Merck is waiting on approval from the FDA for its new vaccine, Gardasil, which block four types of the human papilloma virus (HPV) which causes genital warts and cervical cancer in women. As the AP article points out Merck could really use a new hit because of the 11,500 upcoming Vioxx lawsuits, and its blockbuster statin Zocor losing its patent protection in June.

Testing shows Gardasil is nearly 100 percent effective and works for at least five years, said Dr. Eliav Barr, Merck’s head of biological clinical research. He said some of the first women and girls who got the vaccine will be followed for years to see if booster shots are needed.

The vaccine targets four of the roughly 40 types of human papilloma virus: HPV 16 and 18, which cause about 70 percent of cervical cancer cases, and HPV 6 and 11, which cause 90 percent of genital warts.

HPV is the most common STD in young women, and Merck has already begun running ads about the dangers of HPV — the company is of course prohibited from running ads about Gardasil until the FDA has approved it. A decision is expected by June 8, and when it comes down, Gardasil could become Merck’s newest $1 billion a year drug. Bigger even than the money is the drug itself’s potential: cancer caused by HPV is the #2 cause of cancer, killing over 300,000 women a year.

While pap smears won’t be eliminated entirely, the drug could ease the discomfort of a million US women per year from having precancerous lesions removed. It is thought that two-thirds of cervical cancers could be prevented, but the exact number won’t be known for probably 15-20 years after the drug is released because it can take that long for cervical cancer to develop.

Sometime in late June, the Advisory Committee on Immunization Practices will decide whether or not to recommend routine HPV vaccinations for women between the ages of 11 and 26. Vaccinations for men and older women will be considered if studies currently in progress indicate that it is effective at preventing transmission of the virus to sex partners. Current tests of Gardasil have it near 100% efficacy(!).

Money looks like it might be factor — at first, anyway — as each immunization will cost between $300-500, but I don’t see many insurers balking too much if the clinical data supporting Gardasil’s efficacy is there. As always, it is cheaper to prevent a costly illness like cervical cancer than to have to treat it later on down the road. Some insurers are finally coming to this realization when it comes to things like smoking. Instead of being reactive, insurers are slowly becoming proactive, because it’s better for the health of their subscribers and also for their bottom lines.

As usual, though, there are those that might be opposed to the approval, namely the religious right who fear that Gardasil might send the wrong idea about premarital sex. (A ridiculous notion.) Fortunately, Merck has been able to overcome these fears with its anti-HPV campaign.

Merck’s rival GSK is also currently testing a new vaccine, Cervarix, that works against HPV types 16 and 18. They hope to have approval for their vaccine by the end of the year, and they are also evaluating testing on other HPV types as well.

[tags]Gardasil, HPV, genital warts, STDs, Merck, Cervarix[/tags]