Yes
By: American Council on Science and Health, Partnership for Prevention
All Pre-Teen and Young Teen Girls Should be Vaccinated Against HPV
Aside from cost, there is no valid reason NOT to get it--and of course, the cost becomes trivial when put in context with the potential benefits and future costs averted. There are two vaccines marketed worldwide, except in the U.S., only Merck's quadrivalent Gardasil has been approved by the FDA. (GSK's Cervarix is available elsewhere). Both have been clinically tested over the course of almost a decade, and toxicity and adverse effects have been very uncommon, while serious/severe ones are rare.
On the other hand, infection with the human papillomavirus (HPV) is very common. In the United States, about 11,000 new cases of cervical cancer are diagnosed each year. Almost 4,000 women die of this disease each year. However, about 6 million new cases of genital HPV infection occur each year, including infections with all the different types. About three-quarters of these infections occur in the 15--24 year age group. There are many different strains of HPV, of which two types, HPV-16 and HPV-18--cause about 70% of all cervical cancers. HPV infection is also causally linked to genital warts in both genders. The HPV types involved in causing genital warts are types 6 and 11. It is not known precisely how many of the millions of infections are caused by these pathogenic types.
Most Women Infected with HPV are Unaware of the Infection
Most women infected with HPV are unaware of the infection; most women infected with HPV will fight off the infection over some period of time, becoming HPV-free with no adverse health effects. Some, however, will go on to develop abnormalities in their reproductive areas, which can progress to become abnormal growths which need to be removed surgically; some will become actual cancers. In the early stages, abnormal cells can be detected by the Pap Test; other tests include testing for HPV types. Doing both tests increases the diagnostic accuracy.
Worldwide, the problem is much greater--indeed, cervical cancer is the fifth leading cancer killer in the under-developed world. Reliable estimates are that almost 500,000 cases of cervical cancer occur, and about 250,000 women die from this disease, each year.
The vaccine is effective only if given before infection with the dangerous HPV strains occurs. That is why it should be given to pre-teens and young teens. In fact, HPV is so communicable that, unlike some other STI's, it can be transmitted by close contact without intercourse. That explains why infection with HPV is so common.
Reducing the Pool of Infected Women Would Lower Rates of Transmission
The protective effect of widespread HPV vaccination against cervical cancer requires a substantial fraction of susceptible women to get the vaccine--that would set up a formidable protective wall, even for those not immunized--a concept known as "herd immunity." Reducing the pool of infected women would lower rates of transmission to partners, and thence reduce infections in the community. While vaccinating males would likely have a similar effect on transmission (as well as protecting them against genital warts), there are insufficient data on male response rates to the vaccine to proceed in that direction at present. Of course, since not all cancers are caused by the four types in the vaccine, some routine check-ups for genital abnormalities would still be required: Pap tests and gyn exams. But as the number of cases of cervical HPV fell over time, the incidence of transmission would also fall, and the frequency of medical and surgical interventions for diagnosis and treatment of female reproductive system abnormalities would also plummet--thus giving rise to a net savings for society in terms of health expenditures.
Given these facts, and the fact that the vaccine is safe, and the fact that such vaccinations do NOT (as some "health groups" with moralistic motives have claimed) promote promiscuity, I can't understand why there is any debate or controversy over having all girls between the ages of 9 and 15 vaccinated as quickly as such a program could be organized.
This Vaccine Will Save Lives
Vaccines are among our most effective and reliable weapons to combat disease, as evidenced by the fact that vaccine-preventable disease levels in the U.S. are at or near record lows. One of the most exciting things about this new HPV vaccine is the fact that it will not only protect people from a highly prevelant infectious disease, but actually protect people from cancer.
Most cases of cervical cancer are caused by HPV, and the HPV vaccine can prevent 70 percent of all types of cervical cancer. Every year, about 12,000 women in the U.S. are diagnosed with cervical cancer and almost 4,000 women die from this disease. Worldwide, the American Cancer Society estimates that 274,000 women die every year from cervical cancer. Vaccination can dramaticallly reduce this suffering and the related costs.
The Vaccine is Safe
This FDA and CDC have found the HPV vaccine to be safe and effective,and they continue to monitor its use. Before the vaccine was licensed, studies were conducted worldwide with thousands of females between the ages of 9 and 26 years, and no serious side effects were found. Some recipients reported a soreness in the arm where the shot is administered, and few reported faintness shortly after receiving the vaccine. That's why many doctors ask recipients to stay in their offices for 15 minutes after receiving the shot.
Don't Withhold Vaccines to Influence Behavior
Wearing a helmet when you ride a bicycle does not make you a more reckless bike rider. By the same logic, having your daughter receive the HPV vaccine should not make her any more prone to engage in at-risk behavior.
