Curious observers have been asking me why someone at the University of Illinois would knowingly aid and abet an effort to use the University's reputation to support the commercial objectives of a private firm. I suspect that, when the facts come out, it will be about the money. But I am just speculating.
Let's imagine the following scenario. A major manufacturer of medical equipment, which has succeeded in part by recruiting surgeons to be its spokespersons with the public and in medical conferences, finds that its place in the capital market is faltering. This may be a result of a number of adverse incidents related to the technology. It may be because the market for its machine has become saturated, and it is facing a harder time entering new market segments.
Analysts on Wall Street are talking:
So the company and those people decide to create an advertisement, loaded with people in white coats, to give the impression of an institutional endorsement of the company's product.
Or maybe I have it totally wrong. Maybe it is an absolute coincidence that doctors who have been receiving compensation from this company have appeared in the advertisement. Maybe they posed for another picture, which was used without authorization by the company. Maybe they are totally innocent dupes.
The University requires its researchers to file financial disclosure forms every year.
Did the doctors referred to in the advertisement file these forms? Most, as researchers, are required to: Dr. Antonio Gangemi reports on LinkedIn that he and Dr. Pier C. Giulanotti "have started two main research projects aiming to develop guidelines for training and credentialing in robotic surgery." Dr. Enrico Benedetti lists extensive research activities on his UIC home page, as does Dr. Bernard Pygon.
Questions to be answered: Are these forms a matter of public record? Since they are financial disclosure forms designed to promote unbiased research and encourage public confidence in the accuracy of research endeavors, we'd like to think so. What do they say? Is there any review of those forms by University compliance administrators? For that matter, does the University have compliance administrators who are charged with reviewing the accuracy of such forms? Is there any reconciliation between the dollars listed on the forms and the state tax filings of those individuals? After all, the University is a state entity and could require such a reconciliation.
That's a start. This whole issue could be cleared up by the University's Board of Trustees. So far, the entirety of their public response is published here:
Let's imagine the following scenario. A major manufacturer of medical equipment, which has succeeded in part by recruiting surgeons to be its spokespersons with the public and in medical conferences, finds that its place in the capital market is faltering. This may be a result of a number of adverse incidents related to the technology. It may be because the market for its machine has become saturated, and it is facing a harder time entering new market segments.
Analysts on Wall Street are talking:
- Sell-side analysts aren't happy with the lack of revenue guidance offered by Intuitive Surgical (ISRG) after its Q4 earnings report.
- J.P. Morgan says the earnings call was a disappointment, and that the 2014 outlook is murkier than just a week ago.
- Morgan Stanley says its expectations for guidance were muted, but its below consensus 2014 EPS outlook is coming down another 10%.
- BAML says the stock remains Buy rated but investors must brace for another year of negative earnings growth.
- Canaccord says it wouldn't be buyers on weakness.
So the company and those people decide to create an advertisement, loaded with people in white coats, to give the impression of an institutional endorsement of the company's product.
Or maybe I have it totally wrong. Maybe it is an absolute coincidence that doctors who have been receiving compensation from this company have appeared in the advertisement. Maybe they posed for another picture, which was used without authorization by the company. Maybe they are totally innocent dupes.
The University requires its researchers to file financial disclosure forms every year.
Did the doctors referred to in the advertisement file these forms? Most, as researchers, are required to: Dr. Antonio Gangemi reports on LinkedIn that he and Dr. Pier C. Giulanotti "have started two main research projects aiming to develop guidelines for training and credentialing in robotic surgery." Dr. Enrico Benedetti lists extensive research activities on his UIC home page, as does Dr. Bernard Pygon.
Questions to be answered: Are these forms a matter of public record? Since they are financial disclosure forms designed to promote unbiased research and encourage public confidence in the accuracy of research endeavors, we'd like to think so. What do they say? Is there any review of those forms by University compliance administrators? For that matter, does the University have compliance administrators who are charged with reviewing the accuracy of such forms? Is there any reconciliation between the dollars listed on the forms and the state tax filings of those individuals? After all, the University is a state entity and could require such a reconciliation.
