Gardasil's safety compared to placebo may be exaggerated.

[pnwmom]

According to the National Vaccine Information Center, the new HPV vaccine contains 225 mcg of aluminum. In clinical trials, the researchers were allowed to use a placebo that also contained aluminum, instead of the usual non-reactive saline solution. This could have affected the comparison of side effects in the two groups, if some members of the placebo group had reactions to the aluminum.

On a personal note, an extended family member had the vaccine today. The nurse who gave her the shot failed to read the medical information the young woman provided on the consent form. It was only after giving her the shot that the nurse noticed that she had a history of epilepsy, was taking medication for it, and shouldn't have been given the vaccine. Now we wait.

http://www.inciid.org/article.php?cat=cancer&id=433

The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo.<1> A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.<2>

Animal and human studies have shown that aluminum can cause nerve cell death <3> and that vaccine aluminum adjuvants can allow aluminum to enter the brain, <4 5> as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. <6 7> Nearly 90 percent of Gardasil recipients and 85 percent of aluminum placebo recipients followed-up for safety reported one or more adverse events within 15 days of vaccination, particularly at the injection site.<8> Pain and swelling at injection site occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. <9 10> Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

[rinsd]

1. Going to the NVIC for vaccine is akin to the Family Research Council for TV standards

They are both advocacy groups pure and simple

[HiFructosePronSyrup]

2. And hey...

I'm sure both make up bullshit about how the vaccine is unsafe.

[Horse with no Name]

3. Isn't this same poster who posted incorrect info about the American

Academy of Pediatrics and refused to acknowledge it?
IN-Credible.:eyes:

[HiFructosePronSyrup]

4. Yup.

And that sort of things not isolated to the HPV vaccine, unfortunately.

[pnwmom]

22. Own any Merck stock, perhaps?

I acknowledged that you were correct, after you pointed out to me that the Baltimore Sun reporter hadn't included a quotation to back up the assertion about Pediatrics. I don't know what else you expected me to do.

Something tells me you have your own horse in this race.

[iverglas]

33. hahaha -- oh, oops, that one's been done

Nice try though. How's it go? If you don't have an argument, resort to the FALSE personal attack?


Something tells me you have your own horse in this race.

Hey ... I'll bet Merck has a drug for those voices you seem to be hearing ...

[rinsd]

7. What can yousay? Bozell's "reputation" precedes him

;-)

[pnwmom]

21. Seems odd to be so trustful of the drug industry and the FDA.

Knowing the numbers of drugs that are recalled each year due to safety concerns that are only discovered when they're released to the general public.

[pnwmom]

20. And the current Bush FDA is the fox garding the hen house.

But if you want to give absolute trust the the FDA and Merck's researchers, go ahead.

[pnwmom]

43. The NVIC is responsible for our having informed consent

with regard to the vaccines we give to our children. Do you have a problem with that?

http://www.909shot.com/About.htm

The oldest and largest national organization advocating that vaccine safety reforms be instituted in the mass vaccination system and that Americans be free to make informed vaccination choices, NVIC's co-founders worked with federal legislators to help create and pass the National Childhood Vaccine Injury Act of 1986. This law set up a vaccine injury compensation program and included legal requirements for vaccine providers to: (1) provide benefit and risk information to parents before children are vaccinated; (2) keep written records of vaccine manufacturer names and lot numbers for each vaccination given; and (3) report adverse events following vaccination to the government. The law also preserved the right for vaccine injured persons to bring a lawsuit in the court system if federal compensation is denied or is not sufficient. By 2004, the U.S. Court of Claims had awarded over 1,200 vaccine victims $1.5 billion dollars for their catastrophic vaccine injuries.

