A matter of public trust

Several weeks ago, I raised the issue of whether it was appropriate for the Dean of the College of Medicine at the University of Illinois to be on the Board of Novartis, a major biomedical corporation. My concern was quickly slapped down by a University spokesperson, who said, in part:

The University of Illinois views Dean Azar’s service on the Board of Director of Novartis as appropriate, given that the conflict of interest and commitment is well-managed. The UIC leadership and Dean Azar have commendable records of integrity and in dealing with conflict of interest issues associated with external activities."

I wonder if the University did any research into this matter before giving this response.  I'm going to present some of my own research, derived solely from public sources.  In so doing, please understand that I in no way seek to denigrate the exceptional scientific and clinic record of the Dean.  I merely seek to present facts and context that, in my mind, again raise the issue of governance and propriety--both for the University and for a company that has itself faced questions of ethics and governance:  How can this person exercise a proper duty of care and loyalty to both institutions, not only in terms of time commitment, but also in terms of the overlapping scientific research and clinical interests of the two organizations?  I raise this issue not to accuse anyone of misbehavior, or engaging in conflicts of interest that result in personal gain, but as a matter of public trust.

As noted by Joan Miller, Chief and Chair of Ophthalmology at Massachusetts Eye and Ear Infirmary:

As we try to sort through COI and the relationship between industry and academe, we want to do what is in the best interest of our patients and the public good. We want to maintain the positive advantages of collaboration and philanthropy, especially in educational grants and research, while holding ourselves free from possible bias. We must treasure and ensure the public’s trust. No one can do it better than we can. 

The Novartis business plan

How did Dmitri Azar end up on the Board of Novartis?

In April 2011, Novartis announced its acquisition of Alcon for $51.6 billion:

“With Alcon, we will add eye care as a fifth growth platform alongside innovative pharmaceuticals, generics, vaccines and diagnostics, and consumer health,” said Dr. Daniel Vasella, Chairman of Novartis. “The strong Novartis presence around the world, including in emerging markets, will open new growth prospects for the combined businesses. Novartis and Alcon can be expected to profit from the combination of complementary research and development activities and ultimately benefit patients suffering from eye diseases worldwide.”

“The new Alcon Division will cover more than 70 percent of the eye care segment with more than USD 9 billion in annual revenue,” said Joseph Jimenez, CEO of Novartis.

Less than a year later, in February 2012, Dr. Azar was elected to the Board.  Clearly his credentials in the field could not be questioned and would be of value to the company as it pursued its new line of business:

Dr. Azar, a US citizen, is Dean of the College of Medicine and Professor of Ophthalmology, Bioengineering, and Pharmacology of the University of Illinois at Chicago, USA. He holds a medical degree from the American University of Beirut, Lebanon, an Honorary MA from Harvard University and an Executive MBA from the University of Chicago, Booth School of Business. Dr. Azar is an internationally recognized ophthalmic surgeon and prolific researcher. He has been named one of The Best Doctors in America and one of the Castle Connolly Top Doctors in America annually since 1994. He holds multiple committee positions with the American Academy of Ophthalmology, is a member of the American Ophthalmological Association, and sits on the Board of Trustees of the Chicago Ophthalmological Society and the Association of Research in Vision and Ophthalmology. He has received multiple leadership awards, including the 2009 Lans Distinguished Award from the International Society of Refractive Surgery.

Dr. Azar was well known at Alcon.  After joining the faculty at the University in 2006 as Head of the Department of Ophthalmology & Visual Sciences, he received, in 2007, an Alcon Research Institute award, "represent[ing] a unique example of industry support by identifying exceptional ophthalmic scientists and awarding each with $100,000 unrestricted grants to further their research endeavors."

The relationship grew. In the Illinois Statement of Economic Interests submissions dated 2008, 2009, 2010, 2011, 2012, and 2013, he reported receiving over $5000 for each of the previous years as a consultant to the company as well as getting honoraria in excess of $500.

University purchases of Novartis equipment and supplies

And the relationship has grown in both directions.  Three phacoemulsification machines (for cataract surgery) were purchased from Alcon.  I do not have information about the timing of this purchase decision. If it occurred during his tenure, did Dr. Azar recuse himself from this issue, given his relationship with Alcon? There are competing companies for this type of equipment.  Was the original purchase of equipment a sole source purchase, or were competitive proposals received?  I note that University purchases from around this time were criticized in a report from the State Auditor General--"The University did not review and approve sole source justification forms as required by University Policy."--but it is not clear whether that criticism was directed at this specific purchase.

This kind of decision regarding capital equipment has long-term financial ramifications.  After purchasing the three phacoemulsification machines from Alcon, the University was locked into buying the supplies for these machines from the same company.  For example, in 2009, it entered into a sole source purchase for such supplies.

Purchase of intraocular lens implants, probes, drapes, crescent knives and retractors for Alcon Phaco machines for the period of July 1, 2009 through June 30, 2011. 

Cost:  $1.1 million

This purchase is a sole source because the items are patented and compatible with existing equipment from the only manufacturer. Currently the Hospital owns three Alcon Phaco machines that are used to soften, shatter and remove cataracts. Alcon equipment is a standard in the industry for removal of cataracts in cataract surgery. The supplies are required for the operations of these machines. 

Likewise, in 2013, the University entered into a similar sole source purchase:

The University awarded a contract for PHACO System Packs to Alcon Laboratories, Fort Worth, TX, for an estimated $2,925,000.

Purchase from Alcon Labs their Infinity and Constellation PHACO system packs for the 3 Alcon Phaco machines (a Phaco Machine is a ultrasonic device used to soften, shatted and remove cataracts) currently used in the Hospital Operating Room.

