Sex, Power, and Politics Blog

To start off, I would like to address Kaitlyn’s, Rachel’s, JaNaye’s and Natalie’s comments that Merck’s financial profit cannot be used as “rationale to neglect providing women HPV vaccines”, that Gardasil has been approved “over and over again”, that there are already laws that require similar vaccinations against communicable diseases, that “the vaccine is only going to get safer and more efficient the longer it is in circulation” and that “it’s possible that since this is a newer drug, [the amount of side effects] will go down as years go by”.

Polio and whooping cough vaccines were also approved and mandated by the state, “over and over again”, yet they did not get safer and their side effects did not decrease.  After doing further research, scientists discovered that a) polio vaccines were contaminated with the SV 40 virus, which causes cancer in animals as well as changes in human cell tissue cultures and b) over 80% of children under 5 years of age who had contracted whooping cough had been fully vaccinated (Sinclair 2002).  The Gardasil vaccine was only clinically studied for four years before it was placed on the market (Luksik).  Is this enough time to fully understand the future side effects of a vaccine?

For those who might be thinking “well, that was many years ago; our medical knowledge has improved greatly in the past 50 years”, consider the case of Vioxx in 2001, a drug that Merck (the same company that created Gardasil) developed and marketed.  After Vioxx became widely marketed, the Wall Street Journal published Merck insider emails showing how “Merck sought to distort drug trials to hide evidence of heart disease” (Adams 2004).  Even after a 2001 analysis suggested a ‘clear cut excess number of myocardial infarctions’ as a result of Vioxx, the FDA failed to require additional clinical safety testing (Adams 2004).  They continued to “approve” and allowed the drug to be administered for four years before scientific and public outrage forced them to admit the drug increased heart attacks and strokes and thus take the drug off the market.

I see the point Kaitie made that “companies are…encouraged to make a profit” and thus we “cannot use this as rational to neglect providing women HPV vaccines.”  But can we use this company’s history of marketing knowingly harmful drugs as a basis for scrutiny?  I definitely think so.

In response to Kaitlyn’s second ‘easy answer’, “It is a shame that we have to call into question the motives of these political groups and individuals, but within the context of this debate, these individuals do not influence the core ethical the issue of requiring the vaccine at all”, I would like to provide a scenario.  What if your doctor suggested and prescribed to you a new drug, claiming all of its advantages, then you find out that the company who marketed this drug had been supplying your doctor with monetary benefits?  Would you question your doctor’s motives?  The same can be said about legislators who are pushing for this vaccine to become mandated.  If these legislators were not partially funded by Merck, would there be as strong of a push for this mandate?

Kaitlyn also mentioned in her third ‘easy answer’ that “The great news is that there is an opt-out option for [those who do not wish to receive the vaccine]”.  There may be an opt-out option, but that does not mean it is adequate or efficient.  According to Houppert (2007), parents who opt-out of vaccine requirements are greatly harassed; their names go on a state list, they get calls from the CDC, and some get thrown off health insurance plans, thrown out of public schools, and “grilled by officials about the depth of their religious convictions” about vaccines.  In my opinion, this sounds extremely similar to the readings we did a few weeks ago about the lack of abortion doctors present in our society.  Like Jack Hitt (1998) said in “Who Will Do Abortions Here?”, “Can people be said to possess a right if they’re too afraid to exercise it?”  This is an issue that needs to be addressed.

Many commenters also addressed the issue of inadequate access to pap smears and stated that mandating vaccines in schools at an early age is the only way we can assure all women are protected equally against cervical cancer.  I agree that not everyone has equal access to pap tests and that denying those of a different racial or socioeconomic status equal protection against cervical cancer is immoral.  However, I do not agree that mandating the HPV vaccine is the only way to protect women against this virus.

Even without mandating, the vaccine can still be made accessible to those who are uninsured or low income.  Adding the HPV vaccine to the government’s Vaccine for Children program, which the Advisory Committee on Immunization Practices (ACIP) has already voted to do, would cover the cost for the uninsured and underinsured population and could also lead to insurance companies and state health plans deferring the costs as well (Planned Parenthood 2006).  Merck has also developed plans for a patient assistance program that would provide free vaccines to uninsured or low income adults (Planned Parenthood 2006).  Thus, there are already plans set in place to assure children and adults of all backgrounds get vaccinated without school mandates.

What I am confused about, however, is Kaitie’s argument about “accurate numbers”.  She said her research showed that there were 15,037 reports of adverse effects following Gardasil injections.  Yes, I knew I was not 100% accurate in that statistic, hence why I underestimated.  Additionally, simply because these 15,037 people only make up ~0.06% of the total vaccine recipients does not make their claims any less significant.  15,037 people with adverse side effects and 27 deaths are not something that should be ignored.

