Wednesday, March 20, 2013

Robotic surgery controversies simmer

I'm involved in a protracted and good-natured (I hope) debate about the merits of robotic surgery with a University of Pittsburgh urologist named Ben Davies. Today he tweeted the following (with translation for the Twitter averse):

“I would love for a $ISRG [stock symbol for Intuitive, makers of the robot] MD hater (like @Skepticscalpel) to actually watch 10 open RRPs [radical retropubic prostatectomies] then watch a 10 robotic RRP. Call me with results”

Dr. Davies is a rabid proponent of robotic prostatectomy and by his own admission, is pretty good at it.

I will admit that robotic surgery may indeed be better than open or standard laparoscopic prostatectomy. There is a lot of level 3 evidence to suggest that.

However, a PubMed search today fails to reveal any randomized trials of robotic vs. open or laparoscopic prostatectomy. All research on this subject has been retrospective with the potential flaws associated with that type of study, selection bias, unknown confounding variables, unblinded authors, etc.

In Australia, randomized study of sorts is in progress comparing 200 robotic prostatectomies done by a single surgeon to 200 open prostatectomies done by a different surgeon. A search of ClinicalTrials.gov yields only one other prospective trial in progress. It is a “medico-economic” one from France. There is a trial about whether or not a drain should be used in robotic prostatectomy which assumes that the issue of whether robotic is better than open or standard laparoscopic is settled.

Dr. Davies has a rather narrow view. Although in his field robotic surgery may prove to be better, there is not even anecdotal evidence that it results in improved outcomes for any other type of surgery. Two major gynecologic organizations have recently issued position papers stating that robotic hysterectomy is not indicated for benign disease.

A number of unusual and often devastating complications of robotic surgery are surfacing, which has prompted one state, Massachusetts, to issue an advisory to hospitals.

Defenders of the robot say it's not the technology itself but rather the surgeons who are at fault.

However, the well-documented intense marketing of the robot by its manufacturer and by hospitals attempting to gain market share is pushing surgeons to adopt the method to stay competitive. The amount of training provided may be inadequate and the learning curve for most procedures is unknown but presumed to be long.

So we have a decidedly more expensive technology which even in its possibly most likely area of success, radical prostatectomy, has never been proven more effective in a well-designed prospective study.

I'm afraid I'm going to have to keep pushing on this.

By the way, I appreciate the offer to watch 20 prostatectomies, but must it be 20? How about 4?

30 comments:

NeuroTrumpet said...

On my OBGYN rotation I watched a number of robotic surgeries, and they all took way longer than anticipated and were plagued by complications. I saw more than half a dozen performed (with different attendings), and none went smoothly. Yes, this is anecdotal and surely my perspective is skewed (availability/representativeness heuristic bias etc), but regardless I can't help but be unimpressed. That said, it was definitely cool to sit at the console and watch the tissue be manipulated in 3D...

Skeptical Scalpel said...

NeuroTrumpet, thanks for commenting. Real life is often different than what is portrayed in the literature. That is an important point and one which I tried to make in my fourth from last paragraph.

It's also cool to watch an Imax movie, but it may not be the best way to do surgery.

Anonymous said...

One point to keep in mind is that robotic surgery is easier to do than laparoscopic surgery. This can be demonstrated by the fact that a lot of surgeries like staging procedures for gyn oncology were done mostly open not lap. Only few people did them lap (when robotics was not around, they were done mostly open), because it takes a lot more skill to do them lap. But, when robotic came along, a lot of people started doing them robotically. Robotics is much easier than lap, hence the increased number of robotic prostatectomies and robotic surgery in gyn oncology.

I feel with the ease of robotic platform (I am not debating outcomes that is yet to be proven as you state), the indications for surgery seem to be expanding. People who may have been given seeds for prostate ca are not having prostatectomies. What happened to not checking the PSA anymore routinely.....That would hurt a lot of income of urologists.........

