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Thread: The Opiod Crisis

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    https://www.cnn.com/2019/07/18/healt...ken/index.html

    Now Criminal Charges has hit an opioid exec leaders.

    (CNN)A federal grand jury has indicted pharmaceutical wholesaler Miami-Luken, two of its top former officials, and two pharmacists with conspiring to illegally distribute millions of prescription painkillers in some of the states hit hardest by the opioid epidemic, the Justice Department announced Thursday.

    The indictment says the distribution of oxycodone and hydrocodone was "outside the scope of professional practice and not for a legitimate medical purpose," Benjamin C. Glassman, the US Attorney for the Southern District of Ohio, said in the indictment.
    Miami-Luken, a drug distributor based in Springboro, Ohio, allegedly failed to report suspicious orders and exercise the care needed to prevent the drugs from being diverted from proper use.
    Newly released data shows flow of billions of pain pills from drug companies

    The four individuals charged include Miami-Luken's former president and compliance officer and two West Virginia pharmacists, the release said. They were arrested Thursday morning.
    "Today's arrests should be a wake-up call to distributors and pharmacists who are allowing opioid prescription pills to be illegally sold and dispensed from their facilities," said Drug Enforcement Administration Assistant Administrator John Martin.
    The wholesaler distributed 2.6 million hydrocodone tablets and 2.3 million units of oxycodone to a pharmacy in a West Virginia town of only 1,400 people between 2011 and 2015, the Justice Department said. One of the pharmacists operated in that town, the indictment says.
    The wholesaler also shipped more than 1.8 millions oxycodone tablets to a pharmacy that was under DEA investigation.

    Former pharmaceutical company execs hit with drug trafficking charges
    It's the second time distributors have been criminally charged with these crimes. In April, two former executives of Rochester Drug Co-Operative were charged with illegally distributing opioids and conspiring to defraud the US Drug Enforcement Agency.
    Miami-Luken sold drugs in Kentucky, Indiana, Ohio, Tennessee and West Virginia, according to the Justice Department.
    CNN was unable to contact company officials Thursday. In January, the Dayton Daily News reported the company was in the process of closing.
    If convicted, the defendants could face 20 years in prison.

    US drug overdose deaths fell slightly in 2018
    Opioids, a class of pharmaceuticals that include prescription painkillers as well as illicit drugs like heroin, are at the root of an ongoing public health crisis in the US. In 2017, there were 47,600 opioid-linked drug fatalities in the United States -- more than the number of deaths linked to breast cancer -- according to the Centers for Disease Control and Prevention.

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    https://www.nytimes.com/2019/07/19/h...rugstores.html

    By Jan Hoffman, Katie Thomas and Danny Hakim
    July 19, 2019

    The Walgreens employee was bewildered by the quantity of opioids the company was shipping to just one store. Its pharmacy in Port Richey, Fla. (population 2,831) was ordering 3,271 bottles of oxycodone a month.

    “I don’t know how they can even house this many bottles to be honest,” Barbara Martin, whose job was to review suspicious drug orders, wrote to a colleague in a January 2011 email. The next month, the company shipped another outsized order to the same store.

    The email was among thousands of documents from corporations across the pharmaceutical and retail industries — internal memos, depositions, sales and shipping reports, experts’ analyses, and other confidential information — filed Friday in federal court in Cleveland by lawyers for cities, towns and counties devastated by addiction. They lay out a detailed case of how diverse corporate interests — far beyond the familiar players like Purdue Pharma — fed a deadly opioid epidemic that persisted for nearly two decades.



    Little-known manufacturers of generic pills, superstores like Walmart and chain retailers like Rite Aid also flooded the country with billions of pills, according to the filings. The devastation was so extreme that one Ohio county resorted to a mobile morgue to handle all the corpses of people who died from overdoses.



    ImageFrom left, Mark Trudeau, chief executive of Mallinckrodt, with several city and county officials in St Louis in 2013 when the company unveiled a new logo.
    From left, Mark Trudeau, chief executive of Mallinckrodt, with several city and county officials in St Louis in 2013 when the company unveiled a new logo. CreditWhitney Curtis/Associated Press
    As the epidemic crested, the suppliers with the greatest sales were not the branded manufacturers but those who made generic prescription drugs. Between 2003 and 2011, lawyers for the plaintiffs said in one filing, Mallinckrodt, the Ireland-based manufacturer of generic and branded drugs, sold 53 million orders of opioids. Yet the company stopped and then reported to federal authorities at most 33 orders as suspicious, a ratio the lawyers described as defying credibility.

    The filings represent a signature moment in the run-up to the first trial of nearly 2,000 cases brought by cities and counties nationwide, consolidated in an Ohio federal court. They are seeking billions of dollars in compensation from the corporations implicated in the opioid epidemic.

    Both sides have largely finished gathering evidence, and Friday’s filings attempt to solidify major claims for the first trial, which is scheduled to begin in October. Stemming from a lawsuit brought by Cuyahoga and Summit counties in Ohio, it is intended as a litmus test for the remaining cases. Judge Dan Aaron Polster of Federal District Court of Northern Ohio hopes that the shadow of the trial will goad the sides to reach a national settlement that could award money to cities, towns and counties across the country, and foreclose further opioid lawsuits.

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    Judge Dan Aaron Polster, who is presiding over some 2,000 federal cases arising from the opioid epidemic.
    Credit
    Maddie McGarvey for The New York Times





    With Friday’s briefs, the plaintiffs want the judge to rule that for years, defendants ignored and violated laws that required them to monitor and report suspicious orders. They also argue that defendants created a “public nuisance” — a continuing crisis that affects the far reaches of public health, including neonatal intensive care, foster care, emergency services, detox and rehabilitation programs and the criminal justice system.

    The Carl B. Stokes United States Court House in Cleveland
    Credit
    Maddie McGarvey for The New York Times


    The pharmaceutical industry also filed briefs on Friday. Many submissions, including exhibits, were limited, heavily redacted or outright sealed.

    Manufacturers of generic drugs argued that they do not market their opioids, nor should they be penalized for selling versions of prescriptions approved by the Food and Drug Administration. The pharmacy chains argued that the plaintiffs offered no proof that opioids they distributed only to their own stores had been illegally diverted. And they said that many plaintiffs’ claims were invalid because statutes of limitations had run out.

    Credit
    Gene J. Puskar/Associated Press


    Image

    CreditGene J. Puskar/Associated Press
    But the plaintiffs offered up a less benign view of how opioids flew through the pharmacies.

    When patients of Dr. Adolph Harper, a gynecologist, needed to buy opioids, they often seemed to show up at Rite Aid stores near his office in Akron, Ohio. His clinic prescribed hundreds of thousands of the painkillers, such as OxyContin, Roxicet, Percocet and Opana. He continued to do so even though at least eight patients overdosed and died, the Justice Department has previously said. Dr. Harper was later arrested and sentenced to 10 years in jail.

    But despite all the opioid prescriptions pouring in from Dr. Harper, the company did not identify any suspicious orders coming from Dr. Harper’s clinic, the plaintiffs said. Instead, Rite Aid increased its orders to meet the surge in demand from the clinic.



    For years, long after the opioid crisis began, the giant pharmacy chains, including Walgreens and CVS, and Walmart did almost nothing to fulfill their legal duty to monitor suspicious orders, the plaintiffs’ lawyers claim. While they were supposed to block such orders and alert the Drug Enforcement Administration, they did so rarely.

    One official at Walgreens tasked with monitoring such orders said his department was “not equipped” for that work. The company created lists of suspicious orders that ran thousands of pages, but then shipped them without further review.

    Asked for a response, Walgreens issued a statement saying it “has not distributed prescription controlled substances since 2014 and before that time only distributed to our chain of pharmacies.” The company called itself “an industry leader in combating this crisis.”

    An official at CVS who was listed as the company’s D.E.A. compliance coordinator admitted that it was not her real job, the plaintiffs’ filing said. Much of the company’s compliance was relegated to “pickers and packers” — the warehouse workers at distribution centers who appeared to have no formal training in monitoring and rarely held up orders. In the company’s Indianapolis distribution center, approximately two orders were flagged each year from 2006 to 2014.

    Before 2011, Walmart had no discernible system to monitor suspicious orders. the plaintiffs contended. The company said that it relied on its hourly employees, which the plaintiffs called a “farcical” claim with no evidence of training or policy in place.

    By 2015, the company put a system of storewide limits in place, but it was so forgiving that a store could go from ordering 10 dosages of 10 milligrams of oxycodone in one month, to 7,999 dosages the next, without raising an alarm. In a filing Friday, Walmart said that its pharmacy business accounted “for a vanishingly small part of the relevant market” and noted that an expert for the plaintiffs had concluded that Walmart distributed less than 1.3 percent of the opioids distributed to the Ohio counties that brought the case.

    Rite Aid, in its own filing, said that “plaintiffs have presented no evidence” that the company’s “limited distribution of opioids caused any of their injuries,” an argument echoed by CVS, which said in its filing there was “no evidence’ that any CVS shipment to the counties was misused.



    But the plaintiffs alleged complicity across the opioid supply chain.

    “Failure to identify suspicious orders was their business model,” they said of the defendants. “They turned a blind eye and called themselves mere ‘deliverymen’ with no responsibility for what they delivered or to whom. Just like any street drug courier.”

    As billions of their pills poured into the country, generic manufacturers took a lax approach to tracking suspicious orders, the briefs for the plaintiffs said. They used faulty algorithms to flag questionable orders and frequently handed oversight to customer service employees and account managers, whose pay was tied to drug sales.

    Many of the companies used rudimentary systems to flag orders, for example only singling out cases when a customer ordered more than two or three times the amount that it had in the past. Such systems did not comply with D.E.A. requirements, the plaintiffs said. They did not account for pharmacies that were already ordering inappropriately large quantities of opioids, and many of the tracking systems could be evaded by dividing orders into smaller quantities, or switching to new dosages.

    The generic manufacturer Teva’s program was called “DefOps,” which was short for “Defensible Operations.” It was set up to keep Teva out of trouble and also because it “sounded good,” according to the filing, which cited a deposition of the employee who had designed it.

    In a legal filing Friday, Teva said it had followed the law and that the plaintiffs could not show that its products caused them harm.

    Some companies gave sales employees responsibility for investigating and clearing suspicious orders. That was the case at Mallinckrodt. From 2006 through 2014, the plaintiffs’ lawyers said, Mallinckrodt’s products accounted for a quarter of all the opioids dispensed in the two Ohio counties.


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    Mallinckrodt’s national account managers, whose bonuses were tied to sales, investigated suspicious orders. One order was cleared because a national account manager wanted to keep the “momentum rolling” with a customer, according to the legal filing. Another justified an unusually large order because the customer had been unable to obtain opioids from another source.

    Company officials acknowledged that assigning their sales staff to scrutinize suspicious orders was a conflict of interest, according to emails cited in the legal filing, but allowed the practice to continue.

    A spokesman for Mallinckrodt declined to comment on the legal filings Friday.

    In 2017, Mallinckrodt agreed to pay $35 million to settle federal charges that it had failed to detect suspicious orders of opioids and to report them to the D.E.A. Under that settlement it also agreed to more closely analyze its distribution to ensure its products are not being misused.

    Some manufacturers failed to alter their practices even when they were warned that their drugs were being misused. In 2012, D.E.A. officials met with employees of Actavis, a manufacturer of generic OxyContin and Opana ER, two of the most abused painkillers on the market. The agency urged the company to see for themselves how their products were being used on the ground.

    According to the legal filing, a D.E.A. worker told the Actavis employees “to visit pharmacies who were receiving their products in South Florida, in order for them to witness the long lines at pain clinics, out-of-state license plates, questionable clients, security guard(s) in the parking lots, and signs stating cash payments only.”

    But little changed. Actavis’s ethics and compliance officer later said in a deposition, cited in the plaintiffs’ filing, that the “tone and tenor” of the meeting “made it less productive than it could have been” and that the D.E.A. officials had treated the employees “as street dealers.”




    In a follow-up meeting later that year, the D.E.A. asked Actavis to reduce its manufacturing quota for oxycodone, the active ingredient in OxyContin. The company rejected the agency’s request.

    Following a series of acquisitions, Actavis’s generic products are now owned by Teva, which declined to comment.

    https://www.nytimes.com/2019/07/19/h...rugstores.html

    Part 2

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    https://www.washingtonpost.com/healt...=.5f46ff1ab916

    Now an Opioid abuse lawsuit is announced to be in Ohio.

    PARMA, Ohio — At Knuckleheads Bar & Grill, the subject on a sweltering Saturday afternoon was the drug crisis. More specifically, the recent disclosure that the CVS across the street received more pain pills — 6.4 million — over a seven-year period than any other drugstore in Cuyahoga County.

    “Location, location, location,” said Mike Gorman, 37, who was drinking and hanging out with friends. “It’s right near the highway, which makes it easy to access” from Cleveland.

    And there was the homeless encampment just beyond the CVS, over by the train tracks, behind the strip mall. It’s popular with heroin users, the regulars at the sports bar said.

    “It’s a terrible thing, but I don’t blame CVS,” Gorman said, contending that drug companies made large profits and encouraged doctors to prescribe opioids.


    The CVS in this white working-class suburb of Cleveland is a three-hour drive and, culturally, even farther from the southern Ohio section of Appalachia that has become widely associated with the opioid epidemic.

    But last week’s revelation that drug companies saturated the United States with 76 billion pain pills over seven years shows that no corner of the country escaped the drug crisis. Two other drugstores in this city of 80,000 placed second and fifth on the Drug Enforcement Administration’s list of Cuyahoga County locations. Wholesalers shipped opioids at 5.4 million and 3.7 million doses respectively to those. The list was disclosed by The Washington Post last week.


    Cuyahoga County and nearby Summit County soon will be at the center of the most important legal test of how much responsibility drug companies bear for the opioid epidemic. Barring a settlement, the two counties are scheduled to go to trial in October as the first case among the consolidated lawsuits brought by about 2,000 cities, counties, Native American tribes and other plaintiffs.


