This is a response to an email message posted to a2k and ip-health by Dr. Mary Moran. Among other things, the missive raises the issue of what constitutes a conflict of interest, and also how such conflicts should be managed. Dr. Moran has asked for a response, and this is it.
Dear Dr. Moran,
I am replying to your recent message sent to the a2k and ip-health lists which seems to have been sent as a response to an earlier post concerning the appointment of Paul Herrling to the WHO Consultative Expert Working Group (CEWG) on R&D Financing.
As you know, Dr. Herrling is the author of the FRIND proposal, and according to Novartis, the co-author with you and Holly Wong, of the PDP Plus proposal. On 20 January 2011, KEI, and eight other NGOs involved in global health wrote a letter to the WHO Executive Board, objecting to the Herrling appointment to the CEWG, on the grounds that it would inappropriate for him to participate in the review of his own proposal.
Your experience with the previous Expert Working Group (EWG), was mentioned in my 18 January 2011 blog (https://www.keionline.org/node/1058), on “Conflicts of Interest, and the WHO evaluation of the FRIND and the PDP Plus funding proposals by the CEWG,” briefly, in the context of having given “top rating to two spending proposals never formally submitted to the group,” including one you authored, and another by IAVI, “a group for which Moran was a consultant.” Because your dual role of author and evaluator during the previous EWG was already a source of concern, it was surprising that the WHO would appoint one of your co-authors in PDP Plus to the new CEWG.
With regard to the CEWG, if Paul Herrling is a co-author of PDP Plus, do you think he should evaluate the proposal for the CEWG? Your answer will be informative, regarding to your own perception of what constitutes a conflict of interest, and also how such conflicts should be managed.
In your missive, you suggest that your own authorship of the Industry Research and Development Facilitation Fund (IRFF) did not present an usual conflict, because another EWG member was Mark L. Rohrbaugh from the NIH, and the EWG said kind things about the NIH SBIR grants, and because the EWG also said kind things about the UNITAID patent pool, and Dr. Philippe Douste-Blazy, the Special Adviser to the UN Secretary-General on Innovative Financing for Development, was the Chair of the UNITAID Executive Board. You also object to having mentioned your consultancy with IAVI, on the grounds that the relationship was old and not relevant.
Here are a few comments on your missive.
1. While there were many EWG members and some staff support from the WHO, your role on the EWG was, by all accounts, extraordinary, in terms of the amount of the analysis that you wrote or supervised. This is how the IFPMA described your role in its own internal analysis (http://bit.ly/ifpma-overview), as published by Wikileaks:
As far as the methodology is concerned, Mary Moran, the coordinator of the proposals review process has grouped the proposals in six broad categories and matched their performance against the above indicated criteria and acceptability to target groups. . . . For each of the categories she drew conclusions and identified which are the proposals that best and worst scored.
Informally, some EWG members and WHO staff have also made it clear that you played a very key role, and indeed, the fact that the Secretariat provided you with a consulting contract (APW) to do the evaluation, and wanted you to explain the report to the WHO EB was further evidence of this, as were the many background documents prepared for the EWG and now available from the WHO web site. (links here).
2. While the mention of the UNITAID patent pool was seen positively by many public health groups, it was hardly the focus of the group’s work, which concerned the sustainable financing of R&D. As far as we know, Dr. Philippe Douste-Blazy was appointed to the WHO EWG in his capacity as Special Adviser to the UN Secretary-General on Innovative Financing for Development and does not appear to have financial interest in the outcome of EWG’s work.
3. The fact that Mark Rohrbaugh worked for the NIH, and the NIH runs an SBIR grant program is true. But what is this about? Was Mark Rohrbaugh asking for the EWG to fund the SBIR grant program? No. The SBIR program was established under the Small Business Innovation Development Act of 1982 (P.L. 97-219), and is funded by the US Congress. Plus, Mark Rohrbaugh is a federal employee, not a potential recipient of SBIR grants. We don’t see how anyone would perceive this as a conflict.
4. Thank you for providing some information about work with IAVI (A group whose work we support). Before your email, this is what we knew. You were appointed to the EWG in late 2008, and began your work on the EWG in 2009. Last year you refused to provide Malini Aisola information about the clients of your firm, but Aisola did note that in a paper published on February 3, 2009, after the first meeting of the EWG, you declared having received grants from IAVI. You can certainly further clarify the timing and nature of that relationship, which you yourself declared, as a “competing interest” to PloS. But we are certainly satisfied with the explanation you have given in the email sent to the a2k and ip-health lists. I will note that as regards the EWG, your consulting relationship seemed worth noting in part because IAVI never submitted a proposal to the EWG, yet its unpublished and private proposal ended up having been on the top recommendations for the EWG. And, of course, now that the IAVI, IFPMA/FRIND and Moran proposals have been combined into a single PDP Plus proposal, and one of the co-authors has been appointed to the new group, there is of course the continued collaboration of a, if not the, leading funding proposal to be considered by the CEWG.
5. At the time when you served on the EWG, the WHO official bio said: “Dr Mary Moran of Australia is the Director of the Health Policy Division of the George Institute for International Health in Sydney, Australia. She founded the Pharmaceutical R&D Policy Project at the London School of Economics & Political Science, which is now located at the George Institute.” Last year it was pointed out that the George Institute receives extensive funding by the private for-profit pharmaceutical industry. Last year you added some additional information about the relationship by pointing out that you had a for profit consulting firm that had a contract with the George Institute. So, when the EWG was done, you were either working for a pharmaceutical company funded organization (the George Institute), or working for a for-profit consulting firm, or some combination of both (a consulting firm then working out of a non-profit entity that is partly funded by drug companies). In any event, this is quite different from a civil servant or someone whose primary job is as an academic expert.
Next, consider the nature of the proposals themselves. Your initial proposal endorsed by the EWG was the Industry R&D Facilitation Fund (IRFF). This is described by Results for Development as follows:
The Industry R&D Facilitation Fund (IRFF) is a pooled funding mechanism that would provide secure funding to select Product Development Partnerships (PDPs). The PDPs would receive fixed shares from a pooled fund and must use the funding to expand contracts with the private sector. The funding intends to be flexible, allowing the PDPs to rely on their own expertise in managing their research portfolios. Having a source of predictable funding may also encourage biotechs and pharmaceutical companies to work with PDPs as there is a lesser risk of funding fluctuation. Additionally, a pooled fund may persuade donors, who are unfamiliar with the science of product development, to invest money in a group of PDPs. This eliminates the need to evaluate each PDP individually.
In some versions, the IRFF would provide a subsidy of 80 percent for money given to for-profit pharmaceutical and biotechnology companies. The subsidy for money spent on activities by non-profit institutions would be zero.
It is easy to see how such a proposal might find favor with the for-profit pharmaceutical industry. Do you think that asking for-profit pharmaceutical companies to review such a proposal presents any problems? Or, is this no different than asking non-profit entities, governments or academics to participate in the review?
Finally, the IFPMA/Novartis/FRIND, the IRFF, the Product Development Partnership Financing Facility (PDPFF), and the PDP Plus proposals all call for billions in subsidies that directly benefit private pharmaceutical companies. In the context of building political support for funding such proposal, do you think that PDP organizations benefit from a public perception that the private pharmaceutical companies are directly represented on the entities conducting the review of the proposals, or are the primary authors of the proposals? It may be the case that the WHO review process should exclude these parties, in order to build more confidence in the evaluation, making it arguably easier to fund whatever the CEWG ends up endorsing.
Kind regards,
Thirukumaran Balasubramaniam
Knowledge Ecology International