VZCZCXRO9542
PP RUEHAST RUEHDH RUEHHM RUEHLN RUEHMA RUEHPB RUEHPOD RUEHSL RUEHTM
RUEHTRO
DE RUEHKO #2551/01 3090704
ZNR UUUUU ZZH
P 050704Z NOV 09
FM AMEMBASSY TOKYO
TO RUEHC/SECSTATE WASHDC PRIORITY 7262
INFO RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE
RUEHFK/AMCONSUL FUKUOKA 7254
RUEHNAG/AMCONSUL NAGOYA 4482
RUEHNH/AMCONSUL NAHA 9609
RUEHOK/AMCONSUL OSAKA KOBE 1073
RUEHKSO/AMCONSUL SAPPORO 7765
RUEHGV/USMISSION GENEVA 3610
RUEAUSA/DEPT OF HHS WASHINGTON DC

UNCLAS SECTION 01 OF 02 TOKYO 002551 
 
 
DEPT FOR EAP/J AND OES/IHB 
HHS PASS TO NIH/NCI 
HHS FOR OGHA 
DEPT PASS TO AID/GH/HIDN 
 
SENSTIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: TBIO KSTH ECON PGOV SOCI CASC JA
SUBJECT: ADVANCING U.S.-JAPAN COLLABORATION IN CANCER CLININAL 
TRIALS 
 
REF: TOKYO 1589 
 
TOKYO 00002551  001.2 OF 002 
 
 
¶1. (U) Summary:  Dr. Edward Trimble of the National Cancer Institute 
participated in a series of meetings and programs on October 20 and 
21 as part of Embassy Tokyo's ongoing effort to promote increased 
collaboration between U.S. and Japanese researchers in cancer 
clinical trials.  The activities built on the momentum of a highly 
successful workshop in July (reftel) by increasing awareness of the 
issue among Japanese parliamentarians, patient groups, and 
government officials.    End Summary. 
 
¶2.  (SBU) In cooperation with the Tokyo American Center (TAC), 
Econoffs organized a series of programs for Dr. Edward Trimble of 
the National Cancer Institute designed to raise awareness of the 
importance of international collaboration in cancer clinical trials. 
 U.S. and Japanese researchers agree increased cooperation in 
developing drugs to combat cancer would benefit patients in both 
countries and highlight how strengthened bilateral ties in science, 
technology, and medicine can improve human lives.  Although the 
number of international clinical trials and drug approvals has 
increased in Japan in recent years, they are still far fewer than in 
other advanced countries. Japanese cancer patients do not have 
access to the same cutting-edge drugs as their counterparts in the 
U.S. and Europe.  Meanwhile, the need for international 
collaboration in cancer clinical trials has grown stronger with 
advances in treatment and screening.  International collaboration 
can maximize resources and patients, and lead to more effective 
therapeutic strategies and drugs. 
 
¶3.  (SBU) Dr. Trimble's activities were designed around action items 
identified during the July workshop.  One such item was educating 
Japanese policymakers about the importance of government support for 
and facilitation of academic clinical trials, which, unlike trials 
administered by pharmaceutical companies, can focus on rare types of 
cancer.  To address this action item, TAC and the Embassy organized 
a "benkyo-kai" (study session) for members of the Japanese Diet. 
Given the recent election, which ushered in many new, reform-minded 
parliamentarians from the Democratic Party of Japan (DPJ), the 
timing was perfect.  Nearly a dozen legislators sitting on health 
committees and their policy staff attended the session, among them 
Eriko Fukuda, a young female DPJ legislator who gained national 
prominence as an activist representing hepatitis C victims, and 
Akira Koike, physician and member of the Communist Party (JCP). 
(Koike also arranged for an article on the event to be placed in the 
JCP newspaper Akahata - a first for TAC.)  The Ambassador opened the 
event, lending extra weight to the issue. 
 
¶4.  (SBU) The parliamentary "benkyo-kai" was followed by a study 
session for patient advocates, another group identified in Post's 
action plan as a key stakeholder in the effort to promote 
international collaboration.  Many Japanese patients, wary of side 
effects, are ambivalent about clinical trials.  Greater advocacy on 
the part of patient groups could compel policymakers to improve the 
clinical trial infrastructure in Japan.  Approximately ten 
representatives of patient advocacy groups attended the study 
session.  Dr. Trimble spoke about the National Cancer Institute's 
programs to educate the U.S. public about the benefits and risks of 
clinical trials and distributed materials the Institute uses for 
such public education. 
 
¶5.  (SBU) Dr. Trimble also met with several representatives of the 
Pharmaceuticals and Medical Devices Agency (PMDA), the main Japanese 
drug regulatory body.  PMDA staff expressed support for the concept 
of international collaboration in licensing trials, and told Dr. 
Trimble they encourage Japanese academic investigators to 
participate in global trials.  During the discussion, Dr. Trimble 
was able to dispel some myths that PMDA staff had about the U.S. 
model for cancer clinical trials, such as the belief that control 
groups in U.S. cancer trials are given only a placebo. 
 
¶6.  (SBU) Additionally, Dr. Trimble's program included meetings with 
a pharmaceutical company to learn about industry's role in improving 
the current state of the clinical trials infrastructure in Japan, 
called on a member of the Prime Minister's Council on Science and 
Technology Policy (CSTP), and held a roundtable discussion with 
Japanese public health experts.  His activities in Tokyo were 
followed by a keynote address at a major oncology conference in 
 
TOKYO 00002551  002.2 OF 002 
 
 
Yokohama on the subject of global clinical trials. 
 
¶7.  (SBU) Dr. Trimble's follow-up visit was highly successful in 
terms of accomplishing several goals in our action plan, in 
expanding our range of contacts on this issue, in raising awareness 
of the issue among several key groups and individuals, and in better 
understanding the opportunities and challenges in the endeavor to 
promote greater U.S.-Japan collaboration in clinical trials.  A 
series of related events held between the July 2009 workshop 
(reftel) and Dr. Trimble's October visit, including an oncology 
career development seminar sponsored by the Academy of Cancer 
Experts and TAC, have also highlighted the issue.  The National 
Cancer Institute and Embassy Tokyo have identified several areas for 
further action, including a proposed U.S. study tour for Japanese 
patient advocates under the auspices of the International Visitor 
Leadership Program (IVLP).  At a time when the media is focused on 
the security dimension of the U.S.-Japan relationship, we believe 
that programs like this can highlight other aspects of the of 
U.S.-Japan ties such as the kind of scientific collaboration that 
carries the promise of improving lives. 
 
 
ROOS