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Oklahoma lawsuit against opioid drug makers alleges deceptive marketing contributes to deadly epidemic

OKLAHOMA LAWSUIT AGAINST OPIOID DRUG MAKERS ALLEGES DECEPTIVE MARKETING

OKLAHOMA CITY — Oklahoma Attorney General Mike Hunter on Friday filed suit in Cleveland County against four opioid drug companies, alleging their deceptive marketing practices contributed to the state’s deadly painkiller epidemic. Listed as defendants are Purdue Pharma, Allergan, Cephalon and Janssen Pharmaceuticals. A specific amount of damages being sought was not available. “Our calculations are that it could be in the billions of dollars,” Hunter said. Hunter said he hopes portions of any recovery would go toward rehabilitation and treatment costs. “The settlement ought to be in large part dedicated towards rehabilitation, towards dealing

with the addiction, dealing with addictions as illnesses as opposed to crimes,” Hunter said. The suit also seeks an injunction against the companies to bar misrepresentations and false claims. “These companies have waged a fraudulent, decade-long marketing campaign to profit from the anguish of thousands of Oklahomans,” Hunter said. “These companies have made in excess of $10 billion a year, while our friends, family members, neighbors and loved ones have become addicts, gone to prison or died because of the opioid epidemic. “Today, we begin a fight to hold these companies accountable, slow the crisis and build a healthier state. One death or one addiction related to opioids is too many.”

THEY NEED TO BE

HONEST WHEN THEY MAKE

REPRESENTATIONS TO

DOCTORS ABOUT THE EFFECT

OF A DRUG.

- MICHAEL BURRAGE U.S. DISTRICT JUDGE

Hunter has hired Whitten Burrage, the firm of former U.S. District Judge Michael Burrage, to serve as lead attorney on a contingency basis. Burrage said his niece committed suicide after becoming addicted. His law partner also lost his son to addiction, Burrage said. “This lawsuit is about money that the taxpayers have been out because of the treatment, but it is also about much more,” Burrage said. “The practices that these pharmaceutical companies have engaged in, the lives they have destroyed through their fraudulent conduct, their fraudulent misrepresentations, has to be stopped.” The suit seeks to change the behavior of the companies, Burrage said.

THESE COMPANIES HAVE WAGED A FRAUDULENT, DECADE-LONG MARKETING CAMPAIGN TO PROFIT FROM THE ANGUISH OF THOUSANDS OF OKLAHOMANS. - MIKE HUNTER OKLAHOMA ATTORNEY GENERAL

OTHER STATES THAT HAVE SUED DRUG MAKERS INCLUDE OHIO, MISSOURI AND MISSISSIPPI. - MIKE HUNTER

“They need to be honest when they make representations to doctors about the effect of a drug,” Burrage said. “With opioids, the doctors were lied to. I don’t know how else to say it.” The suit alleges the companies violated Oklahoma’s Medicaid False Claims Act and the Consumer Protection Act and created an ongoing public nuisance. “Over a period of several years, defendants executed massive and unprecedented marketing campaigns through which they misrepresented the risks of addiction from their opioids and touted unsubstantiated benefits,” the suit alleges. As a result of such conduct, the state paid and continues to pay millions of dollars in health care costs due to dependency, the suit alleges. “These costs include unnecessary and excessive opioid prescriptions, substance abuse treatment series,

ambulatory series, inpatient hospital service and emergency department services, among others,” the suit alleges. “Defendants conduct also caused the state of Oklahoma to incur substantial social and economic costs including criminal justice costs, and lost work productivity costs, among others.” The suit alleges the companies hired large forces of sales representatives who misrepresented the drugs to doctors by saying the risk of addiction was low and touting unsubstantiated benefits. The doctors were doing what the drug companies told them was safe, Burrage said. In a statement, Purdue Pharma pointed out its work in developing abuse-deterrent technology and supporting access to Naloxone, which is used to block the effects of opioids, especially in overdose. “While we vigorously deny the allegations in the complaint, we share

the attorney general’s concerns about the opioid crisis and we are committed to working collaboratively to find solutions,” the statement says. Allergan sent a statement saying it “shares society’s concerns about the opioid crisis in the United States.” “Allergan has a history of supporting — and continues to support — the safe, responsible use of prescription medications. This includes opioid medications, which when sold, prescribed and used responsibly, play an appropriate role in pain relief for millions of Americans,” the statement says. A statement from Janssen Pharmaceuticals said the company recognizes that opioid abuse has become a serious public health issue but defended its practices. “We firmly believe Janssen has acted responsibly and in the best interests of patients and physicians with regard to these medicines, which are FDA-approved and carry FDA-mandated warnings about possible risks on every product label,” the statement said. Representatives for Cephalon could not be immediately reached. Other states that have sued drug makers include Ohio, Missouri and Mississippi, Hunter said. In 1996, then Oklahoma Attorney General Drew Edmondson joined other states in a successful lawsuit against tobacco companies to recoup hundreds of millions in tax dollars, which funded medical expenses incurred by smokers.

