[Ip-health] Response to Mary Moran on managing conflicts of interest at the WHO CEWG

Thiru Balasubramaniam thiru at keionline.org
Mon Jan 24 10:58:27 PST 2011


http://keionline.org/node/1065

Response to Mary Moran on managing conflicts of interest at the WHO CEWG


By thiru
Created 24 Jan 2011 - 11:31am
This is a response to an email message posted to a2k [1] and ip-health  
[2] 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 [3] to the WHO Executive  
Board, objecting to the Herrling appointment to the CEWG, on the  
grounds that it would in 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 (http://www.keionline.org/node/ 
1058 [4]), 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.” The fact  
that your dual role of an author and an evaluator was the source of  
concern  regarding the previous EWG; consequently, 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 
  [5]), 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 [6]).

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 [7]), 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 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 [8]. 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 [9] 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 spend 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



Source URL: http://keionline.org/node/1065
Links:
[1] http://lists.keionline.org/pipermail/a2k_lists.keionline.org/2011-January/000365.html
[2] http://lists.keionline.org/pipermail/ip-health_lists.keionline.org/2011-January/000652.html
[3] http://keionline.org/node/1063
[4] http://www.keionline.org/node/1058
[5] http://bit.ly/ifpma-overview
[6] http://www.who.int/phi/ewg_response_wha63_28/en/index.html
[7] http://history.nih.gov/research/downloads/PL97-219.pdf
[8] http://keionline.org/node/758
[9] http://keionline.org/healthresearchpolicy.org/content/industry-rd-facilitation-fund-irff 
”







------------------------------------------------------------


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997








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