NC Lawmakers catch HPV Gardasil Bug

Submitted by NCVoter on

[Edited to make the links clickable —Lance]

NC climbs onto the Gardasil bandwagon.

No, its not in the local news yet, but the "bug" has hit North Carolina in the form of S260.

This bill is just propaganda for the Gardasil vaccine. I urge you to contact lawmakers, the email addresses and sample message enclosed.

I discovered that NC lawmakers had been infected by the HPV/Gardasil bug by following references in the latest Washington Post article, and that led to more research:

"Parents Question the HPV Vaccine"
"Although the government approved Gardasil for women up to 26, it recommended routine administration to girls 11 and 12.."

washingtonpost.com link

Here's the deal - it started with the Gov of Texas, who mandated that all young girls be vaccinated with the Gardasil vaccine, supposedly to prevent HPV and cervical cancer.
medicalnewstoday.com link

It turns out that the Gov is being heavily lobbyied by Merck, the maker of Gardasil.
kaisernetwork.org link

Merck stands to gain enormously from the sale of Gardasil: "A three-dose regimen of Gardasil, given over six months, runs $360 or more.."
washingtonpost.com link

Merck needs to sell this vaccine to make up for the losses caused by deaths and injuries from another medicine it rushed to the market, Vioxx.
nytimes.com link

North Carolina lawmakers wouldn't try to force Gardasil on our pre-pubescent daughters, would they?

Well, not force, but well meaning lawmakers are strongly recommending "vaccines":

Senate Bill 260

SECTION 1. G.S. 115C‑47 is amended by adding a new subdivision to read:

"(49) To Ensure that Schools Provide Information Concerning Cervical Cancer, Cervical Dysplasia, Human Papillomavirus, and the Vaccines Available to Prevent These Diseases. – Local boards of education shall ensure that schools provide parents and guardians with information about cervical cancer, cervical dysplasia, human papillomavirus, and the vaccines available to prevent these diseases. This information shall be provided at the beginning of the school year to parents of children entering grades five through 12. This information shall include the causes and symptoms of these diseases, how they are transmitted, how they may be prevented by vaccination, and places parents and guardians may obtain additional information and vaccinations for their female children."
ncleg.net link

Senate Bill 260 has a very innocent title
"Schools Provide Info on Cervical Cancer" but - bottom line is that parents will believe that they (as responsible parents) should get the vaccines available to prevent these diseases".

Guess which vaccine that would be? Gardasil? Made by Merck.

Never mind the warnings about the Gardasil vaccine:

HPV Vaccine Mandates Risky and Expensive
909shot.com link

February 1, 2007, NVIC Press Release and Citations
Merck's GARDASIL Not Proven Safe for Little Girls, June 27, 2006, NVIC Press Release on GARDASIL aluminum content and clinical trials with reference citations.
909shot.com link

Never mind that Sheila Krumholz, executive director, Center for Responsive Politics, talks about the lobbying efforts and legislative influence of the pharmaceutical industry."
wnyc.org link

Who should you call or write to and tell them to kill this bill that serves to endorse a unsafe and unproven vaccine?

S 260 was referred to the Committee on Health Care on 02/22/2007, so contact the committee members:

Send one email to the entire committee:

copy and paste all in the "to:" field of your email -

stanb@ncleg.net,Williamp@ncleg.net,Katied@ncleg.net,
Tonyf@ncleg.net,Jamesf@ncleg.net,Boba@ncleg.net,
Dougb@ncleg.net,Harrisb@ncleg.net,Peterb@ncleg.net,
Charlied@ncleg.net,Kayh@ncleg.net,Fletcherh@ncleg.net,
Davidh@ncleg.net,Jimja@ncleg.net,Edwardj@ncleg.net,
Elliek@ncleg.net,Vernonm@ncleg.net,martinn@ncleg.net,Tonyr@ncleg.net

Or send a message to individual members:

Committee on Health Care Individual Members
Co-Chairman Sen. Stan Bingham stanb@ncleg.net
Co-Chairman Sen. William R. Purcell Williamp@ncleg.net

