In June 2006, the FDA approved a vaccine from Merck & Co. that prevents four types of human papillomavirus (HPV) in women. The injection for women is known as Gardasil, which is an abbreviation of "guard against squamous intraepithelial lesions." When a woman receives Gardasil, she must receive an initial injection, followed by another shot in two months, and a final dose at six months. This completes the vaccination process, which costs about 360 dollars. It is unknown how long the vaccination will work, but some estimate that it will last at least five or ten years. If its effectiveness wanes, women may need a booster shot. However, it remains to be seen if this will be necessary.
There are over 100 different types (strains) of HPV, and about 40 of these cause genital infections. Of those 40, about half can cause cancer, and some can cause genital warts. The four types of the virus that Gardasil prevents cause 90 percent of genital warts (types 6 and 11) and 70 percent of cervical cancer (types 16 and 18) [1]. So, even though the vaccine only targets a few strains of the virus, those few strains are responsible for causing most cases of cervical cancer and genital warts. Some mistakenly believe that the vaccine prevents 70 percent of HPV. This is not true. Others mistakenly believe that the vaccine is only 70 percent effective. This, also, is not true. The vaccine is extremely effective, but only as it relates to preventing those four types of the virus. While the vaccine may stop two cancer-causing strains of HPV, an article in The New England Journal of Medicine pointed out that blocking these strains of the virus may allow other cancerous HPV strains to fill the void [2]. If this happens, the overall decrease in cervical cancer would be minimal.
According to The Journal of the American Medical Association, 27 percent of women between the ages of 14 and 49 are currently infected with HPV. However, only 3.4 percent are infected with the strains of the virus covered by the current vaccine [3].
Safety Concerns
According to Merck and Co., clinical trials of drug have demonstrated the vaccine to be both safe and effective, although they have not publicized the number of girls tested with the vaccine [4]. Common side effects of the drug include pain at the injection site, swelling, fever, nausea, diarrhea, vomiting, and dizziness.
However, many have serious concerns about the safety of Gardasil. The National Vaccine Information Center (NVIC) criticized the FDA for "fast tracking" the approval of the drug without adequate tests of its safety in girls, and accused Merck and Co. of dishonesty and using "flawed science" to get it licensed [5]. A spokesman of the NVIC has also noted that negative side effects have surfaced in 20 states already, including temporary gastroenteritis, facial paralysis, appendicitis, pelvic inflammatory disease, asthma, brochospasm, loss of vision, and loss of consciousness during what appear to be seizures [6]. Reports of a link between the vaccine and adolescent arthritis have also surfaced [7]. Others fear that the HPV vaccine might lead to infertility, since Gardasil contains Polysorbate 80, which is linked to infertility in mice. Also, if a mother is breastfeeding when she receives the injections, her baby has a higher chance of developing acute respiratory illnesses within 30 days post-vaccination [8]. FDA staff also noted that according to Merck's clinical trial data, if a woman is already infected with strains of the virus targeted by the vaccine, receiving the vaccination may worsen her cervical condition [9].
In May of 2007, Judicial Watch released documents obtained from the FDA, detailing 1,637 reports of adverse reactions to Gardasil, including three deaths: "One physician's assistant reported that a female patient died of a blood clot three hours after getting the Gardasil vaccine. Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting. . . . Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities" [10]. The President of Judicial Watch remarked, "The FDA adverse event reports on the HPV vaccine read like a catalog of horrors" [11]. Five months after their inital report, Judicial Watch released analysis of FDA data, showing that 8 additional deaths had occured. At the time, the CDC confirmed only four deaths, but said that none were linked directly to the vaccine. A spokesman for the CDC added that Judicial Watch is "playing loose" with the data.[12] According to Judicial Watch, the latest count of Gardasil-related deaths is 47. Click here for details.
It has yet to be determined how Gardasil will interact with other drugs or vaccinations, since Merck and Co. only tested the vaccine with the hepatitis B vaccine. Over 40 cases of Guillain-Barre syndrome (an autoimmune disorder) have been reported in girls who received Gardasil with a meningitis vaccine [13].
