"The Evidence Gap"

"Gardasil Vaccine Doubts Grow"

"Should Parents Worry about HPV Vaccine?"

Over the past several weeks, media coverage of the human papillomavirus (HPV) vaccine, Gardasil, has spiked. Some articles have distorted recent reports of adverse events, or side effects, to foment fear about safety and perpetuate the spread of misinformation about the vaccine. Others have put forward cogent critiques of Gardasil's manufacturer Merck, raising questions about the utility of the vaccine in improving women's health.

In the two years since Gardasil became the first HPV vaccine to obtain FDA approval, reproductive and sexual health advocates have faced steady challenges in determining how to react to, and how to shape, the oftentimes divisive discourse surrounding the vaccine. Both before and after the FDA sped up the approval of the vaccine, consumers, providers, and advocates expressed anxieties, but the women's health community's own debate about the vaccine was overshadowed, by Merck's aggressive marketing to consumers and by its lobbying efforts to introduce immediate school mandates for Gardasil. In the midst of new critiques of the vaccine and increased coverage of the alleged adverse events, now is a good time for women's health advocates to reflect on what has happened over the past two years, what remains unknown about the vaccine, and to reaffirm our commitment to providing the highest quality education and advocacy around HPV and cervical cancer prevention.

The Common Cold of Sexually Transmitted Infections

HPV could be called the common cold of sexually transmitted infections-it's passed through skin-to-skin sexual contact, it's widespread throughout the sexually active population, and often your body can resolve the infection on its own. With 6.2 million new infections per year, HPV is the most common STI in the U.S. The vast majority of infections are found in sexually active people between the ages of 15 and 24. A recent study of STI prevalence among young women ages 14 to 19 found that 18% of them had HPV, and a 2007 study found that 44.8% of women ages 20-24 had the virus. Persistent infections may require treatment for genital warts, or in rare cases, can lead to more serious outcomes, like precancerous changes on the cervix or cervical and other anogenital cancers. Around 40 strains of HPV affect the genitals and around 15 strains are known to be oncogenic, or cancer-causing. Where the common cold analogy breaks down is that people infected with HPV most frequently have no symptoms but can still transmit the virus to their sexual partners. So while everyone is familiar with and knows when she has a cold, many have never heard of HPV and its possible consequences - even as they could be carrying the virus and passing it on to their sexual partners.

A New Technology for Prevention

In June 2006, after a six-month priority review process, the FDA announced that a new HPV vaccine, Gardasil, had been approved for use by females ages 9-26. (Priority reviews reduce the FDA's processing time by four months and are generally reserved for "products with potential to provide significant health benefits.") Shortly thereafter, the Centers for Disease Control (CDC) recommended universal vaccination for girls ages 11 and 12, with vaccines offered to girls and women between the ages of 9 and 26. Gardasil is the first HPV vaccine introduced to U.S. markets, the first vaccine with the potential to greatly reduce the incidence of a type of cancer, and the first vaccine approved for use by only one sex. (In Australia, Gardasil is approved for use by both males and females; Merck is continuing to collect data among males and has voiced interest in applying for approval for use among males from the FDA). It is also the most expensive vaccine on the market.

During pre-market trials the vaccine was shown to be 100% effective at protecting against two HPV strains, 16 and 18, that are responsible for 70% of all invasive cervical cancer cases, and strains 6 and 11, which cause approximately 90% of all genital warts. Its potential to address a health problem not tackled by other products and the staggering effectiveness found during trials pumped up expectations and initial praise.

Gardasil Marketing and Lobbying: Pharmaceutical Foul Play?

In contrast to many other industrialized nations, U.S. pharmaceutical companies are allowed to advertise their products directly to consumers. Still, before Gardasil, pharmaceutical companies had not typically marketed vaccines directly to consumers. But from the beginning, Merck took the lead in shaping how education and information about HPV and the vaccine was reaching women. Even before Gardasil was approved, Merck's "Tell Someone" campaign taught potential female consumers that cervical cancer is caused by HPV. After approval, Merck aggressively marketed the vaccine to these consumers, urging them to become "One Less" in the fight against cervical cancer.

