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'Ship, Ship, Ship': Drug Firms' Emails Show Indifference to Crisis
Written by <a href="index.php?option=com_comprofiler&task=userProfile&user=51207"><span class="small">Scott Higham, Sari Horwitz and Steven Rich, The Washington Post</span></a>   
Sunday, 21 July 2019 13:37

Excerpt: "In May 2008, as the opioid epidemic was raging in America, a representative of the nation's largest manufacturer of opioid pain pills sent an email to a client at a wholesale drug distributor in Ohio."

Demonstrators protest the Food and Drug Administration's policies related to pharmaceutical opioids at a rally in front of the Health and Human Services headquarters in Washington in April. (photo: Scott Applewhite/AP)
Demonstrators protest the Food and Drug Administration's policies related to pharmaceutical opioids at a rally in front of the Health and Human Services headquarters in Washington in April. (photo: Scott Applewhite/AP)


'Ship, Ship, Ship': Drug Firms' Emails Show Indifference to Crisis

By Scott Higham, Sari Horwitz and Steven Rich, The Washington Post

21 July 19

 

n May 2008, as the opioid epidemic was raging in America, a representative of the nation’s largest manufacturer of opioid pain pills sent an email to a client at a wholesale drug distributor in Ohio.

Victor Borelli, a national account manager for Mallinckrodt, told Steve Cochrane, the vice president of sales for KeySource Medical, to check his inventories and “[i]f you are low, order more. If you are okay, order a little more, Capesce?”

Then Borelli joked, “destroy this email. . .Is that really possible? Oh Well. . .”

Previously, Borelli used the phrase “ship, ship, ship” to describe his job.

Those email excerpts are quoted in a 144-page plaintiffs’ filing along with thousands of pages of documents unsealed by a judge’s order Friday in a landmark case in Cleveland against many of the largest companies in the drug industry. A Drug Enforcement Administration database released earlier in the week revealed that the companies had inundated the nation with 76 billion oxycodone and hydrocodone pills from 2006 through 2012. Nearly 2,000 cities, counties and towns are alleging that the companies knowingly flooded their communities with opioids, fueling an epidemic that has killed more than 200,000 since 1996.

The filing by plaintiffs depict some drug company employees as driven by profits and undeterred by the knowledge that their products were wreaking havoc across the country. The defendants’ response to the motion is due July 31.

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

“Keep ’em comin’!” Cochrane responded. “Flyin’ out of there. It’s like people are addicted to these things or something. Oh, wait, people are. . .”

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

Borelli and Cochrane did not return calls for comment Friday night.

In a statement Friday night, a spokesman for Mallinckrodt sought to distance the company from Borelli’s email: “This is an outrageously callous email from an individual who has not been employed by the company for many years. It is antithetical to everything that Mallinckrodt stands for and has done to combat opioid abuse and misuse.”

An attorney for KeySource Medical on Saturday declined to comment, citing ongoing litigation.

The Controlled Substances Act requires drug companies to control against diversion, and to design and operate systems to identify “suspicious orders,” defined as “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” The companies are supposed to report such orders to the DEA and refrain from shipping them unless they can determine the drugs are unlikely to be diverted to the black market. The plaintiffs, in the filing, allege that the companies ignored red flags and failed at every level.

At Cardinal Health, one of the nation’s largest drug distributors, then-CEO Kerry Clark in January 2008 wrote in an email to Cardinal senior officials that the company’s “results-oriented culture” was perhaps “leading to ill-advised or shortsighted decisions,” the filing contends.

In the previous 18 months, Cardinal had been hit with nearly $1 billion in “fines, settlements, and lost business as a result of multiple regulatory actions,” the filing alleges, including the suspension of licenses at some of its distribution centers for failing to maintain effective controls against opioid diversion.

Cardinal Health did not immediately return a request for comment Friday night.

On Aug. 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 that have large gaps between the amount of Oxy or Hydro they are allowed to buy (their threshold) and the amount they really need,” according to the filing, which cites Gustin’s statements. “This increases the ‘opportunity’ for diversion by exposing more product for introduction into the pipeline than may be being used for legitimate purposes.”

According to the filing, he had earlier noted to his colleagues that they “need to get out visiting more customers and away from our laptops or the company is going to end up paying the price . . . big time.”

