In November 2006, Merck, the world’s largest drug company, announced that it had made a deal with the Chi-Med, a Chinese pharmaceutical company, to develop drugs and consumer health products based on traditional Chinese medicines, with a special emphases on coming up with promising cancer treatment. Chi-Med has a library of about 10,000 herbal compounds and a staff f 100 research scientists working n a lab in Shanghai. Two promising dugs have already been developed: HMPL-002, a compound used for lung cancer, and HMPL-004, an anti-inflammatory used in the treatment of a bowel disease. In China, Chi-Med makes a tumor treatment made with baked wasp nest and male rat stool. Merck isn’t the only big drug company taking a serious look at traditional Chinese medicine. Novartis, the Swiss giant, has announced plans to open up a $100 million research and development center in Shanghai.[Source: The Times of London]

Chinese folk healers have traditionally treated tiger bites and wounds with frog and toad secretion. In the 1990s, it was discovered that species of frog secrete a previously unknown family of antibiotics. An Australian study showed the Chinese herbal treatments were effective in treating irritable-bowel syndrome, a gastro-intestinal disorder that afflicts between 10 percent and 20 percent of the population in industrialized countries.

In 1995, scientist at Harvard Medical School found that a traditional Chinese herbal medicine made with the kudzu vine helped curb the natural desire of Syrian golden hamsters to consume alcohol. Syrian golden hamsters are often used in alcohol research because they prefers water mixed with alcohol over plain water.

Side affects of anti-cancer drugs have been mitigated with Chinese herbal medicines. Controlled doses of arsenic is now of one of the most common methods used to treat a nasty form of leukemia. The treatment was developed after the study of a concoction used by a shaman in Heilongjiang made from two kinds of ground rock and the venom of local toad.

Promising Research Involving Traditional Chinese Medicine

Yale University professor Yung-Chi Cheng is researching herbal treatments based on ancient Chinese formulas, including a cancer treatment that is currently in drug trials. Among other things he has examined notoginseng plant at a research center in China’s Yunnan Province. Cheng

Peter Gwin wrote in National Geographic: “From a research perspective, it very well may be a golden age. Scientists from leading universities in the United States and Europe, including UCLA, Duke, and Oxford, as well as many in Asia, are looking at the scientific underpinnings of some traditional treatments for diseases such as cancer, diabetes, and Parkinson’s. [Source: Peter Gwin, National Geographic, January 2019]

“My nose is freaking out as I follow Cheng on a tour of his labyrinthine lab at Yale, where his team is analyzing the characteristics of a variety of herbs to investigate their medicinal value. Amid the sighs and gurgles of various chemical experiments, I catch whiffs of black pepper, rosemary, camphor, ginger, chili, cinnamon, and other scents I can’t identify. The back of my throat tingles. I think I might sneeze. I notice I’m hungry for Thai food.

On first impression Cheng may seem like a stereotypical advocate for traditional Chinese medicine. Though he’s been in the United States for five decades since emigrating from Taiwan, he still speaks English with a strong accent, and at 74, he comes from a generation of Chinese that still has a deep attachment to many of the old traditions. “But I didn’t really know much about Chinese medicine,” he says, noting that as a child, his parents took him to doctors practicing science-based medicine.

“Cheng has focused his research solidly in the realm of science, developing antiviral drugs for chronic diseases, such as hepatitis B. But he has also wondered whether there were other cures, based on herbs like wormwood, awaiting rediscovery.

Promising Cancer Treatments Made from Traditional Chinese Medicine

Peter Gwin wrote in National Geographic: Cheng’s found some Chinese herbs “that may prove a breakthrough in cancer treatment. He opens a jar and hands me a pinch of a powder — a mixture of four herbs he calls PHY906. “Taste it,” he says. I put a tiny bit on my tongue. It’s bitter, with hints of licorice. Cheng’s team grew this Ganoderma tsugae fungus in the lab. The species has been found to shrink colorectal tumors in animals. “The Chinese have used herbs for centuries,” Cheng says. “The challenge to scientists is to find out which formulas work, and why.” [Source: Peter Gwin, National Geographic, January 2019]

