Subj: Need for intensified collaboration on Program Effectiveness Research
Date: 7/13/2004 9:25 AM EDT
To: Anthony S. Fauci, NIAID; Jim Kim, WHO
cc: [many to list]
From: Mark Harrington, TAG

Dear Tony & Jim –

Your responses to questions today about collaboration between NIH, WHO, PEPFAR, and other funders, technical and research agencies, and countries involved in scale up of HIV prevention and ART programs in resource-poor settings were disappointing and inadequate. With the approaching recompetition of the $500M/year NIH clinical trials networks and the scale up activities taking place under the aegis of GFATM, 3x5, and PEPFAR comes a precious opportunity to coordinate program evaluation and research activities which would enable everyone to benefit from better information about effective program interventions. At this morning's press conference and (Jim) at this afternoon's rather sterile and futile leadership session on operational research you talked past eachother. Tony, you said that NIH was committed to supporting research relevant to scale-up in RPS as part of the recompetition, but there has been no serious involvement of WHO, other international agencies, or program implementation officers or researchers from developing countries in setting the NIH structure and agenda for the clinical trials recompetition. Jim, you said that when you raised these issues with Tony in April that the response was that "We are NIH, we don't do operational research because it is not hypothesis driven and does not involve randomized controlled trials." Of course there are many kinds of studies including cohort studies, outcome studies, when-to-start studies, MTCT prevention studies, optimization of therapy, cotrimoxazole and isoniazid prophylaxis studies, vaccine, microbicide, behavioral prevention or harm reduction studies, treatment adherence and support stuides, studies of clinical algorithms for initiating and monitoring therapy, etc., etc., which are hypothesis driven and sometimes can be randomized in innovative ways, e.g., by site or by district. Meanwhile NIH has spent 2½ years and millions of dollars setting up international treatment trial sites for the Adult & Pediatric AIDS Clinical Trials Groups without yet enrolling a single patient at an international site in a study designed by international researchers for their own country setting. NIH with an AIDS research budget of $3 billion is positioned to help answer critical questions relevant to evaluating and improving scale-up related program activities. There is already a precedent for effective collaboration among multiple funders and technical agencies in the Monitoring & Evaluation Toolkit agreed to by WHO, World Bank, Unicef, UNAIDS, USAID, Department of State, HHS, CDC, and GFATM and published in June 2004. All 192 member states of the WHO including (even though it often does not seem that way) the USA have endorsed the goals of 3x5 and the UNAIDS "three ones" framework which provides a template for donor and recipient country collaboration with technical agencies on HIV related program activities to avoid wasting time and money on duplicating efforts or leaving critical questions unaddressed. I appeal to you on behalf of those who desperately need effective AIDS prevention and treatment programs to intensify immediately your collaboration by committing publicly and meaningfully to a much stronger partnership to create, implement and support the program effectiveness research agenda in conjunction with and as part of the scale-up activities for HIV prevention and treatment with all relevant stakeholders including affected communities, governments, donors and technical and research agencies. You have the ability to make a difference and cannot afford to miss the opportunity posed by PEPFAR, 3x5, GFATM, etc., to fulfill the responsibilities that go with your leadership.

Yours,

— Mark

Subj: Need for intensified collaboration on Program Effectiveness Research
Date: 7/14/2004 10:22:35 PM EST
From: Jim Kim, WHO
To: Mark Harrington, TAG; Anthony Fauci, NIAID
cc: [many to list]

Hi Mark,

As always, I am very grateful for your commitment to pushing the fight against AIDS forward. Dr. Fauci and I indeed had a good conversation in April but I want you to know that what I said at the meeting was not a quote from him but my own opinion. Dr. Fauci did not give me a yes or no on collaboration between WHO and NIH on operational research but as in April, I remain very eager to initiate a collaboration between NIH and WHO on this topic. As I made clear at the Satellite, a much broader, more intensive operational research agenda with activities to match is needed immediately. I will follow up.

Jim
Jim Yong Kim
Director, Department of HIV/AIDS
World Health Organization

The argument in ten points

1. NIH and WHO need to work together. Currently they are not.

2. We want the US to work with other donors, technical and research agencies and recipient countries to establish a transparent framework for addressing the most important operational research questions related to scale up of HIV testing, prevention, and treatment in resource poor settings, to ensure that PEPFAR, 3x5 and GFATM programs maximize their effectiveness and continually improve their program interventions.

3. NIH as the flagship of the world AIDS research effort must play a critical role in this process.

4. Currently NIH is not working with the other stakeholders listed above to develop a comprehensive and coordinated program effectiveness research agenda (NIAID has trouble working with other institutes at NIH let alone other US or international agencies or donor and recipient governments).

5. The concurrent timing of scale-up and the NIH trials recompetition provides a unique opportunity to synchronize research with program implementation.

6. A new culture of partnership among stakeholders is necessary for success.

7. We have learned in the last twenty years how to do these partnerships in the research programs in developed countries (and we have also learned some things to avoid).

8. We need to find out what happens to people who enter VCT, MTCTP, DOTS, TB/HIV and ART programs. This means cohorts, recording, reporting, monitoring, evaluation, and quality assurance. Done correctly, this could provide the framework for considerably better information about what works than what we have currently. Pilot projects like MSF or Partners in Health report relatively rosy outcomes because a) they are well funded outside of the public sector, b) they have charismatic leadership and hands-on medical expertise, c) they are small pilot projects not country-wide scale-up projects, d) they do not necessarily have systems to record outcomes for all participants, including toxicity switches and losses to follow-up. Since there are no drugs for toxicity switches the incentive to record toxicity requiring such switches is reduced. (An example: in Bangkok, MSF reported losses to follow-up plus treatment success as equaling the total number of survivors. Of course, since 10-15% were lost to follow-up we really do not know if they were alive at all.) (Another example: Kenya reports 100% DOTS implementation, based on the WHO definition of DOTS availability in a district as equaling DOTS implementation, regardless of the number of cases detected or successfully treated in such programs. However fewer than 50% of TB cases are reported in Kenya in the DOTS program. So the availability of a DOTS clinic in a district does not mean that people with TB are using it. Since countries report their own data to WHO and funders, they have a huge incentive to 'optimize' their outcomes. There need to be independent quality assurance (QA) procedures to address this problem.)

9. Other partners, e.g., PEPFAR, 3x5, GFATM, must commit to meaningful participation in recording, reporting, monitoring, evaluation, QA, etc. But NIH with its abundant resources and its mission must play a key role and so far has failed to do so. Simply giving the same money to the same US based networks will not solve the problem. New mechanisms and partnerships are necessary.

10. We expect Tony Fauci to exert leadership in bringing NIH resources to the table to contribute to this worldwide health research emergency. We expect Jim Kim to exert leadership in bringing WHO and its partners to collaborate effectively with NIH and other research agencies to carry out the necessary agenda.