dangerous claims were made by the defendants. For example, the idea patients who appear to be suffering from opioid addiction may have instead a ‘pseudo-addiction’ (false addiction).
“This is a very dangerous message,” Kolodny said. “In other words, you give more opioids. This is the opposite of what doctors had been taught.”
Kolodny said exaggerated claims that opioids can be taken every day for longer periods are false.
“The evidence for this does not exist,” he said. “The evidence shows us patients on opioids are not doing well.”
In past decades before 1980 opioids were rarely used except in cases of end-of-life or cancer pain treatments. In the late 1980s a few proponents such as Dr. Kathleen Foley and Dr. Russell Portenoy favored expanding their use for other conditions such as back pain or arthritis.
In 1995 the Food & Drug Administration (FDA) approved OxyContin, a semi-synthetic opioid manufactured by Purdue Pharma. In October of 2020 Purdue officials reached a settlement of $8.3 billion with the government admitting that the company knowingly and intentionally conspired to aid doctors in providing opioid medications without a legitimate medical purpose.
Kolodny said the American Pain Society; supposedly a patient advocacy group but one critics contend is really a pro-opioid-industry lobbying organization, did a promotional campaign.
“They described pain as the fifth vital sign (like pulse),” Kolodny said. “This impacted how opioids were prescribed. It was a campaign to increase prescribing. The West Virginia Medical Board was influenced by it.”
Kolodny said Johnson & Johnson attempted to quell the fear of opioids by coining the term “oplophobia.”
He said in 1997 the Federation of State Medical Boards, a trade association, teamed with American Pain Society and other advocacy groups who received funding support from manufacturers to model new guidelines for state medical boards. One stipulation was that doctors would not be sanctioned (punished) if they prescribed more opioids.
In 1997, the West Virginia Medical Board responded with a statement that opioids are appropriate for the treatment of chronic (non-cancer) pain. New rules were written for hospitals as well, treating pain as a vital sign.
Kolodny said pain is not a vital sign.
He cited a Center for Disease Controlp study in 2022 that found that long-term use of opioids is not associated with improved pain or bodily function.
“They’re saying we don’t have evidence this works,” Kolodny said. “There is very good evidence of risk. We lack evidence of benefits.”
Kolodny added that doctors were encouraged to prescribe opioids by promotional messaging from the opioid industry. The state attorney exhibited a chart that read, “There is no reliable way to predict which patient will suffer serious harm or benefit from opioid therapy.”
Kolodny said opioid industry officials downplayed the risks to sell their drugs and adopted the position that fear of addiction was inappropriate. He agreed that industry claims of the benefits of the drugs’ effectiveness were “unsubstantiated.” Kolodny also called a suggestion that patients with “broader” types of pain could be treated with opioids an example of “off label” marketing.
