How Pfizer's $2.3B criminal settlement proves Obama wants to 'federalize' healthcare : Neuron Culture

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I write articles on science, medicine, nature, culture and other matters for the New York Times Magazine, The Atlantic, Slate, National Geographic, Scientific American Mind, and other publications, and am working on my fourth book, The Orchid and the Dandelion, which expands on my recent December 2009 Atlantic article. In August 2010, I'll be moving to London for a year to work on the book. I'll also serve as a senior fellow at City University London's MA science journalism program.

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How Pfizer's $2.3B criminal settlement proves Obama wants to 'federalize' healthcare

Posted on: September 2, 2009 9:38 PM, by David Dobbs

You can't make this stuff up. As PharmaGossip (among others, including the Times) reportst, a drug company pays $2.3 billion in fines to settle charges of unprecedented seriousness about practices that directly put patients at risk, and that came out of a four-year federal investigation. And some yahoo right-winger asserts this fine -- years in the works, unprecedented in scope, settling allegations rising from an investigation that started during the Bush Administration -- is really part of Obama's effort to "federalize" medicine and cut costs.

Here's the video of the DOJ's press conference announcing the fine:

Among the terms was a guilty plea to a felony violation for "misbranding Bextra with the intetn to defraud or mislead" and for illegally promoting Bextra, an anti-inflammatory drug, as well as an antibiotic, an antipsychotic, and an anti-epileptic drug. The criminal part of the fine, $1.1 billion, is the biggest criminal settlement ever. This is a massive fine, long in the works, to settle extremely serious allegations. But in a rather incredible column, the Examiner's "Economic Policy Examiner," James McConnell, today opined that no harm was done, and that this massive fine is really part of Obama's attempt to federalize health care and exert cost control.

McConnell first paints Pfizer's transgressions as mere technicalities, then suggests that the fine was levied not because anyone was harmed, but because prescriptions inspired by the illegal off-label marketing generated charges to federal health plans. (That financial injury was only one part of whack-em-with-everything approach the feds used to penalize Pfizer for its transgressions.) He completely ignores the dangers of off-label marketing, Pharma's well-documented fondness for the practice, the way it can harm patients while driving up medical costs, and, of course, the virtually unprecedented seriousness of the case against Pfizer and of the fine. None of that matters to McConnell. To him, this is about Obama finding in a technicality an excuse to reclaim some federal outlays.

This sort of cost control is just the kind of thing we can expect under President Obama's proposed federalization of our health care system. ... Obama says his health care plan won't interfere with your treatment if you like the doctor you have, but how can this be true when the government intends to stop the payment for "off label" drug prescriptions, even in cases where both the patient and the doctor believe the off label use is in fact helping the patient improve his or her condition?

McConnell's bio says his insights "come from direct experience." But his grasp of this issue seems to come from thin air, which he transmutes into hot air blowing a bunch of lies.

PS on 9/3/09: Those doubting the seriousness of these charges and of Pfizer's very deliberate pursuit of an illegal sales strategy should consider this, from Gardiner Harris's Times story:

It was Pfizer's fourth settlement over illegal marketing activities since 2002.
"Among the factors we considered in calibrating this severe punishment was Pfizer's recidivism," said Michael K. Loucks, acting United States attorney for the Massachusetts district.

Amy W. Schulman, Pfizer's general counsel, said that Pfizer had reformed -- again.

"The reasons to trust Pfizer are because, as I have walked the halls at Pfizer, you would see that the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner," she said.

The government charged that executives and sales representatives throughout Pfizer's ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer's sales.

Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement -- a companywide promise to behave.

John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government's Bextra case, said that company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra.

"The whole culture of Pfizer is driven by sales, and if you didn't sell drugs illegally, you were not seen as a team player," said Mr. Kopchinski, whose personal share of the Pfizer settlement is expected to exceed $50 million. Mr. Kopchinski left Pfizer in 2003.

Though the practice apparently has its defenders:

Almost every major drug maker has been accused in recent years of giving kickbacks to doctors or shortchanging federal programs. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would more vigorously prosecute doctors as well.
Dr. Scott Gottlieb, a top F.D.A. official in the Bush administration who now consults for drug makers, said that government prosecutors were increasingly criminalizing "what reasonable people might argue is a reasonable exchange of important clinical information between drug companies and doctors."