    U.S. District Judge Dan Polster, who is presiding over the consolidated case in Cleveland, selected the counties to represent the legal arguments that other plaintiffs have made. The two counties alone are asking for billions of dollars from companies to help stem the crisis.

    [Five takeaways from the DEA’s pain pill database]

    In a statement to The Post Sunday, Mike DeAngelis, senior director for corporate communications at CVS, defended the company’s actions.

    “In the period of time covered by the ARCOS data (2006-2012), our shipments of hydrocodone combination products comprised only 2% of the prescription drugs we shipped to our pharmacies,” he said. “As soon as the DEA reclassified these drugs as Schedule II in October 2014, we stopped distributing them immediately.

    “The DEA possesses data on every single shipment of hydrocodone combination products we shipped to our pharmacies. It did not identify a single shipment to a single CVS Pharmacy in Cuyahoga or Summit Counties as improper.”

    The DEA database: Find the data for where you live VIEW GRAPHIC
    In a court filing released Friday, lawyers for the two counties accuse some of the biggest names in the drug industry of creating a “public nuisance” that endangered the health of residents by failing to control the drug flow, even when they knew, or should have known, that some painkillers were being diverted to illegal use.


    “There can be little doubt that the opioid crisis — the epidemic of opioid availability and use — significantly interferes with the public health and constitutes a public nuisance in both Cuyahoga and Summit counties,” they argued in a request that Polster rule in their favor on that issue even before trial.

    To bolster that argument, they offered an array of statistics that may be critical in the case. In 2016, they said, the death rate from pharmaceutical opioids in Cuyahoga County was 3.26 times higher than the national average. In 2017, county emergency rooms treated an estimated 9,191 people with drug-related health problems, a 21 percent increase over the previous year.

    As the government cracked down on the diversion of pills to the black market, heroin and fentanyl took their place. By March 2016, two people died of a heroin or fentanyl overdose in Cuyahoga County every day, the lawyers alleged.


    [Obama officials failed to focus as fentanyl burned its way across America]

    In Summit County, whose biggest city is Akron, the surge in overdose deaths was so rapid that the county medical examiner brought in a mobile morgue in 2017 to handle the bodies, the plaintiffs wrote.

    The rate of infants born addicted to opioids there rose from 2.9 per 1,000 births between 2004 and 2008 to 13.6 per 1,000 births between 2011 and 2015, they alleged.

    A group of recovering addicts in Abingdon, Va., respond to The Post’s reporting on what company executives said in emails as the opioid crisis raged on. (Joyce Koh, Dalton Bennett/The Washington Post)
    The defendants in the case include giant drug distribution companies such as McKesson, Cardinal Health, AmerisourceBergen, Walgreens and Walmart, and manufacturers such as Purdue Pharma and Mallinckrodt.

    The companies have generally blamed the epidemic on overprescribing by doctors, over-dispensing by pharmacies and on drug abuse by customers. The companies say they were working to supply patients in desperate need of pain relief with legal, highly regulated drugs.


    “We maintain stringent policies, procedures and tools to help ensure that our pharmacists properly exercise their professional responsibility to evaluate controlled substance prescriptions before filling them,” DeAngelis, the CVS spokesman, said Sunday. “Keep in mind that doctors have the primary responsibility to make sure the opioid prescriptions they write are for a legitimate purpose.

    “Over the past several years, we have taken numerous actions to strengthen our existing safeguards to help address the nation’s opioid epidemic that has resulted in a 30% reduction in the amount of controlled substances that our retail pharmacies dispense.”

    The public nuisance argument is the same one made by the state of Oklahoma in a seven-week trial against Johnson & Johnson that concluded last week. The state asked a judge to make the company pay as much as $17.5 billion over 30 years to clean up the drug crisis. Cleveland County District Judge Thad Balkman said he would rule around the end of August.


    Mike Pack, of Akron, Ohio, speaks at a rally addressing the opioid crisis outside the federal courthouse in Cleveland in May 2018. (Mark Gillispie/AP)
    Another 48 states have sued drug companies and are lined up behind Oklahoma in a legal track that runs parallel to the enormous federal “multi-district litigation” in Ohio.

    The intersection where CVS and Knuckleheads sit is typical for the outskirts of Cleveland, whose border is just a few hundred feet away. It has strip malls occupied by discount stores, and a mom-and-pop lunch counter threatened by the Burger King down the road.

    Knuckleheads itself, like its patrons, appears transported here from Cleveland in the exodus to the suburbs that began decades ago. It is a squat stone building with signs promising cheap domestic beer, bar food and a Cleveland Indians game on TV. The men inside drain pints of Budweiser and Miller Lite between smoke breaks in the alley behind a black metal side door.


    The pharmacist on duty at the CVS on Saturday declined to comment on the volume of pills sold there, citing company policy.

    But Frank Cimperman, 58, Knuckleheads’ owner, said he believes “it’s only number one because of the highway, and because you can get a prescription filled there 24 hours a day.”

    Drugstores with easy access to highways have drawn authorities’ interest in the past, including two CVS stores in Sanford, Fla., that were raided and shut down by the DEA in 2012.

    At a Rite Aid in the Clark-Fulton neighborhood of Cleveland, an inner-city community of low-income whites and Hispanics, pharmacy manager Ben Swartz was surprised to learn that his branch ranked third in Cuyahoga County on the DEA database.

    “Wow,” said Swartz, whose store received 4.8 million pills between 2006 and 2012. But he said he is confident that in recent years stricter practices have been put into place.

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    https://www.washingtonpost.com/healt...=.5f46ff1ab916

    Part 2

    “We vet all the prescriptions that come in here,” he said. Extra measures, including verifying diagnoses with doctors, are used for about one in 10 prescriptions, he said.

    “We look for prescribing trends,” Swartz said. “If a doctor’s giving everyone the same drug in the same quantities, we won’t associate with them. We also scrutinize prescriptions for high strength and high quantities, and people using multiple pharmacies and multiple prescribers.”


    Barry Bova holds a picture of his son Brad, who died of a heroin overdose, while marching through the streets of Norwalk, Ohio, in 2017. (Spencer Platt/Getty Images)
    Preliminary data from the U.S. Centers for Disease Control and Prevention released last week showed that drug overdose deaths nationally declined about 5 percent in 2018, the first drop in decades. While deaths from fentanyl are skyrocketing, fatalities from prescription opioids are falling, the data show.

    Residents on the blocks surrounding the Rite Aid spoke of a high rate of heroin use in the area. One person, who spoke on the condition of anonymity because he did not want to be identified as disparaging the area, said the sidewalk in front of an abandoned factory a block south was a “shooting gallery” until two years ago.

    “We used to find hundreds of needles on the sidewalk here,” he said. “But I haven’t seen any in two years, so I think it’s getting better.”

    Steven Rich contributed to this report.

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    https://www.apnews.com/bee60f0700ac4be6a0757457cad42dd8

    And also Opioid abuse issues taking place in Native American Lands.

    FLAGSTAFF, Ariz. (AP) — U.S. government hospitals put Native American patients at increased risk for opioid abuse and overdoses, failing to follow their own protocols for prescribing and dispensing the drugs, according to a federal audit made public Monday.

    The report by the U.S. Department of Health and Human Services’ Office of Inspector General does not say whether patients suffered because of the hospitals’ practices. But all five Indian Health Service hospitals that were reviewed had patients who were given opioids in amounts exceeding federal guidelines, the report said.


    “There are vulnerabilities with this particular population in the opioid prescribing and dispensing practices,” said Carla Lewis, one of the auditors.


    The overdose epidemic that has killed more people than any other drug epidemic in U.S. history has hit indigenous communities hard. Native Americans and Alaska Natives had the second-highest rate of opioid overdose out of all U.S. racial and ethnic groups in 2017, according to the federal Centers for Disease Control and Prevention.

    Navajo Nation President Jonathan Nez called the audit’s findings “very concerning” and said the tribe plans to reach out to its congressional members and the Indian Health Service to ensure the recommendations are addressed.

    The report made more than a dozen recommendations to the Indian Health Service to better track patients’ health records and pain management, ensure opioids are stored under tighter security and update its information technology systems. The agency agreed on every point and said changes are coming.

    The Indian Health Service, the federal agency that administers primary health care for Native Americans, has put an increased focus on opioids lately with a new website and the creation of a committee focused on decreasing overdose deaths, promoting culturally appropriate treatments and ensuring that communities know how to respond.

    The audit covered five of the 25 hospitals directly run by the Indian Health Service: the Phoenix Indian Medical Center in Phoenix; Northern Navajo Medical Center on the Navajo Nation in Shiprock, New Mexico; the Lawton Indian Hospital in Lawton, Oklahoma; the Cass Lake Indian Hospital on the Leech Lake reservation in Cass Lake, Minnesota; and the Fort Yates Hospital on the Standing Rock Sioux reservation in Fort Yates, North Dakota.

    Auditors considered the amount of opioids each hospital dispensed and the percentage increase over three years when deciding which ones to review. They looked at 30 patient records at each hospital, visited the facilities and interviewed staff.

    The auditors found that the hospitals strayed from guidelines in the Indian Health Manual in reviewing treatment for patients and their causes of pain every three months. Patients also must sign a written consent form and an agreement to treat chronic pain with opioids so they know the risks and benefits, as well as the requirement for drug screenings. More than 100 patient records did not include evidence of informed consent, and dozens did not have evidence that providers adequately educated patients.

    The Centers for Disease Control recommends that patients be prescribed no more than 90 morphine milligram equivalents per day, a measure used to compare an opioid dose with morphine.

    The audit found that each hospital met or exceeded that amount at times. At the Shiprock hospital, the daily dosage was more than four times as high. The auditors also found some patients were prescribed opioids and benzodiazepines — commonly used to treat anxiety and insomnia —at the same time, which “puts patients at a greater risk of a potentially fatal overdose.”

    The Indian Health Service said all of its facilities now submit that data so the agency’s top leadership can track it.

    Among the report’s other findings:

    —More than two dozen records showed no evidence patients were screened for drugs with urine tests when they started opioid treatment and periodically after. Providers did not have an alert system to know when patients were due for the urine tests. The Phoenix hospital has since implemented one.

    —Pharmacists are supposed to review patients’ files before filling prescriptions from an outside provider, but that was not done at four of the hospitals. In one case, Fort Yates filled a prescription from an outside provider despite the hospital discontinuing treatment because the patient violated a pain management agreement. The Indian Health Service said it would issue a directive in December for prescribers to track that information.

    —Only the Lawton hospital had opioids secured in a storage cabinet requiring employee authentication for access. One photo attached to the report showed the combination to a safe listed on the safe itself. The Indian Health Service said it has revised its manual to require opioids awaiting pickup to be locked up.

    —Agreements with their states require that hospitals report daily on opioid prescriptions that are filled so patients do not seek the drugs from multiple providers at the same time. Fort Yates and Phoenix now are complying. The Indian Health Service said the reporting would be automated by June 2020.

    At all hospitals, auditors noted that providers did not always review the data before seeing new patients or during the time patients were on opioids for pain.

    “Part of it is to ensure the holistic approach of providing care,” Lewis said.

    Hospital officials and providers often said they were overwhelmed by the number of patients or could not control how regularly they came in — sometimes due to the long distances between patients’ homes and the hospitals.

    Lewis said auditors try to be reasonable in their requests.

    “We try to make recommendations that are going to be actionable and cost-effective for an organization,” she said.

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    https://www.washingtonpost.com/healt...=.5ca1c9085463

    Major opioid manufacturers have asked a judge to throw out the first test case of whether they must pay for the nation’s drug crisis, arguing that two Ohio counties cannot prove the drug companies’ actions were responsible for overdose deaths or other harms, newly unsealed court documents show.

    Lawyers for Purdue Pharma, Mallinckrodt Pharmaceuticals and other drug companies contend that Cuyahoga and Summit counties cannot sufficiently connect the tens of billions of legal painkillers the companies produced to fatalities and addiction. Nor can the counties show that drug company sales calls caused doctors to overprescribe the medications, they said.

    The Ohio counties “have no evidence that their alleged injuries were proximately caused by the collective ‘manufacturers’ . . . rather than by criminal cartels trafficking in deadly street drugs,” the manufacturers argued in criticizing expert testimony presented by lawyers for the two counties.


    The request that federal judge Dan Polster toss out the lawsuit is a common pretrial tactic in civil litigation. More significantly, it is the first full public airing of the legal defense manufacturers are likely to offer in the landmark lawsuit brought by nearly 2,000 cities, counties and other groups across the country, the largest civil case in U.S. history. Polster has urged all sides to settle the case.

    The drug producers’ motion targets the two counties because they are scheduled to go to trial first, in October, as a test case in the enormous lawsuit.

    With plaintiffs trying to prove the drug companies engaged in a civil racketeering enterprise, “it seems the fight is about how granular you have to be when you’re proving these types of . . . claims,” said Elizabeth Chamblee Burch, a law professor at the University of Georgia. “There’s kind of an inherent tension there, because [racketeering] is about proving an aggregate wrong,” she said. “It’s the tension between proving a [racketeering] claim, which requires aggregate proof, versus what you can pin on these particular defendants.”


    Remote mountain towns of southwestern Virginia’s coal country, where fog settles along Route 58 between the hills, received millions of prescription opioid pills between 2006 and 2012. (Melina Mara/The Washington Post)
    A person with knowledge of the defense strategy said the plaintiffs need to show that the companies were conspiring with one another and acting in concert. That’s difficult to do because the companies are fierce competitors, said this person, who spoke on the condition of anonymity because Polster has warned people associated with the case not to comment on it. The idea that the defendants conspired is not consistent with the reality of their business.

    The person said the plaintiffs have not been able to tie alleged false or misleading promotion by drug companies to harm in communities and are relying on statistical data that the defendants believe is poorly modeled.


    The defendants’ motion was unsealed late Tuesday night, after an appellate court ordered Polster to make some material in the case public.

