We’re not in the game of mud-slinging. Far from it. But when there’s a very public dispute taking place involving a “next-generation” surgical technology, we feel the need to share the story.
In the blue corner is Intuitive Surgical, developer, manufacturer and supplier of the now famous daVinci surgical robot system. In the red corner is Citron Research, one of the longest-running online stock commentary websites and arch critic of Intuitive’s activities in the market.
Citron’s self-assessed credentials boast a “track record identifying fraud and terminal business models second to none among any published source”. Rather than just bringing companies down, it says its goal is to provide truthful information in an entertaining format to the investing public.
So why the interest in Intuitive?
Well, Citron’s campaign dates back to last December when it started raising public awareness of what it calls the “undisclosed dangers of robotic surgery”. Since that time the organisation has dug deeper and deeper into the evidence and churned out plenty of analysis that it says does not reflect well on Intiutive and its handling of the surgical adoption of daVinci technology across procedures from prostatectomy through hysterectomy to cholecystectomy.
Most recently, Citron’s homepage, at the time of writing features an open letter to the management and officers of Intuitive Surgical, accusing the company of misuse of statistical data in a release posted last week on its website. Notably the data was sourced from the FDA’s adverse event MAUDE dataset. In essence what Citron is saying is that Intuitive’s use of data direct from MAUDE is contrary to FDA’s guidance on the use of that very data, not least because MAUDE data is submitted voluntarily and highly likely to suffer from under-reporting of device events.
Firstly Citron points out that the data is described by Intuitive as being worldwide, despite the fact that events outside the US are unlikely to feature.
Secondly, and the main point of dispute on this occasion, is Intuitive’s handling of the actual data as presented on the MAUDE database. The issue centers around the dates when adverse events were reported rather than when they occurred. One dataset suggests the trend is going down, the other that it is going up, with a massive spike of reports in Q3 2013. Ironing this out into a trendline shows the reports going up when measured by date of report submission. Intuitive would obviously want to clarify its position, hence it pointing us at the down-trending line for reports by date of occurrence. Intuitive clearly filed a pile of reports in Q3, including 105 injury or death reports in August alone, more than triple any previous month, suggesting, according to Citron, a drastic policy and procedure change at Intuitive (97% of all adverse events reported came from the manufacturer). Citron’s assertion is that the company’s newest release containing this analysis is designed to counter the concerns of anyone observing the reported event line. But that is seemingly only part of the story. Among a litany of horror stories, Citron points to evidence of extremely long experience curves, quoting surgeons who’ve stated that it’s taken them hundreds of cases to get to outcome levels they’d previously attained with conventional open prostatectomy surgery.
Citron Research has had the knives out for Intuitive for some time and you can read their October 13 update here.
You can link directly to Citron’s page here where you’ll see the open letter to Intuitive’s management.