Merck suspends Campaign to Make Gardasil Vaccination Mandatory

http://online.wsj.com/google_login.html?url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB117200727319814015.html%3Fmod%3Dgooglenews_wsj



Sorry, no more story unless you subscribe. There should be other news outlets carrying this shortly.

So far, 400 cases are officially reporting illnesses from the Merck vaccine.

Mike Papantonio says the number is lkely 10 times that. The sysmptoms range from rashes, convulsions and vascular breakdown...the 'live virus' is unstable. One 11 yr old was reported to have blood flow closing down in uterus and intestines.

Mike Papantonio said Merck sent this out in a rush job. That is suspect enough. DONT GIVE THIS VACCINE TO YOUR LITTLE GIRL.

I knew the only reason why GOP officials like the Governor of Texas would advocate such a thing was money.

Some conservative groups criticized Perry's mandate and said that Perry has received campaign contributions from Merck, the Los Angeles Times reports (Los Angeles Times, 2/3). "Follow the money," Cathie Adams, president of the Texas Eagle Forum, said, adding, "It leads to Merck." Merck in 2006 contributed $5,000 to Perry's campaign and has paid three lobbyists up to $250,000 this year, according to the Morning News. One lobbyist, Mike Toomey, formerly served as Perry's chief of staff.
http://www.medicalnewstoday.com/medicalnews.php?newsid=62388

child vaccinated, they will be able to.

If they had the tiniest of legs to stand on with this issue, the mandatory deal would have stood.

Follow the money... as always.

Edited to say I just read this in the WSJ online. Good God! $360!!! For three shots! They must have been seeing dollar signs marching all the way to the bank!

So instead of lobbying to pass laws maybe they just get governors to dictate executive orders???

Then they can quietly proceed with their plans with the discreet and tenacious help of their powerful friends.

or call off inhouse lobbyists.

I think they were getting too much adverse publicity and felt they needed to say something.

Thanks to all who spoke up against fascist mandates from governors.

time around. This is a very hot button issue---some of us here might even agree with fundies on this one.

regarding PErry's EO here in Texas. Her point was she didn't want to send mixed signals to her daughter and opting out is a bother. My point was that it was an abuse of power and parents need more say in their children's medical status, not the schools.

is that obviously our protesting pressure is working!

http://www.bloomberg.com/apps/news?pid=20601103&sid=aU9kKqclspgc&refer=us

>>
Merck & Co. will stop lobbying state officials to require that girls receive the company's Gardasil cervical cancer vaccine before they can attend school.

Merck made the decision after groups including the American Academy of Pediatrics said there wasn't enough state funding to pay for the vaccine or public acceptance, said Rick Haupt, director of medical affairs for Merck's vaccine division, in a telephone interview today.

Merck started a campaign to raise awareness of the vaccine among state lawmakers even before the drug was approved last year, encouraging them to require it for children. Merck decided in the last few days to end the lobbying effort because it had become a distraction, putting the focus on Merck rather than preventing cervical cancer, Haupt said.

``Merck's early push was not the way to go,'' said Larry Pickering, executive secretary of the advisory committee on immunization practices for the U.S. Centers for Disease Control and Prevention in Atlanta. ``We want to convince people to use the vaccine because of its benefits.''
>>

make them back down on the mandatory campaign.

DemEx

Shouldn't they be here screaming about how Merck must hate women now?

I guess the LAW took the wind out of their sails? Or do you suppose they are outraged by this judge's behavior?

:shrug:


Ahhh... concern trolls... such a caution!

And saying that is utterly dishonest-

What people in public health want is to protect womens' health against the prevailing paranoia and ignorance in America. And these threads have really boosted the case for mandates, showing me and many others that mandates will be the only way to overcome the anti-vaccine anti-science crowd on both sides of the aisle.

I reckon Merck figured it was being counter productive- which is why they withdrew support. However, other rational scientists and public health officials will keep on working hard to make sure kids get these vaccines before they enter middle school.

I hope they still campaign hard to make this vaccine availible as cheaply--or free-- to as many women as possible, myself included.

