Gardasil side affects and future programs

Great Debates
1

This is a revisit of an earlier debate on Guardasil. On CBS tonighttheir latest health issue is the high rate of problems with Guardasil (per the National Vaccine Information Center). The earlier debate was about the full court press to get this product to market. According to the article there is a high incidence of emergency room visits attributed to the drug and a number of deaths.

The debate:

Should this be scaled back for young girls until the health risks can be reassessed?

Should this product be pushed on young boys given there are no direct health benefit?

Would you give this to your daughter now?

Would you ever give this to your son?

My earlier position was that it was rushed to market and should have been further tested. So my response would be: yes, no, not right now, hell no.

2

I have no confidence in this drug.

3

FWIW so far it does not seem to be as bad as reported there.

http://www.cdc.gov/vaccinesafety/vaers/FDA_and_CDC_Statement.htm

Based on the last paragraph, I would seriously doubt the latest report until other confirmation appears.

4

The basis of that report is an “analysis” by the National Vaccine Information Council - a group that has existed primarily to fight against vaccines and which leads the way saying that vaccines cause autism, ADD, and just about anything else you can think of. The logic of this particular analysis is that this shot given in three doses has more illness occurring temporally associated with it than a vaccine given once only. Umm, yeah.

What is true? This one hurts like hell. Fainting happens not uncommonly mainly as a consequence of that. Yes, stand up slowly after getting this shot. And this one is not very likely to save many lives - cervical cancer is generally caught early in America. This one will save our daughters from cancer treatment more so than death. The rest is vaccine bashing by the usual suspects.

The questions in order:

No it should not be scaled back.

No, not to boys at this time - most analyses show relatively little additional benefit is gained by giving it to boys at substantially more cost. The additional herd immunity benefit would be fairly modest even if it was a mandatory vaccine and it is a long way from becoming that. (A study.)

Yes, I’ll give it to my daughter. I’d like to minimize her risk of needing cancer treatment.

My boys are going to be past the point by the time it is approved for the gender and age group. If I had a younger son and it became approved then I might - for the sake of my future daughter-in-law. But that is a bit of a stretch.

5

The CBS story dealt with a number of individual examples that stuck out because of the progressive nature of the reaction. With 5,000 emergency room visits attributed to it there appears to be a fairly rapid reaction. Combine that with an increase in reaction for each successive shot and you have some indicator of who not to give it to. Since this is a sexually transmitted disease there is some variables that can be thrown into the decision making process. The age of the child, a history of cancer in the family, other family member reaction to the drug etc…. I don’t see it as an up or down decision if there is growing evidence that the side effects are potentially deadly. Waiting for additional data can be hedged with instructions on safe sex techniques.

6

I didn’t catch the special– was there anything in it that contradicts the info above, provided by GIGOBuster (non-serious and serious-albeit-unrelated reports) or DSeid (National Vaccine Information Council’s involvement)?

7

Well that’s the million dollar question. Who do you believe. This involved information from National Vaccine Information Center which is a non-profit watch group. They’re not a bunch of nutballs and they’re not an official government agency. No drug or vaccine is going to be perfect and it comes down to acceptable levels. My impression from early readings is that this vaccine was aggressively pushed to market. Immediately following the CBS report they promoting the heck out of it again. I’m the first person to wave the flag of profit but I don’t see the need to push this on 11 year old girls when time and a little education can tide us over until more testing is done.

I still remember a drug I was taking that had a side affect of leg cramps. Since I have high blood pressure I was worried it would cause a heart attack. 1 month later it hit the news that it was causing heart attacks and it was pulled soon after. Right up to the day it became news worthy it was a certified drug.

8

Magiver, no, you are wrong. They are a bunch of nutballs. They have been leading the way blaming vaccines for everything. Yeah, according to them the MMR causes autism even though that has been totally disproven and the original suggestive studies have been shown to been made up of faked data. Oh yes, treating the “immune dysfunction” caused by the MMR can lead to a child “recovering from autism>”

There have been well over 16 million doses of Gardasil given in America. It is unavoidable that some individual cases that have a variety of things will occur around the same time as the shots with 16 million doses given, some more and some less than the background rate.

9

The fact that CBS relied on an “analysis” from NVIC severely calls into question their competency and fairness as a news organization.

As DSeid notes, NVIC is not a legitimate consumer affairs group, but a dedicated antivaccinationist organization, headed by strident antivaxer Barbara Loe Fisher (see her profile in Arthur Allen’s book Vaccine). I highly doubt the legitimacy of any study they released, especially if it’s based on reports submitted to the VAERS database.

It bears repeating that the VAERS database is a collection of raw reports of signs and symptoms occurring in people around the time they got vaccinated. Antivaxers jump on these reports as “proof” that vaccines are responsible, ignoring the later findings that most cases turn out to have no demonstrated link to vaccines (including the deaths supposedly attributable to Gardasil).

As I’ve said here before, I’ve had doubts about the wisdom of mandating Gardasil for young girls, basically on a cost/effectiveness basis, plus such a requirement stirs up the crowd that thinks the vaccine encourages illicit sex, as well as antivaxers who’ll accept allies wherever they find them. I do think it will be increasingly valuable to have good anti-HPV vaccines; for one thing there’s evidence that a substantial number of oral cancers are being linked to HPV infection in people who don’t have the other typical risk factors for the disease (i.e. smoking).

10

But there is no such growing evidence. Read the article again. 9700 adverse event reports for 16 million vaccinations; only 6% of those adverse events were serious. That means that .00036% of all Gardasil vaccinations were followed by a serious adverse event. And as the article points out, any adverse event which occurs after a vaccination is reported whether there is any reason to think it is caused by the vaccination or not. Post hoc does not mean propter hoc.

And you have to do the math in the other direction: how many of these 16 million kids would die of cervical cancer were it not for the vaccination? Anti-vaxxers never do this calculation. I suspect that even if all the worst fears of the anti-vaxxers were true (which of course they are not) vaccination would still prove to be an overwhelming public health benefit based on a cost-benefit analysis.

11

Jackmannii, I do not believe that any states currently mandate its use. Texas had passed a mandate and then backed out of it and it died in all the other states considering it I thought.

I think we agree that this vaccine is no MMR. I’ll spend much energy trying to wear an MMR refuser down; this one not so much. But that doesn’t stop me from getting annoyed at obvious disinformation. No denominator but implying that the rate of events is different. What crap.

Sophistry, in fact there were reasons to believe that many of those adverse events had other causes -

Oh yeah, Gardasil caused the drug use and the pre-existing seizure disorder.
:rolleyes:

12

Per your cite there are 16 people with no cause of death. And the idea that blood clots are OK if they can be blamed on other drugs, such as birth control pills does not separate out the compounding effect that may be involved.
**
… Deaths … Of the 27 U.S. reports:

[del]* 3 reports were related to diabetes or heart failure[/del]
[del]* 3 reports were related to viral illnesses or meningitis (an infection in the brain) [/del]
[del]* 2 reports were related to drug use[/del]
[del]* 2 reports were related to blood clots[/del]

  • 5 reports are being evaluated (attempting to follow up/identify case)
  • 1 report is still under review or VAERS is still waiting for additional medical records, such as an autopsy report or death certificate
    [del]* 1 report of seizure disorder (history of seizures) [/del]
  • 3 reports had an unknown cause of death
  • 7 reports that could not be evaluated because they did not have enough information to identify the person, or to verify that a person had died**

I’m not proposing a ban on the drug but there is no reason to endanger 11 year old girls with this drug.

13

What about endangering 11 year old girls by not giving them this drug? 16 unknown causes of death out of 16 million treated is a very small number, and cervical cancer affects a heck of a lot more than 1 in a million. Heck, even granted that cervical cancer is usually treated in time, I’d lay long odds that the death toll from it is still well more than 1 in a million. And even that’s assuming that every single one of the unknown causes of death really is due to the vaccine, when there’s not one single death known to be caused by it.

14

Those are just deaths, not side effects. Some of the side effects are serious. This is a sexually transmitted disease and the risk to an 11 year old is different than the risk to a 16 year old.

I’m not discounting the potential for the drug. Even if it turns out to be dangerous on a low level it is worth identifying those at risk. It may turn out that it significantly raises the risk of blood clots when combined with birth control. Pretty simple thing to rectify for the time it takes for all the shots to be administered. Many drugs have interaction problems and that’s not a deal breaker but it alters the use of the drug.

15

I don’t vaccinate at all, so no.
I’ve spent about 16 years researching the subject (in medical journals, textbooks, product inserts, other such sources).

One of my concerns with this one (and with some others, esp. hep B) is changes in epidemiology down the road as a result of widespread use.
Duration of vaccine-induced immunity is unknown with a new vaccine (at least beyond a certain, limited point) and vaccine-induced immunity is typically much less than the immunity induced by exposure to/infection with the naturally occuring organism.

