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Viewing cable 07JAKARTA310, AVIAN INFLUENZA (AI) SAMPLE SHARING UPDATE

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Reference ID Created Released Classification Origin
07JAKARTA310 2007-02-06 07:41 2011-08-24 01:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Jakarta
VZCZCXYZ0004
RR RUEHWEB

DE RUEHJA #0310/01 0370741
ZNR UUUUU ZZH
R 060741Z FEB 07
FM AMEMBASSY JAKARTA
TO RUEHC/SECSTATE WASHDC 3155
RUEHPH/CDC ATLANTA GA
INFO RUEAUSA/DEPT OF HHS WASHINGTON DC
RUEHRC/USDA FAS WASHDC
RHEHNSC/NSC WASHDC
RUEHRO/AMEMBASSY ROME 1978
RUEHFR/AMEMBASSY PARIS 0977
UNCLAS JAKARTA 000310 
 
SIPDIS 
 
SENSITIVE 
SIPDIS 
 
DEPT FOR EAP/MTS, G/AIAG AND OES 
DEPT PASS TO USAID/ANE/CLEMENTS AND GH/CARROLL 
DEPT ALSO PASS TO HHS/WSTEIGER/ABHAT/MSTLOUIS AND HHS/NIH 
NSC FOR JMELINE 
 
E.O. 12958: N/A 
TAGS: TBIO AMED CASC EAGR AMGT PGOV ID
SUBJECT: AVIAN INFLUENZA (AI) SAMPLE SHARING UPDATE 
 
REF: A) Jakarta 00264    B) Jakarta 00107 
 
1. (SBU) Summary.  The Mission continues working to reverse the 
January 11 verbal directive from the Indonesian National Institute 
of Health and Research Development (NIHRD) instructing NAMRU-2 to no 
longer ship AI specimens to the U.S. Centers for Disease Control and 
Prevention (CDC) until NAMRU-2 signs a Materials Transfer Agreement 
(MTA).  The Ambassador briefed Senior UN System Coordinator for 
Avian and Human Influenza Dr. David Nabarro on the issue on February 
4, and the DCM discussed the issue at length on January 31 with 
NIHRD Director Triono Soendoro.  Visiting CDC influenza branch 
official Dr. Reuben Donis raised the issue with Triono and Director 
General for Disease Control and Environmental Health Dr. Nyoman 
Kandun on February 2.  We have also briefed the World Health 
Organization (WHO) office in Jakarta on the issue.  After more than 
a week of emotional reactions to the issue, Triono has floated the 
idea of concluding an agreement between the NIHRD and CDC to allow 
the flow of samples to restart, an idea we believe has merit.  We 
accordingly recommend no additional Washington action at this time 
pending further discussions between the CDC and NIHRD. 
 
2. (SBU) Summary, continued.  A number of factors appear to be 
driving the Ministry of Health's (MOH) approach to the issue, 
including a lack of understanding about how the WHO reference 
laboratory system works for influenza surveillance, a lack of 
understanding of the capabilities of Indonesia's own laboratories, 
the commercial interests of Indonesia's state-owned pharmaceutical 
companies, frustration over Indonesia's failure so far to benefit 
from research into the Indonesian H5N1 strain, and concerns about 
Indonesia's ability to pay full retail price for the millions of AI 
vaccine doses it hopes to stockpile.  A February 6 Financial Times 
report quotes Triono confirming that the GOI is withholding AI 
samples because it wants to keep control of the intellectual 
property rights of the AI virus.  He reportedly added that the GOI 
would make a major announcement on February 7 of collaboration with 
Baxter International on the development of an AI vaccine.  End 
Summary. 
 