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Federal agency awards

$950,000

to help address opioid to Oklahoma

epidemic

up to $11 million TO 11 STATES TO EXPAND ACCESS TO MEDICATION-ASSISTED TREATMENT SERVICES THE GRANTS WILL PROVIDE

HEROIN OVERDOSE DEATHS IN OKLAHOMA increased to 31 LAST YEAR FROM ONLY 12 IN 2011

The U.S. Department of Health and Human Services on Wednesday announced it will give $950,000 to Oklahoma in support of improved access to treatment for opioid-use disorders. The Medication-Assisted Treatment Prescription Drug Opioid Addiction Grants will provide up to $11 million to 11 states to expand access to medication-assisted treatment services for people with opioid-use disorder. The grant program targets states with the highest rates of primary treatment admissions for heroin and prescription opioids per capita, and it prioritizes those states with the most dramatic recent increases for heroin and opioids. Oklahoma leads the nation in abuse of prescription painkillers, according to recent federal data compiled by the federal Substance Abuse and Mental Health Services Administration. Oklahoma had the highest percentage of individuals 12 and older who reported using prescription painkillers for nonmedical reasons.

Heroin overdose deaths in Oklahoma increased to 31 last year from only 12 in 2011. Data from 2016 shows the year is on track for 40 or more. Health experts have said the increase reflects the rising cost of prescription painkillers as well as increased imports by Mexican cartels. “The epidemic of opioid use disorders involving the non-medical use of prescription opioid pain relievers and the use of heroin has had a devastating impact on individuals, families and communities across our nation,” SAMHSA Principal Deputy Administrator Kana Enomoto said in a statement. “These grants will help address the key elements of the opioid crisis by promoting effective prevention efforts, preventing overdose deaths and helping ensure that people with opioid use disorders are able to receive vital treatment and recovery support services.” The funding announced Wednesday is part of the Department of Health and Human Services’ Opioid Initiative, which was launched in March 2015 and is focused on improving opioid prescribing practices, expanding access to medication-assisted treatment for opioid use disorder and increasing the use of naloxone to reverse opioid overdoses.

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METH, HEROIN DEATHS SURGE IN OKLAHOMA PRESCRIPTION DRUG OVERDOSE DEATHS APPEAR TO BE SUBSIDING IN OKLAHOMA AS NEW LAWS AND OUTREACH EFFORTS TAKE EFFECT. BUT BLACK-MARKET METHAMPHETAMINE AND HEROIN DEATHS ARE SURGING.

Prescription drug overdose deaths appear to be subsiding in Oklahoma as new laws and outreach efforts take effect. But black-market methamphetamine and heroin deaths are surging. Drug law enforcers and medical professionals said they were both encouraged and alarmed by the latest overdose death data, generated by the Office of the Chief Medical Examiner and compiled by the Oklahoma Bureau of Narcotics. The encouragement comes from increasing evidence that tougher oversight and outreach are causing the toll of prescription drug overdoses to stabilize and decline slightly. “Deaths are down because of greater use of the Prescription Monitoring Program and greater awareness by physicians, through conferences, through training, through just networking,” said Narcotics Bureau spokesman Mark Woodward. The alarm stems from a troubling rise in methamphetamine and heroin deaths, some of which might be attributable to former prescription drug users switching to cheaper bootleg drugs. “The Mexican cartels are just pouring ice into this country in record amounts,”

Probably the biggest impact is just more physicians becoming aware that this is a big issue.

- Lyle Kelsey executive director ofthe Oklahoma State Board of Medical Licensure and Supervision .

Woodward said, referring to black-market methamphetamine. “It’s simply just to feed the demand, which still remains very, very high for meth.” Heroin has been making a comeback across the country. The latest data suggests that Oklahoma drug users are beginning to make that transition, too. “Talking to people in recovery, I’ll ask them, ‘What was your drug of choice?’” Woodward said. “Five years ago, it was meth, meth, meth and prescription drugs. But for the last two or three years, (many) said it was heroin.”

