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Internal e-mails from drug manufacturers show indifference to an opioid epidemic




Demonstrators protest at Food and Drug Administration's pharmaceutical opioid guidelines at a rally outside Washington's Health and Human Services headquarters in April. (J. Scott Applewhite / AP)

In May 2008, when the opioid epidemic raged in America, a representative of the country's largest manufacturer of opioid pain pills sent an e-mail to a wholesaler's customer in Ohio.

Victor Borelli, a national account manager for Mallinckrodt, told Steve Cochrane, Vice President of Sales at KeySource Medical, to review his inventories and "[i] If you're low, order more. If you're okay, will you order anything else, Capesce? «

Then Borelli joked:» Destroy this email. , Is that really possible? Well. , , "

Borelli used to refer to the term" ship, ship, ship "to describe his work.

These e-mail excerpts are cited in a 144-page complaint along with thousands of pages of documents unsealed by a judge Order on Friday in a landmark case in Cleveland against many of the largest companies in the pharmaceutical industry. A database of the Drug Enforcement Administration, released earlier this week, found that the companies had flooded the country from 2006 to 2012 with 76 billion oxycodone and hydrocodone pills. Nearly 2,000 cities, counties and municipalities said companies knowingly flooded their communities with opioids, which caused an epidemic that has claimed more than 200,000 lives since 1996.

In the documents filed by the plaintiffs, some employees of drug companies are shown to be profit-driven and undeterred by the realization that their products cause havoc throughout the country. The defendant's response to the request is scheduled for 31 July.

In January 2009, Borelli informed Cochrane in another email that 1,200 bottles of oxycodone 30 mg tablets had been shipped.

. It's like people are dependent on these things or something else Oh, wait guys are … "

Borelli replied," Just like Doritos, go ahead, we'll do more.

Borelli and Cochrane could not be reached immediately for a statement on Friday night.

In a statement on Friday evening, a Mallinckrodt spokesman tried to distance the company from Borelli's e-mail: "This is an outrageous e-mail from a person who has not been employed by the company for many years, it is at odds with what Mallinckrodt stands for and what he has done to combat the abuse and misuse of opioids. "

The Law on Regulated Substances requires pharmaceutical companies to take diversionary measures and to design and operate systems to identify "suspicious orders" that are defined as "orders of abnormal size e, orders that differ significantly from a normal pattern and orders that are unusual in frequency. "Companies should report such orders to the DEA and not send them, unless they can determine that the drugs are unlikely to be sold to be diverted black market. The plaintiffs in the application claim that the companies ignored red flags and failed at all levels. 76 billion opioid pills: exposing an epidemic Cardinal Health, one of the nation's largest drug distributors, Kerry Clark, wrote in January 2008 in an e-mail to high-ranking cardinals that "results-oriented corporate culture" may have led to "ill-considered or shortsighted decisions" have.

Over the past 18 months, Cardinal has experienced "nearly $ 1 billion in fines, settlements and losses" as a result of several regulatory actions, including the suspension of licenses in some unprompted distribution centers Controls against opioid redirection.

On August 31, 2011, McKesson Corp.'s then Director of Regulatory Affairs, David B. Gustin, told his colleagues he was concerned about "the number of accounts we have between the amount of Oxy or Hydro, the they are allowed to buy, and the amount they really need, there are large gaps, "says the file in which Gustin's statements are quoted. "This increases the & # 39; opportunity & # 39; for distraction by exposing more product to the pipeline for introduction than can be used for legitimate purposes."

According to the registration, he had previously told his colleagues that they "need to get out." If you visit more customers and move away from our laptops or business, you pay the price. , , big time.

Another McKesson Director of Regulatory Affairs replied, "I'm overwhelmed. I feel like I'm going down a river without paddles and fighting the rapids. Sooner or later, hopefully later, I have the feeling that we are being burned by a customer who does not have enough due diligence. "

McKesson is the largest drug distributor in the US. According to the DEA database, 14.1 billion oxycodone and hydrocodone pills were sold between 2006 and 2012, representing a market share of 18 percent.

