Benefits and risks of the Gardasil HPV vaccine

Gardasil

An Analysis of the Pros and Cons of Gardasil as a Vaccine for HPV

Gardasil, a new vaccine developed by Merck & Co., was approved in 2006 by the U.S. FDA as a preventative vaccination for HPV (human papillomavirus -- types 6, 11, 16, and 18) -- recommended for girls before the onset of adolescence and for men ages 9 to 25. This paper will discuss the pros and cons of receiving the Gardasil HPV vaccine.

HPV: What It Is

Before discussing the pros and cons of the HPV vaccine a brief discussion of the human papillomavirus may be beneficial. In existence today are almost 200 different types of human papillomavirus -- however, most of these produce no known symptoms.

The symptoms of those types of HPV that do produce them range from warts to cancer. According to the Centers for Disease Control, "Genital human papillomavirus (also called HPV) is the most common sexually transmitted infection (STI). There are more than 40 HPV types that can infect the genital areas of males and females. These HPV types can also infect the mouth and throat. Most people who become infected with HPV do not even know they have it" (Genital HPV Infection -- Fact Sheet). The infection occurs in the mucus membrane, and according to Walboomers et al., the virus is found in a modest estimate of 93% of cases of "invasive cervical cancer worldwide" (Walboomers et al. 12). According to the study, "The extreme rarity of HPV-negative cancers reinforces the rationale for HPV testing in addition to, or even instead of, cervical cytology in routine cervical screening" (Walboomers et al. 12).

Ways to Prevent HPV

How to treat the threat of HPV is now being addressed by physicians as well as pundits, and the concerns range from safety and precaution to moral indignation. The debate not only includes the exploitation of pharmaceutical companies and the dangers that vaccines like Gardasil can pose (especially when testing -- though passing the scrutiny of the FDA -- fails to silence all critics), it also shares a similarity in dimension to the debate that concerned parents with regard to sex education in public schools: exposing pre-adolescent girls and boys to a vaccine connected to sexual transmission some feel is a violation of innocence.

Nonetheless, while those concerns may be voiced in the portion of this paper relegated to the cons of promoting Gardasil, this portion will confine its attention solely to the ways of treating HPV that are now available. According to Nath Amiya and Thappa Devinder, "There is enough evidence to suggest that the prophylactic vaccines are efficacious in preventing various benign and malignant conditions (including cervical cancers) caused by HPV. Even though the vaccine is costly, hypothetical analysis has shown that HPV vaccination will be cost effective in the long run" (Amiya, Devinder 245). However, Amiya and Devinder admit that this is only half of the story when it comes to treating HPV. While both researchers remain optimistic about therapeutic HPV vaccines "still undergoing evaluation in clinical studies," they do observe that "several countries have started mandatory vaccination programs with the prophylactic HPV vaccines [which has caused] conservatives [to voice] concerns regarding the moral impact of such vaccination programs" (Amiya, Devinder 245). The moral and biological health factors surrounding the Gardasil vaccination may now be looked at with a more in depth analysis.

Gardasil

The History of the Vaccine

Biotechnology is not only a science -- it is a business, and the fact that the two are commingled is what makes the advent of Gardasil suspicious in the eyes of some. Yet the distributors of Gardasil attempt to justify their vaccination through scientific clinical studies and analyses.

The development of Gardasil by Merck and Company has already been stated in the introduction. Merck has subsequently gone on record to promote the safe use of the vaccine -- however, because the vaccine is still relatively new on the market, its historical life leaves much to the imagination. Merck's testimony, moreover, may not be construed as one of complete objectivity, since the company obviously has some interest in maintaining that Gardasil's importance and advantages outweighs its insignificance and disadvantages -- if such is actually the case. The United States Food and Drug Administration does list a number of reports concerning the adverse side effects of Gardasil, but before we get to those, let us first review what the FDA has had to say concerning the safety of the drug:

Studies involving approximately 21,000 girls and women were conducted to evaluate the safety and effectiveness of Gardasil before receiving approval by FDA. Approximately half of the study participants received the vaccine, and the other half received a control. These studies showed that in women who have never been infected by HPV types 6, 11, 16 or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina and vulva, and in preventing genital warts caused by these HPV types. This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year. ("Gardasil Vaccine Safety").

The FDA's promotion of Gardasil as a logical choice in the fight against cervical cancer is limited to the above statement. But one wonders if more cannot be said than this? Is Gardasil truly a reliable attack on an actual problem? Is HPV a truly serious threat -- or is this all just an elaborate ruse on the part of pharmaceuticals and academia to ensure grants in academic departments and profitable sales margins for big pharma? These are reasonable questions and consumer and parental doubts are being voiced.