During the 1990s Cheng noted that many cancer patients stopped chemotherapy because of its side effects, including diarrhea and severe nausea. Patients who completed the full course of chemotherapy tended to live the longest, so curbing the side effects, Cheng reasoned, could increase life expectancy. He also knew that Chinese medicine had many herbal treatments for diarrhea and nausea. His colleague Shwu-Huey Liu, an expert in pharmaceutical chemistry who’s fluent in classical Mandarin, searched the Yale library’s large collection of early Chinese medical texts. In an ancient book titled Treatise on Cold Damage, printed on slightly wrinkled bamboo paper, she found an 1,800-year-old recipe for a mixture of skullcap, licorice, peony, and Chinese date, described as a treatment for “diarrhea, abdominal pain, and scorching heat in the anus.” Cheng’s team began trying different blends of the herbal formula. Over the past 20 years, they have proceeded from tests on mice to patients undergoing cancer treatment, overseen by the National Cancer Institute. As Cheng had hoped, almost all the patients who took the herbal formula experienced relief from nausea and other gastrointestinal distress, but something else happened: “Their tumors shrank faster than those of patients who hadn’t taken the herbal formula. “I didn’t expect that,” Cheng says. “So now the question is, Why?”

“Johnson & Johnson and Bristol-Myers Squibb, both major producers of cancer drugs, also would like to know the answer. At a pharmaceutical conference in Philadelphia, I listen as Cheng’s son Peikwen explains to representatives from those and other leading drug companies what is known about how PHY906 works. A Stanford University graduate who also has an MBA, Peikwen, 43, joined his father to form a company to market PHY906 and develop other herbal drugs. He’s dressed in a trim charcoal suit, and his fluency in Mandarin, medical terminology, and Silicon Valley argot equip him to bridge the worlds of Eastern and Western medicine and make him a persuasive advocate.

“After analyzing tumors in mice that were given the formula, Peikwen says, researchers noticed a significant increase in tumor-eating macrophages — white blood cells that gobble up cancer cells. The way the herbs interact appears to be the key. “That’s really where the frontier lies,” Peikwen says. “PHY906 is a cocktail of chemicals — not unlike the drug cocktails that finally proved effective for AIDS patients. We’re just unraveling the original formula and putting it back together in a modern, scientifically based therapy.” To date PHY906 has been used in eight human trials alongside different chemotherapy drugs and radiation to treat colorectal, liver, and pancreatic cancers, Peikwen tells the audience. “We are hopeful that PHY906 will become the first FDA-approved, multi-herb drug.”

Problems Getting FDA Approval for Chinese Medicine

Peter Gwin wrote in National Geographic: “ Producing medicine-grade herbs is extraordinarily difficult. The chemical potency of each herb can vary greatly, depending on many factors — minerals in the soil, the altitude at which it’s grown, when and how it’s harvested. And then there’s the matter of subspecies that may look exactly alike but have slightly different chemical compositions.

“Ask a pot smoker about the difference in potency from one marijuana strain to the next, and you’ll get an earful. Or ask a coffee grower: Arabica beans grown in one part of Ethiopia can have six times as much caffeine as those grown in another part of the country. And depending on how they’re ground and brewed, the same beans can yield different caffeine amounts. [Source: Peter Gwin, National Geographic, January 2019]

“These complications are part of the reason that the U.S. Food and Drug Administration (FDA) has approved only two herbal prescription drugs — a genital wart treatment made from green tea extract and a diarrhea medicine made from the sap of the South American dragon’s blood tree. Both those drugs contain a single herb, but PHY906 is composed of four, which means more variables must be controlled to make a consistent product. “This complexity is partly why there aren’t any FDA-approved, multi-herb drugs,” Peikwen says.

Safety of Chinese Herbal Medicine in China

An article in the Journal of the American College of Cardiology in February 2010 warned that mixing herbal remedies such as St. John’s Wort and gingko biloba with prescribed medication for heart disease could cause dangerous even fatal side effects, especially for people with liver or kidney problems or a propensity to bleed heavily. St. John’s wort is known to interfere with medications for irregular heart beats, high blood pressure and high cholesterol. Ginkgo biloba raises the risks of excessive bleeding. Arshad Jahangir of the Mayo Clinic, Arizona, who worked on the report, told the Times of London, “Many people have a false sense of security about these herbal remedies and drugs because they are seen as “natural.” But “natural” doesn’t always mean they are safe. Every compound we consume has se effect in the body, which ius essence, why people are taking these products to being with.”