The Post had published a significant portion of a government database that records the flood of prescription opiate pain pills that were distributed in the US.

Until Friday, the documents had been sealed under US District Judge Dan Polster's protection order. The order was lifted one year after the release of The Charleston Gazette Mail by The Washington Post and HD Media in West Virginia. The company filed a lawsuit for access to the documents and a DEA database tracking opioid sales system or ARCOS.

The drug companies and the DEA strongly opposed the release of the data and documents, and Polster agreed with them. However, a panel of three judges from the US Court of Appeals for the 6th Circuit in Ohio ordered to publish some of the information in reasonable numbers and publish the database Cleveland provides for the first time specific information on how and in what amount the medication flowed throughout the country, from manufacturers and distributors to pharmacies. The case also sheds light on internal documents and considerations of companies seeking to promote their products and struggling with DEA's enforcement efforts and the most prominent companies – including Mallinckrodt, Cardinal Health, McKesson, Walgreens, CVS, Walmart and Purdue Pharma – represented a civil company that had devastating effects on the communities of the plaintiffs.

The case is a civil claim under the Law on Racketeer-influenced and Corrupt Organizations (RICO) that uses a law originally intended developed to combat organized crime.

In comments to the Post on Tuesday in response to the release of the DEA database, pharmaceutical companies announced a broad defense against their actions during the opioid epidemic. They have previously said that they are trying to sell legal painkillers to legitimate pain patients who had prescriptions. They attributed the epidemic to over-prescribing by doctors and also to corrupt doctors and pharmacists who worked in "pill-mills" distributing medicines with few questions. Companies also said they should not be held responsible for the actions of people who abused the drugs.

The companies said that they are diligently reporting their sales to the DEA and that the agency should have worked with them to do more Combating the epidemic, a point that former DEA agents are arguing about. The companies also note that DEA sets quota for opioid production.

"We are reporting these suspicious orders to the state pharmacy chambers and the DEA, but we do not know how these government agencies handle these reports, if any," Cardinal Health said in a statement.

The companies made statements The complainants reject the allegations.

McKesson said in his statement:

"The accusations of the plaintiffs are exactly that – allegations. They are unproven, untrue, and greatly simplify the evolution of this health crisis and the roles and responsibilities of many players in the pharmaceutical supply chain. "

Mallinckrodt said the company has been" a leader in prevention of drug diversion and abuse prescriptions for years and has invested millions of dollars in a comprehensive opioid abuse program.


Drug Enforcement Administration agents raided a pain management clinic in Delray Beach, Florida in February 2011. This week a DEA database released revealed that drug companies had flooded the nation from 2006 to 2012 with 76 billion oxycodone and hydrocodone pills. (Carline Jean / South Florida Sun-Sentinel / AP)

& # 39; Kingpin within the drug cartel & # 39;

One of the biggest issues The issue in the lawsuit is whether the country's largest pharmaceutical companies have done enough to identify suspicious opioid orders. What exactly is a suspicious arrangement is at the heart of the case.

The DEA has long said that there should be no confusion, as the agency has frequently given guidance and instructions to the industry and repeatedly defined what is a suspicious order. [19659003] The plaintiffs argue that the companies failed to "develop surveillance systems for serious suspicious orders that identify suspicious orders to the DEA" and still ship the medicines.

"Their lack of recognition of suspicious orders was their business model: they turned a blind eye to themselves and called themselves" deliverers "who were not responsible were what they delivered or to whom, "say the plaintiffs. Submission.

Between 1996 and 2018, the plaintiffs allegedly filed hundreds of millions of opioid pills in the county of Summit and Cuyahoga, Ohio, to fulfill orders that were suspicious and "should never have been shipped".

They did not make any effort to identify suspicious orders, neglecting to label assignments that accounted for a reasonable algorithm between one-quarter and ninety percent of their business, and maintained the drug flow in Summit and Cuyahoga Counties, "she said plaintiff. Lawyers wrote.

