Rural county accuses drug makers

Published 11:14 am Friday, June 8, 2018

by Lia Tabackman
Capital News Service

DICKENSON COUNTY
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 County 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 County, 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 County 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 County as one of eight Virginia counties that are vulnerable to the rapid dissemination of HIV and hepatitis C infections among people who inject drugs.