In that disease, the lungs slowly fill with scar tissue, killing a person within two or three years. InterMune sought approval to market it for a more common ailment, idiopathic pulmonary fibrosis (IPF). The drug that Harkonen’s company made is a “biologic response modifier” and had FDA approval for use in two rare inherited diseases. “The courts don’t quite realize the significance of what is in front of them or the furor that might erupt if this kooky precedent is allowed to stand.” Goodman, a pediatrician and biostatistician at Stanford University who submitted a statement supporting Harkonen’s appeal. “If you applied this rule to scientists, a sizable proportion of them might be in jail today,” said Steven N. Some people, however, view it as a sleeping monster, a threat to free speech in science. The case has gotten little attention outside the world of pharmaceutical law. The conviction has wended through motions and appeals since then, and last month Harkonen’s lawyers petitioned the Supreme Court to hear it. Harkonen was found guilty of wire fraud in 2009 for disseminating the press release electronically. The numbers were right it’s the interpretation of them that was deemed criminal. What’s unusual is that everyone agrees there weren’t any factual errors in the four-page document.
ACTIMMUNE INTERFERON GAMMA COPAY ASSISTANCE PROGRAM TRIAL
The press release described a clinical trial of interferon gamma-1b (sold as Actimmune) in 330 patients with a rapidly fatal lung disease. government, a federal jury and the 9th Circuit Court of Appeals, was willfully overstating in a press release the evidence for benefit of a drug his company made.
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