That's a start. This whole issue could be cleared up by the University's Board of Trustees. So far, the entirety of their public response is published here:
I could not have said better myself. Your curious observer fan
ReplyDeleteAlso. Please familiarize yourself with details of manufacturers marketing campaign and you will understand the big picture (lack of academic champions) even more. Maybe NYT was not the first episode. Outstanding and thank you from all of us. Curious observers
ReplyDeleteOh also look up UI code of conduct office
Thank you. That office notes:
ReplyDeleteThe Office of the Secretary of State will begin the annual Statement of Economic Interests process with a mailing to the home addresses of required filers March 17, 2014. To comply with the State Officials and Employees Ethics Act, the University Ethics Office will also be emailing required filers with instructions to return all Statements of Economic Interests to the University Ethics Office for review and forwarding to the Office of the Secretary of State. All Statements of Economic Interests must be filed with the Office of the Secretary of State by May 1, 2014 to avoid fines.
http://www.ethics.uillinois.edu/home/
I imagine some people pictured in the ad are "required filers." Are their previous years' forms on public view?
Well, yes they are on public view.
ReplyDeleteOne question that is asked is "List the nature of professional services rendered (other than to the State of Illinois) to each entity from which income exceeding $5000 was received for professional services rendered during the preceding calendar year by the person making this statement."
Dr. Benedetti, for example, answered "N/A" to this item for 2013, 2012, 2011, 2010, 2009.
Another question that is asked is "List the name of any entity from which a gift or gifts, or honorarium or honoraria, valued singly or in the aggregate in excess of $500, that was received during the preceding calendar year."
ReplyDelete(The actual amount does not have to be listed.)
On this item, Dr. Pier C. Giulanotti lists "Intuitive Surgical" for 2013 and 2012. (I stopped looking after that.)
Got the last message, Anon. Not posting for the obvious reason.
ReplyDeletePaul,
ReplyDeleteGreat work.
I used to work in public accounting with one of the large firms. We were required to update our conflict of interest statements coinciding with investment transactions and then were required to attest quarterly.
I now work in a large health system. We only require annual attestation. Even then, our physicians (and other researchers) complain that this is too burdensome.
This is all driven by money. The medical device manufacturers exploit the weaknesses of the conflict of interest processes and lack of effective education within the physician community as to the significance of the problem.
The physicians are hungry for the publicity be it in a publication or in an advertisement. Their monetary gain is just gravy.
The compliance processes within the health systems or universities is administered by narrow minded egos unwilling to admit that their policies are ineffective.
We need better education and real-time conflict of interest updates with greater transparency.
Keep pushing this issue. Well done.
I don't know of any field other than medicine where working as a consultant with industry is more demonized. We all have bias and conflicts of interest. You certainly use this blog to promote your books and focus only on the good things during your tenure as CEOBIDMC. If physicians did not work with industry patients cataract surgery would still be a one hour procedure followed by a two week hospitalization with significant mortality. Like it or not robotics will be the future of medicine. There is certainly a need for strict oversight but just because a skilled surgeon can do the procedure more quickly today without the assistance of a robot does not mean it will always be so. Soon surgeons in industrialized nations will be saving the lives of children in sub-Saharan Africa with similar devices. I believe your ongoing criticism of a particular robotic company is extremely myopic and wonder from whence the bias arises.
ReplyDeleteYou raise so many straw men that I scarcely know where to begin.
ReplyDeleteThis is not an argument about robotic surgery. I hope what you say is true, that there will some day be clinical evidence that this care modality is superior and more cost-effective than manual laparoscopic surgery. Until there is such evidence, the kinds of ads discussed are, at best, misleading.
Meanwhile, I guess you see no harm or ethical dilemma about using a public university's reputation and name to enhance the financial prospects of a private firm. We certainly part company on that issue.
Likewise, there is no harm--and indeed great benefit--from academia/industry collaborations. Let's just have everything above board, please--because there is the potential for conflicts of interest.
As to my use of this blog, I plead guilty. I bragged a lot about the good work done by the staff at BIDMC because I was damned proud of them. But I also pointed out the flaws of our institution, and my own, when they were important to note.
