~~~ Swine Flu Vaccines - Pandemic laws don't require safety testing or liability

[Guest guest]

Using New Laws for Swine Flu, Designed for Much Deadlier Disease, May

Create a Perfect Storm

 

_http://anthraxvaccihttp://anthrhttp://anhttp://anthhttp://anthttp://anthrax

http://a_

(http://anthraxvaccine.blogspot.com/2009/08/summary-using-new-laws-designed-for.\

html)

 

Friday, August 7, 2009

 

Using New Laws for Swine Flu, Designed for Much Deadlier Disease, May

Create a Perfect Storm

 

1. The US government is using laws designed for dealing with a very deadly

pandemic or bioterrorism to bring in a mass vaccination program for swine

flu, specifically the Public Readiness and Emergency Preparedness Act of

2006.

 

_http://www.hhs.http://www.hhshttp://wwwhttp://www.hhs.http://www.hhhttp://w

ww.http://www.http_

(http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-\

vaccine-qa.html)

 

2. This law removes liability from the manufacturer, medical practitioners

who use the product, and from " government program planners " who decided on

using the law. A suit can only be brought if the DHHS Secretary allows it,

and if there is willful misconduct on the part of the manufacturer.

 

This law has been invoked for swine flu drugs (tamiflu and relenza)

 

_http://edocket.http://edochttp://edhttp://edockehtt_

(http://edocket.access.gpo.gov/2009/pdf/E9-14412.pdf)

 

for swine flu vaccines, and for novel vaccine adjuvants (which may be used

in vaccines to stretch the supply and possibly convey broader immunity)

 

_http://edocket.http://edochttp://edhttp://edockehtt_

(http://edocket.access.gpo.gov/2009/pdf/E9-14948.pdf)

 

3. If testing of these products is very limited, then the manufacturers

are unlikely to become aware of their flaws, and specifically their adverse

effects. Then there can be no willful misconduct.

 

4. Due to the fear that swine flu will cause a large outbreak once

students return to schools, where the virus might rapidly spread, the US

government has stated that vaccine is likely to be available, and used, before

clinical trials are completed.

 

WHO says vaccine will be ready in September. Novartis began testing in

humans in late July, and Sanofi-Aventis and Glaxo-Smith Kline are starting now.

 

_http://www.google.http://www.googhttp://www.http://www.http://www.googlhttp

://www.googl_

(http://www.google.com/hostednews/ap/article/ALeqM5i-Qd-q3ALSGUV0tZqwFVoy1GlGfQD\

99TEJN81)

 

The Europeans are also planning for use before testing is completed,

despite warnings by experts about the potential dangers of untested vaccines.

 

_http://www.google.http://www.googhttp://www.http://www.googlhttp://wwhttp:/

/www.googlht_

(http://www.google.com/hostednews/ap/article/ALeqM5iCajXBnuqbQEUf_cH4_dblpysz_gD\

99MCRJO1)

 

5. The adjuvants likely to be used to strengthen vaccines and stretch the

supply are named MF59 (Novartis) and ASO3 (Glaxo Smith-Kline)5. The

adjuvants likely to be used to strengthen vaccines and stretch the supply are

5.

The adjuvants likely to be used to strengthen vaccines and stretch the

supply are named MF59 (Novartis) and ASO3 (Glaxo Smith-Kline)<WBR>. Only 3

vaccines using this 5. The adjuvants likely to be used to strengthen vac5.

The adjuvants likely to be used to strengthen vaccines and stretch the supply

are named MF59 (Novartis) and ASO3 (Glaxo Smith-Kline)<WBR>. Only 3

vaccines using this type of adjuvant (oil-in-water, a.k.a.

squalene-containing<WBR>) have been licensed in Europe, and none have been

given a license i

 

6. The then-Acting DHHS Secretary issued an Emergency Declaration in

response to the swine flu epidemic on April 26, 2009. This allows use of

unapproved (unlicensed) medical treatments and tests, or use of approved

treatments for unapproved uses.

 

According to the Congressional Research Service, on April 27, 2009, the

Food and Drug Administration issued four Emergency Use Authorizations in

response to requests from the CDC to make available certain drugs, diagnostic

tests and respiratory protection devices.

 

_http://opencrs.http://opencrhttp://_ (http://opencrs.com/document/R40560/)

 

7. Vaccines containing MF59 and ASO3 have not had Emergency Use

Authorizations issued for them--yet. However, the government has purchased $698

million dollars' worth of these adjuvants in recent weeks.

 

_http://www.hhs.http://wwhttp://www.hhs.http://www.hhhttp_

(http://www.hhs.gov/news/press/2009pres/07/20090713b.html)

 

_https://www.https://www.<WBRhttps://wwwhttps://wwhttps://www.<WBRhttps_

(https://www.medicalcountermeasures.gov/BARDA/MCM/panflu/factsheet.aspx)

 

US and WHO officials have indicated the likelihood of their use, which is

the only way to achieve adequate amounts of vaccine for the US and world

population in the fall.

 

8. These vaccines have never been demonstrated to be safe in children,

pregnant women or young adults. They have not undergone comprehensive testing;

for example, MF59 has not and will not be tested for carcinogenicity by

the manufacturer.

 

_http://www.fda.http://www.fdahttp://www.fda.http://www.fda.http://www.fda.h

ttp://www.fda.http://wwwhtt_

(http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeeting\

sConferences/ucm095708.pdf)

See page 391 re MF59 carcinogenicity testing, according to a Novartis

scientist.

 

9. The result of the new bioterrorism laws (passed with the expectation of

use for much more dangerous epidemics than the current swine flu), which

allow use of untested products AND give manufacturers an incentive to avoid

comprehensive testing (to avoid being found guilty of willful misconduct)

have combined with the political imperative to provide citizens vaccines in

a hurry, yielding a Perfect Storm.

 

In the 1976 swine flu vaccine program, 40 million people were vaccinated

with an inadequately tested vaccine. The government gave the vaccine

manufacturers immunity from liability, but created an alternative compensation

program. Five thousand people sought benefits for vaccine injuries.

 

Today, untested vaccines with novel adjuvants that are likely to cause

more autoimmune illness than occurred in 1976 will almost certainly be used.

The manufacturers have been given liability, as have the government program

planners. But no compensation mechanism has been created. And the public

has not been informed.

 

Meryl

 

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609