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Mandatory Gardasil for Immigrant Women
I heard a concerning new piece on NPR this morning. Apparently, women under 27 that are applying for citizenship in the U.S. must take the first does of Gardasil (vaccine against certain types of human papillomavirus) or their citizenship application will be denied. Gardasil is not required of women in the U.S. that have already attained citizenship. Any Center for Disease Control and Prevention (CDC) recommendation is now a mandate for immigrants. The CDC was unaware that their recommendations (intended simply as a recommendation to the public, not to policy) would become mandatory for anyone at this point (particularly with a vaccine that is so new and still being studied as some medical experts are observing indications that there may be more side effects that were not presenting in clinical trials).
While I am all for vaccines, my issues with this practice are:
1) Women that are all ready citizens (naturalized and immigrants that went through the process previously) are not required to take the vaccine; therefore, this practice singles out these women and forces them to a standard that is not required by the rest of the citizenry.
2) Receiving the first dose of Gardasil does not protect against the virus unless the two follow up doses are given, but the first does make women vulnerable to the host of Gardasil possible side effects (of which the medical community is just learning the full ramifications as the virus is so new); therefore, we are forcing these women to risk their health with no benefit.
3) The cost of each dose costs upwards of $250.00 and these women must bare that cost entirely. This vaccine is cost prohibitive to these women and has caused some to wait until they are 27 to immigrate. This can cause women to stay in the U.S. illegally which opens them up to deportation.
4) With the atrocious record of regulated reproductive and women's health issues (a record that includes forced and coerced abortions, sterilization, birth control methods, and experimental medicine), this issue is a return to the thinking that immigrant women's health and reproductive rights are inconsequential.
While I am all for vaccines, my issues with this practice are:
1) Women that are all ready citizens (naturalized and immigrants that went through the process previously) are not required to take the vaccine; therefore, this practice singles out these women and forces them to a standard that is not required by the rest of the citizenry.
2) Receiving the first dose of Gardasil does not protect against the virus unless the two follow up doses are given, but the first does make women vulnerable to the host of Gardasil possible side effects (of which the medical community is just learning the full ramifications as the virus is so new); therefore, we are forcing these women to risk their health with no benefit.
3) The cost of each dose costs upwards of $250.00 and these women must bare that cost entirely. This vaccine is cost prohibitive to these women and has caused some to wait until they are 27 to immigrate. This can cause women to stay in the U.S. illegally which opens them up to deportation.
4) With the atrocious record of regulated reproductive and women's health issues (a record that includes forced and coerced abortions, sterilization, birth control methods, and experimental medicine), this issue is a return to the thinking that immigrant women's health and reproductive rights are inconsequential.
Comments
1) Cost. Many medical insurance plans do not cover the vaccine and there is still a substantial number of people who do not even have health insurance. While there are some programs that may help cover the costs for children receiving the vaccines, those programs are not available to older teens and women that could still be aided by the vaccine. Not to mention the massive costs involved in making the vaccine that widely available in an economy that is already buckling under the weight of soaring health care costs.
2) Who will be required to receive it? Girls as young as 9 and women as old as 26 are eligible for the vaccine. What age group will be required to receive the vaccine? It has not been proven effective in young girls (as it wasn't tested on them) and there is some valid concern by the medical researcher mentioned above , that it may cause health problems in young girls. Also, will girls and women that have medical conditions/take medications/have allergies that would that would make receiving the vaccine a high risk to their overall health be exempt? Women that are pregnant, nursing, or have been exposed to the virus before are not supposed to take the vaccine; will they be exempt?
I am all for Gardasil as an available vaccine. Heck, I even took it last year. I just do not think making it mandatory is wise at this point in time.
Merck has demonstrated efficacy in males, and have filed with the FDA for approval for use of Gardasil in males.
Making it MANDATORY is a problem when the drug itself may not work for more than 5-10 years, will only help a small percentage of people, may itself be harmful in the long term, has some major known side effects, and is cost prohibitive for anyone that doesn't have insurance. With more information about efficacy and side-effects, clearer age guidelines, and some way to provide the vaccine that is not cost prohibitive, then making it mandatory may be the best course of action. Until that time it simply isn't feasible and possibly not safe to make it mandatory.
As for long-term effects, it went through the FDA's approval process for women, which involves a degree of long-term study. No, it's not as long-term as it could be, but no drug is tested for all of its long-term effects; doing so is hideously impractical. The approval and testing process is a balancing act between making sure something is safe and getting it out to the public. It has to be tested until it's safe enough, and then released in time to deal with the problem. If we study the effects of Gardasil on women for, say, 60 years, it is entirely likely that a totally different strain of HPV will emerge and infect the populace, and that will render all that research useless. Microbiology is not a static field of study; combating viral infections is a dynamic endeavor.
