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Counties Sue Drug Makers, Allege ‘Campaign of Deception’

The district attorneys of two California counties have sued five giant pharmaceutical companies, charging that they fraudulently marketed highly addictive drugs meant for terminal cancer patients as safe for chronic pain relief. The resulting explosion in prescription painkillers, the plaintiffs allege, has contributed to the nation’s alarming spike in opiate overdose deaths.

In the civil lawsuit filed Wednesday in Orange County Superior Court, consumer fraud was alleged against the makers of powerful painkillers including OxyContin and Percocet. It asserted that billions have been earned by duping doctors into overly prescribing opiates meant for a much smaller population of mostly dying cancer patients or those at low risk for addiction.

“Because of the deceptive conduct of these drug companies, millions of Americans have become prescription drug addicts and abusers,” Santa Clara County Counsel Danny Chou said in a statement. “The result has been devastating: broken families, skyrocketing medical costs and rampant crime. Instead of taking responsibility for their deceptions, the companies have pocketed billions of dollars in profits.”

Orange County Dist. Atty. Tony Rackauckas cited “an overdose death by heroin or a heroin derivative-type drug every other day” in Orange County among the reasons his office is pursuing the legal action. “It’s really something that’s become epidemic,” Rackauckas told National Public Radio.

Named in the suit filed by the counties of Orange and Santa Clara are Actavis, Endo Health Solutions, Johnson & Johnson’s Janssen Pharmaceuticals, Purdue Pharma and Teva Pharmaceutical Industries’ Cephalon.

“What prompted the lawsuit was this huge increase in overdoses on opiates,” said Susan Kang Schroeder, Rackauckas’ chief of staff. “These drugs were approved really for you to live out the end of your life in less pain [with] your terminal cancer. These companies … have really downplayed their addictive nature and been duping doctors to prescribe them for chronic pain.”

Most of the companies have declined comment or not responded substantively to the lawsuit, although Janssen spokeswoman Robyn Reed Frenze told NPR that Janssen “is committed to ethical business practices and responsible promotion, prescribing and use of all our medications.”

The lawsuit is landing at a time when prescription painkiller abuse has been labeled an epidemic. According to the federal Centers for Disease Control and Prevention, enough prescription painkillers were prescribed in 2010 to medicate every American adult around-the-clock for a month.

Doctors Blamed for Epidemic

The painkillers have caused more deaths than cocaine and heroin combined. There were more than 16,000 overdose deaths in 2010. The CDC reported in March that medical doctors are the leading source of the opiates.

“Opioids, once a niche drug, are now the most prescribed class of drugs — more than blood pressure, cholesterol or anxiety drugs,” the lawsuit states.

At the heart of the suit is the charge of a decades-long campaign of false advertising by the pharmaceutical companies to miscast the opiate drugs as suitable for long-term conditions — back pain or arthritis — when they should be used only for such things as cancer and end-of-life treatment, Rackauckas said.

The lawsuit aims to stop the marketing of such narcotic painkillers and seeks financial damages of an unnamed amount for the costs to patients and the government.

This lawsuit would not be the first filed against Purdue, which makes OxyContin. In 2007, the company and its former executives agreed to pay $634 million to settle criminal and civil charges in which the U.S. Department of Justice claimed the company “misled regulators, doctors and patients about the potential for addiction and abuse,” NPR reported. At the settlement, Purdue “accepted responsibility for the actions of its employees and has put in place training and monitoring programs to prevent over-promotion of OxyContin.”

But Rackauckas said Purdue’s settlement agreement was ignored.

“That didn’t change anything and that’s why this lawsuit can’t just be about money,” Rackauckas told NPR. “We aren’t just looking to tax them on their profits. We are looking for them to change their behavior and to start telling the truth.”

A pharmaceutical company applies for Food and Drug Administration approval for a drug for certain uses, but doctors can prescribe the medication for other conditions, a practice that is not at all uncommon. It’s also why doctors have become the target of expensive marketing and sales appeals.

“We see it as very similar to the tobacco lawsuit in the years before,” Schroeder said. “And we know it’s going to be heavily litigated with deep pockets. … Everybody knows somebody who’s a good, law-abiding person who’s gotten hooked on these drugs just as a result of being in pain for something.”

Cash Cow for Drug Makers

At 105 pages long, the lawsuit expansively lays out its case, filed on behalf of all Californians. It alleges that the opiates from the five drug makers began as a “niche” in the medical marketplace, but that a massive campaign was launched to mainstream the drugs, which by 2010 became an $8-billion cash cow.

“Treatment guidelines that did not receive industry backing are much more reserved and endorse chronic opioid therapy only in narrow circumstances,” the lawsuit notes in support of its fraudulent charges. “The 2012 Guidelines for Responsible Opioid Prescribing in Chronic Non-Cancer Pain” contain “a remarkable disclaimer” that biased members of the pain pill industry had a hand in creating medical guidelines to protect the public. As a result, the suit continues, “the model guidelines are not a model for curtailing controlled substance abuse and may, in fact, be facilitating it.”

What’s more, it states, “The American Society of Interventional Pain Physicians Guidelines further advise that therapeutic opioid use, specifically in high doses over long periods of time in chronic non-cancer pain starting with acute pain, not only lacks scientific evidence, but is, in fact, associated with serious health risks including multiple fatalities, and is based on emotional and political propaganda under the guise of improving the treatment of chronic pain.”

Much remains unknown about how a civil case of this scale will play out. But doctors treating opiate addiction cheered the lawsuit as a step in the right direction toward stemming painkiller abuse.

Orange County has set up a hotline for consumers to call with information that might be helpful to the lawsuit. That number is (714) 347-0501.

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