Monday, May 09, 2022

Inside the sales machine of the ‘kingpin’ of opioid makers. (WaPo)

MALLINCKRODT was also a processor of toxic uranium materials to the U.S. Atomic Energy Commission, contaminating workers and plant suits in Missouri and elsewhere. 

From The Washington Post:

Inside the sales machine of
the ‘kingpin’ of opioid makers

A cache of more than 1.4 million newly released records exposes
the inner workings of the nation’s largest opioid manufacturer.

From left, Mallinckrodt national sales director Victor Borelli, CEO and President Mark C. Trudeau, compliance manager Karen Harper. (Opioid Industry Document Archive; iStock; María Alconada Brooks/The Washington Post)
From left, Mallinckrodt national sales director Victor Borelli, CEO and President Mark C. Trudeau, compliance manager Karen Harper. (Opioid Industry Document Archive; iStock; María Alconada Brooks/The Washington Post)

The largest manufacturer of opioids in the United States once cultivated a reliable stable of hundreds of doctors it could count on to write a steady stream of prescriptions for pain pills.

But one left the United States for Pakistan months before he was indicted on federal drug conspiracy and money laundering charges. Another was barred from practicing medicine after several of his patients died of drug overdoses. Another tried to leave the country in the face of charges that he was operating illegal pill dispensing operations, or pill mills, in two states. He was arrested and sent to prison for eight years.

These doctors were among 239 medical professionals ranked by Mallinckrodt Pharmaceuticals as its top prescribers of opioids during the height of the pain pill epidemic, in 2013. That year, more than 14,000 Americans died of prescription opioid overdoses.

More than a quarter of those prescribers — 65 — were later convicted of crimes related to their medical practices, had their medical licenses suspended or revoked, or paid state or federal fines after being accused of wrongdoing, according to a Washington Post analysis of previously confidential Mallinckrodt documents and emails, along with criminal and civil background checks of the doctors. Between April and September of that year, Mallinckrodt’s sales representatives contacted those 239 prescribers more than 7,000 times.

[The Opioid Files: Follow The Post's investigation of the opioid epidemic]

The documents, made public after years of litigation and bankruptcy proceedings, shed new light on how aggressively Mallinckrodt sought to increase its market share as the epidemic was raging.

The Mallinckrodt documents are part of a cache of 1.4 million records, emails, audio recordings, videotaped depositions and other materials the company turned over as part of its $1.7 billion bankruptcy settlement in 2020. Several state officials with claims against the company, led by Massachusetts Attorney General Maura Healey (D), urged that the documents be made public.

While most Americans may have never heard of Mallinckrodt, the Drug Enforcement Administration called the company in 2010 “the kingpin within the drug cartel” of legitimate companies driving the opioid epidemic. Between 2006 and 2014, Mallinckrodt accounted for 27 percent of the opioid market compared with 18 percent for Purdue Pharma, measured by the potency of the pills they produced, according to an analysis by The Post. While the Sackler family, which owned Purdue, attracted intense national attention and became a cynosure of criticism after the company’s introduction of its blockbuster pill OxyContin, the Mallinckrodt brand slipped under the radar.

“Everybody thinks of Purdue when they think about the opioid epidemic, but Mallinckrodt was far worse,” said Jim Geldhof, a DEA supervisor who investigated Mallinckrodt before retiring in 2016 after four decades with the agency and now works as a consultant to cities suing the opioid industry. “They were up to their eyeballs in oxycodone, and they knew exactly what they were doing. Their drugs had become the most popular on the street and they jumped in with both feet.”

[The government’s struggle to hold opioid manufacturers accountable]

Between 2000 and 2020, more than 270,000 people died of prescription opioid overdoses in the United States.

As the opioid epidemic took hold of the nation, Mallinckrodt’s 30 mg oxycodone tablet became the preferred drug on the street, according to the DEA. The baby-blue-colored pills, the equivalent to a hit of heroin, became so ubiquitous that the smuggling route from Florida to Appalachia became known as the “Blue Highway.”

In Massachusetts, Mallinckrodt’s pain pills were supplied to more than half of those who died of opioid-related overdoses during the past 12 years: 9,673 people, according to an analysis of prescription and overdose death data by the Massachusetts Attorney General’s Office. By comparison, Purdue and its affiliate Rhodes Pharmaceuticals supplied opioids to 2,967 people who died in the state.