Vice Chairman Sen. Katie G. Dorsett Katied@ncleg.net
Vice Chairman Sen. Tony Foriest Tonyf@ncleg.net
Vice Chairman Sen. James Forrester Jamesf@ncleg.net

Members
Sen. Bob Atwater Boba@ncleg.net
Sen. Doug Berger Dougb@ncleg.net
Sen. Harris Blake Harrisb@ncleg.net
Sen. Peter Samuel (Pete)Brunstetter Peterb@ncleg.net
Sen. Charlie S. Dannelly,Charlied@ncleg.net
Sen. Kay R. Hagan Kayh@ncleg.net
Sen. Fletcher L. Hartsell Fletcherh@ncleg.net Jr., Sen. David W. Hoyle Davidh@ncleg.net
Sen. Jim Jacumin Jimja@ncleg.net
Sen. Ed Jones Edwardj@ncleg.net
Sen. Eleanor Kinnaird Elliek@ncleg.net
Sen. Vernon Malone Vernonm@ncleg.net
Sen. Martin L. Nesbitt, Jr., martinn@ncleg.net Sen. Tony Rand Tonyr@ncleg.net
ncleg.net link

Message to lawmakers:

Dear Senator ______

I urge you to block Senate Bill 260.

Lets not experiment with the health of our 11 and 12 year old girls.

It is too soon for our state to pass legislation that recommends vaccines that may not be safe, and may not even be effective. Merck, the manufacturer of one of these vaccines is reeling from lawsuits over damages and deaths caused by its last wonder drug - Vioxx.

Experts are warning that vaccines touted to prevent HPV and cervical cancer are not proven effective and pose serious safety risks to our children.

Lawmakers should not encourage parents to have their children receive vaccines that are not necessary and haven't been proven safe:

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."
909shot.com link

Jon Abramson, chairman of the committee that advises the federal Centers for Disease Control and Prevention on immunization practices. who also is a professor of pediatrics and infectious diseases at Wake Forest University medical school, does not support mandating the vaccines.

According to the Washington post, "Abramson advised Merck & Co. not to lobby lawmakers over Gardasil. Merck disregarded his and others' suggestion, until its role became such a distraction that the company stopped two weeks ago.

'Politics are not a good driver of health-care recommendations,' Abramson said. 'Time will help us decide what's the best policy.'"
washingtonpost.com link

Comments

It isn't enough

Submitted by Lance on

Looking over the points in the first blockquote box, I'm not seeing the argument against vaccination. At most, you've got a good reason here to ask questions, but no compelling argument for taking action to stop S260. Point by point (with the original points in bold):

  • Here's the deal - it started with the Gov of Texas, who mandated that all young girls be vaccinated with the Gardasil vaccine, supposedly to prevent HPV and cervical cancer. So if the Governor of Texas says it's a good idea, then it must be a bad one? I know that's not what you mean, but I'm not sure how else to read this point. To be honest, I have no idea who the Governor of Texas is, but based on what I do know about the state's politics, I imagine I wouldn't like him or her. Still, to suggest that the subject of an order is bad just based on its association with a particular politician is the kind of blatant "guilt by association" argument that really deserves to be ignored.
  • It turns out that the Gov is being heavily lobbyied by Merck, the maker of Gardasil. Same here: it's supposed to be bad just because someone is lobbying for it? I'm sure that if the smallpox vaccine had been invented last week (and not decades ago), the manufacturer would be lobbying governors to require it, too. But it's not like that's a reason to not get vaccinated.
  • Merck stands to gain enormously from the sale of Gardasil: "A three-dose regimen of Gardasil, given over six months, runs $360 or more.." People shouldn't be vaccinated if someone will make money on the transaction? I'm sure Wyeth Consumer Healthcare made a nice margin on the bottle of Robitussin I picked up for Arica tonight, but I still feel pretty good about that purchase.
  • Merck needs to sell this vaccine to make up for the losses caused by deaths and injuries from another medicine it rushed to the market, Vioxx. More guilt by association, this time coupled with the charge that Gardasil was "rushed to the market", but without any evidence that this is true. I clicked the link on this one, and the article doesn't even mention Gardasil.

