Merck To Halt Lobbying For Vaccine 544
theodp writes "Reacting to a furor from some parents, advocacy groups, and public health experts, Merck said yesterday that it would stop lobbying state legislatures to require the use of its new cervical cancer vaccine Gardasil, which acts against strains of the sexually-transmitted human papilloma virus. The $400, 3-shot regimen was approved by the FDA in June. Later that month, a federal advisory panel recommended that females 11-26 years old be vaccinated. The governor of Texas has already signed an executive order making its use mandatory for schoolgirls."
A little perspective first (Score:5, Interesting)
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Re:A little perspective first (Score:5, Insightful)
Do they sprinkle the vaccine with magic faerie dust?
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A little background for your benefit:
There are about 100 types of HPV. About a dozen-twenty are linked to about 80% of cervical cancers. The vaccine in question (Gardasil) offers resistance to 4 of them which account for the (around 90%) of HPV linked cancers. That still leaves a HUGE number of HPV strains for which there is no vaccine that have been linked to cervical cancer. That also leaves non-hpv linked cervical cancer.
You're statement that
Re:A little perspective first (Score:4, Insightful)
Do you even know what cervical caner is? (Score:5, Insightful)
I guess if you have never seen a pelvic exenteration specimen you may not feel as strongly as I might. Hell, I am putting people in my line of work OUT OF WORK, but it isn't about job security, it is about people's lives. Also, it is about the reduced cost to society in pap smears, colposcopy, and everything else involved in cervical cancer surveillance. I don't think any of you, especially the males understand the enormity of impact this vaccine could have. We are talking billions of dollars and hundreds of lives each year.
Get out of your armchair and learn something before proclaiming.
Re:Do you even know what cervical caner is? (Score:5, Interesting)
As a pathologist, you are well aware of treatment options and how frequently (or infrequently, I should say) actual cancer shows up, say CIS -- or even HSIL.
Do you really think it's wise to spend tens of billions in the US alone -- and close to a billion a year for every year after that on a solution just out of phase I testing? Don't get me wrong -- I like the vaccine and am hopeful phase II and III studies will show a much greater lenth of protection -- and perhaps prevent abnormal changes in pre-exposed women who get vaccinated. I'm not ready to make that leap. I'm honestly not sure I'd ever be ready for that leap. Thats a HUGE expense and the money has to come from somewhere.
Disclaimer: I've provided aid in a number of studies following HPV, CIN I, II, III, etc... and have been listed as a contributer in a few research papers. I've also been asked to help facilitate data collection for a number of post-vaccination studies.
Re:Do you even know what cervical caner is? (Score:4, Insightful)
From what I've read, there is no intention on the part of obstetricians to discontinue regular pap smears. In fact, it'd be irresponsible for them to stop, because doing so would be a virtual death sentence (in the form of a late diagnosis) to those affected by all the cervical cancer unabated by this vaccine.
Of course everyone wants a healthier, cancer-free populace. That's not really an issue. Medicine is about balance. Balancing risks and benefits to different treatments. Otherwise, we'd all have our appendices removed and be injected with every vaccine available from birth.
"First do no harm" in the world of evidence-based medicine is tricky business. For one must not only demonstrate that a particular treatment works but also that it doesn't cause more harm (both in an individual patient and in aggregate) than good. And this includes all the risks and benefits be assessed. For instance, a vaccine, even if it does save, 100 lives, effectively does no good if it causes fatal allergic reactions in 1:10,000 and is administered to a population of 1,000,000 people.
Unfortunately, risk-management pieces don't sell newspapers. Once it's mentioned that the vaccine in question prevents cancer the discussion is over. And that's unfortunate because we'd do well to practice caution with any newly developed drug intended to be administered to an entire populace if only for the lack of longitudinal studies.
-Grym
Re:Do you even know what cervical cancer is? (Score:3, Insightful)
Um, what was that line about physician heal thyself? Allow me to impart the clue. Here's what the flamewar that you decided to pile onto consisted of:
WebHostingGuy pointed out that the financial donations were quite small in the large scheme of things.
Dr. Spork claimed that the vaccine was likely to be a 100% cure for cervical cancer, which if you are a doctor, you know if false. There were some other statements about cancer being bad and so on.
