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FDA Denies Merck Expanded Gardasil Approval For Older Women

Posted by Jane Akre
Wednesday, June 25, 2008 11:48 PM EST
Category: Major Medical, Protecting Your Family
Tags: Gardasil, FDA and Prescription Drugs, Women's Health, HPV, Defective Drugs, Drug Products

The fast track for Gardasil slowed today with the FDA denying its expanded approval.



IMAGE SOURCE: ©iStockPhoto/ mature couple/ author: barsik 


Drug maker Merck has been denied approval to market its cervical cancer vaccine, Gardasil to older women.

Merck wants to market Gardasil to women ages 27 through 45, but the Food and Drug Administration said in a letter there are “issues” that preclude approval. Merck has also not been able to win approval to expand the drug’s reach to fight other strains of the human papillomavirus (HPV) that causes some cervical cancers.

The vaccine reportedly protects against four HPV strains ( types 6, 11, 16 and 18), two of which cause genital warts and two that cause about 70 percent of cervical cancers

Most women, about 80 percent, are infected with HPV, which the immune system can supress or HPV goes away on its own the majority of the time.  Gardasil does not address a current HPV infection.

Gardasil was approved in June 2006, for use in young females, ages 9 to 26 to prevent cervical cancer and genital warts. It is only effective if given before exposure and Merck launched an aggressive "One Less" campaign to persuade mothers to have their children innoculated.

Gardasil has been a successful product for Merck, still reeling from the 2004 withdrawal of Vioxx arthritis treatment. The company has agreed to settle claims for $4.85 billion, minimizing exposure that could have fallen into the tens of billions.

According to a Merck spokeswoman, speaking to Reuters, the FDA had concerns about the effectiveness of Gardasil in older women.  

A study of Gardasil by the National Vaccine Information Center (NVIC.org),  found more than 80 reports of adverse reactions including seizures, passing out, and Guillain-Barre syndrome.  The National Vaccine Information Center has alleged that the FDA and Merck fast-tracked Gardasil’s licensure with flawed science.

Many doctors are advising against having a young woman vaccinated until the drug has been on the market for five years and any adverse effects are seen.  

The CDC reported earlier this year that one in four teenage girls is infected with a sexually transmitted disease, the most common HPV.

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.

The first quart profits for Gardasil were $390 million. Gardasil is predicted to jump to $3 billion in profits by 2012.

Competitor, GlaxoSmithKline PLC’s  Cervarix, is the HPV  vaccine of choice in Great Britain and may be approved in the U.S. soon. It has been tested in older women. #

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