Rural county accuses drug makers of fueling opioid epidemic

Tucked between news of budget meetings and beauty pageant winners published in The Dickenson Star’s 2017 “Year in Review” is a grim statistic: Dickenson County was first in the state and sixth in the nation in opioid overdose deaths per capita.

In Dickenson County, in the coalfields of Southwest Virginia bordering Kentucky, residents have been dying of prescription opioid overdoses in recent years at a rate of about 40 per 100,000 people — more than seven times the statewide rate.

The newspaper’s annual review is cited in the introduction of a lawsuit filed by Dickenson against 30 pharmaceutical manufacturers, distributors and providers including Purdue Pharma, Abbott Laboratories and CVS Health Co.

Represented by the Sanford Heisler Sharp law firm and The Cicala Law Firm, Dickenson is suing for $30 million in damages. The suit says the defendants deliberately increased the flow of opioids into the county, state and country.

The case is one of the latest examples of communities across the nation suing pharmaceutical companies and associated businesses and alleging that they had a role in creating the epidemic. In Virginia, the city of Alexandria is suing for $100 million while in neighboring Maryland, Montgomery and Prince George counties have also taken legal action.

Joanne Cicala, founder of the Cicala Law Firm, which has offices in Texas and New York, says those who are responsible for and profited from the epidemic must be held accountable for its costs.

“The opioid epidemic is not accidental. It is not a natural disaster; it is a man-made crisis,” Cicala said. “And worse — the companies that did this were not just seeking to build market share — they knew they were creating addicts.”

In more than 100 pages, the lawsuit tells the story of how Dickenson County — with a population of fewer than 16,000 residents spread out over 334 square miles — was drawn into a prescription opioid overdose epidemic that claimed more than 500 lives across the state in 2017.

Did manufacturers ‘push opioid as safe, effective drugs’?

As with any drug that enters the prescription market, the distribution process begins with manufacturers. In the case of the opioid epidemic, one of the manufacturers is Purdue Pharma, a company known for its best-selling opioid — OxyContin.

In Dickenson, the lawsuit claims, Purdue Pharma and other defendants recognized “the enormous financial possibilities associated with expanding the opioid market.” So they “rolled out a massive and concerted campaign to misrepresent the addictive qualities of their product, and to push opioids as safe, effective drugs for the treatment of chronic pain,” the suit alleges.

According to the lawsuit, the drug manufacturers took part in a “campaign of deception” rooted in a since-disavowed study by Dr. Russell Portenoy published in the Medical Journal, “Pain,” in 1958.

In the study, Portenoy claimed that opioids could be used for long periods of time “without any risk of addiction” to treat chronic pain unrelated to cancer. The study said patients in pain would not become addicted to opioids because their pain drowned out the euphoria associated with the drugs.

Within a decade, Portenoy was financed by at least a dozen pharmaceutical companies, most of which produced prescription opioids.

The lawsuit argues that Portenoy’s study — paired with the practice of spending millions of dollars on promotional activities that understated the risks of opioids — not only legitimized but normalized the prescribing of opioids in Dickenson and across the country.

In the case of OxyContin — Purdue’s time-released version of oxycodone — promotional materials given to physicians included this key sentence: “Delayed absorption as provided by OxyContin tablets is believed to reduce the abuse liability of a drug.”

The drug companies’ sales representatives marketed directly to physicians, ensuring that doctors would be advocates for certain drugs, the lawsuit said. As a result, it contended, the pharmaceutical manufacturers were able to insert their products directly into specific markets.

In 2014 alone, the manufacturing defendants named in the Dickenson lawsuit spent more than $168 million on pursuing branded opioid sales contracts with doctors, the lawsuit said.

Fifty-four years after publishing his study justifying the prescription of opioids, Portenoy acknowledged that he erred in understating the risks of addiction associated with such drugs.

“Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,” Portenoy said in an interview that year with The Wall Street Journal. “We didn’t know then what we know now.”

How pharmacy benefit managers influence drug prices

As explained in the lawsuit, pharmacy benefit managers, or PBMs, are the middleman between the manufacturers and the marketplace; they influence which drugs are used most frequently, set prices for pharmacies and control what drugs are covered by health insurance providers.

PBMs include Caremark, Express Scripts and OptumRX — all named as defendants in the lawsuit. These companies serve as gatekeepers through controlling lists known as “drug formularies” that identify prescription drugs with the greatest overall value.

PBMs and pharmaceutical companies negotiate financial arrangements, including rebates for preferred placement on drug formularies, the lawsuit said. It said manufacturers compete for spots on the list in order to ensure greater utilization of the drugs they make.

