That's the question posed by CNN yesterday. It's a good question. Any time a new vaccine or treatment is available, safety is a concern. Pre-marketing testing is likely to miss very rare reactions, so the government monitors new drugs when they hit the market. Gardasil has so far been quite safe, which does not rule out very rare problems that my crop up as more people are vaccinated.
Added to the general level of suspicion regarding Gardisil is Merck's very aggressive marketing campaign aimed at the public and at state legislators.
All that aside, Gardasil is probably a good idea. Much of the hullabaloo surrounding its use has been ridiculous---attacks from religious fanatics and anti-vaccination cultists. In evaluating this promising new vaccine, we must set aside the noise from the wackos, and view things more objectively.
Gardasil protects against four of the common strains of HPV implicated in cervical, anal, and oral cancers. For it to fulfill it's purpose, it should be given before the onset of sexual activity. This freaks people out. A lot. The idea of vaccinating a pre-pubescent girl against a sexually transmitted disease that causes cancer is disturbing. It's also a good idea.
The CNN article has a clear bias toward fear-mongering. If the fear is justified by the content, that is a good thing. If it is not, it is just bad reporting.
This one is bad reporting.
The article focuses on adverse events reported to VAERS. This system is set up to monitor the safety of vaccines as they are released to the general population. Anyone can report anything that occurs after a vaccine. Theoretically, you could make a report of a car accident if it happens after a shot.
VAERS has received over 7000 reports so far of events after Gardasil shots, 7% of which have been classified as "serious". For all vaccines, VAERS receives about 30,000 reports annually, with about 10-15% of them being classified as "serious". So far, reported serious events such as Guillain-Barré Syndrome and death have not been clearly linked to the vaccine.
The safety of a vaccine cannot be judged soley on VAERS data, as it is very unreliable, however based on the number so far, a much smaller percentage of adverse events are reported after Gardasil than other vaccines.
Gardasil is a hot-button issue, especially for the religious cults. Whether or not to make it mandatory is an important public policy debate. This debate is not informed by poorly-informed hysterical pieces in the press. C'mon, reporters, do your homework!
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If VAERS is a piece of crap database, then why not put a better database in place that is transparent for public review of long term safty of vaccines?
Thanks for providing the analysis and perspective. I would say that this sort of vaccine should not be mandatory because it is not guarding against the sorts of highly contagious infections that quickly spread to impact a community or a population. HPV and its effect on cancer risk is not the sort of public safety concern that legally justifies a battery performed by the state. The same logic could justify mandating a huge number of preventative activities. Perhaps education about the vaccine should be mandatory in order to help people make informed decisions.
I still don't understand the religious angle. Perhaps parents are offended at the suggestion that their morally upstanding daughters just might become promiscuous or marry a formerly promiscuous man. But there is always the possibility of lying partners or acts of rape. I'm still going to wear my seat belt even though I consider myself a competent driver.
Cervical cancer used to be one of the leading causes of death in women. The only reason it's not any more is that Pap smears let us catch the disease before it progresses as badly. In many parts of the world, cervical cancer is still one of the top five cancers diagnosed. HPV is a disease that 8 out of 10 women (people?) contract during their lifetimes.
It's clearly a public safety concern. I think part of the reason that people think that it isn't is that it takes 20+ years between getting infected and getting cancer.
Historically, rape was always seen as evidence that the woman had fallen from grace. Much still remains of this attitude. The refusal to admit that a 'pure' or 'virtuous' woman can still catch HPV via rape is such a remnant.
Pre-pubescent boys should get the vaccine, too. They're not just carriers -- mounting evidence suggests they get various cancers from HPV, too. Have you seen pictures of penile cancers? Not pretty.
@Chuck:
VAERS is a piece of crap database because anyone can report anything to it. Please take the time to Google the story of a doctor who reported that the flu shot turned him into the Incredible Hulk.
VAERS is also necessary for exactly the same reason.
In essence, it boils down to, "Hello world. If you've had a problem with a vaccine, please raise your hand." We get a lot of self-selection; we get a lot of red herrings. But we also get the opportunity to hear about possible problems. VAERS should be viewed as a means of generating hypotheses, not testing them. The distinction is critical.
Here is what they use VAERS for... it is used to investigate adverse reactions:
http://archpedi.ama-assn.org/cgi/reprint/153/12/1279.pdf
Take note that there could be other reasons for the death of the baby, from birth defects to including the one who was found on the floor next to the couch after co-sleeping with the parent.
Here is a posting on a resident of the UK reporting to VAERS that it turned his daughter into Wonder Woman. He even includes a flash video of that submittal to the database:
http://leftbrainrightbrain.co.uk/?p=342
So VAERS is about as scientifically valuable and objective as a phone survey. Push poll away doctors.
Chuck said "So VAERS is about as scientifically valuable and objective as a phone survey."
Kind of... they are more like the radio talk show call-in surveys because they are self-selected.
"Push poll away doctors."
What does that mean?
By the way, phone surveys do have their uses in that they can lead to some other real research.
"Push poll away doctors."
Yeah... reading for comprehension? Remember? You're still doing it wrong.
Chuck, I think you're missing the point of the VAERS database. It's not supposed to be proof of the safety, or lack thereof of a vaccine, it's supposed to be a screening and early warning system, at least as I understand it. Yes, it's full of crap, but when you're trying to be on the alert for possible, but rare problems, you're more worried about type II errors (false negatives) than type I errors (false positives).
The reports can be followed up on, and can lead to more, better tests.
If the current system is full of crap, as everyone as alluded to, then why can't you refine the system and make it better and more transparent? The current system is full of both types of errors. If you can't fix it then trash it.