Finally, yes, I promote my books on this blog from time to time. That's pretty open for the world to see. If people find that offensive, they can choose not to read those posts or not to read the blog altogether.
I'm guessing that your post, which has elements of criticizing me instead of addressing the issues raised here, will be the first of many of that ilk. Frankly, I'm surprised that yours is the first. It's the last refuge of those who don't want to face the uncomfortable facts of this situation.
You know Dave, to me the difference between working as a consultant with industry and going over the line is quite clear. If one is paid a straight salary as a consultant and assists a company in developing new drugs, ideas or devices, and all of this is fully disclosed to everyone INCLUDING patients, it seems probably OK. (I am avoiding all the folderol about patents, funded research etc. for now). But - and we see this all the time - if the doctor is paid to use exclusively the company's product, like a particular hip prosthesis, or if he helped develop it and gets royalties every time that product is used, or if he helps promote that product or drug even under the guise of 'education', or if he gets 'gifts' in return for prescribing their drug - no. Just no. This also applies to hospitals allowing drug companies to fund their CME activities and myriad other activities.
ReplyDeleteWe accept it because it's easy, but that's exactly how the camel's nose gets under the tent.
if you want to do those things, you should resign your clinical post and go work for that company, because that's where your loyalties are. Very simple.
nonlocal MD
The intent of mentioning you is to point out that we all have bias. I have no relationship with any robotic company but have colleagues who employ robotics in surgery. That surgical time and outcomes are inferior to a skilled surgeon is testament to the fact that the academic centers of this country do an excellent job of training surgeons. I read your blog all the time, I like your blog and love the issues you raise. I am not part of the choir though; in my opinion you are on the wrong side of this debate but time will tell. Horses were faster than cars in the beginning and still may be safer for rider and the environment. The cataract surgery analogy I mention also resulted in substantial saving to the healthcare system and resulted in substantial loss of income for the surgeon, yet surgeons embraced it as they are now embracing an expensive laser technology for cataract removal that has the potential to eliminate the need for large numbers of surgeons. Similar things may happen with robotics and proton beam, another nemesis of yours. You are justified to be concerned about bias but also should acknowledge that future innovation with these and other technologies requires research and investigation and that requires funding. Physicians should not be expected to give up income in the pursuit of research.
ReplyDeleteThanks, Dave, for clarifying. I apologize for misconstruing your intent.
ReplyDeleteWhere does Dave's idea come from about the surgeons experiencing loss of income from the cataract innovations? Instead, they did many, many extractions per day and made even more $$. They have been some of the highest paid physicians. CMS recently recognized that and reduced their reimbursement for cataract surgery.
ReplyDeleteTo Dave…
ReplyDeleteMedicine is and will always be different. I don’t care that much if a magazine gives a biased message or somebody uses tools to promote his book. I am on the other end and free to think, listen, and read whatever I want and I will survive the process.
Well, in medicine is different. I would like to make sure that whatever is implanted, whatever surgical technique is used (robotic surgery included) is the best for me not the one that treats better my doctor. A transplant surgeon should use the right immunosuppression for his patient not the one produced by the company that pays for a meeting (luxury hotels and first class flights for special guests). It’s not easy to control but this is why in the medical field we get bombarded with compliance seminars including “Conflict of Interest” classes and tests where you MUST acknowledge that you understand what this is and how you have to behave. When you acknowledge that if you are not compliant you are in big troubles. There is no question about robotic surgery but why should this be an exception? Just for everybody to know robotic surgery is not magic and there are deaths associated to it just like any other surgical procedure.
There is something “holy” in medicine that needs to be preserved. Money is great but I am pretty sure that the UIC doctors don’t need the Intuitive Surgical, Inc. money to make it through the month. I have no problem if the surgeons decide to change and work for the company.
Paul, you got this one quite wrong. None of the surgeons at UIC has taken any payments from Intuitive. This is not about money. UIC agreed to participate because it has revolutionized the field of minimal invasive surgery and wants people to know that this is available. UIC has no budget for advertisement, it was felt to be a great opportunty to show case our extraordinary expertise in this field. Patients do really benefit. E.g. if your daughter needed thyroid surgery would you want her to have a cut across her throat when she could have her surgery through invisible incision in her axilla with the help of the DaVinci robotic system?