In 2007, DEA Mallinckrodt stated that the numerical formula used to monitor suspicious orders was inadequate. The company's suspicious order tracking program from 2008 to 2009 only verified that the customer had a valid DEA registration and that the order was correctly logged in the DEA tracking database.

From 2003 to 2011, Mallinckrodt shipped a total of 53 million orders, dismissing 37,817 as suspicious, but stopped only 33 orders, as the plaintiffs said.

An employee of Mallinckrodt reported in a statement that the DEA had described the company

In 2011, the file cited a document from the Ministry of Justice in which the DEA claimed that Mallinckrodt had "sold excessively" quantities of the Commonly abused forms of oxycodone, 30 mg and 15 mg tablets, which are placed in a stream of trade that would lead to a distraction. "

According to the DEA," although Mallinckrodt was aware of this because of the pattern of excessive sales of his oxycodone, which caused a massive distraction, these suspicious sales continued to be stimulated and supplied, "and the DEA was never over informed the suspicious orders.

In an agreement with the DEA, Mallinckrodt agreed that from 1 January 2008 to 1 January 2012 "certain aspects of the Mallinckrodt system for monitoring and detecting suspicious orders did not meet the standards" stated in letters from the deputy DEA administrators for redirection control.

Mallinckrodt was the country's leading producer of oxycodone and hydrocodone. According to the DEA database, there were 28.8 billion pills from 2006 to 2012, which corresponds to a market share of 37.7 percent. Since then, the company has established a subsidiary for its generic opioid called SpecGx.

The Post reported in 2017 that 500 million of the company's 30 mg oxycodone pills were wrapped in Florida between 2008 and 2012 – 66 percent of the total oxycodone sold in Florida was the state. Pills in this dosage are among the most commonly abused.

The prosecution said that the company failed to report suspicious orders, and Mallinckrodt fined the case this year with a fine of $ 35 million.

"Mallinckrodt's actions and omissions formed a link in the supply chain that resulted in millions of oxycodone pills being sold on the street," said then Attorney General Jeff Sessions.


McKesson Corp., the nation According to the newly released DEA database, the largest opioid distributor distributed 14.1 billion oxycodone and hydrocodone pills from 2006 to 2012, representing a market share of about 18 percent. (Kris Tripplaar / Sipa USA)

Business as usual

The same year that Mallinckrodt paid his fine, McKesson, the country's largest opiate trafficker, was fined $ 150 million by the Department of Justice ,

Due to allegations in the new court records, McKesson frequently increased the amount of opiate pills that were sent to his pharmacy customers.

"McKesson has a long tradition of absolute respect for retail customers with national accounts when it comes to [opioid] threshold increases," argue the plaintiffs in their application, citing a removal from McKesson's senior director of distribution operations.

McKesson According to the notifying party, the number of opioids that its customers could order has been limited, but these limits have often been abolished.

"In August 2014, the DOJ stated that McKesson was apparently prepared to approve threshold increases for opioids for flimsy reasons."

For deliveries to pharmacies in Summit and the Cuyahoga counties, McKesson did not report a single suspicious order between May 2008 and July 2013, it says in the file. During this time McKesson performed 366,000 opioid orders in these two districts.

McKesson reached an agreement with the government in January 2017 for failing to report suspicious orders. It was the second time that the company was fined for suspicious orders. Nine years earlier, she paid $ 13 million.

The government announced in 2017 that McKesson "has not developed and implemented an effective system for detecting and reporting suspicious orders". The company shipped more than 1.6 million orders of opioid pills in 2008 and 2013, but only 16 reported as suspicious, according to the Ministry of Justice.

However, before the ink of the settlement contract was even dry, McKesson already reassured customers who were worried that the flow of opioids would be restricted, that it would remain "business as usual" business. McKesson sent more than 68 million doses of oxycodone and hydrocodone to these districts between 2006 and 2012.

Gustin, McKesson's former director of regulatory affairs, was recently indicted in federal court in Kentucky on charges of illegal distribution of opioids. His lawyer wrote in a lawsuit that the allegations against his client stem from his work at McKesson and "seem to focus on the way he lived his former position as director of regulatory affairs."