Jh
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I work with this stuff. I'm quite familiar with it. Further, I've been a contributor to a number of research papers following HPV, CIN I-III, etc... I'm also taking part in a study gathering data on post vaccinated women.
Actually, thats about 70%, not 90%. It covers 90% of HPV LINKED cancer.
Actually, it's Chlamydia Trach
Vaccinate the men too! (Score:4, Insightful)
I wonder if this is what Merck intended when they were lobbying for it. It wouold be much more cost effective if a) the vaccine was sold at the true marginal cost and b) the gouvernment would vaccinate everybody under 40. The coverage woould be so much wider that those few percent religio-fanatics that object to it would not matter too much.
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Well, that's true in the case of casually-communicated diseases, which jump from host to host indiscriminately.
But HPV basically requires sexual contact in order to be transmitted. Vaccinating all women would isolate the disease to a few populations among gay men (for whom the virus is much less risky) and transmission from bisexual men to women (which would be relatively rare).
I'm not saying that men shouldn't be vaccinated as well, just that it might be jumping the gun a bit to suggest that Merck was inte
Re:A little perspective first (Score:5, Insightful)
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Re:A little perspective first (Score:5, Insightful)
I'm curious about your use of the word "innocent". Are you trying to suggest that girls who have sex are somehow "guilty"? Or that because they had sex they somehow deserveto get cervical cancer?
You do understand that most people in the world "actually have sex". I don't think we really want to condemn them to getting cancer for doing something that we were all designed to do.
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also prevents 90% of genital warts cases (Score:3, Informative)
A few more interesting
What do they think? (Score:5, Insightful)
BTW (Score:2)
Re:What do they think? (Score:5, Insightful)
Do we really know for sure that the vaccine is safe? Yes, they've tested it. But there have been medicines before that have been tested and found "safe", only to be pulled from the market after their release.
At this early stage I think, and this is just my $0.02, that it should be readily available, and that the public should be educated about the benefits and risks, so that they can make up their own minds. After there is a proven track record, then consider making it mandatory.
Can you imagine the social impact if the drug were required for all school age girls, then a few years later they find out that there is a devastating long term effect that hadn't been discovered, or worse, had been discovered but was suppressed in the name of profit?
I think we should tread lightly when we consider forcing the public to take a newly released drug.
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But the FDA generally does a good job of erring on the side of caution, to the point where other crazy people will accuse them of causing deaths by not approving a treatment faster. And given the prevalence of HPV (see the well-cited Wikipedia article, or any other reliable source) and its obvious dangers, vaccination makes sense as public health policy.
Rationality expired a while ago. (Score:5, Insightful)
I'm not saying you are, but as I've been following the progress of this issue, it's seemed to progress something like this:
1) Religious-right insists that anything which might make sex 'safer' is a tool of Satan, and has no purpose besides corrupting their little darlings.
2) Basically everyone else raises eyebrows, questions their sanity.
3) Religious-right folks have a powwow, try to think up rational justification for #1. Failing that, they find a totally different, seemingly rational justification for their position, but which has nothing to do with their actual motives.
4) Everyone else spends a whole lot of time and effort responding to the seemingly rational objection from #3, but are just wasting their time, because the real objection is not rational or practical. It's entirely religious (and somewhat Freudian).
So, in short, you have a good point, but it's going to be an uphill battle to get anyone to take it seriously.
Re:Rationality expired a while ago. (Score:4, Insightful)
But I can fault them for lying and pretending that they're motivated by a concern for health, instead of just coming out and moralizing to me like they want to. It works for me to point out that they're lying about their motivation and lying about health information, yet expecting me to trust them, admitted, proven liars, on moral issues. That usually shuts them up, and that's good enough. I realize they just go peddle their vicious lies to someone else, but sometimes being away from the loony is the best I can hope for. In a perfect world they'd realize "hey, my ideology has turned me into a shameless liar, and since integrity is important, maybe I should rethink this," but I don't think that happens very often.
Re:Rationality expired a while ago. (Score:4, Insightful)
And I STILL think it's a terrible idea to make such a new vaccine mandatory.
Call me nuts, but I cannot trust something so new, where side effects are unknown, and I can't trust Merpk to have my or my children's best interests at heart.
I think it's GREAT that this vaccine is available, but it should NOT be mandatory.