Also Intutive is definitely commercializing this technology. I cannot believe that robotic cholecystectomy provides one advantage over lap chole. Yet FDA approved it for cholecystectomy and now hospitals are charging (and getting reimbursed ) more for robotic cholecystectomy than lap cholecystectomy so hospitals are encouraging surgeons to do robotic cholecystectomy. Who is paying all of us-- tax payers and those who pay health insurance premiums. If I was a CEO of insurance company I would tell a patient I will give the hospital and surgeon X amount of dollars to do your surgery. Anything over patient pays from their pocket. I bet 99% of patients will say give me 4 small scars over 1 larger scar. I know I would. Why the hell did FDA approve the robot for this indication?

Hospitals need to keep the robot busy otherwise it is a expensive piece of equipment not being used. What better way to keep the robot busy than to use for the most commonly used surgery. Then the medical groups advertise their surgeons to public saying "we use the latest and the best" whether it has a benefit or not. I think we as physicians have a responsibility to not let a commercial company make us their pawns.

Anonymous said...

Really interesting that dr Davies couldn´t avoid mentioning the ISRG-stock in his comment on Twitter...Freudian slip ? Well there is alot more to say about THAT, a WHOLE LOT MORE. Apart from the questions how to fill up one´s wallet as quick as possible, there are the medical questions. It is beyond doubt (so far) that Robotic Surgery - especially in Prostatic Surgery - doesn´t add anything of value for the Patients. Yeah, to all the the "Dr Davieses" out there, at the end of the day it is about the...PATIENTS.

@TDintheED said...

I watched several robo hysterectomies while on my OB rotation. The surgeon was a pro with the device, taking only 45 minutes to finish a hyst- scalpel to stitch. He says the robot is faster and easier for him than lap technique because the robot instruments are wristed. Does convenience of the surgeon play a role in supporting robot surgery? Admittedly most surgical tools make the surgeons job easier, but does that alone justify a multimillion dollar piece of equipment?

Skeptical Scalpel said...

Thanks for the three latest comments.

I agree that it makes no sense for cholecystectomy and that the company is driving a lot of the use.

TDintheED had a markedly different experience than did NeuroTrumpet. No question about it, some surgeons are more skilled than others.

Anonymous said...

“We have always known that heedless self interest was bad morals, we now know that it is bad economics.”
Franklin D. Roosevelt

Anonymous said...

“Still another danger is represented by those who, paying lip service to democracy and the common welfare, in their insatiable greed for money and the power which money gives, do not hesitate surreptitiously to evade the laws designed to safeguard the public from monopolistic extortion.
Their final objective toward which all their deceit is directed is to capture political power so that, using the power of the state and the power of the market simultaneously, they may keep the common man in eternal subjection.

They claim to be super-patriots, but they would destroy every liberty guaranteed by the Constitution.
They are patriotic in time of war because it is to their interest to be so, but in time of peace they follow power and the dollar wherever they may lead.”

Henry A. Wallace

* Monopolistic extortion - when hospitals just have to join the Robotic Arms race - otherwise they might lose patients (and in Community Based Hospital Systems, more or less are forced to refer the patients to Robot centres which much higher costs)
* Lip service to democracy and freedom of speech is when reported facts are distorted, or when systematic mistakes and complications never are reported of. Even worse; [in writing so called "Scientific articles"] - when sanctimonious claims of "nothing to declare" in are done (but hidden accounts worth of millions in *specific stocks* from a *specific company* as payment for "services" are to be found in non-reachable tax paradises)
* To destroy every liberty guaranteed, in which the highest request for destruction - would be the liberty of speech - a liberty being used by curious and zealous antagonists, revealing darker and darker thruths to the public - day by day...

Skeptical Scalpel said...

Well, I hope no one blames Bush or Obama for all this.

Anonymous said...

I would just like to point out that a lot depends on the patient. I am NOT an MD nor do I work in health care.