While the vaccine provides significant protection, it does not protect against all forms of cervical cancers. It will still be important that women who receive the vaccine to exercise good judgment and to continue getting screened for cervical cancer. Still, the prospect of a 70% reduction in cervical cancer makes this vaccine a sound and important investment in your daughter's health.
No
By: Sigrid Fry-Revere (Center for Ethical Solutions)
HPV Is Not as Big a Threat as Some People Think
Some General Background. On June 8th, 2006, the Food and Drug Administration (FDA), after an expedited approval process, licensed the pharmaceutical company Merck to sell Gardasil. Gardasil was an amazing breakthrough, a vaccine against four types of human papillomavirus (HPV) for use in girls and women between the ages of 9 and 26. It promised 90 percent effectiveness against two types of viruses that cause 70 percent of all cervical cancers as well as protection against two other viruses known to cause genital warts. Gardasil was, in effect, the first anti-cancer vaccine.
The excitement over Gardasil was almost palpable, yet parents had reservations. Despite Merck’s extensive ad campaign, convincing parents to do the “right thing” for their daughters proved harder than expected. Policymakers were baffled. Why were so many people hesitant to give their children this remarkable new vaccine?
In less than 12 months, more than two dozen states considered mandating HPV vaccination. As of September 2008, only Virginia and the District of Columbia require inoculation for school enrollment, but other states are still considering the policy. In addition, 22 states have instituted public health education programs or financial programs to encourage HPV vaccination.
Just last week, the FDA added the prevention of vulvar and vaginal cancers to the list of potential benefits for Gardasil. This conclusion was based on data from 15,000 women who participated in Merck’s earlier cervical cancer studies. Of the women who were vaccinated with Gardasil, none developed precancerous cells in the vagina or vulva, compared to 10 who received a placebo vaccine and did develop precancerous cells.
The Prevalence of HPV and the Threat It Poses. Cervical cancer is the world's second–deadliest cancer for women, but only because women in developing countries don't have easy access to regular Pap tests. Eighty–three percent of the world's new cases and 85 percent of cervical–cancer deaths occur in developing countries.
The Journal of the American Medical Association reports that among U.S. women aged 14 to 24, the combined rate of infection for all 37 types of sexually transmitted HPV is 33.8 percent -- much lower than the 50 percent cited on Merck's website. More importantly, the rate of infection for HPV 16 and 18 -- the two types of cancer-causing HPV against which Gardasil protects -- are astronomically lower: only 1.5 percent and 0.8 percent, respectively. So even if every U.S. woman between 14 and 24 were vaccinated with Gardasil before being exposed to HPV, the vaccine would only protect 2.3 percent of all U.S. women or around 1 percent of the U.S. population.
Most HPV infections, including the carcinogenic ones, resolve themselves without treatment. The American Cancer Society’s HPV guidelines for physicians explain that approximately 75 percent of all types of HPV infections in adults and 90 percent of those in adolescents disappear on their own. (In my early 40s, I had an HPV infection that turned precancerous, but over a two-year period the infection resolved itself without any treatment whatsoever.)
Deaths from HPV-Related Cancers Are Highly Preventable
Deaths from HPV-related cancers can be prevented without vaccination. I only have data for cervical cancer, but the basic argument for prevention in favor of vaccination should be the same for vulvar and vaginal cancers.
The incidence of death from cervical cancer is declining in the United States because the disease is both easily detected and easily treated. Half of the women in the United States who develop cervical cancer have never been screened; another ten percent have not been screened for at least five years. Of the 9,710 women estimated to have cervical cancer in 2006, an estimated 3,700 will die of the disease. Ninety percent of those deaths could have been prevented with early screening.
Thirty percent of cervical cancers not being caught early enough to be treated at the pre-cancerous stage are potentially due to Pap test failure rates. However, a recently developed DNA test for HPV is expected to reduce the number of pre-cancerous developments that are missed. Early testing in combination with treatment of pre-cancerous cells, according to the American Cancer Society, makes cervical cancer “an almost entirely preventable disease” even without the implementation of a vaccine program.
It should also be noted that the gestation period of HPV from infection to actual cancer is on average 20 years, so there is plenty of time to catch HPV infections and monitor them to see if they become cancerous.
The HPV Vaccine Is Not as Effective as Most People Think
Gardasil works 90 percent of the time against two kinds of viruses that cause 70 percent of cervical cancers. Some people quite reasonably believe, despite Gardasil’s effectiveness, that such a safety net is too precarious to have them change their current detection and treatment practices in favor of vaccination. Even with the newest finding that Gardasil may also protect against vulvar and vaginal cancers, the FDA still recommends that even women and girls who are vaccinated continue to undergo regular testing. So the vaccine is recommended not as an alternative to current detection and treatment options but as an added protection. However, this added protection is neither necessary nor worth the risks inherent in any vaccination program.
