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Northfield Botched Release of Safety Data

Another blood substitute bites the dust.

Northfield Laboratories (NFLD) issued a long-awaited update Wednesday on its phase III trial for the blood substitute Polyheme. The news was ugly, shocking and disturbing all at the same time.

Northfield shares had recently lost half their value in recent Wednesday trading, down $2.28, or 53.7%, to $1.97.

To repeat what I posted in the Columnist Conversation earlier Wednesday: I don't throw around the work "fraud" lightly, but if the Securities and Exchange Commission isn't investigating Northfield yet, it certainly has grounds to do so now.

What has me so riled up is that Northfield has just disclosed -- for the first time -- serious safety concerns related to Polyheme, including a high rate of heart attacks in patients given the blood substitute, in this pivotal phase III trial. Yet it's very likely that Northfield knew about these Polyheme safety problems way back in December 2006 when the company first released "interim" results from the study.

Why did it take Northfield five months to disclose what is certainly material information about its one and only product?

Polyheme's safety and whether the blood substitute was causing heart attacks in patients have been issues that have dogged the company for more than a year. I find it curious that this information from the phase III trial was somehow left undisclosed in December, even though it's inconceivable that such information wasn't known to the company at that time.

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