Officials to review cancer drug approvals

Published: 17/12/2008 05:00

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Update from: http://www.thanhniennews.com/healthy/?catid=8&newsid=44677

Vietnam’s Health Ministry Wednesday launched an investigation into the regulatory approval given to two cervical cancer vaccines.

The investigation team, led by Deputy Minister Trinh Quan Huan, and including chief inspector Tran Quang Trung, Nguyen Huy Quang from the legislation office and Nguyen Trong Thuy from the staff organizing office, will have 15 days to report its findings, Health Minister Nguyen Quoc Trieu announced.

On July 24, Deputy Health Minister Cao Minh Quang approved Gardasil, made by US drug-maker Merck Sharp & Dohme Company, as a vaccine for women aged 9 to 26 against human papillomavirus (HPV) strains 16 and 18 that cause 70 percent of cervical cancer cases.

On November 18, Quang approved English GlaxoSmithKline’s Cervarix vaccine for women 10 to 55 years of age, also effective against HPV types 16 and 18.

However, questions have been raised about unethical lobbying by medical companies to obtain the approvals.

The team will investigate all the documents related to the approvals and the clinical trials of the two vaccines.

The investigation will also examine the role of the Health Ministry’s Science and Training Office and Vietnam Drug Management Bureau.

Truong Viet Dung, head of the Science and Training Office, Wednesday said clinical trials in Vietnam for Cervarix were only conducted on women 25 to 40 years of age.

The trial aimed “to check the vaccines’ safety, not their effectiveness,” Dung said.

He said the office made no conclusion about the vaccines being effective for women of different ages, adding that the final decision about their usage was based on scientific research done overseas and provided by the makers of the vaccines.

Dung said there had been “no research to prove that the vaccines could protect a woman against cervical cancer forever, no findings about for how long the vaccines will remain effective or how often the vaccination should be administered.”

Gardasil and Cervarix are supposed to work after three injections, with Gardasil costing US$100 a shot and Cervarix $37 a shot.

Reported by Nam Son

Provide by Vietnam Travel

Officials to review cancer drug approvals - Health - News |  vietnam travel company

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