SALT LAKE CITY — Two Utah doctors who were among the most prominent advocates of using opioids to treat chronic pain are now entangled in a spate of lawsuits filed against opioid manufacturers in several states.
In one of the most high-profile lawsuits to date filed last week by the Ohio Attorney General, Salt Lake City pain researcher Dr. Lynn Webster and University of Utah anesthesiologist Dr. Perry Fine are named as part of a “small circle of doctors” with ties to the pharmaceutical industry who supported chronic opioid therapy in books, articles, speeches and educational seminars in the 1990s and 2000s.
The Ohio lawsuit does not name Webster or Fine as defendants but instead names them as part of a larger case the state is building against five pharmaceutical companies for deceptive marketing that downplayed the risks of prescription painkillers like OxyContin.
According to the CDC, Utah ranked seventh in the country for drug overdose deaths between 2013 and 2015. Approximately 24 Utahns die every month from overdosing on prescription painkillers, according to the Utah Department of Health. In 2015, 282 Utahns died from prescription opioid overdoses — about six per week.
Ohio, likewise, consistently ranks near the top of drug overdose rates.
The Ohio complaint alleges that drugmakers used "key opinion leaders" like Webster and Fine to spread statements about the risks and benefits of opioids, helping to fuel the prescription painkiller and heroin crisis responsible for the deaths of more than 3,000 people in Ohio last year.
"Our office believes the evidence will show that drug companies used front groups, official sounding communications and authority leaders to promote a message that is different from what would be on the warning labels," Dan Tierney, spokesman for the Ohio Attorney General's Office, said.
Webster and Fine are also named in a lawsuit filed by the city of Chicago as opinion leaders, but are not defendants in that case. They are named as defendants in a similar case brought by several counties in New York against pharmaceutical companies.
Both doctors objected to the claims in the lawsuits and said they did not downplay the risks of opioid use to patients or other doctors.
“Whatever claims are being made are absolutely false,” said Fine, who practices at the Pain Management Center at University of Utah Health. “That’s it.”
“Chronic pain is a very serious public health problem and ... substance abuse and misuse are equally significant and public health problems. And my efforts as a physician have always been to follow my duty to optimize the health and well-being of people with illness or injury."
Webster, who works as the vice president of scientific affairs at research organization PRA Health Sciences, called the Ohio lawsuit’s claims regarding his work “baseless.”
“I have probably, as much as anybody in the country, worked to try and prevent people from harm and all of my educational materials and lectures were about the risk of opioids,” Webster said.
Webster and Fine were known throughout Utah and the U.S. as prominent pain experts in the '90s and '00s.
Both have previously served as presidents of the American Academy of Pain Medicine, a doctors’ group. Webster also developed a risk-screening tool that was used in many states’ opioid prescribing guidelines, including Utah's 2009 overhaul to make guidelines stricter.
The Ohio complaint claims that “key opinion leaders” like Webster and Fine were “selected, funded and elevated by (the pharmaceutical companies) because their public positions supported the use of opioids to treat chronic pain.”
Among other things, the lawsuit mentions a DEA probe that had targeted Webster in 2010, spurred by the number of patients in his former pain clinic who overdosed on opioids. The DEA closed the case without charges in 2014.
The lawsuit also pointedly criticized Webster for promoting a concept called “pseudo-addiction," the notion that some patients who exhibit addiction-like behaviors may simply be undertreated.
In a 2007 book about managing pain and opioid abuse, Webster said that when faced with signs of possible addiction, "in most cases" increasing the dose to see if the patient needed more of the drug "should be the clinician’s first response.”
According to Andrew Kolodny, co-director of Opioid Policy Research at the Heller School for Social Policy and Management at Brandeis University, the concept of "pseudo-addiction" came into vogue in the 1990s as doctors began freely prescribing opioids.
"Primary care doctors were being told that true addiction is extremely rare," Kolodny said.
But then those doctors would see patients coming back looking for more doses at higher levels. That's where "pseudo-addiction" came in, Kolodny said. Under that theory, patients seeking higher doses, acting like an addict, were often not addicts at all. They were, rather, suffering from severe pain and needed higher dosage.
Kolodny declined to comment on any individual doctors, but he was sharply critical of the concept of pseudo-addiction.
"To tell doctors that if your patient looks addicted you should give them more?" he asked incredulously. "That concept must have killed many people."
Webster acknowledged that pseudo-addiction "became an excuse sometimes to provide more medicine.” He also acknowledged that doctors had learned more about opioids over the past 15 years.
“There certainly was a time we thought we could eliminate pain and provide people a quality of life by giving them whatever we needed to,” Webster said. “And I think that we recognize that that’s not the case.”
But “I think today there is an attack on people in pain," he added. "If they’re using an opioid, they’re stigmatized. If you’re prescribing an opioid, you are often accused of contributing to a huge social problem, and I don’t think that is fair.”
The plunge into using opioids to treat chronic pain occurred with very little research or forethought, according to Michael Von Korff, a senior investigator at Kaiser Permanente Washington Health Research Institute who researches opioid risk reduction.
"For nearly 25 years we were acting on expert judgment, rather than on science," Von Korff said.
Von Korff views the mistakes as well-intended treatment, and he puts blame on institutions like the American Pain Society and the American Academy of Pain Medicine, on the industry which pushed to expand usage, and on the doctors who helped normalize it.
Von Korff cites a 1996 consensus statement by the American Academy of Pain Medicine and the American Pain Society on the use of opioids to treat chronic pain as example of how unscientific the field was when the epidemic began. 1996, not coincidentally, was also the first year that OxyContin was approved by the FDA.
Much of that 1996 statement reads like a strong plea advocating wider use of opioids for treat chronic pain and downplaying risks.
"Misunderstanding of addiction and mislabeling of patients as addicts result in unnecessary withholding of opioid medication," the statement argues, adding that "there does not appear to be an arbitrary upper dosage level."
"I tend to assume that people are doing what they think is the best interest of the patients," Von Korff said. "The problem is that the research that should have been done wasn't done. Meanwhile, the professional organizations were getting a lot of money from the pharmaceutical industry."
Webster is still a major researcher for many pharmaceutical companies today. According to the federal government’s Open Payments database, Webster received nearly $100,000 in payments from pharmaceutical companies for speaking engagements and consulting fees in 2015, the most recent year available, as well as $1.4 million in associated research funding.
Fine received $15,000 in payments from pharmaceutical companies that same year, mostly for speaking engagements and consulting fees.
Fine also previously served on the board of the American Pain Foundation, once the nation’s largest organization for pain patients. The foundation shut down in 2012 after reports came out about how much of its funding came from opioid drugmakers.
Fine denied that pharmaceutical companies have ever influenced his medical judgment and said that all professional societies he has been a part of sought only to advocate for patients and advance research into pain treatment.
“I’ve always practiced the highest standard of professionalism and followed the essential obligations of medicine: First, do no harm,” Fine said.