Will the da Vinci robot go the way of laparoscopic surgery?

The real problem is not whether machines think, but whether men do.
– B. F. Skinner

When I was a relatively junior member of the surgical faculty, an even more junior member came to my office and announced that a general surgeon and gynecologist in Georgia had performed gallbladder surgery with a laparoscope.

“Stupid stunt,” I snorted, or something equally derisive and all-knowing.

Some weeks or months later he returned to the topic, telling me it was just the beginning, and we should get in. I admired him, and I was also feeling a little guilty for squelching his enthusiasm. I agreed to visit another medical center with him and have a look.

That experience convinced me the approach was legitimate, and we returned to organize a series of operations in our animal lab to learn the procedure. We struggled initially, but eventually we became proficient enough to satisfy our credentials committee and begin offering the minimally invasive technique to patients.

Fast forward. Laparoscopy revolutionized abdominal surgery on a scale commensurate with that of general anesthesia. Whiz-bang engineers and well-financed manufacturers produced ever more sophisticated instrumentation, extending the benefits of smaller incisions and quicker recoveries to myriad procedures which had theretofore required large incisions and significant tissue trauma.

Those undeniable patient benefits were not the reason, however, that laparoscopy displaced conventional (“open”) gallbladder surgery so rapidly. The reason was … um … market pressure.

Though they got up to speed rather quickly, the makers of laparoscopes and laparoscopic instruments weren’t at first very mobilized and could barely meet the crescendo demand for what were still fairly primitive products. The drivers of the explosive proliferation were the manufacturers of surgical lasers.

In what must rank as one of the great marketing coups in healthcare history, they somehow succeeded in getting the procedure branded as “laser” (rather than “laparoscopic”) gallbladder surgery. They then advertised heavily — to the medical community, of course — but more importantly and effectively to the lay public. One of their executives, in a moment of hubris and indiscretion, told me they knew physicians to be too slow in adopting and applying new technology and products. The strategy was to go over the profession’s head and enflame public interest. They also offered dirt-cheap weekend seminars for surgeons to learn the technique, at which the indispensability of the laser was a point of emphasis.

The strategy worked. Patients began calling surgeons and hospitals to ask if they offered “laser” surgery. Primary care doctors and gastroenterologists started steering patients to “laser” surgeons, even if they were out of town. Those referring doctors also reportedly lowered the threshold for surgical referral, resulting in an increase in the number of what was already one of the most common surgical procedures in America.

General surgeons, faced with the loss of a substantial income stream, flocked to those weekend courses. They also fiercely lobbied hospital administrators for the purchase of lasers and laparoscopic equipment. One of the laser company representatives for our region claimed $750,000 in one year’s commissions (1990 dollars).

One of the most feared complications in gallbladder surgery is injury to the common bile duct, lethal at worst and debilitating at best. In the early years, the weekend wonders posted duct injury rates ten times higher than that in conventional surgery, tragedies for their patients and provender for the plaintiff’s bar. With increasing experience, the development of more sophisticated instruments and, most importantly, thorough and sound training in residency programs rather than hotel ballrooms, the risk:benefit of laparoscopic gallbladder surgery is today the same as that of open technique.

The surgical community, including me, had been convinced of the centrality of the laser. One by one, then in droves, we realized that the less expensive, more dependable, though old-fashioned, electrocautery units already in our OR’s were preferable to the lasers, which began collecting very expensive dust.

Which brings me to the robot.

The only robot approved for soft tissues is called da Vinci and is the sole and exclusive product of Intuitive Surgical. My experience with their marketing efforts parallels in many ways that of “laser” gallbladder surgery. The robot is touted as a means of protecting and expanding market share for many procedures, principal among which are removal of the prostate and uterus. The market is created by direct appeal to the public, and the company provides case studies of hospitals draining caseloads from competitors.

Approximately one-fourth of US hospitals have been convinced enough to purchase at least one robot, and the number of operations performed with da Vinci has risen dramatically in the last few years. The company’s stock traded at $13.88 in mid-2003 and closed recently at $489.31, reflecting the sales and revenue curves.

I’ve been present at several pitches, at one hospital that eventually reacted positively and at one that has yet to buy. The spiel has always been the same, with one exception. At the hospital which bought a robot, the representatives promised that if we would buy two, the company would not sell one to our major competitor for at least one year.

The robot costs around one and a half million dollars, and the yearly upkeep runs to six figures. The company provides some training for surgeons and staff but leaves to individual hospitals the determination of competence. The company will not support devices that are sold to another hospital so, once purchased, forever yours. Robot enthusiasts cite better visualization, less trauma, quicker recoveries, etc. While the adoption rate has not equaled that of “laser” surgery, the increase in utilization has prompted some critical attention, and the results to date are not entirely encouraging. The FDA has announced an investigation of da Vinci and its safety. A liability suit underway is exploring the inadequate training of surgeons and the company’s responsibility, if any. The American Congress of Obstetrics and Gynecology has declared robotic surgery no better than and possibly inferior to other minimally-invasive but less expensive techniques.

One obvious question: is the robot another “laser”?

There is a more fundamental and important question. Granting that the pace of traditional development and evaluation of products may not excite investors, are we going to cede that vital function to those for whom scientific probity may not match their interest in the equity market?

The cost of healthcare is quite rightly in the public and regulatory crosshairs. We must be good stewards and do our part in making certain that expense brings proportionate patient benefit rather than merely market share.

Richard Patterson is a surgeon who blogs at DailyDudley.

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