Triono Describes Concerns during Meeting with DCM 
--------------------------------------------- ---- 
 
3. (SBU) At their January 31 meeting, NIHRD Director Dr. Triono 
Soendoro explained the Ministry of Health's concerns about sample 
sharing to the DCM.  Triono said pharmaceutical companies had 
developed AI vaccines using information from Indonesian AI strains 
without permission and that Indonesia would not benefit from use of 
these strains.  Triono explained that the GOI planned to acquire 5 
million doses of vaccines but now faced having to pay USD 15 for 
each dose.  GOI officials and Parliamentarians are criticizing NIHRD 
for having openly shared samples and posted data on the Genebank, 
without requiring organizations receiving Indonesian samples to sign 
MTAs.  Triono also complained about international researchers 
involved in AI research making uncoordinated public announcements 
about AI in Indonesia or publishing studies on AI without prior GOI 
consultation, further upsetting the GOI. 
 
4. (SBU) The DCM raised concerns that stopping sample flows are 
preventing WHO referral labs from performing full virus 
characterization.  Without full virus sequencing, Indonesia and the 
world will be blind to possible virus changes that could make a 
pandemic more likely.  He noted our concerns that the people of 
Indonesia and the world would suffer the consequences of this GOI 
decision.  At the very least, the international community will see 
Indonesia as jeopardizing global public health and, as a result, 
Indonesia would lose international standing.  However, Triono 
dismissed these concerns and denied that Indonesian researchers are 
not capable of performing full virus characterization.  He claimed 
that researchers at the Eijkman Institute in Jakarta are conducting 
full virus characterization of AI samples and that an Eijkman BSL-3 
laboratory is almost complete.  (Note: Eijkman is capable of 
sequencing amplicons, and has the capability to sequence from each 
gene of the influence of virus, but cannot yet perform full genome 
sequencing.  Without a BSL-3 lab, it also cannot grow the virus to 
conduct biological tests against drug resistance.) 
 
5. (SBU) Triono admitted that MOH officials face enormous pressure 
on the sample control and MTA issue from other GOI agencies and 
Parliament.  He asked why the USG was reluctant to sign a MTA when 
other countries expressed willingness to do so, citing Korea and 
Singapore as examples.  Triono noted other WHO collaborating centers 
in Australia, Japan and the United Kingdom might also be candidates 
for sharing samples if they are willing to sign an MTA. (Note:  We 
understand that the WHO Reference Centers in Tokyo and Melbourne 
have reviewed the MOH's draft MTA and will not sign it.) 
Nonetheless, Triono expressed interest in resolving the current 
sample-sharing blockage and discussed possible ideas for doing so, 
including USG subsidies for the purchase of vaccine needed by 
Indonesian government workers, some sort of joint venture between 
U.S. and Indonesian pharmaceutical companies to develop a H5N1 
vaccine, and a more flexible U.S. approach to the MTA. 
 
CDC Influenza Branch Official Briefs GOI Officials 
--------------------------------------------- ----- 
 
6. (SBU) On February 1-2, visiting CDC influenza branch official Dr. 
Ruben Donis met Triono, Director General for Disease Control and 
Environmental Health Dr. Nyoman Kandun,  and other NIHRD and Eijkman 
Institute staff.  Donis described the necessary research steps for 
full characterization of the AI virus, and explained that growing 
the virus requires sufficient concentrations of genetic material 
that will allow researchers to do full sequencing.  He stressed the 
importance of sequencing from purified virus isolates grown in a 
BSL-3 facility as opposed to characterization of small fragments, or 
amplicons, as is currently conducted by research scientists in 
Indonesia.  Dr. Donis also reviewed with NIHRD the added importance 
of studying virus binding sites and conducting anti-viral testing on 
isolates.  (Note: Indonesian researchers cannot conduct these 
studies at this time.)  Dr. Triono noted that the Eijkman 
Institute's BSL-3 laboratory would not open for another few months. 
With limited analyses only, Indonesian researchers cannot determine 
when subtle but important changes in the virus occur. 
 
7. (U) Donis also explained that WHO referral labs have two main 
objectives for virus study: risk assessment and vaccine development. 
 Donis clarified that as a WHO-Influenza Reference Center, CDC is 
not concerned with vaccine production and vaccine marketing.  CDC 
objectives are to promote public health through promotion of vaccine 
development by open sharing of information.  This fosters 
competition which then drives down the price of vaccines and allows 
for greater vaccination programs.  During the meeting, NIHRD staff 
 
also described a partnership between state-owned pharmaceutical 
company BioPharma and Baxter International Laboratories that has 
produced what they claimed to be an effective human AI vaccine. 
NIHRD officials praised this partnership as a possible model for 
future vaccine development. 
 