Another McKesson regulatory affairs director responded: “I am overwhelmed. I feel that I am going down a river without a paddle and fighting the rapids. Sooner or later, hopefully later I feel we will be burned by a customer that did not get enough due diligence,” according to the filing.

McKesson is the largest drug distributor in the United States. It distributed 14.1 billion oxycodone and hydrocodone pills from 2006 to 2012, about 18 percent of the market, according to the DEA database.

“Suggesting that these two employees’ emails from nearly a decade ago are evidence of wrongdoing ignores the context in which McKesson and our employees were operating,” McKesson spokeswoman Kristin Chasen said in a statement Friday. “Doctors around the country were writing millions of additional opioid prescriptions year over year. Our regulator, the DEA, consistently raised the annual quota of pills that could be produced and distributed, which was a clear statement that the increase in prescriptions was appropriate, expected, and medically necessary. To imply that distributors should have second-guessed or overruled those decisions by the government and the medical community reflects a fundamental misunderstanding of our role. For decades, McKesson has consistently reported opioid transactions to the DEA. We have also invested heavily in further strengthening our anti-diversion program.”

Until Friday, the documents had been sealed under a protective order issued by U.S. District Judge Dan Polster. The order was lifted a year after The Washington Post and HD Media, which publishes the Charleston Gazette-Mail in West Virginia, filed a lawsuit for access to the documents and a DEA database tracking opioid sales, known as the Automation of Reports and Consolidated Orders System, or ARCOS.

The drug companies and the DEA strenuously opposed the release of the data and the documents, and Polster agreed with them. But a three-judge panel of the U.S. Court of Appeals for the 6th Circuit in Ohio ordered that some of the information should be released with reasonable redactions and the database should be made public.

By consolidating cases from around the nation, the Cleveland case, for the first time, provides specific information about how and in what quantity the drugs flowed around the country, from manufacturers and distributors to pharmacies. The case also brings to light internal documents and deliberations by the companies as they sought to promote their products and contend with enforcement efforts by the DEA.

The local and state government plaintiffs in the case argue that the actions of some of America’s biggest and best-known companies — including Mallinckrodt, Cardinal Health, McKesson, Walgreens, CVS, Walmart and Purdue Pharma — amounted to a civil racketeering enterprise that had a devastating effect on the plaintiffs’ communities.

The case is a civil action under the Racketeer Influenced and Corrupt Organizations (RICO) Act, making use of a law originally developed to attack organized crime.

In statements to The Post on Tuesday in response to the release of the DEA database, the drug companies issued broad defenses of their actions during the opioid epidemic. They have said previously that they were trying to sell legal painkillers to legitimate pain patients who had prescriptions. They have blamed the epidemic on overprescribing by physicians and also on corrupt doctors and pharmacists who worked in “pill mills” that handed out drugs with few questions asked. The companies also said they should not be held responsible for the actions of people who abused the drugs.

The companies said that they were diligent about reporting their sales to the DEA and that the agency should have worked with them to do more to fight the epidemic, a point former DEA agents dispute. The companies also note that the DEA set the quotas for opioid production.

“We report those suspicious orders to state boards of pharmacy and to the DEA but we do not know what those government entities do with those reports, if anything,” Cardinal Health said in a statement.

The companies issued statements rejecting the plaintiffs’ allegations.

McKesson said in its statement: “The allegations made by the plaintiffs are just that — allegations. They are unproven, untrue and greatly oversimplify the evolution of this health crisis as well as the roles and responsibilities of the many players in the pharmaceutical supply chain.”

Mallinckrodt said the company “has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multipronged program to address opioid abuse.”

‘Kingpin within the drug cartel’

One of the biggest points of contention in the lawsuit is whether the nation’s largest drug companies did enough to identify suspicious orders of opioids. What exactly constitutes a suspicious order is at the heart of the case.

The DEA has long said there should be no confusion because the agency has given frequent guidance and briefings to the industry, and repeatedly defined what constitutes a suspicious order.

The plaintiffs argue that the companies failed to “design serious suspicious order monitoring systems that would identify suspicious orders to the DEA” and shipped the drugs anyway.

