Friday, June 29, 2018

Papers about robotic surgery outcomes may be swayed by payments from the manufacturer

In 2015 alone, the top 20 surgeons receiving payments from Intuitive Surgical Inc., makers of the da Vinci robot, collected a median of almost $142,000. Of those surgeons, 12 have published 37 papers about the robot with 27 (73%) reaching strongly favorable conclusions about the robot’s effect on clinical outcomes, feasibility, or safety. Nine (24%) were equivocal, and one (2%) study was negative.

These results appeared in a paper published online in the American Journal of Surgery by investigators from the University of Michigan.

The 37 papers consisted of 36 observational studies and 1 randomized controlled trial. Robotic surgery patient outcomes were compared to patients operated on in the same institution or by the same surgeon in 11 papers, patients operated on in a different institution or by a different surgeon in 4 studies, to a database in 4, and to previously published papers in 2 instances. No controls or comparisons were used in 16 (43%) papers.

Intuitive Surgical sponsored six of the studies, all of which had positive outcomes.

According to the CMS Open Payments website, compensation received by the top 20 surgeons ranged from $106,176 to $325,164. Among the top 20 earners were 11 general surgeons, 4 colorectal surgeons, 3 thoracic surgeons, and 2 gynecologists.

Three of the 37 papers contained no conflict of interest disclosure statements.

Several limitations of the study were listed. Most journals favor publishing papers with positive results. It may be that surgeons not receiving any industry payments might have published similar numbers of positive studies. The accuracy of the Open Payments site has been questioned but it is the best resource we have currently.

The authors described their paper as a pilot study and called for more research on not only Intuitive’s effect on the medical literature but also the influence of industry in general.

The paper also illustrates the woeful state of research on robotic surgery—a device that has been used on patients for almost 20 years.


Just a thought said...

Papers are becoming more subjective and poorly written. It is sad. I think the real question is with this tool can you do the surgery safely and do it more minimally invasive for a better outcome. It is simply a tool, in some people’s hands it will benefit the patient and in others it will not.

I think way to much info has come out about it because of the expense instead of accepting it at another tool in the tool box.

artiger said...

If all you have is a sledgehammer, you'll still use it on every nail and thumbtack.

Payments like this are embarrassing to the profession. The average layman/patient reads that and thinks we all get paid (similar amounts) by not only Intuitive but all other device and drug companies. Hell, I can't even get a cup of coffee from a rep these days.

Skeptical Scalpel said...

The payments are probably for teaching or proctoring newly trained robotic surgeons but still, they taint the research.

Skeptical Scalpel said...

Just a thought, some of these new toys have been driven by marketing and subsequent patient demand. There is also the medical arms race. The hospital down the street gets one, and your hospital has to get one too.

Pooperscooper said...

Interesting that none of the top recipients were urologist

Skeptical Scalpel said...

Yes, I found that interesting too. I had emailed the lead author of the paper who said he could not explain the lack of urologists in the top 20. He suggested that it might have been due to the study covering only one year. For other years it could be different.

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