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Thursday, October 3, 2019

The Early Days of the Opioid Crisis: How It Might Have Turned Out Differently


An article in The New York Times tells the tragic story of addiction and its effect on a Virginia coal mining town that has already seen its share of hard times. But it’s more than that. It’s about the lawmakers who had a chance to do the right thing to make OxyContin more difficult to get—and didn’t.

Three brothers bought a small pharmaceutical company, Purdue Pharma

The brothers, all doctors, introduced a version of oxycodone that was reformulated into a slow-release format. That drug was, of course, OxyContin, a powerfully addictive painkiller. The opioid crisis has taken more than 400,000 lives. Hundreds of thousands more addicts are trapped in endless struggles between sobriety and addiction. Many lose that struggle.
Now the Sackler family, realizing they can’t sustain the growing barrage of lawsuits, are declaring bankruptcy. There’s speculation that they’ve salted away billions of dollars in offshore accounts. Purdue Pharma has warned a bankruptcy court that the Sackler family members “may be unwilling–or unable” to contribute billions to a $10–$12 billion settlement toward the costs of the opioid crisis if lawsuits against them are allowed to proceed.

Years before there was an opioid epidemic, Sister Beth Davies saw it coming

In the late 1990s, patient after patient addicted to a new prescription painkiller called OxyContin began walking into Sister Beth Davies’ Appalachian substance-abuse clinic. Around the same time, a local physician, Dr. Art Van Zee, sensed that something was going on as well. Teenagers were coming into his clinic, overdosed on the drug. His lawyer wife, Sue Ella Kobak, had yet another perspective on the growing crisis—a growing wave of crime. All had links to OxyContin.
These three people, each with a unique perspective and first-hand experience with the effects of this addictive drug, were among the first in the country to sound an alarm about the misuse of prescription opioids. This was perhaps the beginning of a cycle of addiction. It spread to illegal opioids like heroin and counterfeit versions of fentanyl. This led to activism against Purdue Pharma that the powerful company crushed.

Those who saw the epidemic unfolding see it as a tragedy of missed opportunities

  • Van Zee believed the FDA could have rechanneled the drug’s force by forcing Purdue Pharma to reformulate OxyContin so that it was harder to abuse. It took until 2010 for the drugmaker to do this.
  • The Justice Department could have changed the behavior of other opioid makers if it had charged executives of Purdue Pharma in 2007 with felonies, in connection with OxyContin’s illegal marketing.
  • Instead, department officials negotiated a deal under which the executives pleaded guilty to misdemeanor charges that did not include jail time.
  • In the years that followed, executives of other opioid makers and distributors kept shipping millions of addictive pain pills into towns like this one, apparently without fear of serious penalties.

The consequences of OxyContin inaction continue to impact this mining town

“I think the trajectory would have been completely different,” Dr. Van Zee said recently. “It would not have reached the magnitude that it did.” This former mining town of about 1,900, set in the far southwestern corner of Virginia near the border of Kentucky is still suffering the consequences of addiction.
  • Van Zee is 72 and gets up at 4am. to take care of paperwork before spending 10- to 12-hour days at a community health clinic. Some of his patients are still addicted to opioids.
  • Sister Beth is now 86, and she continues to run her treatment center. She is seeing more people turning to heroin and fentanyl because they’re cheaper. She’s also seeing the return of methamphetamine. “It never ends, the whole cycle, we are still losing people to these drugs.”

Dr. Van Zee: a reluctant activist who trusted pharmaceutical companies

Both Sister Beth and Ms. Kobak had previously taken on fights in this part of Appalachia to protect the rights of workers and the environment. But Dr. Van Zee was an unlikely activist. When OxyContin came on the market in 1996, he prescribed it for his cancer patients to dull their excruciating pain. He was naïve enough to think that a pharmaceutical company wouldn’t market a drug that had such addictive powers.
A Purdue Pharma sales representative told him that OxyContin was safe because it was a long-acting narcotic; it would not appeal to drug abusers who sought a quick high. But users quickly discovered that crushing an OxyContin pill released large quantities of the narcotic oxycodone.
Sister Beth recalls getting a phone call from the local pharmacist as she was starting to see people addicted to the drug. His words: “Believe me, this is going to be the worst disaster that ever hit Lee County.”

Dr. Van Zee began writing Purdue Pharma executives

Dr. Van Zee was urging the company to pull back on how it was marketing the drug. Frustrated by the lack of response, he and others launched a petition drive in 2001 to convince the FDA to take OxyContin off the market until it could be reformulated and made safer.
  • Several executives met with Sister Beth, Dr. Van Zee, Ms. Kobak and others at a local motel.
  • They listened as the executives tried to convince them to drop the recall petition, and offered $100,000 to help fund addiction treatment in the area.
  • One executive showed a new ad campaign that included a warning label.

By the mid-2000s, the people of Pennington Gap were trying to combat a growing opioid epidemic in other ways.

  • Van Zee received training that allowed him to prescribe buprenorphine, a medicine that blunts cravings for opioids.
  • Sister Beth, Ms. Kobak, Dr. Van Zee and others helped start a local inpatient addiction treatment facility, the only one for many miles.
In 2007 the Justice Department announced criminal indictments against Purdue Pharma and three of its top executives in connection with deceptive marketing of the drug. That July, Sister Beth stood in drizzling rain outside a federal courthouse in Abingdon, VA, disappointed about the outcome of the case.
A judge had approved a deal struck between the Justice Department and the three Purdue executives. Under it, the men were allowed to plead guilty to a single misdemeanor charge that did not accuse them of personal wrongdoing and for which they would not face jail. “I think it would have made a considerable difference if these people had been arrested and done jail time,” she said. This was a slap on the hand.

Twenty years later, the problems of the opioid epidemic continue to plague this town

Drugs tainted by counterfeit fentanyl are now sold on the streets. Many of the town’s population are meth addicts, prone to flying into psychotic rages. The inpatient treatment facility was forced to close after for lack of funding. Government funding was woefully short of what was necessary for people to get the help they needed. Virginia’s decision last year to expand Medicaid, which has paid for treatment of many low-income people in other expansion states, may have helped, along with an injection of federal grant money to states for addiction treatment and prevention.

Sister Beth, Dr. Van Zee and Ms. Kobak: Watching the legal problems of Purdue Pharma

Earlier this year, Dr. Van Zee and Ms. Kobak flew to Oklahoma so the physician could testify as an expert witness in that state’s lawsuit against the drugmaker. But that never happened. In March, Purdue Pharma agreed to pay $270 million to settle. As a result, all its internal documents remain sealed. Oklahoma state officials said they struck the deal because of concerns that Purdue Pharma, which faces thousands of lawsuits, might soon file for bankruptcy, which, of course, it did.
Dr. Van Zee said he couldn’t question the state’s decision but was deeply disappointed. The lawsuits against Purdue Pharma and other opioid manufacturers and distributors have been consolidated under one federal judge in Ohio. Johnson & Johnson was ordered to pay $572 million to Oklahoma for its role in the epidemic. This is one case in one state. There are more than 2,500 lawsuits that are pending against Purdue Pharma.

Failure of public officials to police actions of corporations

After living through the opioid epidemic for 20 years, Dr. Van Zee, Ms. Kobak and Sister Beth all share the belief that the only way to prevent a similar catastrophe is for the truth to come out about the actions of corporations and the failures of public officials to oversee them. “I hope it puts a light on what huge systematic changes we can make so that this doesn’t happen again.” Twenty years later, hundreds of people are struggling with addiction, and the national failure to contain an epidemic has grown more complex.
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