    As yet, the unsealed court records do not include arguments from the major drug distributors and retail chains, which are also defendants in the case.

    Defense attorneys listed in the court papers did not return telephone calls seeking comment Wednesday. A public relations representative for the plaintiffs did not return an email seeking comment.

    The municipalities are seeking billions of dollars to help pay for the costs of treatment, emergency aid and law enforcement in an epidemic they claim started when drug companies ignored clear signs that opioids were being diverted to the black market.

    More than 200,000 people have died of overdoses from legal painkillers in the last two decades. A similar number have succumbed to heroin and illicit fentanyl in the second and third waves of the epidemic.


    The municipalities’ claims against drug producers, distributors and retailers were made public Friday. They argued that some of the biggest and best-known companies in the United States participated in what amounts to a civil racketeering enterprise when they sold vast quantities of drugs that devastated communities across the country. Cuyahoga and Summit also argue that drug distributors created a “public nuisance” that endangered the health of their residents — a problem those companies must pay to help abate.

    The Washington Post also revealed a previously undisclosed database maintained by the Drug Enforcement Administration last week. It shows that the drug industry inundated consumers with 76 billion opioids between 2006 and 2012, many more than experts had previously believed.

    But in court, the question will be whether the two counties, and future plaintiffs, can meet the legal standards necessary to prove the drug companies’ regulated commerce in painkillers was so excessive that it caused the counties harm. In their newly revealed court filing, the manufacturers argued forcefully that the plaintiffs fall far short of proving their case.


    They said the counties have not proved even some of the basic elements required by Polster: that the manufacturers deceptively promoted opioids to sell more than was medically necessary; that the excess drugs were diverted to the black market; and that the counties had to spend money to stop the flow of drugs and clean up the damage.

    The defense argued that one of the counties’ consultants, Meredith Rosenthal, a professor at Harvard University’s T.H. Chan School of Public Health, “made no attempt to measure the effect of the alleged misconduct.” Rosenthal did not separate lawful sales visits to doctors — known in the drug trade as “detailing” — from allegedly illegal promotional activities, they said.

    Her testimony “would provide no evidence about whether and to what extent any alleged deceptive marketing can be causally linked to plaintiffs’ alleged losses,” the defendants wrote.


    Rosenthal did not return an email seeking comment. In her March 25 report, unsealed Friday, she concluded that “promotion caused a large share of the sales of opioids nationally and in the [two counties] during the damage period.” But the numbers that support her conclusions are blacked out in the publicly released documents.

    Another, consultant, David Cutler, compared shipments of prescription opioids to deaths from all types of opioids, the defendants contend.

    “There is no legal or factual basis for holding manufacturer defendants liable for harms caused by illicit drugs,” they wrote. Nor can Cutler pin culpability on any individual manufacturer, they said.

    Cutler, a Harvard economics professor, declined to comment . But his March 25 report, also unsealed Friday, shows that he calculated the impact of prescription opioid shipments on deaths, the crime rate, juvenile protection and other services that counties pay for.


    After 2010, he wrote, “the share of licit mortality attributable to defendants’ misconduct increased from 26.3 percent to 44.6 percent.” However, much of the data behind his conclusions is redacted.

    Other data offered by the plaintiffs measures shipments between wholesale drug distributors — the middlemen in the supply chain — and pharmacies, and therefore does not prove any wrongdoing by manufacturers, the defendants alleged. Manufacturers sit at the top of the supply chain and send drugs to distributors, who bring them to pharmacies and other places where they are purchased and consumed.

    In addition, the drug producers claimed, the analysis does not take into account many other factors that could influence the final data on harm, including the impact doctors and criminal drug dealers might have had.

    Steven Rich contributed to this report.

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    https://www.apnews.com/4b75785affde443aa50bae8e5331542f

    WASHINGTON (AP) — In 2012, as the death toll from the nation’s opioid crisis mounted, drug companies shipped out enough of the powerful and addictive painkillers for every man, woman and child in the U.S. to have nearly a 20-day supply.

    In some counties, mostly in Appalachia, it was well over 100 days.

    An Associated Press analysis of drug distribution data released as a result of lawsuits against the industry also found that the amount of opioids as measured by total potency continued to rise early this decade even as the number of pills distributed began to dip.

    The reason: Doctors were prescribing — and the industry was supplying — stronger pills.



    “It shows it wasn’t just the number of pills being shipped that increased. The actual amount of opioids being prescribed and consumed went up,” said Anna Lembke, a Stanford University professor who researches opioids and is serving as a paid expert witness for plaintiffs in the litigation.

    “We know that the higher the dose of prescribed opioids, and the longer patients are on them, even for a legitimate pain condition, the more likely they are to get addicted.”

    The AP found that the overall amount of opioid medication shipped to pharmacies, medical providers and hospitals increased 55% from 2006 through 2012. The number of pills rose significantly over that period, too — but that increase was lower, about 44%. (The amount of medication was calculated using a standard measure of potency known as a morphine milligram equivalent, or MME.)

    In 2006 and 2007, the counties at the very top of the list of those receiving the most opioids were scattered about the eastern half of the U.S. By 2012, they were all in the Appalachian region. And the numbers were up dramatically.

    For instance, in 2006, Tennessee’s Hamblen County received the most opioid medication per person in the country — about 70 days’ worth of a typical prescription for every man, woman and child. By 2012, the top county was Norton, Virginia, and the number of days’ worth of opioids was a staggering 134.

    In calculating days of medication, the AP used 50 MMEs as a daily dosage. That is the upper limit beyond which the Centers for Disease Control and Prevention urges doctors to use caution.

    The data comes from the federal Drug Enforcement Administration’s collection of information from pharmaceutical companies about how controlled substances were distributed down to pharmacies, doctors and hospitals. It’s a key part of the case for some 2,000 state, local and tribal governments suing the industry over the opioid crisis.



    The first of the federal trials, involving claims from Ohio’s Cuyahoga and Summit counties, is scheduled to start in October.

    Last week, a judge agreed to make public the data covering 2006 through 2012. During that period, opioid overdose-related deaths in the U.S. increased from about 18,000 a year to more than 23,000. Since then, the number has doubled, and opioids have overtaken automobile accidents as the top cause of accidental death in the country.

    Heroin and even stronger illicit drugs such as fentanyl drove the increase for most of this decade. Studies have found that most new heroin users started with prescription drugs that had been prescribed to them or to someone else.

    Plaintiffs in the lawsuits claim drugmakers overstated the benefits of opioids and downplayed their addictiveness, persuading doctors to offer the drugs to more patients and in higher amounts.

    The origins of the opioid crisis are largely traced to the mid-1990s, when Purdue Pharma introduced OxyContin. Up until then, opioids were generally reserved for surgery or cancer patients in extreme pain.

    The government lawsuits also say the companies violated DEA policy by shipping orders even when they believed them to be “suspicious” because they were far larger than normal.

    For example, an e-mail chain from Purdue Pharma, the maker of OxyContin, showed an employee flagging an order at 4:15 p.m. on Oct. 27, 2009, from drug distributor Cardinal Health because it was nearly twice as big as the customer’s usual 12-week order of a certain dosage. The order was worth close to $293,000.

    It was approved at 4:16 p.m., the emails show.

    The e-mail was part of a new trove of industry documents made public this week. They also include a transcript of a testy deposition earlier this year in which an executive at Cardinal Health — one of the nation’s largest drug distributors — said the company has no obligation to the public when it comes to the opioids it ships.

    Cardinal Health counsel Jennifer Norris was asked by a lawyer whether the company wants to “ensure that it does what it can to prevent the public from harm?”

    She answered: “I don’t know that Cardinal owes a duty to the public regarding that.”

    She went on to say, “Cardinal Health has an obligation to perform its duties in accordance with the law, the statute, regulations and guidance.”

    A Cardinal spokeswoman said the comment was made only in a legal context.

    ___

    Mulvihill reported from Cherry Hill, New Jersey. Associated Press data journalists Larry Fenn, Meghan Hoyer and Justin Myers contributed to this article.

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    WASHINGTON (AP) — Dr. Raeford Brown was uniquely positioned to help the U.S. government answer a critical question: Is a new version of the painkiller OxyContin helping fight the national opioid epidemic?

    An expert in pain treatment at the University of Kentucky, Brown led a panel of outside experts advising the Food and Drug Administration on opioids that have been reformulated to deter snorting and injecting.

    There’s just one problem: Neither the company that makes OxyContin nor the FDA has allowed the experts to see data on whether it reduces abuse.

    “We asked for that data probably 40 or 50 times in last four or five years and were denied every time,” said Brown, whose term as an FDA adviser ended in March.


    Nearly a decade ago, the FDA approved reformulated OxyContin and told the company, Purdue Pharma, that it would be evaluated on whether the new version decreased cases of addiction, overdose and death. The data submitted by Purdue to answer that question remains secret.

    “It’s in the public interest that we all know what these drugs are doing and yet none of us can see it, which is really terrifying when you think about it,” Brown told The Associated Press.

    In 2015, Brown and his colleagues were supposed to review follow-up data on OxyContin at a meeting in Washington, but the FDA canceled it only days before. Purdue had pulled its application to update OxyContin’s label with new information on abuse, saying it wanted more time to analyze the data. Such meetings are typically planned months in advance and are almost never canceled.

    A Purdue spokesman said the Stamford, Connecticut-based company has been working to complete four updated study requirements assigned by the FDA in 2016. The company said it has submitted three of the FDA-mandated studies and expects to submit the final one by October.

    “Once all of the studies are completed and FDA has had the opportunity to review the results, we will evaluate options to disseminate this important data to the scientific community,” said Bob Josephson, in a statement.

    But the FDA’s top staffer for opioids said at a public meeting last year that the agency expected the information to become available “years ago.”

    “They have it, but it’s hard for us to force them to submit it,” said Sharon Hertz, FDA’s division director for pain medications.

    The unreleased OxyContin data highlights the FDA’s precarious role as both a public health agency and close confidante of industry. While the agency can order a drugmaker to research important questions, the information itself still belongs to the company and is deemed “confidential commercial information.”


    An FDA spokeswoman said in an email that it would be “premature” to comment on Purdue’s results before they have been fully submitted and reviewed. The agency noted that the company’s final OxyContin study has been delayed. FDA staffers expect the studies “will help us understand the real-world impact of OxyContin’s reformulation on abuse,” said Lyndsay Meyer.

    OVERDOSE DEATHS

    If OxyContin has reduced overdose deaths, federal statistics don’t show it.

    OxyContin remains the best-selling opioid brand in the country, but it accounts for less than 2 percent of U.S. opioid prescriptions, potentially limiting its impact on national trends. (Most opioids prescribed are low-priced generic pills.)

    Since the new formulation was approved in 2010, fatal overdoses involving prescription opioids including OxyContin, Percocet and generic pills have risen more than 30 percent to about 14,500 in 2017, the most recent year for which complete data is available. Preliminary figures released last week suggest drug-related deaths likely fell last year for the first time in decades.

    Some researchers have suggested reformulated OxyContin, combined with tighter prescribing and other measures, accelerated the nationwide shift toward heroin and fentanyl. Those drugs were involved in more than 43,000 overdose deaths in 2017, nearly three times the number as prescription opioids.

    The FDA has now approved seven opioids, including OxyContin, with labeling that they are “expected” to discourage abuse.

    Those pills are intended to be difficult to crush, break or dissolve, but they can still be misused when simply swallowed. And the drugs carry the same addiction risks.

    “The real problem with opioids from the public health perspective is addiction,” said Dr. Lewis Nelson, a Rutgers University emergency medical specialist who also serves as an FDA adviser. “These pills in the reformulated version don’t do anything to reduce the likelihood or magnitude of addiction.”

    Purdue has published preliminary information on reformulated OxyContin in peer-reviewed journals, but the studies are clouded by potential biases and limitations. Many are written by Purdue scientists or researchers whose work is funded by the company. In most cases, the data comes from a network of specialized sources, including poison control centers, law enforcement records and drug rehabilitation clinics.

    Those sources show a positive picture for OxyContin’s performance, with key indicators like emergency calls, law enforcement reports and rates of patients seeking prescriptions from multiple prescribers — known as doctor shopping — dropping.

    But even the study authors acknowledge that those measures don’t necessarily reflect what’s happening across the country. Only a small segment of people misusing opioids ever enter rehabilitation, for instance.

    When FDA researchers decided to independently examine OxyContin abuse in a study using a much larger dataset — a federal government annual survey — they found a different picture. Among people with a history of misusing prescription opioids, rates of OxyContin abuse were similar or higher three years after the drug was reformulated.

    “If you were going to see an impact, this is the population where you should see it. And we didn’t see anything,” said Dr. Christopher Jones, who co-authored the 2017 paper and now works at the Centers for Disease Control and Prevention.

    The paper’s findings square with survey results suggesting less than 5 percent of long-term abusers gave up OxyContin after it was reformulated.

    Garrett Hade of Los Angeles said that when he was addicted to opioids it would take him only a few minutes in his kitchen to prepare OxyContin for injecting.

    “It just became a matter of ‘this is what you have to do today because you have abuse-deterrent OxyContin,’” said Hade, 32, who is in recovery.

    THE CONTINUING COST OF OXYCONTIN

    First launched in 1996, the original OxyContin helped spark a wave of abuse as some people quickly learned to crush the long-acting pills to release a massive opioid dose. Under pressure from regulators, politicians and law enforcement, Purdue reformulated the painkiller in 2010.

    Government data unveiled last week showed Purdue and other drugmakers flooded the U.S. with more than 76 billion opioid pills between 2006 and 2012. Areas that received the most pills also had the highest overdose rates.

    Today, Purdue faces some 2,000 local and state lawsuits alleging its aggressive marketing contributed to the opioid epidemic by downplaying OxyContin’s addiction risks and promoting the drug for common pain ailments. The lawsuits have pushed the company to publicly discuss bankruptcy .

    The reformulation has been good for business.

    The patent on original OxyContin would have expired in 2013, allowing lower-priced generics to gobble up Purdue’s market share. By reformulating the drug, Purdue was able to extend its patent until 2030.

