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Re: Do not take the shot!
when I say something sarcastic now I put a
so people know.. Kind of tough through the computer.. honestly toasty please don't take the shot. they are trying to make kids under 10 get up to 4 shots. Possibly 3 vaccines and the regular flu shot. The link between autism and vaccines are apparent. What will be the side effects of this?
Also just look up squalene. That is the adjuvent they use when stretching out (or boosting as they like to call it) vaccines to make more vaccines. Think of it like McDonalds using preservatives in their food to make more money.Comment
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Re: Do not take the shot!
That's interesting because when I say something in jest, I will sometimes just say something so batshit crazy that no one could possibly believe it to be serious. To each their own, though.
To reiterate my earlier point, I have no love lost for the pharmaceutical industry and as a matter of fact, a good portion of my career is dedicated to busting pharma companies when they release bad drugs, manipulate patents, or engage in other anti-consumer shenanigans.
With that said, though, you have to understand that what you're proposing just makes no sense. It is one thing for a company to be less than straight with the FDA about the safety and efficacy profile of a drug, up to and including releasing a drug into the marketplace that it knows will kill a certain percentage of people that take it because the financial upside makes it worthwhile. That, unfortunately, happens, and it happens more frequently than we'd probably like to think.
Other examples would include Bayer's refusal to allow the generic manufacture of Cipro, which was used to treat anthrax exposure, in the wake of the anthrax attacks. Purely self-interested, putting its profits ahead of the health and safety of the public at large. It made me shake my head, but I wasn't surprised, because it would have cost them a colossal stream of income.
That is different, however, from a drug company intentionally infecting millions of people worldwide with a potentially deadly virus under the guise of providing a vaccine for that virus. I mean, that's something you would expect from comic book villains, not corporations that have shareholders to answer to. What's the financial end game there? That Baxter would then make a mint selling the antidote? Kinda a tough sell -- "Yeah, I know we earlier told you we were selling you vaccine and it turned out to be the virus, but this stuff we have now, this is REALLY the antidote, I promise, no take-backs." Even if they made a ton selling the virus/vaccine in the first place, why torpedo any chance you ever had to sell any drug ever again?
It's so absurd, I can't believe we're discussing it.Comment
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Re: Do not take the shot!
Did you look into Baxters 72 Kilos mistake? Here let me show you.
http://www.theflucase.com/index.php?option=com_content&view=article&id=90:th e-baxterwho-case&catid=42:rokstories&Itemid=〈=pl
I think we are talking about two different things here. Again you are taking it to the extreme as usual because it isn't in the mainstream. I am talking about you getting guillain barre syndrome and other complications that don't show in immediate testing like long term effects. And to be honest why would they give a fuck about you when you can't sue them anyways? As far as repeat customers they could blame it on terrorism or a mistake because it was such a rush order, that would also cause more regulation as well creating more gov't jobs and oversight.
Also 49% of doctors polled by pulse magazine opposed the vaccine.
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Re: Do not take the shot!
I'm just giving you the info man.. take it with a grain of salt I guess. I know I'm not taking the shot though. You do understand that if you get fucked up from it nobody will care and nobody will be held accountable right?
I wish you were this critical of mainstream media..Comment
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Re: Do not take the shot!
This is the PREP Act from 2006 that she apparently ammended.
It is taking me to long to find the official document that she signed. Here is the MSNBC link.
It says that the gov't learned its lesson from 1976 after thousands of people got guillian barre syndrome.Comment
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Re: Do not take the shot!
here it is..
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Determination and Declarations Regarding Emergency Use of Certain
In vitro Diagnostic, Antiviral, and Personal Respiratory Products
Accompanied by Emergency Use Information
AGENCY: Office of the Secretary (OS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to section 564(b) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the
Acting Secretary of HHS determined that a public health emergency
exists nationwide involving Swine Influenza A (now known as 2009-H1N1
Influenza A, or 2009-H1N1 influenza) that affects or has significant
potential to affect national security. On the basis of this
determination, on April 26 and April 27, 2009, the Acting Secretary
declared emergencies justifying the authorization of emergency use of
certain in vitro diagnostic, antiviral, and personal respiratory
protection products accompanied by emergency use information subject to
the terms of any authorization issued by the Commissioner of Food and
Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a). The Acting Secretary
also specified that these declarations are declarations of emergency as
defined by former Secretary Michael O. Leavitt in the October 10, 2008
Declaration under the Public Readiness and Emergency Preparedness
(PREP) Act for Influenza Antivirals Oseltamivir Phosphate and
Zanamavir, as amended, and the December 17, 2008 Declaration under the
PREP Act for Pandemic Influenza Diagnostics, Personal Respiratory
Protection Devices, and Respiratory Support Devices.
