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Ethics Week – COI and Stroke Guidelines

June 7, 2019

Written by Clay Smith

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There is some concern for financial conflict of interest (FCOI) among guideline authors for the American Heart Association (AHA) stroke guidelines. However, just 6% (2/34) of the authors for the 2013 or 2018 AHA guidelines had industry ties related to alteplase in the year of publication. Read the more nuanced discussion below.

Why does this matter?
Genentech donated over $11 million dollars to the American Heart Association (AHA) in the decade prior to the NINDS trial and the AHA’s subsequent class I recommendation of alteplase for acute ischemic stroke. Most stroke guideline authors have financial ties to Genentech. In the era of the ACA Open Payments Database (OPD), what can we learn about potential FCOI among current stroke guideline authors?

COI – It’s not as simple as it may appear
Authors of AAEM, ACEP, and AHA guidelines from 2013-2018 were cross checked with the Medicare OPD for significant (i.e. >$5000) FCOI related to tPA or neurointerventional devices. AAEM and ACEP had none in the 2013, 2015, or 2017 guidelines. The AHA authors had no FCOI for tPA the year of the 2013 guidelines; 11% (2/19) for the year of the 2018 guidelines. The AHA authors had 13% (2/15) with FCOI for neurointerventional devices in 2013; 16% (3/19) in 2018. In the years after the 2013 AHA guideline, ties with industry developed in 27% (4/15) of the authors related to tPA and another 27% (4/15) related to neurointerventional devices. Data after the 2018 guideline publication are not yet available on the OPD. Overall, counting FCOI in the year of and years after the 2013 and 2018 guidelines for both tPA and device manufacturers, the prevalence of potential FCOI was 35% (12/34). However, we need to be circumspect about this. Authors with no industry payments before or at the time of guideline publication did not, in fact, have FCOI by definition. Could they have known they would later “cash in” with subsequent financial ties to industry after publishing these guidelines? Maybe, and that certainly seems to be the position of this article’s authors as they calculate the 35% prevalence number. The other thing to consider is that the guidelines themselves have an extensive section of COI disclosures. So, it’s not as if they are hiding this. So, what to do? We need to be mindful of connections to industry and how they may influence authors; money is powerful. Papers like this are helpful in creating awareness and a critical eye when we read research. But as I read this, FCOI was not as common as I would have thought.

Financial relationships with industry among guideline authors for the management of acute ischemic stroke. Am J Emerg Med. 2019 May;37(5):921-923. doi: 10.1016/j.ajem.2019.01.037. Epub 2019 Jan 24.

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Reviewed by Thomas Davis

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