Gardasil

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See also: HPV vaccine

Gardasil is a vaccine against certain types of the human papillomavirus (HPV), created by researchers Dr. Albert Bennet Jenson and Dr. Shin-je Ghim at the University of Louisville in 2006, following on research done by Professor Ian Frazer of Australia in conjunction with Australian biomedical company, CSL Limited. The vaccine, marketed by Merck & Co. in America, whilst paying royalties to CSL, is designed to prevent infection with HPV types 16, 18, 6, and 11. HPV types 16 and 18 cause about 70% of HPV-related cervical cancer cases. HPV types 6 and 11 cause about 90% of genital wart cases.^[1]

1 Biotechnology
2 Indications
3 Administration
4 Government Mandates
5 Long-Term Impact
6 Clinical Trials
7 References
8 External links

[edit] Biotechnology

The HPV major capsid protein, L1, can spontaneously self-assemble into virus-like particles (VLPs) that resemble authentic HPV virions. Gardasil contains recombinant VLPs assembled from the L1 proteins of HPVs 6, 11, 16 and 18. Since VLPs lack the viral DNA, they cannot induce cancer. They do, however, trigger an antibody response that protects vaccine recipients from becoming infected with the HPV types represented in the vaccine.

[edit] Indications

Gardasil is a prophylactic HPV vaccine, meaning that it is designed to prevent the initial establishment of HPV infections. In worldwide clinical analyses, however, women who were already infected with one or more of the four HPV types targeted by the vaccine (6, 11, 16, or 18) were protected from clinical disease caused by the remaining HPV types in the vaccine. For maximum efficacy, it is recommended that girls receive the vaccine prior to becoming sexually active. Since Gardasil will not block infection with all of the HPV types that can cause cervical cancer, the vaccine should not be considered a substitute for routine Pap smears. The lifetime risk of cervical cancer for women in the U.S., estimated by the National Cancer Institute, is 0.73%. ^[2]

Gardasil also may be used in preventing HPV 16/18-caused anal cancer.^[3] A 2005 study in San Francisco found that 95 percent of HIV-infected gay men also had anal HPV infection, of which 50 percent of had precancerous HPV-caused lesions.^[4]

[edit] Administration

The US Food and Drug Administration (FDA) approved Gardasil on June 8, 2006. Gardasil is currently available.^[5] The drug is also approved for use in Australia, New Zealand, Canada, Mexico, Serbia, Croatia, Malaysia, Brazil and countries of the European Union.

Gardasil is given in three injections over six months, namely at enrollment, and two and six months later.

Adverse effects can include local limited reactions at the site of injection, such as pain, swelling, redness, and itching. Other adverse effects, including seizures, fevers, joint pain, lack of consciousness, and Guillain-Barré syndrome, have been filed with VAERS^[6]; because these events resulted from complex real-life situations and not controlled tests, it is difficult to determine what role, if any, Gardasil played in these episodes.

On June 29, 2006, a panel of experts, the Advisory Committee on Immunization Practices, gave their approval for the vaccination of Gardasil on children as young as nine years old. The ACIP recommended that Gardasil be placed on the childhood immunization schedule at the eleven to twelve year old visit. They also recommended that the vaccine be included in the federal Vaccines for Children Program, which would provide the vaccines free of charge to children under the age of eighteen who are uninsured.^[7]

[edit] Government Mandates

Phyllis Schlafly said that Merck engaged in a "lobbying campaign to make this vaccine compulsory". [1]

Legislation has been introduced in the state of Michigan to make Gardasil mandatory. ^[8]

Texas Governor Rick Perry issued an executive order on February 2, 2007 mandating the vaccine be given to all school girls entering sixth grade, beginning September 2008. By going through an executive order, the Texas Legislature has little recourse in repealing the to-be mandatory vaccinations, but aides for various members of the legislature have said they are looking for legal ways around the order.^[9] On February 22, 2007 a group of Texas families filed a lawsuit to stop the executive order.^[10] It is to be noted that an executive order is not a law but rather a recommendation.

It is worth mentioning that Rick Perry's former Chief of Staff is currently the head of Merck's Texas lobbying team, and that Perry recieved $6000 in campaign contributions from Merck. The high cost of Gardasil is to offset losses due to Vioxx settlements and an official-sounding recommendation by Perry would lead many to believe that vaccination in Texas is mandatory, thus creating a constant pool of customers for Merck and allowing them to regain their losses by Gardasil sales in Texas alone. Being a patent protected vaccine, Merck is the sole producer.

Australia's government announced on 29 Nov 2006 that they will provide this vaccination to all 12-26 year-old women in 2007. After two years, the program will be scaled down to 12-13 year old girls only. Australia also approved Gardasil for boys 9-15 years old, but Australia is not providing government funding for vaccinating boys.^[11] On March 26, 2007, early approval was granted in both Germany and Italy.^[12]

[edit] Long-Term Impact

One unknown property of the vaccines now being researched is their longevity. Since the studies have been of short duration, it is unknown whether the vaccines will last just a few years or for much longer. Further study over time is required to answer this question.

270,000 women died of cervical cancer worldwide in 2002.^[13] Acting FDA Administrator Dr. Andrew von Eschenbach said the vaccine will have "a dramatic effect" on the health of women around the world.^[5] TheAmerican Cancer Society estimated that 9,700 women would develop cervical cancer in the United States in 2006, and 3,700 would die.^[14]

Merck and CSL Limited are expected to market Gardasil as a cancer vaccine, rather than an STD vaccine. It remains unclear how widespread the use of the three-shot series will be, in part because of its $360 list price ($120 each for three shots). Merck and CSL have also suggested that governments make vaccination with Gardasil mandatory for school attendance, which has upset some conservative groups.^[5]^[15] Health freedom organizations and other critics of the political power of pharmaceutical companies have vocally denounced the mandatory vaccination scheme as Merck's way of using forced drugging to pay for Vioxx lawsuits. ^[16]

Another potential issue is that it is not known whether this vaccine has any long-term adverse side effects. Although it has undergone full FDA trials, some fear that detrimental effects may not appear until years or decades after exposure.

See also: vaccine controversy

[edit] Clinical Trials

Merck & Co. conducted a Phase III study named FUTURE II. This clinical trial was a randomized double-blind study with one controlled placebo group and one vaccination group. Over 12,000 women aged 16-26 from thirteen countries participated in the study. Each woman was injected with either Gardasil or a placebo on Day 1, Month 2, and Month 6. In total, 6,082 women were given Gardasil and 6,075 received the placebo.^[17] On February 27, 2006, the independent Data and Safety Monitoring Board recommended the clinical trials be terminated on ethical grounds, so that young women on placebo could receive Gardasil.^[18]