In a June 2007 reply letter, Biederman wrote, the "background research to support the claims of Drs. Kruszewski and Klotz begins and ends with the manufacturer's package insert."
"However, the manufacturer's package insert is neither a standard of care nor the most comprehensive and up-to-date review of the preclinical or clinical science about a molecule," he said. "Were that so, new knowledge or findings would never be able to be conveyed to the field until the company or the U.S. Food and Drug Administration (FDA) determined to alter the manufacturer's package insert."
"Further, the labeling reflects information provided to the FDA at the time of submission of the compound and not necessarily the universe of scientific information available," he wrote.
"The letter by Drs. Kruszewski and Klotz seriously misrepresents the facts, shows ignorance about the neuropharmacologic characteristics of modafinil, and demonstrates a failure to understand the clinical significance of alternative treatments for ADHD," the hubristic Biederman told the Editor.
"As an independent clinician-researcher and not the agent of the manufacturer, I am compelled to base my teaching on all the information and knowledge available to me," he said.
However, an investigation, the very next year, by the US Senate Finance Committee, led by Iowa Republican Senator, Charles Grassley, found Biederman to be far from independent from Cephalon. For instance, when disclosing plans for a study sponsored by Cephalon in 2001, Biederman claimed he had no financial relationship with the sponsor. But seven years later, in March 2008, Grassley found Cephalon had paid him $13,000 in 2001.
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