I've just never wanted it to be mandated. That is all.

anti-vaccine anti-science is utterly dishonest as well. So is calling it 'paranoia and ignorance'. If you can call me those things, then calling you 'Merck-loving' isn't all that different. You want to try to forward your agenda? Drop the insults.

it's clear enough.

Perhaps over inclusive- there are some who simply have a libertarian streak. With respect to them, one of the oldest and most basic responsibilities of government is to protect the public from the spread of preventable diseases.

This isn't a new issue:

The U.S. Supreme Court spoke to this in its landmark 1905 Jacobson v. Massachusetts ruling. The issue was whether the Commonwealth of Massachusetts could require vaccination against smallpox when the disease, one of the most feared in history, had killed hundreds of state residents without violating the individual rights guaranteed by the U.S. Constitution.

Jacobson didn't want to get vaccinated. Litigation ensued- and he lost, for reasons that should be obvious.

http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=US&vol=197&invol=11

And my libertarian streak is pretty small. I think government mandates end where my body begins, but that is not how I feel about government in general. Vaccines where I am are not mandated, and yet we have a pretty high compliance rate (Canada). I don't think forcing vaccines on people is the way to high compliance rates and disease reduction. There are other avenues, such as education, funding, ad campaigns, etc. I also understand that where you are (U.S.), mandating Guardasil means more access for certain people who cannot afford to pay the full $300+ for the series. I think that is one messed up way to get access to vaccines. But, that is just MO.

or Britain or Australia- where my friends and colleagues just shake their heads over the attitudes of Americans. The fact is that fundies- and as evidenced by these threads, many progressives, are ill informed and won't do the right thing and protect their daughters, which is why we need to require vaccines to enter school. Would that it weren't so.

As to HPV- ask a women who's had cervical cancer- or perhaps one of her SO's or survivors about the comparison with small pox. Check out Matcom's thread on point:

http://www.democraticunderground.com/discuss/duboard.php?az=show_topic&forum=389&topic_id=167184

I agree that immunizations should be heavily subsidized- if not free, as they are in countries with rational health care systems. That's a somewhat larger can of worms- and it's where most of us in public health have major problems with the likes of Merck (which did not develop this vaccine- that was largely the life's work of an Ozzie scientist) -they simply have the license to distribute it.

btw: I actually saw a commercial for the vaccine the other day- educational campaigns are important, but alone I don't think they'll get the job done. For instance, how many adults out there do you reckon are vaccinated for Hep A and B?

rush to try to vaccinate every ill away.....witness the load of vaccines that babies and children get over there. Most people here, as well as the medical world and policy makers, think we shouldn't go overboard injecting these substances into babies and children.
No religious reasons not to, nor alternative health ideas either, just the Dutch common sense attitude advocating caution here.

Here, vaccinations are free, but not required to get into schools, and what are offered and strongly urged are a fraction of what is given there. My 2 children had their vaccinations which totaled 7 shots.

As a survivor of cervical cancer 15 years ago with good medical treatment - free - I do NOT wish to see my children vaccinated with this vaccine until more testing is done and results have been obtained.

DemEx

It's taken place over MANY years- and has passed scientific muster in country after country.

Even so, I reckon you won't be signing the petition- ;-)

http://petitions.pm.gov.uk/cervicalcancer/

Although it's not set in stone yet, the UK policy will probably look like this:

UK Schoolgirls to be given cervical cancer jab

The UK Government is to devise a national programme for girls to have the world's first vaccine against cervical cancer early in the new year.

The Department of Health is likely to get school nurses to administer the jab to children and young teenagers. It may also launch a campaign to encourage girls who have left school to go to their GPs for the vaccination.

Thanks to ground-breaking scientific discoveries in the 1990s, cervical cancer is set to be the first common form of cancer that can be avoided through a simple vaccine. The disease is the second-biggest cancer killer of young women after breast cancer across the world and, in developed countries, costs health services billions of pounds in screening, surgery and medicines.

At the moment Gardasil is in the lead over Cervarix, as it has been licensed in both the US and Europe. In America public funding is available in most states. France, Germany and Italy are due to put public money behind the vaccine in the first half of next year. The British Government is set to start making Gardasil available on the NHS towards the end of next year.

http://www.natap.org/2007/newsUpdates/010207_18.htm

and this availability of the vaccine - not mandate - is a most encouraging development.