NVIC's co-founders have represented consumers on vaccine advisory committees such as the Advisory Commission on Childhood Vaccines, the National Vaccine Advisory Committee and the Institute of Medicine's Vaccine Safety Forum. In 1989, the organization held an International Scientific Workshop attended by eminent epidemiologists, neuroimmunologists, molecular biologists, bacteriologists and neuropathologists to evaluate the neurological complications of pertussis and the whole cell pertussis vaccine. In 1996, NVIC realized a major goal when, after 14 years of public advocacy work, the FDA finally licensed a purified pertussis vaccine (DTaP vaccine) for American babies.

[GeorgeGist]

5. From a scientific standpoint...

the inclusion of aluminum in the placebo is a BETTER control than saline. BTW I have a PhD in Immunology and practiced clinical immunology for 30 years.

[TZ]

9. nice to hear from someone who is knowledgable

FYI- I had someone argue with me on a similar thread about how aluminum causes alzheimers. I don't why this stuff keeps getting posted. Vaccines to me are a wonderful thing in general. Don't really understand the stubborness in repeating this argument over and over. Reinforces my tagline really.

[pnwmom]

23. Could you explain that please?

[hlthe2b]

6. Despite its seemingly officious name, the NVIC

National Vaccine Information Center IS NOT a governmental or academically-based site. It is a private anti-vaccine website and like many think tanks, especially those we are familiar with on the RW, some of what it puts out has elements of truth. However, these intermittent tidbits of truth reel many in, only to unquestioningly accept the remaining blatant propaganda.


No drug, no vaccine is 100% safe. No medical professional, no public health expert will argue that. But starting with THAT premise, they (NVIC)do everything possible to essentially argue that all vaccines are unacceptable..

Sadly, statistics can be manipulated.

[bleedingheart]

8. have you ever thought that the anti-vaccine folks may be

proposing a form of population control without actually stating it aloud?

Imagine a world without vaccines.

I doubt the world population would be where it is today.

However that said, I am glad that there are vaccines. My daughter caught whooping cough (pertusis) even though she had been vaccinated because an unvaccinated child had brought it to the daycare center. My daughter, an asthmatic, nearly died because of it.

[TZ]

10. what scares me..

is what will happen if bird flu becomes a pandemic and a lot of these anti-vaccine folk who are very stubborn refuse to get a vaccine. That could be a disaster for many.:scared:

[hlthe2b]

12. Laughably... some of these same people go to the other extreme.

A few years ago, after the anthrax scares, my phone rang off the hook at work from members of the worried well public inquiring about obtaining anthrax vaccine licensed for use in CATTLE and injecting their own family members! In fact the FBI arrested at least one "capitalist" who thought they'd exploit the fear, with a trunk load of veterinary vaccine in his trunk destined for human distribution on the black market.

[pnwmom]

27. You're seriously going to compare a bird flu vaccine and

a vaccine for a disease that isn't spread through casual contact?

I get a flu shot every year. I'm not a anti-vaccine fanatic. I just think this drug could have been tested more before states started to mandate it.

[hlthe2b]

11. I teach classes on previous epidemics and disease control

My students are always shocked when I present the dramatic evidence of parents DEMANDING, neah, BEGGING for a vaccine for polio and the March of Dimes campaign that largely propelled the effort into success. Even after the unfortunate Cutter incident, the public accepted there were risks, but that the risks far outweighed the horror of the disease and lines at vaccination sites circled city blocks. Had that not been the case, we would not have eradicated smallpox worldwide, nor would be be approaching polio elimination throughout the globe, as we have on this continent.

Our perception of acceptable risk changes over time and without the constant deadly threat of many diseases, we see many argue that NO level of risk is acceptable (ironically, while they speed through traffic in their cars, fail to buckle seat belts or wear helmets on bikes and motorcycles, pay no regard to the food they eat--or smoke). That attitude of zero acceptable risk is totally unrealistic for any vaccine or drug.

[bleedingheart]

14. my mother remembers from her childhood the kids who died

from what today is entirely preventable...

Her generation will probably be the last to remember the carnage of diseases like pertusis, mumps, measles, polio, etc...

She remembers her next door neighbor putting the tiny casket of their three year old daughter in the back seat of a cab to take it to the cemetary (they were poor and had laid her out at home as was the practice back then)...

