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January 20, 2000

International center set up here to study traditional Chinese medicine

Some of the 21st century's breakthrough drugs for treating cancer and neurological diseases could be derived from traditional remedies developed in China over the last 3,000 years.

That's the hope among researchers at a new center to be based at Pitt and the UPMC Health System.

The International Traditional Chinese Medicine (TCM) Center will use modern technology and research methods to test the effectiveness of TCM — and, ideally, develop new drugs and win U.S. Food and Drug Administration approval for marketing them.

As early as six months from now, the center could launch its first clinical trial of "at least one or two" Chinese herbal mixtures that appear to stimulate the body's immune system to fight cancer, said Ronald Herberman.

Herberman, director of the University of Pittsburgh Cancer Institute and Pitt associate vice chancellor of Research, Health Sciences, was among the University and UPMC Health System administrators and faculty members who met here on Jan. 18 with representatives of local foundations and China's Ministry of Science and Technology.

At a press conference later that day, meeting participants described the International TCM Center as the first systematic, large-scale international effort to develop scientific and clinical standards for traditional Chinese remedies.

Among Western scientists, opinions of TCM range from "the utmost enthusiasm" to "profound skepticism," said Thomas Detre, UPMC executive vice president for international and academic programs and director of international affairs.

"Yet we have, historically, in China some 3,000 years of experience with plant products which have been said to be helpful with the treatment of a variety of conditions," Detre said. "These experiences cannot be ignored. But they are, by themselves perhaps, insufficient to [justify allowing TCM to] enter the American market and be safely consumed by large numbers of people suffering from various disorders."

Herberman said center activities will focus on:

* Taking plant-based TCM that has shown promise in China and subjecting it to rigorous clinical trials at Pitt and other U.S. institutions, in an effort to get solid evidence that the remedies really work, and

* Isolating active ingredients in effective TCM, which may lead to new drugs.

"By defining new chemical entities from the mixtures, there is the possibility for new intellectual property patents," Herberman said. "We believe that biomedical and other private corporate entities will be very interested in partnering with the TCM Center."

Timothy Parks, president and chief executive officer of the Pittsburgh Regional Alliance, called the center "a singular event for the economic development of the region" and "a unique global partnership."

Project organizers expect to launch the center with an initial investment of $10 million from private and public funding sources. The Jewish Healthcare Foundation has announced plans to contribute $100,000. Additional $100,000 investments will come from UPMC and PhytoMedica, Inc., a global start-up venture founded by Caduceus Capital Health Ventures.

Caduceus is a for-profit, Boston-based group that funds biomedical start-up companies. Last year, UPMC announced that it would contribute $16 million toward Caduceus's $60 million venture capital fund.

Herberman said the TCM Center is recruiting a director and plans to submit, within the next two months, a proposal for the center to be named a regional research site by the National Institutes of Health's National Center for Alternative and Complementary Medicine.

Yongzheng Hui, vice minister of the Chinese Ministry of Science and Technology, said more than 1,000 plant species have been used in preparing "100,000, maybe even 200,000" drug mixtures in China over the centuries. Two years ago, the Chinese government created his ministry to modernize TCM through lab testing, Hui said.

This commitment, combined with Western science's newfound interest in traditional and alternative medicines, led to creation of the Pittsburgh TCM center, news conference participants said.

Hui and Chuan-hong Chen, the Chinese ministry's director, praised Pittsburgh's biomedical and pharmaceutical strengths. They said researchers at Chinese institutions will exchange research findings with colleagues here.

Herberman said he was excited to hear Chinese officials say that TCM herbal mixtures tend to work not by attacking cancer cells or infectious diseases per se, but by stimulating the body's natural processes, particularly the immune system.

"I'm an immunologist myself," he said, "and that is one of the major research strengths of UPCI [the University of Pittsburgh Cancer Institute]."

TCM center researchers haven't decided yet which herbal mixtures to test first, said Herberman, who cited confidentiality considerations in declining to name the substances.

He did allow that they include ginseng and "various root plants" — most of which, Herberman said, he'd never heard of before this week.

"Based on information from the Chinese government," he added, "I can say that some of the more promising mixtures show signs of being useful in treating lung and liver cancer and limiting the spread of various gastro-intestinal cancers to the liver."

It would be "absolutely wonderful" to find cancer cures through TCM, but researchers here would be happy just to develop new drugs to treat symptoms and alleviate patients' suffering, Herberman said.

During the center's first year or so, research probably will focus on cancer-related TCM "but we're not excluding other possibilities," he pointed out. "For example, our Chinese colleagues have mentioned a traditional drug that appears to be effective in treating epilepsy."

In gaining FDA approval for testing TCM-based drugs in humans, toxicity may not be a major hurdle, Herberman said. "That's because the Chinese, traditionally, have followed an entirely different sequence of research and discovery" in testing drugs, he explained.

"The American or Western approach is to do some screening in the laboratory, then in animals, and then in patients. The Chinese approach has been exactly the opposite. They have taken these herbal mixtures or recipes and tried them first in people, and they have been doing so by trial and error over thousands of years," Herberman said. "Through this very long experience, they at least know what is safe and what can be tolerated in people."

It's only been in the last few years that Western scientists have taken TCM seriously, Herber-man noted. "I think a lot of it has been related to not very good communication between the Chinese and colleagues in the United States. There's also been a negative prejudice that needed to be overcome here in the West.

"In our drug design, we tend to go for defining a single chemical molecule [useful in treating illness] and then taking that into clinical studies, whereas the Chinese have done it in the opposite direction by prescribing undefined mixtures of herbs."

Detre rejected a common Western criticism of TCM: that Chinese physicians often prescribe a single plant mixture for a variety of illnesses. Opium (itself a plant-based drug) likewise has been used successfully by Western doctors to treat various conditions: pain, diarrhea, even depression, Detre said.

— Bruce Steele

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