Demonstrators protest the policy of the Food and Drug Administration on Pharma Opioids at a rally at the headquarters of the Health and Social Services in Washington in April. In May 2008, when the opioid epidemic raged in America, a representative of the largest opioid painkiller producer sent an email to a customer of a wholesale drug distributor in Ohio.
Viktor Borrell, a national manager for Mallinckrodt, told Steve Corerein, KeySource Medical's vice president of sales, to check his inventory and "[i] if you are low, order more. If you're fine, order a little longer, Capesce? "
Then Borreli joked," destroy this email. Is this really possible? Oh, fine. ,
Before that, Borrell used the phrase "ship, ship, ship" to describe his work.
These snippets of emails are quoted in the applicants' 144 pages of papers, along with thousands of pages of papers printed by a judge Friday in a remarkable case in Cleveland against many of the largest drug companies. The Anti-Drug Agency database released earlier in the week revealed that companies have flooded the nation with 76 billion oxycodone and hydrocodone pills from 2006 to 2012. Nearly 2000 cities, counties and cities claim that companies have deliberately flooded their communities with opioids nurturing an epidemic that killed more than 200,000 since 1996.
The applicants' file describes some profit-driven pharmaceutical companies and intact knowledge that their products cause chaos all over country. The defendants' response to the proposal is July 31st.
In January 2009, Borrell told Cocreen in another email that 1200 bottles of 30 mg oxycodone tablets had been delivered. "He left there. As if people are addicted to these things or something. Oh, wait, people are. ,
Borreli replied, "Just as Dorito continues to eat.
Borelli and Cochrane did not return calls for comment on Friday night.
In a statement on Friday night, a spokesman for Mallinckrodt tried to distinguish the company from Borelli's email: "This is a shameless brazen email from an individual who has not been hired by the company for many years, this is the opposite of everything , which Mallinckrodt struggles and has done to combat the abuse and abuse of opiates. "
The Controlled Substance Act requires drug companies to control diversion and design and manage systems to identify" suspicious orders "defined as Abnormal orders, orders that differ significantly from the normal model and abnormal orders. "Undertakings must report such orders to the DEA and refrain from transporting them unless they can identify the drugs that are unlikely to In the complaint the plaintiffs claim that the companies have ignored the red flags and failed at every level
76 billion opioid pills: An epidemic revealed
The largest drug distributors, then ments CEO Kerry Clark in January 2008, wrote in an email to senior cardinal that "culture, results-oriented" is probably "lead to ill-advised or short-term solutions." the past 18 months, the Cardinal was hit by nearly $ 1 billion in "fines, settlements, and lost deals as a result of multiple regulatory actions," the complainant argued, including stopping licenses at some of his distribution centers because they did not support
Cardinal Health does not immediately return a request for a comment Friday night.
On 31 August 2011, the then director of McKesson Corp. for regulatory issues, David B. Gus Tin said to his colleagues he was concerned about the "number of bills we have that have large differences between the amount of Oxy or Hydro that they are allowed to buy (their threshold) and the amount of which they really need, "according to the filing, quotes Gustin's statements. "This increases the" possibility "of diversion by exposing more products to the pipeline than can be used for legitimate purposes."
According to the filing, he earlier remarked to his colleagues that "we need to get a visit to more customers and away from our laptops or the company will pay the price.,, Long Time."
Another McKesson director on the questions to the regulator answered: "I'm overloaded, I feel like I'm down on a river without a paddle and I'm struggling with the rapids, sooner or later, I hope that later I will feel that we will be burned by a client who has not received enough "McCesson is the largest drug distributor in the United States According to the DEA data, the DEA database has distributed 14.1 billion pills with oxycodone and hydrocodone from 2006 to 2012, which is about 18% of the market
The post publishes a significant portion of the government database that records the flood of prescription pain tablets distributed to the United States
McKesson did not immediately return a call for comment Friday night.
By Friday, the papers were sealed with a defense order issued by US District Judge Dan Polson. The order was canceled one year after The Washington Post and HD Media, which are publishing Charleston Gazette-Mail in West Virginia, filed a case for access to DEA documents and databases tracking sales of opiates known as Automation of Reports and Consolidated Orders . System or ARCOS.
