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Mind

A Bloody Mess: Pharma, Legal Threats, and Fraud

NeuroskepticBy NeuroskepticAugust 15, 2012 3:41 AM

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Over at ScienceInsider, we read that a German pharma company, Fresenius Kabi, threatened a scientist with legal action

over a paper published in the New England Journal of Medicine

.

The paper asked, in effect: what's the best way to boost blood volume after bleeding? The old-fashioned - and cheap - approach is to give water with various salts, called Ringer's solution. However, it has been proposed that it might be more effective to add a form of starch to the mix, specifically hydroxyethyl starch (HES).

In essence, just as you can use starch to thicken a soup, HES helps to bulk out the blood, increasing the volume, to better compensate for fluid loss. However, HES carries the risk of side effects, including severe kidney damage.

Do the benefits outweigh the risks? That was the question asked by a team of researchers led by Danish Dr Anders Perner. In a double blind, randomized controlled trial, Perner and colleagues compared a particular kind of HES (6% HES 130/0.42) to Ringer's solution, in patients with severe sepsis (blood poisoning) treated in intensive care.

The results showed that HES was actively harmful. It raised the risk of death in these severely ill patients. 51% died, compared to 43% in the control group:

Phew! Glad we know that. If you ever end up in intensive care with sepsis, this paper could well have improved your chances of survival.

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Here's where the legal threats came in. When Perner et al published their work, they described it as a trial of 6% HES 130/0.4. It was in fact a trial of 6% HES 130/0.42. Spot the difference? Fresenius Kabi did, and they weren't happy, because they sell the 130/0.4 product. The trial was, incorrectly, billed as being about their product. It was in fact about a very similar product.

And they really are very similar. The 0.4/0.42 refers to the average hydroxylethyl ratio of the starch. But this is only an average - it varies from molecule to molecule. At ScienceInsider, Perner points out that the ratio varies between 0.40 to 0.44 in the "0.42" brand, and 0.38 to 0.45 in Fresenius Kabi's "0.4".

That's a lot of overlap... 100% overlap actually. Still, a mistake is a mistake, so Perner was right to correct it, but why couldn't they just have asked nicely?

Well... maybe because it's not the first controversy involving Fresenius Kabi and their starchy solutions. In fact, they're linked to one of the biggest scientific scandals in recent years: the case of Dr Joachim Boldt. Boldt was one of the leading researchers in his field, until last year when it was revealed that much of his work was fraudulent, unethical, or both. He's since been made to retract over 90 of his papers - which at one time made him the most-retracted scientist ever.

Now Boldt's main research interest was... hydroxyethyl starch. Much of his work - including many of the retracted papers - seemed to show that HES was both safe and effective, and he received funding from Fresenius Kabi.

So, the fall of Boldt must have deal FresKab a bit of a blow. They developed HES, back in the 1970s, and now the star cheerleader for their invention has been revealed as one of the biggest medical fraud in history. It's not hard to see why they might be feeling especially sensitive right now.

Sure, Boldt received funding from other companies too, and FresKab funded plenty of other researchers too. There's no reason to believe that they were aware of Boldt's misconduct, or that they encouraged it. But indirectly they almost certainly did benefit from it.

Anyway, following the legal threats, the NEJM has now corrected the Perner study. It was not a study of Fresenius Kabi's product. Rather, it was a study of a very similar product, and it showed that this very similar product kills people. So spread the word!

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Perner A, & et al (2012). Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. The New England journal of medicine, 367 (2), 124-34 PMID: 22738085

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