Big Day for Big PharmaSaturday, October 17, 2009
In a previous blog, I mentioned a couple of points about Merck’s Gardasil and GlaxoSmithKline’s Cervarix, with both companies competing for guinea pigs to increase their customer base for HPV vaccines. First, GlaxoSmithKline had applied to the FDA for approval to sell its HPV vaccine, Cervarix, in the United States. Second, Merck had applied to the FDA for approval of its HPV vaccine, Gardasil, as a vaccine for boys and men to prevent genital warts. Both vaccines are touted as offering ‘protection’ against the more common strains of HPV. Merck claims that Gardasil protects against the four most common strains of HPV: types 6, 11, 16 and 18, with HPV types 16 and 18 accounting for 70% of cervical cancers and HPV types 6 and 11 accounting for 90% of all cases of genital warts. Glaxo claims protection from strains 16 and 18 with its Cervarix.
When Merck could smell its competition coming up behind ‘em as Cervarix was destined for approval in the U.S., it began to promote Gardasil as an effective tool in the prevention of genital warts in boys and men (ages 9-26). Glaxo also claimed protection against an additional strain (strain 31) of the HPV virus, so it could differentiate its product, too. Meanwhile, the deaths of Natalie Morton and Stacy Jones (in the UK), both occurring after Cervarix shots, were quietly brushed aside and/or covered up. This week the FDA approved the use of Gardasil for males for prevention of genital warts and it approved Cervarix for use in the U.S. This is from the Bloomberg story on Gardasil’s new approval:
Expanding the shot’s use could revive sales, which declined 5 percent last year, analysts have said.
“This is an important milestone, because the use of Gardasil can now help protect boys and girls and young men and women from certain diseases caused by this common virus,” said Richard Haupt, executive director of Merck Research Laboratories, in the company’s statement.
However, when researchers use their QALY formula (quality adjusted life years), analysts say that the “public-health benefit may not outweigh the expense.” Of course, the story later reports what we all know from educating ourselves about this dilemma: “While 20 million Americans are infected with HPV, most will be able to fight off the infection naturally.” Thus, there is no need for a vaccine other than making big bucks for Big Pharma by scaremongering people into believing they must have protection for every disease, every wart, every headache, every pimple, every fall, every sneeze, and every imagined disorder. Thanks to all the readers (there were many) so sent links to me related to the FDA’s approval.