DATES: The declaration of an emergency justifying the authorization of
emergency use of certain in vitro diagnostic products is effective
April 26, 2009. The declaration of an emergency justifying the
authorization of certain antiviral products is effective April 26,
2009. The declaration of an emergency justifying the authorization of
emergency use of certain respiratory protection products is effective
April 27, 2009.
FOR FURTHER INFORMATION CONTACT: Nicole Lurie, M.D., MSPH, Assistant
Secretary for Preparedness and Response, Office of the Secretary,
Department of Health and Human Services, 200 Independence Avenue, SW.,
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FFDCA, the Commissioner, acting under
delegated authority from the Secretary of HHS, may issue an Emergency
Use Authorization (EUA) authorizing the emergency use of an unapproved
drug, an unapproved or uncleared device, or an unlicensed biological
product, or an unapproved use of an approved drug, approved or cleared
device, or licensed biological product. Before an EUA may be issued,
the Secretary of HHS must declare an emergency justifying the
authorization based on one of three determinations: a determination of
a domestic emergency, or a significant potential for a domestic
emergency, by the Secretary of Homeland Security; a determination of a
military emergency, or a significant potential for a military
emergency, by the Secretary of Defense; or a determination of a public
health emergency by the Secretary of HHS. See 21 U.S.C. 360bbb-3(b)(1).
In the case of a determination by the Secretary of HHS (as was made
here), the Secretary must determine that a public health emergency
exists under section 319 of the Public Health Service (PHS) Act that
affects, or has a significant potential to affect, national security,
and that involves a specified biological, chemical, radiological, or
nuclear agent or agents, or a specified disease or condition that may
be attributable to such agent or agents. Based on such a determination,
the Secretary of HHS may then declare an emergency that justifies the
EUA, at which point the Commissioner may issue an EUA if the criteria
for issuance of an authorization under section 564 of the FFDCA are
met.
The Centers for Disease Control and Prevention (CDC), HHS,
requested that the Food and Drug Administration (FDA) issue EUAs for
certain in vitro diagnostic, antiviral, and personal respiratory
protection products accompanied by emergency use information. The
determination of a public health emergency by the Acting Secretary of
HHS and the declarations of an emergency by the Acting Secretary of HHS
based on that determination, as described below, enabled the Acting
Commissioner to issue EUAs for certain in vitro diagnostic, antiviral,
and personal respiratory protection products
[[Page 38629]]
for emergency use under section 564(a) of the FFDCA, 21 U.S.C. 360bbb-
3(a).
An in vitro diagnostic, CDC Human Influenza Virus Real-time RT-PCR
Detection and Characterization Panel (rRT-PCR Flu Panel), is cleared by
FDA for detection of seasonal Influenza A and subtype determination.
CDC sought an EUA to allow this test to be used with specimen types and
reagents additional to those of the cleared test as a first tier test
for patients suspected of having 2009-H1N1 influenza. CDC also sought
an EUA to allow an in vitro diagnostic that has not been previously
approved or cleared by the FDA, Swine Influenza Virus Real-time RT-PCR
Detection Panel (rRT-PCR Swine Flu Panel), to be used in detecting
2009-H1N1 influenza.
CDC also sought EUAs for certain antiviral drug products, which are
approved by FDA for use in treatment and prophylaxis of influenza for
adult and pediatric use. Relenza[reg] (zanamivir) is approved to treat
acute uncomplicated illnesses due to influenza in adults and children 7
years and older who have been symptomatic for less than two days, and
for the prevention of influenza in adults and children 5 years and
older. Tamiflu[reg] (oseltamivir phosphate) is approved for the
treatment of acute uncomplicated illness due to influenza in patients 1
year and older who have been symptomatic for less than two days, and
for the prevention of influenza in patients 1 year and older. The EUA
for Tamiflu allows for Tamiflu to also be used to treat and prevent
influenza in children under one year, to treat influenza in patients
who have been symptomatic for more than 2 days, and to provide
alternate dosing recommendations for certain pediatric populations. The
EUA for Tamiflu also authorizes distribution of Tamiflu deployed from
the Strategic National Stockpile (SNS) and that has had its expiration
date extended under the Federal government's Shelf Life Extension
Program (SLEP). In addition, under the EUAs, both Tamiflu and Relenza
may be distributed to large segments of the population without
complying with certain prescription label requirements otherwise
applicable to dispensed drug. Under the EUAs, Tamiflu and Relenza are
authorized to be accompanied by certain written information pertaining
to the emergency. The EUAs note that there may be distribution of these
products by a broader range of health care workers, including some
public health officials and volunteers, in accordance with applicable
State and local laws and/or the public health and medical emergency
response of the authority having jurisdiction, subject to the terms and
conditions of the EUA.
Finally, certain personal respiratory protection devices certified
by the National Institute for Occupational Safety and Health (NIOSH),
in accordance with 42 CFR part 84, as non-powered air-purifying
particulate respirators with a minimum filtration efficiency
classification of N95 (known as N95 respirators) have been cleared by
FDA for use by the general public in public health medical emergencies,
such as an influenza pandemic. Other N95 respirators have been cleared
by FDA for use in certain workplace settings. The disposable N95
respirators for which CDC sought an EUA were either not previously
cleared or approved by FDA or were cleared by FDA but only for use in
certain workplace settings. The EUA authorized the emergency use, by
the general public,\1\ of these products, as deployed from the SNS and
accompanied by emergency use information, to help reduce wearer
exposure to airborne germs during this emergency. The specific products
covered by the EUA are identified in the EUA by manufacturer and model
number; fifteen different models of disposable N95 respirators are
covered.
---------------------------------------------------------------------------
\1\ For purposes of this EUA, the term ``general public'' is
broad and includes people performing work-related duties. This EUA
affects only requirements applicable under the Federal Food, Drug,
and Cosmetic Act. It does not affect requirements arising from other
sources of law, such as Occupational Safety and Health
Administration (OSHA) requirements.
---------------------------------------------------------------------------
With issuance of the EUAs for certain in vitro diagnostic products,
laboratories may receive certain in vitro diagnostics covered by the
EUAs for use in detection of 2009-H1N1 influenza, and patients and
health care professionals may receive emergency use information
regarding these in vitro diagnostic products during this public health
emergency involving 2009-H1N1 influenza. With issuance of the EUAs for
certain antiviral products and issuance of the EUA for certain personal
respiratory products, members of the general public may receive certain
antiviral and personal respiratory protection products covered by the
EUAs, accompanied by emergency use information, for immediate use by
them during this 2009-H1N1 influenza emergency. These products and
accompanying information may help to detect the spread of 2009-H1N1
influenza, protect individuals against contracting 2009-H1N1 influenza,
and treat individuals who are ill following exposure to 2009-H1N1
influenza.
In this public health emergency involving 2009-H1N1 influenza, time
is of the essence in detecting, preventing, and treating illness and
death by getting in vitro diagnostic, antiviral and personal
respiratory protection products, accompanied by emergency use
information, to the general public, laboratories, and public health and
health care professionals. By distributing certain in vitro diagnostic
products accompanied by emergency use information, public health and
health care professionals can ensure that spread of the 2009-H1N1
influenza is quickly and accurately detected. By dispensing certain
personal respiratory products accompanied by emergency use information,
the appropriate State and/or public health authority(ies) can ensure
that the products are provided quickly, as appropriate, to help reduce
wearer exposure to airborne germs. By dispensing certain antiviral
products accompanied by emergency use information, public health and
medical professionals and the authorities having jurisdiction to
respond to the emergency in each locality can ensure that the products
are provided quickly, as appropriate, to those who may have been
exposed or are ill, accompanied by the information most important to
their emergency use.
