NephMadness 2016: KDIGO Talks COI
Submit your picks! | For more on NephMadness 2016 | #NephMadness or #MisstepsRegion on Twitter
Researching and writing the missteps section on normalization of hemoglobin, Joel Topf couldn’t avoid the feeling that the KDOQI guidelines played more than an insignificant role in that misstep. That, along with John Ioannidis’ recent contention that evidence-based medicine has been “hijacked“, led to the obvious question, “Where do we stand now? How has KDIGO insulated itself from commercial bias?” To find out, Joel [JT] sent a series of questions to KDIGO CEO, Dr. John Davis (JD). Here is that e-mail interview.
JT: How does KDIGO fund their activities?
JD: KDIGO receives funding from a variety of sources. At present about 80% is from industry. KDIGO is totally transparent and makes all funding public and acknowledges the support in publications, signage, announcements from a podium, and on its web site. It has an active program attempting to broaden its base of support to include other organizations, individuals, and non-pharma companies. With the exception of guidelines themselves, funding is sought for all its activities such as Controversies Conferences, Clinical Practice Conferences, Expert Roundtables, Implementation Kits, and educational tools. No funding is solicited or accepted for guidelines or guideline updates. Those are financed by general KDIGO funds.
JT: How does KDIGO insulate guideline development from industry influence?
JD: KDIGO does not solicit funds from any company for a guideline or guideline update. This is an overt policy approved by the KDIGO Executive Committee and diligently followed by its staff and volunteers.
JT: Do you think disclosure of COI is enough from a guideline committee or do you need to court guideline committee members that are free from COI?
JD: KDIGO always seeks the best in the world to serve on Guideline Work Groups. Such well-known and respected scientists sometimes have long standing relationships with industry as investigators and advisors. These relationships are fully disclosed. They are discussed openly and known to every member of the Work Group. The relationships are published with the work product of the group and are disclosed from the podium in all presentations on the work. They are the first slide in any presentation given by a KDIGO volunteer.
JT: Can you give an example of a time when you had to say “No that plan has to change” because of COI issues?
JD: KDIGO was approached by a company wanting KDIGO to produce and publish an educational tool following a Controversies Conference on a product that had not been discussed at the Conference. In fact, that product had not yet been approved by the FDA at the time of the Conference. KDIGO declined the work.
JT: Do you view pharmaceutical companies any different from diagnostic companies, imaging companies, device companies, or dialysis providers? Is a commercial entity a commercial entity or is there some daylight between those in terms of how you treat them when it comes to COI reporting?
JD: KDIGO sees no difference between the type of commercial entity it works with whether it is a pharmaceutical company or a provider. All companies are treated the same and KDIGO imposes the same standards and practices with any corporate partner.
JT: I had been under the impression that KDIGO had better isolation from commercial interests than we saw with KDOQI in 2006, but I go to http://kdigo.org/home/partners/ and my confidence is shaken. If the perception of conflict is nearly as toxic as actual conflict of interest, how do you assure guideline users of unbiased evidence analysis?
JD: The partners listed on the KDIGO website have supported the programs previously mentioned: Controversies Conferences, Clinical Practice Conferences, Expert Roundtables, Implementation Kits, and educational tools. KDIGO’s work is totally isolated from any corporate influence in its content. Staff members who are involved in fundraising do not attend Guideline Work Group meetings.
JT: Does KDIGO have financial oversight?
JD: It certainly does. KDIGO has a volunteer Secretary/Treasurer who reviews all its financial information and reports it to the Executive Committee at every meeting. KDIGO is a Belgian foundation in the public interest and is subject to Belgian and European Union laws and regulation and institutional oversight. It has an outside accounting firm that prepares its financial reports and an independent auditor that does an annual audit and files the appropriate reports with regulatory authorities.
JT: Does KDIGO leadership address these issues regularly?
JD: Absolutely. The Co-Chairs and Executive Committee have this on their agenda regularly. In the mid-1990s when guidelines in nephrology started, every organization doing guidelines developed their own system. There were questions then about corporate influence. They were more perception than reality, but were taken seriously. Things changed dramatically since then and KDIGO adheres to the strictest standards of integrity. Its processes and methodology have been published in peer-reviewed journals and vetted by experts in the medical ethical field. Every precaution is taken to prevent any perception of non-compliance and absolute prevention of any actual interference. With 18 members of a Work Group or Steering Committee some notification would have come to KDIGO leadership if there had been any attempt at corporate interference. None has. KDIGO relies on total transparency and full disclosure. Other sources of funding, such as government funding, are inadequate and potentially lead to bias and limitations. KDIGO stands by its record and will continue to serve the global kidney community with integrity and dedication to the goal of improving global outcomes for patients.
John Davis is the Chief Executive Officer of Kidney Disease: Improving Global Outcomes or KDIGO. He serves as a Trustee of the corporation registered in Belgium as a Foundation in the Public Interest. He has held those positions since 2004.
John has had more than 30 years experience in the world of medical not-for-profit. Until 2011, he was the Chief Executive Officer of the National Kidney Foundation (NKF), a US charity.
He led NKF’s innovations in education, communication, program development, program implementation, events and fundraising in the United States and in other countries. He has written extensively on all aspects of kidney disease; its detection, treatment and prevention.
This is a fascinating post about a topic which is not discussed enough. I think a truly critically important aspect of guidelines, including the KDIGO guidelines, is the evidence review team and the leadership role that they take in the guidelines. As someone who served on a KDOQI guideline group and participated in these discussions, there is such a tendency to promote opinion (in many cases very expert) and logic, even if the evidence base is not quite sufficient. This is human and likely reflects intellectual bias more than economic bias, although the extent to which our intellectual biases are influenced by commercial factors is far harder to quantify. To ground the discussions and keep them within the sphere of evidence, the evidence review teams, which should have no conflicts, really are critical, and, in my experience, particularly since the anemia guideline, have been very good at this. The Mineral and Bone Disorder Guideline I think is a great example of this, where almost all statements are grade C (low evidence quality), D (very low) or ungraded/opinion, as appropriately reflects the available data at that time.
Guidelines are increasingly important as payers and providers struggle to quantify quality and payers tie reimbursement to quality. Accordingly, this post and interview really is an amazing look into the generation of the framework of what ultimately can become a quality metric and the biases that could be at play.