Kaitie also argued that these reports were not “confirmed” reports.  After looking at the CDC website, however, I did not find any statement saying these 15,037 reports were NOT confirmed, only that 17 of the 44 death reports had not been confirmed.  I would also like to point out that these reports were done through a passive reporting system (the Vaccine Adverse Effects Reporting System), which, according to the government, means that vaccine side effects are highly underreported, even up to 90% (Luksik).

What I find missing from this debate, however, are arguments and evidence showing the actual effectiveness of the HPV vaccine.  You would think this would be one of the most important factors when looking at making a vaccine mandated for children or eve mandated at all.  “Gardasil helps prevent HPV and HPV can cause cervical cancer, thus Gardasil prevents cervical cancer”.  Not necessarily.

Gardasil only vaccinates against 4 of the 15 types of HPV that have been linked to cervical cancer and does not even grant full immunity to them; these 11 remaining strains account for approximately 30% of cervical cancer cases (Luksik).  Gardasil has also been shown to increase the risk of developing cervical disease if the patient already has one of the strains of HPV (FDA 2006).  Especially in the case for those women who cannot afford pap smears, this vaccine may do nothing more than simply shift the dominant cancer-linked HPV strains (Luksik).

Gardasil works by stimulating the body to produce enough antibodies to protect against a possible future infection.  This quantifiable level is called a Titer count, which determines the duration of effectiveness of a vaccine (Luksik).  According to Merck’s official Gardasil package insert, “The minimum anti-HPV titer that confers protective efficacy has not been determined. Because there were few disease cases in individuals naïve…to vaccine HPV types at baseline in the group that received GARDASIL, it has not been possible to establish minimum…antibody levels that protect against clinical disease caused by HPV 6, 11, 16, and/or 18… The duration of immunity following a complete schedule of immunization with GARDASIL has not been established.” (Merck 2009).  I don’t know about you, but this does not convince me of the efficacy of this vaccine.

In addition, Merck only tested this vaccine on women of ages 16-23.  But wait, isn’t the vaccine approved for girls as young as nine years old?  How does Merck know this vaccine is safe for girls under the age of 15?  They don’t.  Merck (2009) itself stated that “the efficacy of GARDASIL in 9- through 15-year-old adolescent girls and boys is inferred.”  Is it fair to require all girls age nine and up to be injected with a vaccine that has never been actually tested for 9- through 15-year olds?  I do not think so.

Considering the amount of information (even from Merck itself) that suggests the effectiveness of Gardasil is entirely unknown, we should by no means make it a mandatory school vaccine.  We do not fully understand the side effects, we have no evidence confirming the efficacy, and we have no knowledge of the duration of immunity this vaccine possesses.  Does this sound like something we should require our young children to be injected with?  I’ll let you decide.

Adams, M. 2004. Reputation of the FDA in shambles after Vioxx scandal; calls for wholesale FDA reform gain momentum. NaturalNews. Available from http://www.naturalnews.com/002157_the_FDA_reform.html (accessed October 2009).

FDA. 2006.  VRBPAC Background Document. Available from http://www.fda.gov/ohrms/DOCKETS/ac/06/briefing/2006-4222B3.pdf (accessed October 2009).

Hitt, J. 1998. Who will do abortions here? The New York Times.

Luksik, P. PhD. Gardasil: important questions and answers. Available from http://www.cogforlife.org/gardasilfacts.htm (accessed October 2009).

Merck & Co., Inc. 2009. Gardasil package insert. Merck & Co., Inc. Whitehouse Station, New Jersey.  Available from http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf (accessed October 2009).

Sinclair, I. 2002. Historical facts exposing the dangers and ineffectiveness of vaccines. Vaccination Debate. Available from http://www.vaccinationdebate.com/web2.html (accessed October 2009).

In response to Keisha’s first post, I noticed some interesting avenues for this debate that we have yet to explore.  I also noticed a few aspects from her post that could be cleared up rather easily.  Thus, the first part of this post will consist of three basic responses to aspects of Keisha’s post which I found to be simple to address – parts which I call “easy answers”.  The second part of this post will focus on the safety of Gardasil, the prevalence of HPV, the need for vaccinations when pap smears can detect cervical cancer, and a rational for making HPV vaccinations part of the back-to-school regimen. With that, let’s just jump right in!

