Scottish Conservative health spokeswoman Mary Scanlon said: “Given this new research, it is now incumbent on the Scottish Government and the chief medical officer to review the vaccination program to ensure that it lives up to the expectations of preventing cervical cancer.”
As Glaxo is forced to wait for FDA’s approval for its own HPV vaccine, Cervarix, will the company use its time on the sidelines to absorb lessons learned from Merck’s missteps? There is a building backlash against Merck’s ‘BIG-FOOT’, political lobbing strategy that aggressively pushes politicians to mandate its vaccine. Merck has pushed through from one political firestorm to the next. An increasing resentful public is feeling like Atlanta to Merck’s Sherman-like march to market share.
The Health Ministry has launched an investigation into the procedures used to approve two cervical cancer vaccines that entered the market this year. The investigation reviews the clinical trials and regulatory approvals made in Viet Nam for the two drugs Gardasil and Cervarix. According to Prof. Nguyen Ba Duc, head of the Cancer Treatment and Prevention Institute in Ha Noi’s K Hospital, the vaccines supposedly protect women for life. But the vaccines have been in circulation for only three years, and the claims had not been conclusively proven, he said
GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007. In addition, given that final data from GSK’s Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these data in the first half of 2009. The timing depends on reaching a certain number of cases in order to conduct the final analysis. An FDA action on the application is expected to take up to six months following this submission. Interim data from this study were filed in the original application for the vaccine in March, 2007. The company does not expect that new clinical studies will be required for approval.
BBC story diagrams the corporate infighting over which multi-national Pharma Giant wins the very profitable HPV vaccine contract with the UK public health department. Glaxo needed a win big time. Merck has effectively shut them out of the lucrative American market, (the paper work has the FDA logo, but in the ‘Mercky’ world of vaccine politics, Merck lobbyists know how to deliver…a politician, regulator, or an agency, Merck Money moves opinion and decisions.) Merck won’t stop fighting to get a piece of the UK school girl market. Expect continuous stream of Merck public relations rhetoric throughout the balance of 2008 and up to the International Human Papilloma Virus Conference, held in Sweden next June. Both Merck and Glaxo are scheduled to deliver papers. In the Merck world view, “Its not over, until it is over.”
Glaxo, still struggling to overcome the Avandia diabetes pill controversy and subsequent lost revenue, has been dealt another blow by the FDA. The agency has issued a “complete response letter” to Glaxo for its Cervarix vaccine. It is unclear whether the FDA will require additional clinical trials for Cervarix. The unexpected delay in approval could last as little as six-months or as long as two-years.
The FDA’s approval for the ‘other’ HPV-vaccine, Cervarix is still delayed. GlaxoSmithKline, the world’s second-largest drugmaker, requested a ‘priority’ review, potentially prompting an approval decision and sale of the Cervarix vaccine by the end of 2007, said James Tursi, Glaxo’s director of medical affairs for cervical cancer vaccines, at a medical meeting in San Diego.
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