HPV Vaccine Alert

HPV (Human Papillomavirus) Vaccine
Many state legislatures are considering or have passed measures that would make it optional or, in some cases, mandatory, for all young girls in their respective states to be vaccinated with the HPV vaccine, a newly approved drug that has been shown to be effective in preventing certain sexually transmitted viruses, some of which cause cervical cancer.

A featured article in NYTimes.com (Feb. 17, 2007) entitled Furor on Rush to Require Cervical Cancer Vaccine reports “a roaring backlash has some health experts worried that the proponents, including the vaccine’s maker, Merck, have pushed too far too fast, potentially undermining eventual prospects for the broadest possible immunization”

The article states, “Typically new vaccines, like the one for chicken pox in the mid-1990’s, have been rolled out gradually in this country, with public health officials endorsing mandatory use only after several years of experience have shown the new products to be generally safe and effective.”

An advisory panel of the federal Centers for Disease Control and Prevention recommended last summer that girls and women ages 11 to 26 be vaccinated with Gardasil, but their recommendation did not call for mandatory vaccination.” That initiative appears to have come a lobby campaign launched by the manufacturer of the newly-approved drug, Merck & Co. "Even before the vaccine’s approval, … Merck had begun laying the political foundation in state legislatures to promote widespread vaccination of young girls.” According to the article, “Merck declined to disclose its lobbying and advertising budget for the vaccine.”

Analysts project a $5 billion a year market for H.P.V. vaccines. Some analysts reportedly told NYTimes.com that “Merck is intent on inoculating as many girls as possible before the introduction of [competitor] GlaxoSmithKline’s product, which could become available this year.”

Women in Government, a national, non-profit, bi-partisan organization of women state legislators has actively promoted the wide-spread inoculation of grade school girls, calling it a “fight against cervical cancer.” According to the NYTimes.com article, Women in Government has received funding from Merck. The article describes Women in Government as “Merck’s main partner in the vaccination campaign.”

Some of the bills are calling for compulsory vaccination with an “opt out” provision, letting parents for religious, moral or other grounds to choose not to have their daughters inoculated. But, according to the NYTimes.com article, such provisions have raised concerns among public health experts. “A lot of us are concerned that if you allow people to opt out of one vaccine, they will opt out of other vaccines that are due at the same time,” said Dr. Mark Myers, executive director of the National Network for Immunization Information . . .”

The article also suggested an alternate reason for the targeting of grade schools girls for the mandatory vaccination programs, other than it being an age before they are likely to be sexually active. “Dr. Bocchini of the American Academy of Pediatrics also said too much of the Gardasil focus was being placed on 11- and 12-year-olds, when legislatures should be focusing on trying to obtain funding to vaccinate girls and women in the 13-to-26 age group, many of whom are not covered by the federal vaccine programs aimed at children.”

The Women in Government website page called Challenge to Eliminate Cervical Cancer Campaign  provides a map with a detailed report of the activity throughout the US. As of Feb. 17, 2007, they reported that 45 states have introduced legislation or resolutions and that 40 states have enacted legislation or resolutions. Their interactive webpage permits you to see what the status is of each state.

Issue:  This is an important step with many implications. To rush such a measure through without proper public discussion and education is not a positive public policy measure. Meta United urges the public to speak and be heard in support of a less invasive approach. Rather than mandating the vaccination and punishing girls who do not get it by barring them from school, as the new Virginia lawl would do (with an opt out provision), the vaccinations can be made optional, as some states are doing, and programs can be set up for further study, debate and education, as the Montana bill would do. Montana Bill 

For facts about HPV, go to the Food & Drug Administration Website. 

The FDA has recently approved an HPV (human papillomavirus) vaccine called Gardasil (produced by Merck & Co.) for girls and women between the ages of 9 and 26. It has not yet approved a competing vaccine being produced by GlaxoSmithKline.

The rush is on to make the HPV vaccine mandatory or optional for all grade-school age girls throughout the United States.

Three doses of HPV vaccine over a six-month period are recommended. Merck has priced Gardasil at $120 per dose, though purchases made through state governments may get a reduced price. Some providers may charge more, and there is usually a fee for administering the vaccine. At this time, not all insurers cover the cost of the HPV vaccine.
  
Clinical trials indicate that Gardasil can help prevent the spread of human papillomavirus, the most common sexually transmitted disease in the United States. An estimated 20 million Americans are infected. Certain strains of the virus have been linked to cervical cancer.

It is the cervical cancer link that is being highlighted in the legislative debates. But there are other issues that should also be discussed. We call upon citizen activists to bring the following 12 issues to the debate.

1~ Should this decision be left up to parents, their children, and their doctors, not the state?

2~ This is not a communicable disease in schools, so why are girls being barred from school if they do not receive the vaccine?

3~ Why was this vaccine tested primarily on girls and women? How effective would it be if administered to boys and men? How do the side effects for males compare to the side effects for females?

4~ What are the long-term side effects? Is there a chance it could affect a woman’s fertility or pregnancy?

5~ The HPV is vaccine is being marketed as a means to prevent cervical cancer, a disease of women. Each year, genital HPV infection is primarily responsible for about 10,400 new cases of cervical cancer and 3,700 deaths in the U.S. Is inoculating millions of girls in the US, irrespective of sexual activity, a reasonable response?

6~ How long is the HPV vaccine effective? For how long was its effectiveness tested in the trials? Will subsequent vaccinations be required, and if so, how often?

7~ Since the vaccine is not effective once the virus has been contracted, should girls be tested for the virus before being administered the vaccine?

8~ Should the vaccine be mandatory for all females, without regard to the likelihood of exposure to the problem it is meant to address?

9~ Can the populations most likely to be affected be mitigated, or down-staged, with comprehensive screening or other less invasive means?

10~ With the rush to devote precious public health resources to the HPV vaccine, what, if any, secondary prevention programs are being displaced to do so?

11~ How effective would an educational or health outreach campaign be, compared to wholesale HPV vaccination of all young girls, and how would the cost-benefit ratios compare?

12~ Is this rush being promoted by Merck to market its product before the GlaxoSmithKline's HPV vaccine receives final approval?

An article in The Oncologist in April, 2006, entitled The Promise of the Human Papillomavirus Vaccine Does Not Confer Immunity Against Ethical Reflection gives a good description of the pros and cons of this vaccine.  

The recent announcement of an experimental vaccine against human papillomavirus (HPV) has raised great hopes and expectations. Promising trial results, however, should not obscure ethical issues related to a vaccine’s ultimate distrbiution. Although lay media might view an HPV vaccine as a panacea, an ethical reality exists, affecting public knowledge, health care disparities, and parental consent for childhood vaccination.

HPV is a sexually transmitted disease that is spread by both men and women. The article states:

Moreover, a vaccine for a sexually transmitted disease directed only toward women might reinforce the widespread belief that they ought to take sole responsibility for issues related to reproductive health. Women already bear a disproportionate burden for matters of reproductive decision making. Studies show that men do not perceive themselves to be susceptible to HPV and do not believe HPV infection to be a severe problem for themselves. We must consider then whether these vaccines ought to be tested on men and, if shown to be effective, recommended for them as well. This sort of gender-neutral inclusion can emphasize the need for both men and women to share responsibility equally for sexual and reproductive matters, perhaps having more impact on the sociology of sexually transmitted diseases than vaccines alone.

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