Easy answer #1: Keisha brought up the ethical nature of pharmaceutical companies in her debate, please see paragraphs 7-9 of my previous post for responses to these concerns.  Once again, in a capitalistic society companies are allowed and even (think back to Econ 101 folks) encouraged to make a profit.  We cannot use this as rational to neglect providing women HPV vaccines.

Easy answer #2: The articles that Keisha summarized about political connections to Gardasil are valid.  But as an independent debater, with no connections to Merck, I personally will not financially profit from any monetary gain Merck is given through requiring the vaccine.  Thus, while I am advocating for the requirement, I, unlike the specific scuzzy political individuals or groups that Keisha sited, have no ulterior motives.  It is a shame that we have to call into question the motives of these political groups and individuals, but within the context of this debate, these individuals do not influence the core ethical the issue of requiring the vaccine at all.

Easy answer #3: Finally, Keisha brought up the fact that she did not want to get vaccinated and did not want to be forced to be vaccinated.  She also noted that this is something that should be left up to the parents to decide.  I agree – with it all.  The great news is that there is an opt-out option for you.  Please reference the fifth and sixth paragraphs of my initial post concerning the opt-out choice available to parents who believe that their child should not receive the vaccination.

Alright, now for the fun stuff.

Let’s talk about the safety of Gardasil.  Gardasil is approved or recommended over and over again.  Reputable organizations such as the CDEC, American College of Obstetricians and Gynecologists, American Academy of Pediatrics, American Academy of Family Physicians and the American College Health Association are just a few of the groups who have formally recommended the use of Gardasil. This does not even take into account the through screening process the vaccination needed to go through in order to be approved by the FDA.  We can question the safety of any drug, but when will we have “enough” evidence to know that it is safe?  If you are going to make the point that it might not be safe, make some standard for us to judge the safety of a drug by – what standards does it need to meet?  Keisha raised concerns about the HPV vaccination being unsafe because of its side effects, but any nursing major can tell you that with pretty much any drug there are going to be side effects.  Keisha specifically called attention to the fact that HPV vaccinations have higher instances of serious health problems than the other meningococcal (fancy word for “bacterial,” I had to look it up) vaccinations.  Of course we should not be surprised by the fact that meningococcal vaccinations have different side effects than HPV vaccinations, since HPV is viral, not bacterial.

Keisha sited that there have been “more than10,000 reports of injuries and deaths related to Gardasil injections” in 2008.  But the inner statistician in me is always weary of round numbers, so I found a few accurate numbers from the reputable CDC page: according to the CDC, “as of September 1, 2009, more than 26 million doses of Gardasil were distributed in the United States”.  And how many reports of adverse events following the vaccination were there as of September 1, 2009?  15,037 (CDC).  That means that .06%* of the total number of vaccinations had reports of adverse conditions.  Furthermore, these are only reports, not necessarily confirmed reports at that.

Now that we can put the concerns of the drugs safety behind us, we can focus on the prevalence of HPV which Keisha brought into question.  Keisha stated that “the prevalence and detriment of HPV is highly overestimated”.  Yet, where Keisha sees “highly overestimated” occurrences of HPV, I see the statistic that by the age of 50, “at least 80% of women will have acquired sexually transmitted HPV” (Planed Parenthood, 1).  To me, that is the definition of prevalent.  As far as the detriment of HPV goes, cervical cancer, caused by HPV causes more than 3,000 deaths a year.  That is 3,000 (to borrow from all of those breast cancer research commercials out there) mothers, daughters, wives, and sisters that could be saved if we were to take the consequences of HPV more seriously.

Next, I was confused by your questions concerning “What is the point of getting a vaccine to prevent cancer when you would have to get screened as often as you would without the vaccine?  What is the point of getting a vaccine when adequate screening could assure a 100% survival rate?”.  To me this assumes that everyone has equal access to health care and the means to visit the doctor annually for a pap smear.  If we were to vaccinate children early enough, we can significantly reduce their risk of getting cervical cancer.  We must do this early, as I pointed out in my previous post, to catch kids before they drop out of school.  Unfortunately, these kids who drop out of school are at the greatest risk for not having adequate health insurance since they will lack a high school diploma – a necessary credential for getting nearly any job, especially one with healthcare benefits.  These people cannot afford to independently pay for a pap smear.  Furthermore, if they could scrape together the money every year for a pap smear, they would still need to leave work to do so, thus forfeiting valuable income that they need to support themselves.