“Their failure to identify suspicious orders was their business model: they turned a blind eye and called themselves mere ‘deliverymen’ with no responsibility for what they delivered or to whom,” according to the plaintiffs’ filing.

Between 1996 and 2018, the plaintiffs alleged in the filing, drug companies shipped hundreds of millions of opioid pills into Summit and Cuyahoga counties in Ohio, filling orders that were suspicious and “should never have been shipped.”

“They made no effort actually to identify suspicious orders, failed to flag orders that, under any reasonable algorithm, represented between one-quarter and 90 percent of their business, and kept the flow of drugs coming into Summit and Cuyahoga Counties,” the plaintiffs’ lawyers wrote.

In 2007, the DEA told Mallinckrodt that the numeric formula it used to monitor suspicious orders was insufficient, the filing contended. It alleges the company’s suspicious order monitoring program from 2008 through 2009 consisted of solely verifying that the customer had a valid DEA registration and that the order was accurately logged into the DEA’s tracking database.

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

A Mallinckrodt employee said in a deposition that the DEA had described the company as the “kingpin within the drug cartel” in a meeting with the agency in July 2010, according to a footnote in the filing.

In 2011, the filing cites a Justice Department document in which the DEA alleged that Mallinckrodt “sold excessive amounts of the most highly abused forms of oxycodone, 30 mg and 15 mg tablets, placing them into a stream of commerce that would result in diversion.”

According to the DEA, the filing states, “even though Mallinckrodt knew of the pattern of excessive sales of its oxycodone feeding massive diversion, it continued to incentivize and supply these suspicious sales,” and never notified the DEA of the suspicious orders.

In a settlement with the DEA, Mallinckrodt agreed that from Jan. 1, 2008, through Jan. 1, 2012, “certain aspects of Mallinckrodt’s system to monitor and detect suspicious orders did not meet the standards” outlined in letters from the DEA deputy administrator for diversion control.

Mallinckrodt was the nation’s leading manufacturer of oxycodone and hydrocodone, with 28.8 billion pills from 2006 to 2012, 37.7 percent of the market, according to the DEA database. It has since created a subsidiary for its generic opioids called SpecGx.

The Post reported in 2017 that federal prosecutors said 500 million of the company’s 30 mg oxycodone pills wound up in Florida between 2008 and 2012 — 66 percent of all oxycodone sold in the state. Pills at that dosage are among the most widely abused.

Prosecutors said the company failed to report suspicious orders, and Mallinckrodt that year settled the case by paying a $35 million fine.

“Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street,” then-Attorney General Jeff Sessions said at the time.

‘Business as usual’

The same year that Mallinckrodt paid its fine, McKesson, the nation’s largest drug distributor, was fined a record $150 million by the Justice Department.

According to allegations in the new court filing, McKesson frequently increased the amount of opioid pills it sent to its pharmacy customers.

“McKesson has a long history of absolute deference to retail national account customers when it comes to [opioid] threshold increases,” the plaintiffs argue in their filing, citing a deposition of McKesson’s senior director of distribution operations.

McKesson had set limits on the amount of opioids its customers could order, the filing contends, but those limits were often lifted.

“In August 2014, DOJ noted that McKesson appeared to be willing to approve threshold increases for opioids for the flimsiest of reasons,” the filing contends.

For shipments to pharmacies in Summit and Cuyahoga counties, McKesson did not report a single suspicious order between May 2008 and July 2013, the filing says. During that time, McKesson filled 366,000 opioid orders in those two counties.

McKesson reached its settlement with the government in January 2017 for allegations of failing to report suspicious orders. It was the second time the company was fined over suspicious orders. Nine years earlier, it paid $13 million.

The government said in 2017 that McKesson “failed to design and implement an effective system to detect and report ‘suspicious orders.’ ” The company shipped more than 1.6 million orders of opioid pills between 2008 and 2013 but reported just 16 as suspicious, according to the Justice Department.

However, “before the ink of the settlement agreement was even dry,” the new filing argues , McKesson was already reassuring customers who were concerned that the flow of opioids would be curtailed that it would remain “business as usual” at the company. McKesson sent more than 68 million doses of oxycodone and hydrocodone to those counties between 2006 and 2012, according to DEA tracking data analyzed by The Post.