“For the first time in a long time, industry secrets are going to be turned over to the public and millions of documents will live online in an archive forever,” Healey said. “Making this evidence available to the public will hopefully pave the way for important reforms that will stop dangerous conduct and save lives.”

Massachusetts resident Cheryl Juaire, who lost two of her three sons to opioid overdoses, 23-year-old Corey and 42-year-old Sean Merrill, applauded the release of the documents.

“It helps to heal the families to know what really happened and to know that their child had a disease and where it started and who caused it,” she said. “There is a healing in knowing.”

In videotaped depositions taken between 2018 and 2020 as part of a national lawsuit against Mallinckrodt, top company executives took little or no responsibility for the opioid epidemic. Several skirted questions about whether an opioid epidemic even existed.

The Mallinckrodt files are being made available through the Opioid Industry Documents Archive, a digital repository of material generated by state and federal lawsuits against drug companies and managed by Johns Hopkins University and the University of California at San Francisco. The Post was provided exclusive access to the files, the largest disclosure of its kind by an opioid company to date.

Among the documents was the company’s promotional material, including a reggae song with the chorus: “You can start at the middle, you can start at the top. You can start with very little but that’s not where you should stop. Your patient needs relief, mon, so please do what you should.”

Listen to the song

For years, drug companies have argued they were simply filling orders written by medical professionals for legitimate patients. But the Mallinckrodt files show that the company had detailed knowledge of the prescribing patterns of doctors and bemoaned their loss when they fell into trouble with regulators.

Other key findings from the files:

  • Company managers pressured sales representatives to find doctors who would write large numbers of prescriptions and then targeted them for continued business. They rewarded top performers with bonuses and overseas vacations; and fired those failing to meet quarterly sales goals.
  • Three years after one sales rep cautioned that a dozen doctors in his region were running pill mills, illegal pain clinics that dispense large amounts of narcotics, five of them remained on the company’s preferred list of prescribers.
  • Mallinckrodt paid top prescribers thousands of dollars to extol the virtues of the company’s drugs to fellow doctors at “speaker programs” held at fine restaurants and resorts. All it took “was a speaker program to get them writing,” one sales rep wrote.
  • Mallinckrodt played a key role in an industry-wide effort to convince the health-care industry that addiction was rare among opioid users and marketed its drugs to specific segments of society. “With older adults, start dose low, go slow,” the company wrote in marketing material for drug industry trade shows. “But go!!”

“While Mallinckrodt does not agree with the allegations regarding decade-old issues, it has spent the past three years negotiating a comprehensive, complete and final settlement that resolves the opioid litigation against it, provides $1.725 billion to a trust serving affected communities, and allows Mallinckrodt to continue to serve patients with critical health needs under an independently monitored compliance program,” a company spokesperson said in a statement to The Post.

‘A lavish lifestyle’

Although generics made up the majority of Mallinckrodt’s business, the company also produced and marketed its own brand of time-release narcotics to remain relevant in the increasingly competitive opioid market. One of the drugs the company made and marketed directly to doctors was called Exalgo, a hydromorphone tablet and a close cousin of the pill manufactured and marketed by Purdue, OxyContin.

[Little-known makers of generic drugs played central role in opioid crisis, records show  ]

Mallinckrodt deployed a national sales team in an effort to turn Exalgo into a blockbuster of its own. Despite the company’s ambitions, Exalgo never caught on. It represented less than 1 percent of the company’s overall opioid sales. The Exalgo sales force was disbanded in 2015.

The internal documents show that the company’s sales managers grew deeply concerned about falling sales numbers when their top prescribers lost their medical licenses or went to prison.

The managers frequently checked in with their regional sales reps, asking them which prescribers had moved, died, lost their licenses or been arrested. The sales team also lamented the loss of doctors who were under investigation and tried to find a way to make up for those sales by recruiting physicians who could write prescriptions.

Some medical professionals pushed back against Mallinckrodt’s marketing. Dante Langston, a physician assistant in Colorado Springs, wrote an email to the Exalgo sales team in March 2011, urging the company to stop sending out opioid promotional material. He compared members of the company’s sales team to “the stereotypical used-car salesmen.”

The Mallinckrodt reps who small-talked their way into doctors’ offices were no different than those from Purdue Pharma, Langston wrote. He said they resorted to the same tactics of free food and “good ol’ boy kinds of talk,” he recalled in a recent interview.

