Tuesday, February 12, 2008

Surviving Sepsis Guidelines 2004-2008: evidence based or market based?

Since their release in 2004 the Surviving Sepsis guidelines, because of support from Eli Lilly and a recommendation for activated protein C (Xigris), have been loudly criticized as representing “marketing disguised as evidence based medicine.” Given widespread industry ties with research and guideline development we hear a great deal of such criticism these days. Many have called for greater distance between industry and the medical profession. Some would go so far as to reject, out of hand, any guideline recommendations or study findings when industry affiliations are apparent. My approach in following this debate the past several years is simple: don’t judge guidelines and authors by the company they keep; just go with the evidence.

The history of the Surviving Sepsis Guidelines (SSG) provides an object lesson. In 2006 I expressed my view that the 2004 recommendation for activated protein C in severe sepsis was based on the best available evidence at the time and that some critics were merely appealing to popular corporate hatred rather than scientific evidence.

Last September I reviewed new evidence which raised concerns about the risks and benefits of activated protein C (apC), suggested that patient selection was less clear and wondered how the guideline authors would incorporate this new evidence in their next update.

When I discussed sepsis treatment in my year end roundup of issues in hospital medicine I reserved judgment about whether the SSG authors had allowed marketing to trump EBM. After all, the revised guidelines were due out soon, and we could wait and see what the authors did with the new (and somewhat negative) evidence. I predicted that if the authors really followed the evidence they would weaken their recommendation for apC.

Shortly after I wrote that post the 2008 SSGs were published and I was able to access the abstract, which I commented on here. The abstract gave a hint that indeed the guideline authors had followed the evidence. Their recommendation for apC was downgraded.

But I reserved final judgment until I had an opportunity to view the full text of the guidelines, reproduced here via Medscape. This document confirms that the use of apC has been downgraded to a weak recommendation. The SSG authors have followed the evidence. The accusation of “marketing disguised as EBM” no longer has credence.

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