A group of aging scientists and researchers say they long ago found a solution to what many call the inhumane treatment of bears that are killed or farmed for their bile, which Chinese medicine claims to have medicinal properties.

Zhou Jie, 85, says his biggest wish is for authorities to finally approve synthetic bear bile that his team helped develop in the 1980s and 1990s.

Zhou, former Party secretary of Shenyang Pharmaceutical University in Northeast China's Liaoning Province, is among a handful of now gray-haired retirees who started researching the chemical structure and pharmacology of bear bile almost 30 years ago.

They believe there may be no need for the 68 legal bear farms that harvest the bile of 6,000 captive bears. Animal rights activists believe the true number of bears, undergoing the almost daily procedure that drains their bile, is far larger than official statistics indicate.

In the 1990s the government stopped approving new bear farms which are now scattered throughout 11 provinces.

Recent controversy over a bear farm's plan to expand by listing on the stock market has prompted Zhou and other scientists to speak out about the alternative they helped develop.

The debate spilled into the political arena this week with two ministers offering different views about bear bile production on the sidelines of the ongoing Two Sessions. Health Minister Chen Zhu said Sunday that the animals shouldn't be sacrificed if there is an available alternative, while Wang Guoqiang, chief of the State Administration of Traditional Chinese Medicine, said it's very difficult to make a synthetic substitute and defended the practice of extracting bile from live bears.  "Not killing the bears for their bile is progress," said Wang.

The elder scientists and researchers want the State Food and Drug Administration (SDA) to license synthetic bear bile for use in drugs but suggest the powerful bear bile industry may be holding approval back. The industry says if bear farming were to be shut down it would cost 183 pharmaceutical companies over 10 billion yuan ($1.59 billion) and eliminate tens of thousands of jobs. Animal rights activists say the industry's statistics are exaggerated.

Zhou says the search for synthetic bear bile started in 1983 when the government began encouraging research into alternatives for important traditional medicines such as tiger bones, musk and bear bile.

International convention an impetus

In 1980, China joined CITES, the Convention on International Trade in Endangered Species of Wild Fauna and Flora. Around that time the government also passed laws and issued regulations to preserve wildlife, including those used in Traditional Chinese Medicine (TCM).

"Out of the need to protect wildlife and to ensure the supply of TCM ingredients, we heeded the call and started the project," recalled Zhou.

It took researchers and experts from the university and Liaoning pharmaceutical research institute six years to analyze the chemical composition of bear bile and make a synthetic compound.

"We used the best bear bile on the market, and completed studies on lab animals to determine the synthetic drug's efficacy, pharmacology and toxicology," said Zhou.

In 1990, an assessment by the Ministry of Health, which oversaw the approval of new drugs at the time, reported that their synthetic version was similar to natural bear bile.

The results of clinical trials at four hospitals also showed that the synthetic compound could replace the natural bear bile drugs on the market.

In 1992, when CITES added bears to its annex and banned the export of bear bile and its products, Chinese authorities requested more trials on synthetic bear bile.

"They told us that considering China may export the drug in the future we should do more research, and we obliged," said Zhou.

The State-owned pharmaceutical companies which funded the project backed out of the research when they were privatized, said Zhou. Although the additional clinical trials were completed in 1995, Zhou said they didn't receive the case files until 2002 and many files had been lost.

In 2005, the administration told the researchers to conduct even more clinical trials which they completed in 2007. The administration is still reviewing the results of this last round of trials, according to Zhou.

Synthetic alternatives of some traditional medicines such as tiger bone, bezoar and musk have been developed and approved. Doctors have prescribed the use of buffalo horns to replace rhino horns which are banned from export.

Bear bile has been an important ingredient in TCM for thousands of years and is said to have a long list of curative properties. It can act as a detoxifier, sooth the liver and brighten the eyesight, according to TCM encyclopedias. Liquid bear bile is made into powder, and along with other compounds is used to treat sore eyes, sore throat, respiratory infections and hemorrhoids.