8. (SBU) In his meetings with Donis and the DCM, Triono praised the 
NIHRD's interactions with NAMRU-2 and expressed strong support for 
keeping collaboration going.  He has emphasized the need for more 
time to find constructive solutions and requested that the USG not 
increase pressure on the issue at this time.  He said he would 
discuss with Minister of Health Dr. Fadilah Supari the possibility 
of the NIHRD and CDC concluding an agreement on sample sharing that 
would remove NAMRU-2 from the middle of the MTA issue and allow the 
sample flow to resume. (Comment: One possible approach for the 
NIHRD-CDC agreement would be to incorporate language from January 
2007 WHO best practices documents on influenza viruses and sequence 
data sharing that reiterates the obligations of WHO member states to 
share influenza samples for risk assessment and vaccine development 
purposes, but also calls on the WHO Director General to "take 
appropriate action" if a WHO collaborating center or H5 reference 
laboratory misuses a virus for research or commercial purposes.) 
 
Competition with Indonesian Vaccine Developers? 
--------------------------------------------- -- 
 
9. (U) On January 30, Reuters ran a newswire about CSL, an 
Australian plasma products maker that has successfully developed an 
AI vaccine that may be ready for widespread use within six months. 
The next day, Minister of Health Supari reportedly criticized the 
firm for using Indonesian virus samples for the vaccine "without 
Indonesia's permission" because the Indonesian H5N1 strain is 
"Indonesia's intellectual property."  Siti also revealed that 
Indonesia is developing its own vaccine in cooperation with the 
American Pharmaceutical company Baxter International.  (Note: 
NAMRU-2 researchers tell us that CSL produced its vaccine via 
reverse genetics from a DNA sequence from an Indonesian H5N1 virus 
isolate obtained from a website at the U.S. National Institutes of 
Health.  On August 3, 2006, Supari gave the WHO-Influenza Reference 
Centers permission to post sequence information from Indonesian 
viruses for the purpose of additional study and vaccine 
production.) 
 
Press Gets in on the Story 
-------------------------- 
 
10. (SBU) On February 1, we also briefed Indonesia WHO Director 
George Peterson on the sample sharing issue in anticipation of UN 
System Senior Coordinator for Avian and Human Influenza David 
Navarro's February 2-4 visit to Indonesia of February 4.  Peterson 
expressed serious concern about the development and promised to 
immediately contact WHO Geneva and alert Navarro to the 
developments.  The Ambassador spoke with Nabarro via telephone on 
the issue on February 3, emphasizing our view that this is an 
international issue that requires all of our attention.  Nabarro 
said he would raise the issue in his meetings. 
 
11. (SBU) A Jakarta-based Financial Times (FT) reporter questioned 
Nabarro aggressively on the issue at a February 4 press conference, 
asking Nabarro and National Committee for AI Control and Pandemic 
Preparedness (KOMNAS) Executive Director Bayu Krisnamurthi 
repeatedly if Indonesia had stopped sharing AI samples.  Neither 
Nabarro nor Krisnamurthi answered the question directly; 
Krisnamurthi noted only that the issue remains "under discussion." 
On February 6, the FT ran a story quoting Triono confirming that the 
GOI is withholding AI samples because it wants to keep control of 
the intellectual property rights of the AI virus.  He reportedly 
added that the GOI would make a major announcement on February 7 of 
collaboration with Baxter International on the development of an AI 
vaccine. 
 
12. (SBU) Comment:  We are inclined to believe Triono's claim that 
he is facing strong pressure on the sample sharing issue and wants 
to resolve it quickly, and recommend no additional Washington action 
at this time pending further discussions between the CDC and NIHRD. 
But Triono likely has little time--now that press has picked up the 
fact that AI sample sharing has stopped, pressure on the GOI is 
likely to increase, particularly if Indonesia reports another large 
cluster as happened in January.  End Comment. 
 
PASCOE