Category Archives: GardasilMerck’s Garasil vaccine, promoted to prevent cervical cancer and genital warts, roared onto the market in 2006, but since then has decelerated sharply. Merck has been lobbying to increase its potential market to boys and mature women. It failed to persuade FDA to broaden use to older women–up to the age of 45–but now has convinced an agency advisory committee that Gardasil would be useful for boys and young men.
Gardasil® is the only HPV vaccine to have clinical efficacy and safety for women up to 45 years added to its product information. Gardasil® is a four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,3,4,5
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.
The review of these new applications is only likely to heat up the HPV Vaccine controversy. Both vaccines have been harshly criticized by social conservatives in the U.S. And some medical experts have joined in as well, arguing that screening can be an equally effective method in stopping cancer. Nevertheless, more than 100 countries have approved the vaccines and many strongly support their use, noting high rates of efficacy.
Fresh controversies are heating up over the marketing of products to prevent cervical cancer The U.S. Food & Drug Administration is gearing up to make critical decisions about two controversial vaccines. On Sept. 9 an FDA advisory committee will consider whether Merck (MRK)’s Gardasil, given to girls to prevent cancer-causing human papilloma virus (HPV), should [...]
During Merck’s recent earnings call, EVP Ken Frazier touted the Gardasil push, saying he expected “sequential growth” in the vaccine’s sales “as we leverage the back-to-school season.” Second-quarter sales amounted to $268 million, down 28 percent from the same period last year and 18 percent from two years ago.But–and this is a big ‘but’–Frazier also said during that call that the 13-to-18-year-old market for Gardasil has already peaked. So despite the back-to-school campaign, Merck is looking outside that age group for any real growth in the vaccine. Frazier said the company is “firmly committed to achieving greater vaccination rates in the 19-to-26 age group.” And it’s still hoping for new indications–for boys and for women up to age 45–from the FDA.
So why is it that USA citizens in many states have the option to choose whether they or their children have the HPV vaccine but immigrants can not? In order to become a permanent, legal resident of the U.S, immigrants now must receive a vaccine that is not required of U.S. citizens. This is like saying these people are less important or more likely to be infected. This surely is wrong.
Earlier this week the Journal of the American Medical Association published an analysis of safety data that found the most common serious side effect was fainting, though some more severe adverse event occurred in Gardasil patients, including more than two dozen deaths. But the FDA and CDC say there’s no evidence the deaths or other severe effects were actually caused by the shot, and the agencies emphasize that they have reviewed the same safety data repeatedly.
Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing. Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.
The latest issue of JAMA delivered a mixed blessing to Merck’s Gardasil. In a headliner study published by the Journal of the American Medical Association, the side effects of the human papillomavirus shot were deemed reasonable. Serious adverse events cropped in up those who got the vaccine–including some 32 deaths and two cases of Lou Gehrig’s disease–but there’s no evidence the shot actually caused them. The most common complications were fainting and clot risk.
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