Gustin, McKesson’s former director of regulatory affairs, was recently indicted in federal court in Kentucky on a charge of illegally distributing opioids. His attorney wrote in a court filing that the allegations against his client stem from his job at McKesson and “seem to focus on the manner by which he performed his former position as Director of Regulatory Affairs.”

Gustin’s lawyer and the prosecutor in the case did not return calls for comment.

Pickers and packers

The plaintiffs in the Cleveland case alleged that CVS, the nation’s largest pharmacy chain, did not implement required controls to identify suspicious orders from 2006 until early to mid-2009.

The CVS compliance coordinator said that her title “was only for reference and not her real job position and that the only thing she ever did related to suspicious order monitoring was to update the [Standard Operating Procedures Manual],” the plaintiffs allege.

A system that CVS used to monitor suspicious orders was known as “Pickers and Packers,” according to the filing.

The pickers and packers were workers in the distribution centers who would pick and pack opioid orders. A CVS official testified that the company did not have any written policies, guidance or training programs to teach the pickers and packers how to detect suspicious orders, according to the filing.

“Instead, the Pickers and Packers would identify orders based on a gut feeling or a crude rule of thumb that essentially can be summarized that they believed the order was simply too large,” the filing states. “One of the Pickers and Packers . . . testified that she was trained by another Picker and Packer in 1996 and that as a rule a Picker and Packer should not send out more than 12 of the small bottles, six of the larger bottles and two or three of the largest bottles. She used this rule of thumb for her entire career.”

CVS’s system flagged few orders, the filing contends : A CVS distribution center in Indianapolis flagged two orders per year from 2006 through 2014.

CVS rejected the plaintiffs’ arguments.

“As part of our response in this case, we will be presenting the expert opinion of a former high-ranking DEA official who concluded independently that our systems were compliant and that the plaintiffs’ analysis is unfounded,” CVS spokesman Mike DeAngelis said.

‘Obvious signs of diversion’

Walgreens used a formula to identify thousands of pharmacy orders as suspicious but shipped them anyway, the filing alleges. The orders were reported to the DEA after they had been shipped, according to agency documents quoted in the filing.

“Suspicious orders are to be reported as discovered, not in a collection of monthly completed transactions,” the DEA wrote in an immediate suspension order issued against Walgreens in 2012. “Notwithstanding the ample guidance available, Walgreens has failed to maintain an adequate suspicious order reporting system and as a result, has ignored readily identifiable orders and ordering patterns that, based on the information available throughout the Walgreens Corporation, should have been obvious signs of diversion.”

In one case, Walgreens’s suspicious order report to the DEA was 1,712 pages long and contained six months’ worth of orders, including reports on 836 pharmacies in more than a dozen states and Puerto Rico, the filing alleges.

The filing also alleges that Walgreens stores could “place ad hoc ‘PDQ’ (“pretty darn quick”) orders to controlled substances outside of their normal order days and outside of the [suspicious order monitoring] analysis and limits.”

The Post has previously reported that Kristine Atwell, who managed distribution of controlled substances for the company’s warehouse in Jupiter, Fla., sent an email on Jan. 10, 2011, to corporate headquarters urging that some of the stores be required to justify their large quantity of orders.

“I ran a query to see how many bottles we have sent to store #3836 and we have shipped them 3271 bottles between 12/1/10 and 1/10/11,” Atwell wrote. “I don’t know how they can even house this many bottle[s] to be honest. How do we go about checking the validity of these orders?”

A bottle sent by a wholesaler generally contains 100 pills.

Walgreens never checked, the DEA said. Between April 2010 and February 2012, the Jupiter distribution center sent 13.7 million oxycodone doses to six Florida stores, records show, many times the norm, the DEA said.

Walgreens ranked second among distributors in the nation, with 13 billion pills and 16.5 percent of the market for oxycodone and hydrocodone from 2006 through 2012, the DEA database shows. It stopped distributing opioids to its stores in 2014, but continues to dispense controlled substances.

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

In a statement to The Post earlier in the week, Walgreens defended its operations, saying, “Walgreens has been an industry leader in combating this crisis in the communities where our pharmacists live and work.”

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0 # chapdrum 2019-07-21 20:12
In just six years (2006-2012), 76 billion pills shipped. To a country with about 350 million people.