DemEx

and if so, what might the headmaster say? Curious.

I'll have to ask a friend of mine (who has two little girls- not yet near the proper age for the vaccine) what she thinks. Both she and her husband hold PhD's in molecular biology- so they're science biased- yet they've also been known to whinge about the NHS, and about what we in America call "public schools." ;-)

One thing we can all agree on though:

"the vaccine... is a most encouraging development."

So yes, I'd keep my girl out of the queu until longer studies have been carried out with safety and effectiveness against cervical cancer (not just some strains of the virus) proven.

DemEx

Something else that I have heard.

I'll let you know when I get hold of my friends- My guess is that they'll have a different take on the matter than yours.

against mandates ordering children to have vaccines?
LOL..
Lots of people have different takes on this matter - no need to hunt up your friends.

:hi:

DemEx

The NHS sends letters out to to families for check ups for each child in the UK at specific intervals and parents take them into their GP's. Among other things, vaccinations are given per schedule. Certain things are done at school, where kids get things like hearing and vision tests- or vaccinations.

Again, a perfunctory letter is sent out maybe a week before- but there's no "opt out" clause or anything like that. It's just assumed that people want to take care of their kids, although my friends reckon someone could decline, almost no one does.

Because there are major public health information campaigns, and because it's a "social norm" (people generally trust science) kids queu up, get their jabs, without any hue and cry. Herd immunity is built up for almost all of the preventable diseases on the Island. With HPV, of course, herd immunity will take decades to develop, because so many adults and teens are already infected.

One exception that they noted was the MMR vaccine, which some people decided to do separately; Mumps at one time, Measles at another and rubella at another. You have to pay to do that- and so some who were concerned about the 3 in 1 vaccine didn't treat their kids, which resulted in sporadic outbreaks of disease (i.e. insufficient herd immunity built up in certain regions).

Americans have no such social norm- as we can see from the right and from the left sides of the aisle, all too many people have little respect for science. They don't understand or trust the international testing and approval processes. They think "oh, we need even more testing and study (as if any amount will be enough- kind of like global warming) or they'll give some other less than rational reason to withhold protection for their children.

Some, like a particular poster on this thread, will twist and obfuscate the science- and try to perpetrate and spread unfounded paranoia.

Because this is so prevalent in American, we need mandates whereas the British citizens do not. Why have a mandate when damn near everyone does the right thing as a matter of course? The least intrusive means of carrying out a mandate is to deny entry into school unless you can show a valid vaccination- or produce a titer showing that you have immunity to a particular disease. I had to do this for rubella before I was admitted to grad school.

Some people felt that even this was too "intrusion" and were none too pleased about it. However, back in the 80's, there were several epidemics of rubella that went around college campus'. Along with being very unpleasant (particularly for adults) this disease is extremely dangerous to pregnant women- it causes horrendous birth defects.

So, mandates were required to prevent the spread of rubella- just as they NEED to be required to prevent the spread of HPV and resulting cervical cancers.

From here:

http://www.phac-aspc.gc.ca/tmp-pmv/2005/rubella050517_e.html



Since September 01, 2004, the Netherlands have recorded 299 lab confirmed cases of rubella including 22 cases in pregnant women. This represents a sharp increase when compared to the annual average of five cases from 2000 to 2003. Of the infected, only one had been vaccinated against rubella in the past; most cases (93%) had declined vaccination on the basis of religious beliefs.


In the last couple of years, the minute handfull of cases in the US (less than twenty, if I recall - care to compare populations of the two countries?) have all been traced to unvaccinated foreigners. I suspect many of the cases in the Netherlands are for the same reason.

95 % take part in the program.