There are arguments against required Gardasil vaccination -- I've seen them presented on this website. And while my general sense is that there's less harm to be found in vaccinating girls against HPV than in not, I understand that others feel that the risk/benefit balance tilts the other way or is a close enough call that state governments should stay out of it.

I guess I'm saying that you'll get a lot more people to join in in your campaign if you really lay out the risk/benefit argument (as opposed to attempting to smear a vaccine by associating it with Texas, Vioxx and capitalism generally).

health risks to our 9 year old daughters biggest concern

Submitted by NCVoter on

The legislation should be warning about the dangers of the vaccine, not recommending the vaccine.

This vaccine, (just like Merck's Vioxx) has been rushed to the market thanks to big Pharma's influence on Govt. It has not been properly studied, and not studied for long enough.

Health Risks:

WASHINGTON, Feb. 21 /PRNewswire-USNewswire/ — The National Vaccine Information Center (NVIC) today released a new analysis of the federal
Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck’s GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal
(collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the
fingers and limbs, all of which should be reported to VAERS immediately.
http://www.healthsalon.org/66/hpv-vaccine-not-without-risk/

How about these "side effects" for your 9, 10 and 11 year old daughters?

According to NVIC’s report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or
pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome. Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck’s Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13.
(Also at http://www.healthsalon.org/66/hpv-vaccine-not-without-risk/ )

Gardasil as a cause of HPV?

"NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination."

How about the effect on the Medicaid budget for a vaccine that costs $360.00 per patient,
www.washingtonpost.com/wp-dyn/content/article/2006/07/17/AR2006071700955.htm
and that we don't know if it works or if its safe?

What or who will have to be cut out of Medicaid to pay for Merck's latest cash cow? Some poor children?
NC is struggling to cover the CHIPS program now:
http://galen.org/statehealth.asp?DocID=982

Some number correcting, here.

Submitted by C. Diane on

You take the 14% incidence of syncope and 8% incidence of GBS as if they're the entire study population, when in fact they are only of the 385 reported events through VAERS, which is a hell of a lot smaller than 14% of the thousands studied. 14% of 385 is 54 patients, and 8% is 31. This misuse of statistics is common in scare tactics.

And I'm calling bullshit on this one:
NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination.

Gardasil is a recombinant vaccine. This means that there are no live, attenuated viruses or no killed viruses used in the making of the vaccine. The various surface antigens are synthesized in yeast -- not even in HPV viral cell lines!! -- and purified. It's NOT INFECTIOUS.

More likely is that they had been infected prior to vaccination (or during the series of injections) and not known it. I'd hope they ran blood tests to see if they were exposed to HPV prior to the study; otherwise it's not very well-designed.

PSA

Submitted by Blue South on

I saw something about this that broke down the amount of people that get HPV, and how often that becomes cervical cancer. It was some new study that showed the rates of HPV to be higher but the cancer rate to be lower.

Anywho, ignoring the science I dont understand it mentioned something very important. 85% of those that died from cervical cancer never got a Pap smear.

Draft Brad Miller -- NC Sen ActBlue :::Petition

"Keep the Faith"

Still another reason we need

Submitted by Pat Anthony on

Universal Health Care. What woman doesn't get a pap smear? A woman who can't afford to go to the doctor.

Back to the vaccine, so this comment won't be totally OT - I think there is a big difference between requiring a vaccine and making a vaccine available. I would be interested to hear the pros and cons of the vaccine itself. How can we weigh the risks and benefits if we are only told what the benefits are, and not the risks, or the rate of occurence of unfavorable consequences, or even what age patients the vaccine has been tested on?