Also, it's a vaccine. Of course it wears off. Many vaccines do. That, in and of itself, is not sufficient reason to not administer it. If anything, it just underscores the need to subsidize it and vaccinate everyone.
An effective public health management strategy must have a multi-pronged approach. We need education, we need the research, we need the tools, and we need the communication. If anything in that strategy falters, the whole thing is useless. If we know that something works to combat cervical cancer, and we've done enough research to justify its usage in the public (which we have, according to the FDA), then we need to get it out there.
EDIT: Here's the abstract for the Phase III study conducted by Merck. The followed the subjects for an average of 3 years following the first dose.
I think that this vaccination should be mandatory. I've been vaccinated, my friends have been vaccinated, and if I have any daughters or sons they will be vaccinated against HPV. I should note that in the people I know that have been vaccinated there are people who tested negative and people who tested POSITIVE for HPV up to a year before they were vaccinated. Genital cancer and warts are not all you have to worry about with HPV infection. Women need to worry about damage to the areas infected, including the cervix, genital region, mouth, and throat. Yes, this virus infects any sort of mucus membrane epithelium. Which is why HPV increases risk of throat cancer. You really like oral sex? Well, if your partner is infected you too can now get throat cancer in addition to genital warts and all those other fun STIs! Let's talk about babies too. Let's say you're infected and want to have a baby, well now you might not be able to carry a baby to term because HPV scarring and damage has rendered your cervix incompetent and it can't hold a fetus in your uterus. But, if you make it to full term all you have to worry about is having infectious virus present during the vaginal birth. Then your baby can get all sorts of HPV infections on its vocal cords, mouth, throat, eyes, etc, that may or may not be fixed with surgery. Guys can also get cancer of their rectum, genital tract and the oral cavity in addition to warts.
As for the first dose not protecting against infection/lesions this is unsurprising. Most vaccines need a booster to work effectively. Maybe mandating that these women get the first shot will encourage them to complete the series once they have their citizenship. The time table for the second and third doses can be flexible and still be effective. Where are these risks associated with the vaccine that you keep talking about? I know Merck expanded its warnings to include "joint and muscle pain, fatigue, physical weakness and general malaise" but those happen with almost any vaccine. There have been reports of paralysis/demyelination, hypersensitivity and anaphylaxis however there has not been any link between paralysis/demyelination and the vaccination yet. Australia's mandatory vaccination program is supposed to get 2.2 million women vaccinated and so far, 5 may have experienced paralysis as a result of vaccination, 7 women had anaphylaxis ( 4 of which had a negative skin test when given the VPLs alone - meaning they reacted to something else in the vaccine ). In fact "181 235 doses of HPV vaccine have been administered and 78 adverse events following vaccination have been reported. Twenty-two cases of “allergic reaction” have been reported, but no reports of anaphylaxis have been received." 78 events that include the malaise, muscle aches, is good for a vaccine I think, but I'd have to consult with a classmate that actually does vaccine work to be sure.
As for the vaccine being ineffective in people that are HPV positive already, long term protection, or in young populations here is the pilot study comparing 10-15 year olds (boys and girls) with women. And the vaccine was tolerated in the younger kids and they seroconverted just as well as the older women. There's also evidence (unpublished from seminars I've attended) that these vaccines also offer some cross protective immunity. This paper looks at 5 year post vaccination antibody titers and says "Available data on the quadrivalent HPV vaccine demonstrated that long-term immune memory was induced, with anti-HPV geometric mean titers after 5 years remaining at or above those observed with natural infection." This also indicates that vaccination can induce higher antibody titers than natural infection, which means its still useful for women/men that have tested positive for HPV. A higher antibody titer may help to control a persistent infection which would lead to a lower incidence of cancer/lesions. This would be especially true if infected woman had a non-vaccine strain of HPV infection.
As for your exemptions don't include pregnant or nursing women. This subset of the population isn't supposed to get vaccinated unless they're at risk for something specific (ie me doing my influenza work means I need my flu shot even if I'm pregnant/nursing, or a woman that tests negative for Rubella but working with kids should get the vaccination). The only people that should be exempt are people who are genuinely hypersensitive to the vaccination by showing some sort of reaction to the hepatitis B, diphtheria, tetanus, or pertussis vaccine (it shares its non-HPV parts with these vaccines).
I'm not going to comment on the expense of the vaccine, as Pete already did. But, a lot of insurance companies have appeals you can go through to try and get something paid for. My insurance paid for mine completely because cost of cancer > vaccine for them.
