March 16, 2009

When Lilly Pays Out $800M, Where Does That Money Go?

It's easy to get confused by big numbers and health care reform by subterfuge.

[Judge] Kelly immediately imposed sentence, ordering [Lilly] to pay $615 million, including a criminal fine of $515 million and $100 million in forfeiture.
Not for me to judge the criminal sentence.  Next:

The charge against Eli Lilly was announced earlier this month simultaneously with a civil settlement in the amount of $800 million. The total monetary settlement totaled $1.415 billion.

What civil settlement?

In the civil settlement agreement, Eli Lilly agreed to pay the United States approximately $438,171,543.58 to settle allegations that it caused invalid claims for payment for Zyprexa to be submitted to various government programs such as Medicaid, TRICARE, [etc] for unapproved off-label uses.  Also, Eli Lilly agreed to pay various state Medicaid programs more than $361,828,456.42 to settle similar claims.


First, an aside: why is it called "Zyprexa" in legal documents but "olanzapine" in medical journals?  Is anyone fooled by this?  This idiocy also extends to reporting about the drug: Psychiatric Times, same issue: FDA considers pediatric labeling for olanzapine; Lilly Off-Promotion of Zyprexa.

Richard when he gives you money, Dick when he doesn't, I guess.


So $800M gets paid to the government because Lilly caused doctors to write Zyprexa off label.

Think about this.  I'm not arguing the sentence.  If the government simply wants to create a law that says off-label promotion is subject to a billion dollars in penalties, ok.  Again, I'm no judge.

But under what logic can the marketing Zyprexa off- label be considered causing a false claim for payment?  This isn't a clever legal trick: the False Claims Act is the explicit mechanism for policing off-label promotion. 

Yet it's lunacy.   The doctors wrote the script.  Therefore it can never be a false claim, unless they're accusing the doctor of making the false claim, which they're not.  If a doctor saw in a dream that Lipitor can calm an agitated demented patient and they try it, that's not a false claim.  It's probably not even negligence.

The reason this matters is that we are in America, not Greece, or Spain, or Russia.  Either we're upholding the law, or we're devising stratagems to go after whoever is currently politically unpopular.  How you police something is more important than catching bad guys.  This is why cops can't plant drugs on a suspect that they know is guilty.  Right?

So if you're saying that Lilly caused doctors to unknowingly file a false claim, then you have to pick between one of these two choices:

a) either doctors were actually deluded by Lilly and thought that Zyprexa was FDA approved for "agitation in dementia," in which case it is very likely that their entire medical practice is one gigantic false claim; or

b) they knew that it was not approved for that, but were convinced by Lilly's marketing that it might actually work for that, so they prescribed it.

If you chose b), it should be immediately obvious that Lilly "caused" only Day 1 of the Zyprexa Experiment; everything else after that was the doctor's determination of whether it was working, worth it, etc.

Before anyone argues with me, understand what's at stake: physician autonomy.  Anything that "causes" doctors to do something against their will or judgment; anything that "helps" physicians "practice better"-- all of these things presuppose that doctors are not able to figure things out for themselves.  So then why have doctors in the first place?  You may as well boot up a few Prescribatons and upload the Texas Algorithm 2.0 and let them medicate the consequences of the rest of the government's failed social policies.

Why resort to saying that off-label promotion is bad because it does something to doctors instead of saying it is bad in and of itself?

Oh: because when the government says a doctor was caused to do or not do something, what's soon to follow is the government telling a doctor to do or not do something. 

Also interesting/horrifying, is this allegation:

Eli Lilly trained [its reps] to promote Zyprexa by focusing on symptoms, rather than FDA approved indications.

If we can just put aside our hatred of Big Pharma for one second, can anyone explain the difference between "symptoms," and an "indication" having no other objective characteristics except those symptoms?  Oh, I hear the arguers clicking the caps lock.  Be careful what you wish for.  Would it have been better if doctors were "taught" to recognize "dementia related psychosis" as a schizophrenia-spectrum disorder?  Oh, like you can tell them apart on MRI?  Dementia praecox, after all. 

I may be quick to point out the idiotic things doctors do; but none of those things, none of them are more idiotic than the things doctors are told to do, under the pretense of science (e.g. clinical guidelines) or the law.



The qui tam relators will receive $78 million from the federal share of the settlement amount.

Those would be the 6 or so former reps turned whistleblowers.  No honor among thieves, or something.