    Since 2010, OxyContin has generated more than $21 billion in U.S. sales, according to pharmaceutical tracking service IQVIA.

    Purdue viewed the anti-abuse reformulation as a “key driver” of new prescriptions and stressed the features in promotions to doctors, according to its marketing materials. Purdue stopped promoting OxyContin directly to doctors last year amid mounting scrutiny.

    Meanwhile Purdue has steadily increased OxyContin’s price more than 95 percent, to $22 per pill for the drug’s highest dose, according to data firm Elsevier.

    Whether the drug’s anti-abuse features warrant those costs has been debated.

    The nonprofit group Institute for Clinical and Economic Review has found mixed evidence for OxyContin’s ability to fight abuse.

    Dr. Peter Lurie, a former FDA senior official, co-authored the 2017 paper that found OxyContin misuse was essentially unchanged among long-term users.

    Now president of the nonprofit Center for Science in the Public Interest, Lurie notes that OxyContin is by far the most prescribed and most studied abuse-deterrent opioid.

    “If we can’t prove it for OxyContin, how are we going to show it for anything else?” he asked.

    ___

    Follow Matthew Perrone on Twitter: @AP_FDAwriter

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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    https://www.washingtonpost.com/inves...=.01bd84268d7a

    Douglas S. Boothe was the leader of a little-known generic-drug maker seven years ago when federal agents approached his company with an urgent plea: Slash production of an addictive pain medication that was fueling a national crisis.

    Boothe “wasn’t interested” and rejected the Drug Enforcement Administration’s request that Actavis voluntarily cut its supply of oxycodone to U.S. pharmacies, according to exhibits unsealed recently in a landmark lawsuit that accuses drug companies of recklessly distributing billions of addictive pain pills despite glaring signs of abuse.

    Now, Boothe is among a crop of figures from the generic-drug industry — from high-ranking executives to salesmen to account managers — whose decisions during the height of the country’s opioid epidemic have been thrust into the national spotlight after the release of the documents.


    [Newly unsealed exhibits in opioid case reveal inner workings of the drug industry]

    Drugmaker Purdue Pharma and its owners, the Sackler family, have for years borne the brunt of public criticism for inventing and deceptively marketing one of the most well-known opioid painkillers, OxyContin, in the 1990s. But the records show that by 2006, as the death rate accelerated, a handful of obscure generic-drug manufacturers were selling the bulk of opioid pills flooding the country.

    The documents and a DEA database that tracks every opioid pill sold in the United States from 2006 through 2012 are being made public a year after The Washington Post and the owner of the Charleston Gazette-Mail in West Virginia began pushing for their release. The database provides a road map of accountability for these sales. It attributes the vast majority of the 76 billion opioid pills produced and shipped from 2006 through 2012 to three companies that are now controlled by large multinational drugmakers: SpecGx, a subsidiary of Ireland-based Mallinckrodt; Par Pharmaceutical, owned by Endo Pharmaceuticals, also in Ireland; and Actavis, part of Israel-based Teva Pharmaceutical Industries.

    The Post had made public a significant portion of a government database that records the flood of prescription opioid pain pills distributed across the U.S. VIEW GRAPHIC
    The Post had made public a significant portion of a government database that records the flood of prescription opioid pain pills distributed across the U.S.
    The records show how these and other generic-pain-pill makers rushed to gain market share as the nation’s deadliest drug epidemic spun out of control. The records also reveal that some of the manufacturers were warned by auditors or regulators that they were not meeting federal requirements for detecting suspicious orders.


    Boothe, Actavis’s chief executive in those years, denied culpability in a deposition unsealed Tuesday. Although federal law compels companies to monitor the pattern, frequency and amounts of drug orders, Boothe emphasized that Actavis could not control how its drugs were ultimately used.


    At Actavis, Douglas S. Boothe rejected the DEA’s request that the company voluntarily cut its supply of oxycodone to U.S. pharmacies, according to recently unsealed exhibits. (Impax Laboratories)
    “Once it goes outside of our chain of custody, we have no capability or responsibility or accountability,” Boothe said in the November deposition. “Once we ship a valid order to a wholesaler or ship a valid order to a distributor . . . our chain of custody is finished at that point.”

    Boothe has not responded to voice mails, text messages or calls in recent days, or to messages left with his assistant at an Illinois drug company, Akorn, where he is now chief executive. Teva, Mallinckrodt and Endo declined to comment for this story.


    In statements to The Post for its stories about the newly unsealed documents, the drug companies have issued multiple defenses of their actions during the crisis. They contend they were trying to sell legal painkillers to legitimate patients who had prescriptions. They also blamed the crisis on overprescribing by physicians and on corrupt doctors and pharmacists who worked in “pill mills” that handed out drugs with few questions asked.

    The companies further asserted that they should not be held responsible for the actions of those who abused the drugs and that the DEA had all the information it needed to block pills from reaching the black market.

    On the DEA’s radar
    By 2004, eight years after it had been introduced, OxyContin had mushroomed into the most frequently prescribed narcotic for moderate to severe pain in the United States. For Purdue, it had been an era of enormous profitability as the exclusive producer of the drug, which earned the company more than $1 billion a year.


    But in several court rulings, federal judges in New York and Washington that year invalidated a Purdue patent on OxyContin for misrepresenting to regulators how effective the drug was at lower doses. The decisions helped clear the way for generics manufacturers to compete for market share years earlier than they might have otherwise. Although Purdue would ultimately prevail on appeal, the dam had broken; generics began pouring into the market.

    Typically, generic-drug companies are able to produce less-expensive versions of a patented drug only long after its introduction, by which time its risks and benefits are well known. In the case of OxyContin, however, those risks were very much in dispute. In 2007, Purdue and several current and former executives pleaded guilty in federal court and agreed to pay a total of $635 million to settle charges they had fraudulently marketed OxyContin as a drug that was less addictive than other narcotics and that had few side effects.
    Part 1

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    https://www.washingtonpost.com/inves...=.01bd84268d7a

    Part 2

    Since the landmark fine for deceptive marketing, opioid manufacturers have faced few penalties. Mallinckrodt became the first in 2017, paying $35 million to settle DEA complaints it did not adequately work to detect suspicious opioid orders.


    Three years before Purdue’s settlement, the Food and Drug Administration approved the first generic versions of OxyContin, known as oxycodone hydrochloride. Among the early drugmakers to win approval for a generic was Amide Pharmaceutical, a privately held company in Little Falls, N.J., with 200 employees.

    With its approval in hand, and construction of a manufacturing plant underway to make billions of pills a year, Amide became the target of a buyout by what was then Actavis, a company based in Europe. Announcing the purchase in 2005, Actavis boasted that Amide would give the company an “important foothold in the US market . . . to generate significant opportunities to drive revenue growth.”

    Months later, Actavis bought a second New Jersey generics company and installed one of its executives, Boothe, as the head of the companies’ combined generics division.


    Actavis’s sales of the generic version of OxyContin and other drugs containing oxycodone grew from 559 million in 2006 to more than 1.1 billion in 2012, according to the DEA database. Its sales of hydrocodone, another opioid pain reliever, rose from 2.2 billion to nearly 3 billion.

    ‘We were addicted to their pill, but they were addicted to the money’
    A group of recovering addicts in Abingdon, Va., respond to The Post’s reporting on what company executives said in emails as the opioid crisis raged on. (Joyce Koh, Dalton Bennett/The Washington Post)

    Even as their sales of opioids surged, the generic drugmakers maintained a low profile.

    “We weren’t really a household name — none of us,” Nancy Baran, Actavis’s head of customer service in those years, said in a recent interview. “Generics are not advertised on TV. No one ever hears your name. I worked at the company for 10 years, and my friends would still ask, ‘Where?’ ”

    Inside the DEA’s headquarters near the Pentagon in Northern Virginia, however, Actavis and Mallinckrodt would eventually bubble up on the radar of agents frustrated with their inability to curb the steep increase in prescribed opioids.


    The DEA had tried going after unscrupulous doctors, but each case took months to stop a single bad actor. Agents had met with distributors, pressing them to cut off suspicious pharmacies, but the flow of drugs kept increasing.

    “We kept trying to work our way back up the chain, to the source,” Barbara J. Boockholdt, then the chief of the regulatory section for DEA’s Office of Diversion Control, said in an interview.

    In 2011, Boockholdt walked across the hallway at DEA headquarters to an office that handles the agency’s drug-ordering database — known as the Automation of Reports and Consolidated Orders System, or ARCOS — and asked for reports on the nation’s largest opioid manufacturers.

    [How has your community been affected by the opioid crisis?]

    “I was shocked; I couldn’t believe it, Mallinckrodt was the biggest, and then there was Actavis,” Boockholdt said. “Everyone had been talking about Purdue, but they weren’t even close.”


    Agents in Boockholdt’s office analyzed the supply chains, tracing oxycodone from Actavis’s plants in New Jersey to Walgreens and other pharmacies in Florida, some selling a million doses a year. They put together a presentation that ran more than 100 pages, a document that was made public on Tuesday. They put copies in three-ring binders and called in Actavis.

    On Sept. 12, 2012, executives from the company were led into a windowless conference room on the sixth floor of the DEA’s headquarters. There, one of Boockholdt’s deputies began by talking about how Florida was having, on average, 11 fatal overdoses a day.

    Then the lights were dimmed, and Boockholdt ticked through 60 charts and graphs showing that Actavis had sent nearly 240 million pills to Florida during the previous 30 months — more oxycodone than the manufacturer had sent to almost all other states combined.

    Actavis officials were taken aback, the court records show. Michael R. Clarke, the company’s vice president for ethics and compliance, testified in a deposition that it felt like DEA officials were treating Actavis like “street dealers.”

    Clarke had expected a more collegial approach like, “You know, that’s great, that’s fine, maybe you can do this better. We were looking for that sort of interchange, and it wasn’t that,” Clarke testified in December, according to the newly unsealed documents. “It was pretty clear that they believed that we were one of the manufacturers that led to whatever problem they identified related to diversion of opioids.”

    Boockholdt told Baran, Actavis’s head of customer service, that she needed to send people to South Florida to get to know the company’s customers — “the long lines at pain clinics, out-of-state license plates, questionable clients, security guard (s) in the parking lots and signs stating cash payments only.”

    The exchange is included in a 200-page internal memorandum, made public this past week, in which Boockholdt memorialized that Actavis had been put on notice to monitor its sales more closely.

    Baran assured the DEA that “to the best of its ability” Actavis would do so, the memo says.

    Baran told The Post this week, after her name surfaced in the documents, that she had not previously encountered the kinds of stories the DEA was describing. More typically, she dealt with “ people upset about labeling or packaging,” she said. “It was that kind of stuff.”

    In October, a month after the meeting in Virginia, the DEA came knocking at the company’s headquarters in Morristown, N.J., seeking dramatic action — a 30 to 40 percent voluntary reduction in the company’s production of oxycodone, Clarke testified. “It was us essentially reducing what we were making so that there would be less product out there, as opposed to DEA stepping up its enforcement efforts for, you know, that level of criminal activity,” Clarke said.

    He and another executive took the request to Boothe, a Princeton University and Wharton business school graduate who had been a vice president of Xerox before converting to a career in pharmaceuticals. Across the Atlantic, Actavis’s parent organization was in disarray, controlled by Deutsche Bank after its billionaire owner had defaulted on loans. Boothe held firm, Clarke testified.

    “You know, he wasn’t interested in voluntarily reducing our quota, particularly by 30 or 40 percent, without understanding that there was something else to be had,” Clarke said.

    Clarke declined to comment for this story.

    The giant
    Boockholdt and the DEA had already summoned executives of the largest oxycodone manufacturer — Mallinckrodt — to the agency’s headquarters for a similar warning a year earlier. The Aug. 23, 2011, meeting became known among federal agents as the “earthquake meeting,” occurring the day of a rare magnitude-5.8 temblor in the Washington region.

    DEA officials showed the company the hundreds of millions of doses of oxycodone Mallinckrodt was shipping to distributors and the number of arrests being made for oxycodone possession and sale in those areas, Boockholdt said.

    It wasn’t the first such indication of concern the company had received from the DEA.

    Four months earlier, in April 2011, a top company compliance officer had distributed a training document saying that a DEA representative in St. Louis had referred to the company in a conversation as “the kingpin within the drug cartel.”

    The document, labeled as a presentation for the “Executive Committee,” was emailed to the pharmaceutical giant’s vice president for global supply chain, according to the unsealed records.

    The database lists Mallinckrodt subsidiary SpecGx as the maker of just over 2 billion pills that were shipped to Florida. Nationwide, the company would produce 28.9 billion pills during the years covered by the database — more than 80 for each person in the country.

    [Five takeaways from the DEA’s pain pill database]

    After the meeting with DEA officials, Mallinckrodt briefly reduced shipments, Boockholdt told The Post. The company also notified more than 40 of its distributors that they would no longer receive rebates if they continued to supply specific pharmacies whose orders were deemed suspicious.

    But Mallinckrodt’s output of opioid pills soon ramped back up, Boockholdt said.

    At the time, Mallinckrodt was also failing to shore up its own system for tracking suspicious orders, according to recently released documents, which the company had fought to keep sealed.

    Karen Harper, a senior manager for controlled substance compliance, testified in a deposition that she told her superiors in 2008 that Mallinckrodt was not capable of detecting suspicious orders and that its systems needed to be upgraded. But company executives decided against hiring an outside vendor to help detect such orders, she said.

    In 2010, the company changed an algorithm for flagging “peculiar” orders — from those twice as large as the average from the previous year to those three times as large — because there were too many orders to review, Harper said.

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    By 2016, while the company was in then-confidential negotiations with the Justice Department for failing to report suspicious orders, Mallinckrodt consolidated its specialty generic business in a new subsidiary registered in Delaware, called SpecGx LLC — the entity credited in the DEA database with Mallinckrodt’s opioid sales.

