America's Most Admired Lawbreaker: Chapter 4, "Massaging the Data, Spreading the Word"

The Ghostwriters

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 outlined one of its key selling points: “Ensuring Vast Opinion Leader Access.”

“No other medical education company has the tremendous access to top opinion leaders that Excerpta Medica does … ” Excerpta promised. “Our parent company, Reed Elsevier, is the largest supplier of medical information in the world, publishing over 700 medical journals in almost every conceivable therapeutic area. Each journal has an editorial board composed of renown specialists throughout the world who are available to us as consultants, advisory board members, speakers, and in other capacities. We provide this significant access to all of our clients.” (The Excerpta connection to the giant Europe-based publisher would be severed in 2010, when it was sold to a unit of the giant advertising agency Omnicom.)

Now, in 2000, Excerpta began working on a plan to place dozens of Risperdal articles in medical journals. “Awareness articles” and “original reports,” of which a total of 39 were planned, would cost $22,000 each in fees, plus fees for the “authors.” Shorter pieces would be $9,000 each.

As Excerpta later explained when it presented its plan to Janssen executives, the goal was to publish clinical data and marketing that supported the use of Risperdal for mood disorders. “Overall, the plan supports risperidone’s market expansion into the treatment of patients with bipolar disorder and, more broadly, into the treatment of patients with mood disorders,” the presentation promised.

Significantly, one example of a “core message” piece, according to the Excerpta proposal, would be a scholarly article that conveyed the message that Gorsky and his team had decided that they needed to fend off attacks by competitors: “prolactin elevation sometimes seen with Risperdal treatment is not (directly) linked to clinical abnormalities.”

To that end, in August 2000, Excerpta’s Michelle Daniels emailed Dr. Robert Findling, a renowned child psychiatrist at Case Western Reserve University hospital (he is now director of child and adolescent psychiatry at Johns Hopkins), to ask if he would be a lead author of an article that would be based on the results of Risperdal studies involving children taking the drug over an extended period. The data was not in yet, but the working title was “The Safety and Efficacy of Open-Label Risperidone in Conduct Disorder in Mild, Moderate and Borderline Mentally Retarded Children Aged 5 to 12 Years.”

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To read Chapter 4 in its entirety and view the accompanying materials online, visit The Huffington Post: Highline website: http://huff.to/1ip77Qu.

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