In December 2010, a new law will go into effect in Hong Kong that requires all traditional Chinese medicines sold to be safe, but says nothing about whether they work or not. From December, any sale, import or possession of unregistered proprietary Chinese medicine will be an offense subject to a maximum penalty of HK$100,000 and two years' imprisonment. [Source: Ella Lee, South China Morning Post, August 16, 2010]

The enforcement of a section under the Chinese Medicine Ordinance comes 11 years after the law was passed in 1999, and seven years after a registration system for these products was introduced in 2003. Although the 11,000 products sold in Hong Kong will have their “safety” tested, they will not be subject to tests for “quality” or “efficacy”. More than 80 per cent of the proprietary Chinese medicines sold in Hong Kong will lack scientific proof of their quality and efficacy.

Quality refers to the medicine's ingredients, shelf life and manufacturing method, while efficacy means the drug's effectiveness for treating certain conditions. Some products may require clinical trials to prove efficacy. The Department of Health, facing repeated criticism over its slow progress on the matter, says it has yet to work out a timetable on when these products would eventually be tested comprehensively.

Drug safety in Hong Kong has been a growing public concern after a spate of incidents in recent years. In March 2010, Po Chai Pills were found to contain cancer-causing chemicals. This came a year after a locally produced Western drug, Purinol, was contaminated with a rare fungus that killed eight leukaemia patients. A law that requires proper labels and package inserts will not come into force until December 2011.

As of June 2010, the makers of 16,560 proprietary Chinese medicinal products had applied to the Chinese Medicines Board for registration. Of the products, 11,260 have been granted temporary registration and can continue to be sold after December 2010. The Department of Health said these products had been proven “safe” based on three separate tests - heavy metals and toxicity, pesticide residue and microbial limit. But in order to get a full registration, traders must also prove the quality and efficacy of the products.

Society of Hospital Pharmacists vice-president William Chui Chun-ming said, “It is acceptable for the department to allow a soft landing for the trade, given that Chinese medicine has a long history and it's complicated. However, we should not allow the current situation to stand forever. Traders who fail to get a full licence in two to three years should have their products banned from the market.”

Critical Studies of Chinese Medicine

These days critics of Chinese medicine within are becoming more and more vocal. Some claim that the medicines are ineffective and dangerous because they are sometimes used in lieu of Western medicines that are effective and sometimes contain toxic substance. Some have compared Chinese medicine to witchcraft, with practitioners killed at offering excuses why it doesn’t work. . Other want to Chinese medicine stripped of its protected status by the Chinese constitution, require pratcitioners of traditional medicine ro receive Western training and traditional cures undergo thorough Western-style testing.

As a rule alternative medicines — including Chinese medicines — have not been studied as carefully or put through the same kind of scrutiny as modern medicines. Those that have been studied have often been done so with dodgy science — namely small sample sizes and lack of control groups.

In the United States, the National Center for Complementary and Alternative Medicine (NCCAM) has a $122 million budget to study alterative medicine with rigorous methodology in cooperation with the National Institute of Health (NIH). The trials are longer and larger and if one treatment shows promise it is studied more carefully, which is the usual pattern with modern medicine.

Many criticize the efforts as waste of money and giving legitimacy to quack medicines.Steven Novella at Yale Medical School told the Washington Post, “What has happened is that the very fact that NIH is supporting a study is used to market alternative medicine. It is used to lend an appearance of legitimacy to treatments that not legitimate.”

In the United States and Japan several Chinese medicines and herbal cures have been banned after being linked to several deaths, In the United States ephedra was banned after it was linked to heart attacks and strokes. See Japan. Some treatment contain heavy metals, other arsenic and mercury Practitioners of Chinese medicine have said the problem was on eh dosage and incorrect application not o je drug itself.

One of the chief critics in China is Professor Zhang Gongyao. He said, “Traditional Chinese medicine has no clear understanding of the human body, of the functions of medicines and their links to disease. It’s like a boat without a compass: it may reach the shore, but it’s all up to luck.”

Herbal Remedy Blamed for High Cancer Rate in Taiwan

In April 2012, AFP reported: “A toxic ingredient in a popular herbal remedy is linked to more than half of all cases of urinary tract cancer in Taiwan where use of traditional medicine is widespread, a US study said. Aristolochic acid (AA) is a potent human carcinogen that is found naturally in Aristolochia plants, an ingredient common in botanical Asian remedies for aiding weight loss, easing joint pain and improving stomach ailments. [Source: AFP, April 11, 2012]

“The ancient herb has been touted around the world for thousands of years for everything from gout to childbirth, but scientists now know it carries serious risks of causing kidney disease and urinary cancers. The latest research found it can interact with a person's DNA and form unique biomarkers of exposure, as well as creating signals within tumor suppressing genes that indicate the carcinogen has been ingested.

