A Booster Shot for Pandemic Preparedness?

[Guest guest]

The following essay responds to Clerici's opinion editorial, " A Booster

Shot for Pandemic Preparedness, " July 31, 2006. The original opinion

editorial is available at Mr. Clerici's law firm's website:

http://www.mckennalong.com/news-inthe-1741.html.

Mr. Clerici makes interesting recommendations such as, " Congress should act

now to provide additional incentives, such as expanded liability protection

to businesses that make reasonable and prudent efforts to prepare for a

pandemic. " The objectivity of this recommendation can be placed in context

when the readers become aware that the column failed to mention that Clerici

is a lobbyist for Emergent Biosolutions (formerly known as BioPort), the

maker of a decades-old anthrax vaccine. Liability for vaccine adverse

reactions certainly would be less severe if the company was immunized.

Mr. Clerici is correct that millions of Anthrax Vaccine doses were procured

by the US Government in the rush for the previous non-validated manufacturer

to be reopened following the domestic anthrax letters attack in the fall of

2001, resulting in five deaths. But according to the Center for Disease

Control's Deputy Director, Gerberding, none of the 10,000 plus workers

from the Congressional offices and Postal workers who received the

antibiotic regimen developed Anthrax[1]. Therefore, the false logic that

the anthrax vaccine plays any part in a pandemic preparedness is a

nonstarter.

According to the anthrax vaccines own product label[2], updated in January

2002, six deaths have been attributed to the anthrax vaccine, and 5-35% of

recipients can expect to experience a systemic reaction. In December 2004,

the FDA stated that the anthrax vaccine from BioPort could be linked to 16

deaths, and in November of 2005 the number rose to 21.[3] In December of

2005 the Department of Defense (DoD) was exposed for not reporting to

Congress over 20,000 hospitalizations that involved troops that received the

anthrax vaccine.[4] In addition to this adverse reaction profile, the FDA

also warns that evidence exists from a US Navy study about pregnancy risk of

congenital birth defects.[5]

In December 2005 the FDA attempted to shield the manufacturer through new

licensing, but the Government Accountability Office (GAO) remains more

objective. In GAO Testimony before the U.S. House Subcommittee on National

Security, Emerging Threats and International Relations on May 6, 2006

compelling testimony about the old anthrax vaccine was placed on the record.

[6] GAO effectively dismissed the FDA's new licensing of anthrax vaccine

and reaffirmed myriad negative findings.

GAO identified a number of problems with the licensed anthrax vaccine.

" These included . long-term and short-term safety of the vaccine . (and)

uncertainty about the vaccine's efficacy. " As well, considering the DC

District court found and upheld a ruling about the vaccine's illegal

mandatory use by the DoD, the GAO continued to reaffirm that " DoD's studies,

while showing some positive results, may not be extrapolated to humans. "

GAO also reminded the Congress that the " current anthrax vaccine may have

diminished efficacy against certain virulent strains of anthrax. "

This last point is particularly compelling considering our government has

spent, and is allocating billions of dollars into drugs and vaccines to

fight bioterrorism and pandemics. This approach however does not pass the

common sense test, given that pathogens can be biogenetically engineered or

they can mutate, thus making that drug or vaccine useless.[7]

It should also be addressed that the billions of dollars being spent on

countermeasures for biodefense and pandemics doesn't account for future

monies to treat adverse events or compensate the victims from these

countermeasures. In fact, in all the bills on bioterrorism and pandemics,

any forethought for recipients is non-existent. This of course is not the

case for the manufacturers thanks to the efforts of Mr. Clerici, and others,

such as Sen. Frist. In 2006 Sen. Frist added to the DoD's Appropriations

bill legal language that indemnified manufacturer's from liability for their

products when used in a national emergency, whether it's a pandemic or

bioterrorism, and whether those threats are real or speculated. Any person

acting on behalf of the Government is also not responsible for what happens

to the recipients. Looks like those who Mr. Clerici has consulted for, and

Sen. Frist, will be off the hook.

Emergent Biosolutions announced on August 29, 2006 that it has applied for

and been granted its safety application that originated from the Safety Act

of 2002. In short, the Safety Act provides:

a.. Exclusive jurisdiction in federal court for suits against the Sellers

of " qualified anti-terrorism technologies "

b.. A limitation on the liability of Sellers of qualified anti-terrorism

technologies to an amount of liability insurance coverage specified for each

individual technology, provided that Sellers will not be required to obtain

any more liability insurance coverage than is reasonably available " at

prices and terms that will not unreasonably distort the sales price " of the

technology;

c.. A prohibition on joint and several liability for non-economic damages,

so that Sellers can only be liable for that percentage of non-economic

damages proportionate to their responsibility for the harm;

d.. A complete bar on punitive damages and prejudgment interest;

e.. A reduction of plaintiffs' recovery by amounts plaintiffs received

from " collateral sources " , such as insurance benefits and other government

benefits; and

f.. A rebuttable presumption that the seller is entitled to the

" government contractor defense " , provided that its " Qualified Anti-Terrorism

Technology " also is certified by DHS as an " Approved Product for Homeland

Security " .

American Taxpayers - you have been had, and it's costing billions of

dollars. You have also lost your constitutional right of seeking redress

through the judicial process.

Clearly Mr. Clerici has written a compelling essay in line with his

employment as a consultant for a pharmaceutical manufacturer, but in doing

so he omitted critical information, an objective portrayal of facts and

risks, and therefore misled his readers. Fortunately in America we have the

right to identify misinformation from paid spokespersons when they're

misleading our Citizens.

Rather than creating then passing hasty and dangerous bills which are doing

nothing more than empowering pharmaceutical companies and putting Americans

at dire risk, Congress actually needs to stop and address the challenges as

opposed to implementing quick and deadly fixes. Congress also needs to

involve more individuals/organizations outside of the PHARMA industry to

address these concerns in an unbiased collaborative effort. A quick and

one-sided plan can be deadlier and more chaotic than no plan.

Randi J. Airola

randiceaj@...

517-819-5926

Competing interest: Veteran

--------------------------------------------------------------------------------

[1] http://www.bt.cdc.gov/DocumentsApp/Anthrax/12212001/postalworkers.pdf -

page 5

[2] http://www.emergentbiosolutions.com/pdf/emergent_biothrax_us.pdf

[3]

http://www.nti.org/d_newswire/issues/2005/11/21/e6ab1e9c-4ae3-42ff-b9fa-87b14ca9\

9111.html

[4] http://www.dailypress.com/news/local/dp-anth-day1dec02,0,6152311.story

[5] http://www.obfocus.com/reference/Formulary/FDACategory.htm

[6] http://reform.house.gov/UploadedFiles/%20May%209%20Testimony.pdf

[7]

http://www.washingtonpost.com/wp-dyn/content/article/2006/07/30/AR2006073000580.\

html?referrer=email

Randi Airola

517-819-5926

When Good People do Nothing....

" Today Americans would be outraged if U. N. troops entered Los Angeles to

restore order; tomorrow they will be grateful! This is especially true if

they were told there was an outside threat from beyond, whether real or

promulgated, that threatened our very existence. It is then that all people

of the world will plead with world leaders to deliver them from this evil.

The one thing every man fears is the unknown. When presented with this

scenario, individual rights will be willingly relinquished for the guarantee

of their well being granted to them by their world government. "

~ Henry Kissinger

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