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Gardasil: Of Time and Money

The New York Times reported on February 17, 2007 that even some who support use of Merck's HPV vaccine Gardasil question the rush in state legislatures to make inoculation with this expensive and new vaccine mandatory. Over twenty states have legislation pending. Last fall, legislation was defeated in Michigan's legislature. Gardasil is very expensive at about $350-400 for the three-shot course.

"The decision to make [the vaccine] mandatory this early has created a significant controversy over things that have nothing to do with the vaccine," said Dr. Joseph A. Bocchini, chairman of the committee on infectious diseases of the American Academy of Pediatrics.

Questions are raised about the safety of the vaccine. Questions are also raised about Merck's contributions to Women in Government, a national association of state legislators. This group is a moving force promoting legislation around the country to approve mandatory vaccination in an effort to eradicate the virus that causes cervical cancer. Women in Government has posted model mandatory vaccination legislation on its Web site, www.womeningovernment.org

According to the New York Times, the drug maker GlaxoSmithKline is also developing a vaccine that, like Gardasil, is intended to inoculate against the human papilloma virus, or H.P.V., which is known to be the cause of cervical cancer. Some analysts have predicted that the market for H.P.V. vaccines is potentially $5 billion a year market. Is Merck's push for legislation, then, intended to corner the market before Glaxo can get its product approved?

Gardasil | Merck | Lobbying

More on Merck's Gardasil vaccine:

The Washington Post reported on February 11, 2007 thatLawmakers in Virginia and 17 other states are considering laws making vaccination mandatory.

Merck has hired a high-powered lobbying firm to push legislation in some states And no wonder: if Gardasil becomes mandatory and if Merck is successful in lobbying for state funding of the $360 vaccine for girls who have no health care insurance and whose care is funded by medicaid, Merck stands to reap billions of dollars in profits.

The Washington Post story "Drugmaker Assists in Pushing for Mandate for HPV Vaccination" made be read online. Last accessed Feb. 11, 2007.

Earlier articles on Gardasil posted in Updates in Michigan Family Law may be read here:

Texas Governor Mandates Gardasil® for sixth graders

HPV Vaccine and Informed Consent

HPV Vaccine: Mandatory for Teenagers or Not?

Technorati Tags: HPV vaccine, gardasil, HPV Virus,  Gardasil,  Cervical Cancer Vaccine

Texas Governor Mandates Gardasil® for sixth graders

This news from the Associated Press: Republican Governor Rick Perry in Texas bypassed the legislature completely, and issued an executive order mandating vaccination against HPV of schoolgirls entering the sixth grade (girls usually aged 11 and 12) in September 2008. The vaccine,  Gardasil, is manufactured by Merck.

Obviously, the governor intended to avoid opposition in the Legislature from conservatives and also to sidetrack parents’ rights groups who argue that requiring the HPV vaccine would send a message to children that premarital sex is OK and would interfere with a parent’s right to make important medical decisions for his or her child.

The governor’s executive order also mandated free distribution of the vaccine to girls 9 to 18 who do not have health insurance coverage. The vaccine costs about $360 for a three-shot regimen. Additionally, he ordered that Gardasil be made available to women ages 19 to 21 who are covered by Medicaid.

Critics are quick to point out that Merck is committing monies to lobby among state legislators to stimulate enactment of legislation that would make the vaccination mandatory just like vaccination for measles, mumps, and rubella. These critics claim that such mandatory vaccination could create billions of dollars in sales for Merck.

Other critics question the safety of the vaccine.

HPV Vaccine and Informed Consent

On January 17, 2007 I posted an article titled HPV Vaccine: Mandatory for Teenagers or Not? to this blog. The article discusses the Merck vaccine against HPV called Gardasil. In this article, I stated:

"Let’s talk turkey about a tough subject—the incredible incidence of sexually transmitted disease among Americans. HPV is a serious sexually transmitted disease. Some strains of it cause about 70% of cervical cancers. HPV is rampant among Americans. For the facts, see a 1-page FAQ sheet from the American Social Health Association.

"In June 2006, the U.S. Food and Drug Administration (FDA) approved Gardasil®, a vaccine by Merck and Company to prevent cervical cancer and genital warts caused by certain types of HPV. The vaccine is licensed for use in girls and women ages 9-26 years. In clinical trials Gardasil was shown to be nearly 100% effective at blocking persistent infection and disease with the “high-risk” HPV types responsible for 70% of cervical cancers (HPV 16 and 18) and the “low-risk” types (HPV 6 and 11) associated with 90% of genital warts."

Dr. Moira Dolan has published an essay titled: Not So Miraculous: Telling the Truth About the New Vaccine Gardasil®–Does it Prevent Cancer? A Guide for Informed Consent. You may read it here.

Technorati Tags: HPV vaccine, gardasil, HPV Virus,  Gardasil,  Cervical Cancer Vaccine

HPV Vaccine: Mandatory for Teenagers or Not?

Let’s talk turkey about a tough subject—the incredible incidence of sexually transmitted disease among Americans. HPV is a serious sexually transmitted disease. Some strains of it cause about 70% of cervical cancers. HPV is rampant among Americans.

For the facts, see a 1-page FAQ sheet from the American Social Health Association.

In June 2006, the U.S. Food and Drug Administration (FDA) approved Gardasil, a vaccine by Merck and Company to prevent cervical cancer and genital warts caused by certain types of HPV. The vaccine is licensed for use in girls and women ages 9-26 years. In clinical trials Gardasil was shown to be nearly 100% effective at blocking persistent infection and disease with the “high-risk” HPV types responsible for 70% of cervical cancers (HPV 16 and 18) and the “low-risk” types (HPV 6 and 11) associated with 90% of genital warts.

The CDC has released a bulletin in which it states that 50% of sexually active people will become infected with HPV.