The girl had died of diptheria.


She also remembers people not going to public pools or even venturing to movie theaters because of polio scares.

[hlthe2b]

16. There is a possibility that the public will relive that scenario...

If and when we have a worst case scenario influenza pandemic, many will helplessly see family members die at home. We simply do NOT have the health care infrastructure to deal with it. Worst, though, unlike your Mom or our grandmothers, the basic knowledge of home health care, nursing, and all that went with the "Dr. Mom" of decades past, has been lost.

[pnwmom]

28. My children are fully vaccinated except for the one vaccine

they had problems with -- the old DPT vaccine. ( I only found out that my baby sister had died of encephalitis the day after having the DPT vaccine when my mother and I had a conversation about my children's reactions. My sister's pediatrician had never told my parents -- maybe he didn't even know -- that encephalitis was a known but rare side effect of the whole cell vaccine.)

I am not anti-vaccine. We get flu shots every year. But I am cautious. We are not in a health emergency due to HPV and we don't need to make it mandatory as soon as it is released.

[iverglas]

17. "zero acceptable risk"

How right you are on that.

We do things that create the risk. No one is particularly to blame for most such things. In the case of HPV, people quite unknowingly spread the virus for all the time its existence wasn't even known, and by the time it was discovered it was widespread. It's just a fact: the things we do create risks for ourselves and others. And nobody is immune to the risks that then exist -- voluntary abstinence from sex just doesn't protect anyone against disease transmission as a result of non-consensual sex, just for example.

We pollute water, virtually by our very existence, given our numbers and concentrations, so we have to chlorinate the water we want to drink ... and then there is rebellion against the new risks created:

http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/C/Chlorination.html

The widespread chlorination of municipal water supplies has been one of the public health triumphs of the past century.

... the EPA estimates that if everyone in the U.S. drank water containing 100 ppb of THMs (compounds formed by reaction of chlorine with organic material) for their entire lives, then their chance of developing cancer (currently about 25%, representing some 500,000 cancer deaths per year) would increase by some 700 cases per year.

Claiming that they were responding to the questions raised by the U.S. EPA over the safety of THMs, officials in Peru began, in the late 80s, shutting down some of the chlorinators in the capital city, Lima, as well as in other cities and towns.

In January 1991, an outbreak of cholera began in several towns just north of Lima. Within weeks the epidemic of this dangerous disease (the first epidemic of cholera in the Western hemisphere in a century) spread throughout Peru and eventually through much of South and Central America. Once introduced into a city, town, or village, the disease spread rapidly through contaminated, but now unchlorinated, water supplies.

By Dec. 31, 1992 — 23 months after the epidemic began,
* a total of 731,312 cases had been recorded with
* 6,323 deaths.

Do nothing just isn't really an option when we're dealing with two options that both involve risk. Doing nothing -- not having one's child vaccinated against HPV -- means exposing the child to a high risk of contracting HPV, and a very definite risk of developing conditions that lead to cervical cancer.

The risks exist, whether anyone likes them or not, and they exist for both the do-something option and the do-nothing option.

How right you are to point out how zero risk suddenly becomes the only acceptable (if non-existent) option for some people when it comes to a particular situation, while they are busy taking every variety of risk in everything else they do. Their kids are exposed to worse risks most minutes of the day, but this one (not proved and not even reasonably hypothesized as it is) just has to have the line drawn above it.

The aim is always to reduce risk. Eliminating it would be nice, but it's seldom an option.

[pnwmom]

25. Then I'm sure you realize that their is no epidemic going on

that requires this vaccine to be made mandatory as soon as it has been released to the general public. And that many drugs' adverse effects only become fully evident once they are released to the general public.

[hlthe2b]

32. Making it mandatory, only means it will be covered by VFC

under Federal funding, which likewise means private insurers and medicaid will pick it up as well. There is NO state in the US that does not have an opt out for parents--whether on religious, medical, (or in a few states, philosophical grounds).

So, now, knowing this, what exactly is YOUR reason for saying you would prefer young girls NOT to be offered the chance to protect themself from the viruses that account for 70% of all cervical cancer? Hmmm? YOU do not know better and DO NOT get to decide for all the young girls (and eventually adolescent boys) at risk in this country.. You can decide to let your daughter remain at risk, if you so desire.

[pnwmom]

36. Making it mandatory will mean that many more girls will be the

guinea pigs in the first year of its release.

From the Baltimore Sun:

http://www.baltimoresun.com/news/local/politics/bal-te.md.cervical29jan29,0,2725203.story?coll=bal-mdpolitics-headlines

(Note: Dr. Myers, who says he is "wildly enthusiastic" about the vaccine -- but who doesn't recommend making it mandatory -- is the director of a PRO vaccine web site)

"A lot of us are worried it's a little early to be pushing a mandated HPV vaccine," said Dr. Martin Myers, director of the National Network for Immunization Information. "It's not that I'm not wildly enthusiastic about this vaccine. I am. But many of us are concerned a mandate may be premature, and it's important for people to realize that this isn't as clear-cut as with some previous vaccines."

He added, "It's not the vaccine community pushing for this."

http://www.immunizationinfo.org/

About NNII

The mission of the National Network for Immunization Information (NNii) is to provide the public, health professionals, policy makers, and the media with up-to-date, scientifically valid information related to immunization to help them understand the issues and to make informed decisions.

Our Mission
The National Network for Immunization Information (NNii) is an affiliation of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, the American Academy of Pediatrics, the American Nurses Association, the American Academy of Family Physicians, the National Association of Pediatric Nurse Practitioners, the American College of Obstetricians and Gynecologists, the University of Texas Medical Branch, the Society for Adolescent medicine and the American Medical Association.

[bleedingheart]

38. well there is also no mandatory law that forces people to inform partners

of their infectious STD's.

One of my best friends from college got genital warts from one of her very first sex partners (a guy she thought she was in love with) and when she went to tell him about her infection...he knew he was infected but had not sought treatment because he was ashamed and then assaulted her when she pressed him to do so...

Now she goes for her pap smear every year fearing that one day she will end up with a cervical cancer diagnosis.

Perhaps some young women out there will be saved from what my friend went through.

[pnwmom]

41. I hope that this is a wonderful vaccine.

But I don't think it should be pushed on MILLIONS of young girls by making it mandatory right after release. Better to release it, follow it carefully for serious adverse effects -- and then make it mandatory, after it is proven safe.

Every month or so we hear about some big, important, new drug that has just been pulled from the market because it turned out not to be as safe as everyone thought. Why can't we wait awhile to make sure that Gardasil is as safe as the smaller studies predict, before we inject it into millions of schoolchildren?

[ProfessorGAC]

13. An Interesting Theory

Don't know if you're right or wrong, but it certainly is something to consider as a motivation.
The Professor

[HiFructosePronSyrup]

15. I don't think so.

I believe the antivaccine folks are sincere. Loony, but sincere.

[jsamuel]

18. I think there may be a broad brush problem here.

For example, I am in general for vaccines. However, my cat died from one, directly. So, I have decided to be more cautious about which vaccines are absolutely necessary and which aren't. Also, I am concerned about any drug or medical procedure which has not been tested for at least 5 or preferably 10 years since that is the amount of time that it takes to determine what long term side effects are associated with the drugs. Why is that loony?

[hlthe2b]

19. There is a dramatic difference between informing oneself

and weighing risks/benefits either armed with full and unbiased information, or in consultation with your health provider (who we assume is well-informed) in making a decision versus what we are witnessing.

What I believe is underlying most of the controversy in the many related threads, is this notion that NO VACCINE produced by Merck (or others) could possibly be safe, effective, appropriate, just because we do not trust the profit motivations of BigPharma. The broad brush then is extended to the entire medical, academic research, public health-epidemiology communities. Because clearly, if the latter is in support of this vaccine, then we ALL must be part of the conspiracy...?

[pnwmom]

31. That is absolutely not my contention.

As I said, my children are fully vaccinated, except for the old DPT that they had to stop taking. And every year we get our flu shots.

But I weigh the risks and benefits of each vaccine separately. For instance, my oldest child developed a painful reaction to the "live" oral polio vaccine -- painful, but not life threatening. I tried to find a injectable version for her to have instead, but it wasn't available anywhere. When my son came along, he had the same reaction. My doctor was still promoting the oral vaccine -- he had lots of arguments about "herd immunity" -- but I was finally able to find the injection at the county health department. By the time my third child was born, the medical community had made a complete about face. They dropped completely all the arguments for the oral vaccine, and now wanted all children to have the injections of the killed vaccine -- the same one I'd been begging for all along.

In the case of Gardasil, I think that many people ARE being spun by the huge media campaign. We aren't in the middle of a public health emergency, and there is no overwhelming reason to make the vaccine mandatory before we have more information on adverse effects -- which will be coming in as the drug is released.

Some have argued that it won't be covered by insurance or medicaid unless it is mandatory. That can be handled on a state level. My state, Washington, has already decided to make the vaccine available for free, but not to make it mandatory. I think we should be cautious about arguing that we need to make it mandatory so lower income girls can receive it. That also means that lower income girls are more likely to be the victims of any adverse effects that are discovered during the post release period.

[hlthe2b]

34. Where to start?

or should I even try.. It is so obvious you have shut yourself off from any explanation or discussion that runs counter to your preconceived notion. Start with the fact the oral polio vaccine continues to be the vaccine used in those parts of the world that are still struggling to elimante polio. Why? Because it confers the most broad spectrum protection (both enteric and humoral) necessary when polio continues to circulate. Yes, there is a slight risk of reversion to active polio virus, which is why industrialized countries that had already achieved elimination status could and should revert to using only the killed form, i.e., the injectable form. WHile it confers slightly less protection, even the extremely rare 8 cases per year of infection from oral polio vaccine that were seen in this country were rightly deemed too much risk when the risk of natural polio infection was so low.

Should you ever have to go to India, Bangladesh, parts of Africa, where we have not yet fully eliminated polio, however, you would be far better off having had the oral form. In fact knowledgeable overseas travelers struggle to obtain it, since we no longer have it routinely available in this country,,

Having said that, I will just let you continue.. You don't understand how the approval processes nor the recommendation processes work. But, I am too tired tonight to get into that with you. Perhaps someone else will, although I doubt you will listen.

[pnwmom]

37. It makes complete sense that a knowledgeable traveler to certain

countries might want to get the oral form of the vaccine. That doesn't mean that the injectable shouldn't be the preferred choice here, as you agree. In fact, with my second child, since my doctor still was promoting the oral vaccine, we agreed that he would have the injection first, to build his immunity, and then the oral vaccine.

You also agree that 8 cases of year of polio as a result of the polio vaccine were too many. That was the SAME situation that was in effect when my oldest had her oral vaccine, but at that time the medical community was convinced that it was acceptable to have those cases. I argued that if the ONLY polio cases that were occurring in this country were due to the live polio vaccine itself (and had been for a number of years), then surely the killed vaccine offered adequate protection. And sometime between the births of my first and last child, the medical community made an about face and agreed with my position.

I have no idea how you can claim that I have shut myself off from any idea that threatens my "pre-conceived" notion. I am not an anti-vaccine person. I'm an informed consent, examine-the-risks-and-benefits-of-each-vaccine-separately-person. You, on the other hand, seem to take an all or nothing approach.

[pnwmom]

29. I'm not an anti-vaccine person. My children are fully vaccinated,

except for the one vaccine they had problems with (the old DPT vaccine, which has now been replaced by a much safer split cell vaccine, thanks in large part to the efforts of the NVIC).