This is one part of the Federal Government's strategy to encourage
preparedness at all levels of government to enable the nation to
respond effectively in response to this public health emergency.
II. Determination of the Acting Secretary of Health and Human Services
On April 26, 2009, pursuant to section 564(b)(1)(C) of the FFDCA,
21 U.S.C. 360bbb-3(b)(1)(A), and section 319 of the PHS Act, 42 U.S.C.
247d, the Acting Secretary of HHS determined, as a consequence of
confirmed cases of Swine Influenza A (swH1N1) (now called ``2009-H1N1
influenza'') in California, Texas, Kansas, and New York, and after
consultation with public health officials as necessary, that a public
health emergency exists nationwide involving 2009-H1N1 influenza that
affects or has significant potential to affect national security.
III. Declarations of the Acting Secretary of Health and Human Services
On April 26, 2009, on the basis of the Acting Secretary's
determination on April 26, 2009, pursuant to section 319 of the Public
Health Service Act, 42 U.S.C. 247d, that a public health emergency
exists involving 2009-H1N1 influenza that affects or has significant
[[Page 38630]]
potential to affect national security, and pursuant to section 564(b)
of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), the
Acting Secretary declared an emergency justifying the authorization of
the emergency use of certain in vitro diagnostics for detection of
Swine Influenza A (now called ``2009-H1N1 influenza'') accompanied by
emergency use information subject to the terms of any authorization
issued under 21 U.S.C. 360bbb-3(a). The Secretary further specified
that the declaration is a declaration of emergency, as defined in the
December 17, 2008, Declaration under the PREP Act for Pandemic
Influenza Diagnostics, Personal Respiratory Protection Devices, and
Respiratory Support Devices, published at 73 FR 78362 (December 22,
200.
Also, on April 26, 2009, on the basis of the Acting Secretary's
determination on April 26, 2009, pursuant to section 319 of the Public
Health Service Act, 42 U.S.C. 247d, that a public health emergency
exists involving Swine Influenza A that affects or has significant
potential to affect national security, and pursuant to section 564(b)
of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), the
Acting Secretary declared an emergency justifying the authorization of
the emergency use of certain products from the neuraminidase class of
antivirals oseltamivir phosphate and zanamivir accompanied by emergency
use information subject to the terms of any authorization issued under
21 U.S.C. 360bbb-3(a). The Secretary further specified that the
declaration is a declaration of emergency, as defined in the October
10, 2008, Declaration under the PREP Act for Influenza Antivirals
Oseltamivir Phosphate and Zanamivir, published at 73 FR 61861 (October
17, 200, as amended. The Acting Secretary's April 26, 2009, amendment
to the October 10, 2008 Declaration under the PREP Act for Influenza
Antivirals Oseltamivir Phosphate and Zanamivir is separately published
elsewhere in this issue of the Federal Register.
On April 27, 2009, on the basis of the Acting Secretary's
determination on April 26, 2009, pursuant to section 319 of the Public
Health Service Act, 42 U.S.C. 247d, that a public health emergency
exists involving Swine Influenza A that affects, or has significant
potential to affect, national security; and pursuant to section 564(b)
of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), the
Acting Secretary declared an emergency justifying the authorization of
the emergency use of certain personal respiratory protection devices,
accompanied by emergency use information subject to the terms of any
authorization issued under 21 U.S.C. 360bbb-3(a). The Secretary further
specified that the declaration is a declaration of emergency, as
defined in the December 17, 2008, Declaration under the PREP Act for
Pandemic Influenza Diagnostics, Personal Respiratory Protection
Devices, and Respiratory Support Devices, 73 FR 78362 (December 22,
200
Notice of the authorizations issued by the FDA Commissioner under
21 U.S.C. 360bbb-3 is provided elsewhere in this Federal Register.
Dated: July 28, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-18432 Filed 8-3-09; 8:45 am]
BILLING CODE 4150-37-PComment
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Re: Do not take the shot!
it's not just the vaccine it is also Tamiflu and Relenza
or here
Comment
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Re: Do not take the shot!
Well, I agree, that's bullshit. At least it carves out intentional actions, but given the standard for proving that, not sure how helpful that is.Comment
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