Orange County Sues Opioid Drug Makers Suit Broadens Assault on Spiraling Opioid Abuse
by ERIC BERGER Special Contributor to Annals News & Perspective
Southern California lawsuit, raising a legal theory that opioid drug makers engaged in a vast conspiracy of deception to increase prescribing and mask the harmful effects of their products, has opened a new front in the war on opioid abuse. Nearly 50 people die from an overdose of prescription painkillers every day in the United States. What’s more, the statistics documenting US opioid abuse continue to get worse. Sales of painkillers in the United States have increased more than 300% since 1999, according to the Centers for Disease Control and Prevention (CDC), and the problem has permeated deep into US emergency departments (EDs), where more than 30 people are admitted daily because of opioid complications. Federal agencies such as the CDC and Drug Enforcement Administration (DEA) use terms such as “devastating” and “alarming” to describe this increase of opioid use, but so far their efforts to rein in abuse have met with mixed success. As a result, more local governments have begun stepping up to fight the problem. Most notably, officials at the city and county level have targeted the drug companies that make the painkillers by taking the battle into the courtroom. Lawyers in Southern California’s Orange County struck first in May 2014 by filing a 100-page complaint against 5
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drug manufacturers, Actavis (which makes Kadian), Endo Health Solutions (Opana, Percocet, and Percodan), Janssen Pharmaceuticals (Duragesic and Ultram), Purdue Pharmaceuticals (OxyContin), and Teva/Cephalon (Actiq and Fentora). According to the lawsuit, as recently as the 1990s the market for opioids was limited to use for short-term postsurgical and trauma-related pain, and for palliative care. Physicians were reluctant to prescribe the medication for wider uses because of their addictive nature. “In order to expand the market for opioids and realize blockbuster profits, defendants needed to create a sea-change in medical and public perception that would permit the use of opioids for long periods of time to treat more common aches and pains, like lower back pain, arthritis, and headaches,” the lawsuit states. “Opioid makers Purdue, Janssen, Endo, Cephalon, and Actavis, through a common, sophisticated, and deeply deceptive marketing campaign that continues to the present, set out to, and did, reverse the popular and medical understanding of opioids.” The Orange County litigants said these companies “spent millions of dollars funding, assisting, and encouraging doctors and front groups that would pioneer a new and far broader market for their potent and highly addictive drugs.” That market was the treatment of chronic pain. The companies engaged in a “campaign of deception,” the lawsuit says, which misrepresented the efficacy of opioids, trivialized
their health risks, and overstated their superiority compared with conventional treatments. To accomplish this, the drug manufacturers directed employees, front groups, and physicians to publicize misleading information. They also provided funding to organizations such as the now-defunct American Pain Foundation and the American Academy of Pain Medicine. “I see that these lawsuits are setting up straw men,” said Lynn Webster, MD, the American Academy of Pain Medicine’s immediate past president. “What this really amounts to in my opinion is a reflection in the financial war between payers [the cities] and industry, and unfortunately patients are lost in this battle.. They’ve set us up as front men. At a minimum, it’s insulting. If I’m a front man, it’s a front man for patients.” “These front groups, aided by millions of dollars in grants from Defendants and assistance from public relations firms hired by Defendants, spread the misrepresentations central to Defendants’ fraudulent promotion of opioids,” the lawsuit states. “Indeed, Defendants influenced, if not outright controlled, the messages disseminated by many of these front groups.”
DECEPTIVE MARKETING he California officials pursuing the lawsuit said they felt compelled to pursue the litigation to protect the public health. They do not seek to ban the drugs, but rather want to force the companies to end what they believe are deceptive marketing practices. “We have charged these pharmaceutical companies for knowingly harming public health by waging a massive campaign to sell huge quantities of these dangerous drugs for profit,” said Orange County District Attorney Tony Rackauckas, JD. “It is imperative for prescription drugs to be taken to promote
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health, not endanger lives, and that those responsible for producing these drugs not engage in deception.” Four of the companies named in the lawsuit have declined to comment because of the pending nature of the litigation. However, Janssen did issue a statement that said, “Janssen is committed to ethical business practices and responsible promotion, prescribing and use of all our medications. We’re currently reviewing the complaint.”
