Merck Wants Gardasil Fast Tracked

The FDA will speed its review of Gardasil for use in adult women trying to avoid the humanpapilloma virus (HPV).

Gardasil was intended as a vaccine for use in pre-teens before sex to protect girls against HPV, a leading sexually transmittable disease.  

Now in sort of a turn-about, Merck is announcing that the FDA is giving the drug company a priority review and will consider whether to expand the recommended age of users to women ages 27 to 45 after company studies showed it prevented 91 percent of precancerous lesions and genital warts in women ages 24 to 45.

A priority review means the FDA can decide to short-cut the usual 10 month review process to six months.

The government reports about 3,600 deaths in the U.S. every year from cervical cancer which can come from HPV. Gardasil works to protect against two strains of HPV that cause cancer and two strains that cause genital warts. There are up to 70 strains of the HPV.

Is it effective in older women?  It’s estimated more than six million men and women contract HPV every year and many are already infected and don’t know it. 

Gardasil will not cure an existing HPV infection. It is intended for older women who may not have any HPV strains. And it is not recommended for women who are pregnant – a good likelihood among the 20 and 30 year old age bracket.

Currently the drug is only approved in the U.S. for girls age 9 through the age of 26.

A research paper by the Guttmacher Institute, a nonprofit that focuses on sexual and reproductive health, says that HPV is spread through skin to skin contact, not through bodily fluids, so a condom would be effective in stopping its spread.

Gardasil, made by Merck is already controversial because of the aggressive advertising and lobbying on behalf of Merck to convince state legislators to introduce laws to have the vaccine mandated for preteens.

Under executive order, Texas 11 and 12-year-olds will have to receive Gardasil before they enter school.

There have been many reported cases of paralysis and even deaths associated with its use.

Many doctors say parents should wait until a girl is older than nine and closer to an age when they will become sexually active, as the length of effectiveness of Gardasil is not known.  

Others believe a drug should be on the market five years before you volunteer to receive it.
Gardasil was approved in June 2006.

If timing is everything, the recent revelation that one in four girls has some sort of sexually transmitted disease, including HPV might be a contributor to healthy sales which Merck reported at about $1.5 billion last year. 

Adding older females could add another billion annually.

A competitor could likely share in some of that revenue.  Cervarix, made by GlaxoSmithKline PLC is awaiting FDA approval.  #