Chuck said "If the current system is full of crap, as everyone as alluded to, then why can't YOU refine the system and make it better and more transparent? The current system is full of both types of errors. If YOU can't fix it then trash it."
Please tell us who "you" in those two sentences are supposed to be.
How would YOU (as in Chuck, you, yourself) improve the reporting system?
VAERS is a useful tool, but it is of course full of a lot of noise. For instance, I know that one of the negative events associated with the gardasil vaccine is a broken nose. Did the vaccine cause it? Of course not, the patient fainted after getting a shot (some people just do that), and fell and hit her nose. Still gets reported.
And stop feeding that troll. I think he's proved himself to be a rabid fool and not worth your time.
When I said "you" I was referring to those individuals that enter data into VAERS, maintain the system, and do reporting and analysis on the data in the system.
IMO if someone faints as an adverse reaction to a vaccine and breaks their nose then that is an adverse reaction. The additional medical costs, pain, and suffering would not have happened if the individual had not received the vaccine.
MarkH: If I'm not worth your time then why should anyone waste their time seeing you? It would be to beneath you to see them wouldn't it?
Anti-vaxers are especially virulent here in NJ since we are now the state with the " most mandatory vaccinations"(61). Various groups such NJ Vaccination Choice have sprung up with internet "information" sites, lobbying efforts, telephone campaigns,etc., aided and abetted by Gary Null and the Green -the- Vaccine movement.Gardasil has certainly added fuel to the fire.Their latest tactic is the introduction of a "consciencious exemption" bill in the legislature which would allow a non-religious or "philosophical" exemption to vaccination.(Supposedly, 19 states already have similar exemptions).If this passes,I guess parents can "just say no" to vaccinations (and rationality).I've noticed that a few local pols have shown support by writing op-eds or articles in the local news: The Daily Record.Our governor, Jon Corzine has remained staunchly on the side of reason, despite continuous attacks.
Anti-vaxers are especially virulent here in NJ , now that we are the state with the most (61) mandatory vaccines.Groups like NJ Vaccination Choice have sprung up with web "information" sites, lobbying efforts,and phone campaigns,aided and abetted by the likes of Gary Null and the Green the Vaccine movement.One of their latest tactics is introducing a "consciencious exemption" bill,which would allow a non-religious or "philosophical" exemption,like 19 other states.Gardisil has certainly added fuel to the fire.I guess parents could then "just say no" to vaccination ( and reason).Some local pols have even expressed support in op-eds and articles in the local paper(Daily Record).Our governor, Jon Corzine has remained steadfast, despite continuous attacks by the anti-vaxers.
I'm the parent of 2 young teen daughters and 2 pre-teen sons. I held off on this vaccine for the first couple of years not because I thought it wasn't worthwhile--I think it's very important for personal and public health reasons--but because I was concerned about the new vaccine. I remember a few years ago there was a new rotavirus vaccine that had to be pulled and I guess reformulated because it was associated with intussusception and I wanted a little more time to be sure of the safety of this one.
I'm a little ambivalent about my own attitude--was I letting other parents' children carry the risk of public health for my own children's benefit? I don't know. I DO know that once it had been established for a year that there were no weird problems with the vaccine, I had my daughters receive it. If it's offered, I will have my sons get it too. This, despite the fact that we are part of a very sexually conservative religious group. I can share my values and hopes with my children, but I can't control them once they're grown; nor can I completely protect them from rape, much as I wish I could protect the entire world population from rape. At least I can do my part and protect them from this risk which is both medically and statistically serious.
And yeah, I did have my littler ones receive the newer rotavirus vaccine. Rotavirus is nasty, nasty, nasty, and I don't want them to suffer it when there is now a safe vaccine available.
Not all the fear-mongers are anti-vax nutjobs. Some are just prone to panic. I think we should look into appealing to panic. I say we play up the "pedophiles are going to steal your babies in the night and give them genital warts" angle and see if that doesn't get a few more of them to receive the jab.
Here is another take on it from Utah:
http://deseretnews.com/article/1,5143,700240635,00.html
I thought one of the main criticisms of Gardasil was the price tag. Does it still cost several hundred bucks a shot?
Since I'm getting a divorce, and just barely fit into the age range, and I've had an instance of cervical dysplasia, I got the first shot of Gardasil last month. They told me that I can get the last one (divorce = no health insurance) at Planned Parenthood for no more than $30. So no, not hundreds of dollars.
You can view gardasil (and other vaccine or drug adverse events) here: http://www.fdable.com/main/search_vaccines?all_search=gardasil
AERS and VAERS have pros and cons, but as others have pointed out, the information that gets reported gets the ball rolling w/ respect to drug and vaccine safety signals.
Straw man arguments and broad-based insults of people that disagree with you pretty much invalidated any reasonable points made in the article for me. You find rabid and self-serving people on both sides of this issue. I happened to find this blog reading up on the latest news on Gardasil.
google(dot)com/hostednews/afp/article/ALeqM5gIPeSOSkC3zU3Xd4HMRiovY9ri-Q
"Spain withdraws cervical cancer shot after illnesses
Feb 10, 2009
MADRID (AFP) â Spanish health authorities have withdrawn tens of thousands of doses of a vaccine against cervical cancer after two teenagers who received the shots were hospitalised, regional authorities said on Tuesday..."
cbg-meb.nl/NR/rdonlyres/DF40BBC5-2D06-441D-8AA5-85F2FE25C4CE/0/Gardasil_pressrelease(dot)pdf
"EMEA statement on the safety of Gardasil
The European Medicines Agency (EMEA) has received reports of deaths in women who had
previously received Gardasil, including two reports concerning the sudden and unexpected deaths of
two young women in the European Union..."