Pharmaceutical companies and DEA stubbornly opposed the publication of the data and documents, and Pössner agreed with them. But the three-member panel of the US Court of Appeals in Ohio County 6 ordered some of the information to be published with reasonable edits and the database be made public.
By consolidating cases across the country, the Cleveland Case for the first time provides specific information on how and to what extent the drugs ran across the country, from manufacturers and distributors to pharmacies. The case also reveals internal documents and discussions from companies as they seek to promote their products and fight DEA's enforcement efforts.
Local and public claimants claim that the actions of some of the largest US companies and the most famous companies – including Mallinckrodt, Cardinal Health, McKesson, Walgreens, CVS, Walmart and Purdue Pharma – are a civilian racketeer, which has a devastating effect on the applicants' communities. The case is a civil action under the Law of Infighting and Corrupt Rage Organizations, using an initially developed law on the attack on organized crime.
In The Post's statements on Tuesday in response to the release of the DEA database, pharmaceutical companies issued broad protections of their actions during the opioid epidemic. Earlier, they said they were trying to sell legal painkillers to legitimate pain patients who had prescriptions. They accused the epidemic of over-prescription by doctors, as well as corrupt doctors and pharmacists who worked in "pill mills" who gave drugs to a few questions. Companies also said they should not be held accountable for the actions of people who have abused drugs.
Companies said they were keen to report their sales to DEA and that the agency should work with them to do more to fight the epidemic, a former DEA agent. Companies also note that DEA sets quotas for opiate production. "We report these suspicious orders to the State Pharmacy Committees and the DEA, but we do not know what these government bodies are doing with these reports, if any," said Cardinal Health.
McKesson said in his statement: "The allegations made by the plaintiffs are just that – allegations. They are unproven, untrue and very simplified the evolution of this health crisis as well as the role and responsibilities of many actors in the pharmaceutical supply chain. "
Mallinckrodt said the company" has been leading the recipe for years. abduction and drug abuse, and has invested millions of dollars in a multi-profile anti-abuse program. "
The Anti-Drugs Agency attacked a pain clinic in Delray Beach, Florida in February 2011, revealed that pharmaceutical companies have flooded the nation with 76 billion oxycodone and hydrocodone pills from 2006 to 2012 (Carline Jean / South Florida's Sun-Sentinel / AP]
"Kingpin within a drug cartel"
One of the biggest points The dispute in the case is whether the largest pharmaceutical companies in the country have done enough to identify suspicious orders for opiates. What exactly is a suspicious order is at the root of the case.
DEA has long said that there should be no confusion because the agency has often given instructions and industry briefings and has repeatedly determined what a suspicious order is. 19659003] The complainants argue that companies have failed to "design robust suspicious order monitoring systems that could identify suspicious orders for DEA" and have ever transported drugs.
"Their inability to identify suspicious orders is their business model: they closed their eyes and were simply" suppliers "without any responsibility for what they delivered or to whom, according to the applicants, filing the application. Between 1996 and 2018, the applicants claimed that when filing the applications, the pharmaceutical companies sent hundreds of millions of opiate pills to the top and Quychhoga counties in Ohio, following orders that were suspicious and "never to be carried "They did not make any effort to identify suspicious orders, failed to signal orders that, by any reasonable algorithm, represented between a quarter and 90 percent of their business, and kept the flow of drugs coming from the Samit and K counties "The complainants" In 2007, DEA told Mallinckrodt that the digital formula used to track suspicious orders was inadequate, the submission of applications was too low. He argues that the suspicious order monitoring program of the company from 2008 to 2009 consisted only in the fact that the customer had a valid DEA registration and that the order had entered the DEA tracking database.
From 2003 to 2011 Mallinckrodt sent a total of 53 million orders, placing 37,817 as suspicious, but stopped only 33 orders, the plaintiffs said.
A Mallinckrodt employee said DEA described the company as a "king in the framework of a drug cartel" during a meeting with the agency in July 2010, according to a footnote in the application.
