The last time I had been in the clinic was for my Hepatitis-B vaccine. I screamed so loudly I scared the kids in the waiting room. Now, six years later, the same nauseating feelings of pre-shot anxiety were rising in my throat.
I ignored the fact I was the only person out of preschool there with her mom. Sitting in a folding chair in the waiting room, I tried to think about anything other than a sharp inch of metal plunging into my arm.
""Sarah Nance,"" the nurse beckoned, looking up uncaringly from her clipboard.
She swabbed down my arm and with an assistant, prepared to administer the vaccine. I flinched for an entire minute before and after injection, gripping the edge of my chair so tightly I thought I'd leave a permanent indent in my hand.
Shots are not fun. Many young women go off to college with a simple meningitis booster and the promise of a needle-free adulthood. However, a new vaccine, Gardasil, has been growing in popularity among young women and many even become state mandated.
HPV is a common viral infection, according to John Shalkham, program director of the UW-Madison School of Cytotechnology.
""In the United States, there will be over six million people infected with HPV this year and about 20 million people in the United States presently have it,"" he said. Additionally, Shalkham said about 15 percent of the female population in the United States have HPV.
Many strains of HPV are not dangerous, said professor Lynn Sterud, former education coordinator of the UW-Madison cytology school. Low-risk papillomavirus is responsible for any kind of wart, such as plantar warts. However, certain strains of HPV are high-risk and target the genital organs, potentially producing genital warts or developing into cervical cancer.
Although developing cervical cancer is uncommon, HPV can still be a dangerous infection.
""You don't know you have it,"" Shalkham said. ""In most cases it goes away on its own ... the development of cancer is relatively infrequent.""
HPV is spread through intimate genital contact, making it fairly common in younger, sexually active adults.
""If you come in [sexual] contact with someone who is infected, you will most likely be infected,"" Sterud said. ""At least 50 percent of men and women who are sexually active acquire an HPV infection at some time.""
Although there is a blood test for HPV, the most common diagnostic tool is the Pap smear, which the American Cancer Society recommends for all sexually active women.
Anew vaccine by Merck aims to lower the occurrences of HPV and therefore the rates of cervical cancer. Merck has released the vaccine Gardasil and is currently the only producer of an HPV vaccine.
""This vaccine has been designed to protect people against four different strains of HPV, the ones that are most likely to lead to disease,"" Sterud said.
Even if a patient has already been exposed to HPV, the vaccine may still prove beneficial.
""It's pretty unlikely that you would have been exposed to all four of these HPV viruses, so you could get protection from the ones that you hadn't been exposed to,"" Sterud said.
Kim Mackey, clinical assistant professor at the UW-Madison School of Medicine and Public Health, pointed out the vaccine won't necessarily lead to fewer cases of cervical cancer but still has substantial benefits.
""One of the things that is underappreciated is that there aren't many people with cervical cancer,"" he said. ""It's hard to get the number of cervical cancer deaths down. [But] if we could save 500,000 trips to the gynecologist for abnormal Pap smears, that's a pretty big issue.""
According to Winters, the vaccine is covered by nearly all insurances, and both Meriter Hospital and Student Health Services offer it.
""I got the vaccine because my doctor recommended that I get it,"" sophomore Lauren Dahlin said. ""If it's a way to prevent cancer, it's worth it.""
However, some women are more hesitant to receive the vaccine.
""I haven't decided yet, just for the fact that I don't have a lot of knowledge about it,"" freshman Lynn Dickman said. ""It doesn't seem like a pressing issue for me. It's not like I'm going to die tomorrow if I don't get it.""
Because the vaccine is so new, many unanswered questions worry patients and doctors.
According to Dr. David Ayoub, director of the Prairie Collaborative, an Illinois non-profit organization dealing with vaccine safety, the testing done on Gardasil only followed patients for two years.
""The safety studies are too short,"" he said. ""The studies that have been published thus far have all been funded by Merck. The authors on these papers are Merck employees or paid by Merck. Most of these studies have patent holders of the vaccine as co-authors, and that's a major conflict of interest.""
The newness of the vaccine is a concern to some, but such a response is typical for a newly introduced inoculation, according to Mackey.
""We can't get away from the newness of the vaccine,"" Mackey said. ""As for the long-term side effects, only time will tell.""
According to Winters, side effects have been rare.
""It's been very well tolerated,"" she said. ""I haven't known anyone who reacted badly.""
Although the vaccine has only been in clinical trials for a few years, there have been relatively few complications, according to Shalkham, such as swelling at the sight of the injection.
However, according to Ayoub, vaccine problems have already been reported on the Vaccine Adverse Event Reporting System used by the Food and Drug Administration and the Center for Disease Control and Prevention.
""Since the drug was approved in June last year—and up to the end of January—they have posted over 615 complications,"" Ayoub said.
Ayoub acknowledged this was a small percentage of instances, but said since the reporting system is not mandated only a small amount of complications get reported.
""There's no way of knowing what the true prevalence [of complications] is,"" he said.
