Merck's Gardasil cleared - now you can inject your 9 year old girl against an STD

Whilst the role of the Human Papilloma Virus (HPV) in 99% of cervical cancer cases has only become apparent in the last ten years, action has been swift to provide some protection as it's the second most common cancer among women, with more than 270,000 deaths reported each year worldwide.

In the U.S., deaths from cervical cancer are relatively low, but the costs of screening for the HPV virus and treating infections and cervical cancer add up to $6 billion a year. ( A UK / NHS test costs US $ 80) An estimated 80% of deaths from cervical cancer occur in the developing world, where pap tests and cancer screening are rare and hugely expensive.

HPV has many variants only some of which are connected with cervical cancer - the virus is sexually transmitted (between female / female as well) and exposure increases with number of partners and activity.

The Food and Drug Administration (FDA) yesterday approved Merck's (MRK:NYSE) Gardasil, the first vaccine against a virus that causes cervical cancer and genital warts.Merck licenses the Gardasil technology from CSL Ltd. of Australia. The vaccine was approved in Mexico last week. Merck has filed applications in five continents, including the large European Union market as well as Australia, Argentina and Brazil. The company is also trying to expand Gardasil's availability to developing countries.

The agency gave the product broad approval Thursday, saying that the vaccine is appropriate for treating girls as young as 9 years old and women as old as 26.

The vaccine is approved for two types of HPV, that Merck says accounts for 70% of cervical cancers. The vaccine also prevents two types of HPV that account for 90% of genital warts.

Rivals GlaxoSmithKline (GSK:NYSE) , which is developing the HPV vaccine called Cervarix. GlaxoSmithKline expects to file an application with the FDA by the end of the year. This does not target the strains that cause genital warts.

"Use of Gardasil can help significantly reduce the human and economic burden of cervical cancer, precancerous or low-grade lesions and genital warts," said Dr. Kevin Ault, associate professor in the department of gynecology and obstetrics at Atlanta's Emory University School of Medicine, in a press release issued by Merck. Ault was the clinical study investigator for Gardasil.

The vaccine is now available for ordering. The Gardasil regimen requires three injections over six months. Merck is charging $120 per dose. The company has created a new program in which it will provide free vaccines to adults who are uninsured and can't afford vaccines. Merck vaccines, including Gardasil, will be covered by this program in the Q3 2006r.

The FDA notes that Merck will conduct additional studies, including those to further evaluate Gardasil's safety and long-term effectiveness. Merck will monitor women who receive Gardasil while unknowingly pregnant, and the company also is studying whether Gardasil is safe and effective for treating genital warts in males.

The FDA says human papillomavirus is the most common sexually transmitted infection in the U.S. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that more than half of all sexually active men and women become infected at some time in their lives.

On average, there are 9,710 new cases of cervical cancer and 3,700 cervical-cancer deaths each year in the U.S. Worldwide, cervical cancer is the second most common cancer in women, with an estimated yearly toll of 470,000 new cases and 233,000 deaths.

The FDA bluntly points out that the vaccine is only effective when given prior to infection. However, Merck says that if Gardasil is given to a woman infected with one type of HPV targeted by the vaccine, she still could be protected from the three other types covered by the vaccine.

Because Gardasil doesn't protect against less common types of HPV, the FDA says routine and regular pap tests "remain critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops."

The Bill & Melinda Gates Foundation, endowed by Microsoft (MSFT ) founder Bill Gates, has earmarked $50 million for the prevention of cervical cancer. "But it remains to be seen whether the developing world will be willing to invest in a vaccine where the reduction in cancer will not be seen for many years because of the long interval between infection and development of the cancer," says Dr. Douglas R. Lowy. He headed the research team at the National Institutes of Health in Bethesda, Md., whose original discovery is the basis of both the Merck and GSK vaccines.

A lot rides on the success of these vaccines - GSK has lost two of its best-selling drugs, antidepressants Paxil and Wellbutrin, to generic competition, and it will be at least 2 years before any of its most promising new medicines hit the market. Merck, which has had several drugs fail in clinical trials, is desperate for good news after it pulled its blockbuster painkiller Vioxx from the market in September because of a link to heart attacks and stroke.

Moral hurdles

Despite the obvious benefits, the vaccines will not be an easy sell: There are social and moral hurdles to overcome. "The biggest problem for companies will be convincing society of the need to vaccinate young girls against what is essentially a sexually transmitted disease," says Dr. Anne Szarewski, a clinical consultant at Cancer Research UK, which is conducting phase iii trials of Cervarix at Margaret Pyke Centre in London. Who claim on their website to be one of the biggest contraceptive centres in the world seeing between 600 and 900 patients per week. Their research team, is part of the Academic Department of Obstetrics & Gynaecology, University College London,

"Mom, do you really want to vaccinate your nine year old against Sexually Transmitted Disease"?

"Mom ? Why do I need these shots ?"