CHARLESTON – Attorneys defending opioid drug companies accused of causing an epidemic in West Virginia brought in a pain specialist doctor to refute the testimony of witnesses for the state who claimed doctors had become reckless in over-prescribing pain pills.
“Why did the prescribing of opioids increase (in the 1990’s)?" a defense attorney asked Dr. Carolyn Warfield, a professor with the Harvard Medical School specializing in anesthesiology, during May 9 testimony.
“In the 1970s, doctors had so much fear of opioids they were only used in operating rooms for surgery or for patients who died,” Warfield said. “I saw suffering (pain). A group of pain management doctors around the country decided we should use these drugs for patients suffering (non-cancer pain). The result was, we started using opioids and got good results. Some of these patients would have killed themselves, commit suicide. The (drug) side effects were low.”
The trial in the Kanawha Circuit Court is being streamed live courtesy of Courtroom View Network.
Opioid suppliers Teva, Cephalon (now part of Teva) and Allergen are accused of ignoring the addictive danger of opioid pills so they could increase their profits and causing an epidemic. The charges include creating a public nuisance and violating the West Virginia Consumer Protection and Control Act.
In 2019, West Virginia Attorney General Patrick Morrisey filed lawsuits against the drug manufacturers in the Boone Circuit Court. The case was subsequently moved to the Kanawha Court and is being heard in a bench trial with no jury. Judge Derek Swope will decide the verdict.
Plaintiff attorneys claim the epidemic started in the 1990s when the medical community, in the beginning encouraged by a few "opioid revisionist doctors" and later supported by drug manufacturers and distributors; abandoned what had been a former tighter policy of prescribing opioids mostly for terminal and cancer treatments. Instead they alleged, backers of more opioids began to recklessly prescribe and promote the drugs for less serious conditions, describing pain as a fifth vital sign (as in a pulse).
Pain alone is not a vital sign, the state’s attorneys claim.
Anti-drug diversion in-house programs required of the companies by the DEA were ineffective, the attorneys contended.
Defense attorneys argue the epidemic was caused by societal problems, illegal drug abuse including heroin and fentanyl, and not by manufacturing companies legally supplying doctors and hospitals with the pain pills they prescribed.
Janssen, the drug subsidiary of Johnson & Johnson, settled with the state on April 18, agreeing to pay $99 million although company officials denied any wrongdoing. An additional defendant Endo also settled with the state in March for $26 million.
A suspicious drug order includes one that is larger in quantity than normal or more frequent ordering than normal.
During the May 9 session defense attorneys sought testimony from Warfield designed to show that allowing patients to suffer with untreated chronic pain was unconscionable. She also refuted the testimony of star witnesses for the state including Dr. Katherine Keyes, an epidemiologist, and Dr. Andrew Kolodny, medical director of opioid policy research at the Heller School (Brandeis University).
Both had said opioids were not effective treatments for non-cancer pain.
“Do you agree?” Warfield was asked.
“I very much disagree,” she said. “Dr. Keyes has never treated pain. Dr. Kolodny, he’s not an academic, he’s an addiction specialist. He’s never had to sit across from a 70-year-old woman with shingles or a man who’s had five back surgeries. He doesn’t see patients with pain.”
Warfield said she usually doesn’t start treating a patient who has pain on opioids, but an over-the-counter drug such as Tylenol.
“There are lots of other things we try first,” she said.
“How do you determine the correct (opioid) dose?”
Warfield said if a patient is already on opioid treatments the dose is known. For those starting on it a low dose is usually given. The dose can be increased until the pain subsides.
“Until the pain is reduced or because of side effects (nausea), we can’t go higher,” Warfield said. “Opioids don’t have a ceiling. As long as the pain is relieved, you go slowly (increase dose) and then stay at that dose. You can for years. There’s not a maximum dose like with Advil. The right dose is different for everybody.”
Warfield said doctors have always been aware of the potential addiction risks of drugs like Norco and Kadian, and others based with morphine.
“Do the labels make it (risk) clear?”
“Yes," Warfield said. "All drugs have a risk, but for certain patients, the benefits outweigh the risks. The Food & Drug Administration and the Centers for Disease Control agree with me that for certain patients, opioids are appropriate. The West Virginia Board of Medicine would also agree. Opioids can be appropriate for non-cancer chronic pain.”
Defense attorneys exhibited a chart that read in part, “Pain is soul destroying.”
Warfield was asked if she was a “key opinion leader” (pro-opioids).
“I considered myself an expert in the field,” she responded.
She agreed she had served on speaker’s bureaus lecturing on pain management at medical schools and (health) conventions, but said her opinion was not changed because pro-opioid industry organizations contributed funding for such events.
“I never changed my talk based on who paid for it,” Warfield said.
She agreed that marketing of drugs by sales reps to manufacturers and distributors was meant to increase sales, but usually the reps pointed out a new drug’s benefits as a treatment.
“I never heard from anyone, ‘you should use opioids instead of Advil,'” Warfield said.
“Did marketing change your view?”
“Of course not, am I going to tell a patient in horrible pain I can’t give you an opioid? It (marketing) won’t change my decision on what’s best for my patient.”
“Were doctors brainwashed (into using opioids)?”
“No.”
Under cross examination attorneys for the state attempted to portray Warfield as a pro-opioid spokesman for Purdue Pharma, and disputed what they said were her claims that opioid addiction among patients was rare (less than one percent).
In 2020 Purdue settled with government officials for $8.3 billion after company officials admitted they conspired with doctors prescribing opioids for non-medical reasons.
Warfield agreed that if you expand a (drug) market, you will see an increase in overdose deaths.
“The higher the dose, the greater the risk,” the state’s attorney said.
“That’s correct,” Warfield said.
Warfield was asked about her participation on a speaker’s bureau funded by Purdue.
“Many medical professionals were on the speaker’s bureau then (1980s),” she said. “It was very common.”
Attention was called to “grass roots” supporters in the 1980s such as the doctors Russell Portenoy and Kathleen Foley who advocated wider use of opioids before the involvement of manufacturers, distributors and pharmacies. They were opposed to what was called “opioid phobia.”
Warfield was asked if she had been influenced in her opinions by companies like Purdue
“You don’t believe your views were influenced by the industry?”
“I relied on my own knowledge,” Warfield said.
