Tuesday, March 30, 2010

Conflict of Interest or Conflict of Virtue, You Decide

In October of 2006, the Stanford University School of Medicine implemented a program called SIIP. The acronym stood for Stanford Industry Interactions Policy. This policy governs interactions largely in the clinical and educational arenas with pharma, biotech, and medical device companies. The provisions in this policy address gifts from these industries, access of sales and marketing reps on campus, and industry support of education.

Stanford was among the first institutions to embrace such a policy. Considering the scrutiny that academic institutions and physicians are under, it's a wonder that more institutions are not promulgating the importance of this type of policy, or are they? The concern that Stanford has is that all interactions between physicians and industry must be ethical, cannot create conflicts of interest that could result in compromising patient safety, data integrity, the integrity of the educational and training program, and the reputation of faculty members at the institution. Individual physicians must consciously and actively divorce clinical care decisions from any perceived or actual benefits expected from a company. Stanford believes that it is unacceptable for patient care decisions to be influenced by the possibility of personal financial gain. It comes down to the old adage, "give a surgeon a hammer, everything becomes a nail." More on that later.

The concerns for Stanford include:

Gifts and compensation (Buying dinner, fee for attending a dinner presentation, etc)
Financial support for educational and other activities (Reps paying for educational programs that involve use of company products, i.e. AO Courses as an example)
Full disclosure of relationships with industry (Consultancies, Stock Options, Royalties, Honorarium's, etc.)
Access to the facility by sales and marketing representative
Providing scholarship or any other educational funding to residents

The Dean's concerns are legitimate in that a faculty member's relationship, whether it be a full-time or adjunct professor, could tarnish the University's image. Immediately, the Jeff Wang/UCLA, Zdeblick/Wisconsin and Polly/Minnesota scenario come to mind. Philip Pizzo's concern is the deteriorating image of the surgeon in the eyes of the public let alone the potential affect it can have in patient care. But we're not here to rehash old news. The purpose of the post is to ask our readers their opinion on the interaction between physician and company. Does a conflict of interest exist? Can a physician's judgement be influenced by their financial ties to a corporation and the success of a product? Have surgeons behavior, mostly influenced by commercial remuneration, distorted the fine line between outcomes and clinical marketing? Should there be two sets of guidelines, one for private practice, and one for academia? Or should there be stricter rules on how a surgeon can market his skills? In the larger picture, medicine has become no different than other areas of business, where everyone has a spokesperson for a brand. The real question is, if they weren't getting paid, or did not have a financial stake in a product, or a company, would they really care? Would they really use some of these products?

Maybe, Dr. Pizzo is on to something, or, maybe he is just missing out on an opportunity to maximize Stanford's ability to generate capital by commercializing the department at the medical school? It's an interesting time within the industry. Wall Street and it's analysts' have lowered the bar for the industry as a whole, yet, forecasted that the spine cartel should achieve their financial objectives by adjusting revenue and foreign currency in hope that the industry is still appealing to lure future investors, and, also to drive up the value of their own investments in these companies.

So in the spirit of debate, are you hearing other major academic institutions across the U.S. addressing their concerns about the commercial relationships between their faculty members and the industry? Or, is this an isolated situation?

The sacred Hindu scripture known as "the Gita" once said, "the fruits of action, are emphatically not the point of action." TSB wants to know want our readers think?


  1. As someone wise once said, "To segregate industry from medicine makes about as much as sense as segregating blacks from whites." The collaboration between the two improves patient care in the form of better technology.

    Do we need policies in place, of course we do. However, policies that are over the top will prohibit academic centers from recruiting the best and brightest as they will filter out into the best community hospitals. Talented surgeons with bright ideas not being rewarded for thoughtful innovation will bring only the mediocre surgeons to these academic centers. Those who would rather be on cruise control that to achieve great heights will become the academic staff at places like Stanford.

  2. I may be mistaken, but I believe that if a HCP wishes to attend an AO course, they do so at their own expense. Synthes, who is linked to the AO, does not pay for a HCP to attend an AO sponsored course as the AO is their own entity.

  3. You are sorely mistaken on how things work if you believe that all AO courses are funded by HCPs on their own. Sorely sorely mistaken.

    Synthes continually dances near, around and past the line of what is ethical when when it comes to it's association with the AO Society. I assume there will be backlash to this comment but I am speaking on personal anecdotal experience in my territory.

  4. Massachusetts and Vermont have passed very strict laws governing industry/provider relationships. The financial gain for the state (in the form of exorbitant annual "administrative fees") reeks of government sponsored extortion but in the long run it should help level the playing field. Don't be surprised if more states begin to adopt these measures, particularly left leaning states that are desperate to find new revenue sources.

  5. Synthes and the reps that work for them are among the biggest hypocrites regarding the AO. They constantly state that they don't "buy" surgeons and they only are interested in surgeon education and patient benefit. That being said, it is interesting that any and all AO surgeon affilitions and courses/materials only contain Synthes products and monies. If you truly were interested in educating surgeons on all techniques, etc. would you not have more than one company represented?