The University has determined that this purchase is only economically available from this source because the item or service is copyrighted or patented and is not available except from the holder of the copyright or patent. 

The same equipment was purchased for the Millennium Park Eye Center, the site where Dr. Azar sees patients.

Leading edge technology purchases

In 2012, the University acquired a new LenSX laser for cataract surgery from Alcon, among the first in the Midwest.  Did Dr. Azar recuse himself from this issue, given his relationship with Novartis?  The Alcon femtosecond laser is not the only one on the market.  Again, I do not have documentation as to whether the purchase was a sole source procurement, or whether a competitive process was used.  But this article suggests that the former was the case, quoting a member of Dr. Azar's faculty, who (as I discuss below) receives financial support from Alcon:

Another consideration for Dr. de la Cruz in choosing the LenSx Laser was the university's prior experience with Alcon. "The technology fits well in our operating room, because we already have the Infiniti phaco system," Dr. de la Cruz says. "We were confident the company would provide good support and maintenance."

While it is common for academic centers to invest in state-of-the-art technology for research purposes, it is still appropriate to ask if purchase of this machine was a good business choice for the University.  Did such a conversation take place among University officials?  If so, did Dr. Azar recuse himself from the discussion of this issue, given his relationship with Novartis?  Under whose authority did the purchase take place? According to this 2011 article, the cost-effectiveness of this approach is not yet proven:

The final discussion point for FLACS is cost. These laser machines with integrated OCT or Scheimpflug technology will add considerable cost to a currently standard procedure. The final cost -benefit analysis will be more complete once long-term data on the laser systems is available. Because the size of the laser platforms is quite large, many surgery centers may require an extra step of moving a patient from the preoperative laser suite to the operating room. This will also be an extra cost in both time and efficiency.

A Medscape article also found:

Femtosecond laser-assisted cataract surgery (FLACS) represents a potential paradigm shift in cataract surgery, but it is not without controversy. Advocates of the technology herald FLACS as a revolution that promises superior outcomes and an improved safety profile for patients. Conversely, detractors point to the large financial costs involved and claim that similar results are achievable with conventional small-incision phacoemulsification. . . . While in its infancy, FLACS sets out the exciting possibility of a new level of precision in cataract surgery. However, further work in the form of large scale, phase 3 randomised controlled trials are required to demonstrate whether its theoretical benefits are significant in practice and worthy of the necessary huge financial investment and system overhaul. Whether it gains widespread acceptance is likely to be influenced by a complex interplay of scientific and socio-economic factors in years to come. 

Use of this equipment was not covered by Medicare at the time of purchase by the University:

[P]reliminary published research has not been scientifically powerful enough to persuade private insurers or Medicare -- which pays for about 8 of every 10 conventional cataract procedures in the United States -- to compensate providers for the extra cost of using femtosecond lasers in cataract surgery. Practitioners are prohibited from billing Medicare beneficiaries for costs that the federal insurance program will not pay.  

"[But] in truth, you can't add femtosecond surgery [to your practice]," William W. Culbertson, MD, a professor of ophthalmology at Bascom Palmer Eye Institute in Miami, Florida, said. "You would lose money on every procedure." 

Or, as summarized here:

The use of a femtosecond laser during cataract surgery is a new and exciting option but an extremely expensive one. It raises important questions about reimbursement as well as the technology’s potential. 

There have also been concerns raised about training residents and fellows on this equipment.  At the University of Illinous, this became the topic of a research study:

Ophthalmology residents and fellows at the University of Illinois at Chicago performed a retrospective study comparing their experiences performing cataract surgery with and without the femtosecond laser. The 6-month results were reported at the 2013 meeting of the Association for Research in Vision and Ophthalmology.

The researchers concluded that resident surgeons on the initial learning curve for cataract surgery are capable of safely learning standard phacoemulsification techniques along with use of the LenSx Laser system. In addition, the LenSx Laser system appears to allow cataract extraction with less energy, which may result in improved long-term outcomes.

Was Alcon involved in sponsoring this research?  As noted in this February 2014 advertising supplement, Dr. de la Cruz--the lead faculty author for the research project--has received funding from the company (although his 2013 Statement of Economic Interests contains no hint of that.  Perhaps it will be included in the 2014 report.)

Did Dr. Azar recuse himself from any involvement in the decision to conduct the research or any aspects of it, given his relationship with Novartis?

Alcon involvement in University education programs

Beyond these matters, it is well documented and disclosed that Alcon supports continuing medical education programs at the University. Here's one example:

As Joan Miller notes in her comment above, this is not unusual and--properly disclosed--can be of value to all.  That's not the issue at the University of Illinois.  The issue at UIC is whether there is anything about the dual positions held by Dr. Azar that lead to his involvement in the decision to invite or include Alcon--particularly in preference to other ophthalmic equipment suppliers--to be the sponsor of such programs.

Conclusion

I for one believe it would take a superhuman effort on the part of the Dean to recuse himself from every financial analysis, purchase decision, research decision, and educational decision at the University of Illinois that has the potential to involve Novartis or its competitors.  As noted, I am in no way asserting or implying that this superb physician and researcher has improperly benefited or that he has failed to disclose under state law or University policy.  What I am saying is that both institutions require a person to exercise a proper duty of care and loyalty to each of them.  It is inconceivable to me that this is possible in this case, not only in terms of time commitment, but also in terms of the overlapping scientific research and clinical interests of the two organizations.

It is this matter that faces the Trustees of the University of Illinois.  It is this matter of public trust.