Thursday, October 29, 2009

Are Vaccinations Really Backed By Reliable Safety Testing and Clinical Trials?

Most parents (and physicians alike) assume that vaccinations undergo rigorous safety testing and clinical trials before they are released. The appropriate level of research conducted on vaccinations should be double blind placebo controlled studies with follow up monitoring for a few years... you would think. In the unfortunate and dismal reality of vaccine safety testing however, not only are most vaccines not tested against placebos (let alone with double blind studies) there may also be a pathetically miniscule number of trial participants, safety trials that leave out participants of the age group that is actually vaccinated, and a duration of monitoring post trial that would make even the most ethically flexible scientist cringe.

The details, followed by the product insert links so you can check for yourself if so inclined:

MMRII: the Measles, Mumps and Rubella Vaccination

The safety trial only observed 284 participants aged 11 months to 7 years. Merck did not even bother to state the duration of the trial or the duration or method of monitoring.

http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf

INFANRIX: the Diphtheria, Tetanus and Pertussis (DTaP) Vaccine

There were 407 infants monitored for only 8 days. The vaccination was not compared to a control, but to the whole cell DTP vaccine.

http://us.gsk.com/products/assets/us_infanrix.pdf

I-POL: the Polio Vaccine

The I-pol vaccine safety and clinical trials are a bit of an eyebrow raiser. While they do claim there were 1,300 infants (aged 2, 4 and 18 months) in the trial, they state that 4 different trials made up this group of infants. There is no information regarding location, method, duration of monitoring, etcetera. The I-pol vaccine was also not compared to a control such as saline but rather to the whole cell DTP vaccine. Interestingly the product insert states that the I-pols adverse reactions were "comparable in frequency and severity to that reported for DTP given alone." (the whole cell DTP vaccine which was banned because it was too dangerous to administer... that's reassuring!)

https://www.vaccineshoppe.com/US_PDF/IPOL_942420_11.06.pdf

Act-HiB: the Haeomophilus Influenzae Type B Vaccine

401 infants were observed in the safety trials, that's it. There was no duration of monitoring or methodological details listed. As an odd sidebar they did include the random factor that 3 of the 401 infants suffered seizures. (wonder why the CDC doesn't have THAT 'vaccine adverse reaction statistic' on their website)

http://www.novaccine.com/pdffiles/Act_HIB_package_insert.pdf

Havrix: the Hepatitis A Vaccine

According to the product insert, there were an enormous number of participants: 32,900, engaged in 60 clinical trials! Which is pretty... interesting. How exactly and why exactly did they choose to do it that way?? At any rate, the information posted for the two principle safety trials (the only ones they include any information about specifically on the p.i.): The first stated it was compared to the Energix B vaccination, the second stated it was compared to Infanrix DTaP vaccination and a conjugatae HiB vaccine (both). Duration of monitoring on the first study was not noted, however in the second study the amount of duration was only 4 days post vaccination via the use of "diary cards" given to the parents.

http://us.gsk.com/products/assets/us_havrix.pdf

Energix B: the Hepatitis B Vaccine

Every trial participant in this clinical and safety trial were 6 years or older! This vaccination is administered to infants 12 hours out of the womb and given regularly on the recommended childhood immunization schedule otherwise from birth through five! Talk about an obtuse methodological error. The vaccine was also compared not to a control but to another vaccination.

http://us.gsk.com/products/assets/us_engerixb.pdf

Prevnar: the Pneumococcal Vaccine

Was tested against another vaccine and not a control (an "investigative" aka experimental, Men C vaccine no less). No specific date of monitoring for adverse reactions was given but the product insert did state "the pre protocol analysis of the primary end point included cases which occured >14 days after the third dose."

http://www.wyeth.com/content/showlabeling.asp?id=134

Menactra: the Meningococcal Vaccine

The vaccination was compared to the Menomune vaccination and not a control. There were 7 days of solicited monitoring post vaccination via "diary cards" included in the 28 days of unsolicited adverse reaction monitoring post vaccination (aka if the parent had something happen to their child they could report it within those 28 days, but nobody would be contacting them after the intial 7 days to find out).

https://www.vaccineshoppe.com/image.cfm?doc_id=8826&image_type=product_pdf

Fluzone: the Influenza Vaccine

Was not compared to a control. Safety study included a total of 31 children (19 children aged 6 to 23 months and 12 children aged 24 to 36 months), that's it! They were given two total doses of vaccines spaced one month apart and local and systemic reactions were only solicited for 3 days post vaccination.

https://www.vaccineshoppe.com/image.cfm?doc_id=10913&image_type=product_pdf

Note: the Rotavirus and Gardasil vaccinations were the only ones that checked out for being placebo controlled and appropriately conducted. Good job guys!

Unfortunately these are two vaccinations designed for totally mild conditions which both admit to a causative association with FATALITY. If it wasn't such a terrible combination, you would think God had a keen sense of humor. The only two appropriately researched vaccinations are the ones made for innocuous conditions and they can cause death in their recipients? Woooow.

If you don't believe me check out the Rotavirus vaccine product insert which concedes to an uncontested causation of death (which is oddly the reason the first rotavirus vaccine got banned, although the manner of death was different... I guess it takes them a while to learn!):

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133920.htm

Or the Gardasil vaccine product insert which concedes to an uncontested causation of arrhythmia, which can most certainly be fatal, among a VERY long list of debilitating diseases including Asthma, Sepsis, Pancreatic cancer and rheumatoid arthritis.

http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

The point of this article on safety studies is clear: the next time you get the thought that the FDA or any other governmental entity is absolutely ensuring your safety with it's "rigid" safety testing standards of drugs and pharmaceutical products, please think again! If this is how pathetic the standards are for testing chemicals that are going to be injected into infants bodies is, imagine how "stringent" the standards must be for adult medicines.

Always make sure you look at the product inserts for yourself before consenting to using any pharmaceutical product. There is a laundry list of FDA approved drugs out there that carry more serious adverse reaction risks than the condition they were designed to treat. And never forget, being a smart patient benefits you as well as your physician. Thanks for reading.

No comments:

Post a Comment