“In Taiwan, where previous research has shown about one-third of the population has taken AA in recent years, rates of urinary tract and kidney cancer are about four times higher than in Western countries where use is less common, said the findings in the Proceedings of the National Academy of Sciences. "It is a rare tumor and Taiwan has the highest incidence of any country in the world," said lead author Arthur Grollman of the department of pharmacological sciences at Stony Brook University in New York. "The fact that Taiwan had the highest incidence both of cancer and this renal disease -- that was our clue that something was going on there," Grollman told AFP.

“The research was based on 151 patients with urinary tract cancer, of whom 60 percent showed specific mutations linked to the herbal remedy. In particular, after being ingested the acid forms a unique kind of lesion in the renal cortex, and also gives rise to a particular mutational signature in the TP53 tumor suppressing gene, said the study.

“The herb is known in Europe by the name birthwort because it was often given to women during childbirth. Derived from the Greek, "aristolochia" means noble birth. "This has been used by every culture in the world from the earliest written record," said Grollman.Signs of harm have emerged in recent decades, and the acid is blamed for causing a kidney disease called Balkan endemic nephropathy, first described in 1956, that afflicted rural farmers in Bosnia and Herzegovina, Bulgaria, Croatia, Romania and Serbia. The villagers were found to be baking seeds from a weed called Aristolochia clematitis in their bread. In the 1990s, a group of Belgian women reported sudden late stage kidney failure after taking a weight loss drug that contained AA.

“And even though many countries have taken steps to warn of the risks, the ingredient is difficult to control and still finds its way into products via the Internet, said Grollman, adding that most of the AA products currently being used in Taiwan are made in China."Many countries ban it but it is always available on the Internet. And in fact you can't ban it in the United States. You can only ban its importation." The US Food and Drug Administration warned of the risks of aristolochic acid in 2001 after two patients developed serious kidney disease after using botanical products containing it. "Natural is not necessarily safe, nor is long-term usage," said Grollman.

DNA Tests Point Out Dangers with Traditional Chinese Medicine

In April 2012, AFP reported: “A host of potential toxins, allergens and traces of endangered animals showed up in DNA sequencing tests on 15 Chinese traditional medicines, researchers said. Despite their popularity, little scientific evidence exists to prove the benefits of Chinese traditional medicines (TCMs), and a growing body of research has begun to point to their potential dangers. [Source: AFP, April 13, 2012]

“The samples analysed for this study included herbal teas, capsules, powders and flakes that were seized by Australian border officials and were subsequently tested by scientists at Australia's Murdoch University. Plant agents suspected of causing urinary tract and kidney cancer such as Aristolochic acid, as well as the potentially poisonous herb ephedra were among the dangerous elements found.

“TCMs have a long cultural history, but today consumers need to be aware of the legal and health safety issues before adopting them as a treatment option," said lead researcher Michael Bunce, a Murdoch University Australian Research Council Future Fellow. Some of the 68 different plant families that were detected in the 15 samples can be toxic if taken in the wrong doses, but the packaging did not list the concentrations of the elements inside, he said.

“We also found traces from trade restricted animals that are classified as vulnerable, endangered, or critically endangered, including the Asiatic black bear and Saiga antelope" he said, adding that some contained ingredients that were not included on the label. "A product labelled as 100 per cent Saiga antelope contained considerable quantities of goat and sheep DNA," he said. "Another product, Mongnan Tianbao pills, contained deer and cow DNA, the latter of which may violate some religious or cultural strictures.”

“Performing any in-depth analysis of the biological elements contained in traditional therapies has been difficult in the past because the act of processing ingredients into powders and pills mingled the components too much. But the approach used by researchers for this study, described as second-generation, high throughput sequencing, was both efficient and cost-effective, said researcher Megan Coghlan. "The approach has the ability to unravel complex mixtures of plant and animal products," she said. "We found multiple samples that contained DNA from animals listed as trade-restricted according to the Convention on International Trade in Endangered Species Legislation. Put simply, these TCMs are not legal." Future tests could help customs officials track the illegal trade of endangered species as well as clamp down on dangerous ingredients, she added.

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