Vaccines have helped save lives and literally wipe out incidences of some diseases. Polio, for example, has been all but eliminated. It still occurs in underdeveloped countries, but the United States has not seen an occurrence since 1979 (Polio Vaccine Timeline, 2005, ¶ 8). Practicing mandatory immunization led to victory over this debilitating and life-threatening disease with now just over 1,200 cases reported globally (2005, ¶ 11). It makes for good statistics, good press, and good sense, but times have changed since Jonas Salk went into his lab at the University of Michigan School of Public Health and discovered a vaccine for polio.
Motivations today are different because research labs belong to big drug companies, the FDA has become lax, organizations rally behind a perceived cure, and politicians’ campaigns get support from these organizations and companies. Does it make sense to allow politics, corporations and organizations with good intentions to mandate vaccines for our children that have not been carefully tested? The vaccine against the Human Papilomavirus (HPV) may be just such a vaccine. Is the threat of cervical cancer resulting from HPV strong enough to warrant widespread mandated vaccination of young girls against the virus?
What is HPV?
HPV is a very common sexually transmitted disease (STD). There are approximately 100 known strains of HPV. “In more than 90 percent of cases, the infections are harmless and go away without treatment.” (Clinical Trials Results, 2005, ¶ 3). “At least 50% of sexually active people will get HPV at some time in their lives. Every year in the United States (U.S.), about 6.2 million people get HPV. It is most common in young women and men who are in their late teens and early 20s” (HPV Q&A, 2006, August, ¶ 26). According to an article published in 1997 in the American Journal of Medicine, about 74 percent of Americans--nearly three out of four--have been infected with genital HPV at some point in their lives (Learn About HPV, 1998, ¶ 13). Among those ages 15-49, only one in four Americans has not had a genital HPV infection (1998, ¶ 14). Most often genital HPV produces no symptoms or illness, so a person who has been infected may never know about it. Certain types of the virus increase the risk of cervical cancer in women. “The concept of HPV testing is not new but represents evolving technology,” and is recommended in the event of an abnormal Pap smear (Apgar & Brotzman, 1999, ¶ 12). The Center for Disease Control (CDC) warns that condoms may limit contact with the virus but are not an effective prevention because the entire genital area is not protected.
The Study
The pharmaceutical company Merck developed the vaccine called Gardasil and supported a study which is expected to continue following participants for 4 years. The study focused on one strain (HPV 16) known to cause 50% of cervical cancers. Approximately a dozen strains are involved in all other cervical cancers. Allan Hildesheim, Ph.D., a senior investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute (NCI) says that the current study “is an exciting first step toward a vaccine that can prevent cervical cancer,” However, he adds; larger studies are needed to confirm that the vaccine is safe and effective for healthy young women (Clinical Trials Results, 2005, ¶ 6).
The threat is not of epidemic proportions as compared to polio and other deadly diseases which are currently vaccinated for. The vaccine only prevents a small percentage of HPV strains known to cause cervical cancer. These strains may account for up to seventy percent of HPV-associated cancer of the cervix, but the vaccine does not prevent cervical cancer that is not associated with HPV. Twelve known strains are considered high-risk, but only one of these was focused on in the study
The table below compares statistics of polio and HPV.
|
Polio |
HPV |
Most reported cases (1952 epidemic) |
57,628 |
15,000 (annually) |
Clinical trial subjects (1954) |
15,000 |
1,533 |
Clinical Trial length |
2 years |
17 months |
Number of strains |
3 |
100/40/12/1 |
The media and pharmaceutical companies’ effort to tout the drug as a “cervical cancer vaccine” implies that the drug will prevent the disease, but in the study it is said to have only prevented one strain of the virus. The clinical trials lasted only seventeen months on a small sample with very narrow focus (Clinical Trials Results, 2005). Compared to the two-year field trials and 15,000 participants with the polio vaccine, is this enough information on the effects of the vaccine to begin inoculation of females as young as age nine?
The Players
ACIP
The Advisory Committee on Immunization Practices (ACIP) is made up of 15 experts in immunization. They are chosen by the Secretary of the U. S. Department of Health and Human Services “to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) on the most effective means to prevent vaccine-preventable diseases.” (ACIP, 2007, ¶ 1) The goal of the ACIP is to advise and assist “the Department and the Nation in reducing the incidence of vaccine preventable diseases and to increase the safe usage of vaccines and related biological products.” (ACIP, 2007, ¶ 1)
The ACIP provides “written recommendations for the routine administration of vaccines to the pediatric and adult populations, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines.” (2007, ¶ 2) There is no other agency in the federal government of this type. The ACIP has recommended the HPV vaccine for 11-12 year-old girls, and indicates that it can be given to girls as young as 9. They also recommended it for 13-26 year-old females who have never received the complete vaccine series (HPV Q&A, 2006, August, ¶ 2).