You can also look at this argument from an ethnic perspective.  According to a 2009 Gallup poll, 41.5% of Hispanic and 19.9% of Black adult Americans are uninsured.  Pair that with statistics from the National Center for Education Statistics, which notes that in 2007 the dropout rate for Black students was 8.4% and the dropout rate for Hispanics was 21.4% (NCES) and you can see why these children need to be vaccinated early in school.  When they have such a high drop out rate followed by a high rate of being uninsured – annual pap smears become not a viable option for these women.  Now, when you compare these statistics to that of white Americans, where only 11.6% of the population is uninsured and the white student population has a mere 5.3% dropout rate we can see how ethnicity becomes part of the larger issue.  If we neglect to make this vaccine mandatory, minority adult women will be at an increased risk for cervical cancer because they did not have the opportunity to be vaccinated at a younger age; furthermore they will be less likely to get annual pap smears than their white counterparts. From this perspective, with out mandatory HPV vaccinations our society could be considered discriminatory at the best and promoting white privilege at the worst.

The last point I wanted to make was in response to Keisha’s statement that “if HPV is not transmitted in a school setting, the government has no right to mandate the HPV vaccine for all female children enrolled in school”.  This is a very valid point, and one which takes considerable thought; however, we already do vaccinate children for diseases which are not communicable in school.  For example, we all have places on our record for when our last tetanus shot was received, even though, tetanus cannot be transmitted from one person to another in school.  Furthermore, many states require students to be vaccinated for Hepatitis B which, much like HPV, is sexually transmitted (Dailard).  Having HPV vaccinations be part of a back-to-school regimen is not “egregious,” as Keisha put it – it is necessary.  It is necessary because it keeps women safe, for life, from the most common strains of HPV.

I would love to end this post with some dramatic and quip-y phrase, but I will stick to the basics.  HPV vaccinations save lives. Making it mandatory and part of the state’s back-to-school vaccinations will make it more available and affordable to the general populace and encourage health insurance companies to cover the vaccination.  When it comes down to it, I have yet to see a moral, ethical, or philosophical reason for not making this vaccination mandatory.

Footnotes:

* I rounded up too!  The actual number is .0578346154%

Dillard: http://www.guttmacher.org/pubs/gpr/09/4/gpr090412.html

NCES: http://nces.ed.gov/FastFacts/display.asp?id=16

http://www.gallup.com/poll/121820/one-six-adults-without-health-insurance.aspx

http://www.cdc.gov/vaccinesafety/Vaccines/HPV/gardasil.html

“Gardasil is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases.”  To most people, this sounds pretty great, doesn’t it?  So, we should require all girls of ages 10-12 to receive this vaccine, right?  I mean, who wouldn’t want to help prevent their daughter from getting cervical cancer?  Although I am not yet a mother, I can confidently say that if I had a daughter, I would undeniably want to prevent my daughter from cervical cancer.  Whether or not I want to do this through an HPV vaccine, however, is a different story.

I do not deny that Gardasil can be a useful vaccine; however, I cannot help but question the pharmaceutical company behind it.  Why has there been such a strong push to fast-track this vaccine into the market and into the schools?  Not only has it been estimated that Merck & Co., Inc would make over $4 billion a year on the Gardasil vaccine with each shot series costing $360 for the patient, but GlaxoSmithKline has developed an HPV vaccine of their own as well (Houppert 2007).  The Merck company clearly understands that if they do not get this vaccine on the market fast to as many young women as possible, they are going to lose their monopoly on this new vaccine market.

This same financial incentive can be seen in politicians and organizations that have advocated for this vaccine.  Rick Perry, the Governor of Texas in 2007, issued an executive order that made the vaccine compulsory for all sixth grade girls; what is not well-known is that he received $6,000 in campaign contributions from Merck and his former chief of staff served as a lobbyist for the company as well.  Women in Government, a nonprofit organization composed of female state legislators that has strongly advocated in a variety of legislative bodies for making the vaccine compulsory, was also funded by Merck (Houppert 2007).

Additionally, Merck has a history of marketing drugs the resulted in thousands of deaths.  For instance, in 2004 they marked the arthritis drug, Vioxx, which resulted in 28,000 deaths before they withdrew it from the market (Houppert 2007).  In the words of Heather Boonstra, a public policy analyst at the Alan Guttmacher Institute, “Because Merck itself has pushed so hard to make the vaccine mandatory, there’s a bit of skepticism about industry’s motives.”  I would say that I have more than a bit of skepticism.

