Confessions of a Serial Whistleblower - Pharmaceutical Executive


Confessions of a Serial Whistleblower

Pharmaceutical Executive

You have to read these agreements, which I have done with certain pleasure, because they're so ridiculous. You can promise anything you want in life, but if there are no consequences nobody cares. It's like kids. You tell them not to steal the candy, but if you don't do anything, they're going to continue to do it, right?

It's the same thing here because the consequences in these agreements are so little. You know, Pfizer had $2-billion in sales of Neurontin [gabapentin] per year, and they received a $400-million fine. If you do that, it's almost like you're saying, "Well, let's do more off-label marketing."

But the true penalty comes when the company is no longer allowed to sell their drugs to the government.

That's a very good point. But I'm not aware of it happening. It's all a game and I think once you get into it, you start to realize it. Just look at the Serono deal, where they paid $704 million for [inducing demand for the AIDS-wasting drug Serostim]. There was a ban placed on a subsidiary from selling to the government, but as Serono pointed out in the press release, that's not going to stop them from selling anything. The main company was not affected.

A Massachusetts US District Court recently dismissed your case against Pfizer. Why have you told reporters that you are happy about the decision?

Because the judge struck down what Pfizer had said to the press about me. The judge said I was not a parasite on their lawsuit—that I was the original source of the information [about Genotropin's off-label marketing], not Pfizer.

We had to overcome four hurdles to win, and we overcame three. The fourth hurdle, which we didn't overcome in this ruling, was essentially a technicality. This particular circuit requested a specific false claim on a specific patient to be submitted. That is a very tough hurdle to overcome, and quite frankly, if that would be applied to all false claims cases in the future, there will never be a drug company again convicted in the First Circuit.

Why is it difficult to show a specific claim?

We know that Pfizer has a database with all this information. But since the judge dismissed the case, which we will proceed with anyway, we can't subpoena them. But it's a catch 22. We are working on trying to get the claim, but how do you get that information? You need to get the patient's name and the diagnosis of somebody who has received a drug for off-label purposes, but HIPAA makes that very difficult.

What makes that a bit crazy is that other circuits have not applied that very stringent standard. My point is that most of the circuits allowed the cases to proceed without a specific patient record. This judge did what he had to do, but unless this is reversed, there will never again be a drug company convicted in the First Circuit under the False Claims Act, which obviously the drug companies would be jubilant about because then the whole act has been rendered impotent. So I can assure you, this is something all the drug company lawyers are watching extremely carefully right now.

Is there a bright side in all of this?

All this stuff that's going on with me, and in the industry in general [in terms of prosecution of companies], it's probably for the public good. This is simply going to be an ongoing process. I just wish I wasn't personally involved, quite frankly. But now that I am, I'm going to make sure I'm doing it in such a way that, hopefully, I do win. I'm going to do it in such a way that at least is entertaining.


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