Since the drug is new, the long-term side effects have yet to be determined. Hopefully, serious effects of the drug will be rare, improvements will be made, and it will prove to be an effective help in decreasing rates of cervical cancer worldwide, which takes the lives of about 288,000 women annually [14].
Mandating the vaccine
Because Gardasil has been approved for use in women aged 9-26, there has been much debate over whether or not states should mandate the vaccine. The governor of Texas, Rick Perry, signed an executive order requiring all girls entering sixth grade to receive the injections. He was widely criticized for the move, especially when it was revealed that his former chief of staff, Mike Toomey, lobbied for Merck. Further controversy arose when it was discovered that Merck made a $5000 contribution to his political campaign on the same day that members of his cabinet met for a "HPV Vaccine for Children Briefing" [15]. A spokesman for the governor said the timing of the donation was a coincidence.
Many government officials in Texas opposed the mandate, including the only practicing physician in the Texas legislature, Dr. John Zerwas. The Texas Medical Association, the American Academy of Pediatrics, the Association of American Physicians and Surgeons, and others have also recommended against a mandate. One common reason for their hesitation is the fact that the drug only went through three and a half years of testing [16]. The director of the National Institutes of Health added, "We don't know what the long-term effects of Gardasil are because it's too early, so I would say to walk before you run. . . . You have to understand that in public health, what the doctor says is not always the only thing that counts"[17].
Thankfully, not long after the governor's mandate, the Texas legislature overturned the governor's decision by a decision of 178 to 3. Governor Perry could have vetoed the bill, but decided that such a move would be futile, since there was sufficient legislative support for an override (which would have required only a two-thirds vote form the House and Senate) [18]. Similarly in South Carolina, a bill mandating the vaccine for girls failed to clear the House of Representatives, due to a lack of support.
One reason why legislators are hesitant to mandate the drug is because HPV is not a contagious disease, like measles, that could be easily transmitted from student to student. Since it is a sexually transmitted disease, its transmission depends upon one's behavior. In fact, the number one risk factor for genital HPV infection is one's number of lifetime sexual partners [19].
While the CDC recommends routine use of the vaccine for adolescent females, Dr. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices (ACIP) said that lawmakers should not make the vaccination mandatory, and that Merck should not lobby the state governments to require it for school attendance [20]. Likewise, the chair of the American Academy of Pediatrics' committee on infectious disease does not support making the vaccine mandatory. "I think it's too early," he said. "This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine" [21].
One cancer prevention researcher remarked, "Giving it to 11-year-olds is a great big public health experiment."[22.] She added, "This vaccine should not be mandated for 11-year-old girls. It has not been tested in little girls for efficacy." She noted that Merck "bridged" the studies to apply to young girls [23]. This means that the pharmaceutical company assumed that the drug would work in young girls because it works for older ones. While this may be true, the lack of data gives many a reason for concern.
Thankfully, Merck suspended its lobbying efforts, in the midst of a firestorm of criticism from parents and others. Debate is sure to continue, especially since HPV vaccines are "projected to spawn an $8 billion-a-year global market by 2010," according to Fortune magazine [24].
Ethical Concerns
Certain vaccines are created in an immoral way. For example, the vaccines for rabies, rubella, hepatitis A (some), varicella, and zoster are produced using cell lines derived from aborted babies. However, Gardasil does not come from such cell lines. Therefore, there is no ethical problem regarding its production.
Should girls receive the vaccine? This decision needs to be made by the young woman, her family, and her physician. Some fear that widespread promotion of the vaccine will serve as an endorsement for promiscuous behavior. However, both the Catholic Medical Association and the Medical Institute for Sexual Health support widespread, but not mandatory use of the vaccine. Both of these organizations are dedicated to promoting abstinence until marriage.
Many abstinent teens have expressed a desire not to receive the vaccination. Their decision should be respected, since purity prevents all genital HPV infections. If an abstinent teenage girl planned to marry a man who had previously been sexually active, she could always receive the vaccination prior to her marriage. By then, more data will have been gathered as to the safety and efficacy of the vaccine.