Also the vaccine may be temporary; it is as yet unknown when its protections will wear off. Gardasil was tested for an average of three years and, while everyone hopes that immunity is permanent, there is no proof it will be. The vaccine may wear off in five, ten, or 15 years, and at some point everyone who was vaccinated will need at least a booster shot and undergo all the expense and risks that such shots entail.
Children vaccinated in the sixth grade (or as early as age 9 if recommendations made by Merck, the FDA, the Centers for Disease Control and Prevention (CDC) and some politicians are followed) could potentially lose their immunity by the time they are seniors in high school.
The Vaccine Could Create a False Sense of Security
Every healthcare authority that has advocated HPV vaccinations always adds that the vaccine should not be seen as a substitute for regular testing, but what if the vaccine lulls young women into a false sense of security? Gardasil protects only against HPV types 16 and 18. It does not protect against more than a dozen other types of HPV responsible for 30 percent of cervical cancers. What if women don’t realize the necessity of regular Pap tests or use the vaccine as an excuse to avoid inconvenient or unpleasant visits to the gynecologist? As a result, some pre-cancerous conditions may go undetected before it's too late.
The New England Journal of Medicine recently reported potentially analogous problems with the chickenpox vaccine -- not only did the incidence of illness among those vaccinated increase over time, so did the severity of the illness itself.
Need for HPV Vaccination Likely to Be Eclipsed by Other Developments
On average, HPV infections take 20 years to develop into cancers. With the rate of current medical progress, it is quite probable that a vaccine to cure cervical cancer will be ready for clinical trials in five to ten years. Hence, it is reasonable to hesitate in the face of rapidly advancing medical developments and not vaccinate now for an illness that in all likelihood won’t manifest for another 20 years.
HPV Vaccination Does Little to Promote the Common Good
If the HPV vaccine were risk-free and cost nothing, it would make sense to provide women and girls with the extra protection the vaccine provides, but the vaccine is neither risk- nor cost-free.
The Hazards Outweigh the Benefits. There is no evidence at this time that the HPV vaccine causes more dangerous side effects than the average vaccine, but the number of serious adverse events is still high enough to warrant thinking twice before vaccinating oneself or a child. In light of the CDC’s data on serious adverse effects of the vaccine, a 2007 study in the New England Journal of Medicine suggests that vaccinating every American girl between the ages of 11 and 26 would prevent 217 cervical cancer deaths, but there would also be approximately 77 deaths related to the vaccination itself and 1,698 non-fatal serious side-effects.* Such side-effects include Guillain-Barre Syndrome (in which the immune system attacks the nervous system and can cause weakness or paralysis), Stevens-Johnson Syndrome (a life-threatening allergic reaction), blood clots, seizures, and dizziness resulting in falls with trauma. The risk of one of these 1,775 deaths or serious adverse reactions is roughly eight times greater than that of death from cervical cancer, and parents (or young women old enough to choose for themselves) could reasonably choose to avoid these risks, especially since cervical cancer is “almost entirely preventable” by safer means.
The Costs Outweigh the Benefits. At a cost of $360 per person for the initial set of vaccinations believed to create immunity and an anticipated need for additional boosters, the HPV vaccine is one of the most expensive vaccinations in history. No wonder Merck is eager to sell the vaccine in the U.S. rather than in developing countries where the vaccine would potentially be useful -- 80 percent of all cervical cancer deaths occur in developing countries where testing programs are few and far between. If individuals wish to be vaccinated or have their children vaccinated despite the risks and lack of benefits, that certainly is a choice they should have, but whether the billions being spent on educational campaigns supporting HPV vaccination is a wise expenditure of taxpayers’ dollars is another question. The high risk-benefit ratio of HPV vaccination makes public health policies that encourage such superfluous vaccinations a waste of community resources.
The Principle of Unintended Consequences
There are potential unknown hazards to worry about. Gardasil protects against the most common but also the least dangerous forms of cancer-causing human papillomavirus. What if the HPV vaccine creates an environment in which more virulent forms of HPV, against which the vaccine provides no protection, thrive? There is no scientific evidence to support such a claim, but antibiotic resistant “superbugs” provide a case in point.
Finally, Gardasil was primarily tested on adult women, making it possible that there are unknown risks associated with vaccinating younger girls. The possibility isn't as far-fetched as one might think. In 1976, the swine flu vaccine was administered on a large scale, arguably without sufficient testing. The vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine had a 5 percent fatality rate and a 10 percent rate of permanent paralysis. Yet, among the millions of people who were never vaccinated, there was only one death that could be definitively traced to the flu itself.
Comments