John Conway, a pediatric and infectious disease specialist and associate professor at the UW-Madison medical school, noted the FDA engages in studies, even after the vaccine is approved, where they observe long-term effects.
""There's lots of drugs that get licensed by the FDA and the initial testing and studies looked good and then years later it gets pulled off the market,"" Conway said. ""It doesn't happen very often with vaccines, but it does happen.""
Additionally, according to Ayoub, some side effects of Gardasil may potentially be caused by reactions to the aluminum contained in the vaccine—used to aid absorption into the body. Because in tests both the placebo and non-placebo groups received shots containing aluminum, its side effects were ignored, Ayoub added.
""[Merck] used a placebo group that had aluminum exposure and the aluminum in this vaccine is a very high dose of aluminum,"" Ayoub said. ""A lot of people think that maybe half to two-thirds of the these complications are basically aluminum toxicity.""
Another issue is the possible need for booster shots.
""The question I think that we still have is the duration of protection,"" Shalkham said. ""Is this a life-time protection or is this going to disappear over time?""
Doctors are also concerned the vaccine only protects against four of the most common HPV strains, leaving other high-risk strains unaccounted for.
""[The vaccine contains] the most common forms related to cancer,"" Ayoub said. ""What happens when you suppress those? The others may become dominant. You might actually get more cancer, or more aggressive cancer. So it's imperative that you have got to do the long-term studies. They just haven't been done.""
Currently, many states are considering legislation making the vaccine mandatory, but opponents worry about Merck monopolizing the vaccine.
""There's a bunch of states that have moved aggressively forward to mandate the vaccine,"" Mackey said. At least 20 states are considering mandates.
Controversy arose in Texas when Gov. Rick Perry bypassed the state legislature and enacted an executive order mandating the vaccine for all middle school girls in Texas. Allegations of a conflict of interest surfaced when it was discovered Perry's former chief of staff is now a lobbyist at Merck. On Feb. 25, 2007, The Los Angeles Times reported Perry met with lobbyists in October 2006, a few hours later Merck donated several thousand dollars to the incumbent governor's campaign.
Some Wisconsin legislators are considering the idea of a mandate, but no bill has been proposed yet.
State Sen. Fred Risser, D-Madison, said he supports a mandate because society should do whatever it can to prevent cervical cancer.
""There is a bill that is being circulated and I'm one of the co-authors of it,"" he said. ""This bill provides that the shot would be available to girls 11 years old.""
Risser acknowledged such a bill may be difficult to pass, so certain measures have been included to increase support for the bill.
""This bill provides a parental opt-out in it,"" Risser said. ""It's just like any other shot.""
State Rep. Spencer Black, D-Madison, said no health officials have called his office to propose the idea.
""The jury is still out on whether [a mandate] is a good idea,"" he said. ""The lack of a lengthy track record is one of the issues that would be considered if a bill were to be proposed.""
One of the biggest drawbacks to a bill is the price of the vaccine. According to Risser, it would cost the state $11 million a year to vaccinate all 11-year-old girls.
Dr. Joseph Bocchini, chairman of the committee on infectious diseases for the American Academy of Pediatrics, said it is important health officials use mandates sparingly.
""The American Academy of Pediatrics thinks that it's more important now, rather than talk about mandates, to educate the public, to make them aware of HPV and its consequences,"" Bocchini said. ""If we do that, then we think that most parents are likely to accept this vaccine for their daughters.""
UW-Madison students have varying opinions on the vaccine mandate.
""I think that's taking away people's rights,"" freshman Lynsey Spaeth said. ""You should have the right to say if you want the vaccine or not.""
Freshman Katherine Schwerdtfeger agreed: ""I think it should be a choice as long as people are well educated about their options.""
According to Conway, the push for a mandate goes against the typical process of slowly letting a vaccine gain public favor before mandating it.
""A lot of it came down to the company that makes the vaccine lobbying the legislators and trying to get them to pull this,"" he said.
Ayoub agrees, noting the influence of Merck on the mandate process.
""Merck had a front-row seat [with the legislators, specifically the Women in Government] and they were able to spin and get their one-sided story and I think that a lot of legislators came back thinking that they were legitimately going to do something to stop cancer,"" Ayoub said. ""It's sad when the drug companies that have so much profit are the ones who are writing the bills and not the doctors.""
On Feb. 21, The New York Times reported Merck would stop lobbying state legislatures to mandate the vaccine after public health officials called its campaign counterproductive.
Conway stressed the majority of the medical community supports the vaccine.
""Most groups actually think it's a good vaccine and a great idea,"" he said, ""but just didn't think the school mandate legislation thing was the right way to go for it.""
Ultimately opinion on Gardasil is remains very divided.
""It becomes kind of a leap of faith to trust Merck-funded and created science,"" Ayoub said.
As for statewide mandates for girls entering school, doctors and legislators alike are undecided.
""Until we know that this thing really is long-term safe, long-term going to work well, plenty of it available and we've got a way to pay for it,"" Conway said, ""it seems premature to rush people to do it.""