ReplyDeleteThe critical issue we agree with you, and work to improve it, is that not many surgeons are well trained. However, this technology is not going to go away. It is going to get better and better, and eventuallly most surgeons will become competent.
I do not think that you want to lower yourself to this level of communication. You know that this kind diffimation and bad mouthing never leaves any winner, just losers.
Why not work constructively, in the interest of patients in providing a framework within this technology can be used for treating patients in a safer and less traumatic way then with conventional surgery? You have the skills to help build a quality program. You should really visit UIC and their surgeons, talk to patients and their families what robotic surgery has done for them.
Note: I have deleted ad hominem attacks from this comment. Paul
Robotic thyroid surgery takes 8-10 hours. Conventional takes 2 at the most. To insert the robotic arms for thyroid surgery your daughter will need a 10 cm incision in each axilla. In a few cases this operation has gone wrong - can't say much more - and a neck incision resulted in some cases. Classic example of representation bias.
ReplyDeleteI heard once from a Univ. of Chicago economist that people make bad decisions not because they are bad but because they have the wrong incentives. I think this statement is quite fascinating.
ReplyDeleteIf you tell a surgeon (I am one): “would you cut your costs by standardizing your procedure, your surgical tray, minimize the equipment that you use, using less disposables and so forth… WITHOUT compromise YOUR outcomes, …we will return you the savings” what do you think it would happen? Answer: process improvement. The thing is that nobody asks the surgeon this. Here, I notice a disconnect between MDs and administrators. I know only 1 place where this question has been asked (hint. In Ohio).
Similarly, if a surgeon is faced by using the robot or not and asked: “hey man, here is a cost benefit analysis of your OR practice. Ceteris paribus (financially AND clinically), what would like to do? The difference (or part of it) is your gravy (like one said)”. The answer is clear. This is what has happened in a few centers. (BTW. It would be more fun if the CEO would tell the surgeon “hey, 10 hours? You pay the difference in OR time – just kidding)
One more thing. Look… the robot is easier to use than conventional laparoscopy. We have all tried it, even for the fun of it. Regardless, we are not using it. WHY?? Answer: because it makes no difference in outcomes. It’s just a marketing tool (You have it, ergo I must have it) or ego-tool (“I do robotic surgery”, sounds kool), which is some cases, once acquired is underutilized and so the high fixed cost are NOT spread out with number of procedures.
So what has happed is that the surgeon (the expert, not the one who relies on the robot to overcome his technical weaknesses – separate discussion) whose income is RVU based is faster than the robot who is paradoxically easier to use… isn’t that amazing?
Dear Anon 12:14,
ReplyDeleteDr. G.'s incentive - and that of other mentioned in this blog - are shown here (public record):
http://data.illinimedia.com/salaries/index
Dr. G.'s salary is not quite RVU based as he has an endowed chair which accounts for.. whatever
To clarify.
ReplyDeleteYes, unfortunately this is also an issue of money. As reported on this blog Dr. G reported receiving money from Intuitive Surgical, Inc. in 2012 and 2013. And if you read carefully the add more then one doctor akwoledges receiving money from the company.
It appears anon 11:00 must have drunk the Kool-Aid of unethical advertising himself, since his/her comment lacks all credibility. First, it is ridiculous to say no one at UI took any payments from Intuitive when several surgeons themselves list such payments on their disclosure forms, as Paul and others have pointed out. Since I doubt this misstatement is from ignorance, it must be from lying.
ReplyDeleteSecond, the admonition that Paul does not want to lower himself to this level of badmouthing and "diffimation" (defamation?) is laughable given Paul's note that he has 'deleted ad hominem attacks" from the comment.
Third, talking to patients and families who are grateful for their robotic surgery tells one nothing except that no other option was presented to them, as seems obvious from all the commentary.
This comment itself is below the level of commentary on this blog, which is read by thoughtful and educated people trained in critical thinking. In short, anon, give us a break. It is lying which 'never leaves any winner, just losers."
nonlocal MD