HIGHLIGHTS OF THE LATEST STATISTICS:

• The total number of deaths officially attributed to overdoses dipped to 823 in 2015 from 870 the previous year. From 2001 to 2010, the number of fatal overdoses increased 137 percent, from 344 to 814. Since 2010, the annual death toll has increased only 1 percent. • Five frequently-prescribed opioid painkillers were a factor in 482 deaths last year, or 59 percent of all fatal overdoses. In 2010, those five drugs contributed to 588 deaths, or 72 percent of the total. Oxycodone was the most frequent offender, followed closely by hydrocodone. (Because some deaths involve “cocktails” of lethal drugs, the individual drug tallies add up to more than 823.) • Prescription benzodiazepine tranquilizers continue to be a factor in many overdoses, showing little change over five years. Alprazolam (Xanax) and diazepam (Valium) contributed to 195 deaths last year, or 24 percent of total overdoses. “Benzos” are seldom lethal by themselves but can be deadly when combined with opioids or alcohol. • Methamphetamine overdoses are soaring. They accounted for 265 deaths last year, or nearly a third of all fatal overdoses. The total represented a 157 percent increase since 2010ʹs death toll of 103. The fatality count keeps climbing despite a dramatic decline in the number of Oklahoma meth lab busts. Officials attributed the change to surging imports of Mexican meth. • Heroin overdoses might soon account for 1 in 10 opioid-related deaths in Oklahoma. They increased to 31 last year from only 12 in 2011. So far in 2016, they are on track to hit 40 or more. Health experts said the increase reflects the rising cost of prescription painkillers as well as increased imports by Mexican cartels. “We’re seeing an increase in heroin because of the cost of Oxy (oxycodone),” said Hal Vorse, a physician who treats addicts at a clinic in Oklahoma City.

“Talking to people in recovery, I’ll ask them , ‘What was your drug of choice?’” Five years ago, it was meth, meth, meth and prescription drugs.

But for the last two or three years, (many) said it was heroin.”

- Mark Woodward Narcotics Bureau spokesman

“I saw a guy today who was doing 300 milligrams a day of oxycodone,” Vorse said. “That’s a $300- to $400-a-day habit ... They can get the same effect at about a third of the cost by using heroin.” Vorse said prescription oxycodone is currently selling on the street for $1 to $1.25 per milligram. A frequent user might need as much as 100 milligrams a day just to ward off withdrawal symptoms. The rising use of black-market drugs such as methamphetamine and heroin appears to be an unintended, if perhaps unavoidable, consequence of concerted efforts to combat the significant increase in prescription drug abuse over the last two decades. They cited several changes in recent years. First, a new law that took effect in

November 2014 reclassified hydrocodone “combo” painkillers such as Lortab and Norco as Schedule II controlled dangerous substances. That meant doctors could not write prescriptions for more than 90 days Another new law enacted in 2014 expanded the ability of emergency medical personnel and family members to administer Naloxone, a drug that reverses the effects of opioid overdoses. Its increased availability is believed to be reducing the number of fatal overdoses among people who continue to abuse dangerous drugs. Yet another new law that took effect in November 2015 requires doctors to check the state’s Prescription Monitoring Program database at least and could no longer phone in prescriptions to pharmacists.

once every six months before prescribing opioid painkillers or benzodiazepine tranquilizers. That helps them spot abusers who are obtaining overlapping prescriptions from other doctors. Meanwhile, extensive coverage of prescription drug abuse and more aggressive education programs aimed at health professionals and patients have heightened awareness of the overdose crisis. In addition, tougher enforcement actions, including highly publicized criminal prosecutions of overprescribing physicians and shutdowns of high-volume “pill-mill” clinics, might be causing doctors to exercise more caution. “Probably the biggest impact is just more physicians becoming aware that this is a big issue,” said Lyle Kelsey, executive director of the Oklahoma State Board of Medical Licensure and Supervision. “I think it’s really starting to settle out into two categories – those (doctors) that play the game and want to rack up a bunch of money and get out ... and those that are trying to take all of the knowledge and say, ‘How can we do this right?’” Kelsey said. “Ten, 15 years ago, everybody was pushing the idea that you couldn’t get hooked on opiates, and you could just prescribe them,” Kelsey said. “Now, it’s kind of like standing in front of a locomotive and trying to slow it down.” Oklahoma Watch is a nonprofit, nonpartisan media organization that produces in-depth and investigative content on a range of public-policy issues facing the state. For more Oklahoma Watch content, go to oklahomawatch.org.

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tion Grants will provide up to $11 million to 11 states to expand access to medication-assisted treatment services

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