Following FDA approval and the CDC recommendations, Merck immediately moved to lobby for school mandates - and to pass mandates while their product was the only vaccine on the market. Vaccines are typically available for years before being required for school entry-following FDA approval of the chickenpox vaccine in 1995 it took three years before states began to pass mandates; for Hepatitis B it took eight years. A gradual roll-out allows for education, provider and patient acceptance, and the opportunity to answer remaining questions from pre-market trials. In 2007, approximately 24 states, and the District of Columbia, introduced bills to require girls to receive the vaccine before entry into sixth grade.

But as the subject of school mandates became more and more controversial, partly due to the growing skepticism surrounding Merck's educational and lobbying efforts, many of the bills stopped moving, were defeated, or were withdrawn during the middle of legislative sessions. While some in the advocacy community supported mandates because they can determine immediate financing mechanisms to cover the growing numbers of under and uninsured, many of us felt that the momentum surrounding mandate legislation was building at an unprecedented pace with help from Merck's lobbying. At this point, the terms of the debate ceased to be our own: the pro-mandate side was bolstered by the pharmaceutical company's marketing and lobbying, while those within the women's health community who opposed mandates were overshadowed in the media by those who argued against mandates by blaming women's sexuality and behavior for disease.

The Politics of Prevention: Regulating Female Sexuality

Preventive technologies reliably trigger opposition from religious conservatives, demonstrating their constant desire to control and condemn sexuality, especially female sexuality. Religious conservatives consistently claim that access to sexual and reproductive health prevention will promote and increase promiscuity. Their relationship with HPV has been complicated: even before the introduction of the vaccine, conservatives used HPV as a tool to push abstinence-only messages and to argue that condoms are not effective, because they cannot completely protect against HPV transmission. Religious conservatives raised concerns about the vaccine because of the provocative message it would send to young girls who, they argue, should be receiving abstinence-only information instead.

Yet there have also been significant hesitations from our own health advocacy community about whether, and how quickly, we should promote the use of this technology as a tool to prevent HPV, as well as cervical cancer.

Vaccine Anxieties

Reproductive health advocates have enjoyed a thorny relationship with the FDA in recent years. After FDA commissioners held up the over-the-counter approval of Plan B for purely political reasons, advocates called on the FDA to stop withholding critical reproductive health care tools from women. Yet some advocates felt differently about Gardasil, another preventive tool, and voiced concerns about the product's safety and fast approval. Meanwhile, anti-vaccine advocates used the controversy surrounding Gardasil's introduction, and Merck's questionable behavior, to press for their own goals for vaccine reform. And some within communities of color, which carry the largest burden of cervical cancer cases and deaths, have expressed some concern about the vaccine because of historic oppression through medical experimentation and the targeted promotion of provider-controlled medical technologies. For example, in a 2007 survey of California parents with daughters who would be eligible for the HPV vaccine, African American and Asian American parents were less likely to say that they would choose to vaccinate.

What Remains Unknown

Studies published after Gardasil was introduced found that the vaccine's real-life efficacy isn't as impressive as its trial performance, most likely because many women may already be infected with one of the targeted strains, or because cancer-causing HPV strains not prevented by the vaccine are responsible for a larger proportion of pre-cancerous conditions than previously thought.  It also remains unclear what the vaccine's effect will be on the body's natural immunity response to combat HPV.

This new information confirms that the vaccine should not be the only approach to HPV and cervical cancer prevention. But the vaccine still offers considerable protection against HPV, and we should advocate for its availability to those who choose to use it. (Recall that when advocates were presented with new data showing that emergency contraception does not have the same aggregate effectiveness that we once thought, we did not abandon our efforts to educate women about the medication and ensure that it is widely accessible.)

