Quote Of The Day: A ‘Detestable’ Johnson & Johnson

Quote Of The Day: A ‘Detestable’ Johnson & Johnson

June 9th, 2011 // 12:49 pm @ jmpickett

In explaining his decision to penalize Johnson & Johnson a healthy $327 million for deceptive marketing of its Risperdal antipsychotic, South Carolina Circuit Court Judge Roger Crouch late last week made a point of reciting a part of the famed credo that is religiously repeated by execs at the health care giant: “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs, everything we do must be of high quality.”

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Why? He wanted to contrast the credo with actions taken by the Johnson & Johnson team. To set the stage for his remarks, Crouch offered this: “It it is the loss of the company’s focus, upon the primary objective of its credo, which brings us to this discussion.” And it is some discussion. Crouch proceeds to explore the notion of lying, deception and manipulation – in this case, finding ways to convince doctors to prescribe Risperdal based on misleading, incomplete or concealed data.

Specifically, he recounts how results from two studies were not disclosed for years and that J&J used “pretenses” to keep them hidden from view because they did not “fit the marketing department’s vision” for promotion. He then chastises J&J for a “concerted effort to conceal that information and to manipulate that information…for the purpose of protecting and improving its market share.” Then, he notes, one study was released only after the Risperdal patent had expired.

But Crouch is far from done. He admonishes J&J for failing to include information about side effects on the labeling for years. He writes that it was especially critical for such info to have been available when most patients treated with Risperdal suffer from conditions that may impair their ability to make informed decisions. “Because of the diminished mental capacity of the patients being treated, this court finds the actions of the defendants, upon this (patient population), to be detestable,” he wrote.

Crouch then adds that J&J exhibited a “callous disregard to a patient’s right to have all information available, and in the hands of their physician, before deciding to use or continue to use the drug. Further, I find that the defendants allowed the ‘profits at all costs’ mentality to cloud the vision of their own responsibilities as acknowledged in their credo.” He concludes that bad faith was considerable when it came to labeling matters.

And, yes, there is more. The judge scolds J&J for the contents of a Dear Doctor letter sent in November 2003, a time when the FDA sought a labeling change for all atypical antipsychotics over concerns the drugs cause diabetes, among other issues. But after a “careful review” of e-mail threads, Crouch writes J&J tried to spin the message. The letter listed eight mostly irrelevant studies, including one comparing Risperdal to Eli Lilly’s Zyprexa, even though the FDA instructed J&J not to do so.

The letter also failed to mention the hidden studies, although the FDA had asked three years earlier for J&J to provide all information concerning diabetes and hyperglycemia. Meanwhile, J&J included the letter in the materials that sales reps took to visit doctors, but did not include a follow up letter, which included corrections that were required by the FDA. Writes Crouch: “Who knows how many of those mothers, fathers and patients referenced in their credo, to be owed their best, were influenced into making incorrect decisions concerning their drug therapy?”