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Gardasil Disappoints Merck As Blockbuster

Posted by Jane Akre
Thursday, September 18, 2008 12:04 PM EST
Category: Major Medical, Protecting Your Family
Tags: Gardasil, HPV, FDA and Prescription Drugs, Merck, Judicial Watch, Defective Drugs, Vaccines, Teenagers, Wrongful Death, Vaccine Immunity

Gardasil not the blockbuster Merck had predicted



IMAGE SOURCE: © ©iStockphoto/ girl being vaccinated/ author: pflorendo


The latest label expansion for the human papilomavirus (HPV) vaccine by the FDA occurred Monday, when Gardasil was approved for the prevention of two rare vaginal and vulvar cancers.

But Gardasil is not the blockbuster drug maker Merck had hoped it would be.

Typically an expanded label means an expanded market, but market watchers are wary.

"We are waiting to see if there is increased uptake of the product in the second half," said Miller Tabak analyst Les Funtleyder tells Forbes. "The company has had trouble connecting with the pre-sexually active set with Gardasil. It hasn't really taken off in that group."

The second quarter 2008 earnings brought Merck a 9.0 percent sales decrease largely due to the FDA refusal earlier this summer to approve Gardasil for women ages 27 through 45 for the prevention of cervical cancers.

Gardasil is the only drug approved to prevent four strains of HPV in girls ages 9 through 26.  So far about 18 million women have received the vaccine since it was approved in 2006. 

But Gardasil has not met expectations as a blockbuster, largely because of the controversy surrounding it. 

Ethicists debate whether young girls should be given a vaccine to prevent sexually-transmitted diseases. Parents and doctors are concerned about the short time on the market, and the long-term effects, especially given the incidents of adverse effects including death.

Judicial Watch gathered information from freedom of information requests to put on its web site concerning the adverse health event reports on Gardasil. The group reports the vaccine is linked to 21 deaths and more than 9,000 adverse reactions including outbreaks of genital wards as well as 10 miscarriages.   

Still Merck predicts 2008 revenue on Gardasil will climb to between $1.4 billion and $1.6 billion. The current expansion may not affect those numbers.

But the newest expansion for Gardasil might.

The U.S. government is mandating HPV vaccines for new U.S. residents. The U.S. Citizenship and Immigration Services (USCIS) announced Wednesday that girls who want to become legal permanent residents of the U.S. must have the HPV vaccine. 

The new rule is outlined in the CDC “Technical Instructions to Civil Surgeons for Vaccination Requirements”.   Girls and young adult women will have to show proof they are vaccinated with Gardasil before they are granted legal permanent resident status.

Any HPV vaccine is not a recommended substitute for routine cervical screening.  #

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