U.S. Limits Anthrax Vaccine Liability--Global Security Newswire

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U.S. Limits Anthrax Vaccine Liability--Global Security Newswire

Elaine Grossman

Global Security Newswire Oct. 17, 2008

WASHINGTON - The U.S. Health and Human Services Department early this

month moved to shield government, industry and business officials from

lawsuits filed by those who have received the anthrax vaccine (see GSN

<http://www.nti.org/d_newswire/issues/2007/9/5/14e90604-dd3f-42d1-9285-34ea695db\

21a.html

> , Sept. 5, 2007).

Health and Human Services Secretary Leavitt established legal

immunity for public and private officials who oversee the production

or distribution of the anthrax vaccine by declaring a " public health

emergency " due to the risk of a bioterrorism attack. He said the

emergency began on Oct. 1 and would run through Dec. 31, 2015.

U.S. law provides protection from lawsuits to individuals responsible

for selected countermeasures, including antibiotics, during a declared

emergency. Under the Public Readiness and Emergency Preparedness Act,

which President W. Bush signed into law in December 2005, a

health and human services secretary's emergency declaration can limit

financial risk for government program planners and the manufacturers

or distributors of pharmaceutical countermeasures. One exception to

this immunity would be willful misconduct on the part of covered

individuals. The ramifications, in this instance, could be to prevent

individuals who have received one or more anthrax inoculations from

taking grievances to court, based on claims that the vaccine caused

severe adverse reactions or did not work. The anthrax vaccine has

proven particularly controversial following reports of serious adverse

events, including some deaths, among U.S. recipients (see GSN

<http://www.nti.org/d_newswire/issues/2005/11/21/e6ab1e9c-4ae3-42ff-b9fa-87b14ca\

99111.html

> , Nov. 21, 2005).

In addition, there are some doubts about the vaccine's efficacy in

protecting people from developing anthrax after breathing in spores

during a biological attack. A 2003 lawsuit - based on lapses in the

Food and Drug Administration's drug-approval process for the vaccine -

temporarily shut down the Defense Department's compulsory anthrax

shots program. Mandatory inoculations resumed in 2006 for personnel

whose assignments are judged to put them at heightened risk of

exposure to anthrax (see GSN

<http://www.nti.org/d_newswire/issues/2005/12/16/da976f97-51ae-4b2c-a63f-b6a5fd5\

92234.html

> , Dec. 16, 2005).

Leavitt's declaration <http://edocket.access.gpo.gov/2008/E8-23547.htm

> was published in the Federal Register and quietly heralded at the

end of a two-page news release

<http://www.hhs.gov/news/press/2008pres/10/20081001a.html

> devoted largely to another anthrax-related initiative (see GSN

<http://www.nti.org/d_newswire/issues/2008/10/2/bf39cf1b-7298-474d-86f1-11d56160\

bd70.html

> , Oct. 2).

Among the activities now afforded liability protection are those

" related to developing, manufacturing, distributing, prescribing,

dispensing, administering and using anthrax countermeasures in

preparation for, and in response to, a potential anthrax attack, " the

HHS news release states. " This includes entities, such as large 'big-

box' retail stores, retail pharmacies, and other private sector

businesses, that help to deliver and distribute medicines. " Health and

Human Services argued the legal shield is essential to guarantee that

countermeasures are there if U.S. citizens need them. " Providing

liability protection to all involved in such efforts will help ensure

their full participation and bolster response efforts, " according to

the news release. " Preparedness is a shared responsibility that must

involve all sectors of society, including the private sector,

community groups, families and individuals, " Leavitt stated in the

release. " We are using the authorities available to us to do all we

can to support preparedness at all levels. "

The move comes as a pivotal advisory group convened by the U.S.

Centers for Disease Control and Prevention prepares to decide whether

state and local health officials should consider giving anthrax

vaccines to as many as 3 million civilian first responders nationwide

(see GSN

<http://www.nti.org/d_newswire/issues/2008/10/16/55608b41-33c1-4553-8ce0-7a70426\

c4771.html

> , Oct. 16).

Millions of U.S. military personnel have already received the vaccines

since the Pentagon's shots program began in 1997, but the law

prohibits service members or their families from holding the

government liable for injury or death. Now that the population of

vaccine recipients could expand to include millions of civilians - who

normally do have a right to take medical injury claims to court -

federal response planners and government contractors might be growing

nervous about their potential legal vulnerability, according to

vaccine critics. " There are people still getting ill from side effects

and from the vaccine, " Michels, an attorney in litigation

targeting the Pentagon's inoculation program, told Global Security

Newswire this week. " When they expand this vaccine from the military

population to a civilian population, they're going to have people who

sue. "

Emergent BioSolutions of Rockville, Md. - the nation's only

manufacturer of an FDA-approved anthrax vaccine - recently announced

<http://www.emergentbiosolutions.com/NewsReleases.aspx?ReleaseID=1204156

> that Health and Human Services had ordered 14.5 million doses of

its BioThrax vaccine, worth as much as $404 million. The company is

already under a $448 million contract to produce 18.8 million doses of

the vaccine. The vaccine regimen calls for six shots over an 18 month

period, plus annual boosters.

Michels said commercial interests appear to be playing a role in the

legal immunity issue. He questioned whether there had been any bona

fide escalation in the anthrax threat sufficient to justify the

declaration of an emergency. " We have no indications [now] ... that

we're much more likely to be attacked by anthrax, " Michels said. " But

[government officials] see the writing on the wall. They see ... an

erosion of [lawsuit] immunity for vaccine manufacturers as a result of

widespread civilian use. "

Meryl Nass, a bioterrorism expert who has been highly critical of

federal handling of anthrax vaccine issues, accused Leavitt of taking

more interest in protecting bureaucrats from legal action than in

protecting the public from health threats. " How do you decide there is

an emergency when there is no evidence of one? " she asked in e-mailed

comments last week. Noting the HHS secretary's designation of

" governmental program planners " as among those afforded legal immunity

by the declaration, Nass asserted that the agency " designates an

emergency as a means to protect itself. "

Leavitt's declaration, though, states that " targeted liability

protections for anthrax countermeasures " are " based on a credible risk

that the threat of exposure to [anthrax] and the resulting disease

constitutes a public health emergency. " The document does not offer

additional details on the nature or level of threat. A request that

Health and Human Services elaborate on the basis for the public health

emergency declaration went unanswered at press time.

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

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