ACIP Chair Says, "No HPV Mandate"

"We have endorsed a mandate because the vaccine — Merck’s Gardasil — looks highly effective against strains that cause 70 percent of all cervical cancer....The strongest arguments against moving ahead quickly tend to be practical and financial. States have typically used school mandates for vaccines that are already in wide use, and it is possible that unexpected side effects could emerge (though any mandate could be suspended if that happened). Health professionals also need to be certain that there are stable supplies, adequate insurance coverage, ample public money to vaccinate low-income children and physician support." - Editorial, The New York Times (Feb. 26)

"The chairman of the federal panel that recommended the new cervical-cancer vaccine for pre- teen girls says lawmakers should not make the inoculation mandatory, as the District and more than 20 states, including Virginia, are considering. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices (ACIP), also said he and panel members told Merck & Co., the drug Gardasil's maker, not to lobby state lawmakers to require the vaccine for school attendance. "I told Merck my personal opinion that it shouldn't be mandated," Dr. Abramson told The Washington Times. "And they heard it from other committee members."...... ACIP is the only entity in the federal government to issue immunization recommendations and does not recommend a vaccine be made mandatory; those decisions are left to the states. But the committee's recommendation on the use of a vaccine often plays the lead role in whether states will act to make it part of their mandatory vaccine list, said Barbara Fisher, president of the National Vaccine Information Center, which is opposed to laws making Gardasil mandatory. "They are the signal for states to act," she said. "The committee knows that and I think they see people getting upset about it." - Gregory Lopes,
The Washington Times (Feb. 27)

"Based on this analysis, Dunne et al found the overall prevalence of HPV (any type) infection was 26.8% in females 14 through 59 years of age....the combined prevalence of [vaccine types] HPV-6, HPV- 11, HPV-16 and HPV-18 was 3.4%....the combined prevalence of the 2 high-risk types, HPV-16 and HPV- 18 [most associated with cervical cancer] was approximately 2%....Follow-up prevalence studies will be important not only to evaluate [quadrivalent HPV] vaccine effectiveness but also to address the question of whether other high-risk oncogenic HPV types will fill the ecological niche created by the expected decline in HPV-16 and HPV-18. Studies of cost-effectiveness of the vaccine have used HPV prevalence estimates from selected populations, including some outside of the United States. Now it will be important to assess the cost-effectiveness of the vaccine using these new prevalence data from US females." - Editorial, JAMA (Feb. 28)

"Even among women most likely to be infected - sexually active 18- to 25-year-olds - these two cancer-causing HPV strains were relatively uncommon, infecting 3.5 percent. Experts say these findings, published today, do not change the conclusion that the public-health benefits of vaccination are worth the cost. But the new data may create confusion and fuel controversy over whether to mandate inoculation of pubescent girls. At least 20 states are considering proposals. The study supports the notion that there should not be a "rush to make this vaccine mandatory," said Kenneth Chaiken, a Dallas lawyer representing six parents who are suing the Texas governor over his order requiring vaccination of sixth-grade girls. Barbara Loe Fisher, president of the National Vaccine Information Center, a nonprofit advocacy group that contends all vaccines pose risks the public is not warned about, said she was "shocked" by the new data. "This is not what most people in America who have looked at publicity for this vaccine were led to believe," she said." - Marie McCullough,
Philadelphia Inquirer (Feb 28)

Barbara Loe Fisher Commentary:

A study was published in today's Journal of the American Medical Association (JAMA) estimating the population prevalence of HPV infection in American women aged 14 to 59 years old. What the CDC study authors found was an overall prevalence of HPV (any type) infection in 26.8 % of the American females studied, with 3.4% infected with one of the four HPV types in Merck's quadrivalent vaccine and 2% infected with one of the two vaccine types (HPV 16 and 18) associated with cervical cancer. The study noted that 90 percent of all HPV infections are cleared from the body and do not become chronic. This means that less than one quarter of one percent of all American women are at risk for chronic infection with one of the two HPV types associated with cervical cancer which are contained in Merck's GARDASIL vaccine.

These new HPV prevalence data seriously call into question the cost benefit ratio for GARDASIL, particularly when taking into account short and long term serious vaccine reactions being reported to the Vaccine Adverse Event Reporting System (VAERS), such as five cases of Guillain Barre Syndrome (GBS) and cases of syncope with seizures, facial paralysis and other signs of brain and immune system dysfunction. The Editorial in JAMA also questioned whether the two HPV types in the vaccine would be replaced by the other HPV types associated with cervical cancer, limiting the vaccine's effectiveness. On May 18, 2006, the FDA staff questioned this possibility, as did NVIC in its Feb. 24, 2007 press release ( go to

The Washington Times reports that ACIP chairman Jon Abramson and other committee members did not want GARDASIL mandated. If this is true, then ACIP should have stated that fact clearly when they made their recommendation in the summer of 2006 that all 11 year old girls get the vaccine. In light of newly published HPV prevalence data and the fact that Merck only studied GARDASIL in a few hundred eleven year old girls for a few years, together with reports of serious adverse events such as GBS coming into VAERS, the CDC's ACIP members should be more worried about unanimously recommending GARDASIL for routine use with inadequate supporting evidence.

Finally, The New York Times came out with another editorial endorsing the HPV vaccine mandates, despite the growing list of outstanding scientific questions about the vaccine's necessity, safety and effectiveness. The New York Times is behind the times with its knee jerk endorsement of school mandates for this vaccine. Whoever wrote the editorial is particularly cruel to endorse mandates while acknowledging that "it is possible that unexpected side effects could emerge, though any mandate could be suspended if that happened." Is the New York Times editorial staff going to take responsibility for the children who are required to take GARDASIL and suffer serious side effects already reported to VAERS, or the children who will be injured if it is eventually revealed that GARDASIL has more "unexpected side effects?" American children should not be viewed as guinea pigs by drug companies, health officials, doctors, politicians or newspaper editors.

To hear a 30 minute interview explaining the scientific and policy issues relating to proposed HPV vaccine mandates, listen to a tape of the
Feb. 22 Brian Lehrer show on WNYC radio entitled "Strange Bedfellows". Describing the show, WNYC says "At least 20 states are considering mandatory vaccination of young girls against the sexually transmitted virus that causes cervical cancer. But the backlash has been fast and furious--and has led to some unlikely alliances. Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, and Moira Gaul, director of women's and reproductive health at the Family Research Council, talk about their opposition to mandatory vaccination. Sheila Krumholz, executive director, Center for Responsive Politics, talks about the lobbying efforts and legislative influence of the pharmaceutical industry."

No comments: