Author: James

OPIUM WARS 

November 1,2017
the staff of the Ridgewood blog

Trenton NJ,  Attorney General Christopher S. Porrino announced today that the State has filed a five-count lawsuit against Purdue Pharma L.P. alleging a “direct” link between New Jersey’s opioid crisis and a push by Purdue to boost profits by deceptively marketing addictive medications and exploiting vulnerable new markets, such as the elderly and the “opioid-naïve.” The lawsuit charges Purdue with widespread deception about the risks and benefits of these dangerously addictive pain medications.

“When we point the finger of blame for the deadly epidemic that has killed thousands in New Jersey, Purdue is in the bullseye of the target,” said Attorney General Porrino. “Today, my office took the first step toward holding them legally and financially responsible for their deception.”

Filed today in Superior Court in Essex County, the State’s 100-page complaint charges that Purdue manipulated the public and even the medical community to embrace the view that pain was undertreated and that opioids should be the first-line solution for patients suffering from chronic conditions such as moderate back pain, migraine headaches and arthritis. The complaint alleges that Purdue aggressively marketed its blockbuster opioid drugs – particularly OxyContin – as safe, effective, long-term treatments for chronic pain. It also alleges Purdue failed to disclose that it had no studies to support the efficacy or safety of opioid medications for treatment periods longer than 12 weeks.

“In a campaign of almost inconceivable callousness and irresponsibility, we allege that Purdue has spent hundreds of millions of marketing dollars to downplay the addiction risk associated with taking opioids for chronic pain, all the while exaggerating the benefits of using these dangerous drugs,” Porrino said. “We allege that this fraudulent conduct has not only given false hope to many pain patients, it has led to addiction, overdose, and death. It also has cost the State hundreds of millions on opioid prescriptions and the broader health and social effects of overprescribing. Many of these prescriptions never should have been written.”

The State’s investigation yielded evidence that each Purdue sales representative in New Jersey was required to visit 7-8 doctors per day, 5 days a week, to promote these opioids. The highest volume prescribers were given the title of “Super Core Prescribers,” and received special attention from Purdue. Sales representatives were compensated based on reaching their “Rx quota” for each drug. For OxyContin alone, the quotas were in the range of 500-700 prescriptions per month for each sales representative – amounting to quotas of 6,000-8,400 prescriptions per year for each sales representative. Attorney General Porrino noted, “The sheer number of marketing visits made by Purdue sales representatives to New Jersey prescribers is staggering – and based on the number of prescriptions, the scheme clearly was a smashing success for the company.”

Purdue makes and sells a variety of opioid pain medications including Dilaudid, Dilaudid HP, Butrans and Hysingla ER. However, the company’s most popular opioid pain medication by far is OxyContin. Since the market debut of OxyContin in 1996, Purdue has generated overall sales estimated at more than $35 billion. The company’s current annual revenues are estimated at approximately $3 billion, mostly from the sale of OxyContin.

According to the complaint, the State’s largest Medicaid managed care organization has paid $109 million for opioids through the Medicaid program since 2008, the State paid another $6 million under its Workers’ Compensation Program since 2008, and approximately $136 million under its State Employee and Retiree Health Plan since 2012. Meanwhile, New Jersey consumers – including individuals, employers and private insurers – easily have paid hundreds of millions for opioid prescriptions. In addition to these costs, the State and private consumers have paid millions of dollars to treat addiction, overdose and other injuries associated with opioid overprescribing and misuse.

The State’s complaint seeks monetary damages for false claims, maximum statutory penalties under the Consumer Fraud Act and the False Claims Act, disgorgement of ill-gotten gains and other relief as contribution for the expensive solutions — including addiction treatment and prescriber education — which are necessary to abate the crisis in New Jersey.

“Prescribing opioids for routine chronic pain is dangerous and, in many cases, inappropriate,” said Attorney General Porrino. “However, in New Jersey and across the nation it became mainstream medical practice and the treatment of first resort. How did that happen? It happened because certain companies within the pharmaceutical industry saw a chance to grow their profits by peddling extraordinarily potent, highly-addictive opioid drugs for routine pain. We allege that Purdue Pharma was chief among these opportunistic and predatory companies.”

According to the State’s complaint, Purdue’s campaign to change the health care landscape with regard to opioids began in the late 1990s. Prior to that, the lawsuit notes, opioids were used on a much more limited basis – to treat acute trauma-related pain, post-surgical pain or for palliative care – because the drugs were considered too addictive and debilitating for long-term use. Faced with a medical and popular understanding of opioids that constrained its market, the complaint alleges that Purdue aggressively set out to change the image of opioids by encouraging prescribers to believe the drugs would permanently reduce pain in chronic pain patients and improve their function, with little or no addiction risk.

