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belt,” Wilcox said, patting his waistline. Hewas a thick, powerful man with a voice that carried like thunder over distance, a throwback sales executive who landed big contracts with hospitals and HMOs over golf, meals, and cigars. “What do you think, Jennifer? Will that belt graphic work for our revenue chart in the annual report?”
    Everyone at the table chuckled.
    Home run. After eliciting the reaction he had hoped for with the depiction of the belt, Brian moved quickly past the slide.
    The purpose of his presentation was to promote and defend the business case for Caladon Pharmaceuticals to seek FDA approval for Zuprone as a weight-loss drug, a strategy Brian recommended and expected the executive team to support. Zuprone already was approved and marketed as an antianxiety drug, which in itself covered a broad and vague range of indications. The problem was that Zuprone had captured only a minor share in the crowded antianxiety market. There were lots of “me too” competitors, and Zuprone was one of them. Yet, even at the time of launch, evidence existed of the weight-loss benefits. Over the past three years, active off-label prescribing of Zuprone for weight loss had increased the drug’s sales and profitability, and over the past six months, since Wilcox came aboard via the acquisition and immediately assigned Brian the mission of educating more physicians about the weight-loss benefits of Zuprone, sales had soared.
    Seeking FDA approval for a second therapeutic indication could be cost prohibitive. Zuprone had already been through years of development and clinical trials for its original intent; repeating the process for weight loss would add significant costs to the drug’s balance sheet. But Brian’s projections pointed to increased profit because the second indication—obesity—
was
a growing market with no end in sight, as his clever belt slide indicated. Caladon could use the same manufacturing process and facility, and simply package, name, and market the drug differently for weight loss—once the application was submitted, clinical trials conducted, and FDA approval granted.
    “The anecdotal evidence looks good in terms of number of prescriptions already written,” Garcia said. “But two things: One, we can’t go back and track these patients and call that a clinical study. And two, how much is our marketing responsible for the bump in number of prescriptions for obesity?”
    “What about the research at UCSF, that guy McLellan?” Wilcox said. “We’ve been hosting a seminar that references his study.”
    “It’s not the same thing,” said Jennifer Stallworth. “Research studies are not controlled clinical trials. They’re simply data points to help make our own decision whether to move forward or not. The patients who’ve been prescribed off-label have had none of the usual safeguards or controls in place. Though there is a chance some of the prescription history data can be transferred to trials.”
    “I don’t want to be accused of human experimentation if we try to co-opt the existing data,” Garcia said.
    “I wouldn’t worry about that,” Stallworth said.
“Richardson v. Miller
set precedents there. As long as the physician was seeking optimal treatment and the drug use was customary—even if off-label—it wouldn’t be considered experimentation.”
    “If we start using anecdotal data about all this off-label prescribing, someone at the FDA might start wondering about the volume and how we built momentum,” Garcia said.
    Brian stepped in to regain control. “Regardless of anecdotal data, we have to conduct every stage of trial for FDA approval. And I’ve projected the costs of clinical trials …” He quickly forwarded a few slides to a table of data.
    Wilcox grunted. Everyone turned to look at him.
    “When is Stephen coming?” Wilcox said. Stephen Jeffries was the medical director of Pherogenix. He’d been a founder of the company now owned by