Regulating TCM


  • Health
  • Sunday, 11 Jan 2004

Traditional and complementary medicine (TCM) has over the years been sought by many to cure illnesses and ailments. AUDREY EDWARDS spoke to Health Deputy Director-General, Datuk Dr Ismail Merican, on efforts to ensure TCM is safe and beneficial for those who use it. 

Datuk Dr Ismail Merican ... 'People are well advised to get used to the idea. We do not want people going around the streets like what we see in Chow Kit with pieces of paper claiming all sorts of things.'

THE growing popularity of TCM, declared health Deputy Director-General, Datuk Dr Ismail Merican, can no longer be ignored even by Western-trained doctors.  

“If they do not know that their patients are taking TCM, which may be registered or unregistered products, then it can be detrimental. There have been cases of people taking TCM or herbal medicine who ended up with liver failure. 

“The doctors need to investigate and patients should feel free to tell their doctors what they are taking. And doctors should not be against it or appear intimidating,” he said. 

The Government and Health Ministry, he revealed, had taken the necessary steps five years ago to regulate herbal medicine, including the setting up of the National Standing Committee for TCM, which Dr Ismail heads. 

He is firm in emphasising that the ministry does not support or endorse TCM, but rather encourages it in ways that will make it safe and accepted, such as getting practitioners or researchers to carry out trials for herbal medicine or natural products. 

A visit by Health Minister Datuk Chua Jui Meng to Myanmar last year had him and officials looking at the country’s TCM operations, such as the set-up of a specific TCM division. Consequently, Dr Ismail revealed, the ministry would be setting up a separate division for TCM of its own in Malaysia. 

The division, which would be formed this year, would have its own director, and its responsibilities include looking at implementing decisions made by the standing committee, such as making sure registration and training of practitioners are carried out.  

Products would still be handled by the Drug Control Authority while research would be under the Standing Committee. “If this does not show how serious we are, I do not know what will,” he said, adding that the division would also formulate policies. 

Both former Prime Minister Tun Dr Mahathir Mohamad and his successor Datuk Seri Abdullah Ahmad Badawi have been very supportive of the efforts to promote herbal medicine, both in research, development and commercialisation. 

“We realised that traditional medicine was becoming very popular and acceptable to the masses, not just in Malaysia, but rest of the world. In the US and UK, 50% of people have used TCM therapy in their lifetime. A recent study in UK shows that 10% of them use TCM every year. It is a worldwide phenomenon and we cannot run away from it. So, we have to address it,” he said. 

Many Malaysians, he observed, are very keen to find out more about TCM. “Initially, there was some resistance among Western-trained doctors. But the fact is, the masses are very keen about TCM because they feel TCM employs a more holistic approach which deals with the art of healing rather than a cure for the disease. The difference is there,” he said. 

In Malaysia, the definition of TCM refers to indigenous practices in traditional medicine, which have been handed down from generation to generation. Complementary medicine, on the other hand, refers to forms of therapy such as aromatherapy, reflexology and ozone therapy.  

Integration of Western and herbal medicine 

Indeed, the Health Minister recently encouraged nine-year old leukaemia patient Phang Man Vui to seek traditional treatment in China as local doctors had ruled out his chances for survival and exhausted all means of Western medical methods. 

The growing popularity of traditional and complementary medicine (TMC) can no longer e ignored by the establishment.

Phang, who was diagnosed with acute lymphoblastic leukaemia in May 2002, died this month after exhausting the available avenues for treatment.  

Dr Ismail felt that the decision to integrate herbal and Western medicine was still in the hands of the patient’s management team. Therefore, if an individual appeared and said that he could provide TCM assistance, the team would have to discuss the matter before giving the method support. 

“This is only fair to both the patient and members of the management team because there may be complications which the management team would have to handle. 

“We allow others to come in and discuss with us the reason for their suggested therapy, as long as they have evidence, be it anecdotal or historical. You cannot get something that is based on hearsay alone. It would be quite a dangerous precedent,” he added.  

In the case of life-long diseases, while it is the right of the patient to seek whatever treatment they believe in, he or she should still see a Western-trained doctor, said Dr Ismail. Only after certain conditions have been ruled out and the patient was still unhappy, should they move on to TCM for a second opinion. 

This is because Western medicine still has the gadgets, methodology, diagnostic kits and science as proof, he added. 

Dr Ismail explained that integrated medicine could be divided into three entities. There could be a combination of the two worlds, with Western medicine maintained as the core, or combining the two but with TCM as the core, and also a synthesis of both elements where one doctor promotes both equally. 

The National Standing Committee for TCM 

This is a world’s first because this committee is made up of practitioners representing five umbrella bodies – Malay, Chinese and Indian homeopathy and complementary therapies, representatives from World Health Organisation (WHO), the Malaysian Medical Association, university representatives and ministry senior officials. 

