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Male Immunization with Gardasil Not Deemed Cost Effective

admin — Sat, 24 Oct 2009 12:54:55 +0000

Although Gardasil has been proven to protect against two strains of the human papillomavirus (HPV) that cause cervical cancer, as well as two additional strains that cause genital warts, the Advisory Committee on Immunization Practices has voted against its use as a routine immunization for boys and men. However, the committee did vote, almost unanimously, to allow doctors to recommend the vaccine be given to males to reduce their likelihood of acquiring genital warts.

HPV is a sexually transmitted pathogen that is believed to cause approximately 70 percent of all cervical cancers. In addition, HPV has been associated with more rare forms of cancer of the throat, genitals and anus, as well as genital warts. Studies have found Gardasil not only to be safe, but also to be nearly 100 percent effective in preventing pre-cancerous cervical lesions from the four HPV strains that it targets. In addition, findings have shown that Gardasil is far more effective in females when given before they become sexually active.

Since first being approved by the U.S. Food and Drug Administration (FDA) in 2006 for use in females, the issue of whether or not to use Gardasil for males has been strongly debated. Advocates for use of Gardasil as a routine immunization among males believe that widespread use of the vaccine may reduce cervical cancer rates, since males commonly transmit HPV to females.

Although in early October the FDA approved the Gardasil vaccine for use among males aged 9 through 26, results of a study conducted in the same month revealed that immunization among males was not cost effective, as costs would outweigh the health benefit of the vaccine. Now, the results of the final vote by the Advisory Committee on Immunization Practices reported to the U.S. Centers for Disease Control and Prevention (CDC) has apparently put this issue to rest. The vaccine will not be approved for boys as part of the childhood immunization schedule.

The pivotal study published in the British Medical Journal made a comparison between a female-only vaccination program and a co-ed vaccination program. Researchers from the Harvard School of Public Health performed the analysis. According to lead researcher Jane Kim, an assistant professor of health decision science, “This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money.”

The basis of a good value was deemed as having cost-effectiveness ratios ranging from $50,000 to $100,000 per quality-adjusted life year, or the cost of the vaccine versus the number of added years someone would gain by getting the vaccine. By assuming lifelong protection among 75 percent coverage, the routine vaccination of girls who were 12 years of age was found to be a good value at less than $50,000 per quality adjusted life year. However, by adding boys of the same age, the cost-effectiveness ratio was increased to over $100,000 per quality adjusted life year.

Currently, the CDC recommends Gardasil for girls ages 11 and 12, and for women ages 13 to 26, who have not been vaccinated for the prevention cervical cancer. The disease claims 4,000 female lives annually in the United State alone.

New HIV Test Approved by FDA

admin — Mon, 21 Sep 2009 19:49:09 +0000

Each year, an estimated 56,300 people in the U.S. become newly infected with HIV, the virus that causes AIDS—in part because about one-quarter of the more than 1.1 million Americans believed to be living with HIV don’t know they are infected, according to the Centers for Disease Control and Prevention. HIV is transmitted primarily through sexual intercourse or contact with infected blood, semen, or cervical and vaginal fluids; injection-drug use; and perinatally from infected mothers to their infants. HIV transmission has also been reported in recipients of blood, blood-containing organs such as the kidney, liver, heart pancreas, bone, and skin or highly vascular tissues from HIV-infected donors. However, improvements in donor education, donor screening and blood testing has resulted in a continued decrease in the risk of transfusion and organ transplant transmission of HIV—improvements that now include a new test that detects the presence of antibodies for both types of HIV.

Approved by the U.S. Food and Drug Administration (FDA) on Friday, the Abbott Prism HIV O Plus assay is licensed for screening donated blood and blood specimens from other living donors, and for screening specimens from organ donors when specimens are obtained while the donor’s heart is still beating and from cadavers. Positive results from the test require confirmation from supplemental tests. The assay is one of five tests that run on Illinois-based Abbott’s Prism System, a fully automated instrument also used to test blood for hepatitis.

Both types of HIV have been detected in the United States and Europe. Type 1, which consists of various subgroups, including group M, the most common subgroup of the virus in the United States, and group O, found primarily in Cameroon and other areas of West Africa; and type 2, which is found primarily in West Africa. Once HIV enters the body, the body starts to produce cells and particles to fight the virus called antibodies. The HIV antibodies are different from antibodies for the flu, a cold, or other infections.

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Before 1985, there were no tests to screen blood and organ donations for HIV. Today, blood and organ banks screen out most potential donors at risk for infection in advance through extensive testing. The risk of acquiring HIV from a blood transfusion today is estimated to be 1 in 4 for every 600,000 transfusions. The risk of acquiring HIV from organ transplantation is probably similar.

Most HIV tests look for these antibodies rather than the virus itself. Previously, the two primary blood tests used to detect the HIV antibodies were the enzyme-linked immunosorbent assay (ELISA), and the Western blot assay, used to confirm the results of a positive ELISA test. These tests do not tell how long a person has been infected, how sick they might be, or if they have AIDS (acquired immune deficiency syndrome), which is the final and most serious stage of HIV disease.

AIDS is the fifth leading cause of death among people aged 25-44 in the United States, down from number one in 1995. About 25 million people worldwide have died from this infection since the start of the epidemic, and in 2006, there were approximately 40 million people worldwide living with HIV/AIDS.