Merck
Merck’s website outlines their corporate responsibility as “discovering, developing and delivering novel medicines and vaccines that can make a difference in people's lives. But our mission also entails something more. As a Company, we seek to maintain high ethical standards and a culture that values honesty, integrity and transparency in all that we do.” (Merck.com, 2007) However, although there is no known way to diagnose HPV in men, Merck has begun recruiting for Gardasil trials in males. (hpvvaccinetrials.com, 2007)
Merck has a history of releasing drugs to the public after FDA approval that later resulted in health challenges to those using them. In February 2007, the FDA notified health care providers and consumers of 28 post-marketing reports of intussusception following administration of the Merck-developed RotaTeq vaccine against rotavirus. “Rotavirus is the leading cause of severe gastroenteritis in children aged <5 years worldwide (MMWR Weekly, 2007, ¶ 1).” “Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted. One portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction.” (FDA Public Health Notification, 2007, February 13, ¶ 1). Since the first draft of this essay, new information was released that indicates the vaccine does not increase the risk of intussusception over the occurrence of the condition in patients not receiving the vaccine. Infants inoculated with RotaTeq will continue to be monitored by the CDC, FDA and Merck for up to 21 days after inoculation. It seems that the occurrence of the condition may be related to possible replication of the virus in the bowel once infants have been vaccinated (MMWR Weekly, 2007, ¶ 3).
Merck voluntarily removed the drug Vioxx (rofecoxib) from the market in 2004 following increased rates of myocardial infarction and stroke among patients who received the drug for longer than 18 months (Soloway, 2004, ¶ 1). One year after the initial release of Vioxx in 1999, cardiovascular incidents were linked to the drug, but Merck attributed it to patient use of another anti-inflammatory drug and defended Vioxx (¶ 1).
In December of 2006, the FDA alerted health care professionals and patients treated with the Merck drug Rituxan (rituximab) of an emerging risk of a fatal viral infection of the central nervous system. This side effect has been reported in patients as late as 12 months after their last dose of Rituxan. (FDA News, 2006, December 18, ¶ 1). The drug was used to treat systemic lupus erythematosus (SLE). “SLE is not an approved indication for Rituxan. Rituxan is approved only for the treatment of patients with non-Hodgkin's lymphoma and patients with rheumatoid arthritis whose disease no longer responds to other common treatments” (2006, December 18, ¶ 1).
The FDA
On June 27, 2006, National Public Radio’s show Morning Edition reported that the FDA “has shown less of an inclination to follow the advice of its staff, according to an investigation by the Democratic staff of a House committee. The result has been a measurable drop in the number of recalls and warnings by the agency between 2000 and 2005” (Silberner, 2006). The report accuses the FDA of insufficient attention to prescription drugs on the market. The transcript of the show discusses recent lenient behaviors by the FDA toward pharmaceutical companies.
The Game
Amy Gardner, staff writer for The Washington Post reports that lawmakers in Virginia and 17 other states are considering requiring the vaccine in young girls. She writes that Legislatures are doing so at the urging of Merck & Co., which earned approval from the FDA in June of 2006 for Gardasil. Merck is a longstanding contributor to political campaigns in Virginia and has spent nearly $40,000 in contributions over the past two years. “It has also hired Williams Mullen Strategies, a prominent lobbying firm, to spearhead the company's efforts to persuade lawmakers in Richmond to vote for a mandatory vaccine” (2007, ¶ 8).
Texas Governor Rick Perry issued an executive order—making Texas the first to do so—and bypassed the legislature to mandate the vaccination of girls before entering the sixth grade (Paddock, 2006, February 6). Governor Perry received campaign donations from Merck to the tune of $6,000 and he has several ties to Merck and Women in Government (USA Today, 2007, February 6). One of the drug company's three lobbyists in Texas is Mike Toomey, Perry's former chief of staff. His current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government. Perry also received $6,000 from Merck's political action committee during his re-election campaign (Washington Post, 2007, February 11).
Conclusions
Throughout my research for this essay there was a mountain of information available, much of which was conflicting. There was a trend associated with new statistics as study of HPV continues. It is clear that all the facts are far from discovery. With the American Cancer Society, the FDA, the National Institutes of Health and state and federal governments all singing the praises of this new vaccine, there’s no wonder the public is confused. Parents want the right to control the health of their children. They are now being forced by potential legislation to have them inoculated against a health threat that isn’t fully understood with a compound that has not been fully tested. Some parents are excited about the prospect of protecting their little girls from this common virus and possible cancer-causing effects of it.