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Despite the inflammatory name on the link to the blog article, it isn't mandatory. Even the article contradicts itself in the first paragraph:
On Saturday, February 3, Texas Governor Rick Perry signed an executive order to make the newly-released human papilloma virus (HPV) vaccine Gardasil mandatory for all young girls before entry into the sixth grade. Starting in the 2008-2009 school year, the new bill would allow pare
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Re:Rationality expired a while ago. (Score:4, Insightful)
Just saying that you'll keep your kid inside when they get it doesn't help, since they're contagious two days before any symptoms show.
Here [wikipedia.org] is some more information on that "inconvenience". My grandfather suffers from shingles caused by chickenpox and it's no fun.
Besides, if your kid gets it, is it fair for your kid to pass it on to everyone else who hasn't had it? How about an adult who never got it?
The requirement is for the unopinionated. (Score:5, Insightful)
Really, the purpose of making the vaccine required, rather than optional, is to require the huge 'silent majority' of people who don't have a strong opinion either way, and will just do whatever is easiest and requires the least amount of effort from them, to get their kids vaccinated. Without a requirement to do so, they won't bother, regardless of the long-term benefits. They just want to get the kid off to school; they'll schedule a doctor's appointment and cough up the cash if that's what it takes, but otherwise they never will.
Basically, the purpose of the requirement is to make sure girls whose parents are too stupid, ignorant, or lazy to have an opinion either way, don't get punished later on. Parents with a strong opinion in favor of vaccination aren't really affected, because their daughters would have gotten it anyway, and parents who are strongly opposed can always opt out along with the Christian Scientists.
This isn't really a policy that's aimed at the extreme ends of the spectrum, it's aimed at the middle, but as usual it's really being argued on by people who really have the least at stake.
Re:What do they think? (Score:5, Insightful)
I don't think ANY reasonable person is against vaccination -- just against MANDATORY vaccination.
You may want to look at this [medscape.com].
Perhaps after more studies there'll be a more compelling reason, say after results of the phase II or phase III studies, but I can still see huge arguments against based on economic reasons. It's a hell of a lot cheaper to make paps available to under served women than it is to vaccinate every woman aged 11-26 -- then every 11 year old every year...
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I have not heard of an economic reason before. I don't know what the costs of the alternative tests are, or of the treatments should treatment be found needed. I have heard that the current pap tests a
Re:What do they think? (Score:4, Interesting)
Volume might reduce prices, and affect the economics, of course. I didn't see anything in that article (I admit I skimmed it) that discussed the expense of treating cervical cancer. It's rare, yes, but that's still a few thousand women every year (and many of them die), and I never heard that treating cancer was cheap.
But imagine someone came up with a vaccine for tooth decay [homeunix.org], and we'll assume it was expensive, too. Would you argue that it's cheaper to provide (assumed less effective) dentistry to 'underserved' kids and adults? (Oh, and you didn't advance the 'moral' argument, but this analogy makes plain how stupid it is. How many people would argue seriously against a 'dental caries' vaccine because you can avoid tooth decay by good behavior, and it might encourage kids to eat more sweets leading to more obesity?)
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Re:What do they think? (Score:5, Insightful)
Re: Hypocracy in action (Score:4, Interesting)
And what about my son? He claims to be intent to remain celibate till marriage (he's 14, let's see if he still has this attitude in 5 years time...). Isn't he at risk if the girl he falls for has anything other than a "perfect" past?
It seems to me that not only is there loud shouts of "only celibacy really works" (and yes. celibacy DOES work, but it's totally realistic to expect everyone to do that, or more precisely not do it...), but this whole argument from the religious right and from the "Women's movement" smacks of "all evil is born of woman". Seriously, immunising little girls against a STD will turn them into little 2-bob tunnel-cunted gutter sluts that will screw anyone that moves?
The fact is that such am immunisation will probably not drive a kid towards sexual activity in any way. The real drivers are surely that effectiveness of parents and teachers in giving these kids self-respect and in them gaining a real appreciation for the real issues of STDs and the emotional costs of sexual behaviour.
I find this whole debate rather ridiculous, except for the implications for human and women's rights. Why do you Americans let the wacko right dictate so much rubbish?
DISCLAIMER:
I am a practising Christian. I am a Socialist and active supporter of our Political Left. I am not an American.
