New York – Traditional Chinese medicine (TCM) has gained legal and consumer recognition in the United States in the last 30 years, but achieving its current status was no simple task.
"Back in the 1970s, TCM had no legal status, and most Western doctors were hostile to non-conventional medical practice," John Scott, president of Golden Flower Chinese Herbs, said.
When Scott and his wife, Lorena Monda, founded Golden Flower Chinese Herbs in 1990 to produce and distribute Chinese herbal formulae, Chinese herbs were already quite popular, especially in the Chinatowns of big American cities like San Francisco and New York City.
However, in those days, Chinese medicine was not a legal entity.
Mark Blumenthal, founder and executive director of American Botanical Council, said though California was the first state to legalize acupuncture in 1978, Chinese herbal medicine continued to remain in the "twilight zone" until the US Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994.
According to its website, the US Food and Drug Administration (FDA) defines a "dietary supplement" as a product taken by mouth that contains a 'dietary ingredient' intended to supplement the diet which includes vitamins, minerals and herbs or other botanicals.
"After 1994, with Chinese herbal medicine declared a 'dietary supplement,' you can't legally say you are treating diseases. This is difficult for us because TCM is an old practice for treating illnesses and diseases. Our method of perceiving diseases is considered different from modern medicine," Scott said.
But there has been a growing demand for acupuncture in the US – a practice now legalized in 44 states, as compared to just four states 30 years ago.
Insurance companies pose another major threat to the legitimacy of the practice, making a distinction between acupuncture treatments and Chinese herbal treatments. A patient can make an insurance claim for acupuncture but not for herbal treatment.
"Insurance companies won't pay for treatment of diseases with herbal medicine. Acupuncture coverage depends on the insurance policy and its restrictions, as well as the conditions of the patient," Scott said.
But there is a ray of hope for herbal medicine to be legitimized for treatment of illnesses and diseases.
In July, the Compound Danshen Dripping Pill, a Chinese herbal treatment for angina and coronary heart disease, successfully completed the FDA's Phase II clinical trials. Once it passes Phase III investigations, which would most likely happen in 2013, it would be the first-ever Chinese medicine to become a prescription drug in the US.
Blumenthal said that this would be an FDA endorsement of the herbal combination to treat potentially serious illnesses.
"There is no government approval of 'herbal supplements' to treat cancers. But in this case, you have a government review of what is being sold by an acupuncturist or at the health food stores. This will be the first time the government approved of Chinese medicine as drug use," he said.
While it is generally believed that the FDA-approved Danshen could pave the way for an increased acceptance and use of Chinese medicine by certain members of the medical profession, some TCM practitioners think it will mean "losing access".
Bill Reddy, an acupuncturist based in Annadale, Virginia, thinks that Chinese herbal medicine should be prescribed by a properly trained herbal practitioner.
"We do not diagnose illnesses and diseases the same way as Western medicine, and do not prescribe our herbs with the 'one size fits all' mentality that dominates Western medicine," Reddy said.
Blumenthal said that if Danshen is standardized as a prescription drug, it is possible that it would be prepared in a different formula from those sold by acupuncturists.
Due to the chemical complexity of Chinese herbs, Blumenthal thinks it would be very challenging to make herbs into a pharmaceutical drug which contains one or two molecules, but, he said, "You will have a reliable and standardized medicine."
"This does not mean that those sold by acupuncturists will not be as good. Depending on its use, those traditionally made may be better for some illnesses. However, there is no clinical proof of that."
Though difficult, it is not impossible for Chinese herbs to pass the FDA's drug approval process, he added.
Blumenthal thinks that if Danshen is approved as a drug, in the long run, it will help legitimize TCM in the eyes of the Western communities and even stimulate more investments in Chinese medicine.
It costs a reported $800 million to $1.3 billion to conduct the research and development needed to bring a new drug to the market, according to an article on HerbalGram magazine issued by the American Botanical Council.
There is currently no available data showing how many companies are in line to make applications for Chinese medicine to be approved for drug use. A staff member at the FDA Office of Public Affairs said they are unable to comment on drugs under development or even confirm they are the subject of clinical trials.
According to Blumenthal, there have been only two drug approvals for Chinese medicine in the last 50 years.
In 2006, the FDA gave drug approval to Veregen® Ointment, which contains Chinese green tea leaves, to treat genital warts caused by human papillomavirus in the US.
Danshen could be the first multi-chemical plant approved for drug use, said Blumenthal.