DISPROPORTIONATE SUFFERING he sweeping lawsuit is reminiscent of past legislation against the tobacco companies, which returned multibillion-dollar settlements to states. Rackauckas contends that the 5 drug manufacturers broke California’s laws against false advertising, unfair business practices, and creating a public nuisance. Robert Fellmeth, JD, a University of San Diego School of Law professor and former deputy district attorney, told the Los Angeles Times that he believes the manufacturers will challenge the counties’ authority over federally regulated drugs. However, said Fellmeth, who helped write the state’s unfair business practices law, this case is consistent with the intent of the California law. “California is suffering disproportionately from this problem, so it is appropriate for this state to take up this hammer,” he told the Times. There is also a precedent on the federal level for such lawsuits. In a 2007 federal case, Purdue Pharma, which manufactures OxyContin, agreed to pay $635 million to defendants and acknowledged that its “fraudulent conduct caused a greater amount of OxyContin to be available for illegal use than otherwise would have been available.” On June 2, the city of Chicago joined Southern California by filing a similar lawsuit in Illinois state court. “For years, big pharma has deceived the public about the true risks and benefits of highly potent and highly addictive painkillers in order to expand their customer base and increase their bottom
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line,” Chicago Mayor Rahm Emanuel, MA, said. “It’s time for these companies to end these irresponsible practices and be held accountable.” Both of the lawsuits cited as evidence of the marketing campaigns the staggering rate at which Americans have begun using opioids compared with the rest of the world. As of 2010, the most recent year for which national data were available, 254 million opioid prescriptions were filled in the United States, making them the most prescribed class of drugs in the country. Although US residents represent less than 5% of the world’s population, they consumed 80% of the opioids supplied around the world and 99% of the global hydrocodone supply. In 2010, the lawsuits note, opioids generated $8 billion in revenue for drug companies. The significant increase in opioid use has also caught the attention of state officials, particular attorneys general. At their annual summer meeting on Mackinac Island, MI, the National Association of Attorneys General spent a lot of time discussing the problem. During a presentation, Jack Conway, JD, the Kentucky attorney general, explained how a prescription drug monitoring program had helped reduce the use of most opioids in the state in a single year from 2012 to 2013, by 10% for most substances, and cut the use of oxymorphone by 35%. Under Kentucky state law, controlled substance administration or dispensing must be reported within 1 day to the state. Registration in the state’s monitoring system is now mandatory for Kentucky practitioners or pharmacists authorized to prescribe or dispense controlled substances to people. Initially, some physicians and pharmacists opposed the regulation, Conway said. However, he added, the system’s relative ease of use and effectiveness have changed some attitudes. “It’s not quite the bogeyman doctors thought it would be,” he said. As of the June meeting, he noted, 49 states had implemented monitoring programs, with legislation in Missouri pending. As of early November, that state’s bill still had not passed.
At the state level, governors also expressed increasing concern this year about opioid use. During his state of the state speech earlier this year, Vermont Gov. Peter Shumlin noted the increase of painkiller use. Since 2000, he said, Vermont has seen a more than a 770% increase in treatment for all opiates, and that opiate abuse has led to increased heroin use. In 2013, Shumlin said, there were twice as many federal indictments against heroin dealers than in the previous 2 years and more than 5 times as many as had been obtained in 2010. “In every corner of our state, heroin and opiate drug addiction threatens us,” he said. “It threatens the safety that has always blessed our state. It is a crisis bubbling just beneath the surface that may be invisible to many, but is already highly visible to law enforcement, medical personnel, social service and addiction treatment providers, and too many Vermont families. It requires all of us to take action before the quality of life that we cherish so much is compromised.” Federal officials have also raised concerns about the link between opioids and heroin. In testimony before the US Senate’s Committee on the Judiciary, the DEA’s administrator, Michele Leonhart, BS, said South American and Mexican drug trafficking organizations have exploited this increased demand by producing heroin with increased purity that is not only more readily available but also cheaper. Heroin seizures have increased by nearly 300% from 2008 to 2013, Leonhart said. During a similar period, from 2008 to 2010, heroin-related overdose deaths increased by 45%. “This disturbing increase may be attributable to increased purity and a younger, less experienced user population,” Leonhart said. In many communities, DEA officials note, opioids cost substantially more than heroin. Black-market sales for prescription controlled substances are typically 5 to 10 times their retail value, and DEA investigations have found that the “street” cost of prescription opioids steadily increases with the relative strength of the drug. For example, generally, hydrocodone combination Volume 65, no. 1 : January 2015
products can be purchased for as little as $5 to $7 per tablet, but stronger prescription drugs are sold for $80 per tablet or more in the case of the previous 80-mg formulation of OxyContin. Heroin, in contrast, costs about $10 per bag and provides a similar high. “As the administration takes a multifaceted approach to curb the availability of prescription-based painkillers on the illicit market, those addicted to opioids who are not seeking medication-assisted therapy may increasingly turn to cheaper or more easily obtained alternatives, such as heroin,” Leonhart said.
