HPV vaccine hype needs a shot in the arm

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SACRAMENTO, Calif. — Support for Merck's newly developed human-papillomavirus vaccine, Gardasil, has floundered amid widespread concern that the vaccine—intended for girls as young as 9 years old—may cause serious adverse reactions in some recipients. Members of the medical community, including the American Academy of Pediatrics, have joined parents in calling on lawmakers to slow down the race to mandate the HPV vaccine.

Spurred by the media frenzy surrounding the U.S. Food and Drug Administration's approval of Gardasil in June, 20 states have pushed forward legislation to require the HPV vaccine. In Texas, Gov. Rick Perry, by way of executive order, is requiring all girls entering sixth grade to be vaccinated. On March 14 the state's House voted 118-23 to overturn the order. The state senate is considering a similar bill.

California's Assembly Bill AB 16 would add the HPV vaccine to the state's list of "mandatory" vaccines for girls entering seventh grade.

This rush represents a vastly truncated timeline for the adoption of a new vaccine—a process that has traditionally taken several years to allow the medical community to test drugs before mandating their use on young children, who may be at greater risk for medical side effects.

Mounting evidence supports doctors' and parents' concerns that the HPV vaccine has not been adequately tested. It is premature and irresponsible to subject California's children to mandatory treatment with a drug that has had no long-term studies and was only tested on 1,184 pre-teen girls.

Incidents of adverse reactions to Gardasil have rapidly increased each month since the drug's FDA approval. As of February, the National Vaccine Information Center had reported 385 incidents of adverse side effects associated with Gardasil—including temporary loss of vision, seizures, paralysis, and HPV infection causing genital warts. In eleven cases the incidents were considered "life-threatening" or "disabling;" two-thirds of the cases were hospitalized or received medical treatment.

The effects of administering Gardasil in combination with other medications are unknown and would amount to performing a medical experiment on pre-teen girls.

On March 13, in response to these results, the testimony of health and family advocates, and thousands of calls, emails, and faxes from concerned citizens, the bipartisan Health Committee delayed further hearing of AB 16 to allow the bill to be rewritten to address the Committee's concerns. Chief among them was the risk of mandating a drug that has only been on the market for less than a year.


Benefits oversold?
While some supporters of the HPV vaccine may prefer to downplay the drug's negative impact, it appears that Gardasil's beneficial results may have been oversold.

While the vaccine does appear to block two of the most common strains of HPV that cause cervical cancer, Gardasil does not block against all strains of HPV that cause genital warts and cervical cancer. This fact was lost among headlines that hyped Gardasil—suggesting that more than one in four women (ages 14 to 59) is infected with HPV. Hidden in a footnote from a report in the Journal of the American Medical Association, is the fact that only 3.4 percent of the women studied had an infection against which Gardasil would protect.

Despite vaccination, women are still vulnerable. The shocking report of widespread HPV infection actually underscores the failures of "safe sex" to protect women against sexually transmitted diseases. Abstinence and monogamy, it seems, are still the only real protection against sexually transmitted diseases, including HPV.

"Education needs to come first," said Dr. Joseph Bocchini, chairman of the American Academy of Pediatrics' committee on infectious disease. "Much of the public doesn't know about HPV and its link to cervical cancer and other diseases. You can't put a mandate ahead of that." In other words, Gardasil cannot be promoted as a panacea leading some females to disregard the importance of medical screens for HPV and cervical cancer.

While it is appropriate for legislators to make recommendations that support general health and well being, government must exercise restraint to limit medical liability and to avoid trampling on parents' rights.


Limited exposure
Unlike nearly all the other diseases covered by public health immunization laws, HPV is a sexually transmitted—not airborne—disease. A responsible and scientifically accurate program must consider the behavior choices that contribute to the contraction of this disease. Parents, not legislators, are the appropriate and best source for sexual behavior and health information for pre-teen girls.

It is the duty of the state to ensure "full disclosure" so that parents are educated about HPV, the vaccine and their right to "opt out" pre-teen daughters from this and other vaccines as a "right of conscience." Currently AB 16 includes confusing language; in fact, the use of the word "mandatory" in the bill is deceptive, as parents can opt out from this vaccine. The lack of awareness of this option would deter parents from discovering and asserting their right.

Gardasil is currently the lone HPV vaccine on the market. Laws to "mandate" the vaccine would promote a monopoly for Merck, before competitors have a chance to achieve a similar, even improved, vaccine. In the wake of widespread criticism, Merck suddenly dropped its political lobbying efforts in late February. Now, AB 16 is stalled in the state Legislature Merck needs another "shot in the arm" to boost its vaccine.


Llewellyn Bailes is a public policy specialist for California Family Council.

Published, April 2007