As a patient, I had two different surgeries with the same surgeon. First I asked why have surgery, why not treat with pills, and why do anything at all? Second, after we decided surgery was the best choice, open, lap, or robotic? In one case the surgeon defended open and in the second he defended lap.

The problem that I see is that most patient do not do the home work and do not ask the surgeon why they are suggesting X and they they are not suggesting Y and Z.

Yes, I see the not so hidden hand of money in the picture but I also see that a lot of patients want the robotic surgery because that is what the patient was told by ads was the best.

And, no my surgeon was not upset at my questions and he did take the time to carefully explain why he made the suggestion that he did.

John R Willis

Skeptical Scalpel said...

Not-so-anonymous John, thanks for the interesting comments.

I agree that patients should do their homework and that ads saying robotic surgery is best can be very misleading.

In the words of the immortal Sy Syms (a discount clothing store owner in New York), "An educated consumer is our best customer."

Anonymous said...

The writing is on the wall for intuitive when will we all wake up and realize: The emperor's got no clothes....

Skeptical Scalpel said...

I guess we will see how this turns out.

Anonymous said...

Is it possible that the robotIc procedure could be less traumatic than an open procedure? If so, would this result in an improved quality-of-life metric such as shorter rehabilitation time? As a patient, employee I would be interested in how quickly I could return to pre-surgical condition activities. I would likely choose to undergo a robotic procedure if it offered an improved QOL even if it were more expensive.

My question may be naive as I am not a physician.

Anonymous said...

To Anon, from another Anon (w.experience of dealing with Robotic complications and years of experience in cleaning up the mess of people running away and hiding from their own activities)

Good questions, and I have some replies (and follow-up questions too):

1) Patient select ion: A very high investment cost in this device and the dearly needed request for high volumes of patients to train on - has in for instance Prostatic surgery led to following scenario: Patients who never ever needed surgery and can, by all available Peer Viewed science, be dealt with in a conservative manner (Watchful waiting and so forth)- have been processed in the Robotic machine. No science, no medical request.
a) Do you want to undergo unnecessary surgery for a Prostatic cancer which is indolent and by all available science never ever needed surgical procedures?
b) Which one of the training "objects" do you wish to be ? Number 1, 8 or 14?

2) Improved quality of life you ask -
a) If nothing screws up - you will have the exactly same QoL as the patient who has undergone open surgery by very experienced hands.
b) If you get butchered by the device - well then I tell you - "Good Luck and hopefully you will recover in 3-12 months"
c) All available scientific publications today - have yet not shown any difference in two major QoL-matters (1) Potency (2) Continence (in comparing open Prostatic surgery with Robotic)

So next follow up question to you as possible patient: What is your choice with that background? And further, are you YOURSELF prepared to add directly from your own pocket for the extra expense of 3000-4000 USD entailing that procedure and let off the presure on your highly taxed fellow citizens or your insurance company?

Because at the end of the day, SOMEBODY has to pay for the thin air being presented to the public.

You are not naive - but you have the right to hear the replies to your questions. And not replies from people who consider you being a bag of money walking around on two legs, but replies from professionals considering you as a patient as worthy as being a fellow brother,sister or kin

Take care and watch out for people trying to sell you George Washington Bridge!



Skeptical Scalpel said...

That's a lot more than I was preparing to say. I hope we hear from the other side of the debate.

artiger said...

I'd like to try to defend the other side, but I can't. US medicine has become a giant game of "grab the cash and pass the trash".

stephen said...

Let's not forget that at the core of the adoption of robotic surgery here(U.S) is the difference in the training of surgeons, with more than 2000 davinci systems active in the U.S. with an estimated cost of $1.2MM ea. If we invested that money in training surgeons in minimally invasive techniques we could replicate the results we are getting with robotic assistance at a fraction of the cost and more surgeons could provide these outcomes. note that in the EU robotics represents only a fraction of procedures performed here with similar outcomes. As laparoscopy and other minimally invasive techniques are well established. It is also key to note that robotic proponents always point to studies that compare robotic assistance to open laparotomy not to laparoscopy. The recent JAMA article is not the only paper in gynecology to expose this nor will it be the last.