I submit that all who could be affected by cervical cancer, HPV and possible vaccination against it should ask a few questions. Can we trust the FDA when they appear to be lax in enforcing their own rules? Can we trust a drug company that is involved in lobbying states to make it a mandatory immunization and therefore perpetuating the lining of their corporate pockets? This company’s lobbying efforts seem a bit out of line with its desire to maintain “high ethical standards” and “honesty, integrity and transparency.” Can we trust lawmakers and state legislation, or anyone else who would rush toward the dark tunnel that is quickly, albeit falsely, being perceived as a “cure” for cervical cancer?
The vaccine worked in seventeen months of clinical trials. This is a good thing. It’s encouraging that there is a possible prevention of many cervical cancers, one of the most common causes of death to women. But what happens down the road when after mandatory inoculation extremely adverse affects are associated with the vaccine? Who will mandate health care to treat these effects? Who will pay the medical bills of women who discover that they have been permanently damaged by something they were forced to take as children? In the event of such a catastrophe, it is likely that Merck will take the fall and all fingers will point to their desire to quickly get the drug to market. Lawsuits will abound and but states would have already spent millions providing the vaccine at no cost to recipients and lawmakers who thought it was a good idea will be long gone from office. The vaccine is too new to mandate inoculation of all pubescent females. Consider the consequences before disaster and use good judgment by waiting until Gardasil, and other up-and-coming vaccines for HPV are fully tested and proven safe.
References
.Advisory committee on immunization practices (ACIP). (2007). Retrieved February 15, 2007, from http://www.cdc.gov/nip/acip/
Apgar, B.S. & Brotzman, G. (1999, May 15). Human papillomavirus testing in the evaluation of the minimally abnormal papanicolaou smear. American Family Physician, 59 (10). Retrieved February 17, 2007 from http://www.aafp.org/ afp/990515ap/2794.html
Clinical Trial Results: Vaccine protects against virus linked to half of all cervical cancers. (2005). Retrieved February 16, 2007, from http://www.cancer.gov/ clinicaltrials/ results/cervical-cancer-vaccine1102
Corporate responsibility: Committed to making a difference. (n.d.). Retrieved February 14, 2007, from http://www.merck.com/cr/
FDA Warns of Safety Concern Regarding Rituxan in New Patient Population. (2006, December 18). FDA News. Retrieved February 17, 2007, from http://www. fda.gov/bbs/topics/NEWS/2006/NEW01532.html
HPV investigational vaccine study: about this research study. (2007). Retrieved February 16, 2007, from http://www.hpvvaccinetrials.com/secure/ hpv_studies/hpv_studies.html
HPV vaccine questions and answers. (2006, August). Retrieved February 15, 2007, from http://www.cdc .gov/std/HPV/STDFact-HPV-vaccine.htm#hpvvac1
Information on RotaTeq and intussusception. (2007, February 13). FDA Public Health Notification. Retrieved February 18, 2007, from http://www.fda.gov/ cber/safety/phnrota021307.htm
Gardner, A. (2007, February 11). Drugmaker assists in pushing for mandate for HPV vaccination. The Washington Post. Retrieved February 13, 2007, from http://www.washingtonpost.com/wp-dyn/content/article/2007/02/10/ AR2007021001279.html
Learn about HPV: myths and misconceptions. American Social Health Association, Adapted from 10 Myths About HPV by Sandra Ackerman. Retrieved March 10, 2007, from http://www.ashastd.org/hpv/hpv_learn_myths.cfm
Paddock, C. (2007, February 6). Texas governor Perry stands firm on HPV vaccination mandate for schoolgirls. Medical News Today. Retrieved March 10, 2007, from http://www.medicalnewstoday.com/healthnews. php?newsid=62417
Polio vaccine timeline. (2005). Retrieved February 17, 2007, from http://www.cdc. gov/nip/ events/polio-vacc-50th/timeline.htm
Post-marketing monitoring of intussusception after RotaTeq™ vaccination --- United States, February 1, 2006--February 15, 2007, (2007, March 16). MMWR Weekly, Retrieved March 17, 2007, from http://www.cdc.gov/mmwr/ preview/mmwrhtml/mm5610a3.htm
Profit and public health: A useful vaccine, and a tone-deaf lobbying campaign on its behalf, Editorial, (2007, February 11). The Washington Post. Retrieved March 10, 2007 http://www.washingtonpost.com/wp-dyn/content/article/ 2007/02/10/ AR2007021001178.html
Silberner, S. (2006, June 27). Democrats Say FDA Recalls and Warnings Have Slowed. Morning Edition (National Public Radio). Retrieved February 17, 2007, from http://www.npr.org/templates/story/story.php?storyId=5514421
Soloway, B. (2004). Rofecoxib (Vioxx) recalled. Journal Watch. Retrieved February 15, 2007, from http://general-medicine.jwatch.org/cgi/ content/full/2004/1231/1
Copyright March 17, 2007
by Iva Lawson
