Unpacking Gardasil’s Controversy

In my final piece for my health and science writing course, I discuss the controversy over the HPV vaccine. 

Unpacking Gardasil’s Controversy 

By Julianne Cuba

In a commercial that first aired over eight years ago, young women proudly stated that they were “one less.” By getting vaccinated, they said, you could be one less, too. Those notorious commercials seem to have run their course; but the idea those young women were advocating– Gardasil– is still prevalent, and no less controversial, today.

But not all women were entranced and coerced by the commercials to go out and get vaccinated; many, like 22-year-old Kaitlyn Eng, were turned off by the vaccine’s heavy commercialization.

“My pediatrician recommended it before I started having sex,” Eng said. “I was about 14 years old, and seeing the commercials kind of pushed me away from it. I questioned whether it was really for health reasons, or just a money maker.”

Over the past few years, controversy over the vaccine, Gardasil, has flourished: Is it safe? Will it lead to Multiple Sclerosis, paralysis, other severe adverse reactions, or even death?

Despite consensus from the scientific community that Gardasil is safe and effective, women’s health advocates and consumers still question its necessity.

Gardasil, a drug created by Merck Co., is a vaccine to protect against the Human Papillomavirus (HPV). HPV is the most common sexually transmitted infection, and nearly one in two people, both men and women, will get at least one strain of HPV in their lifetime. The CDC says that by age 50, nearly 80 percent of women will have had an HPV infection.

It is estimated that there are 14 million new cases of HPV in the United States each year, and currently, approximately 79 million people are living with an HPV infection in the United States.

HPV has over 100 different strains of infection; but there are four, which are known to be the most dangerous. Two of the strains—16 and 18— lead to about 70 percent of all cervical cancer cases, and the other two—6 and 11—lead to about 90 percent of all cases of genital warts in males and females.

The likelihood of cervical cancer, however, is far less common— .7 percent of women will be diagnosed with cervical cancer in their lifetime, and .2 percent of those cases will result in death. But, it is impossible to detect which strain of HPV one has.

Because of the confirmed association between HPV and cervical cancer, and the increasingly high numbers of HPV, nearly eight years ago, in 2006, the CDC recommended Gardasil for girls age nine to 26.

Less than five months after the FDA approved Merck’s Gardasil, in early June 2006, television programs began airing those “one less” commercials, with the hopes of getting girls vaccinated.

In the most recent study from 2013 from the National Foundation for Infectious Diseases, only 38 percent of girls will complete the three recommended doses of Gardasil, while only 14 percent of boys will—who also began getting vaccinated in 2011. For a vaccine—and right now, the only vaccine—that was created to prevent cancer, the statistics of those getting vaccinated do little to show its communal acceptance. From where does the dichotomy between doctors and patients originate?

Unlike Eng, 23-year-old Ashley Herrera’s then-pediatrician, urged her, as a child, not to get the vaccine because of its new status. But just two years ago, Herrera made the decision, with the help of her gynecologist, to get Gardasil after a routine Pap smear came back with abnormal test results.

“My doctor recommended that I get it to protect myself,” Herrera said. “You can’t identify which strain an individual has, and you can be infected by more than one strain.”

Though stated on the National Foundation for Infectious Diseases’ website that the Gardasil shot causes no more pain than any other shot, Herrera said her experience was a painful one.

“First it felt like a truck went over my arm,” Herrera said. “I could actually feel the vaccine going into my body. I’ve never felt anything like that before.”

As a Master’s of Public Health candidate at Stony Brook University, Herrera says she sees things from two different perspectives—that of a public health advocate, and as a patient.

“The reason that people are hesitant to get it is because it’s something that involves sexual activity,” Herrera said. “Parents may think that their child doesn’t need it because they’re not sexually active, but you need to be protected before you become sexually active.”

As a public health student, Herrera said that she sees the benefits in requiring vaccination, but as a patient, she said, she still believes in the freedom of choice.

In the argument over whether or not to require the Gardasil vaccine, the state of Virginia has already decided. In Virginia, Gardasil is required for all girls entering the sixth grade. The notion supporting required vaccinations is to make Gardasil a “herd vaccine,” meaning the infection could become completely eliminated if every person were to get vaccinated. Back in the late 19th to early 20th centuries, herd vaccination was used for smallpox, until it was declared eradicated by the World Health Organization (WHO) in 1980.

Dr. Mark Einstein, Gynecologic Oncologist at the Albert Einstein College of Medicine said, “with any sort of vaccine program, something as communicable as HPV, like small pox, if you are able to achieve herd vaccination, like small pox, you can potentially eradicate HPV.”

But smallpox is certainly not like HPV—one is a highly transmittable airborne infection; and the other, is a sexually transmitted infection that can only be transmitted through sexual intercourse. Unlike with smallpox, one’s presence—with an HPV infection—in a room, does not put others at risk.

Nonetheless, herd vaccinations were started in Australia—where Gardasil was first made—and U.S. doctors and scientists are now analyzing their results, contemplating herd vaccination here.

“We’ve seen glimpse of herd vaccination in Australia, where they had a very active vaccine program early on,” Dr. Einstein said. “And we’ve seen a 93% sharp decline in new genital warts in Australian women. We’ve hit a coalmine; warts have a much shorter timeline. In a very well vaccinated population, we’re already seeing results.”

The problem with Australia’s results, and with Dr. Einstein’s confidence in Gardasil’s protection against cervical cancer, is that because genital warts have a much shorter timeline, responses to the vaccine for warts, and warts alone, are clear—but not for cervical cancer. From just the results seen in Australia, it’s not certain that Gardasil will offer the same protection against the two cancer-causing strains of HPV.

