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Catch the 'silent killer' through vaccine
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Xiao Gui received good and bad news simultaneously early this month. The good news was that vaccines --- Gardasil and Cervarix -- to prevent cervical cancer do exist.

The bad news was that neither of the two vaccines was yet available in China.

Xiao, 40, was very anxious to be vaccinated against HPV (human papilloma virus), as she was diagnosed HPV positive.

Quietly damaging cells in cervix and invades surrounding tissues, HPV is a primary risk factor leading to pre-cancerous lesions in cervix.

"My gynecologist told me if my HPV infection is persistent, the chance of developing cervical cancer is very high. I don't want to die. My little girl is only 14," Xiao said, trying to hold back her tears.

The world's first vaccine against HPV, Gardasil, was developed by Merck & Co Inc in the United States and won approval from the U.S. Food and Drug Administration (FDA) in June 2006. It is on the market in 85 countries and regions now, including the United States, Australia, EU and China's Hong Kong, Macao and Taiwan regions, according to Merck.

In the meantime, the British firm GSK (GlaxoSmithKline) had its vaccine Cervarix approved for the EU, Australia, the Philippines and Macao last May.

Regarded in medical community as a "silent killer" of women, cervical cancer, is the second biggest threat to women's health after breast cancer. It claims one woman's life every two seconds worldwide, regardless of the socio-economic background or nationality. Hong Kong pop diva Anita Miu, dubbed the Madonna of Asia, lost her life to cervical cancer at age 40 in 2003.

The latest figures released by the World Health Organization (WHO) suggest that cervical cancer affects nearly 500,000 a year worldwide, with more than 100,000 cases in China.

HPV is identified as the chief cause of cervical cancer, and is found in almost all cervical cancer cases. Yet, of 100 strains of HPV, the most lethal are the 16 and 18 strains which together make out 71 percent of cervical cancer cases worldwide.

In China, however, 85 percent of cervical cancers are attributed to the 16 and 18 strains of the HPV, according to epidemiological survey results released at the 24th International HPV Conference held in Beijing last week.

The one-year-long (2006-2007) survey of 1,244 patients with cervical cancer and pre-cancer was conducted in 19 hospitals across the country, said Dr. Qiao Youlin, director for the Department of Cancer Epidemiology at the Chinese Academy of Medical Sciences, who was principal investigator for the survey.

The vaccine Cervarix is designed to prime the immune system against the 16 and 18 strains of the HPV, said Dr. Tang Haiwen, director for Vaccines Department of GSK, North Asia. More importantly, he said, "It's 100 percent effective for five years based on our surveillance of the first group of women who took part in."

Both Merck and GSK tried to involve China in their global multi-center clinic trials for the vaccines years ago. Early in 2006, they both submitted their patent applications to China's State Food and Drug Administration (SFDA).

So far, Dr. Tang Haiwen of GSK said they had approval from the SFDA only to conduct clinical trials for Cervarix in China. "But at this point, it's hard to anticipate when it will be approved for the Chinese market as each country has its own regulations and procedures."

Theoretically, the anti-HPV vaccine, either Gardasil or Cervarix, is effective for women of all ages. Gardasil made by Merck targets women aged nine to 26. "Our clinical trials, however, discovered that it is also effective for women as old as 45," Merck said.

Merck is to submit the findings to the U.S. FDA to won approval for introducing the vaccine to women below 45 years.

The cost of Gardasil is over 300 U.S. dollars for a complete series of three shots over six months. Many Chinese experts worry the vaccine is out of reach for ordinary people like Ms. Xiao Gui, who earns 3,500 yuan a month as a researcher.

"Few rich women with HPV infection here could afford buying the vaccines from overseas," said a Chinese oncologist.

Dr. Hugues Bogaerts, vice president for GSK's Worldwide Medical Affairs, noticed the vaccine was a special commodity. The price normally varies depending on different groups and different countries. "Ours would be lower in developing countries, compared with developed countries."

As HPV is sexually transmitted, experts in American and Australia recommend the Gardasil and the Cervarix vaccines to be given to pre-teens before they become sexually active.

However, some Chinese experts are worried the vaccine may encourage promiscuity among teenagers, triggering ethical complaints once introduced into the country.

Dr. Qiao Youlin said HPV is a very common virus. "It's irrational to make a value judgment just because it's transmitted via skin contact and sexual activities."

In fact, the cumulated chance of exposure to HPV is up 80-percent for every sexually active woman in their lifetime. Therefore, "you cannot really say which social group is 'moral' or high-risk", said Dr. Qiao.

He warned a regular screening for cervical cancer is still necessary and crucial for all women in order to stop the cancer before it starts, even if the vaccine becomes available in China in the future.

(Xinhua News Agency November 17, 2007)

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