January 18, 2006

Pharma whistleblower lawsuit

On his always newsworthy blog, Merrill Goozner wrote this week about a drug company whistle-blower lawsuit that was unsealed in a Maine courtroom last week. Gooz wrote:

"The suit was filed by Paul McDermott, a former drug salesman for Genentech, Inc. While the focus of his complaint was Rituxan, an anti-cancer drug heavily promoted for use with rheumatoid arthritis patients by its co-sponsors, Genentech and Biogen-Idec, its explosive charges are an indictment of the drug industry’s entire system for reaching out to physicians to promote the off-label use of drugs. The suit called the system an illegal kickback scheme aimed at defrauding Medicare.

Here’s how it works. According to the complaint, Genentech and Biogen-Idec identified key opinion leaders among rheumatologists and signed them up as consultants. The drug reps then set up a series of “rheumatoid arthritis roundtable dinners” at fancy steak houses in many major cities (Morton’s and Ruth Chris got most of the business). The key opinion leaders were flown in and paid $2,000 to $2,500 to give presentations on the off-label use of the drug.

Don’t forget: It’s illegal for a drug company itself to promote the off-label use of a drug. But if a company outsider (the “consultant”) at a continuing medical education seminar or at a fancy dinner presents the information, then the company can pretend its hands are clean. In the words of the complaint, “materials promoting Rituxan for off-label treatment of rheumatoid arthritis are more fully accepted and integrated into physicians’ personal belief systems when they are presented as educational in nature in contrast to material that is clearly identified as promotional.”

The suit gave examples of physicians who refused to participate after learning they couldn’t change the slides or materials conveniently prepared by Genentech and Biogen sales reps.

The suit also alleged that Genentech marketers identified key journals where articles promoting the off-label use of Rituxan should appear, encouraged its consultants to write articles that would appear in those journals, and, in some cases, wrote the articles for the consultants. Not surprisingly, the off-label use of Rituxan for arthristis, which costs about $15,000 per treatment, has soared in recent years. Since most rheumatoid arthritis sufferers are seniors, Medicare picks up the tab.

McDermott was eventually fired after asking for a transfer. Genentech and Biogen are contesting the charges. Though the case was brought under the Civil War era False Claims Act, which returns two-thirds of any recovery to the government, the Bush administration’s Justice Department last week refused to intervene in the case."

Posted by schwitz at January 18, 2006 04:49 PM | TrackBack
Comments

Just wanted to alert you to a story I did on organ transplants and the uninsured:

http://abcnews.go.com/Health/story?id=1514702

Thanks,
Joy
(health producer, abcnews.com)

Posted by: Joy at January 20, 2006 10:18 AM
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