In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.
We are presently addressing an issue that involves the health and well being of every young girl and young women in the world. This is in regards to the HPV vaccines. With international collaboration we brought together information about these two vaccines and distributed a detailed paper to the 13 scientists that advise the EU but to other concerned parties such as the Minister of Health for Germany. We are seeing good responses coming from England, Scotland and the Netherlands in regards to efforts being made to suspend these vaccines pending further safety studies, etc. Since the distribution of this paper and a second paper to these scientists and other concerned parties we are now seeing an upsurge in responses from other countries around the world.
International Coalition of Advocates for the People’s first educational advocacy effort has been a success. Seven women who became international advocates wrote a paper about HPV vaccines to educate all necessary parties in Europe. This paper has been distributed throughout Europe and to select individuals in the United States. Presently, thirteen German scientists from the Robert Koch Institute are questioning the effectiveness of these vaccines. They are also asking for evidence now from the Standing Committee based on the scientists’ views.
“Startups could co-locate with us and create a new type of foundation for discovery,” Witty told the International Association of Science Parks conference in Raleigh, home to one of the country’s largest research centers. And he reiterated GSK’s interest in small acquisitions and partnerships to provide a fresh jolt of new ideas for a company in bad need of good drug development programs. Witty also underscored that the presence of large academic institutions staffed with top researchers won’t be enough to woo companies like GSK in the future. Even more important, he says, is a pro-business attitude “to make the interface between industry and academia porous.”
Netherlands-based advocates, Janny Stokvis and Annelies Witlam have worked tirelessly to distribute the HPV-vaccine research paper produced by International Coalition of Advocates For The People and submitted to the Robert Koch Institute for review. They have supported the HPV-vaccine education process in the Netherlands, the UK, EU Canada and America and are founding members of the International Coalition of Advocates For The People (ICAP). I am proud to be counted amongst their professional associates.
All any of us, who have raised questions about the rapid deployment of the HPV vaccines, Gadasil and Cervarix, have ever wanted, is an objective review of the clinic trial information by scientist not related to Big Pharma. In Germany, the Robert Koch Institute is in that process right now. The question American, Canadian, and other EU citizens are asking is, “Why are our own governmental agencies and regulators so against a similar objective review of the clinic trial information and independent medical review of the thousands of reported HPV-vaccine adverse effect cases? Is the no “Robert Koch Institute-like” organization that can ask the questions for our citizens?”
“What concerns us is that the two manufacturers of the vaccine aren’t always using facts. They claim that a lot of high-risk strains of cancer-causing virus are protected against but equally there are others that are not. If protection is not more than 20 per cent then that is an awful lot of money to be spending, particularly as the vaccines have quite serious side-effects.” — Professor Martina Doren, of the Charitie Hospital in Berlin:
LEADING scientists and doctors have raised fresh concerns about the safety of a cervical cancer vaccine. They have accused the manufacturers of Cervarix and another jab, Gardasil, of making misleading claims. More than 1,300 British girls have reported adverse reactions to Cervarix, ranging from paralysis to convulsions and sight problems.
All around the world concerns are mounting about the effectiveness and the safety of the HPV vaccines. Whilst many of our Governments refuse to listen to public concern and ignore the ever increasing numbers of children who have had adverse reactions to the Gardasil and Cervarix vaccines, in Germany their concerns are at last being looked at and examined carefully. The Robert Koch Institute in Germany which makes recommendations on the public funding of vaccines, is reviewing its vaccination programme after 13 experts called for a reassessment of its HPV vaccination programme and an end to “misleading information” about the effectiveness of the HPV-vaccine.
Touting competing studies, Merck and Glaxo use 25th International Papillomavirus Conference as venue to fight for increased sales for their HPV-vaccines, Gardasil and Cervarix. Glaxo released a new Cervarix vs. Gardasil head-to-head study, saying Cervarix prompted a stronger immune response. Merck has been promoting its own ‘new’ study data, which claims Gardasil offers protection from certain HPV strains for up to 9.5 years. Can trial data make a big difference in revenues for either company? Merck is facing declining sales and Glaxo has yet to gain FDA approval and is dealing with efficacy issues in the U.K.
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