Pick up any herbal remedy in an American drugstore and you'll find the following disclaimer in fine print: "This statement has not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease." The disclaimer is intended to alert consumers to the fact that the FDA does not regulate herbal products and therefore cannot vouch for their effectiveness. In fact, if you decide to treat your cold with Echinacea, for example, you have no real assurance of how much Echinacea is really in that capsule or its level of quality.
Although the US FDA is not yet regulating supplements, the China Food and Drug Administration (CFDA) is. One of the leaders in the effort is Dr. De-an Guo of the Shanghai Research Center for TCM Modernization. "TCM" stands for "Traditional Chinese Medicine," the 2,000+-year-old system of medical treatment that spans everything from acupuncture to herbal remedies. TCM compounds have been proven to be effective at treating a wide range of conditions, from inflammation to angina. Earlier this year, the journal Science published a study showing that the Chinese herb han fang ji, or stephania root, was effective at blocking the Ebola virus in mice.
Dr. Guo's Center is part of Shanghai Institute of Materia Medica (SIMM), a comprehensive institute engaged in fundamental and applied research in drug discovery and development. SIMM-trained scientists have developed globally-successful drugs that treat conditions such as malaria, heavy metal poisoning, cancer, and Alzheimer's disease.
Dr. Guo's work is focused primarily on ensuring that commercial TCM products meet modern quality standards. According to Dr. Guo, modern TCM products must be safe, must be quality- controllable, efficacious, and their mode of action must be explainable, or clarified, in some way. "TCM remedies are complicated mixtures with, many, many components in them," explained Dr. Guo. "A single herb can contain hundreds of individual constituents. So how do you properly analyze them to identify the major and minor components in the mixture? That’s our main goal. And after that, you want to develop some proper quality standards for each herbal medicine. We also do some modern systems biology work to study the pharmacology and modes of actions of these mixtures."
Currently, TCM quality standards are mainly based on the presence of a single marker in a sample, but Dr. Guo pointed out that this is not a method without its drawbacks, since an unscrupulous manufacturer could simply add that single marker into the formulation to falsify the results and make it look like it is something it really isn’t. "We’re now using UPLC to profile the whole chemical component, and to quantify the major markers," said Dr. Guo. "You can quantify several major markers, instead of a single marker. We're taking a more holistic approach, including fingerprint profiling, multi-component quantification, testing for pesticides, heavy metals, and microbial contaminations. Then you can really identify whether it is the true herb and attest to its quality."
In addition to Waters UPLC systems, the Shanghai Research Center for TCM Modernization uses the ACQUITY QDa Mass Detector, the ACQUITY UPC2 Convergence Chromatography system, and a XEVO GS-XS QToF mass spectrometer. "Analytical tools are key to TCM research. Without clarifying the chemical components of TCM you cannot talk about mode of action. UPC2 has really enabled a higher level of detection. The advancement of separations technology is really benefiting the TCM industry," said Dr. Guo.
SIMM's modern facility in Shanghai is a long way from rural Shandong Province, where Dr. Guo was born in 1962. "It’s a very poor place," said Dr. Guo. "And then I moved to Northeast China, and grew up there. That’s why I worked so hard, trying to improve my family situation. Growing up in that kind of environment was hard, but it was a good thing, I think, because now I’m not afraid of any difficulty."
The young De-an Guo did well in school, winning a national mathematics award, and eventually earned a PhD at the Peking University Health Science Center, the most prestigious medical school in China. His degree is in pharmacognosy, the study of medicines derived from natural sources.
In 1993, Dr. Guo came to the United States to work with Dr. W. David Ness, first at the University of Georgia, and later at Texas Tech, to support his research in sterol biosynthesis.
About 15 years ago in China, Dr. Guo met Professor Ikhlas Khan, PhD, a research professor of pharmacognosy and associate director of the National Center for Natural Products Research at the University of Mississippi. The two kindred spirits established the Sino-US TCM Center to further their collaboration, which led to Dr. Guo being appointed as a guest professor at Ole Miss.
Dr. Guo's pioneering work has resulted in the publication of more than 540 academic papers, focused primarily on analysis and quality control. In 2013, he was presented with the Norman R. Farnsworth Excellence in Botanical Research award by the American Botanical Council. He was also editor-in-chief of the 2010 edition of the Pharmacopoeia of the People’s Republic of China and sits on the editorial boards of several highly respected international scientific journals, including Planta Medica and Journal of Ethnopharmacology.
Away from the laboratory, Dr. Guo is a sports fan. "I like to watch NBA basketball, it is my favorite," he noted. "And boxing -- heavyweight boxing. I don’t know why, I just like watching it." Had he not pursued a scientific career, Dr. Guo might have gone into public service. "Maybe a politician, I don’t know," he said. "Once, after I came back from the States, they tried to recruit me to be one of the city’s vice-mayors."
For the moment, De-an Guo is too focused on his work exploring the secrets of TCM. "I can foresee that if we build a really comprehensive library with all the herbs, then address the quality issues for the identity and the quality, that will really be the solution," said Dr. Guo. "Then you don’t need to do it every time for each product that comes in. You just develop the kind of rooting methodology, then you discover the sample, then you do the analysis, then you put into the library. That will tell you if it's authentic or it’s good quality, or it’s a bad one. But that will take a lot of investment and several years to complete."
Dr. Guo's ultimate aspiration, however, is simply to share TCM with the world. "I hope that TCM will be well-recognized internationally as a medicine that could play a more important role in health management and treating diseases," he concluded. "I want to really provide evidence so that people believe TCM works, that you can benefit from TCM, not only in China, but throughout the world."