SCHEDULE II n August, the DEA sought to curb use of opioids by moving to reclassify drugs such as Vicodin and put them in the schedule II “controlled substances” list. However, the classification of OxyContin on this list previously had failed to stem much of its abuse. Some in Congress, including Massachusetts Democratic Senator Ed Markey, JD, are pushing the federal government to take much more comprehensive actions to curb opioid abuse. In a report titled “Overdosed: A Comprehensive Federal Strategy for Addressing America’s Pre-
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scription Drug and Heroin Epidemic,” Markey outlined a number of prevention, treatment, and enforcement steps to address the issue. He called for further tracking of opioid prescriptions, for example, as well as increasing the capacity and willingness of health care providers to serve more patients with addiction. “I have seen how this crisis is killing our neighbors, shattering families, and straining our society to handle the addiction epidemic,” Markey said. “Heroin and prescription drug addiction and overdoses often leave people and their families devastated and without hope. We need to create a national, comprehensive plan to prevent more addictions, treat those who are addicted, and aid those who are trying to help addicts through the courts or treatment facilities.” Markey, however, said he realizes opioids have their place in emergency medical care. Along with the reform legislation he has introduced, he’s also sponsoring a bill, S. 2092, to protect physicians who administer lifesaving opioid overdose prevention drugs from legal liability. Although the legislation has bipartisan support, as of early November it remains in committee. The American College of Emergency Physicians (ACEP) addressed the issue of
The Aging of NIH Investigators Congressman’s Provocative Op-Ed Bemoans Lack of Young Investigator Funding
by ERIC BERGER Special Contributor to Annals News & Perspective
he National Institutes of Health (NIH) has long worried about how best to stem an increase in the average age of scientists and physicians to whom it grants research funds. But in October, a US
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representative from Maryland, who is also a practicing anesthesiologist, escalated the issue with a fiery op-ed in the New York Times titled “Young, Brilliant and Underfunded.”1 In his essay, Andy Harris, MD, wrote, “As a physician who conducted NIH-funded research before entering politics, I saw firsthand how the most innovative thinking frequently came from younger scientists.”
opioids in 2012 by introducing guidelines that called for increased research into the effectiveness of policies to stem opioid use. The college was concerned that a single public policy didn’t fit all occasions, specifically the need to check a database before administering a painkiller in a life-and-death situation in the ED. As part of the policy statement adopted in October 2012, ACEP said it “opposes non-evidence–based public or private limits on prescribing opiates, mandatory opioid-related documentation, and mandatory opioid-related CME.” Section editor: Truman J. Milling, Jr, MD Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www. icmje.org). The author has stated that no such relationships exist. The views expressed in News and Perspective are those of the authors, and do not reflect the views and opinions of the American College of Emergency Physicians or the editorial board of Annals of Emergency Medicine. http://dx.doi.org/10.1016/j.annemergmed. 2014.11.007
Dr. Harris then went on to cite a study by the National Bureau of Economic Research that reviewed the work of 2,000 Nobel Prize winners and other notable scientists in the 20th century, and found that most had their critical insights when they were in their 30s. However, Dr. Harris added, the median age of first-time R01 grant recipients has increased to 42 years, and the median age of all grant recipients was 52 years. Moreover, the proportion of grant recipients aged 66 years and older, about 7% of all NIH grants, is double that of recipients aged 36 years and younger. “It’s not enough to throw money at researchers, especially when it goes to people who, though well regarded in their fields, are past the age when they are most likely to make a significant contribution to science,” Dr. Harris wrote. Annals of Emergency Medicine 17A