    The next year, the company agreed to pay a $35 million penalty, acknowledging “certain aspects of Mallinckrodt’s system to monitor and detect suspicious orders did not meet the standards” set by the DEA.

    The company’s identity will soon change again. Mallinckrodt announced in April that it plans to change its name to Sonorant Therapeutics, spinning off ‘Mallinckrodt Inc.’ as a separate company for its generics business. It said in federal filings that liabilities arising from opioid litigation would “remain with Mallinckrodt Inc. or its subsidiaries following the separation.”

    The company’s outside spokesman, Daniel Yunger, said Mallinckrodt declined to comment for this story.

    Years of auditors’ concerns
    The other large manufacturer of generic opioids listed in the database, Par Pharmaceutical, did not even have a system to detect sales orders that had the hallmarks the government associated with drug diversion, according to an outside auditing firm whose reports were made public this past week.

    “There is no Suspicious Ordering Monitoring System in place,” the auditors wrote in May 2010, referring to a reporting mechanism required by the DEA.

    “A program must be instituted based on customers’ sales volumes, seasonal fluctuations, etc., with a firm statistical analysis as the basis for such a program,” wrote the auditors from the firm BuzzeoPDMA.

    Par did not act on that advice for years, records show. Instead, employees inside Par’s sales department were responsible for monitoring orders, according to company documents and an executive at Par’s current parent company, Endo Pharmaceuticals.

    Founded in 1978, Par quickly established itself in the generic drug industry. Soon after it went public in 1984, the company ran into legal troubles.

    In 1989, the company and two of its executives pleaded guilty to charges of bribing FDA officials in exchange for fast approvals for generic drugs. Two years later, the company pleaded guilty to 10 charges involving falsified applications for drug approvals and other infractions and agreed to pay $2.5 million in fines.

    Over the following decades, the New York-based company regained its footing. By 2006, Par had more than 700 employees and was describing itself as “the world’s sixth largest manufacturer and distributor of generic pharmaceuticals,” according to archived versions of its website.

    Its annual revenue had grown to more than $1 billion by 2012, documents show.

    As late as 2015, though, the outside auditors still had concerns about Par’s oversight of opioid sales. The auditor noted that federal regulators might take issue with the company’s method for vetting orders.

    “Par’s current SOM [Suspicious Ordering Monitoring] system as it currently operates may be difficult to explain and defend during a DEA review,” the auditor wrote.

    A lawyer in the case pressed Stephen C. Macrides, Endo’s senior vice president of global supply chain, on why Par notified the DEA of no suspicious orders between 2010 and 2015.

    “If an order was deemed suspicious, it would have been reported to the DEA,” Macrides said.

    He did not respond to messages seeking comment.

    By September 2015, Par’s market value had multiplied. It was acquired for $8 billion by Endo, an Irish company that also manufactured and distributed opioids.

    Steven Rich, Alice Crites and Julie Tate contributed to this report.
    https://www.washingtonpost.com/inves...=.01bd84268d7a


    Part 3

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    https://www.wrvo.org/post/opioid-cri...ctive-services

    Stacy Alvord, the director of Oswego County's Department of Social Services, says she's never seen anything quite like the opioid epidemic in her 40 years of work in child welfare.

    "In the last decade - five years, things have really gotten scarier as far as just how toxic these drugs are," Alvord said.

    On the front lines of this battle are the caseworkers at Child Protective Services, who Alvord says are seeing an increase in violence in the community.

    "Some of these drugs will make people psychotic and even have impacts for permanent brain impairment, so it gets very volatile at times in the field for them," Alvord said. "It’s very exhausting work and we're doing our best to provide whatever supports we can to our caseworkers."

    Alvord recently had to add funds to the overtime budget because of the increased workload that the opioid crisis and some office vacancies are having on her staff. From 2017 to 2018, the number petitions the Oswego County Department of Social Services filed increased 40 percent from 308 to 511. Many of those were requests to remove a child from a home where drugs were being used and place them with a relative or in foster care.

    "More than half of those petitions that we filed, families were in over their heads when it came to addiction," Alvord said.

    The situation is much the same in Onondaga County. According to James Czarniak, deputy commissioner of Child Welfare, reports of opioid use in the home and the resulting investigations and removals of children are all up over the last 5-7 years. That's starting to have a cumulative effect.

    "The more cases the court has to process, the longer everybody’s cases become because the court timeline just can’t catch up to the volume that’s going in there," Czarniak said.

    Even if Child Protective Services is able to remove the child from that home, the ultimate goal is to get them back by helping the parent recover from their disease. But Czarniak says the issue with opioids is that the treatment cycle takes longer than recovery from other drugs, adding to each caseworker's workload.

    "You can open up clinics, you can open up providers, but really helping get families to them and consistently staying with those services requires a lot of support and help and all the while, we have a child who's in foster care that needs a lot of attention because that's a very traumatic event for them as well," He said. "The struggle for child welfare is where does your caseworker put their time the most when you have those two major things - a child who needs to be looked after, cared for, kept in a setting that's least traumatic, and then work on a plan to get the parent what they need to be able to reunify and then if that doesn’t happen, having an alternative plan like a relative or somewhere safe and meet the aspirations we want for that child - to be happy, healthy, go to school? That's just a lot."

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    https://nanaimonewsnow.com/2019/05/3...-deaths-stats/

    VANCOUVER — Statistics Canada has released data showing life expectancy stopped increasing for the first time in four decades as young men and women died at higher rates, mostly due to opioid-related overdoses in British Columbia, followed by Alberta.

    The agency says life expectancy did not go up from 2016 to 2017 for either men or women after an upward trend from the mid-1990s to 2012, but overall gains then started to stall, even as older Canadians lived longer.

    It says the declines were most notable in British Columbia, where life expectancy fell in 2017 for the second year in a row, especially for young men between the ages of 20 and 44.



    StatsCan says that while older men are living longer from factors including improved cancer outcomes, drug-related deaths of young men almost completely offset those gains while a similar pattern emerged among young women, but to a lesser extent.

    The agency says death rates due to overdose were 2.1 times higher for men and 1.6 times higher for women in 2017 compared with 2015 but those are likely underestimates because the cause of death in some cases has not yet been determined due to ongoing investigations.

    Statistics Canada says 4,108 overdose deaths were recorded in Canada in 2017, and nearly 1,100 of those involved people between the ages of 30 and 39.

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    https://newrepublic.com/article/1545...orporate-greed


    “Just like Doritos keep eating. We’ll make more.”

    “It’s like people are addicted to these things or something. Oh, wait, people are...”

    These lines are from emails sent between opioid manufacturers and distributors, recently pried loose by attorneys general suing Big Pharma for its role in fueling a massive wave of overdose deaths. Similar to the damning internal memos revealing that Big Tobacco knew that cigarettes indeed caused cancer, these emails appear to show that Big Pharma knew that a significant share of their product was landing in the street, feeding addiction. And yet they kept shipping out obscene quantities to rural towns across America, creating even more demand.

    Nearly every step of the pharmaceutical supply chain is implicated in the soaring death rate. According to the Centers for Disease Control and Prevention, prescription opioids killed 218,000 people from 1999 to 2017. Many of the companies—from Johnson & Johnson to obscure distributors like Cardinal Health—are listed as defendants in hundreds of lawsuits filed by nearly every state in the country. The government thinks these corporations should pay up and treat the addiction their products caused. But the companies claim to have been acting legally and in compliance with federal regulators like the Drug Enforcement Administration (DEA). Was it all, technically, legal?


    What the opioid crisis illustrates is not that there are a few bad apples in the pharmaceutical industry, but that the country’s entire health care system is driven by profit at the expense of public health and safety. Drug manufacturers, pharmacy chains, drug distributors, and insurance companies got rich while people, especially people lower down the income ladder, suffered—and the DEA, through neglect or incompetence or a mix of both, watched it all happen.

    While there are significant similarities between Big Pharma and Big Tobacco, there is also a key difference that makes today’s story of corporate malfeasance even worse: namely, that the supply chain for tobacco is much simpler than opioids, which are, theoretically, tightly controlled substances that pass through a dizzying array of actors and regulators.


    First, a doctor must write a prescription, which must be filled at a pharmacy, and is likely paid for by an insurance company. Depending on the needs of their customers, pharmacies place orders for these drugs (customers, it turns out, need a lot of them). Shipping companies then go between the pharmacy and the drug manufacturers. Overseeing this entire system is the DEA, which sets the quota for how many opioids a company is allowed to manufacture, and tracks where those pills go.

    While politicians are making hay out of Big Pharma’s wanton greed and recklessness, far less attention has been paid to the DEA. Attorneys general suing Big Pharma recently unearthed a database that both the corporations and the government—each for their own self-interested reasons—fought to keep sealed, called the Automation of Reports and Consolidated Orders System (ARCOS). Mammoth in size and granular in detail, ARCOS tracks the shipments of every single controlled substance, from the company that manufactured it, to the company that shipped it, to the pharmacy that received it. It is the world atlas for how the opioid crisis began.

    All told, from 2006 to 2012, roughly 76 billion oxycodone and hydrocodone pills criss-crossed America, according to a Washington Post analysis. While many of these pills went to legitimate patients, millions more were showered on troubled communities with a voracious thirst for pain relief. While drug manufacturers produced more and more opioids (approved by the DEA), and distributors shipped those pills to pharmacies all over the country (tracked by the DEA), drug companies saw record profits—and America’s overdose death rate soared off the charts.


    “I think this [database] brings home what we all knew,” says Corey Davis, an attorney and public health expert at the Network for Public Health Law. “This wasn’t just incompetence on the part of the DEA and the Department of Justice, it was knowing and intentional failure to do what most people think is their jobs.”

    What is the DEA’s job, exactly? Its first task, and the one most associated with the agency, is the Sicario-esque disruption of illicit flows of drugs coming into the U.S. from abroad, like intercepting speedboats filled with cocaine. Its other major responsibility is controlling licit pharmaceuticals. “The whole goal of the prescription system is to make sure that patients are getting their medications, and that medications are not going to those who aren’t patients,” which is called “diversion,” says Bryce Pardo, a drug policy researcher at the RAND Corporation. “That’s the whole point of the system, which was invented a hundred years ago. Clearly, the system broke. The system failed.”

    Pardo points out, in the DEA’s defense, the story of a so-called DEA whistle-blower blaming a pharma-backed piece of legislation passed by Congress in 2016, which prevented agents from stopping suspicious shipments of opioids, and stunted investigations into the very corporations that are now being villainized and sued. Just as DEA agents were working their way up the pharmaceutical supply chain, much as they would in a case against any transnational crime organization, Congress hamstrung their enforcement efforts.

    Or so the story goes—but that’s not the whole of it. “These companies, often times acting legally, were asking for preclearance from the DEA to go about their business,” says Leo Beletsky, a professor of law and health sciences at Northeastern University (where I’m currently a journalism fellow). “Now, the DEA is saying their hands were tied when, in fact, their hands were not tied. They were completely asleep at the wheel. And by the time the DEA began constricting the [prescription] supply and targeting certain doctors and distributors, it was too late.”

    In drug policy scholarship, there is a concept called the “balloon hypothesis.” When one end of a balloon gets squeezed, the air inside, rather than disappearing, rushes to fill the other end of the balloon. The balloon hypothesis is used to describe, often critically, America’s drug enforcement strategy. If cocaine production in Colombia is stamped out, production will shift to, say, Peru. If the Dark Web’s Silk Road gets shut down, a new Dark Web market pops up. The air has to go somewhere.

    The balloon hypothesis also applies to the ever-shifting demand for drugs. “Over a period of 20 years, the DEA provided the green light to a 39-fold increase in the oxycodone quota and a 12-fold increase in the hydrocodone quota, even as our opioid epidemic unfolded,” Senator Dick Durbin wrote in a letter to the editor to The Washington Post.

    In other words, the prescription balloon expanded, under the DEA’s watch, big time. But starting in 2011, the prescription market finally began to shrink after Purdue Pharma reformulated its blockbuster drug OxyContin with so-called abuse deterrent technology, and pill mills serving the black market were shut down. The supply was squeezed. The air still had to go somewhere, and it rushed to deadlier opioids like heroin spiked with illicit fentanyl. With enforcement focused on prescription opioids, the overdose crisis got worse.

    Dan Ciccarone, a physician-researcher at the University of California, San Francisco who studies heroin use, says the crisis unfolded in three waves: Prescription painkillers gave way to old-fashioned heroin, which gave way to illicit fentanyl. “Big Pharma has egg on its face,” Ciccarone says. “It obviously could have played a more responsible role here. But at the same time, I don’t want the buck to stop there.”

    “The only solution to the puzzle is to focus on demand,” he adds. “And we’ve been avoiding this for years. We need to structurally reduce demand through a healthier society.”

    That means asking why 200 pills per person per year went to places like Mingo County, West Virginia. Mingo County, deep in coal country, ranks first out of 55 West Virginia counties for rates of obesity, binge drinking, and teen births. And West Virginia ranks first in the nation for poor health outcomes. In a town of 24,000 residents, 42 percent of the children live below the poverty line and 35 percent of adults over 25 did not graduate high school.

    The Big Pharma lawsuits and the ARCOS database show how these pills landed in Mingo County. But they do not answer why. To researchers like Ciccarone, it’s no mystery. “Disenfranchisement, loneliness, lack of purpose, multigenerational job loss, lack of hope, and the lack of future,” he said, listing off the “social determinants of health” that determine why some people get addicted and not others.

    Big Pharma did not create the demand for pain relief in Mingo County, but they were eager to supply it. The DEA did little to stop Big Pharma, but even a beefed-up enforcement strategy would probably have struggled to counteract the ravages—physical, emotional, existential—brought on by a deeply unequal society with a broken health care system.

    “There is a reason why drugs fall into fault zones in American society,” Ciccarone says. On the flip side, there’s a reason why Europe is not seeing epidemic levels of drug overdose deaths. “That’s because Europe has healthier societies, and more sane drug policies,” he adds.