The two cancer-causing strains of HPV, type 16 and 18, cause nearly 70 percent of all cervical cancer cases. And though there is no way to tell which strain one has, the good news, is that about 90 percent of all HPV infections clear up on their own within two years.

The remaining 10 percent that don’t clear do have the potential to cause cervical cancer; however, cervical cancer takes about 10 to 15 years to develop, and invasive cervical cancer, 20-40. Routine pap smears—recommended every five years for women over 30 without HPV, and every six months for women with HPV—detect abnormal cells, which typically mean a present HPV infection; and they are a reliable preventative measure for cervical cancer.

Dr. Paul Offit, American pediatrician with a specialization in infectious diseases, and expert in vaccines, immunology, and virology said, “we will know the impact within 20-25 years. By 2026 we will see an effect, and what you’ll see is that those who haven’t received the vaccine are at an increased risk.”

But presently, there are no number or statistics to prove Dr. Offit’s statement.

In an article from The New York Times from August 2014, Dr. Offit wrote, “Another common misperception is that the HPV vaccine is ineffective and immunity is short-lived…Regarding how long immunity will last, the HPV vaccine is made in the same manner as the hepatitis B vaccine, for which immunity lasts at least 30 years. Immunity provided by the HPV vaccine is likely to be no different.”

But the CDC says otherwise. On its website, the CDC says, “Research suggests that vaccine protection is long-lasting. Current studies have followed vaccinated individuals for six years, and show that there is no evidence of weakened protection over time.”

According to the Immunization Action Coalition, “The length of immunity is usually not known when a vaccine is first introduced. So far, studies have shown people to still be protected after 8 years. More research is being done to find out how long protection will last, and if a booster dose will eventually be needed.”

Eight-year-old girls that are getting vaccinated, the earliest it is recommended by the CDC, may not have immunity to HPV by the time they are in their early twenties.

It is also stated on the CDC’s website that Gardasil is not recommended for women over the age of 26 because there is no proven protection against HPV-related diseases beyond the age of 26. The CDC says, “HPV vaccination is not currently recommended for women over age 26 years. Clinical trials showed that, overall, HPV vaccination offered women limited or no protection against HPV-related diseases. For women over age 26 years, the best way to prevent cervical cancer is to get routine cervical cancer screening, as recommended.”

Why is there such a disparity in protection for 26-year-old women?

As stated in a May 2013 article from The Times, “thanks to Pap tests, fatal cervical cancers are almost unknown today in rich countries.” The U.S. is one of those rich countries. In the United States, Pap smears are a reliable method in screening for, and protecting against cervical cancer for all women, especially when the efficacy and length of protection from Gardasil is unknown.

Twenty-two year old Brittney Vallarella, from Smithtown, experienced a similar situation to Herrera. Vallarella said that her mother and doctor were originally uncomfortable giving her the vaccine when it first came out; but just recently, Vallarella, now a mother herself, received her second dose of Gardasil this past summer, after she stopped breastfeeding.

As a mother who’s soon going to have to make the decision on whether or not to vaccinate her child, Vallarella said that there are a lot more options to weigh, “I’m not a fan of the government telling people what to do. It’s a personal decision. I don’t think its been out long enough for the government to tell people what to do, and I think it’s so controversial because it doesn’t necessarily mean you won’t get cancer.”

On May 22, 2013, the National Vaccine Injury Compensation Program (VICP) listed all petitions filed with U.S. Department of Health and Human Services, (HHS) Health Resources and Services Administration. From 1989 to May 2013, $2.6 billion were awarded to petitioners for vaccine claims. In 2013, over $180 million were awarded to petitions by the U.S. Federal Court. Of those $180 million, as stated in Judicial Watch one month prior to HHS’s public release of the information, $6 million were awarded to 49 victims of the HPV vaccine—10 were deaths.

In the official report on the U.S. Department of Health and Human Services, under ‘Vaccines Listed in Claims as Reported by Petitioners,’ 30 specified vaccines are listed with the number of filed injuries and deaths, and whether they were compensated or dismissed. A total of 204 claims were made against the HPV vaccine, Gardasil: 194 injuries and 10 deaths. The U.S. Federal Court compensated only 59 of the claims, and dismissed 61.

Out of the other 30 listed vaccines, only nine of them have higher-reported numbers of death, including Hepatitis B (53), Influenza (59), and Measles-Mumps-Rubella (MMR) (56). But, patients only started getting the HPV vaccine once it got licensure in 2006, while the vaccines for Hep. B, Influenza and MMR, have been around since the early 1980’s. Those numbers certainly don’t attest to Gardasil’s safety.

Our Bodies Ourselves (OBOS), a nonprofit, public-interest organization based in Cambridge, Massachusetts, is directed, and co-founded, by Judy Norsigian. Norsigian, a renowned international speaker and women’s health advocate, is a strong proponent of a women’s right to her own body. On its website, OBOS says, “There is no question that HPV vaccines represent an important scientific advance in the field of vaccine research, but exaggerating their potential benefit in places such as North America will not serve us well. In countries where there is little or no access to Pap screening, current HPV vaccines might have much more potential for saving lives. Important questions will be answered over time as use of the HPV vaccine expands and improved vaccines are developed. For example, are three doses of vaccine required for long-term protection? Will booster shots be needed to maintain protection throughout adulthood? If so, how many? What rare complications associated with these vaccines might be identified as more young women use the vaccine over time?”

Only eight years after its licensure, Gardasil has become a required vaccine for many young women. The scientific community fully supports the vaccine and advocates for its safety and efficacy. But still, consumers and women’s advocates remain cautious and wary of the drug’s necessity.

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