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Re:What do they think? (Score:4, Insightful)
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Re:What do they think? (Score:5, Funny)
Re:What do they think? (Score:5, Insightful)
Re:What do they think? (Score:5, Insightful)
The thing about drug companies is that they're a necessary evil: yes, they're in it for profit, but the products that they make a profit on save lives.
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This is some seriously fucked up shit!
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It's not an "HPV vaccine"; it's targeted. (Score:2)
The vaccine doesn't target all these strains, it goes after several specific ones that have been empirically linked to cervical cancer and abnormal pap smears / precancerous cellular growth.
So get
Re:Vaccination based on assumption (Score:4, Informative)
Gimme a break (Score:4, Insightful)
These companies shouldn't even be allowed to contribute $1. As a matter of fact, government figures shouldn't be allowed to receive any money from any businesses. The sole reason that a business would contribute money to a politician is to get some favors. That is the bottom line. This story stinks and stinks real bad.
gasmonso http://religousfreaks.com/ [religousfreaks.com]Re: (Score:2)
1. Cervical Cancer
It's the second most prevalent cancer in women worldwide, and the 8th most common in the USA.
2. How expensive this vaccine is.
$400 is a lot of money to most people.
What would be interesting to see is if it would be less expensive for insurance companies (or medicare/medicaid) to pay for all covered women without current HPV infections to have the vaccine or to treat cancer as it happens.
Re:Gimme a break (Score:5, Insightful)
I live in Austin, Texas, and basically people have been going apeshit for a week or two. Without any law, concerned parents already have the means to give this shot to their daughters (just ask your doctor). So why make it a legal issue?
This has been in the local news quite a bit recently, and I recall hearing various bits on the radio, such as: Rick Perry's brother works for Merck, Perry had large sums of money transferred into his account by Merck within days of announcing this law, and Perry usually doesn't take a stand for anything at all so it's extremely odd that he's pushing something as wide-sweeping as requiring all girls 11+ years old to get a shot. In the press, Perry keeps saying things like, "I want to do whatever I can to protect life", etc.
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This story freaks the hell out of me. I understand that there are necessary vaccines like polio and the like, but this appears to be solely driven by big business for the sole purpose of profiting. This is a step in the wrong direction to say the least and I hope you guys really drive that point home in Texas to send a message that we won't stand for this shit.
gasmonso http://religiousfreaks.com/ [religiousfreaks.com]Okay, here is your break (Score:5, Insightful)
And if someone doesn't want to get vaccinated they can opt out.
p.s. The large sum of money was $6,000 out of the $24 "million" of his campaign contributions. And there is bills in 20 other states which are going to require girls to get the vaccine. And if his brother worked for Merck why isn't is printed in all the news articles? That would be great at selling more papers.
Re:Gimme a break (Score:4, Insightful)
But I completely see your logic...why make it a legal issue? Why should we require kids to get ANY vaccinations? We should just make them all optional. What kind of dumb person would want to eradicate something that causes cancer? It makes absolutely no sense to me. Fuck vaccines, yay diseases!
Re:Gimme a break (Score:5, Informative)
You can't really eradicate a disease through a program of voluntary vaccination.
*As an aside, you may have heard that this vaccine will be voluntary, blah blah blah. That's because the Federal Law has an exemption such that your child does not have to be vaccinated against anything to attend school, as long as you claim it goes against your religious (defined as moral or ethical) beliefs. Legally, you don't have to go into any further details to get an exemption. Just put it in writing & send it to the school.
Christian activists (Score:2, Insightful)
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Naming (Score:2, Insightful)
I'm all for vaccinating everyone with this. But the campaign to fool the public by calling it a cervical cancer vaccine deserved to fail. And shame on all the newspapers and news organizations that went along with it. (I'm talking about you,
Actually (Score:2)
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Shrug ... not really surprising. (Score:3, Interesting)
I think you just answered your own question, or at least responded to your own argument, there.
There's probably no FDA approval for men, because Merck didn't submit any data for men, which they didn't do, because they didn't do studies on men. They didn't do studies on men, because it wasn't as cost-effective, because there are more straight women in the world than there are gay men.
I don't think th
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And a hell of a lot cheaper than $400 x 2 million woman/children every year a mandatory vaccination would call for.
Further, of the HPV strains which are linked to cancer (there's about a doz
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from cancer.gov:
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There's a difference between preventative tools and diagnostic tools; given the choice between something that actually prevents cervical cancer, and a system that will probably catch it so that it can be treated surgically,
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It is true that the pap is not a preventative but diagnostic tool. Paps will continue to be needed as the HPV vaccines only work for 3 or 4 HPV types (and theres like 20 which are linked to cancer).
We're talking about fair
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Merck is not legally allowed to advertise it as a treatment for any cancer. It's a vaccine, not a treatment.
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Wrong Info on Blog (Score:5, Informative)
1. The blog states the vaccine only decreases the chance--that's wrong. If you have not been previously infected with HPV then there is a 100% effective rate.
2. In 2007 the incidence of cervical cancer went up.
3. Yep, it is the most expensive, however it is the ONLY vaccine which prevent cancer and DEATH. (And yeah it made $70 million, chump change for a company which made $22 billion in 2006).
4. Wrong. Gardasil is already a part of this program. Having a mandate will not change liability at all.
5. There is 5 year data now with another 3 1/2 year data prior to the launch of the drug; that's 8 1/2 years of data now.
6. This is true, however, in the current data there has been no wane in the immunity; and vaccines typically never need booster shots due to the way vaccines work.
7. Yes, neither was any other drug on the market.
8. Pure speculation. There has been no proof that aluminum is harmful. Gardasil was tested with Hepatitis B because it has the same aluminum compound and has been on the market for 19 years.
9. There are currently studies going on with boys and safety data is already available for boys in the label. Also, the EU and Australia are already using on boys.
10. It's ironic that the blog ends with making an uninformed decision when all the facts are wrong on the site.
Yeah, this seems like a shrill for Gardasil but I have personal knowledge of this drug and sometimes setting the facts straight on a drug which is saving lives need some truth out there among the free range blogs which aren't providing accurate information.
Actually, mercury is in most vaccines (Score:3, Insightful)
Mercury is present in most vaccine formulations, in at least "trace amounts". It seems that some people are able to process this without an issue, but there is suspicion that many of the vaccine-related issues that have been correlated to vaccinations may be a result of a lesser abi
We should always be pessimistic... (Score:2, Insightful)
It's always easy to say that a new product or technology is going to improve our lives. There will always be studies stating that the "insert new thing here" is safe and will fix what ails us. Science and medicine are not perfect. New developments frequently come about which contradict previous scientific dogma. It is quite possible that some lasting damage will be done to these girls that did not show up earlier. I'm not saying that we should listen to the religious right. But we shouldn't use a vacc
Good idea - bad implementation (Score:3, Insightful)
That said, if I had a daughter in that age range I'd seriously consider getting her the vaccine because it has to be administered early to be effective. And I really don't think it needs to be discussed with the kids any more than a measles vaccine does - it's just another shot they'd be getting.
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Re:Good idea - bad implementation (Score:5, Insightful)
Why not? Choosing to remain unvaccinated hurts others. [wikipedia.org]
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why does the government require this? (Score:2, Insightful)
But when the government requires it, and is heavily lobbied by a drug company, that kinda rubs me the wrong way. Shouldn't these decisions be left up to the parents and doctors?
Whatever the case, it doesn't keep me up at night. As long as the fundies don't OUTLAW vaccines
Let me get this straight.. (Score:5, Insightful)
Which brings me to my point: FUCK OFF MERCK.
You jackasses think that you should have the exclusive right to manufacture a product and force it on everyone via bribed government officials? That is sick,immoral, and anti-capitalistic.
Guess the religious nuts got what they wanted... (Score:2)
On the minus side, it really shows how far we've slipped into rule by religious nuts. I'm not one for religion, but I don't have a problem with those who are. Religion provides comfort for people who can't deal with the world as-is. The problem is when it starts intruding on public life. W
Why only the women? (Score:2)
As it is now, a guy who wanted to get the shots would probably have trouble getting the protection for various social reasons (poorly educated clinic workers who think the treatment is gender specific etc). Heck, since it has been marketed as a "girl thing" a lot of guys probably wouldn't even think to ask.
It's great to stop the cancer, but st
$400? Not bad. (Score:4, Insightful)
Given the cost of drug development, I'm surprised it's only $400. Vaccines are a one-time profit for Merck until their patent runs out. Given the alternative costs of therapies (guaranteed revenue), there's a good chance Merck just might not be as evil as they are made to be. $400 doesn't get you much in the medical world these days--not even an hour with a specialist at my doctor's office. Again, this is symptomatic of a broken system where someone else always ends up paying the cost of medical treatment or you never knowing until the bill bites you. We should be so lucky that the established price is at the forefront of the discussion.