The material you provided is informative, but they study a 5 year wondow and do not address what age group should receive the drug. If the vaccine wears off in 5 years, then giving it to 9 year-olds will be fairly ineffective as most girls will be just reaching the point of sexual activity. Can/should the vaccine be given again? I am genuinely asking as I do not know.
If the recommended age group is over the age of 18, then many people that would be required to receive the vaccine will have to pay for it out of pocket. With the high cost of the vaccine combined with the cost of the appointment to receive the vaccine, this simply may not be an option. Particularly when condoms, which also help prevent the spread of these particular viruses, are so easily obtained and cheap and Pap smears are already available for those women with insurance.
Vaccines are amazing and making them mandatory can save an untold number of lives. I, and the CDC for that matter, am not at a point where saying this particular vaccine should be mandatory for all women (let alone all people) as there isn't even a consensus about when the vaccine should be administered. That may change soon, and when it does, great!
Regardless of the issue of making it mandatory for all women/people in the U.S., how do you feel about making the first dose mandatory for women applying for citizenship while the vaccine is still elective for all else?
The point has been made that receiving the first does may increase the likelihood of women completing the vaccine with the two follow-up shots, but I think it is fairly unlikely based on cost unless these women immediately obtain health insurance when they become citizens.
Another consideration is how infectious the illness is. This is a disease that isn't airborne or simply transferred by touching a doorknob. There is considerably less potential for an epidemic than with, say, smallpox. Mandatory vaccines for highly infectious diseases are much more necessary. Yes, there are many horrible symptoms, but there are pretty clearly defined risk factors for contracting HPV. Avoiding those risks cuts down your risk of getting the disease significantly. If you don't want to cut down on risky behavior or are worried about accidental/non-consensual exposure, you can always choose to get the vaccine.
My concern is not that there may be risks (almost every medical treatment has some risk involved), it is that we do not know what the risks and rewards will be in the long term. It is barely possible for those that are eligible for the vaccine and can afford it to make a truly informed choice. If the vaccine was mandatory with the information we currently have, the medical community and law makers would be making that same relatively uninformed choice for the entire population. It may have limited consequences and great benefits - but it may not and until enough time passes to have all of the data on long term benefits v. long term risks, then any legislation would be shortsighted.
You are also spot on in identifying that HPV can be prevented via other methods and that it is spread via contact (usually sexual contact). This isn't smallpox. It is "out" there. This is a question of making it mandatory which requires more than three years of study in older girls and more that 18 months of study in younger girls just to determine what age group would most benefit, let alone long term efficacy and health risks. This may be deemed safe enough to make it available, but has it been deemed safe and beneficial enough to make it mandatory for the whole population?
You also didn't address any of the other complications associated with HPV, the other cancers not in the genital region and the complications that a positive HPV test can have on a woman's ability to have a healthy baby or carry to term.
I'm writing up more but I need to get some work done and this was the point I needed to address most.
I do not have a direct source, but here is a news source that says in a three years study, condoms did help prevent HPV.
Moreover, it seems like a targeted effort to promote the vaccine and make it easily available would be beneficial, but why make it mandatory when we can easily identify who is at risk and target the vaccine and other prevention methods to them - particularly in light of the fact that we simply do not know what the risks and benefits will be for more than five years out?
Again, all for the vaccine. Is making it mandatory at this point really the best solution (not only in a dollars and cents mindset, but for the population's overall well being)? We simply do not know. When we have more information, then the issue of making it mandatory should be considered.
EDIT: Here is a source regarding the study I referenced above. Condoms aren't 100% guaranteed, but this study indicates that they help a lot.
So, how much studying should we do before we decide to go ahead? Clearly, you say that 5 years is insufficient; the FDA disagrees. What's enough? 10 years? 20?
Studies like that are only practical to a certain extent. If a woman is vaccinated at age 15, and 20 years later she mysteriously becomes sterile, it'll be incredibly difficult to nail down the cause. There are a huge number of variables that can occur in those 20 years to affect fertility. There is a point of diminishing returns with long-term studies, and as I mentioned before, when it comes to microbiological world, 50 years is enough time to make all of your previous research invalid.
The point I'm making is that we have a tool that can effectively stop 70% of cases of cervical cancer when administered properly. That's a goddamn silver bullet against cervical cancer. In the medical world, a single vaccine with 70% efficacy is ridiculous. The studies we've done have demonstrated minimal side effects (as Lisa pointed out), and the long-term outlook so far is positive. Why should we hold back?
Let's pretend that cost is a non-issue. If we got the government to subsidize the vaccine so that everyone who wants one could get one, would that be OK? Would it also be OK to make it mandatory for everyone in that case?