“It just reminded me of the way that if you walk onto a car lot, it feels like you’re a piece of fruit that’s attracting a lot of flies,” he said.

Due diligence

Not long before Langston wrote to Mallinckrodt, DEA investigators had begun examining the drugmaker after a South Florida doctor was charged with drug trafficking and manslaughter because one of his patients had died of an overdose.

The doctor, Barry Schultz, who was later convicted, received most of his oxycodone through wholesale companies that worked directly with Mallinckrodt. In one year alone, Schultz received more than 20,000 tablets of Mallinckrodt-made oxycodone tablets through one of the company’s middlemen, Sunrise Wholesale of Broward County, Fla.

DEA investigators also noticed that another wholesale drug company, KeySource Medical, operating out of Cincinnati, was pouring massive amounts of oxycodone into Florida. In 2010, it sent 41 million tablets of Mallinckrodt-made oxycodone to the state — nearly 2.5 pills for every man, woman and child. The DEA eventually revoked the registrations of Sunrise and KeySource, barring them from distributing controlled substances.

[Internal drug company emails show indifference to opioid epidemic]

In addition to the internal emails and documents, the Mallinckrodt files released Tuesday contain numerous videotaped depositions of the company’s top executives. The depositions were taken by plaintiffs’ attorneys as they prepared for a possible trial against Mallinckrodt.

Karen Harper held a variety of compliance positions during her 44-year career with the company. She was responsible for ensuring that Mallinckrodt complied with federal laws regulating narcotics. Drug companies are required to “maintain effective controls” over controlled substances to make sure they do not reach the black market. If companies receive suspicious or peculiar orders and they can’t determine why they are so large or frequent, they are supposed to halt those orders and notify the DEA.

“You did not always perform due diligence on peculiar orders before shipping them, correct?” plaintiffs’ attorney David Ko asked Harper during her deposition on Jan. 15, 2019.

“Correct,” she said.

In another deposition, a national sales account manager for the company, Steven Becker, was asked about the amount of oxycodone he sold to drug distributors while he was working for Mallinckrodt.

“You understand that a significant number of people died overdosing on oxycodone?” plaintiffs’ attorney Derek W. Loeser asked.

“I don’t know how many people passed away — or died from this epidemic,” Becker replied.

Loeser showed Becker a number of news articles documenting the rising death toll from oxycodone overdoses.

“But you know from the articles that we’ve gone over and you've read at the time that you were selling oxycodone that a significant number of people were, in fact, dying because of overdoses on oxycodone?”

“I believe so,” Becker said.

“Mr. Becker, can you please tell the jury if you have any regrets regarding your involvement in the sale and distribution of opioids during the time that you worked for Mallinckrodt?”

“No,” he said.

About this story

To conduct this examination, The Washington Post reviewed records contained in a cache of 1.4 million files that Mallinckrodt agreed to make public as part of its $1.7 billion bankruptcy settlement. Included in these files were the company’s rankings of its top prescribers nationwide during the second and third quarters of 2013.

Mallinckrodt ranked doctors across more than 100 regions based on prescribing patterns and volume. The Post compiled a list of 239 doctors named by the company as one of its top three prescribers in their region for both quarters.

The Post checked each of the 239 doctors by reviewing criminal records, medical board sanctions, DEA registration records and civil lawsuits. The Post found that 27 doctors had been convicted of criminal charges relating to their medical practices, 30 lost their medical licenses, 13 paid civil fines and other penalties, and 10 faced medical board sanctions such as license suspensions. Some doctors fell into multiple categories; in all, 65 individuals faced at least one of these penalties. In addition, The Post examined internal company reports that recorded the number of calls Mallinckrodt’s sales representatives made to each of these doctors.

The Mallinckrodt files were provided exclusively to The Post by Johns Hopkins University and the University of California at San Francisco, which oversee the Opioid Industry Document Archive. The files were added to the digital repository of records and made public Tuesday as part of national litigation involving nearly 4,000 cities, towns, counties and Indian tribes. The documents are available at

Video produced by Leila Barghouty, Jayne Orenstein and Luis Velarde. Illustrations by María Alconada Brooks and design and development by Yutao Chen. Social media by Angel Mendoza. Research by Monika Mathur, Alice Crites and Christopher Rowland. Story edited by Herman Wong, Jeff Leen and Meghan Hoyer. Copy editing by Karen Funfgeld.

No comments: