This letter puts in a nutshell the recent news on anthrax vaccine purchases, liability shields and change in CDC guidelines on use of anthrax vaccine

[Guest guest]

October 23, 2008

Dear Representative --------,

I am writing with concerns about a liability shield just issued for

anthrax vaccine, a huge new waste of government funds in anthrax

vaccine purchases by DHHS, and expansion of anthrax vaccinations to

civilian first responders, which is poised to begin after a CDC

Advisory Committee on Immunization Practices (ACIP) vote this

Wednesday, October 22, 2008.

A controversial bill, the Public Readiness and Emergency Preparedness

Act (PREPA, Division C of P.L. 109-148) passed in December 2005. A CRS

report on this bill reveals that the bill provides almost complete

immunity from liability for manufacturers of “covered

countermeasures,” preempts state and local laws, and extends blanket

immunity to “government program planners.”

(http://www.usembassy.at/en/download/pdf/medical_biodefense.pdf

)

On October 1, 2008 DHHS Secretary Leavitt, in consultation with DHS

Secretary Chertoff, issued a Declaration of an anthrax emergency,

invoking the provisions of PREPA for anthrax countermeasures through

2015 (http://www.kansascity.com/105/story/846427.html)

(http://edocket.access.gpo.gov/2008/E8-23547.htm

). On October 10, additional Declarations were issued for smallpox,

botulinum toxin and radiation sickness emergencies. Secretary Chertoff

acknowledged to Secretary Leavitt in a September 23, 2008 memorandum

there was no evidence of an anthrax emergency, but that the non-

negligible risk of a future anthrax epidemic was sufficient to declare

an emergency and trigger PREPA’s liability protections.

(http://www.dhs.gov/xlibrary/assets/

ofsec_signed_determination092308.pdf).

On October 1, DHHS contracted to buy an additional 14.5 million doses

of anthrax vaccine at a cost of $364-404 million dollars, although

DHHS already has about 25 million doses stored or on order, which cost

taxpayers $500 million.

(http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100102951\

..html

). Yet a 2007 GAO Report discussing anthrax vaccine noted that,

" Officials from the [DOD Vaccine Healthcare Centers] VHC Network and

CDC estimate that between 1 and 2 percent of immunized individuals may

experience severe adverse events, which could result in disability or

death. " (http://www.gao.gov/cgi-bin/getrpt?GAO-07-787R) GAO also noted

in October 2007 that $10 million worth of anthrax vaccine was expiring

monthly in DHHS’ stockpile.

(http://www.washingtonpost.com/wp-dyn/content/article/2007/10/22/AR2007102202111\

..html

).

The CDC recently asked its Advisory Committee on Immunization

Practices to change its 2000 and 2002 recommendations, which it did,

making anthrax vaccine available to civilian first responders, a group

of 3 million people. The vote took place on October 22-23, and

coincided with the loss of legal protections for recipients.

Although this is an extraordinarily difficult and busy period for

legislators, I hope you will agree that invoking nonexistent

emergencies drastically reduces the constitutionally guaranteed right

of redress for recipients of “covered countermeasures” such as anthrax

vaccine, while at the same time, the recipient pool is about to expand

to civilians.

Would you please help overturn this egregious assault on our civil

rights? PREPA should be revoked. Emergency declarations should be

limited to true emergencies. Liability shields encourage the

production and use of untested or sloppily manufactured drugs, and

should be used only with great care.

CDC has failed to share detailed safety data from its own 2002-2006

clinical trial of anthrax vaccine recipients with the public; yet

there were 229 severe adverse events and 7 deaths during the trial.

CDC should follow the precautionary principle with respect to this

controversial vaccine, which has demonstrated neither safety nor

efficacy in humans. In particular, CDC should not encourage new,

expanded use of vaccine in the wake of reduced legal protections for

recipients. A myriad of poor outcomes may result from providing

anthrax vaccine to up to 3 million first responders.

I would be happy to provide additional information to your staff, and

was very glad to have met with you and several of your staff to

discuss anthrax vaccine over the past several years.

Sincerely yours,

Meryl Nass, MD

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

W 207 288-5081 ext. 1220

C 207 522-5229

H 207 244-9165

pager 207 818-0708

http://anthraxvaccine.blogspot.com

http://www.anthraxvaccine.org