Last year, the Supreme Court declared unconstitutional the Stolen Valor Act, which made it a crime for a person to falsely claim to have won a military medal (United States v. Alvarez). But the decision offered little guidance on how the context of a lie may protect it from becoming a crime.
The Harkonen case, which includes no false statements, is all about context. That’s one reason that courts, one way or another, may want to walk it back.
“The reason we may want to let Harkonen go may have very little to do with whether he’s truthful or a liar,” Guzelian said. “It may instead have to do with our mistrust of government’s ability to decide whether he’s a liar.”
‘Shoes never stop falling’
Harkonen left InterMune 10 years ago. He went to work for a privately held biotech company doing Alzheimer’s disease research, but he resigned after his conviction in September 2009. He hasn’t worked since.
In September 2011, the Department of Health and Human Services excluded him for five years from working for any organization that gets money from Medicare or Medicaid — essentially all medical institutions. If his conviction is not overturned by the Supreme Court, the FDA will bar him from employment by any company seeking the agency’s approval for a product; he is appealing the ban. California is coming after his medical license.
“The shoes never stop falling,” he said.
Things haven’t turned out too well for interferon gamma-1b, either.
InterMune did run another trial. It was big — 826 patients at 81 hospitals — in order to maximize the chance of getting clear-cut results. It enrolled only people with mild to moderate lung damage, the subgroup whose success was touted in the press release.
And it failed.
A little more than a year into the study, more people on the drug had died (15 percent) than people on placebo (13 percent). That was the death knell for the drug. Most insurers stopped paying for it.
It’s possible that there’s a subgroup of patients, not yet fully identified, who benefit. For example, data suggest that people whose cells still make a fair amount of interferon gamma are helped by the high-priced drug. But it’s unlikely anyone will be trying to figure that out soon.
Certainly not Scott Harkonen.