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Another Setback for Gardasil

Posted by Jane Akre
Friday, January 09, 2009 11:58 AM EST
Category: Major Medical, Protecting Your Family
Tags: Gardasil, Merck & Co, FDA and Prescription Drugs, HPV, Cervical Cancer, Genital Warts

Gardasil faces another FDA setback in efforts to prescribe it to older women.



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


Merck & Co has had high hopes for its cervical cancer drug, Gardasil.

It aggressively advertised use of the drug after it was approved in 2006, in its “One Less” campaign for use in adolescent and teenage girls.

Merck has lobbied female legislators to introduce state laws to make the vaccine mandatory, largely unsuccessful so far. Merck says it has since dropped lobbying for Gardasil school-requirements and is focused on educating lawmakers.

In its latest push, Merck wants Gardasil to be used by women ages 27 to 45. It is currently approved in women and girls ages 9 to 26.

But the Food and Drug Administration (FDA) is putting that plan on hold until it receives more data from Merck & Co. Merck’s initial application included data from patients collected over two years. The FDA wants to review the final results of a four-year study which are forthcoming with research done and delivered to the FDA by Merck.

This is the second setback for the drug maker over Gardasil.

Last June, the FDA denied Merck’s request to expand the use in older women. About 80 percent of adult women have been exposed to the humanpapilloma virus (HPV), which  causes cervical cancer and genital warts. Their own immune system keeps it in check. Gardasil is less effective after someone has been exposed to the virus.

While the drug had blockbuster potential and strong sales after its 2006 launch, 2008 sales reportedly flattened, partially due to adverse health effects. 

The nonprofit group, Judicial Watch, has made public the FDA’s reports, including 10 deaths since September 2007, and more than 140 serious adverse events following inoculations of the vaccine.

Then there was the news reported in the New England Journal of Medicine in August that suggests the results might not be worth the price of Gardasil. A three shot series costs $350. 

Merck & Co’s latest push is to give Gardasil to males after a study released in November said it might be effective in preventing genital warts and penile cancer.

Projected sales figures for 2009 stand at $1.4 billion to $1.6 billion, reports Reuters. 

Merck & Co shares fell 2 percent in morning trading. #

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