The complaint alleges that part of Purdue’s push to mainstream opioids was aided by Dr. Russell Portenoy, a pain management specialist who received “substantial” funding from Purdue to conduct research, and was paid to serve as a Purdue consultant. In the late 1990s, the State’s complaint notes that Portenoy led a successful campaign in the national medical community to make pain “the fifth vital sign” — to be checked in every health care encounter – putting it on par with measuring blood pressure, heart rate, body temperature and breathing. Purdue’s early marketing of OxyContin lead to criminal fraud charges against the company and its executives, charges that Purdue paid more than $600 million to settle with the U.S. Department of Justice in 2007. But Purdue built upon those foundational deceptions, and continued deceptive and unconscionable marketing from 2007 through the present.

Among other actions in the 2007-2017 timeframe, the complaint charges that Purdue:

Blanketed the State with sales representatives trained to emphasize the benefits of opioids, minimize their risks, deflect questions about addiction risks, and encourage doctors to consult unbranded websites and materials that did the same.

Funded and created “unbranded” educational materials and websites that never identified Purdue or its products by name because they were deceptively designed to look like the work of unaffiliated patient advocacy groups. These unbranded materials magnified and supported Purdue’s deceptive marketing scheme.

Promoted the unsubstantiated concept of “pseudoaddiction” to assure doctors that patients showing signs of addiction were actually suffering from undertreated pain and needed more medication.

Promoted its 2010 “abuse-deterrent” reformulation of OxyContin by distributing and recommending materials that misleadingly described the signs of abuse as the stigmata of injecting or snorting opioids—skin popping, track marks, and perforated nasal septa – when, in fact, oral use (swallowing a pill) is the most common method of abuse and was not minimized by the 2010 “abuse-deterrent” reformulation.

Refused to acknowledge that OxyContin ER does not provide 12 hours of constant pain relief, despite widely reported end-of-dose failure. Instead, Purdue recommended that doctors prescribe patients with end-of-dose supplemental opioids for short-term relief and higher doses of OxyContin ER, putting patients in a perpetual cycle of craving their medication and at greater risk for addiction.

Ignored a growing body of research showing that long-term use of opioids was neither safe nor effective.

The company also trained its sales representatives to persuade doctors to prescribe OxyContin and Purdue’s other opioids for the elderly and for “opioid naïve” patients (patients who had not previously taken opioids). The complaint alleges that “Purdue’s decisions to target the elderly and opioid-naïve patients reflect, yet again, a business strategy that placed little, if any, value on the well-being and safety of consumers. Elderly patients taking opioids are at greater risk for fracture and hospitalization, and they have increased vulnerability to adverse drug effects such as respiratory depression.”

A Purdue sales representative interviewed by the State recalled intense pressure from Purdue to persuade doctors to convert patients from over-the-counter medications – such as Advil or Tylenol – to a “low dose” of OxyContin. Purdue knew, however, that chronic pain patients don’t stay on a “low dose” of OxyContin – as their bodies develop a tolerance to the drug, the dosage will likely be increased. In fact, Purdue’s marketing scheme included a focus on “titrating up” – the technical word for increasing a patient’s opioid dosage.

“This conduct was incredibly exploitative and put people in danger. As we allege in our complaint, Purdue targeted New Jersey seniors and the opioid-naïve for a reason – they were a growth sector,” Attorney General Porrino said.

Porrino noted that, according to the State’s complaint, “one in three” enrollees in Medicare Part D (the prescription benefit) received at least one opioid prescription in 2016.

The State’s lawsuit notes that recent findings by both the federal Food and Drug Administration (FDA) and the national Centers for Disease Control (CDC) directly debunk Purdue’s claims about the efficacy and limited risks associated with opioids.

The CDC has confirmed there are no controlled studies about the use of opioids beyond 12 weeks, and the federal Agency for Healthcare Research and Quality has made plain “there is no evidence that opioids improve patients’ pain and function long-term.”

The State’s lawsuit contends that such information clearly contradicts Purdue’s claim that long-term use of opioids improves function and quality of life. The lawsuit also asserts that, according to some research, opioids actually are ineffective at treating chronic pain, and can worsen a patient’s health not only by putting the patient at risk for addiction and overdose, but also by increasing the likelihood of other debilitating conditions, such as substance abuse, depression, and anxiety.