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This series of blogposts is based on multiple sources, links to some of which appear at the end.
Mallinckrodt plc is an American-Irish company which manufactured semi-synthetic opioid drugs like hydrocodone, hydromorphone, and oxycodone. Between 2006 and 2014, Mallinckrodt accounted for 27% of opioid market compared to 18% of Purdue Pharma.
The investigations show that Mallinckrodt, the largest manufacturer of opioids in the US had been able to cultivate hundreds of loyal prescribers, thanks to its aggressive marketing tactics. They ranked 239 healthcare providers as their top prescribers during the height of the epidemic in 2013, the year in which more than 14,000 people died of prescription opioid overuse. Between April and September of 2013, Mallinckrodt’s sales representatives contacted these 239 prescribers more than 7,000 times; almost 5 visits every month, a very aggressive average indeed. 65 of these were later convicted of crimes related to their medical practices, had their medical licenses suspended or revoked, or paid fines for wrongdoing.
Three were at the top of this list.
Syed Jawed Akhtar Zaidi ran a popular pain clinic in Solon, Ohio. He was on a watch list and less than a year later, a federal jury indicted him with the conspiracy to distribute controlled substances, healthcare fraud, distribution of controlled substances, and money laundering. Before he could be convicted, he left for Pakistan, and remains at large.
Egyptian Fathalla Mashali operated four busy pain clinics in Massachusetts and Rhodes Island. Mashali and his clinics came under investigation by FBI and DEA because four of his employees had complained to law enforcement about his unprofessional, unethical, and unlawful behavior. He used the money made from fraudulent billing to live a lavish lifestyle. Mashali was arrested in 2014 while trying to board a plane to Egypt. He later pleaded guilty to healthcare fraud, mail fraud, and money laundering. He was convicted and sent to prison for eight years.
The third one favored by Mallinckrodt was George Griffin, an orthopedic surgeon in Cincinnati. In 2010, State Medical Board of Ohio had determined that Griffin had overprescribed pain pills to more than a dozen patients. He appealed and continued to prescribe. For one patient, he prescribed 640mg a day of OxyContin, an extremely excessive dose. Griffin was arrested in 2019 and was convicted a year later. He was sentenced to 40 months in prison.
As the opioid epidemic roared, Purdue Pharma got more attraction for its role with its brand OxyContin. The fact was that Mallinckrodt had bigger market share – 27% vs 18% of Purdue, but somehow its products remained rather oblivious. Jim Geldhof, a Drug Enforcement Agency supervisor, who investigated Mallinckrodt said, “Everybody thinks of Purdue when they think about the opioid epidemic, but Mallinckrodt was far worse. 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.” Mallinckrodt’s 30mg oxycodone tablet became the preferred drug on the street. The baby-blue-colored pills, the equivalent of a hit of heroin, became so ubiquitous that the smuggling route from Florida to Appalachia became known as the ‘Blue Highway’.
Other key findings from Washington Post investigation are these. [Quote]
- 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 runningpill 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. Like other companies, Mallinckrodt touted its paid speakers’ program for doctors, hosting dinners and speeches at pharmaceutical conventions. The company advertised these get-togethers as an opportunity to provide educational resources for prescribers.
- 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!!” [Unquote]
Some wholesalers also facilitated delivery of opioid drugs to various market. For example, KeySource Medical, operating out of Cincinnati sent 41 million tablets of Mallinckrodt-made oxycodone tablets to the state in 2010 alone. Sunrise Wholesale of Broward County was running similar operation. Registrations of both of them were revoked by DEA.
They have entered into an agreement for paying $1.6 billions against opioid lawsuits. The company applied for bankruptcy in 2020 and was allowed to restructure in February 2022. It is still functional.
Mallinckrodt spokesperson says, “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,”
To be Continued……
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