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    https://patch.com/new-jersey/pointpl...an-idol-prison

    A decade ago, Antonella Barba sang three songs before she was eliminated from "American Idol." But even then, she still had dreams.

    Barba, 32, seemed on the verge of a successful singing career, even as she initially ran into some hot water when some provocative photos of her surfaced online.

    Barba released the single "Jersey Girl" and identified herself as a singer, violinist and pianist on her Instagram page and sang the National Anthem before a Los Angeles Dodgers baseball game. She sang with other "American Idol" alums on Jimmy Kimmel's TV show (see videos below).

    She got to meet and befriend famous people, having her picture taken with the likes of Al Pacino and Magic Johnson.

    "Told Magic in April when I sang at the game that I'd see him at the playoffs and now we're at the playoffs," she wrote in one Twitter post two years ago.

    Now, even as the Point Pleasant Boro resident still has an official website that says "Coming Soon," it appears that Barba's dreams have come and gone.

    Barba pleaded guilty on Tuesday to possessing with intent to distribute 400 grams or more of fentanyl, according to a U.S. Attorney's Office release.

    That's enough of the drug, many more times powerful than heroin, to kill 200,000 people.

    Barba faces a mandatory minimum sentence of 10 years in prison and a maximum sentence of life in prison when sentenced on November 21. Actual sentences for federal crimes are typically less than the maximum penalties (story continues below tweet)


    Megan Shinn 13News Now
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    #13NewsNow Former American Idol contestant, Antonella Barba, goes into the #Norfolk Federal Courthouse for her Plea Agreement Hearing.

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    According to court documents, Barba was parked in downtown Norfolk, Va. at approximately 11:05 p.m. in October 2018, when she was approached by law enforcement. A dog handler screened Barba's rental vehicle with a drug dog, which alerted on the vehicle, according to the release.

    The canine officer searched Barba's rental vehicle and discovered a closed shoebox in plain view on the front passenger floorboard. The officer opened the shoebox and discovered a plastic bag containing a large quantity of a white, rock-like substance, according to the release.

    Barba subsequently admitted she had landed at Washington-Dulles at 4 p.m. on a flight from Los Angeles and that she rented a car there and drove to Norfolk, according to the release.

    The substance seized from Barba's rental car was submitted to the U.S. Customs and Border Protection Savannah Laboratory for forensic analysis, and a forensic scientist determined the substance to be fentanyl – a Schedule II controlled substance – with a total weight of 830.9 grams.

    A federal district court judge will determine any sentence after taking into account the U.S. Sentencing Guidelines and other statutory factors.

    A year ago, Barba told a different story.

    Eric Korslund, a Virginia-based criminal defense attorney, once told Patch that Barba ran into trouble with police while she was on her cell phone sitting in the driver's seat of a rented vehicle in downtown Norfolk, Va.

    A police officer asked for her identification and soon let her go, but another police officer then pulled her over with a police dog and searched the vehicle, he said. He found drugs, Korslund said, but Barba denies knowing they were there.

    "She was very cooperative with police. She gave them full identification," Korslund said.

    As for her state-of-mind, Korslund said, "She's been doing very well considering the circumstances."

    Now, a decade after near-stardom, Barba has stopped denying.

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    https://www.washingtonpost.com/healt...=.be7317ba7a4d

    CLEVELAND — ARCOS was a secret database. The powerful interests who knew all about it — the drug industry and the federal government, specifically — wanted to maintain that secrecy.

    ARCOS, for Automation of Reports and Consolidated Orders System, was established by the Drug Enforcement Administration to track the manufacture and distribution of prescription drugs, including billions of opioid painkillers that have sparked a deadly epidemic.

    Now, crucial records from this database have been made public — only after a protracted legal battle in federal court. The journey of the ARCOS data into sunlight began with lawsuits by drug-ravaged communities, and took the final steps through legal action by The Washington Post and the Charleston Gazette-Mail of West Virginia.

    The Post’s legal team relied largely on a sole practitioner in suburban Akron, Ohio, Karen Lefton, who works out of a small third-floor office near Summit Mall. When someone calls the Lefton Group seeking an attorney, the person who answers the phone is Lefton.

    “The most powerful people in pharmaceutical America didn’t want it released, and a lot of the most powerful people in the Department of Justice didn’t want it released,” Lefton said of the ARCOS database. “Aside from that, it was a walk in the park.”


    Attorney Karen Lefton made the oral argument for The Washington Post to the U.S. Court of Appeals for the 6th Circuit, whose ruling led to the public release of data on opioid painkillers. (Dustin Franz for The Washington Post)
    She’s one lawyer of hundreds involved in a sprawling, costly, enormously complicated agglomeration of lawsuits filed against nearly two dozen big drug companies and now being litigated in federal court in Cleveland. The plaintiffs are approximately 2,000 cities, counties, Native American tribes and other local government entities. They accuse the drug manufacturers of understating the risks of the opioids, and accuse the distributors of failing to monitor suspiciously large orders.

    These consolidated lawsuits have parallels with the lawsuits against major tobacco companies two decades ago. Joe Rice, one of the lead attorneys for the plaintiffs in the opioids case, also led the tobacco litigation on behalf of dozens of state attorneys general. That case resulted in a landmark 1998 settlement in which the companies agreed to cease certain marketing practices and pay out more than $200 billion over the course of 25 years.


    This new case is bigger, Rice said.

    “I believe this is the most complex civil litigation case that our judicial system has dealt with, maybe ever,” Rice said.

    U.S. District Judge Dan Polster has urged the parties to settle. He has set a firm trial date of Oct. 21, with two Ohio counties, Cuyahoga and Summit, serving as the bellwether cases representing all the plaintiffs.

    Industry attorneys have denied wrongdoing by their clients, saying they were making and distributing legal drugs intended for patients in legitimate need of pain relief. The defendants also said the DEA had all the ARCOS data and could have intervened if it detected criminal activity. The drug companies contended that the ARCOS data should remain secret because its disclosure would result in commercial harm.
    Mark Cheffo, national counsel for Purdue Pharma, a defendant in the federal case, said Purdue wants to be part of a solution to the drug epidemic, but litigation is not the answer.

    “We are not going to solve this problem in the courthouse. We’re going to need to solve this with a much more holistic approach that involves a multidisciplinary effort to solve what is really an illegal heroin and fentanyl problem in America,” Cheffo said.


    [Distributors, pharmacies and manufacturers respond to previously unreleased DEA data about opioid sales]

    An attorney for the Justice Department told Polster in 2018 that the ARCOS database should remain largely confidential to protect trade secrets, the location of warehouses containing drugs, and ongoing and future criminal investigations.

    Last year, after protracted negotiations, Polster ordered the DEA to turn ARCOS data over to the plaintiffs as part of the pretrial discovery process — but under a “protective order” that prevented the data from being released to the public.

    In effect, the public, as represented by local governments, had community-specific information for the purposes of the lawsuits, but those governments could not share that information with the public via the news media.


    “It was a Solomon’s decision,” said Paul Farrell Jr., co-lead counsel for the plaintiffs. “You’re telling me that I can get the data and I can show it to the mayor, but the mayor can’t show it to the people he represents?”

    The Post, joined by HD Media, owners of the Gazette-Mail, fought to have the ARCOS information made public. The Gazette-Mail won a Pulitzer Prize for blockbuster stories by reporter Eric Eyre in 2016 that used ARCOS data — released by the West Virginia attorney general — to show that hundreds of millions of opioid pills had been shipped into the state. Two law professors at West Virginia University, Patrick McGinley and Suzanne Weise, have been representing HD Media.

    In such cases, The Post typically hires outside attorneys from prestigious law firms in the D.C. area or wherever a case is being tried. But many law firms were already representing clients in the massive litigation and were “conflicted out,” in legal parlance. For example, Williams & Connolly, a D.C. firm often hired by The Post, was representing one of the drug distributors and playing a leading role for the defendants.


    Firms in Cleveland and Cincinnati that had conflicts in the case passed along to The Post the name of Karen Lefton.

    Lefton, 62, began her career at the Akron Beacon Journal in 1980 as a cub reporter covering the northern suburbs. She decided she needed to understand the law better, so in her spare time she obtained a law degree from the University of Akron and then passed the bar, and eventually took a job as the newspaper’s general counsel.

    The newspaper business hit hard times, and the Beacon Journal was no exception. In 2008 she left the paper and joined a local firm, then set up her own practice.

    When she first got a call from The Post, Lefton said, “I thought it was your circulation department.”


    Karen Lefton talks with her team in their office in Fairlawn, Ohio, on July 29. (Dustin Franz for The Washington Post)
    Lefton recalls the first time she entered Polster’s courtroom. It was jammed with veteran, high-dollar lawyers from white-shoe law firms.

    “Plaintiffs were on the left, defendants on the right. Everyone knows one another. I was waiting for them to break out the keg,” she said.


    The media lawyers sought the ARCOS data, arguing that Polster erred in issuing an “overbroad, permanent, blanket protective order,” as Lefton put it in a recent interview. But last summer Polster ruled against the media, saying he had good cause for his protective order because the data was sensitive to distributors and pharmacies as confidential business information and sensitive to the DEA for law enforcement efforts.

    Polster declined to comment for this article, and his assistants said he is not giving interviews. A reporter visiting his 18th floor chambers was turned away.

    HD Media and The Post appealed Polster’s decision to the U.S. Court of Appeals for the 6th Circuit, based in Cincinnati.

    [The opioid files: Follow The Post’s investigation of the opioid epidemic]

    As the newspaper industry has contracted, it has been forced to be more selective in going to court to obtain public records. The power of the news media has been shaped not only by the First Amendment but by the resources to hire lawyers to challenge powerful interests — to fight all the way to the Supreme Court for the right to publish the Pentagon Papers, for instance.


    News organizations today are more likely to spend legal dollars on defensive actions rather than newsgathering lawsuits to access public records, said Katie Townsend, legal director at the Reporter’s Committee for Freedom of the Press, a Washington-based nonprofit.

    Part 1

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    The ARCOS appeal was not risk-free: An unfavorable decision could have made it more difficult for media lawyers to fight protective orders in the future. No one wants to pursue a case to the point that it creates “bad law.”

    The industry defendants argued that the news media didn’t need the raw data of ARCOS, because available aggregated data shows in general where pills were flowing.

    Lefton’s court filing took issue with that: “There is no validity to the Pharmaceutical Defendants’ claim that access to aggregated data is every bit as good as access to raw transactional data. If it were, then the news media would not be working so hard to get the transactional data and the DEA would not be working so hard to conceal it.”


    In Cincinnati, Lefton made the oral argument for The Post, and noticed at the end that the stone-faced judges did not offer any encouraging words, gestures or expressions, which she took as a good sign. It’s when they nod or smile that you know you’ve lost, she said.

    On June 20, a three-judge panel of the 6th Circuit issued a smashing victory for the news media. By a 2-1 vote, it ruled that Polster had exceeded his discretion in issuing the protective order sealing the ARCOS data. The appellate judges called Polster’s reasoning “bizarre” and said the judge abused his discretion by “acting irrationally.”

    The appellate judges noted that Polster had said that the ARCOS data would become public if the case went to trial. The judges wrote, “These statements suggest that at least part of the reason for the district court’s about face on what interests Defendants and the DEA have in nondisclosure of the ARCOS data might have been a desire to use the threat of publicly disclosing the data as a bargaining chip in settlement discussions. If this was a motivation for its holding, then the district court abused its discretion by considering an improper factor.”

    The appellate court ordered Polster to amend his protective order, a process that led not only to the release of ARCOS data from 2006 to 2012 but also the unsealing of numerous court filings.

    The ARCOS database is now available in a searchable format on The Washington Post’s website.

    Internal documents show what drug companies knew about the spread of opioids in America VIEW GRAPHIC
    The database has allowed the public to see the astonishing scale of the prescription opioid deluge. The industry shipped 76 billion oxycodone and hydrocodone pills over that seven-year period, with the numbers ratcheting upward in that time. Some small-town pharmacies handled upward of 5 million pills each.

    In a court filing this week, the DEA said it can’t confirm or deny that it is investigating any of the companies mentioned in a recent Post story about the ARCOS data, as that “would tip off any such companies who may be under investigation.” The filing continued: “The harm, however, has already been done. If any of the companies that DEA may be investigating did not already think they were under scrutiny, they will now suspect that they may be based on the news reports calling out their data.”

    McGinley, the West Virginia law professor representing the owner of the Charleston newspaper, said the DEA’s argument has no merit, because companies embroiled in the epidemic have long been aware that they are in the law enforcement spotlight.

    “Why do they want to keep this secret? Because it’s in*cred*ibly embarrassing,” McGinley said. “With regard to the DEA, it shows lapses in enforcement. With regard to the drug companies, it shows 76 billion pills flooded the country. It’s not rocket science why they wanted to keep it secret.”
    Part 2


    https://www.washingtonpost.com/healt...=.be7317ba7a4d

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    https://www.nbcnews.com/news/us-news...risis-n1035541

    As the nation grapples with an opioid crisis that kills more than 130 people every day, Colorado thinks a solution may lie in a joint, a vape pen or a topical.

    On Friday, it becomes the third state in the nation after New York and Illinois to allow doctors to recommend medical marijuana for any condition for which they would prescribe an opioid.

    In two other states, Pennsylvania and New Jersey, patients diagnosed with opioid use disorder may be advised to use medical marijuana instead of opioids.

    In most states where medical marijuana is legal, it can be accessed for general pain relief. But now in Colorado, post-operative patients or those struggling with acute pain from an injury can potentially use medical marijuana instead of opioids.

    “It was designed to give physicians a legal, open option to discuss [medical marijuana use] with patients,” said Colorado Rep. Edie Hooton, a Democrat, who co-sponsored the bill. “It normalizes the conversation around the issue.”

    Image: Marijuana smokers in ColoradoAn attendee of the Denver 420 Rally in 2016. Colorado becomes the third state in the nation to allow doctors to prescribe medical marijuana for pain instead of opioids. Proponents of the new law said the choice will help curb opioid dependence. Jason Connolly / AFP - Getty Images file
    Research does not yet categorically support the idea that medical cannabis can replace opioids or reduce opioid dependence or overdose.

    Last year, the Minnesota Department of Health released the results of its study of 2,245 patients taking medical marijuana for “intractable pain,” which is chronic. (The Colorado bill focuses on acute pain.) Of the 353 patients who self-reported that they were using opioids when they began consuming medical marijuana, 63 percent had reduced or eliminated their opioid use after six months.

    But another 2018 study published in the Journal of Addiction Medicine found the opposite — that medical marijuana users “were significantly more likely to report medical use of prescription drugs in the past 12 months.”

    “The science for this is really in its infancy, and policy is far outpacing what we know based on evidence,” said Ziva Cooper, research director at the University of California, Los Angeles, Cannabis Research Initiative. “We’re very far from coming up with a conclusive statement saying cannabis can be helpful as a substitute for opioids based on controlled studies.”

    Much of the excitement surrounding the potential for cannabis to reduce opioid-related deaths originated with a 2014 study published in JAMA Internal Medicine, which found that between 1999 and 2010, states with medical cannabis laws saw close to a 25 percent reduction in opioid overdose deaths.

    Those results were recently challenged when a new study expanded the original analysis through 2017 and found that states with medical cannabis laws had a nearly 23 percent increase in overdose deaths.

    “Cannabinoids have demonstrated therapeutic benefits, but reducing population-level opioid overdose mortality does not appear to be among them,” the authors concluded.

    One of the researchers went so far as to say, in a JAMA editorial published several months before the new study, “substituting cannabis for opioid addiction treatments is potentially harmful” and that the recommendation for substituting medical cannabis for opioids does not “meet the standards of rigor desirable for medical treatment decisions.”

    Yet state lawmakers said there’s enough promising evidence to support opening up a dialogue between physicians and patients about options when it comes to acute pain.

    “We want to give folks a legitimate alternative,” said Amanda Bent, former policy manager with the Colorado office of the Drug Policy Alliance, which supported Colorado’s legislation.

    Hooton said the bipartisan bill was never “about treating opioid addiction.” Yet others openly promoted it as a way to curb opioid use and overdose fatalities, which lines up with its portrayal in other states.

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    https://www.nytimes.com/2019/08/05/h...ettlement.html

    Over the last 18 months, progress toward a settlement in the massive federal opioid litigation has stalled, even as the costs of the crisis continue to mount.

    Now, an inventive plan to jump-start negotiations, recently put forth by lawyers for the nearly 2,000 cities and counties that have brought cases, is facing attacks from an unlikely source. Pushback that could torpedo it is coming less from the corporate defendants than from the localities? uneasy allies: the states.

    It is a struggle over power, politics and money. And in an arena filled with outsize egos, the fight is also very much about who will get to claim credit for resolving a public health crisis that has killed more than 200,000 people since 1999 and sunk many more into debilitating addiction.

    A hearing on the proposal is scheduled for Tuesday in Cleveland before the federal judge who is overseeing the cases, Dan A. Polster.



    The plan was devised to address a major sticking point: The defendants, including manufacturers that developed and made the drugs, Fortune 20 companies that distributed them and national pharmacy chains that sold them, want an end to the constant stream of lawsuits.

    So lawyers for the plaintiffs suggested allowing all 34,000 towns, cities and counties in the country to vote on settlement offers. After an offer is approved, they will be bound by the outcome and can bring no further suits. All voting communities affected by the crisis would get a portion of the payout.

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    But a letter signed by a bipartisan coalition of 39 state attorneys general raises arguments that could topple the ambitious proposal and further slow talks.

    Rather than myriad cities and counties, they contend, it is the states, through law enforcement and regulatory authority, that can efficiently wrest a high-impact national agreement. They maintain that this plan goes behind the backs of the states pursuing cases brought by their own attorneys general, who are elected or appointed. By contrast, local governments are using private lawyers, who work on contingency fees.

    The states also fear that the plan would corral money for the cities and counties that they should control. And because this ?negotiation class? is untested, they argue, it is likely to be appealed, delaying remedies for everyone.

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    ?In my view, it?s the plaintiffs? lawyers using local governments to hijack the sovereignty of the states and create ?city states,? ? said Dave Yost, the Ohio attorney general, who filed a letter critical of the plan. ?But this is not the United City-States of America.?

    The plaintiffs also intend their proposal to be a course correction to the Big Tobacco settlement, as well as a possible template for future resolutions in such public welfare areas as firearms, climate change and environmental pollution.

    The 1998 Master Tobacco Settlement, which resulted in payouts of some $250 billion, was struck between five cigarette manufacturers and 46 states seeking reimbursement for their Medicaid programs for treating tobacco-related illnesses. But much of the money went to discretionary funds of state legislatures. Especially in the wake of the 2008 financial crisis, hefty amounts were redirected to balancing budgets and fixing potholes, rather than to local prevention and treatment programs.

    Still bitter about those outcomes, communities whose coffers had been depleted by the opioid crisis decided to sign with private lawyers, circumventing the states.

    Since 2013, when Chicago filed its opioid lawsuit, platoons of these private lawyers have taken more than 500 depositions, filed thousands of motions, read through more than 50 million pages of documents and analyzed raw code from the Drug Enforcement Administration about pill distribution. At Judge Polster?s direction, they have shared their trove with the states.

    ?None of the attorneys general complained while we were doing all that,? said Paul Geller, an attorney whose opioid clients include Los Angeles. ?It kind of makes you wonder why seeking to organize for negotiation purposes all of a sudden crosses the line for them.?

    Strictly speaking, the states, whose cases are in state court, have no say in the federal litigation. While all are suing some manufacturers, fewer are going after the deep-pocketed distributors, and fewer still have named pharmacy chains. With the exception of some states, including Oklahoma, Massachusetts and New York, opioid litigation by many attorneys general lags behind the federal cases.

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    But mindful that the conclusion of federal and state cases likely depends on each other, Judge Polster has regularly solicited input from the attorneys general.

    So how do they really feel? The states bluntly say that the negotiation plan usurps a role that is properly theirs.

    Under the legal doctrine called ?parens patriae? ? parent of the nation ? states, in a wide swath of cases, often assume the role of vindicating the interests of vulnerable citizens.

    ?We have a vision of the state attorneys general as being preferable because they?re insulated from money,? said Adam Zimmerman, who teaches complex litigation at Loyola Law School, Los Angeles.

    ?But they?re not insulated from politics,? he added, noting that the position is often a steppingstone to higher political office.

    Mr. Yost, the Ohio attorney general, and others argue that these cases should be resolved from the top down, not the bottom up. But each state?s relationship with local government, enshrined in its constitution and laws, varies. Funding sources for the diverse costs of the opioid crisis, whether local or state, also differ from state to state.

    And so the states say they should disburse the money. The fly in that ointment is that many states preclude attorneys general from distributing settlement money, because their legislatures control such funds.

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    Rather than approving the plaintiffs? plan, Mr. Yost said, Judge Polster could ascertain each state?s relationship with its municipalities. He could then encourage those with similar laws and interests to negotiate in groups. That process, Mr. Yost predicted, would be more streamlined than this proposal.

    ?If I were a defendant, I?d be very wary of dealing with the cities and counties, knowing that the state attorneys general were still gunning for me,? said Elizabeth C. Burch, a law professor at the University of Georgia who closely follows the litigation. ?I?d be more inclined to do a global deal with them that pre-empts the city and county cases.?

    Mr. Yost said that if the states oversaw negotiations, private lawyers would still get paid ? any settlement would include a separate money bucket for them. ?But I think that?s a one-gallon bucket for washing the car and they think it should be an oil tanker.?

    There?s a love-hate relationship between the states and private lawyers, he said. While a government?s use of private lawyers dates to early English common law, the biggest boost to that practice came during the tobacco litigation itself, when state attorneys general, strapped for resources, turned to them.

    Some of those very same lawyers are now in the opioid litigation, working for cities and counties ? and, indeed, a handful of states. Mr. Geller?s opioid clients include Maryland?s Montgomery County in federal court and Maryland itself, in state court.

    While that dual representation may prompt skepticism, Mr. Geller said that it served the interests of time and coordination, because so much material overlaps.

    At the outset of the litigation, Judge Polster established two parallel tracks. One is to prepare for trial, the first of which is set for Oct. 21 in Cleveland.

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    The second is to pursue negotiation, to bring remedies as soon as possible. That track has sputtered along, mostly because the defendants have pointed fingers at each other, disputed liability and faulted the federal government?s role in overseeing the sale and distribution of drugs.

    The concept for this negotiation group was developed by several law professors, who now have roles in the opioid litigation, and refined by the plaintiffs? lawyers. (The group would not include other parties like tribes and third-party payers.)

    It uses an allocation map that shows each municipality what share to expect from a settlement, calculated with federal data about pill distribution, opioid-related overdoses and deaths.

    ?All the political entities have gotten notice about this plan,? said Samuel Issacharoff, a law professor at New York University who worked on the proposal, referring to the cities and counties, ?and it?s noteworthy that we?ve heard no substantial opposition to it.?

    If Judge Polster does certify the proposal, it is unclear whether the states or even the defendants can appeal.

    The manufacturers? motion says that they ?take no position on whether the court should grant plaintiffs? motion,? a possible indication of their willingness to negotiate.

    But the distributors are fighting hard. The plaintiffs responded by saying, essentially, that the plan is not about the distributors ? it is only about how to organize the plaintiffs. If the distributors do not like the plan, the plaintiffs? lawyers wrote, ?fine. Don?t negotiate with it. Don?t settle with it.?

    Nonetheless, added Mr. Geller, who represents Los Angeles, ?it?s time to try to land the plane.?

  21. #71
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    https://www.latimes.com/california/s...-opioid-crisis

    As the nation’s opioid crisis deepened over the last decade, drug makers and distributors worked to deflect attention from their own roles in creating widespread addiction, according to lawyers for hundreds of cities, counties, tribes and other entities suing key pharmaceutical industry players.

    One drug distributor highlighted the roles of “pill mills,” unethical doctors and pharmacies that dished up narcotic painkillers by the millions, court records state. Another focused on prescriptions acquired illegally from friends and relatives.

    But Purdue Pharma, the maker of the widely abused painkiller OxyContin, considered a different tack.

    Internal documents from 2016 show company officials discussed diverting online traffic away from a series of stories published by the Los Angeles Times that detailed the company’s marketing of OxyContin and its links to the deadly opioid crisis.



    World map made of OxyContin pills created on Dec. 16, 2016 using OxyContin 80 mg pills shot in the s


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    “If Purdue doesn’t fill this vacuum, someone else will — and it won’t be Purdue’s narrative,” a member of the company’s digital support team wrote in a memo to Purdue officials, laying out a strategy to drive traffic to a friendly website, PurduePharmaFacts.com.

    “By purchasing highly targeted strings of keywords that people are likely to use to find out more information about the articles, we can ensure that PurduePharmaFacts.com is at the top of a user’s search results,” a related PowerPoint presentation stated.

    “We’ve tailored the recommendation to capture only people searching for information related to the Times articles and to not interfere with Purdue’s marketing efforts surrounding OxyContin or spark curiosity where there was none before,” it said.




    It’s unclear if the strategy was carried out or, if it was, whether it was effective. PurduePharmaFacts.com does not appear to be a functioning website.

    The company issued a statement late Wednesday saying it created “a dedicated website with the relevant facts for the public to view.

    “This is a very standard practice used by companies and organizations to address inaccurate and unbalanced news coverage.”

    The documents describing Purdue’s strategy were filed earlier in the day in U.S. District Court in Cleveland by attorneys for Cuyahoga and Starke counties in Ohio. They are among more than 1,500 governments and other entities that have sued key players in the opioid epidemic to recover their costs for services and other damages stemming from the addiction crisis.

    The plaintiffs’ claims include that the drug industry contributed to the deadly opioid epidemic by deceptively marketing the highly addictive prescription painkillers.

    The first of the lawsuits is scheduled for trial later this year.

    “Throughout these public ‘messaging’ initiatives, the emphasis was on deflecting attention, blame or litigation away from the pharmaceutical industry for their role in recklessly distributing opioid products into the supply chain and ‘inoculating’ the industry from litigation — like this case,” lawyers for the Ohio counties wrote in Wednesday’s court filing.

    The Times’ 2016 investigative series showed how decisions by Purdue, a Connecticut corporation owned by the Sackler family, fueled the opioid epidemic. The newspaper found that OxyContin, the company’s best-selling product, wears off hours earlier than its advertised 12-hour duration in many patients, exposing them to increased risk of addiction. It also described how the company’s lawyers and security department gathered extensive evidence suggesting specific doctors and pharmacies across the nation were engaged in drug trafficking, but did not shut off the flow of OxyContin to them and, in many cases, did not share the information with law enforcement.






    Purdue, which by 2016 had collected more than $31 billion from OxyContin sales, disputed The Times’ findings.

    U.S. opioid overdose deaths rose from 8,048 in 1999 to 47,600 in 2017, according to the Centers for Disease Control and Prevention.

  22. #72
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    https://www.npr.org/sections/health-...tims-be-left-o


    Babies born to mothers who used opioids during pregnancy represent one of the most distressing legacies of an opioid epidemic that has claimed almost 400,000 lives and ravaged communities.

    In fact, many of the ongoing lawsuits filed against drug companies make reference to these babies, fighting through withdrawal in hospital nurseries.

    The cluster of symptoms they experience, which include tremors, seizures and respiratory distress, is known as neonatal abstinence syndrome. Until recently, doctors rarely looked for the condition. Then case numbers quadrupled over a decade. Hospital care for newborns with NAS has cost Medicaid billions of dollars.

    Studies indicate more than 30,000 babies with the condition are born every year in the U.S. — about one every 15 minutes. Although their plight is mentioned in opioid-related litigation, there are growing concerns that those same children will be left out of financial settlements being negotiated right now.

