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China faces uphill battle to curb fast spread AIDS
( 2003-11-13 09:09) (China Daily)

Although AIDS is no longer a taboo subject in China today, discussion largely remains confined to the medical community or the press.

AIDS remains a distant, medical issue for most ordinary Chinese people, it is an issue they cannot control nor are concerned about.

Things have changed in the past few years, with increased media coverage and promtion of public awareness for AIDS. On Monday, more than 300 delegates from around the world met in Beijing to have a high-profile discussion of the issue.

The meeting, entitled the AIDS and SARS Summit and held in Tsinghua University, may have been the most inclusive of its kind in China. The participants included scientists, doctors, high-ranking government officials, non-government organization activists, AIDS patients and even former US President Bill Clinton, who turned up halfway through the meeting, causing a sensation in the audience.

His remarks, which focused on international co-operation to curb the spread of the disease, also ended in a dramatic way, when a young man who has suffered from AIDS for six years, went up to hug Clinton amidst applause from the audience.

Nonetheless, a sense of frustration and anxiety still prevailed at the summit.

Most participants pointed out that China is facing an uphill battle to curbing the fast spread of AIDS.

Latest statistics from the Ministry of Health of China show that China has 840,000 HIV carriers, with 80,000 confirmed AIDS patients.

Information from the scientists attending the summit pointed to a difficult future, if not a discouraging one, for the development of effective treatments for the disease in a short period of time.

"We are at a difficult stage," said Zeng Yi, director of the Department of Tumor Viruses and HIV Institute of Virology. "The world's first test of an AIDS vaccines on human beings failed early this year."

He was referring to a DNA vaccine known as AIDSVAX developed by a US company, Vaxgen. The vaccine is the first in the world that has completed three-stage clinical trials early this year.

But test results showed little effect.

Despite the initial setback, scientists are not going to give up.

Elusive virus

"The failure of the vaccine gave us a chance to rethink about the approaches we used to develop vaccines," said Shao Yiming, a Chinese researcher, "It by no means suggested that we should quit our efforts in this direction."

In the long run, vaccines, instead of drugs, may prove the ultimate preventative method for the AIDS epidemic, he said.

A couple of Chinese research centres, led by the AIDS Control and Prevention Centre under the Ministry of Health, are now engaged in AIDS treatment and vaccine research, according to Shao, who is deputy director of the centre.

They have experimented in the past eight years with several types of AIDS vaccine candidates, such as the DNA vaccine, and observed positive results in the laboratory, he revealed.

Experiments suggested that one of the candidates called VLP (Virus Like particles) have succeeded to a certain degree in "educating" the mice's immune system to fight HIV.

They have filed an application to the State Administration of Drugs and Food a few months ago for clinical observation.

According to Shao, any vaccine must get through a three-phase clinical observation before being approved for production and normal application.

This process generally stretches between six to eight years, during which the vaccines are applied on an increasing number of volunteers to examine its safety and effectiveness.

Ever since the first clinical observation of an AIDS vaccine in 1987, over 20 candidate vaccines have been tested in the world on thousands of volunteers but none proved qualified so far, Shao said. Some of them failed halfway.

At present, around 20 candidate vaccines are undergoing clinical trials, most of which are in their first stage.

The AIDSVAX is only the latest to come into this category, Shao said.

One major reason for the failure is that HIV, unlike other known viruses, is notoriously elusive through its ability to mutate.

"A vaccine may prove effective to HIV at a certain stage, but in most cases, the HIV variants will soon offset its effect," he said.

But Shao said development of the new vaccines has taken on a fast track internationally and laboratory experiments take less time than before.

If things go smoothly, their vaccine could go into third-stage clinical trial by 2008.

But there are still too many uncertainties, as shown in the case of AIDSVAX, Shao admitted.

For the time being, drugs remain the most immediate treatment for AIDS, Zeng Yi said.

Yet, like many other developing countries, China is also now grappling with the issue of intellectual property rights of the expensive drugs developed by big pharmaceutical companies.

None of these drugs were developed by a Chinese company.

Most of these drugs have obtained protection under China's intellectual property laws and their prices, therefore, remain unaffordable for most Chinese AIDS patients.

Compulsory licensing

Last year, four AIDS drugs run out of their protection period under Chinese law, thus opening the door for domestic companies to manufacture generic versions of these drugs without the need to pay a licensing fees.

Experts noted that such a change may cut the cost of treatment using the four drugs by up to 90 per cent.

But calls for compulsory licensing of other AIDS drugs makers have never died down.

One main reason is that the effectiveness of the treatment may be limited by the availability of the drugs used.

For instance, the famous AIDS "cocktail treatment," requires continued taking of a combination of drugs.

With a limited pool of drugs available, the human body of the AIDS patient may develop a resistance to the treatment, said Li Jinliang, president of the Shanghai-based Desano Company.

The company has been engaged in the development of AIDS drugs and also has manufactured generic versions of the above four drugs.

"With only these four drugs available, it would be difficult to avoid the onset of drug resistance," said Li.

He suggested that the authorities consider the compulsory licensing of other drugs under Chinese intellectual property laws.

Chinese law allows the compulsory licensing of certain patents in case of State emergencies or other unusual circumstances and it must be for the public good. However, this provision has not been tested in practice in China or anywhere else, Li said.

Two year ago in Doha, Qatar, the World Trade Organization issued the "Doha Declaration," which states that during a national emergency - such as "HIV/AIDS, tuberculosis, malaria and other epidemics" - it is permissible for a country to grant a compulsory licence to a local "third party" manufacturer to supply a drug for domestic use despite the drug being under patent.

It was also recognized at Doha that countries without a manufacturing capacity would face difficulties in making any use of compulsory licensing provisions.

China, however, has a sufficient manufacturing capacity for these drugs, Li said.

The patent issue over the vaccines is also looming, Shao said.

Few pharmaceutical companies would wait until the completion of the drug development to file patent applications. They would apply during the process at the time they consider to be most appropriate, adding to the difficulties for other researchers or developers, Shao said.

"The serious situations now forced us to rethink the protection of patents or lives," he said, "the patients could not wait 15 years for the drug to be available, not even a single day."

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