I see that several have been added since my children were young too:

http://www.euvac.net/graphics/euvac/vaccination/netherlands.html

http://www.vaccineethics.org/labels/Gardasil.html

More on Texas HPV vaccine mandate backlash

There continues to be a tremendous amount of coverage of Gardasil in the media, most of it focused on reaction to Texas Gov. Rick Perry's nearly-three-week-old executive order rather than the vaccine itself, HPV, or cervical cancer.
Saturday's New York Times wrote about the "Furor on Rush to Require Cervical Cancer Vaccine." The story's premise:

"But a roaring backlash has some health experts worried that the proponents, including the vaccine's maker, Merck, have pushed too far too fast, potentially undermining eventual prospects for the broadest possible immunization."
Syndicated columnist Clarence Page writes, "Don't judge cancer vaccine by Austin political fallout," attempting to encourage the public to distinguish the political controversy created by Perry's actions from the merits and potential benefits of the vaccine itself. He argues,

"With emotions heated up, a lot of misinformation and unnecessary anxieties already are being stirred up over the new vaccine. The least grounded appears to be the fear that it will encourage more sexual activity outside marriage. Our society unfortunately has many larger reasons for that and it is a worthy debate for another time.

For now, Gardasil appears to be a very important and welcome life-saving step forward in the fight against cancer. Don't judge it by the political confusion it has caused."


For an example of emotions heated up, take a glance at this political cartoon at Newstarget.com.

A few more op-eds of note: In Newsday, Marc Siegel writes in favor of broad vaccination (though not explicitly addressing the question of mandates). In the Atlanta Journal-Constitution, Former Rep. Bob Barr writes against mandates, in part:

"None of these concerns will likely deter the legion of Big Government types out there who — allied with the many do-gooders populating state legislatures from California to New York, and prodded by companies willing to spend millions to make billions — will allow nothing to stand in the way of 'good government,' whether the people want it or not."

As far as news goes, the latest in Texas is an effort in the state legislature to effectively reverse Perry's executive order. According to this story, a hearing on the topic yesterday went well into the night. The Houston Chronicle has more.
Finally, the Arts and Leisure section of Sunday's New York Times took a closer look at the visual and creative elements of Merck's "One Less" television commercial.

Labels: Gardasil, HPV, Mandates, Merck

i've added it to my other store of info re: gardasil.

GARDASIL was tested on less than 600 girls under 16 in total.

The Facts About GARDASIL

1. GARDASIL is a vaccine for 4 strains of the human papillomavirus (HPV), two strains that are strongly associated (and probably cause) genital warts and two strains that are typically associated (and may cause) cervical cancer. About 90% of people with genital warts show exposure to one of the two HPV strains strongly suspected to cause genital warts. About 70% of women with cervical cancer show exposure to one of the other two HPV strains that the vaccine is designed to confer resistance to.

2. HPV is a sexually communicable virus. It is not contagious without prolonged skin to skin contact. When you consider all strains of HPV, over 70% of sexually active males and females have been exposed. A condom helps a lot (70% less likely to get it), but has not been shown to stop transmission in all cases (only one study of 82 college girls who self-reported about condom use has been done). For the vast majority of women, exposure to HPV strains (even the four "bad ones" protected for in GARDASIL) results in no known health complications of any kind.

3. Cervical cancer is not a deadly nor prevalent cancer in the US or any other first world nation. Cervical cancer rates have declined sharply over the last 30 years and are still declining. Cervical cancer accounts for less than 1% of of all female cancer cases and deaths in the US. Cervical cancer is typically very treatable and the prognosis for a healthy outcome is good. The typical exceptions to this case are old women, women who are already unhealthy and women who don't get pap smears until after the cancer has existed for many years.

4. Merck's clinical studies for GARDASIL were problematic in several ways. Only 20,541 women were used (half got the "placebo") and their health was followed up for only four years at maximum and typically 1-3 years only. More critically, only 1,121 of these subjects were less than 16. The younger subjects were only followed up for a maximum of 18 months. Furthermore, less than 10% of these subjects received true placebo injections. The others were given injections containing an aluminum salt adjuvant (vaccine enhancer) that is also a component of GARDASIL. This is scientifically preposterous, especially when you consider that similar alum adjuvants are suspected to be responsible for Gulf War disease and other possible vaccination related complications.