Many TCM advocates insist that bear bile is irreplaceable. The TCM association stands firmly behind the bear farm industry. "There isn't one single product that could replace bear bile," declared Zhou Chaofan, a researcher at China Academy of TCM, at a discussion organized by bear bile product manufacturer Guizhentang Pharmaceuticals on February 22.

Many other experts of TCM shared Zhou's view, saying that the effect of bear bile is a result of all the components that can't be completely replaced.

In 2003 and 2004, the SDA, which is in charge of drug approval, told Zhou Jie that his team's synthetic product could no longer use the term "artificial bear bile," which the researchers strongly objected to.

"Our artificial bile is exactly the same in composition and structure as the real thing, which the Ministry of Health recognized in 1990," said Zhou.

Other experts say there are also herbal alternatives to bear bile.

"To be honest, rarely is there an ingredient in a TCM that can't be duplicated synthetically," said Zhou, who has a background in TCM. "But it's the TCM system and theory that's at stake here."

Researchers have determined the main components of bear bile to be ursodeoxycholic acid (UDCA) and chenodesoxycholic acid. There are in fact imported and domestic drugs that use UDCA, which are commonly used to treat gallstones.

"In practice, we found that UDCA is also effective in clearing liver heat and therefore according to TCM theory, also treats diseases of the eye and throat," said Yao Fengyun, 57, who participated in the project in the 1980s and now heads a private pharmaceutical company that makes drugs containing UDCA.

"But they are two different systems, Chinese and Western medicine," she said.

In 2008 and 2009, the drug review board held two panel discussions on artificial bear bile products and many experts questioned their efficacy, said Zhou Jie, laughing in dismay, whose method of making synthetic bear bile was patented in 2006.

"If the authorities want to insist that synthetics can't replace the real thing, then show us some evidence," said Yao. "We have all the studies to back us up."

Bear farms boom

While medical experts were working on synthetic alternatives, the bear farming industry started to take off.

In 1984, China introduced the "free drip" method of bile extraction used in North Korea. The method, which punctures a hole in the abdomen to reach the bear's gallbladder, is considered by pharmaceutical companies and some TCM practitioners to be more humane than the old methods of putting a metal jacket on the bear and implanting a plastic tube inside the animal.

By the time the researchers finished their pre-clinical studies, bear bile extracted from live bears using the free drip method had been approved and was on the market spurring the growth of bear bile farms around China.

Zhou said his team was told that bear farming could meet market demand. "We figured that the authorities were implying that we don't need synthetics, but we believed bear farming wouldn't be sustainable," said Zhou.

Official records show there are over 240 medicines that use bear bile as a raw ingredient mainly in powder form which sells for around 100 to 150 yuan per gram.

Synthetic bear bile products cost 30 percent less than free drip bile, said Yao.

"The truth is, bear bile farming industry has been rather mysterious, which the public rarely has access to," said Zhang Xiaohai, director of External Affairs China at Animals Asia, a Hong Kong-based NGO devoted to ending bear farming.

"We just don't know how much money is involved in this industry," he said.

TCM defends itself

The TCM association issued a statement attacking Animals Asia for trying to sabotage the TCM industry. Top management from Guizhentang Pharmaceuticals in Fujian Province told Southern Metropolis Daily that the company, which farms over 600 bears, sells about two tons of bile powder a year and has annual revenues of 100 to 200 million yuan.

Shanghai Kaibao Pharmaceuticals, a listed company and major purchaser of bear bile powder, reported a net profit of over 1.6 billion yuan in 2011.

"Making an artificial alternative is complicated and requires a lot of expert discussion and review to determine if it matches the clinical efficacy of the natural product," Zhang Wei, head of the registration division of the SDA, told China Youth Daily.

"It's still under review and will be approved if it meets the requirements," he said. "But we can't approve something that doesn't meet the requirements just to find an alternative."

"We don't have any money," said Zhou Jie. "We didn't even have the money to get the clinical trial case files back." They have had to stop their research and several of the original researchers have since passed away.

"The only thing we can do now is wait," said Zhou. "Whatever requirement they might come up with, we're confident we can meet it."