NORMAN, Okla. (Legal Newsline) – An opioid researcher called as a defense expert witness told an Oklahoma courtroom June 27 that the opioid medication Duragesic produced by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, had been approved by the Food and Drug Administration (FDA) because the benefits of the drug outweighed the risk.
“Is this a drug that cannot be abused?” asked Larry Ottaway, the attorney for Johnson & Johnson.
“No,” said Dr. Bruce Moskovitz, former therapeutic director of scientific affairs at Janssen. “Any drug can be abused. All drugs have risks.”
Duragesic was first offered on the market by Janssen in 1991 and continues to be sold today.
The trial in the Cleveland County District Court is being streamed live courtesy of Courtroom View Network.
Oklahoma Attorney General Mike Hunter alleges that J&J and its prescription drug subsidiary Janssen carried out a fraudulent advertising campaign to oversupply opiates in Oklahoma for profits leading to an epidemic Hunter called the worst in the state's history. J&J's opioid brands are Duragesic, which dispenses opioids by the use of a timed-release patch, and a pill called Nucynta.
Thousands of cases are still pending around the country, and the Oklahoma case is being followed nationwide. It's also the first opioid trial under the "public nuisance" legal theory, attempting to hold pharmaceutical companies, distributors and pharmacies liable for the nation's addiction crisis. Critics of the nuisance claim say the state’s case is in reality a products liability case.
Two other co-defendant pharmaceutical companies, Purdue Pharma of Connecticut and Teva Pharmaceutical based in Israel, earlier settled with Oklahoma, $270 million from Purdue and $85 million from Teva. That left J&J (and Janssen) as sole defendants in the case.
In the Purdue Pharma settlement, private attorneys took in $60 million, while about $200 million went to a research project at Oklahoma State University, which is Hunter's alma mater.
Purdue officials pleaded guilty in 2007 of misleading the public about the risk of addiction from their opioid pain killer OxyContin and agreed to pay $600 million, at the time one of the largest pharmaceutical settlements in U.S. history.
Moskovitz described the phases of bringing a drug to market. He said a determination is made based on need whether to bring a drug to trials.
“Many drugs never make it past that point,” Moskovitz said. “But typically tests are eventually done on human volunteers.”
Dosages are determined and then the drug is tested on a patient population. Preliminary assessments are made on how effective the drug is. In the pivotal phase the FDA decides if the drug benefit outweighs its risks.
The process of marketing a drug like Nucynta, Moskovitz said, can take a decade and involve the work of hundreds of technicians. Monitoring through a Risk Evaluation and Mitigation Strategy (REMS) program and through the FDA occurs before the product is brought to market and after.
“For most [drug] compounds the FDA reviews the product [before market] for nine months,” Moskovitz said.
‘What if the FDA approves?” Ottaway asked.
“Then the drug is packaged and labeled with information how to select the right patient, the dose and instructions,” Moskovitz said.
Post-market monitoring looks for potential adverse events, possible side effects of the medication by information-gathering (scientific literature and the Internet), as well as surveillance for potential problems in cooperation with law enforcement and drug officers.
“What is an opioid?” Ottaway asked.
“It’s a compound that attaches itself to a receptor in the nervous system that reduces how we perceive pain,” Moskovitz said.
Moskovitz explained that there are short-duration opioids and longer duration, an example Nucynta ER (extended release). Drugs are ranked by schedule, or potency, from one to four, with heroin a schedule one drug because it has no medical advantage.
Nucynta (a pill) and the Duragesic patch are schedule two drugs, which Moskovitz said means they are among the most restrictive of drugs but with medical benefits.
“Does failure to treat pain increase the pain?” Ottaway asked.
“Yes,” Moskovitz said. “If left untreated it makes the severity of pain worse. Acute pain can progress to chronic pain.”
Fentanyl, the substance used in Duragesic, Moskovitz said lessens pain and is also used as an anesthetic during surgery.
Tasmanian Alkaloids, a poppy processing subsidiary of Johnson & Johnson from 1982 to 2016, produced about 40 percent of the world’s legal opiate crop. The firm based in Tasmania developed a new strain of poppy that officials called Norman, the crop used to create a substance called thebaine that was used in the production of OxyContin and other opioids.
“Is fentanyl derived from poppies?” Ottaway asked.
“No, Moskovitz said. “It [fentanyl] is a synthetic product.”
Moskovitz added that to receive such drugs there cannot be renewals. Each prescription must be new and each proscribing physician must be licensed by the Drug Enforcement Administration (DEA).
Moskovitz said the Duragesic patch offered certain advantages, for example a patient who can’t take a pill orally.
“What if I ate it [patch]?” Ottaway asked.
“You could die from respiratory depression,” Moskovitz responded.
Ottaway exhibited an advisory document that said abuse of the Duragesic patch appeared to be quite low. Moskovitz agreed, noting that difficulty in extracting fentanyl from the patch was one of the reasons.
Labeling for the product advised that its use is for “pain that cannot be managed by lesser means.”
“Has this been approved for chronic pain?” Ottaway asked.
“Yes,” Moskovitz said.
“Has it ever been promoted for everyday pain?”
“No.”
FDA approval of the drug described it as “safe and effective.” However, a warning also added that it is a desirable drug for abuse.
Moskovitz said continuing surveillance from 1995 though the early 2000s showed that Duragesic and fentanyl had lower rates of abuse than other opioids.