5. Both the "placebo" groups and the vaccination groups reported a myriad of short term and medium term health problems over the course of their evaluations. The majority of both groups reported minor health complications near the injection site or near the time of the injection. Among the vaccination group, reports of such complications were slightly higher. The small sample that was given a real placebo reported far fewer complications -- as in less than half. Furthermore, most if not all longer term complications were written off as not being potentially vaccine caused for all subjects.

6. Because the pool of test subjects was so small and the rates of cervical cancer are so low, NOT A SINGLE CONTROL SUBJECT ACTUALLY CONTRACTED CERVICAL CANCER IN ANY WAY, SHAPE OR FORM -- MUCH LESS DIED OF IT. Instead, this vaccine's supposed efficacy is based on the fact that the vaccinated group ended up with far fewer cases (5 vs. about 200) of genital warts and "precancerous lesions" (dysplasias) than the alum injected "control" subjects.

7. Because the tests included just four years of follow up at most, the long term effects and efficacy of this vaccine are completely unknown for anyone. All but the shortest term effects are completely unknown for little girls. Considering the tiny size of youngster study, the data about the shortest terms side effects for girls are also dubious.

8. GARDASIL is the most expensive vaccine ever marketed. It requires three vaccinations at $120 a pop for a total price tag of $360. It is expected to be Merck's biggest cash cow of this and the next decade.

These are simply the facts of the situation as presented by Merck and the FDA.

Sources -

Merck and the FDA: http://www.fda.gov/cber/label/hpvmer060806LB.htm

NY Times: http://tinyurl.com/2cyzsj

News article about alum injections causing neural death in mice: http://www.straight.com/article/vaccines-show-sinister-side

Published, peer reviewed medical paper about alum injections causing neural death in mice: http://tinyurl.com/3xhtdz

rush to try to vaccinate every ill away...

So what do YOU propose we use to fight HPV? Vitamin C? Acupuncture?

Ah, I pine for the good old days of smallpox.

and more testing of this vaccine for those who want more longterm evidence of safety and efficacy.

Offer these to whoever wants them, but no mandatory jabbing.
As I said above, vaccinations are not mandatory here, but my children are vaccinated with the basic 7 or so series of shots.

I have read that US babies have series of 24 shots before their second birthday.
This has to remain a choice IMHO.

DemEx

Enjoying the NHS, I reckon that you may have forgotten the state of health care in America.

btw: here's the childhood vaccination schedule through age 6. I think you'll find that far fewer jabs are required than you've heard:

http://www.cispimmunize.org/IZSchedule_Childhood.pdf

What do you think has been reducing US cervical cancer rates by about 4% a year for the last 30 years before GARDASIL?

There is a very strong connection with rejecting modern scientific advances with a complete lack of understanding of modern science. You may not be one of these individuals, but there have been some frightening threads that were filled with flat-out misconceptions and wrong information.

of modern science simply because one opposes vaccines in general. And 'wrong information' in this debate is extremely subjective.
The problem with this debate is there is no middle ground to search for information. ALL the information is either produced by the pharm companies, or the vaccine-injured children advocacy groups. Both, obviously, have a lot riding on their view being accepted. But it makes it extremely difficult for those of us who want hard core scientific research on which to base our decision. The closest you can usually get is the package insert, and that is written by the pharm company. There is a scarcity of large double-blind studies. There is no where to go for a good modern analysis of risk vs benefit for each individual vaccine and the disease it is supposed to prevent. It leaves some people struggling to research on their own, and often it's easy to fall on one side of the argument or the other and it becomes an ideological struggle, which is what seems to be going on in these threads.

it becomes apparent just how threatened some people are when you approach their sacred cows.

You're a friggin' creationist for crying out loud.

Talk about totally dishonest.

no proven safety or efficacy track record and no proven clinical benefits against cervical cancer contraction rates that was only clinically tested on a couple hundred preteens -- its targeted population for three mandatory injections?

Both GARDASIL and annual HPV screenings are very expensive on a cost per year of life gained basis. However, there is a big difference between annual HPV screenings and GARDASIL and that is that annual HPV screenings have actually been DEMONSTRATED to reduce cervical cancer contraction and mortality rates. In contrast, medical cost vs. benefit models that consider GARDASIL plus biennial or triennial HPV screenings are based on a slew of currently unproven hopeful assumptions about GARDASIL.

