USA stunned by Texas' mandatory Gardasil vaccination plan

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gardasylThe debate in the USA over the use of Merck & Co's cervical cancer vaccine Gardasil is reaching boiling point after the Governor of Texas announced plans for mandatory vaccination programmes for girls aged 11 and 12.

Republican Governor Rick Perry last week chose to employ an executive order, thus bypassing any opposition in the legislature, which makes Texas the first state to require that girls receive the human papillomavirus vaccine that causes cervical cancer before they can enter the sixth grade at school, beginning September 2008. The order does not specifically mention Gardasil but Merck's vaccine is the only HPV treatment on the market at the moment, although GlaxoSmithKline's Cervarix is expected to be filed for approval in the USA by April.

Gov Perry has also directed state health authorities to make the vaccine immediately available through the Texas Vaccines for Children programme for "young women" aged 9 to 18, and through Medicaid for those aged 19 to 21. The directive also states that "parents may choose to opt out of mandatory vaccinations for reasons of conscience, including religious beliefs" but this has not been enough to calm a tide of criticism about Gov Perry's actions.

Opponents of the order claim that abstinence and fidelity are the best defence against sexually transmitted diseases like HPV and not a vaccine which conservative groups say will lead to a rise in promiscuity. Critics have also slammed the link between the governor and Merck as one of the drug company's three lobbyists in Texas is Mike Toomey, Gov Perry's former chief of staff. The governor also received funds from Merck's political action committee during his re-election campaign.

However the governor says his position is based on health matters only and his views, though not necessarily the method employed, was backed by the US Centers for Disease Control's advisory committee on immunisation practices last June which recommended Gardasil be routinely given to young girls. HPV is the leading cause of cervical cancer, which results in nearly a half-million diagnoses and 240,000 deaths each year.

Merck itself has been criticised in some circles for its promotion of a national immunisation programme and been accused of profiteering. When Gardasil was launched last June, Merck's catalogue price was $120 per dose and a person needs three doses for protection. It contributed $155 million to Merck's fourth-quarter 2006 sales.

Meantime, Reuters has reported that France will subsidise Gardasil soon, noting that health minister Xavier Bertrand told a radio station that "we will subsidise it. Why? Because it's a major step towards improving the health of the public."

Mr Bertrand added that "we have already got the process under way and before the end of the first half of 2007, before July, it will be subsidised."

source PharmaTimes