Cancer vaccines embroiled in controversy

Published: 16/12/2008 05:00

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Update from: http://www.thanhniennews.com/healthy/?catid=8&newsid=44640

Vietnam’s Health Ministry has approved two vaccines against cervical cancer but concerns have risen about their effectiveness.

Participants at a conference in Ho Chi Minh City on Saturday warned against complacency among women getting themselves vaccinated, saying their long-term effectiveness was still to be ascertained.

Meanwhile, local reports have surfaced about unethical lobbying by medical companies to obtain regulatory approval for their products, including vaccines.

Cao Minh Quang, the deputy health minister, had on July 24 announced regulatory approval for the Gardasil vaccine in Vietnam, manufactured by the US-based Merck Sharp & Dohme Company (MSD), also known as Merck & Co.

The vaccine is to protect women from 9 to 26 years of age against human papillomavirus (HPV) strains 16 and 18 that currently cause 70 percent of cervical cancer cases.

On November 18, Quang approved the Cervarix vaccine, manufactured by England’s GlaxoSmithKline (GSK) for women 10 to 55 years of age, also effective against HPV types 16 and 18.

However, officials of local cancer associations have raised doubts about the vaccines’ capacity and questioned lobbying efforts made during the application for approval.

Gardasil and Cervarix are supposed to work after three injections, with the former costing US$100 each and the latter $37.

More than 140 types of HPV are acknowledged to cause cervical cancer with 16 and 18 classified as high-risk.

As the approved vaccines cannot be effective against all HPV infections that cause the disease, people shouldn’t think that they will be absolutely safe from cervical cancer once they are vaccinated, experts said at the conference in HCMC on Saturday.

Nguyen Chan Hung, chairman of the HCMC Cancer Association, said the vaccination still “surrenders to 30 percent of cervical cancer cases.”

The vaccines have been experimented worldwide for only six years and there’s little evidence to ensure that they will be effective for long, Hung said.

Professor Nguyen Ba Duc, head of the Cancer Treatment and Prevention Institute, said only those women who have not had sex will benefit much from the vaccines.

Nguyen Thi Tuong Vi, GSK’s vaccine director in Vietnam, said Cervarix has been approved in 90 countries, including Europe in 2007.

Vi said clinical experiments of the vaccine had been conducted in Vietnam.

However, Do Gia Canh from the Health Ministry said “the matter should be considered further and we shouldn’t approve the vaccine for women aged 10 to 55.”

Among the countries that Cervarix has won approval, 40 gave it for women aged 10 to 25, six for 10 to 45 and only two for 10 to 55.

The European Community’s health agency has only approved the vaccine for women aged 10 to 25 and the clinical experiment in Vietnam was only conducted on 220 women 25 to 40 years of age, Canh said.

On July 18, Quang sent a letter to MSD’s Chief Executive Officer Richard Clark and administrative president for the Asia-Pacific region, Ramesh Subramanian, to complain about the company’s unethical lobbying activities in Vietnam, the Tuoi Tre newspaper reported Monday.

According to Tuoi Tre, Quang suggested that MSD cooperates and investigates the activities of its Vietnam office.

Kha My Linh, head of MSD Vietnam, told Tuoi Tre that an MSD investigation that began mid-August did not find any evidence about her office bribing or lobbying any Vietnamese official while seeking approval for Gardasil.

Linh said MSD had sent the investigation’s results to the Health Ministry, according to Tuoi Tre.

Meanwhile, the regional director of GSK, Goh Choo Beng, has said the company sends the same application to every country for regulatory approval and has made no special effort to intervene in the decision of Vietnam’s Health Ministry.

Reported by Thanh Tung – Nam Son

Provide by Vietnam Travel

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