Wednesday, February 21, 2007

Something to Think About

Gardasil is not available in Canada yet (oh, wait, a little Google search just showed an article in Chatelaine that says it was approved last July 2006)...I didn't know it had been approved (but I don't think it's publicly funded yet). So, this is even more of an issue! And, some of the other vaccines are also available. Read it carefully. I've added some bolds/italics.
I have stayed away from the vaccine debate, I really haven't looked into it much. I agree with the theory of vaccines, and that they do have some benefits. I agree that there are some questionable ingredients in vaccines. I agree that it seems awfully invasive to be giving infants so many vaccines. I haven't agreed with vaccines causing everything under the sun. But I did read this report someone sent into the 'Slightly Crunchy Attachment Parenting' Yahoo group. Attachment Parenting does not mean you have to be anti-vax, although Dr Sears has a chart if you want to do selective or delayed vaxing. I mean, really, what's the chance of a 2 month old getting injured by something that might cause tetanus? Anyway, read on...

(I somehow lost the main title...blame the fever)

Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS WASHINGTON, Feb. 21 /PRNewswire- -USNewswire/ --

The National Vaccine Information Center (NVIC) today released a new analysis of the federalVaccine 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 CDCto warn parents and doctors that GARDASIL should not be combined with other vaccines (you mean, the DOCTORS hadn't known this?!) and that young girls should be monitored for at least 24 hours forsyncopal (collapse/fainting) episodes that can be accompaniedby seizure activity, as well as symptoms of tingling, numbness and lossof sensation in the fingers and limbs, all of which should be reported toVAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 (but Texas made it mandatory for girls entering GRADE 6 ) in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming intoVAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling,numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria --acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome.

And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine."

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, facialparalysis 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 maybe causing health problems that could be important. For example, reports toVAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warningto doctors and consumers on Feb. 13.

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D."Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues relatedto giving this vaccine.

Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated (what about telling the ways to lower the risk of getting HPV?).

"NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report. In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff statedthat Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. -" Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the "HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine. "There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPVtypes will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth's PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine.

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events.
There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. "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.

"For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction toVAERS, go to HYPERLINK "http://www.nvic. org."http://www.nvic. -org. SOURCE National Vaccine Information Center


Well--I think I've made up my mind on this one! Oh, Megan just puked on the couch...

2 comments:

Talisman said...

This vaccination makes me thankful I only have boys (until they make it required for boys too). I really hope 15-20 years down the line we aren't in an epidemic of infertility and birth defects thanks to this vaccination.

On another note: I hope your puker feels better soon!

z said...

i'm sorry you guys are having a rough time again!! loads of ~~~~get well soon~~~~ vibes heading your way!!

you know, i *have* HPV and haven't ever considered the vaccination for Juliet. that vaccination scares me more than the others. i'm going to hope that being honest, open and talking about HPV will give her the knowledge she needs to do her best to avoid it herself!