The hamartia​ culture of J&J

SUMMARY: A Philadelphia jury on Tuesday awarded $8 billion in punitive damages against Johnson & Johnson and one of its subsidiaries over a drug the companies made that the plaintiff’s attorneys say is linked to the abnormal growth of female breast tissue in boys. Once again J&J is caught.

In his richly-detailed narrative, Brill recounts how Johnson & Johnson set ambitious revenue targets in its internal business plans that required reaching a market far broader than the narrow population of adults with the most severe psychiatric disorders that the FDA had told J&J it could promote to.

Despite these FDA restrictions – and repeated warnings from the FDA that Brill documents – the company promoted the drug to doctors treating the elderly as a solution for a broad range of less severe behavioral issues, including restlessness and dementia. The aggressive marketing efforts continued even as data from clinical studies continued to make it more obvious that the drug caused strokes and other dangerous side effects.

Among other findings:

During one peak sales year, Risperdal accounted for 14% of all of Johnson & Johnson’s profit.

Johnson & Johnson used Legos and a “back to school” campaign to promote Risperdal, despite FDA regulations not allowing the company to market it to children. Similarly, it created an ElderCare team for Risperdal, even though the FDA wouldn’t allow the company to market it to the elderly. Under federal law, violation of these FDA restrictions is a crime.

The company tweaked or disregarded several studies showing how dangerous the drug was for children and the elderly.

J&J paid hundreds of doctors to ensure that Risperdal got a good name in the medical community. Some of those doctors put their names on an article published in a prestigious medical journal reports that included faulty science about the drug’s safety. One of those doctor-authors now concedes to Brill that his involvement in the article “was the most difficult thing in my career.”

No single drug is U.S. history has incurred larger criminal fines and civil damages payments for illegal marketing than Risperdal. Nonetheless, Brill calculates that J&J stands to make billions on the drug, giving lie to the idea that our system serves as a deterrent to bad behavior.Among other findings:

During one peak sales year, Risperdal accounted for 14% of all of Johnson & Johnson’s profit.

Johnson & Johnson used Legos and a “back to school” campaign to promote Risperdal, despite FDA regulations not allowing the company to market it to children. Similarly, it created an ElderCare team for Risperdal, even though the FDA wouldn’t allow the company to market it to the elderly. Under federal law, violation of these FDA restrictions is a crime.

The company tweaked or disregarded several studies showing how dangerous the drug was for children and the elderly.

J&J paid hundreds of doctors to ensure that Risperdal got a good name in the medical community. Some of those doctors put their names on an article published in a prestigious medical journal reports that included faulty science about the drug’s safety. One of those doctor-authors now concedes to Brill that his involvement in the article “was the most difficult thing in my career.”

No single drug is U.S. history has incurred larger criminal fines and civil damages payments for illegal marketing than Risperdal. Nonetheless, Brill calculates that J&J stands to make billions on the drug, giving lie to the idea that our system serves as a deterrent to bad behavior.

Among other findings:During one peak sales year, Risperdal accounted for 14% of all of Johnson & Johnson’s profit.

Johnson & Johnson used Legos and a “back to school” campaign to promote Risperdal, despite FDA regulations not allowing the company to market it to children. Similarly, it created an ElderCare team for Risperdal, even though the FDA wouldn’t allow the company to market it to the elderly. Under federal law, violation of these FDA restrictions is a crime.

The company tweaked or disregarded several studies showing how dangerous the drug was for children and the elderly.

J&J paid hundreds of doctors to ensure that Risperdal got a good name in the medical community. Some of those doctors put their names on an article published in a prestigious medical journal reports that included faulty science about the drug’s safety. One of those doctor-authors now concedes to Brill that his involvement in the article “was the most difficult thing in my career.”

No single drug is U.S. history has incurred larger criminal fines and civil damages payments for illegal marketing than Risperdal. Nonetheless, Brill calculates that J&J stands to make billions on the drug, giving lie to the idea that our system serves as a deterrent to bad behavior.

Among other findings:

  • During one peak sales year, Risperdal accounted for 14% of all of Johnson & Johnson’s profit.
  • Johnson & Johnson used Legos and a “back to school” campaign to promote Risperdal, despite FDA regulations not allowing the company to market it to children. Similarly, it created an ElderCare team for Risperdal, even though the FDA wouldn’t allow the company to market it to the elderly. Under federal law, violation of these FDA restrictions is a crime.
  • The company tweaked or disregarded several studies showing how dangerous the drug was for children and the elderly.
  • J&J paid hundreds of doctors to ensure that Risperdal got a good name in the medical community. Some of those doctors put their names on an article published in a prestigious medical journal reports that included faulty science about the drug’s safety. One of those doctor-authors now concedes to Brill that his involvement in the article “was the most difficult thing in my career.”
  • No single drug is U.S. history has incurred larger criminal fines and civil damages payments for illegal marketing than Risperdal.

Tone Jones, a Texas-based Janssen manager, would later testify that the directive to focus on children came straight from the home office. Jones—who would win a 2001 sales award at a ceremony presided over by Alex Gorsky—was asked in court, “In your experience, would promoting Risperdal off-label to children get you fired?”

“No,” he replied.

“Would it get you a bonus?”

“Yes,” he answered, whereupon he produced a letter from a regional supervisor awarding him a bonus based on “your performance quotient of 131.05%.”

Doctors who prescribed the most Risperdal were recruited to be paid speakers and were called “whales.” They were so important to the business “that we needed to see them for sure on a weekly basis, if not every day pretty much.”

In November 2000, Johnson & Johnson research scientists got troubling numbers on breast enlargement. The study’s protocol, “special attention” was paid to prolactin—had now found that of 319 children, including 266 males, 8.6 percent of the males had developed gynecomastia, or breasts. When the final results including more participants were tabulated, the percentage of males was 5.5 percent. 

An updated Risperdal business plan that management signed off on in September 2000 unabashedly signaled that Johnson & Johnson would ignore the regulators and any bothersome data and keep going after children.

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