Baldwin and Fischer
NORMAN, Okla. (Legal Newsline) – In a trial to determine if Johnson & Johnson helped to cause an opioid epidemic, a health officer with the Oklahoma State University in Tulsa on Thursday said the addiction outbreak will cost millions of dollars to alleviate and decades to see major progress.
“How long will it take?” asked Lisa Baldwin the attorney hired by the State of Oklahoma.
“At least 20 years but preferably 30 years to treat the breadth of the opioid addiction in our state,” responded Dr. Julie A. Croff, executive director for the Center for Wellness and Recovery at OSU.
“Do you have an opinion on whether a medical addiction department at each of the state’s medical schools (costing $11.7 million per year) as you described is necessary to abate Oklahoma’s opioid crisis?” Baldwin asked.
“I do, it’s reasonable and necessary,” Croff responded.
Croff was asked if she favored an endowed chairperson at each of the state’s medical schools at a cost of $14 million.
“It’s reasonable and necessary,” Croff said.
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 Pharmaceuticals carried out a fraudulent advertising campaign to over-supply 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.
The cost to abate the drug crisis officials called the worst health emergency in the state’s history could cost $17.5 billion according to the Washington Post.
Croff appeared as an expert witness called by the state to testify on solutions to the state’s opioid drug crisis from an academic perspective.
She proposed adding 222 licensed alcohol and drug abuse counselors on the state’s college campuses, one counselor per 1,000 students at a projected cost of $16.9 million (2018 costs).
Currently she said OSU has two such counselors.
"Typically counselors can't do the same activities as those trained in alcohol and drug counseling," Croff said. "So it is necessary to have this expertise statewide on campuses."
Croff, who said the cost figures (salaries for personnel) were based on payroll data, indicated the budget could be “phased-down” in the future as the problem abates and fewer counselors are needed over time.
Other recommendations were upgrades in continuing medical education for health care providers costing $5.5 million between 2019 and 2038, addiction medical courses costing $12.9 million between 2019 and 2038, and case management services between 2019 and 2038 costing an estimated $67.3 million.
Croft, who leads the Center for Wellness and Recovery that was founded in 2017, has been in her post for one year.
The campus facilities in place include an out-patient clinic training residents (doctors in training) in addiction management and a program called The Extension for Community Health Care Outcomes (Project ECHO), a medical education collaborative that empowers clinicians in rural and under-served areas of the state to provide specialty care.
Croff said her role is to work with clinicians and to bring researchers into the programs to develop best practices in dealing with the opioid epidemic. Medical school training is offering addiction courses on how to treat opioid use disorder. Croff said it is one of the first such programs in the country.
Fellowships, financial support for graduate students in the field (addiction) are also available.
“Our first goal is to address pain by advocating for a healthier lifestyle,” Croff told the court, “considering alternatives other than an opioid prescription, including mindfulness, positive psychology, yoga and cognitive behavioral therapy.”
Croff called the developing science a “de-escalation” of the use of opioids.
“There are lots of non-pharmacological avenues to recommend,” she said.
One of the non-drug techniques is called osteopathic manipulation (pressure and stretching of joints to relieve pain).
Croff said one new and innovative area of study is the analyzing of brain stimulation called deep transcranial magnetic stimulation (TMS), for example for the treatment of depression.
Another proposal would track mothers and their babies suffering from opioid use disorder (OUD) to understand how the brain in such children is impacted over a number of years.
State attorneys exhibited a chart listing the impacts of a baby inheriting opioid drug addiction from a mother called “neonatal abstinence syndrome.” It includes slow heartbeat, requirement for oxygen or blood transfusion, premature low weight at birth, and late infant speech development.
“We want (opioid) prescription for less than a week,” Croff said. “We need patients to understand what an opioid is and the risks.”
Croff said if an opioid is used longer than a week, it is the health care provider’s responsibility to screen and monitor the use to prevent addiction.
“We want to catch it when a patient exhibits mild use disorder,” she said, “so we can move to treatment.”
Under cross examination, Johnson & Johnson attorney Amy Fischer asked Croff if she was a medical doctor or a psychiatrist.
“No,” Croff answered.
“You’ve not written a prescription, fair?” Fischer asked.
“That’s fair,” Croff said.
“You didn’t actively engage in scientific research to form your opinions in this case?” Fischer asked.
“I have conducted observations of opioid use in populations that are in my studies,” Croff said.
“But using your own definition, interacting with individuals, testing those theories and identifying solutions, you didn’t actually do research to form your opinions, correct?” Fischer said.
“Specific to the abatement plan we discussed today, we are testing those solutions, they are in progress now, so we don’t have those results today,” Croff said.
“All I’m asking is if you did research?” Fischer said.
“Specific to interacting with subjects, no,” Croff said.
“Prior to this, you had never developed a university-based treatment and training program to address the opioid crisis, use and abuse?” Fischer asked.
“Correct,” Croff said.
“Prior to 2018 you never developed a continuing medical education program specific to opioids?”
“Correct,” Croff said.
“Prior to 2018 your efforts were not directed to opioids, correct?”
“Your research before was directed to alcohol?” Fischer asked.
“Alcohol and other drugs,” Croff answered.
“Fair to say the majority was alcohol?”
“That’s fair to say.”
“You don’t have any medical training, correct?”