Now, let us say that Merck had absolutely no financial incentives for producing and marketing this vaccine.  Would I then give this vaccine to my 10-year-old daughter?  No, I would not because the prevalence and detriment of HPV is highly overestimated.  Approximately 80% of women ages 15-25 infected with HPV have transient infections, meaning they are temporary and easily cleared without medical intervention.  DNA testing has shown that 70% of these women naturally cleared their HPV infections within one year and only 9% continued to be affected after two years (Planned Parenthood 2006).  Clearly, the majority of women infected with HPV do not get cervical cancer.

You may be wondering, well, what about the other 20% of those women?  The number of deaths due to cervical cancer in the U.S. dropped 74% between 1955 and 1992 and is currently dropping 4% annually; this decline is due to routine screening using Pap tests, and not vaccines.  For those women who do develop invasive cervical cancer, the five year survival rate is 91% for early invasive cancer and 100% for preinvasive cervical cancer (Planned Parenthood 2006).

Thus, if women get regular pap tests, their risk of dying from cervical cancer is extremely low, regardless if they get a vaccine or not.  According to Planned Parenthood (2006), “Even if Gardasil is 100 percent effective, it only prevents HPV types that cause 70 percent of cervical cancers. Women will still need screening to protect themselves against the other 30 percent.”  What is the point of getting a vaccine to prevent cancer when you would have to get screened as often as you would without the vaccine?  What is the point of getting a vaccine when adequate screening could assure a 100% survival rate?

Some people may argue that requiring HPV vaccines for children in school would target those young women who do not have access to adequate pap tests and assure that all women would have equal access to cervical cancer prevention.  According to Barbara Loe Fisher (the head of the National Vaccine Information Center), however, making the HPV vaccine a mandatory part of children’s vaccine protocol is “egregious because HPV is not a disease communicated in a school setting like other diseases with mandatory vaccines” (Houppert 2007).  Because HPV is not casually transmissible, this repudiates the government’s “compelling rationale” for requiring protection against the disease (Colgrove 2006).

If HPV is not transmitted in a school setting, the government has no right to mandate the HPV vaccine for all female children enrolled in school.  If I am not sexually active and do not plan on doing so until I am married, the government has no right to inject a vaccine in my body that protects against a virus that is solely sexually transmitted.  Parents should have the right to choose whether or not their child is vaccinated against HPV because they can provide better and healthier alternatives for their children, such as abstinence and condom use, which decrease the risk of acquiring HPV by 100 and 70%, respectively (Stein 2005; Schaffer 2006).  According to Colgrove (2006), mandating HPV vaccines “force[s] a child to undergo an intervention that may be irreconcilable with her family’s religious values and beliefs”.

This is not only a parental rights issue, however; it is also an issue of a child’s right to be protected against the forced injection of a vaccine that can cause detrimental and fatal side effects.  In 2006, more than 10,000 reports of injuries and deaths related to Gardasil injections were made to the Vaccine Adverse Events Reporting System; these reports were deemed as “coincidence” by federal health officials (Fisher 2009).  I do not know about you, but 10,000 injuries and deaths does not seem like a coincidence to me.  A study by NVIC in 2008 further opposed this idea of “coincidence” when it showed that death and serious health problems were reported three to 30 times more frequently after Gardasil vaccinations than Menactra (meningococcal) vaccinations.  If the side effects due to Gardasil were a coincidence, then “there would be little or no difference between the frequency and severity of vaccine-related adverse events between [the] two vaccines” (Fisher 2009).

Gardasil is manufactured by a pharmaceutical company with a history of placing profit over patient health and promoted by legislators whom are funded by this same company.  It is meant to protect against a cancer which only arises from 80% of HPV infections, has already been steadily decreasing in prevalence over the past 50 years, and has a 100% survival rate with adequate screening.  More generally, it protects against a virus that is not transmitted in a school setting, is only transmitted through sexual activity, and can be prevented through abstinence and condom use.  Gardasil has also caused more than 10,000 injuries and deaths since 1996.  Does the HPV vaccine really sound that great after all?  I do not think so.

Colgrove, J. 2006. The ethics and politics of compulsory HPV vaccination. The New England journal of medicine.

Fisher, B. L. 2009. Gardasil death & brain damage: a national tragedy. National Vaccine Information Center.

Houppert, K. 2007. Who’s afraid of Gardisil? The Nation.

Merck & Co., Inc. 2009. Important information about Gardasil. Merck & Co., Inc. Available from http://www.gardasil.com/ (accessed November 2009).

Planned Parenthood. 2006. HPV: the most common sexually transmitted virus.

Schaffer, A. 2006. Viral effect: the campaign for abstinence hits a dead end on HPV. Slate.

Stein, Rob. 2005. Cervical cancer vaccine gets injected with a social issue. Washington Post.