    Robbie Nicholson, a mother in Eagleville, Tenn., tried to comfort her second child while the baby slowly underwent withdrawal from drugs Nicholson had taken during pregnancy.

    "The whole experience is just traumatizing, really," Nicholson says.

    Nicholson's ordeal actually began right after her first pregnancy. To help with postpartum recovery, her doctor prescribed her a pile of Percocets. That was the norm.

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    "Back then, it was like I was on them for a full month. And then he was like, 'OK, you're done.' And I was like, 'Oh my God, I've got a newborn, first-time mom, no energy, no sleep, like that was getting me through,' " she says. "It just built and built and built off that."

    After developing a full-blown addiction to painkillers, Nicholson eventually found her way into recovery. In accordance with evidence-based guidelines, she took buprenorphine, a medication that helps keep her opioid cravings at bay. And then came another pregnancy.

    But buprenorphine — as well as methadone, another drug used in medication-assisted addiction treatment — is a special kind of opioid. Its use during pregnancy can still result in withdrawal symptoms for the newborn, although increasingly physicians have decided that the benefits of keeping a mother on the medication, to help her stay sober and stable during pregnancy, outweigh the risk of her giving birth to a baby with neonatal abstinence syndrome.

    Treatment protocols for NAS vary from hospital to hospital, but over time doctors and neonatal nurses have become better at diagnosing the condition and weaning newborns safely. Sometimes the mom and her baby can even stay together if the infant doesn't have to be sent to the neonatal intensive care unit.

    But not much is known about the long-term effects of NAS, and parents and medical professionals both worry about the future of children exposed in utero to opioids.

    "I wanted her to be perfect, and she is absolutely perfect," Nicholson says. "But in the back of my mind, it's always going to be there."

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    There are thousands of children like Nicholson's daughter entering the education system. Dr. Stephen Patrick, a neonatologist in Nashville, says schools and early childhood programs are on the front lines now.

    "You hear teachers talking about infants with a development delay," he says. "I just got an email this morning from somebody."

    Studies haven't proven a direct link between in utero exposure to opioids and behavior problems in kids. And it's challenging to untangle which problems might stem from the lingering effects of maternal drug use, as opposed to the impacts of growing up with a mother who struggles with addiction and perhaps unemployment and housing instability as well. But Patrick, who leads the Center for Child Health Policy at Vanderbilt University, says that is what his and others' ongoing research wants to find out.

    As states, cities, counties and even hospitals go after drug companies in court, Patrick fears these children will be left out. He points to public discussion of pending settlements and the settlement deals struck between pharmaceutical companies and the state of Oklahoma, which make little or no mention of children.

    Settlement funds could be used to monitor the health of children who had NAS, to pay for treatment of any developmental problems, and to help schools serving those children, Patrick explains.

    "We need to be in the mix right now, in schools, understanding how we can support teachers, how we can support students as they try to learn, even as we work out was there cause and effect of opioid use and developmental delays or issues in school," he says.

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    https://upnorthlive.com/news/local/m...state-declines

    MICHIGAN (WPBN/WGTU) -- The number of overdose deaths in the State of Michigan has decreased after several years of seeing an increase, according to the Michigan Department of Health and Human Services (MDHHS).

    The MDHHS said overall overdose deaths declined by 3.2 percent from 2017’s 2,686 tally – with the deaths down for the first time in six years.

    In 2018, there were 2,599 overdose deaths, 2,036 of which were opioid-related, said MDHHS.

    “This is a step in the right direction, however, there is much work to be done, particularly when it comes to disparities and access to treatment,” said Dr. Joneigh Khaldun, chief medical executive and chief deputy for health for MDHHS. “We have a plan in Michigan to cut opioid-related overdose deaths by half in five years and we will be using all available resources to make that goal a reality.”

    Health officials said the decline in opioid-related overdose deaths in 2018 was largely driven by decreases in the number of deaths due to poisoning be heroin and commonly prescribed natural and semisynthetic drugs such as oxycodone, hydrocodone, hydromorphone and oxymorphone.

    While overdose deaths involving opioids decline, drug poisoning deaths involving synthetic opioids such as fentanyl continue to climb, said the MDHHS.

    “With the devastation that the opioid epidemic inflicts on families and communities, the Michigan State Police is committed to doing all that we can to help,” said Col. Joe Gasper, director of the Michigan State Police. “Whether it be from a prevention standpoint with our Angel Program that assists those struggling with opioid use to find treatment or our efforts to arrest drug traffickers and interdict shipments of fentanyl coming into our state, we’re committed to working with our state and federal partners to combat this deadly epidemic.”

    MDHHS is firmly committed to ensuring equitable access to prevention, treatment, and harm reduction and taking targeted steps to address racial disparities:

    Overall overdose mortality rates among white residents decreased by 6.5 percent, while rates among black residents increased by 14.7 percent.
    Opioid overdose mortality rates among white residents decreased by 5.1 percent, while rates among black residents increased by 19.9 percent.
    Michigan residents of other races experienced a 9.1 percent decrease in overall overdose mortality and an 8.7 percent decrease in opioid overdose mortality.
    Gov. Gretchen Whitmer, MDHHS and other members of the Michigan Opioids Task Force recently announced a slate of steps the state is taking to combat the opioid epidemic.

    The state’s strategy addresses three key areas: preventing opioid misuse, ensuring individuals using opioids can access high-quality recovery treatment and reducing the harm caused by opioids to individuals and their communities.

    Efforts include:

    Launching a $1 million statewide anti-stigma campaign focused on changing the conversation about opioid use disorder treatment and encouraging Michiganders to seek treatment to help improve their lives and ultimately prevent overdoses.
    Releasing a toolkit for medical providers on safer opioid prescribing practices along with the University of Michigan Injury Prevention Center.
    Removing prior authorization requirements for specific medications used to treat these disorders, including buprenorphine, as of Monday, Dec. 2.
    Beginning Medication-Assisted Treatment programs in three state prisons with a goal of expanding treatment to all facilities by 2023.
    Expanding syringe service programs across the state to help reduce the amount of harm caused by opioid use disorder to individuals and their communities from 13 to 25 agencies.
    More information about opioids and the additional steps residents can take to protect themselves and loved ones can be found online.

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    https://www.usatoday.com/story/news/...ic/2620671001/

    BOSTON – Tufts University on Thursday announced the immediate removal of the Sackler name from all buildings and programs at its medical school, with leaders citing the family's role in the nation's opioid crisis.

    The decision is among the most dramatic rebukes leveled by a growing list of institutions that have cut ties with the Sackler family. The family owns Purdue Pharma, the maker of the addictive opioid painkiller OxyContin, and has donated millions to colleges, universities and museums.

    Tufts' financial ties date back to 1980 when the university’s graduate school of biomedical studies was founded with a Sackler gift. The family has given Tufts $15.1 million in philanthropic gifts since that time.

    Tufts President Anthony Monaco pointed to the "human toll of the opioid epidemic, in which members of the Sackler family and their company Purdue Pharma are associated." In a statement he said, "it is clear that continuing to display the Sackler name is inconsistent" with the university's values.

    The decision to strip the family's name "also acknowledges the countless individuals and families who have suffered so much loss, harm, and sorrow as a result of the opioid crisis," and, he said "acknowledges members of our own community who have struggled on a daily basis with the university’s very public association with the Sackler name.”

    Despite the move, Tufts does not plan to return the unspent portion of the family's donation. School officials say the money will be used on causes such as cancer and epilepsy research.

    The university, which is not accepting new Sackler donations, also plans an education exhibit inside the medical school to explain the Sackler family's involvement and teach lessons from the opioid epidemic.

    "We are not seeking to erase this chapter of Tufts’ history,” Monaco said.

    More:Prestigious universities around the world accepted more than $60M from OxyContin family

    The affected buildings and programs are: the Sackler School of Graduate Biomedical Sciences; the Arthur M. Sackler Center for Medical Education; the Sackler Laboratory for the Convergence of Biomedical, Physical and Engineering Sciences; the Sackler Families Fund for Collaborative Cancer Biology Research; and the Richard S. Sackler, M.D. Endowed Research Fund.

    As part of the announcement, Tufts revealed plans to establish a $3 million endowment to support education, research and civic engagement programs aimed at preventing and treating substance abuse and addiction.

    According to Tufts, the Sackler family's donations began with contributions 40 years ago from Arthur Sackler, who died in 1987, a decade before his company introduced OxyContin.

    Tufts' decision follows an internal investigation this year into the university's ties with Purdue Pharma and members of the Sackler family. The report was led by former U.S. Attorney for Massachusetts Donald Stern.

    Tuft launched the investigation after the state of Massachusetts, in a complaint filed against the drug company, accused it of trying to buy influence at the university in a push to expand the prescribing of the pill by physicians, The Boston Globe reported.

    More:OxyContin maker agrees to tentative opioids settlement but it falls short of national deal

    Tufts said the Stern report, released Thursday, found no wrongdoing by the university, or any breach of policy or arrangement in which the Sacklers agreed to fund a program in exchange for certain outcomes or curricula. But the report did conclude there was "an appearance of too close a relationship between Purdue, the Sacklers, and Tufts."

    "This donor relationship existed and continued in the face of growing evidence and concern about Purdue’s role in marketing opioids, without the necessary scrutiny and due diligence," the report said.

    Daniel Connolly, the Sackler family's attorney, in a statement said the family is "seeking to have this improper decision reversed" and is currently reviewing all available options.

    He called the Stern report's findings of no wrongdoing or threat to academic integrity "emblematic of so many of the negative stories surrounding Purdue and the family, that a careful look at the facts proves the allegations to be false and sensational."

    He said Tufts' decision was not based on findings in the report but rather "unproven allegations" about the Sackler family and Purdue.

    "There is something particularly disturbing and intellectually dishonest when juxtaposing the results of the Stern investigation with the decision to remove the name of a donor who made gifts in good faith starting almost 40 years ago."

    In response to Tufts' decision, Jillian Sackler, the widow of Arthur Sackler, said her late husband had "nothing to do with OxyContin," nor were any of his philanthropic gifts connected to opioids or deceptive medical marketing, "which he likewise had nothing to do with."

    "It deeply saddens me to witness Arthur being blamed for actions taken by his brothers and other OxySacklers.”

    The Associated Press reported last month prestigious universities worldwide accepted $60 million from the Sackler foundation over the past five years as the company fought lawsuits stemming from the opioid epidemic. Some of those lawsuits have come from states and local municipalities.

    Schools including Tufts and museums that benefited from Sackler donations have attracted protests in recent months calling for them to disassociate from the pharmaceutical dynasty.

    Tufts appears to be the first university to drop the Sackler name.

    The Metropolitan Museum of Art and the Guggenheim Museum no longer accept money from the Sackler family. Yale University also has agreed to stop accepting new Sackler gifts, but buildings and centers on campus – and at other institutions including Harvard, Columbia and Cornell universities – still carry the Sackler name.

    At Harvard University, the AP reported, activists have pressured the school to strip the Sackler name from a campus museum, but administrators have argued the money for the building was given before OxyContin was developed.

    Peter Dolan, chairman of the Tufts Board of Trustees, said the decision to remove the Sackler name was made after "long, difficult, and thoughtful deliberation."

    "This is a step the university has never taken before. We were compelled to take action by the extraordinary circumstances of this public health crisis and its impact on our mission," he said.

    "We are grateful for the students, faculty, and alumni we met with who made it clear that the Sackler name now runs counter to the mission of the medical school, has had a negative impact on their studies and professional careers, and contradicts the purpose for which the gifts were initially given: to advance public health and research."

    Contributing: Associated Press

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    https://www.cbsnews.com/news/home-de...opioid-crisis/

    Home Depot's CEO thinks millions of dollars in merchandise stolen from stores then stashed in private warehouses might be related to the nation's ongoing opioid crisis.


    CEO Craig Menear told Wall Street analysts that the increase in stolen goods stems partly from what he called "organized retail crime" that is on the rise in the U.S. "We have a hypothesis that this ties to the opioid crisis, but we're not positive about that," he said during a conference call on Wednesday. "But what we can tell you is that, working hand-in-hand with law enforcement, we are seeing significant busts that are happening."

    Menear didn't give an exact figure for the company's losses from theft. But he cited an incident earlier this year in which $16.5 million worth of goods were stolen from multiple retailers and stored in a warehouse. There was $1.4 million worth of Home Depot merchandise in the warehouse.

    "Where we work with law enforcement, we'll go into a warehouse facility that gets hit, and it is literally millions and millions of dollars of multiple retailers' goods in these facilities," Menear said.

    Home Depot has increased security at stores and pushed lawmakers to pass tougher legislation to prosecute people who shoplift, said Home Depot spokeswoman Margaret Smith. The retailer also works with law enforcement when they're investigating theft, including providing store surveillance footage to officers.

    The company has "initiated several pilots" to protect stores, some focused on the short-term goal of safeguarding high-priced items and other measures that are technology-based and would lower theft overall, Ann-Marie Campbell, a Home Depot executive vice president, said in the call.


    Between 2015 and 2018 alone, the opioid epidemic cost the U.S. economy $631 billion, according to the Society of Actuaries. But Menear's comments are a rare example of a well-known company connecting the crisis to hits in its own earnings.

    "[T]he most significant impact to our [operating] margin outlook is continued pressure from 'shrink,' primarily driven by product theft," Menear said, using a retail industry term for inventory losses.

    Loop Capital analyst Laura Champine, who follows Home Depot, said the CEO's comments are the first mention of opioid-related thefts hurting profits. Even more troubling, Champine said, was that company officials used phrases like "organized retail crime" and "working hand-in-hand with law enforcement."

    "That's a bunch of words they normally don't use in these calls," she said. "We're hearing about truck loads of product being stolen. If they can't get it under control, it will hurt their stock."


    Home Depot, which has about 400,000 employees, had sales of $108 billion in 2018, up 7.2% from 2017.

    The financial losses from store thefts are much larger than analysts anticipated, said Morningstar analyst Jaime Katz. Strategies that Home Depot will use to curb the problem likely won't show results until well into 2020, she said.

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