Another remaining question is whether inoculated women will need follow-up booster shots to continue protection. So far there are data showing that Gardasil provides protection against targeted HPV strains for at least five years. A recent study emphasizes the vaccine is most cost effective when given to preadolescent girls. If vaccinated women will require a booster shot to continue protection, the cost effectiveness of the vaccine in preventing disease will also be lessened. In the wake of these discussions, advocates should always emphasize the importance of policies that support education and coverage to ensure equal access to available health care.

The media's continued attention on adverse event reports following vaccination has raised some concerns about Gardasil's safety. Over the past two years Merck has distributed 16 million doses of the vaccine throughout the United States. The FDA and CDC work together to track vaccine safety through the Vaccine Adverse Events Reporting System (VAERS), which is designed to collect reports to help identify possible side effects and safety concerns linked to vaccines. VAERS has received 9,749 reports of adverse events occurring after vaccination with Gardasil. After reviewing the adverse events reported to VAERS it was found that 6% of the reports were considered serious, which is around half the average number for other vaccines. These events have not yet been causally linked to the vaccine. For example, the reports of blood clots may be linked to other risk factors, including the use of oral contraceptives, a risk many advocates trust women to weigh themselves given comprehensive information.

But the media continues to distort the facts, increasing confusion and fear. Advocates should work to contextualize these concerns, providing accurate information to address the anxieties of women who have already been vaccinated, and for those considering her options. We can all agree that women deserve accurate information in order to weigh possible risk and potential benefits and make their own decisions about what is best for their health.

How to Move Forward

Gardasil's introduction presented advocates with a host of complexities to negotiate, both familiar and new. We were familiar with investigating the federal government's oversight of medical technologies marketed to women as well as religious conservatives' anxieties around sexuality that reliably target any reproductive and sexual health prevention messages or health care. We are used to responding to the oftentimes market-driven decisions made by pharmaceutical companies. But new questions about vaccine technology, oversight, policy, coverage and reimbursement mechanisms, as well as the heightened anti-vaccine debates, arose with the old.

We cannot ignore the complex questions raised by HPV vaccines- after all, GlaxoSmithKline is currently seeking FDA approval for a new HPV vaccine and scientists are working on other vaccines, including an HIV vaccine. If science is investigating vaccine technology as a way to promote sexual and reproductive preventive health, we as advocates must tackle these questions in order to provide the best education and advocacy. While the questions are complex, we can mobilize around our common principles and work together to achieve our ultimate goals of improving access to health care and increasing information to empower women.

The widespread lack of familiarity with HPV and the media's sensational reporting on the issue has contributed to the anxiety and confusion surrounding the introduction of the vaccine, and is a flag for health advocates that our work should include more creative and aggressive HPV education for the communities we serve. When designing HPV education for women and adolescents we should stress prevention by using condoms and the availability of the vaccine, as well as the importance of consistent screening with Pap testing. Regardless of whether you choose to vaccinate yourself or your daughter, all women still need to have regular Pap screening because the vaccine does not provide protection against all HPV strains that have been linked to cancer.

As the disparities on all reproductive and sexual health indicators continue to widen, cervical cancer is no exception. Women with reduced access to preventive health care, like consistent Pap testing, are more likely to develop cervical cancer, which, compared with most other cancers, can largely be prevented through the treatment of precancerous conditions. U.S. cervical cancer incidences and mortality rates are almost twice as high among African-American and Latina women. Studies have also shown that Vietnamese and Korean women have higher rates of cervical cancer in the U.S. Now that mandate policies have largely taken a backseat, there is an opportunity to focus broad-based education on HPV prevention, including the availability of a vaccine, and cervical cancer screening in the communities where anxieties have been highest.

While we may have lost the first opportunity to shape education and messaging surrounding HPV prevention and the vaccine, taking into account what we've learned so far, we can work together to seize current opportunities and increase education and access for women. Thankfully, the damage to public confidence and understanding of the vaccine fueled by Merck's lobbying and marketing efforts is starting to be repaired. Now is the moment that advocates can reclaim the discourse and promote comprehensive HPV and cervical cancer education, including information about all forms of prevention, screening, and treatment.