James' World 2

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Since he had begun taking Risperdal, Austin Pledger was having fewer tantrums. The reports Benita Pledger read from her son’s school reflected what she was seeing at home: “His frustration behavior has improved greatly,” his special education teacher wrote in April 2004. But it was far from a complete turnaround. Austin would still erupt in volatile behavior, biting himself or suddenly dropping to the floor and pounding his head.

Benita and Phillip continued to dote on him, and marveled at his ever-amazing feats of memory. He could now recite long passages from books that he was starting to be able to read. He amazed his parents almost every day by completing the required phrase, when just a few letter clues had been posted, as he watched his favorite TV show, “Wheel of Fortune.”

But despite Benita’s incessant efforts to control Austin’s diet, her son had…

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Allen Jones had had an uneventful career working as an investigator for the Office of Inspector General in Pennsylvania. But in July 2002, he noticed that a new account had been set up to receive payments from the Janssen division of Johnson & Johnson. What was that for?

The bank account, he was told, was meant to cover travel expenses for health department officials so that they could examine a program that their colleagues in Texas had told them about. It seemed like a promising way to create modern prescription guidelines for Pennsylvania’s use of antipsychotic drugs in state mental institutions and among Medicaid patients, including children, the officials explained to Jones.

By September 2002, Jones says, he was “pretty sure something was wrong here.” One of the state’s pharmacists, he found, had been accepting speaking fees in addition to travel expenses. J&J was…

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Six days before Austin Pledger swallowed his first Risperdal, Janssen scientists and marketing executives met with an advisory board of doctors in a luxury hotel suite in New York. The group wrestled with problems concerning the prolactin and gynecomastia data that had come in from the clinical study Gorsky and his team had ordered up, hoping to put the issue to rest.

This new study was actually a study of studies. It pooled the one study called “INT-41”—which had the largest number of participants and the worst results and had devoted what those who conducted it called “special attention to prolactin”—with four smaller, more general studies that had produced less troubling numbers.

Although this approach diluted the bad news for Janssen, there were still two problems.

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In 1999, Johnson & Johnson had signed a contract with a company called Excerpta Medica. Its specialty was medical marketing. Its sub-specialty was producing ghostwritten, data-filled studies on the efficacy and safety of a client’s drugs, finding the right academic scholars to be listed as the authors and then placing the articles in prestigious academic journals.

Excerpta’s and Johnson & Johnson’s partnership with academics and the journals that publish them was not unusual. Over the last 20 years, research into the effects of specific drugs has become almost exclusively funded by drug companies that have an interest in the results. The government, through agencies such as the National Institutes of Health, sponsors generic research related to various diseases, but beyond that initial stage, most of the work is paid for by the pharmaceutical or biomedical industries.

In a detailed presentation to Johnson & Johnson, Excerpta…

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By the beginning of 1999, Johnson & Johnson had expanded the ElderCare unit to 136 salespeople from 83, and the materials they were using to pitch doctors had caught the FDA’s eye. On January 5, Lisa Stockbridge of the FDA’s Division of Drug Marketing, Advertising and Communications wrote to Janssen’s director of regulatory affairs complaining that “presentations that focus on this population are misleading in that they imply that the drug has been found to be specifically effective in the elderly population.

“Risperdal is indicated for the management of manifestations of psychotic disorders,” Stockbridge added. “However, Janssen is disseminating materials that imply, without adequate substantiation, that Risperdal is safe and effective in specifically treating hostility in the elderly.”

Stockbridge also cited a sales tactic that seemed to stand R.W. Johnson’s Credo of putting patients first on its head. Janssen’s materials, she wrote, “are lacking in…