So we are confronted with a dilemma:

1) If we cross our fingers about GARDASIL, rush to make GARDASIL vaccination mandatory and back off to biennial or triennial HPV screenings, we may be able to save a little on costs overall while reducing the already low US cervical cancer cancer contraction and death rates very slightly.

2) Alternatively, we can keep doing HPV screen tests annually for every US woman with a first class health plan and extend these tests to uninsured women as well, resulting in a definite further decrease in US cervical cancer rates. In this case, GARDASIL's cost per year of life gained (even with all assumptions tweaked to the best case for GARDASIL) becomes stratospherically high. Thus, we offer GARDASIL only to those who wish to pay for it then further study this population. When all the data are actually in on GARDASIL, we could then act appropriately in terms of backing off on HPV screenings among the population of women with proven cervical cancer protection from GARDASIL.

Now, which of these strategies would be most optimal in terms of Merck's projected profits? And which other strategy would be most circumspect in terms protecting US women's health?

The bottom line is that this vaccine is ridiculously overpriced unless it offers lifetime protection against HPV 16 and 18 (unproven), this actually translates to 70% protection against cervical cancer (unproven), it has no associated long term risks (unproven), and we back off to biennial or triennial HPV screening tests (proving we weren't actually serious about eliminating cervical cancer to begin with).

it's not worth arguing about.

and these folk are going to hurt women and girls.

vaccine being mandated so soon after release? There is not only one RATIONAL point of view on this issue.

I have concerns about Gardasil being mandated now, but I am NOT anti-vaccine or anti-science. My children are vaccinated, we all get the flu vaccines every year, and my husband and two other family members are PhD level scientists. Nothing could be further from the truth than to say I'm anti-science.

Yet instead of debating the mandating of this vaccine on the merits of the issue, what I see constantly here is an effort to dismiss anyone with concerns as an anti-vaccine "loony."

Just because some of us could see the positive side of this vaccine and were attacked for that ("Merck lover") etc, doesn't mean we love Merck nor support them.

the edge of the road in Bedminster and she yelled at me in that Thurston Howell sort of way to get my horse off her property. She was growing grass in this shaded area. My ordinary Quarter Horse and I with my western saddle moved. I never forgot her hautiness.

because as a non-mandated vaccine, people will have to pay for it out of pocket.

in the meantime, people who didn't want it could have opted out of it if it was mandated.

I guess the powers decided they didn't want to foot the bill, after all. let the poor get cervical cancer.

for girls to have it, they can set up a special fund to provide it through county health departments. Why not start lobbying for that?

whereas mandated vaccinations always have opt-out clauses, AND are funded.

the vaccine free to doctor's offices and clinics everywhere, for any family that wants it.

You should ask your state governor to follow suit.

annual HPV screenings as part of their annual pap smears. This will save a lot more US women from cervical cancer than GARSASIL's best case scenario.

I also think we should have universal, single-payer health care.

But saying "that would be better than a mandated, funded vaccine, so screw THAT" is the same logic as saying "I am not voting for a Democrat because the two-party system is unfair and unrepresentative"

that HPV screenings in and by themselves do not protect you from cervical cancer. I personally wouldn't want my daughter to have to get painful biopsies if her paps comeb back abnormal.

But as I recall from another thread, you think cervical dysplasia and painful treatments for it are, like, whatever, no big deal.

They can run campaigns that affect millions of people? And even make it mandatory?

It kind of validates my sig line. Local, state and national governments are wimps, wussies and weak-kneed cowards when faced with a big, bad lobbyist.

I am sure that if Merck came out with an AIDS vaccine there would be people who would hate that too, but somehow I think vaccines are good things.

But then again if you want to really end the world population problem, just eliminate all the vaccines and let people have a taste of what it used to be like...

Yesterday's front page:

Some former top aides to Rick Perry who have moved to the private sector have a nearly $10 million stake in state business

http://www.dfw.com/mld/dfw/16739251.htm

Good that preteen's won't be forced to accept this vaccination, bad because this is a valuable drug that should be given to every preteen girls to prevent cancer..