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Gardasil for Boys?

Posted by Jane Akre
Friday, September 11, 2009 1:03 PM EST
Category: Protecting Your Family
Tags: Gardasil, HPV, Ceravix, Merck, GSK, FDA, CDC, Cervical Cancer, Penile Cancer

Gardasil may be recommended for boys if the FDA follows its advisory panel.

Penile Cancers Rare

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IMAGE SOURCE: ©iStockphoto/ romantic couple

An FDA panel looking at the efficacy and safety of giving boys the vaccine, Gardasil, advises a “wait and see” approach until more evidence is in.

A Food and Drug Administration (FDA) advisory panel voted Wednesday to approve use of the human papillomavirus (HPV) drug for use in males ages 9-to-26 to protect against genital warts and penile and anus cancers, but a conservative approach is encouraged until more evidence is in, reports ABC News.

The FDA usually follows its panels’ advice.

Gardasil is already approved to protect against four strains of HPV, two of which cause warts, and two that cause 70 percent of cervical cancers.

Still undetermined is how long the drug lasts, whether it protects females from male carriers, and whether it protects males against the rare cases of anal and penis cancers.

Rival, Ceravix

Merck, Gardasil’s maker, has been counting on expanding lagging sales. That is especially important since the FDA turned down its application for use in older women, and now that rival, Ceravix, is close to being approved.

The advisory panel said that Ceravix, made by GlaxoSmithKline, appears to be safe in girls and women ages 10-to-25. Studies have shown that the vaccine prevents infection with HPV 93 percent of the time.

The introduction of Cervarix was delayed in 2007 when the FDA said it needed more research on the vaccine.

Advice from professional medical groups will come next, but a recent New England Journal of Medicine (NEJM) study questions the independence of these groups.

The NEJM article says Merck & Co paid for a favorable medical opinion from three medical associations to promote Gardasil, dishing out a total of $750,000 to the American College Health Association, the Society of Gynecological Oncologists, and the American Society for Colposcopy and Cervical Pathology, reports the Washington Post.

The medical groups would then launch an educational campaign promoting use of the cervical cancer drug, almost identical to the marketing done by Merck for the drug.

Adverse Events

According to Judicial Watch, a Washington D.C. based nonprofit public interest group, there have been nearly 9,000 adverse health events reported to the government concerning the drug, including a number of deaths reported since September 2007 and at least 18 deaths.

Background on HPV

Dr. Bernadine Healy, former head of the National Institutes of Health and the American Red Cross, and now reporting for U.S. News, says the CDC is trying to identify 25,000 cancers primarily associated with HPV. She cautions even the best vaccine can have side effects.

The Centers for Disease Control and Prevention (CDC) reports there are 6.2 million cases of HPV diagnosed each year in men and women and about 20 million Americans are currently infected with HPV.

At least 50% of sexually active men and women acquire genital HPV infection at some point in their lives. While about 1% of sexually active adults in the U.S. have genital warts at any one time.

The American Cancer Society estimates that in 2008, 11,070 women will be diagnosed with cervical cancer in the U.S. #


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