  6. I've seen these types of policies implemented at my local academic facility, but they haven't been rigorously followed up to this point. Wouldn't it be nice if some closer attention was paid to the docs in private practice? Might change the opinion of several of my docs who are dating their reps ... no conflict of interest there, right?

  7. A conflict of interest absolutely exists. Whether it be through a consulting agreement or honorarium or any other form of jargon that justifies offering a financial benefit to a physician.

    One has to wonder what would happen to the smaller spine companies if the financial terms used above were to be eliminated from the medical industry? Could they survive on their "me too" products alone? Would surgeons turn to simpler devices with better instrumentation? Would this inspire more innovation and better healthcare for the future?

    All companies are involved in offering physicians some form of financial benefit. With that said, some companies do it legally and others do not. With the recent activity of the DOJ, companies are becoming smarter. One company has direct reps and also sells through distribution. Higher commission rates are paid to distributors to allow for the under-the-table or "consulting" agreements to take place while the company can turn its head and play dumb.

    If the DOJ needs a place to start as far as illegal payments/conflicts of interest are concerned, research the '08 financials and visit the companies who allocate more than 50% of sales revenue to "Selling General & Administrative". One company allocated more than 74%.

    Insurance is yet another issue. Would the FDA approve an investigational device? No is a more than safe answer. Yet there are insurance companies refusing to reimburse/approve these technologies. Their excuse is "device XYZ is investigational". Then there are surgeons who will not offer these devices to their patients, even when they know they are an ideal candidate and they believe in the technology, because reimbursement is poor when compared to alternative methods of treatment. Yes, healthcare is a business for physicians too, however patients are placing all their trust in their doctors hands. Patients truly believe that they are receiving the best possible treatment for their condition. How would they feel if they knew the truth? How would they feel if they were a candidate for a new and approved technology (disc arthroplasty) but that their surgeon is going to fuse them because they will make more money in the end?

    Finally, what do we do about the surgeons who are over instrumenting (ie: XLIF w/stab incision & interspinous device) so they reimbursed a greater amount? Is this needed in some cases - absolutely. Are there times where this is unnecessary - absolutely.

    Solutions, unrealistic or not - eliminate the ability for physician's to have any financial interest in anything medically related that could be viewed as a conflict of interest; if a physician wants to consult, then the medical company would need to hire the physician to a full-time role and the physician would lose his/her license to practice; sales representatives would no longer be able to provide anything of monetary value to the physician and/or their office; insurance companies would be required to reimburse for all FDA approved products/procedures; and require hospitals and surgery centers to use a model similar to the Cleveland Clinic which will help promote practicing medicine that is best for the patient, not best for the individual doctors checking accounts - bye bye private practice.

  8. I feel practical anatomy & surgical education workshops conducted at institutions is a good step in the right direction for innovation. Although, companies will be looking over their shoulder seeing who else is looking at their products. For other reasons, companies can donate to the institution on their own free will and not have a work station no larger than the competitor. It’s a good venue for comradery / network. Call me naïve, but is there any other reasons why this would be a bad idea for institutions?
    Good post TSB………S.S.

  9. Ever been to an AO meeting? look at the faculty and you will see quite a few Medtronic and Depuy consultants.

  10. Look at what happens in Europe...they have much more flexibility in how they compensate doctors who are involved with industry, and they are way ahead of us with such things as total ankle implants as well as antibiotic delivery systems. Common sense has gone out the window. Sound rules are good and necessary, but you can't help stupid.

  11. Pee Wee:

    Are you commenting on conflicts of interest or are you selling total ankle implants. If you want to advertise, you'll have to pay.

  12. LOL at anonymous question...I'm selling antibiotics!

  13. There is a gap in learning for residents that industry has filled for ages. Honestly I don't see a problem in the support of resident education, but if COI policies cut that out, there will be an adjustment period where residents will not be exposed to the same amount of learning opportunities that their predecessors were exposed to. Eventually University departments will adapt to this, but I'm not sure they want to take on the extra cost of providing additional educational ops for the residents, and if they aren't patient care will ultimately suffer.

    There is a thin line between industry/surgeon collaboration, and industry/surgeon collusion. Collaboration should be encouraged as it allows for education, innovation, and ultimately an improvement in patient care.

  14. "The nation that makes a great distinction between its scholars
    and its warriors, will have its thinking done by cowards and its
    fighting done by fools." --Thucydides

    I see the same trap here.

    It used to be that incompetent surgeons with ambition would go work at FDA (joking - except for Martin Yahiro, who fainted at the sight of blood), corporations tend not to want to hire them.

    Seriously, if you do too much to segregate the R&D from the intended user population you will end up with technologies/treatments designed by fools for use by cowards; a slight twist on Thucydides' statement.