FRANKLIN, TENN.—Three years ago, when an oncologist named Robert Oldham created a company called Biotherapeutics, some called it genius; some called it downright unethical; still others called it capitalism in its most predatory form. But everyone acknowledged that the concept bad the potential to change the face of cancer therapy.

Oldham, former head of the National Cancer Institute’s biological therapy program, proposed to offer experimental treatments to any cancer patient who could afford them—treatments that would oth erwise be available only to the tiny portion of patients who fit into the institute’s strict guidelines for clinical trials. And he neatly circumvented FDA restrictions on using unapproved therapies with a clever scheme that removed his operations from federal jurisdiction.

In their desperate search for a cure, Oldham predicted, cancer patients would flock to his door, wallets in hand. Plenty of other people agreed, and they put up $40 million to launch...

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