New Developments
In October 2009, the FDA approved the use of another HPV vaccine, Cervarix, in females aged 10 to 25 years. This vaccine only targets two strains of HPV (16 and 18), and therefore reduces the risk of cervical cancer, but not genital warts. The FDA has also approved the use of Gardasil in males aged 9 to 26 years, in order to reduce the risk of genital warts.
_________________________________
[1]. Kahn, "Vaccination as a Prevention Strategy for Human Papillomavirus-Related Diseases," Journal of Adolescent Health 37: 6S (2005): S10-6; Munoz, et al., "Chapter 1: HPV in the Etiology of Human Cancer," Vaccine 24 (S3) S1-S10 (2006).
[2]. G. F. Sawaya and K. Smith-McCune, "HPV Vaccination-More Answers, More Questions," The New England Journal of Medicine 356:19 (10 May 2007): 1991-1993.
[3]. Dunne, et al., "Prevalence of HPV Infection Among Females in the United States," The Journal of the American Medical Association 297:8 (February 2007): 813-819.
[4]. Brittany Wilson, "Bill Banning All Federal Funding for Mandatory STD Vaccinations Introduced in the House of Representatives," www.abstinence.net (13 March 2007).
[5]. National Vaccine Information Center, "Merck's Gardasil Vaccine not Proven Safe for Little Girls," Washington, D.C. (27 June 2006).
[6]. "Vaccine Center Issues Warning," The Washington Times (3 February 2007); NVIC Statement on dangers of Gardasil; Susan E. Wills, "HPV: The Hype, the Fear, and the Facts," National Catholic Register (18-24 March 2007), 7.
[7]. Brittany Wilson, "Bill Banning All Federal Funding for Mandatory STD Vaccinations Introduced in the House of Representatives," www.abstinence.net (13 March 2007).
[8]. Gardasil® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] Merck & Co. October 2006.
[9]. Susan E. Wills, "HPV: The Hype, the Fear, and the Facts," National Catholic Register (18-24 March 2007), 7.
[10]. Press Release, "Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine," Washington, D.C. (23 May 2007).
[11]. Press Release, "Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine," Washington, D.C. (23 May 2007).
[12.] "Judical Watch Releases Analysis of FDA Data Claiming Gardasil Vaccination Can Lead to Serious Health Problems, Death," Oct. 8, 2007. www.medicalnewstoday.com.
[13]. "Top Researcher: Untested' Vaccine Could Harm," worldnetdaily.com (15 March 2007).
[14]. World Health Organization, International Agency for Research on Cancer, 2006 (www.iarc.fr).
[15]. Associated Press, "Vaccine Meeting, Merck Donation Coincide," (21 February 2007).
[16]. "Abstinence Clearinghouse Statement on Mandated HPV Vaccine," 14 (February 2007).
[17]. Angela Zimm, "GlaxoSmithKline Seeks Approval for Cervical Vaccine," Bloomburg (29 March 2007)
[18]. Janet Elliott, "Reluctant Governor Yields on HPV Shot," Houston Chronicle (9 May 2007).
[19]. Baseman, et al., "The Epidemiology of Human Papillomavirus Infections," Journal of Clinical Virology 32 S:1 (2005): 16-24.
[20]. Gregory Lopes "CDC Doctor Opposes Law for Vaccine," The Washington Times (February 27, 2007).
[21]. Nikita Stewart and Rob Stein, "D.C. Bill Would Mandate Vaccine: Proposal for Girls Under 13 Targets Cervical Cancer," The Washington Post (10 January 2007), A01.
[22]. Dr. DIane M. Harper, as quoted by Cindy Bevington, Fort Wayne Daily News (March 14, 2007).
[23]. "Top Researcher: Untested' Vaccine Could Harm," worldnetdaily.com (15 March 2007).
[24]. Janet Guyon, "The Coming Storm Over a Cancer Vaccine," Fortune (31 October 2005).