Studies and Reports Regarding Gardasil

However, the various reports and studies coming in testifying to adverse effects may tell a different story:

On August 19, 2009, the Journal of the American Medical Association (JAMA) published an article coauthored by FDA and CDC that reviews the safety data for Gardasil for select adverse events that have been reported to VAERS, from the time period starting from product licensure in June 2006 through December 31, 2008 (JAMA. 2009;302(7):750-757). The article describes 12,424 reports of adverse events following Gardasil vaccination. Of these, 772 were reports of serious events (6.2% of the reports) and the remaining 11,652 (93.8%) were classified as non-serious. During this time period, the manufacturer, Merck and Co., has distributed over 23 million doses of Gardasil in the United States. The information contained in this update is based on the same information contained in the article published in JAMA. FDA will provide a future update to information on the number of reports of adverse events and doses distributed. ("Gardasil Vaccine Safety").

What we see here is a genuine push from the pharmaceutical industry to establish Gardasil as a combatant of cervical cancer and specific types of HPV. Unfortunately, this is information is completely one sided -- and even the FDA reports incidents of negligence concerning the administration of the vaccine: "VAERS reports include syncope (fainting), pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after syncope may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. FDA and CDC have taken steps to remind immunization providers about the recommendation that individuals be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall" ("Gardasil Vaccine Safety"). Moreover, "Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil" ("Gardasil Vaccine Safety"). On top of this, "concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of December 31, 2008, 32 deaths had been reported to VAERS" ("Gardasil Vaccine Safety"). The FDA testifies that these incidents are still being investigated and that there remains to be seen any connection between the vaccine and the patient's death.

But let us leave these objections aside for now and turn to some of the pros that have been published concerning the advantageous use of Gardasil.

Positive Reviews of Gardasil

In 2009, both the Centers for Disease Control and the U.S. Food and Drug Administration came out in favor of the use of Gardasil. Nonetheless, shares in Merck stock were still down 1 percentage point upon the reception of the positive news. The explanation for this could be that despite the findings (or lack thereof) to support the idea that Gardasil is everything its creators say it is, consumers and market analysts distrust the support of government agencies just as much as they do the new drugs of pharmaceutical companies like Merck. Of course, explaining such a thesis is beyond the parameters of this paper -- so instead, we will simply note the review that appeared in Reuters to confirm for the public what perhaps the public already suspected (that corporations and government agencies are extremely cozy). Perhaps the latter sentiment may be regarded as baseless speculation, but as we shall see after this section, there are a number of researchers whose view supports such a sentiment. Nonetheless, here is the report made available by the mainstream media in 2009:

CDC and FDA researchers wrote in the Journal of the American Medical Association that problems such as fainting and nausea remained rare among females who received Gardasil and the vaccine did not appear to be causing unusual side effects. The researchers said 32 deaths were listed in a government database that collects reports of health problems seen in people after vaccination. The reports show only that a patient became ill or died after receiving a vaccine, not that a vaccine was the cause. The FDA and CDC statement said 'concerns have been raised about' the reports of deaths of people who received Gardasil. 'There was not a common pattern to the deaths that would suggest they were caused by the vaccine,' the agencies said. Also, 'there is no evidence that Gardasil has increased the rate of' Guillain-Barre Syndrome, a rare neurological disorder that causes muscle weakness, the agencies said. ("Update 2: U.S. health officials back safety of Merck vaccine")

That review was followed by this one from the pages of Financial Times -- a publication that is telling of the way in which corporate America and public health institutions go hand in hand: "We are confident in the safety profile of Gardasil,' said Pam Eisele, a Merck spokeswoman. 'Leading health organisations throughout the world have reviewed all the safety information available and continue to recommend its use'" ("Merck Rejects Bachmann Vaccine Claims"). This article appeared, of course, after the GOP primary debate in which Michelle Bachmann accused Rick Perry of taking bribes from big pharma to push new drugs onto an unsuspecting public -- vaccines for HPV being among them.

Cons

Negative Reviews: Attacks on Merck's Research

Negative reviews have arisen to tell the other side of the story of Gardasil. It appears, based on the research by Wendy McMahon, that there are too many political facets to the promotion of Gardasil -- and not enough scientific evidence to back its claims. McMahon's research, based on several peer reviewed articles as well as the discussions involving "political actions to either promote or prevent a school entry Gardasil mandate," finds that "Gardasil should not be mandated for young girls entering the sixth grade as further studies must be done to ensure the safety and efficacy of the vaccine" (McMahon 1).

Adverse Effects

Susan Brinkmann is one researcher who has not bought the story that Gardasil can and does do everything it is promoted as doing. In fact, Brinkmann notes Dr. Diane Harper, "lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix," as saying that the new drugs "will do little to reduce cervical cancer rates and, even though they're being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15" (Brinkmann). Here, for example, is a case where a physician speaking at the 4th International Public Conference on Vaccination -- and placed on a panel designed to give support for the vaccine -- actually does the opposite and promotes a view that is negative in regard to Gardasil. "I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn't help but question why we need the vaccine at all,' said Joan Robinson, Assistant Editor at the Population Research Institute" (Brinkmann). How exactly could that be?