In 2011, the filing cites a document from the Ministry of Justice, in which DEA claims Mallinckrodt has sold excessive quantities of the most abused forms of oxycodone, tablets of 30 mg and 15 mg, which place them in commercial a stream that would lead to diversion. "
According to the DEA, the filing statement states that" although Mallinckrodt knew about the Overdose Oxycodone Model Fed by Mass Diversion, it continued to stimulate and deliver these suspicious sales, "and never informed DEA about suspicious orders.
In agreement with DEA, Mallinckrodt agreed that from January 1, 2008 to January 1, 2012, "Some aspects of the Mallinckrodt system for surveillance and suspicious procurement do not meet the standards," set out in letters from a deputy DEA administrator for diversion control.
Mallinckrodt is a leading manufacturer in the country of oxycodone and hydrocodone, with 28.8 billion pills from 2006 to 2012, 37.7% of the market, according to the DEA database. Since then, has established a subsidiary for its generic opiates, called SpecGx.
The Post reported in 2017 that federal prosecutors said 500 million tablets of the 30 mg oxycodone company died in Florida between 2008 and 2012 – 66% of all oxycodone sold in the state. Tablets at this dose are among the most widely abused.
Prosecutors said the company did not report suspicious orders, and Mallinckrodt settled the case by paying a $ 35 million fine. "The actions and omissions of Mallinckrodt form a link in the supply chain that has led to the sale of millions of oxycodone pills to the street," then Chief Prosecutor Jeff Sainsons said.
McKesson Corp. The largest opioid distributor to release 14.1 billion oxycodone and hydrocodone tablets from 2006 to 2012, about 18% of the market, according to the new DEA database.
That same year, when Mallinckrodt paid a fine, McKesson, the country's largest drug distributor, was fined a record $ 150 million by the Ministry of Justice.
With regard to allegations in new court judgments, McKesson often increases the amount of opioid pills sent to pharmacy customers.
McKesson has a long history of absolute respect for customers of national retail accounts when it comes to raising the threshold [opioid]"the plaintiffs claim when filing them, citing McKesson's senior distribution manager .
McKesson has set limits on the amount of opioids customers can order, claims are claimed, but these restrictions have often been removed.
"In August 2014, the DOJ noted that McKesson appeared ready to approve opioid thresholds for the most uncontested reasons," the complainant said. a suspicious order between May 2008 and July 2013, the documentation says. Meanwhile, McCascon filled 366,000 opiate orders in these two counties.
McCasnon reached his agreement with the government in January 2017 on charges of not reporting suspicious orders. This was the second time the company was fined for suspicious orders. Nine years earlier he paid $ 13 million.
The government stated in 2017 that McKesson "failed to develop and deploy an effective system for detecting and reporting" suspicious orders ". 2008 and 2013, but reported only 16 as suspicious, according to the Ministry of Justice.
However, "before the inking agreement agreement was even dry," McKesson said, reassuring customers who were concerned that the flow of opiates would be cut short that it would remain "commonplace for business" company. McKesson has sent more than 68 million doses of oxycodone and hydrocodone in these counties between 2006 and 2012, according to DEA data analyzed by The Post.
Gustin, former McKesson's director of regulatory affairs, was recently charged with a federal court in Kentucky for allegedly illicit proliferation of opiates. His lawyer wrote in a lawsuit that claims against his client stemmed from his work at McKesson and "appear to be focusing on how he served his former post as director of regulatory affairs."
Gustin & the prosecutor's case does not return calls for comment.
Northwest Norton, with a population of about 4,000, saw millions of prescription opiates for seven years, with the city's CVS pharmacy receiving 1.3 million opioids from 2006 to 2012, according to the DEA database. (19659020) Collectors and Packers
The plaintiffs in Cleveland's case claim that CVS, the country's largest pharmacy chain, has not put in place the necessary controls to identify suspicious orders from 2006 to Beginning in the middle of 2009
CVS Coordinator says CV's headline "is for reference only, not for a real job, and that the only thing she did about monitoring suspicious orders is to updated [Standard Operating Procedures Manual]"the plaintiffs claim. 19659003] A system used by CVS to monitor suspicious orders was known as "Gatherers and Packers", according to the submission. Bakeries and packers were workers in the distribution centers that chose and packaged opioid orders. A CVS official testifies that the company does not have any written policies, guidelines or training programs to teach collectors and packers how to find suspicious orders, according to the submission. "Instead, Collectors and packers would identify orders based on sensitivity or rough rule, which in essence can be summed up that they believed the order was just too great," the filing said. "One of the collectors and packers. , , свидетелства, че е била обучена от друг Picker and Packer през 1996 г. и че по правило Picker и Packer не трябва да изпращат повече от 12 малки бутилки, шест от по-големите бутилки и две или три от най-големите бутилки. Тя използва това правило за цялата си кариера. ”
Системата на CVS е маркирала няколко поръчки, подаването твърди: Център за дистрибуция на CVS в Индианаполис е маркирал две поръчки годишно от 2006 до 2014 г.
