Autism and SIDS listed on PI's

iVillage Member
Registered: 07-17-2005
Autism and SIDS listed on PI's
25
Thu, 11-12-2009 - 9:42pm

Not really a debate, just a very simple question.

Citizen -

Since you ignore most of the straight-forward questions you’re asked, let’s see how you do with this one:

If vaccines can not cause/trigger Autism and SIDS then why are both listed on the package insert as an adverse event of the Tripedia vaccine?

http://www.fda.gov/downloads/Biologi.../UCM101580.pdf

And no, you have not seen me on any anti-vax websites because I RARELY ever visit them, much less post on one of them. I don’t buy the products sold on them either.

I'm asking you for a simple, straight-forward answer. Don't bring George Bush into it, don't call me any names, don't try to change the subject, just answer the question.

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iVillage Member
Registered: 06-16-2009
Thu, 11-12-2009 - 10:26pm
I was initially surprised by this as well but some further reading answered my questions. Those are side effects that are listed as reported side effects post market release.

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iVillage Member
Registered: 11-06-2009
Fri, 11-13-2009 - 11:18am

My bad on the other site comment - I saw another crunchymomto2 and thought it was a fairly unique moniker.


Here is your question -


If vaccines can not cause/trigger Autism and SIDS then why are both listed on the package insert as an adverse event of the Tripedia vaccine?


Here is my answer -


Because printing all reported adverse effects is required by law.

iVillage Member
Registered: 06-16-2009
Fri, 11-13-2009 - 2:29pm

Is it actually the LAW to list all reported side effects on the insert?

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iVillage Member
Registered: 11-06-2009
Fri, 11-13-2009 - 3:09pm

The law governing reporting on package inserts is outlined here, 21 CFR 201.57(d).


"The labeling requirements for biological products are found in several sections of the Federal Food, Drug, and Cosmetic Act (FDCA) and the PHS Act, including: Sections 201, 502, and 503 of the FDCA, and section 351 of the PHS Act. In addition to the statutory provisions, FDA's regulations on labeling requirements, including the content and format requirements for vaccine labeling, are found primarily in 21 CFR Parts 201 and 601.


Pursuant to 21 CFR 201.57(d), labeling must describe contraindications (situations in which the drug should not be used because the risk of use clearly outweighs any possible benefit). The warning section of labeling, defined in section 201.57(e), requires, among other things, a description of serious adverse reactions, potential safety hazards, steps that should be taken in the occurrence of a serious adverse reaction and potential safety hazard, and limitations in use imposed by them"


http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074845.htm


It is supported by the information collected under 21 CFR, Subpart D - Reporting of Adverse Experiences, Section 600.80.

iVillage Member
Registered: 06-16-2009
Fri, 11-13-2009 - 3:26pm
Do you recognize that what you just posted supports my theory that they are being manipulative when they list drownings and car accidents?

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iVillage Member
Registered: 10-18-2007
Fri, 11-13-2009 - 10:15pm

Shall we venture further into Title 21?

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c1305c860d37147d5485b0236ae5d630;rgn=div5;view=text;node=21%3A7.0.1.1.1;idno=21;cc=ecfr

Quote: "(p) The word safety means the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time."

Please legally define "relative".

Quote: "(r) Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances."

Hate to be repetitive, but please legally define relative. Case law (of precedent level) is preferred.

Further...

§ 600.80 Postmarketing reporting of adverse experiences.

Quote: "(e) Postmarketing studies. (1) Licensed manufacturers are not required to submit a 15-day Alert report under paragraph (c) of this section for an adverse experience obtained from a postmarketing clinical study (whether or not conducted under a biological investigational new drug application) unless the licensed manufacturer concludes that there is a reasonable possibility that the product caused the adverse experience."

Fox minding the henhouse anyone? And....

§ 600.90 Waivers.

(a) A licensed manufacturer may ask the Food and Drug Administration to waive under this section any requirement that applies to the licensed manufacturer under §§600.80 and 600.81. A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain one of the following:

(1) An explanation why the licensed manufacturer's compliance with the requirement is unnecessary or cannot be achieved,

(2) A description of an alternative submission that satisfies the purpose of the requirement, or

(3) Other information justifying a waiver.

(b) FDA may grant a waiver if it finds one of the following:

(1) The licensed manufacturer's compliance with the requirement is unnecessary or cannot be achieved,

(2) The licensed manufacturer's alternative submission satisfies the requirement, or

(3) The licensed manufacturer's submission otherwise justifies a waiver.

Nothing like ambiguous nonsense legally defining an adverse event and creating loopholes at every turn....

**** edited for snark.




Edited 11/14/2009 7:36 am ET by criticalthinker
iVillage Member
Registered: 07-17-2005
Sat, 11-14-2009 - 9:21pm

I don't understand what part of walking like a duck makes it not a duck ;)

"Events were included in this list because of the seriousness or frequency of reporting."

So for some strange reason, people are only reporting Autism when it occurs shortly after a vaccine? The fact that it was reported once is good enough for me, but I'm not a scientist so there ya go.

It occurs, after vaccine. SIDS and Autism occurs. The word coincidence is just that - a word.

So goes the same for words like "causation". It's a word!

"Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to components of Tripedia vaccine.2"

That crap seems to be some sort of adopted slogan for our government and those who lobby...we're too stupid to use today's technology to reliably estimate when it comes to safety - is that it? Oh but when it comes to money, then ALL SORTS of supposedly "reliable" nonsense is used. IF only people knew how skewed those numbers are!

But that's our government for ya. Millions of us know how to post a PDF file, but they try to make the public believe they just can't handle putting a bill on a website so that *we the people* know what our elected officials are voting for.

Again - and this is not directed at you Charlotte - but if Autism occurs frequently enough for the corrupt ba$tards to put it on a PI - that should tell us something! Too many babies are dying of SIDS and instead of SIDS and Autism being the focus of studies - breast implants and Viagra are!!!

iVillage Member
Registered: 07-17-2005
Sat, 11-14-2009 - 10:01pm

"Who wrote the rule that says drownings and car accident victims must be listed?"

That's a great question. It does seem rather absurd that they would include either. Is that another way of saying the car accident or drowning wouldn't have resulted in death if not for the vaccine?

Pathetic word games.

iVillage Member
Registered: 07-17-2005
Sat, 11-14-2009 - 10:14pm
My thoughts exactly!
iVillage Member
Registered: 10-18-2007
Mon, 11-16-2009 - 9:42am

I honestly don't care what the word "event" translates into, if the vaccine maker gets to decide whether or not the event is necessary to study post-marketing, who cares? If they get to apply for a waiver during virtually every part of the manufacture, who cares?

You don't get to mandate a biologic for universal use and get a pass on the rules (however loose they may be).

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