But I am a big-business skeptic. And a Bush FDA skeptic. And I am aware that anyone who takes a new drug or vaccine soon after its release is one of the research subjects, since the FDA now relies more heavily than ever on collecting post-release data to determine the safety of new drugs.

[HiFructosePronSyrup]

35. You accused somebody up thread of owning Merck stock.

So it appears you're into paranoia and conspiracy theories.

:shrug:

[pnwmom]

40. I didn't accuse, I asked.

Let's assume that poster doesn't own stock in Merck. It's still an issue we should all be aware of. How do you know that some of the strongest proponents of drugs and vaccines on these boards aren't industry representatives or otherwise financially entangled with the pharma industry?

[pnwmom]

26. And my sister died from the old DPT vaccine. Thanks to NVIC, we have

a better vaccine nonw.

She developed encephalitis within a day and died. Several of the cousins in our family also had seizures and other extreme reactions. Thanks to the efforts of the NVIC, the FDA and CDC prodded the drug companies to develop the safer split cell vaccine that is used now.

[bleedingheart]

39. there is always room for improvement as technologies change

and as we learn more...but that is entirely different from preaching against vaccinations...

[pnwmom]

42. I'm not preaching against vaccinations in general.

I preach for informed consent and reasonable caution.

In this case, I think it's reasonable to wait until this vaccine has been out in the market for a while before we make it mandatory. Cervical cancer deaths are only 1% of cancer deaths in this country. We have pap smears and there's no emergency. Why can't we wait to make sure that there are no unexpected risks once the drug is being used on the larger population?

Already, we can see issues that have come up that didn't come up in the controlled studies. For instance, some doctors are administering this vaccine along with other vaccines, and the safety of the HPV was never studied under those circumstances. Also, there is the factor of user error. What happened to my relative, for example, when the nurse mistakenly gave her the vaccine BEFORE she read the medical history form. If there is a pattern of mistakes that occur like this, then changes can be made in the protocol to protect girls with epilepsy -- for example, maybe the doctor or nurse should be advised to specifically ask whether they have epilepsy or what other medications they are taking. Wouldn't it be better to work out any of these "kinks" (assuming that's all that occurs) on a smaller segment of the population BEFORE we declare the vaccine mandatory and inject it into millions?

[pnwmom]

24. This organization is why we all sign consent forms now before vaccines.

I wish it had been around BEFORE my sister had a DPT vaccine and died from encephalitis, a known but then unpublicized adverse effect.

http://www.909shot.com/About.htm

[pnwmom]

30. I didn't edit fast enough to include this, from the NVIC website:

The oldest and largest national organization advocating that vaccine safety reforms be instituted in the mass vaccination system and that Americans be free to make informed vaccination choices, NVIC's co-founders worked with federal legislators to help create and pass the National Childhood Vaccine Injury Act of 1986. This law set up a vaccine injury compensation program and included legal requirements for vaccine providers to: (1) provide benefit and risk information to parents before children are vaccinated; (2) keep written records of vaccine manufacturer names and lot numbers for each vaccination given; and (3) report adverse events following vaccination to the government. The law also preserved the right for vaccine injured persons to bring a lawsuit in the court system if federal compensation is denied or is not sufficient. By 2004, the U.S. Court of Claims had awarded over 1,200 vaccine victims $1.5 billion dollars for their catastrophic vaccine injuries.

NVIC's co-founders have represented consumers on vaccine advisory committees such as the Advisory Commission on Childhood Vaccines, the National Vaccine Advisory Committee and the Institute of Medicine's Vaccine Safety Forum. In 1989, the organization held an International Scientific Workshop attended by eminent epidemiologists, neuroimmunologists, molecular biologists, bacteriologists and neuropathologists to evaluate the neurological complications of pertussis and the whole cell pertussis vaccine. In 1996, NVIC realized a major goal when, after 14 years of public advocacy work, the FDA finally licensed a purified pertussis vaccine (DTaP vaccine) for American babies.