The set-up enables all parties concerned to discuss and understand each other’s concerns before coming up with solutions that are accepted by all. 

One success that materialised from this committee was the TCM policy, which contained four aspects: training, practice, product and research. Training would eventually see all those who want to practise TCM have proper training from local or overseas accredited centres. 

Dr Ismail said the next step would be making registration of practitioners compulsory once the TCM Act was passed. This is expected to occur by the end of 2005. Currently, registration is carried out by the umbrella bodies based on guidelines given by them and the Health Ministry on a voluntary basis. “People are well advised to get used to the idea. We do not want people going around the streets like Chow Kit road with pieces of paper claiming all sorts of things,” he said. 

The next step would be registering products with the Drug Control Authority, which Dr Ismail emphasised did not mean that a medicine was effective, but only that it was safe and of a certain quality. 

Challenges  

The most difficult aspect, admitted Dr Ismail, is getting the last component – research. Although the Government has allocated some RM120mil to researchers, hoping that they could produce commercial products, this has so far been unsuccessful. 

Among the reasons, he said, was that research methodology carried out earlier did not have much direction. “The Government is concerned because so much money has been spent, not only to promote the herbal medicine industry, but also in funding to researchers in various research institutes, universities and the Health Ministry. But we have not seen anything yet.  

“What you do get is stuff in the market saying that it can enhance manhood or make one prettier. This is not of concern to us. What we want is researchers doing proper, meaningful and high quality research that follows the guidelines,” he said. “Only when they produce their findings and say it can cure or treat a certain disease, marketing it worldwide would be possible.” 

To overcome this hurdle, the Cabinet has approved the setting up of the National Committee for Research and Development in Herbal Medicine. Headed by Dr Ismail, this ministerial committee is to address the problem by providing direction and guidance to researchers besides integrating herbal medical research in the country. 

It comprises ministries such as Education, Agriculture, Primary Industries, International Trade and Industry, Domestic Trade and Consumer Affairs, Science, Technology and Environment and Health, and agencies like Mardi, Frim and universities. 

The committee has come up with four guidelines for researchers – clinical evaluation of TCM intervention, level and kind of evidence to support their claim, standardisation, claims and clinical evaluation and guide to international property rights management. 

The first guideline provides research guidelines on what one can or cannot do, while the second guideline requires researchers to produce clinical trials to back up their claims of a product – either to cure or prevent diseases. Termed as a high level claim, they have to conduct proper clinical research. 

Dr Ismail said that one of the main problems with TCM (compared to other chemical entities) is standardisation. Research for certain drugs, such as beta-blockers or diabetic tablets, is very simple and clear. “But for herbal medicine, it is not so clear because there is a mixture of various constituents. The challenge is pinpointing one single ingredient so that we can standardise the extract and use that as the active ingredient to support research,” he explained. 

Besides this, the international property rights management guide makes it easier for the committee to decide which project is going to be funded by the Science, Technology and Environment Ministry. 

This initiative by the ministry, Dr Ismail said, had also caught WHO’s attention and “we have shared our guidelines with various countries such as Korea and China.” WHO, he added, sought not only cooperation with Malaysia, but also exchange of ideas about TCM policies. 

A global hub for integrated medicine has also been set up, which Dr Ismail says is comprehensive and unique compared to other websites because it not only gives out information for all levels of society, including healthcare providers, the public, scientists and businessmen, but also has a search engine which could track down information in Chinese. Thus, information ranging from research, trade, policy to conservation could be acquired by various people. 

National Institute of Natural Products and Vaccinology 

The announcement by Tun Dr Mahathir in the stimulus package last year included the setting up of the National Institute of Natural Products and Vaccinology. This has since been expanded to include Biologicals.  

Situated in Biovalley, the institute would provide a state of the art environment where researchers could link with industries, which would then know of any product undergoing research that had potential for commercialisation. “We are not starting from scratch because we will get people with the capabilities to park themselves in Biovalley, work with our researchers and provide the impetus to move forward,” he said, adding that many Malaysians were interested to jumpstart the project. 

He also said that the institute would most likely be corporatised in order to cut down red tape. 

In the area of vaccinology, research and development would start again after it was stopped in the 1980s due to concerns of cost efficiency. This, Dr Ismail said, would be for vaccines which some countries “may not like to do” such as the Nipah virus, dengue, malaria and the Severe Acute Respiratory Syndrome virus. 

Another aim is to mass produce vaccines already available like the Hepatitis B and polio vaccines.  

Future of TCM 

The future, said Dr Ismail, is good, with the Government pushing for commercialisation of products. “It will not happen tomorrow, but the fact that we have embarked on this initiative is a great start. The time will come when Malaysia will be able to tap into its biodiverse resources to produce natural products that can treat and cure diseases,” he said. 

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