Skeptical Scalpel said...

stephen, good comments. You are correct that most of the robotic "studies" are comparisons to open surgery.

By the way, here is a salvo from the other side. http://is.gd/BskiS1

Anonymous said...

Dr Davies writes (see link provided above)

"...Guess what? Patients don't care about cost and surgeons don't either. As a practicing surgeon, do you want me to worry about cost when I'm standing over your loved one in the operating room? Or, would you rather I care more about producing a more favorable outcome? Outcome is going to trump cost every time..."

Reply: Guess what - Patients care about receiving totally unmotivated surgery.The major part of the so called Prostatic "cancers" never should be treated with surgery - and dr Davies knows that damn well. All serious and well-established science today says about the majority of these indolent cancers: Hands off!! And Dr Davies has the Chutzpah to call everybody an "idiot" every second line in his so called "article"... The point is that you shouldn´t "stand over anybodies loved ones" at all - the majority should be treated in a sensible way with Watchful Waiting. Sounding like an raging Neanderthal every second word one utters doesn´t change that fact.

And guess - what Lawyers aren´t that bad. I know a whole bunch of persons who will need them in the near future - and this comment isn´t for Dr Davies in anyway - there are other aspects on the matter of making money on Robotics without entailing him personally...History will show

Skeptical Scalpel said...

A new point of view in the discussion--whether all these prostatectomies are needed, robotic or not.

That's the subject of another intense debate.

Anonymous said...

I want to ask a question. Can anybody claim that if one does not do a procedure (any procedure i.e. prostatectomy or gyn surgery or gyn one) robotically then that surgeon is not providing standard of care. Because these comments are being used by some surgeon to protect their own sandbox/business and make others look incompetent or substandard surgeons

Anonymous said...

From Anon to Anon. Robotic surgery is NOT standard care. No way that serious bodies or entities in any of the surgical specialities has accepted this as standard care. You can´t sell George Washington Bridge to serious persons who have true aspirations in being scientific and work after the principles evidence based medicine.

artiger said...

"...Patients don't care about cost and surgeons don't either."

I think that's what has gotten us into today's mess in health care.

Skeptical Scalpel said...

I agree. I don't think it was too clever for him to have said that.

artiger said...

You may quote me if you like. Hell, you don't even have to credit me; after all, he's the one who said it.

young frustrated surgeon said...

here is an article from the new york time march 25 2013 depicting the sales tactics and under education of physicians when it comes to the robot . "Salesmen in the Surgical Suite"-http://www.nytimes.com/2013/03/26/health/salesmen-in-the-surgical-suite.html?pagewanted=all

Anonymous said...

I think the preponderance of evidence is that screening for prostatic cancer does no good, maybe even does harm. The only major organization that still suggests screening is the American Urological Association (surprise).

As the number of screenings go down, treatments (radiotherapy, surgery - robotic or not) should also decrease. Unfortunately, the lay (and some doctors') perspective is statistically unsophisticated. It is not uncommon to encounter anecdotes such as "I thought I was perfectly healthy, then my cancer test came back positive. I had my prostate taken out by this wonderful surgeon. Now I leak urine and can't have sex, but I am alive! Thank god I had that test so the doctors could save my life."



Carol Sly said...

I had an ovary removed with "the robot" as my surgeon called it and my recovery time was short and sweet. Minimal pain medication was necessary post op and I was back to running and working out just one week later and two weeks post op I ran 15 miles.

My surgeon was also excellent, so there is that.

Skeptical Scalpel said...

Young, the lawyers are on the prowl. It will be interesting to see the verdict in that case.

Anon, that is a very common "testimonial."

Carol, I am glad you did well. Using the robot to remove an ovary is like shooting rabbits with a cannon. They are just as dead if they're shot with a .22. I'm sure you would have done as well with conventional laparoscopy.

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