My letter explaining the October PREPA Declaration, new anthrax vaccine purchases, the CDC vote on civilian vaccinations and their impact

October 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 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.”

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) . 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.

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. 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." GAO also noted in October 2007 that $10 million worth of anthrax vaccine was expiring monthly in DHHS’ stockpile.

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