Besides, it works against a virus, a communicable disease that can be conceivably arrested and perhaps eradicated, for far less than the cost of the effective treatment for the cancer it causes. Treat it forever or squash it now. Shouldn't something this simple be prioritized? How is this different from everything else we get shots for if people who don't have health insurance can get it, and those that don't want it won't have it forced down their throat?
I'm Encouraged (Score:5, Interesting)
The problem here is that the religious right is being its usual shrill self and is drowning out any potentially legitimate reasons there might be for parents not to get the immunization for their daughters. One such reason might be a desire to wait and be certain the vaccine is actually safe and effective. We've seen a lot of drugs taken off the market recently because of unforeseen dangers and side effects. (Anti-arthritic drugs come to mind.) However there are enough lunatics around who equate the HPV vaccine with enabling their teenage daughters to have sex without fear. I can imagine that conversation: Don't have sex, you can get cancer from it. It's to be hoped that these idiots don't drown out the voices of reason. It's interesting that they either (a) haven't succeeded in convincing their daughters of their message, or (b) want to control the morals of other peoples' daughters.
At this point, mandatory immunizations for school seem to cover what used to be thought of as infectious "childhood diseases" such as measles, mumps, diphtheria, polio, and all the others. Those caused massive epidemics in the past. The difference here is that cervical cancer won't run through the schools like wildfire endangering everyone who breathes the common air.
On balance, I suppose I'd rather see the vaccine made mandatory than to see it become a privilege of those who can afford it.
Anybody remember Thalidomide? (Score:3, Insightful)
I think such vaccinations should not be pushed upon the people, especially if only one company sells it. It would give them a monopoly on this vaccine, a government funded monopoly for that.
I think we should first test it out further before getting the whole population vaccined. Once it's a generic product, then we should maybe recommend it highly to everybody. I hate to have a government forced vaccination, kinda like Hitler had the Jews, gays and certain religious groups tagged.
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Any good parent will be able to prevent his daughter from being exposed to HPV.
HAHAHAHAHAHAHAHAHAHA
That's fuckin hilarious. Almost as if you're saying "The solution to end all wars is simple, institute world peace!". To think that parents can stop their kids from having sex is absurd. Unless you homeschool your kid and keep them locked up in a closet 24/7, there are some times where children are *gasp* not under direct supervi
Re:Not the government's responsibility (Score:5, Informative)
More to the point, I'm not sure people realize just how easy it is to contract HPV. Not only that, but there really aren't any tests for males. It usually shows no symptoms, though I think that certain types result in genital warts.
Sex isn't even necessary to contract it. A large chunk of the adult population has it and doesn't know it. I could have it, for all I know. But it causes cervical cancer.
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As far as the other things go, I don't think birth control should be mandatory because it doesn't prevent diseases. They do place restrictions on children driving (learners permits, curfews, reduced point limit on licenses, only allowing people of certain ages in the car at the same time, etc.). I have no problem with that, and I don't know anyone who does asi
Opt out (Score:2)
Re:That's great news (Score:5, Insightful)
... because HPV vaccination prevents AIDS and pregnancy.
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And has no bearing on whether her _husband_ carries HPV from previous encounters.
DIAF, you nutjob.
--
BMO
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Boys are coming (Score:2)
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I can tell you that if this were available to me I would get it. I wish to be protected from as many diseases and ailments as possible no matter what the cause.
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You really seem to misunderstand vaccination, along with the people who modded you insightful. Vaccination works by introducing a biological compound (usually a dead virus) that is similar to a real virus. By exposing the immune system to this agent, the immune system is stimulated so that when you encounter a r
Re:Anecdote (Score:4, Insightful)
This vaccine has nothing at all to do with attending public school. It's not an airborne disease, and so isn't something you could possible contract at school. The idea that states are requiring it for students is overstepping their authority, and corruption, in the most blatant terms.
This is totalitarianism, pure and simple. The state now tells you what medicines you must take, and you have no choice in the matter. Worried about side-effects? Worried about taking unnecessary medication? Too bad. It's the law.