Not only do PBMs have the power to make opioids cheaper – they can make less addictive medications harder to acquire, the lawsuit said. For example, it said, United Healthcare places morphine on its lowest-cost coverage tier with no prior permission required; in contrast, Lyrica, a non-opioid drug prescribed for nerve pain, is on the most expensive tier, requiring patients to try other drugs first.

Not just a health crisis but an economic one

The impact of the opioid epidemic in Dickenson is multifaceted. While the county’s overdose rates are the most conspicuous consequence of the epidemic, the increased flow of opioids into the region has had a ripple effect on the county’s economy, health-care system and workforce.

In 2017, the U.S. Centers for Disease Control and Prevention identified Dickenson as one of eight Virginia counties that are vulnerable to the rapid dissemination of HIV and hepatitis C infections among people who inject drugs.

L. Christopher Plein, a professor of public administration at West Virginia University, said the opioid epidemic is a public health crisis, but it also has far-reaching economic consequences.

“Communities become severely stressed by having to respond and deal with this crisis, and they may lack the resources to provide treatment, engage law enforcement and provide recovery services,” Plein said. “These communities may not be as attractive to outside investors and businesses if they develop a reputation of being tied to the opioid epidemic.”

The lawsuit argues that the opioid epidemic has significantly and negatively impacted nearly every aspect of the county’s $26 million budget and the public services it provides, including health care, emergency medical services, social services, law enforcement and drug prevention, education and treatment.

Dickenson has had to buy opioid antagonists such as naloxone – medications that can reverse drug overdoses. Moreover, the county has lost tax revenues because of the opioid crisis, the lawsuit said.

For example, the drug epidemic has affected the job market and workforce in Dickenson. The Virginia Employment Commission reported last week that Dickenson’s unemployment rate in March was 6.6 percent — double the statewide rate. Dickenson had the fifth-highest jobless rate among Virginia’s 133 counties and cities.

Del. Todd Pillion, R-Abingdon, says these consequences can no longer be ignored.

“Dickenson County is on the tipping point of having an unemployable workforce,” Pillion said. “They have difficulty recruiting industry because the only articles in the news are talking about overdoses and opioids.”

Purdue responds: ‘No longer promoting opioids’

In response to the growing number of lawsuits brought against the company, Purdue Pharma announced in February that it would stop marketing opioid drugs to doctors.

“We have restructured and significantly reduced our commercial operation and will no longer be promoting opioids to prescribers,” the company said in a written statement.

Purdue officials said that they cut their sales staff in half in the week following the announcement and that the remaining staff would pivot to focus on other products.

Kevin Sharp, lead counsel for Dickenson County’s lawsuit, called the announcement a step in the right direction. But he said the damage already inflicted demands a more comprehensive response.

“There’s a lot more that has to be done to solve this problem,” Sharp said. “They have to remedy past harm. And the parties are going to have to work together to find out the best way to minimize – and end if possible – the harm that is being caused.”

Purdue Pharma has yet to file a response to the Dickenson County lawsuit but provided the following statement:

“We are deeply troubled by the prescription and illicit opioid abuse crisis, and we are dedicated to being part of the solution. As a company grounded in science, we must balance patient access to FDA-approved medicines with collaborative efforts to solve this public health challenge.

“Although our products account for less than 2 percent of the total opioid prescriptions, as a company, we’ve distributed the CDC Guideline for Prescribing Opioids for Chronic Pain, developed three of the first four FDA-approved opioid medications with abuse-deterrent properties and partner with law enforcement to ensure access to naloxone.”

Expanding treatment for opioid addiction

In April 2017, the Virginia Department of Medical Assistance Services launched the Addiction Recovery and Treatment Services program to help increase access to treatment for Virginians battling opioid addiction.

The ARTS program was established primarily to help ease the burden on hospital emergency departments in treating patients with opioid-related issues, particularly in rural areas like Dickenson County.

The program expands treatment to Medicaid recipients by combining traditional medicine with counseling and other support systems. It also offers training and financial incentives to providers to encourage participation among outpatient treatment centers, doctors and hospitals.

“Providers are responding to the critical need for addiction treatment,” said Dr. Katherine Neuhausen, chief medical officer for DMAS. “Today, more than 350 new organizations are providing these life-saving services to Virginia Medicaid members. The number of outpatient opioid treatment services has increased from six to 108, including 79 office-based opioid treatment programs combining medication with counseling and other essential supports.”

According to an evaluation by Virginia Commonwealth University’s Department of Health Behavior and Policy, the program has increased the number of Medicaid recipients receiving treatment for opioid addiction by more than 50 percent, and the number of opioid-related emergency hospital visits by Medicaid recipients declined by nearly one third.