Tuesday, March 18, 2008

Off-Label Promotion - An Indictment

As regular readers of this blog know, we’re interested in off-label promotion issues, and we unapologetically take the position that, as long as the information involved is truthful, the right of a company to tell the public about all medical conditions, on and off label, that its product helps prevent or treat is protected by the First Amendment.

The First Amendment issue, of course, remains unresolved. In Caputo one of us intervened against the government as amicus to make sure that that issue was not resolved badly due to bad facts

Well, we’re wondering whether there may be another possible show-down coming from the left coast. We’ve just received word that the CEO, not just the operational people, of InterMune, a company that made an interferon-related drug, has been indicted for off-label promotion. The government’s press release says that the defendant lied about the results of a study, and other things. That may well be true; we don't know – but that’s what we'd expect any good prosecutor to say at this stage of the game.

Who knows what the evidence will actually show.

Our advice? As long as the prosecutors stick to statements that are demonstrably and provably false, the First Amendment isn’t going to be implicated. But Caputo should be a lesson to everyone. Don’t throw in the kitchen sink, as it gives the defendants weighty constitutional arguments that prosecutors would do well to avoid. Even on pretty bad facts, the First Amendment issues surrounding off-label promotion gave the Seventh Circuit a lot of pause in Caputo.

We'll be watching to see if it happens again.


B. Martin, MD said...

The charges read less like an indictment against off-label promotion and more like an indictment against false and misleading promotion. The charges are essentially that Harkonen orchestrated a misleading marketing campaign to promote and sell Actimmune for an unapproved fatal condition, idiopathic pulmonary fibrosis, on the basis of really flimsy data. So I don't think, at this point, that free speech is going to (or should) enter into the crux of the argument. For further discussion, see http://bmartinmd.com/2008/03/former-intermune-ceo-indicted.html.

Beck/Herrmann said...

That's a press release giving the point of view of the prosecutor. Maybe it's right, maybe not. We suspect the defendant might have another point of view.

b. martin, md said...

Yes, I understand there are at least 2 sides to every...

However, the study data that Harkonen and InterMune used to support Actimmune therapy in IPH are very weak by evidence-based standards. There was the small, open-label study in the NEJM (Zeische et al, 1999), and that's pretty much about it. I couldn't find any peer-reviewed report of the phase 3 GIPF-001 trial (the results of which were negative for the primary endpoint), and the follow-up INSPIRE trial was terminated for lack of efficacy.

Harkonen et al were evidently using the small (N = 18) NEJM study and a post-hoc subgroup analysis of GIPF-001 to support their alleged promotion of Actimmune in IPF.

b. martin, md said...

Oops, I take that back. GIPF-001 results were published in the NEJM in 2004 (Raghu et al--who was, incidentally, quoted in the Intermune 2002 press release).

In the 58-week, double-blind trial of Actimmune vs corticosteroids in 330 patients with IPF, Actimmune did not signficantly affect progression-free survival (the primary endpoint), measures of lung function, or the quality of life. Treatment with Actimmune appeared to be less well tolerated than corticosteroids, and there were more pneumonias in the Actimmune-treated group.

The authors concluded that, given the size and duration of the trial, a survival benefit could not be ruled out.

The post-hoc subgroup analysis of GIPF-001 is what prompted the INSPIRE trial of Actimmune in patients with mild-to-moderate IPF.

Beck/Herrmann said...

So, b martin, md, you've obviously got the background, more than us, to evaluate whether use of this study by the defendant was a reasonable scientific judgment. What do you say?

Anonymous said...

As virtually anyone in the VIOXX Plaintiff Education Group (VPEG) understands, the "settlement" set in motion, and accelerated momentum that had been building, that in effect caused the TRAMPLING OF THE ATTORNEY-CLIENT RELATIONSHIP. Don't agree, I don't think you are close enough to the real world...There is a MAJOR civil rights violation which has occurred, and I strongly suggest that the PSC fix it, and do it now. The PSC needs to really understerdand that even though Judge Fallon has requested it, attorneys all across the country ARE NOT "sitting down" with their clients and going over the "settlement" details. It is an absolute horror show, and VPEG has proof. It has been such a shame, and maybe a crime of civil rights violation.

Dennis Harrison
VPEG member
bone and spine healing issues