United States and China Sign Research Agreement on Traditional Chinese Medicine

On July 16, 2008, U.S. Health and Human Services Secretary Mike Leavitt and Chinese Vice-Minister of Health Wang Guoquiang signed a memorandum of understanding (MOU) agreement to foster collaboration between researchers studying integrative and traditional Chinese medicine (TCM) in both countries.

The MOU follows an earlier agreement, signed in 2006, between the National Center for Complementary and Alternative Medicine (NCCIH) and the Chinese Ministry of Science and Technology. The new agreement encompasses a much larger number of interested institutions in the U.S. and China.

Jeffrey D. White, M.D., director of the National Cancer Institute’s (NCI) Office of Cancer Complementary and Alternative Medicine (OCCAM) commented: “What’s exciting is that this new MOU strongly reflects an interest in TCM at the top levels of HHS, and it shows a growing, sustained interest on the part of the Chinese government to support evidence-based investigations of TCM, in collaboration with foreign investigators. From a practical standpoint, what this agreement does is set a framework for encouraging collaborative activity and will help shepherd projects along that are already underway.”

The 2008 MOU on TCM was signed at the beginning of a two-day traditional Chinese medicine Research Roundtable held at the National Institutes of Health (NIH) that highlighted research in areas of TCM that “displayed examples of opportunities for future collaborations between U.S. and Chinese researchers,” Dr. White reported. The presenters discussed “diagnostic approaches and ways that might help identify subgroups of cancer patients who might have different reactions to different conventional treatments,” he added, “as well as quality control of herbal medicines and how to standardize herbal approaches in a way that would make research results more reproducible.”

In addition to signing the MOU, the meeting also included expert presentations on five topics:

• Health Care Impact: Convergence of TCM and Western Medicine in China, Integrative Medicine in the U.S.- Richard Nahin, Senior Advisor for Scientific Coordination and Outreach, NCCIH and Lu Aiping, Professor, China Academy of Chinese Medical Sciences (CACMS)
• Criteria and Standards for Evaluation of Clinical Efficacy of TCM- Brian Berman, Director, The Center for Integrative Medicine, University of Maryland and Wu Darong, Associate Chief Doctor, Guang Dong Provincial Hospital
• Application of Genomics, Proteomics, and Systems Biology to Study of TCM- Yung-chi Tommy Cheng, Henry Bronson Professor of Pharmacology, Yale University and Jia Wei, Principle Investigator, Shanghai Center for Systems Biomedicine
• Acupuncture: Biological Basis and Promising Applications- David Yue-Wei Lee, Associate Professor of Psychiatry Harvard University and Yu Xiaochun, Professor, CACMS
• Product Safety and TCM: Natural Product Chemistry- Ikhlas Khan, Professor of Pharmacognosy, University of Mississippi and Ye Zuguang, Professor, CACMS

One example of an ongoing TCM project is an NCI-funded collaboration between M.D. Anderson Cancer Center in Houston, Texas and Fudan University Cancer Hospital in Shanghai, China which currently includes both laboratory research and clinical trials of cancer treatments and symptom management using TCM preparations. “There are a growing number of investigators in the United States with an interest in this area, and the new MOU could create opportunities for other groups who want to do similar work,” said Dr. White.

A few Food and Drug Administration approved chemotherapy drugs in the United States are derived from compounds used in TCM, including arsenic trioxide (now used for the treatment of acute promyelocytic leukemia), and camptothecin, which was isolated from the bark of the Chinese tree Camptotheca acuminate, and has been slightly modified to produce the cancer drugs topotecan and irinotecan.

One of the major focuses of the new MOU with China addresses a challenge often faced by investigators interested in studying natural products, such as herbal compounds. “For investigators, there is always a problem getting proper material for such studies,” noted Dr. Cheng, chairman of the Consortium for Globalization of Chinese Medicine. “For any herbs and natural compounds of interest, we need to know the availability of the herbs, where they came from, where they can grow, and how well they are characterized. For Chinese medicine to be acceptable in this part of the world, you have to address the quality of your study material, have the clinical evidence that it works, understand how it works, and know how it interacts with other drugs to some extent.”

The MOU highlights several areas where collaboration could help improve the methodology for research and development of TCM-based therapeutics, including the application of genomics, proteomics, and systems biology.

Dr. Cheng and Dr. Francesco Marincola, chief of the Infectious Disease and Immunogenetics Section at the NIH Clinical Center, have been collaborating on a proof-of-principle experiment that is an example of the multi-step validation that will be essential in future collaborative studies on TCM products. They are studying the use of irinotecan in conjunction with a Chinese herbal combination called PHY906 in a mouse model of colon cancer.

Dr. Cheng’s laboratory has characterized the herbs using techniques including mass spectrometry and biological fingerprinting to make sure the herbal product is the same between batches. They also tested the combination against tumors in mice to see if the combination had a stronger anti-tumor effect than irinotecan alone and if PHY906 could decrease the toxicity of irinotecan. Dr. Marincola’s group has taken samples of treated tumors and blood cells from the mice and performed whole-genome expression scans to determine what cellular pathways are affected by the drugs.