Unexplained deaths, birth defects

Submitted by NCVoter on

The Illinois Vaccine Awareness Coalition raises serious concerns, including questions about some unexplained deaths:

IVAC's concerns about Human Papilomavirus (HPV) Vaccine Types 6, 11, 16, 18 from vaccine package insert

lack of safety studies on the ingredients singly, combined, cumulative, synergistically with other vaccines' ingredients;

aluminum as an ingredient and in placebo;
unknown ingredients in culture medium;
lack of identity of trial subjects: country, race;
“clinical trials population approximated general population of American women;”
only 4 yr follow up;
no accounts for 7 deaths out of 17 subjects who died;
confusion re injection into pregnant women:
“Gardasil is not recommended for pregnant women.”

unknown if Gardasil can cause fetal harm when infected into a pregnant woeman or if it effects reproduction capacity;

“Gardasil should be given to a pregnant woman only if clearly needed.”

“Merck & Co..., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to Gardasil.”

birth abnormalities within 30 days of mother's vaccination: narrowing of pyloric sphincterthat blocks food passage from stomach into duodenum; kidney distension/obstruction, hip abnormality, club foot:

no studies on male fertility;

unknown if vaccine is excreted in breast milk;
in clinical studies, higher number of breast fed babies, whose mothers received Gardasil, had acute respiratory illnesses within 30 days after mother vaccination as compared to babies whose mothers received placebos;

no studies of vaccine given with other vaccines other that hepatitis B vaccine nor does it state specifically which hepatitis B vaccine used in study;

confusion about immogenicity bridging, that effectiveness of vaccine in 9-15 year old girls is inferred;
http://www.vaccineawareness.org/concerns.htm#09

Total straw man

Submitted by Lance on

Can you identify one person saying that vaccination IS a substitute for screening? If not, what's you point?

Straw girl.

Submitted by James on

n/t

Here we go again

Submitted by Ashevillein on

this time I am ducking and covering.

Me too.

Submitted by James on

n/t

Man, I am digging a deeper hole

Submitted by Ashevillein on

you are welcome in, if you need... I will cut you a fighting step even.

bring your own shelter half.

I'm just gonna do this:

Submitted by C. Diane on

write to my reps in SUPPORT of the legislation. Neener neener.

Yeah but . . .

Submitted by James on

you're just a ding-dong pharmacist. Whaddayouknow?

:)

So in a perfect world

Submitted by Lance on

We wouldn't be studying any medicines that are out in the market? This is just a bit loony -- is there a personal side to this story that we're missing here?

"Phase 4 trials"

Submitted by C. Diane on

is what we call them. Plenty go on every day; normally it's nothing formal, but FDA has an adverse reaction reporting page for non-biologicals, too.

The vaccine was given a priority review, which means the FDA made a decision in 6 months of its final submission. Biologics follow a different procedure than other drugs, so all the dates and INDs and NDUs aren't on the site.

FDA approved VIOXX too, Fox in the Henhouse

Submitted by NCVoter on

So now Merck has HPV, or Help Pay for Vioxx losses.

Under a bizarre law enacted in 1992 known as PDUFA (Prescription Drug User Fee Act) the FDA receives over half the money it needs for new drug approvals from Big Pharma itself – a system more akin to Big Pharma paying the mob for protection than the FDA ensuring drug safety for the public. This law must be renewed later this year and already the FDA is asking for even larger sums of money from Big Pharma. The fox is indeed buying the keys to the henhouse. Life and death hang in the balance.

GlaxoSmithKline

Submitted by gregflynn on

Sorry to be late to this thread but I had heard this on NPR earlier in February:

By all accounts, Merck, the first manufacturer of an HPV vaccine — Gardasil — wants to move fast, too. Drug maker GlaxoSmithKline is close on Merck's heels with its own HPV vaccine. So Merck has initiated a massive ad campaign that is part public education and part hard sell.

Glaxo actually had the first, but it was limited to 2 strains

Submitted by Betsy Muse on

they are quickly working on 2nd and 3rd generation vaccines that will be therapeutic as well as prophylactic making Gardisil obsolete.


Robin Hayes lied. Nobody died, but thousands of folks lost their jobs.



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