CVS отхвърли аргументите на ищците
"Твърденията на ищците за CVS по този въпрос не са основателни и ние агресивно се защитаваме срещу тях", се казва в изявлението на компанията.
"Явни признаци на отклонение"
Walgreens използва формула идентифицират хиляди аптечни заповеди като подозрителни, но въпреки това ги изпращат. Нарежданията са докладвани на DEA след като са били изпратени, съгласно документи на агенцията, цитирани в подаването.
„Подозрителните поръчки трябва да бъдат докладвани както са открити а не в сбор от месечни приключени сделки, „DEA написа в заповед за незабавно спиране, издадена срещу Walgreens през 2012 г.“ Независимо от наличните достатъчно указания, Walgreens не успя да поддържа адекватна система за докладване на подозрителни поръчки и като резултат игнорира лесно разпознаваеми поръчки и модели на поръчки, които въз основа на информацията, която е налична в цялата корпорация Walgreens, трябва да е била очевиден знак за отклонение. ”
В един случай докладът на Walgreens за подозрителна поръчка към DEA е бил дълъг 1,712 страници и съдържа шестмесечни поръчки, включително доклади за 836 аптеки в повече от дузина щати и Пуерто Рико, подаването твърди.
Подаването също така твърди, че магазините на Walgreens могат да „поставят ad hoc„ PDQ “( "Доста дяволски бързи") поръчки за контролирани вещества извън обичайните им дни на поръчка и извън анализа и ограниченията .
The Post по-рано съобщава, че Кристин Атуел, която управлява дистрибуцията на контролирани вещества за склада на компанията в Юпитер, Флорида, изпрати електронно писмо на 10 януари 2011 г. в централата на фирмата, призовавайки някои от магазините да бъдат задължени да оправдаят голямото си количество поръчки. изпратени до магазина # 3836 и ние ги изпратихме 3271 бутилки между 12/1/10 и 1/10/11, ”пише Атуел. "Не знам как те дори могат да поставят тази много бутилка [s]за да бъда честен. Как да проверим валидността на тези заповеди? ”
Бутилка, изпратена от търговец на едро, обикновено съдържа 100 хапчета. Между април 2010 г. и февруари 2012 г. разпределителният център на Юпитер е изпратил 13,7 милиона оксикодонови дози до шест магазина във Флорида, показват записи, многократно по-високи от нормата, съобщи ДЕА. 16,5% от пазара на оксикодон и хидрокодон от 2006 до 2012 г., показва базата данни на DEA. Тя спря разпространението на опиати в магазините си през 2014 г., но продължава да разпределя контролирани вещества.
Като част от споразумение с DEA през юни 2013 г., Walgreens заяви, че нейното „докладване за подозрителни поръчки за разпространение в някои аптеки не отговаря на стандартите Компанията е платила на правителството глоба в размер на 80 милиона долара.
В изявление пред The Post по-рано през седмицата, Walgreens защитава операциите си, като казва: „Walgreens е лидер в борбата с тази криза в общности, където живеят и работят нашите фармацевти. ”
Аарон К. Дейвис, Джен Абелсън, Ейми Брийт, Робърт О'Хароу младши, Шон Бобург, Дженифър Дженкинс, Андрю Ба Тран, Аарон Уилямс и Кейти Зезима допринесоха за този доклад.
Една отдалечена долина във Вирджиния е била наводнена от предписани опиоиди
Слушайте публикации: Как постът е получил достъп до базата данни DEA