HPV on the other hand infects a cell and then integrates into your cell's genome (like HIV) or its DNA sits as an episome with your cell's DNA. When it is like this your cell does not make any virus proteins and your immune system does not know you have an infection. When the virus finally does activate and cause cells to divide (resulting in warts/lesions/cancer) there may or may not be enough virus protein present for your immune system to know what's going on. Your doctor or immune system may recognize what it is eventually but by that point you may need major treatment. Even if one lesion/wart/cancer is taken care of you will have other cells that are still infected with latent HPV. This means it can come back years later and you will need to go through the process of taking care of warts/lesions/cancer again. Throughout this whole process it is also possible to be asymptomatic or have microscopic lesions in areas that are not tested with a pap smear. During these periods it is possible to spread HPV to another person, making it very similar to a herpes infection. Also, as opposed to flu or a cold infection a typical HPV cervical infection takes 4-20 months to clear the initial infection, and that it is quite common to see it reactivate around menopause. That's a really long time to be infectious. This makes HPV very infectious with statistics like 60% of HPV negative women became positive in a 5 year period, at least 40% of women have been infected with HPV, ~50% in women 20-24, ~39.3% of 17-23 year old girls in a hospital in Kentucky, ~50% of men developed HPV after 15.5 months, I could post more statistics but HPV has become very wide spread. This is because of the asymptomatic phase I mentioned earlier and the problem that most people don't develop warts when they're infected and they just continue to spread it without knowing they've ever been infected. Here are the risks of HPV infection: Cervical cancer, anal cancer, head and neck cancers, cervical lesions, friable cervix, cervical lesion removal resulting in friable cervix or incompetent cervix (unable to carry to term unless cervix sewn shut), mother can pass HPV to baby in form of papillomas in the respiratory tract that needs frequent surgery to correct, anal warts, penile cancer, depression.
Vaccine: Shown efficacious in boys and girls 10 and up, provides higher antibody titer than natural infection, provides neutralizing antibodies (prevents virus from infecting a cell), rat study shows fertility is not compromised and immunity passed to young for a period of 77 days, don't need to worry about cancer or cervical problems.
With all the research I've seen today I stand by my decision to be vaccinated and that I think mandatory HPV vaccination is a good thing. I agree with Pete that again, the government should subsidize it and that the earlier we can vaccinate the better.
Another reason I think HPV vaccination should be mandatory is because no matter how careful someone is their sexual partner can easily undo all their precautions. Waiting until marriage won't keep someone from getting infected if their significant other has slept with at least one other person. People lie, people don't disclose STI information even when they should. This study looked at people with genital warts, and of 54 participants "23 participants who did not disclose until after first having sexual intercourse." These people did not inform their sexual partner of their STI status before having sex. This study looks at genital herpes but I'm showing it to illustrate not disclosing STI status. "Respondents identified 87 "regular" partners and 37 "casual" partners. Respondents had informed 54/87 regular partners and 8/37 casual partners." How can 38% of these people with genital herpes not tell their regular partner they have a permanent STI? Until this is fixed as a society I think the vaccine should be mandatory. Once people are more open and reliable in reporting their STI status to partners then we could move to a voluntary schedule.
1) The vaccine isn't yet mandatory for the majority of citizens, like many listed above are. We should either require it for all or none. This has the appearance of using these immigrant women as a test population rather than safeguarding them and the population at large.
2) The vaccine is one of the most expensive vaccines on the market. The full series of shots range from $360 - more than $700. If these women are required by law to get the vaccine when the rest of the population isn't, they should receive it at reduced cost.
3) They only require the first shot. If the vaccine is required, then all three shots should be necessary. There is no point whatsoever (other than increased profits) to require the first shot without the two subsequent shots.
This isn't an easy question...there are quite a few reasonable pros and cons. The amount it would cost to educate and counsel each citizen on the choice would be much higher than the cost of simply subsidizing the vaccine. Therefore, it's probably reasonable from a financial standpoint to simply subsidize the vaccine and require it. They could even administer it in school, as they do with Hep B (also a multiple-shot vaccine) and MMR shots. I personally would prefer to have the choice, but I can acknowledge that a high % of Americans don't have the mental acuity to make the decision or take proper precautions themselves.
I agree with Kate about requiring all or none, in both senses. An immunity requirement for citizenship only makes sense if it's required of everyone. Sure, we don't require natural-born citizens to take the same academic test that immigrants do, but that's academic and not physiological. (Which, btw, I am against. Citizens should be required to know how their government works to vote. This should be required to pass high school.) Also in the full vaccination sense...WTF is the purpose of requiring the first shot, but none of the others?
I'm also totally with you about requiring natural-born citizens to pass the same test administered to immigrants.