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FDA approves Gardasil for Use in Males, approves new HPV Vaccine for females

From the FDA: Gardasil Approved for Use in Males

The quadrivalent human papillomavirus vaccine (Gardasil) has been approved to help prevent genital warts in males aged 9 through 26, the FDA announced on Friday. As in girls and young women, the vaccine will be given as three injections over a 6-month period. This is good news since males are carriers of the HPV virus and can infect their female sexual partners.

From the FDA: New HPV Vaccine Approved for Females

The agency also approved a bivalent HPV vaccine (Cervarix), manufactured by Glaxo Smith Kline, for use in females aged 10 through 25, according to the manufacturer. The vaccine, which protects against HPV types 16 and 18, both causes of almost all cervical cancers, is expected to be available in the U.S. by the end of 2009.

FDA news release on Gardasil (Free)

Manufacturer news release on Cervarix [New drug from Glaxo Smith Kline] (Free)

Physician's First Watch coverage of FDA advisory panel recommendations on both approvals (Free)

Gardasil concerns | Safe or not?

A client sent me a December 2007 article that I somehow missed during my intensive look at the dangers of HPV (which are serious) and the possible value of vaccination with Merck's Gardasil. You may recall that many of my posts questioned Merck's heavy-handed marketing and lobbying strategies. [Those earlier posts may be read here.]

Parents with teenage daughters may wish to review this article prior to decision-making on whether or not to ask their family doctor to vaccinate with Gardasil. Frank Strehl, "Gardasil: pros and cons," Original Internist, December 2007, <http://findarticles.com/p/articles/mi_m0FDL/is_4_14/ai_n24354801/?tag=content;col1>, <http://tinyurl.com/mn4gm6> (Accessed August 11, 2009)

HPV | Changing teenagers' futures in a heartbeat

I was recently struck by how easy it is for teen sex to change in a heartbeat the future of young women without a teenager even knowing what has happened until it is too late.

I've written extensively about the dangers of teen sex and the rampant increase in incidence of HPV infection. HPV is the STD that keeps on giving, spreading exponentially when an infected boy or girl has sex with others. There are three strains of HPV that cause virtually all cervical cancers.

Here's a story about how cervical cancer changed one woman's life forever. She is a survivor of cervical cancer caused by HPV. She had it twice. Now she is unable to conceive or carry a child. She and her husband will be fortunate indeed if just one of the remaining cryo-preserved embryos that they saved before her treatment allows them to have children.

FDA approves Gardasil to prevent vulvar and vaginal cancers

Many of my regular readers know that I post often about social issues, in particular teen pregnancy and the prevalence of human papillomavirus (HPV). HPV is a sexually transmitted disease. Two strains of it (16 & 18) cause virtually 100% of all cervical cancers. See National Cancer Institute Q & A.

The FDA announced on Friday that the HPV vaccine Gardasil has been approved for two additional uses — prevention of vaginal and vulvar cancers caused by HPV types 16 and 18.

Teen pregnancy | Abstinence education not an option

Teen pregnancy is becoming a huge issue as birth rates once again rise and as the percentages of first births to unmarried mothers increases after a hiatus between 1991 and 2006. An op-ed piece by June Carbone of University of Missouri-Kansas City and Naomi Cahn of George Washington University, both family law professors, was published in STLtoday.com on September 5,  2008. It's well worth reading by family lawyers counseling their clients and also by parents.

HPV Vaccine | Marketing hype or effective protection?

Regular readers know that I have frequently blogged on the topic of Gardasil, Merck's HPV vaccine.

The New York Times today (August 20, 2008) published an in-depth article examining the manner in which Merck has marketed the drug and the controversies surrounding Merck's efforts. Merck calls the efforts "education," but critics call it marketing. This article is certainly worth reading by all parents of teenage girls. The New York Times article can be accessed here. Drug Makers’ Push Leads to Cancer Vaccines’ Fast Rise

My Blog article "Human papillomavirus (HPV) is more prevalent than we thought" provides statistics and links to my other collected writings on the topic of Gardasil.

For further reading, The Evidence Gap is a the New York Times' series that explores medical treatments in use despite scant proof they work and discusses steps toward more consistent use of evidence-based medicine.

Approval of Gardasil for Women 27 to 45 delayed

Recently, I was asked by a Michigan family lawyer whether Gardasil, Merck & Co’s cervical cancer vaccine, could safely be used by older women. Gardasil was approved in June 2006 for use with females ages 9-26 to prevent cervical cancer and genital warts. Merck had applied for the use of Gardasil in women ages 27 through 45.

STDs | One in 4 teenage girls has one

One-fourth of American girls aged 14 to 19 have a sexually transmitted disease, CDC researchers reported yesterday at the 2008 National STD Prevention Conference in Chicago.

As part of the National Health and Nutrition Examination Survey, some 800 teenage girls were asked about human papillomavirus, chlamydia, genital herpes, and trichomoniasis, and also submitted vaginal swabs for testing.

Among other findings:

• STDs were more common in black than white teens (48% vs. 20%).
• HPV and chlamydia were found most often — in 18% and 4% of all girls, respectively.
• Some 15% of infected girls had more than one STD.

You can read the CDC press release here. (Free)

New York Times story "Sex Infections Found in Quarter of Teenaged Girls"

Teenagers and oral sex | The prevalence, the dangers, some safeguards

Huge social issues today are teen sex, teen pregnancy, and the high incidence of human papillomavirus [“HPV”] infection among teenagers. On June 12, 2007, the New York Times reported on a case in Georgia in which a judge ordered the release of a teenager sentenced to 10 years in prison without parole for having consensual oral sex with a girl. He was 17; she was 15. The statute at that time would have made vaginal sex between consenting teenagers a misdemeanor, but there was no such “savings clause” for oral sex. The statute has since been amended to include oral sex in the so-called “Romeo-Juliet” exception to a statutory rape charge.

New Hampshire offers free Gardasil | Program swamped

New Hampshire began offering Gardasil to eligible girls without charge in January 2007. The New Hampshire program includes girls aged 9 through 18, although the FDA has approved and recommended the vaccine for all girls aged 9 through 26. State officials report that the demand is outstripping supply and that some healthcare providers have waiting lists.  Apparently advertising has stimulated demand, and the state’s budget will permit inoculation of only about one-quarter of eligible girls this year.  New Hampshire is encouraging parents to check with their health care insurers to see whether coverage is available.

Statistics on the high prevalence of HPV infection and other recent posts about Gardasil on this Blog may be found here.

May 12, 2007 New York Times article about the New Hampshire program

To visit Jeanne Hannah's website for more information, click here:

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