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.
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 [...]
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.
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.
Possible positive drivers for Merck this quarter might be seen in its Singulair and Januvia sales. Weighing on this quarters earnings will be the loss of patent protection on Fosamex and slower Gardasil sales. Sales of cholesterol drugs Vytorin and Zetia, co-marketed by Schering-Plough (SGP), might also be disappointing especially in a weak economy with cheaper alternatives.
State mandated Gardasil shots for preteen girls to protect them from the viruses that causes cervical cancer, are targeting the wrong age group. Middle-school girls inoculated with the HPV vaccine will be no older than eighteen when they pass Gardasil’s five-year window of proven effectiveness — more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV). Merck & Co. has repeatedly refused to respond to requests for its HPV incubation statistics, stating that it is still studying the longevity of Gardasil.
FDA recommends that consumers stop using these products and throw them away
On June 16, 2009 The FDA issued the following product recall. The recall was triggered when the FDA received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products. FDA is alerting consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia).
The Gardasil issues I researched were the relatively limited trial period, the sketchy trail data; the cost benefit of a drug that was design to prevent a cancer that has been declining in both incidence and mortality for over 40-years. Cervical cancer is easily detected by regular PAP screening and in the early stages, the most treatable cancer. The other aspect of Gardasil roll-up that didn’t pass the smell test was the Merck Marauder School of lobbying today for a more profitable tomorrow. Merck literally carpet-bombed the halls of power and influence with cash to get GARDASIL approved by the FDA (while holding up the Glaxo HPV-vaccine, Cervarix), they got Gardasil endorsed by the CDC and mandated in many states as yet another vaccine necessary to attend school, and managed to get state legislators to pass bills to force insurance companies to pay for the Gardasil shot. As I researched the payouts and pay offs of state, local and federal representatives, I asked when did safety go on sale? Then I found out about Merck paying doctors to go on the stump to endorse Gardasil. Some docs with great speaking skills picked up several hundred thousand dollars in a year. Then there was the scandal about “Medical Journal-Like’ publications written by ‘bought and paid for’ doctors who dutifully regurgitated the WORD according to Merck.
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