As with hep B, another mainly sexually transmitted infection for which the vaccine is being administered to the very young and those at lowest risk of exposure, when immunity wanes (not if, WHEN, based on all we know about vaccines and immunology) in say, 20 years, the recipients will be left with no natural immunity to protect them, and at a time when their risks of exposure are greatest. (adulthood when they are sexually active, and in the case of hep B, at risk of passing the infection on to their infants at birth, when the risks of serious complications, for the infant, are highest).

Ok, so we’ll just give a booster. No problem. Wrong. The reason hep B is administered to infants and children is that the approach of vaccinating adults, esp. those in high risk populations, was tried and failed miserably. (as it tends to compared to mandatory vaccination of infants and children…you cannot force an adult to be vaccinated in most cases, and uptake tends to be far below the threshhold necessary for “herd” immunity).

The same problem does and will exist with HPV vaccine.

FTR, I base my claim of the reasoning behind the hep B mandate on records from CDC meetings and statements made by scientists involved. Other rationales are put forth as well, but they are minor compared to the issue of uptake.

The vast majority of women exposed to HPV clear the infection from their system quickly and gain immunity to reinfection, probably for life. (same as with hep B)
The vaccine will prevent (or is intended to, anyway) infection and the development of natural immunity, resulting in millions of adult women lacking immunity to this very common organism(s) at a time when they will tend to be at much higher risk for exposure/infection and the complications sometimes involved.

I agree with the OP that too little is yet known about this vaccine, not only its safety for the individual recipient at the time but about its effect on the epidemiology of this infection, a much more serious concern.

16

16 million VAERS reports. A report is defined as an event occuring within the week. That’s 16 million weeks. 307,692 teen years. In that amount of teen years we’d expect about 225 kids to die of some cause or another. (Mortality rate for teens in America is about 75/100K/yr.) The VAERS number is less than 15% of that. One should logically conclude that Gardasil is protective, eh?

The way in which this vaccine bashing group used the data is not the way the data set is designed to be used. (Of course neither was what I just did, but it makes at least as much sense.)

17

It’s also important to note that the VAERS system was designed and implemented with the goal of keeping cases out of the courts (and so discouraging not only litigation but the proving of causation and setting of precedents.)

VAERS has never acknowledged causation, even when it has awarded damages. This is a primary function of the system…plausible deniability. It was instituted more to protect the vaccine industry (who largely funds it through surtaxes on their products) than the public.

Hence, despite a previously healthy child ending up a profoundly retarded paraplegic immediately following her 3rd dose of DPT, following 2 progressively more serious reactions to the product, over 50 years of data supporting the rare occurance of such side effects, the testimony of several Drs. and scientists that the vaccine caused her injuries, and the award of a large sum to her for her lifelong care, the official position of VAERS (and those who parrot the party line) is that no causation is proven/ exists. (An actual case involving someone I know personally).

If cases like this were allowed to end up in court, the vaccine makers would face many more and much more costly settlements.

While I feel it is important to report all vaccine reactions or suspected reactions (and reliable estimates are that the vast majority are never reported), VAERS does not exist to protect the public or impartially investigate vaccine safety. It exists to shield the vaccine industry (and to a lesser degree government) from liability.

18

Yeah, one potential epidemiological consequence of widespread use is herd immunity. Which is why even though free riders like you don’t vaccinate, your kids still don’t get polio, smallpox, rubella, mumps, etc., etc., etc., etc., etc., etc. You can thank the rest of us any time you want.

19

Yes, because if B follows A, then B is caused by A. :rolleyes:

Even if we grant your ill-founded claim that Gardasil caused this tragic event, you are ignoring (as I mentioned above that anti-vaxxers always do) the benefits of vaccination. Suppose some people suffer terrible death as a result of Gardasil. Guess what? Cervical cancer is pretty shitty too. How many people are spared that death as a result of the 16 million Gardasil vaccinations? You can’t just tally up the (supposed) costs of vaccination; any cost-benefit analysis must also, you know, weigh the benefits.

If people like you were more common, we’d still be fighting polio in the US. (It’s because of people like you that polio hasn’t been eradicated yet world-wide.)

20

what is the benefit of this vacine to an 11 year old? Same question for Hep-B? these are transmitted diseases with known transmission paths.