“The government has always agreed that there was no falsification of data here,” said Allan Gordus, a lawyer in the Justice Department’s office of consumer litigation, during the sentencing phase. “Whether there was falsification of the conclusions that could be drawn from the data — that was what the trial was all about.”
Does context matter?
Harkonen’s defenders also think that context is important.
The press release said the results for the primary endpoint weren’t statistically significant. A Morgan Stanley analyst wrote the next day that the study probably wasn’t enough to get Actimmune an FDA label for IPF, although that wasn’t out of the question. When the study was published in the New England Journal of Medicine in January 2004, the authors wrote that “a clinically significant survival benefit could not be ruled out.”
In short, Harkonen’s defense team argued that nobody was deceived by the press release. InterMune’s executive was just expressing an opinion on the usefulness of his company’s drug — an opinion the government didn’t share.
“The fact that somebody else doesn’t think the evidence is enough — does that foreclose you from holding a different view?” his attorney, Mark E. Haddad, said in an interview.
Steven Goodman, the pediatrician and biostatistician, believes that “context” also includes what IPF patients are thinking.
“Part of the issue goes to the level of proof a patient would need when facing a fatal disease with no treatment,” he said. The fact that the study’s main result barely missed statistical significance “is far from proof that the treatment didn’t work. And if I were a patient, I would want to know that.”
(Goodman, who is editor of the journal Clinical Trials, was on the faculty of Johns Hopkins’s Bloomberg School of Public Health when he was hired by Harkonen to assist in the appeals.)
United States v. Harkonen is one more milestone in the long and winding road toward determining when in America a false statement is a crime.
As a general rule, for speech to lose protection of the First Amendment, it must fall into such categories as obscenity, incitement to imminent lawless action, fraud, perjury and false commercial speech. Only some of those categories involve untrue statements. Over the years, rulings have occasionally hinged on such things as the size of the lettering on a product label and the views of people in focus groups.
“We are starting to see these cases with increasing frequency,” said Christopher P. Guzelian, a First Amendment scholar who teaches at the Thomas Jefferson School of Law in San Diego.