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Lemons into Lemonade: How an off-label marketing fine can be good for business 10/30/2012

Posted by ALT in Pharmaceuticals.
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2000: Sales of Pfizer’s Neurontin, a medication approved for the treatment of epilepsy, reach nearly $1 billion — a big surprise for a medication geared towards such a small, niche market.

2002: The media breaks the story of a lawsuit (Franklin v. Pfizer) charging that Pfizer illegally marketed Neurontin off-label as a treatment for individuals labeled as “bipolar.”

May, 2004: Pfizer pleads guilty to charges of marketing Neurontin off-label and pays $430 million in fines. By some estimates, around 90% of Neurontin sales were for off-label purposes.

(3 months later)
August, 2004: Generic form of Neurontin (gabapentin) becomes available.

(4 months later)
December, 2004: The FDA approves Pfizer’s Lyrica, a new drug for epilepsy similar to Neurontin. The company begins to aggressively market this new, patented (ie, expensive) drug.

(Can you see where this is going?)

2009: Pfizer settles another off-label marketing suit for $2.3 billion involving Lyrica and several other drugs.

2011: Sales of Lyrica reach $3.1 billion, 2 years before patent is set to expire.

Neurontin was coming off patent anyway and the lawsuits simply accelerated the desired shift from off-label Neurontin use to off-label Lyrica use.

-Dr. Randall S. Stafford, who studies drug marketing

2012: A new study documents an increase in spending on epilepsy drugs prescribed off-label for individuals labeled as “bipolar.” The authors suggest that off-label marketing lawsuits merely caused a substitution  of new epilepsy medications for old ones in the off-label marketing/prescribing equation.

In recent years there have been several large lawsuits setting out to punish pharmaceutical companies for illegal off-label promotion…[I] suspected that it might be possible that there could be unintended consequences of that. The unintended consequences are substitution of similarly unsubstantiated [and patented] products and an increase in spending [on off-label prescriptions] overall.

-Meredith Chance, pharmaceutical policy researcher and co-author of a new study: “Intended and Unintended Consequences of the Gabapentin Off-Label Marketing Lawsuit Among Patients With Bipolar Disorder

The end was near for Neurontin, and Lyrica was waiting in the wings.  Was taking the hit for off-label marketing in 2004 all part of a plan to boost sales for forthcoming Lyrica, now the star performer in the Pfizer portfolio?

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1. Madam Nomad - 10/30/2012

What slime these amorals be, to paraphrase Shakespeare. Gabapentin f–ed me up! Still have neuropathy in face & extremities. They didn’t mention that it causes neuropathy, which is one if its supposed indications. Why is it so imperative to snow people who get upset? There’s a war against those who don’t handle their stress appropriately!

2. R2DTew - 10/31/2012

Just the cost of doing business, when business is making stuff that people think (are made to think?) will help them. So what’s a crazy person to do? Just resign themselves to being crazy? Try to sieve through the biased information to extract what’s real? Hope you aren’t that one in a million who responds exactly the opposite from what’s expected (advertised) from a med? Figure a larger body count is part of the price we humans must pay for how we’ve civilized (or not) ourselves in this ‘modern age’ (and hope you aren’t one of the bodies)? Figure there really is nothing worth living for? Take enough street drugs or likker and smokes that you don’t care and can’t tell any longer you’re nuts or feeling bad?

I do think it’s useful to keep up the drum beat that big pharma is a vested interest that’s not going to betray its interests and will continue ‘spinning’ information about their products. But I think also it’s probably unreasonable to expect that drum beat is going to be much more than ‘mood music’ to the companies who are transgressors. At least anytime soon. Which means some other strategy is needed, a strategy to deal with what YOU feel if you’re one of those who feel and think stuff that’s uncomfortable, chaotic, unsettling (not just to others, but to yourself).

So how can I deal with my nuttiness? Enjoy it? That’s tough to do if I’m anxious all the time. Or caught in some sort of reactivity so compelling I can’t control it. Or convinced I’m surrounded by legions of other beings whose main interest is torment.

It’s worth keeping in mind what desperation is, why people feel so desperate that they are willing to try drugs of some kind — ANYTHING! — to get out of what’s happening right now. Exploitation of the desperate is practically the definition of modern-day entrepreneur-ship.

Seems we have yet to find any other way to be a community (society). Love, of course, has been suggested, but for some reason, it’s difficult to manifest.

3. Lemons into Lemonade: How an off-label marketing fine can be good for business « freakoutcrazy - 11/02/2012

[…] by AltMentalities […]

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