Gustin's lawyer and the prosecutor in The Case did not raise any views for comment.

Order pickers and packers

The plaintiffs in the Cleveland case stated that CVS, the country's largest pharmacy chain, did not carry out any necessary controls to identify suspicious orders from 2006 until the beginning of mid-2009

The CVS Compliance Coordinator stated that her title was "for reference only, not as a real job, and that the only thing she has ever done in connection with monitoring suspicious orders was updating [Standard Operating Procedures Manual] was, "claim the plaintiffs. 19659003] According to the file, a system used by CVS to monitor suspicious orders was called a "picker and packer".

The pickers and packers were workers in the distribution centers picking and packing opioid orders. A CVS employee testified that the company had no written policies, guides, or training programs to teach pickers and packers to identify suspicious orders.

"Instead, the pickers and packers identified orders based on a gut feeling or a rough rule of thumb, which in essence could be summarized as saying that the order was just too big," reads the file. "One of the pickers and packers. , , testified that she was trained by another picker and packer in 1996, and that a picker and packer should normally ship no more than 12 of the small bottles, six of the larger bottles and two or three of the largest bottles. She has used this rule of thumb for her entire career. "

CVS system reports only a few orders, according to the results of the submission: A CVS distribution center in Indianapolis reported two orders per year from 2006 to 2014.

CVS rejected the plaintiffs' arguments.

"The plaintiffs' allegations about CVS in this matter have no justification and we are aggressively defending them," the company said in a statement.

"Obvious Signs of Distraction"

Walgreens used a formula for thousands of pharmacy orders being classified as suspicious but still shipped, the allegations said. The orders were reported to the DEA after dispatch according to the agency documents specified in the file.

"Suspicious orders are as uncovered to report and not in a collection of monthly transactions. "In 2012, DEA ordered an immediate suspension against Walgreens." Despite the extensive guidance available, Walgreens did not maintain an adequate system to report suspicious orders and as a result ignored easily identifiable orders and order patterns created on this basis. The information available throughout the Walgreens Corporation should have been a clear indication of distraction , "

In one case, Walgreens included a suspicious order message to the DEA's 1,712 pages and contained orders worth six months, including notifications of 836 pharmacies in more than a dozen states, and Puerto Rico claims that Walgreens stores" ad hoc "PDQ" could place ("damn fast") orders for controlled substances outside their normal order days and beyond the [suspicious order monitoring] analysis and limits. "

The Post previously reported that Kristine Atwell was distributing controlled substances for the company's warehouse Managed in Jupiter, Florida, sent an e-mail to corporate headquarters on January 10, 2011, asking some of the stores to justify their large volume of orders.

"I did a query to see how many bottles we have. We sent them to the 3836 store between 01.12.10 and 10.01.11 and shipped 3271 bottles," wrote Atwell. "I do not know how they can accommodate these many bottles [s] to be honest. How can we check the validity of these orders? "

A bottle shipped by a wholesaler generally contains 100 tablets.

Walgreens has never audited, according to the DEA. Between April 2010 and February 2012, the Jupiter distribution center shipped 13.7 million oxycodone doses to six stores in Florida.

Walgreens ranked second among distributors in the US with 13 billion tablets and 13 billion tablets, according to the DEA database. The DEA database shows that the market share for oxycodone and hydrocodone from 2006 to 2012 is 16.5 percent. It discontinued the distribution of opioids to its businesses in 2014, but continues to discard controlled substances.

As part of a settlement with the DEA in June 2013, Walgreens announced that its "suspicious order message for distribution to certain pharmacies did not meet the standards identified by the DEA. "The company paid the government a fine of $ 80 million.

In a statement to the Post earlier this week, Walgreens defended its business and said, "Walgreens has been an industry leader in tackling this crisis in the US communities where our pharmacists live and work.

Aaron C. Davis, Jenn Abelson, Amy Brittain, Robert O'Harrow Jr., Shawn Boburg, Jennifer Jenkins, Andrew Ba Tran, Aaron Williams and Katie Zezima all contributed to the report.


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