HHS Declares Emergency, Limits Anthrax Vaccine Legal Liability

Damn that Bush Administration is sneaky.

Apparently Secretary Michael Levitt, who is rumored to be telling people in his church parking lot that he knows that mercury in vaccines causes autism, whose department conceded that vaccines caused Hannah Poling's autism, and who will not release the Poling case files to the Polings so that they can understand what reasoning HHS used in making that determination, has declared a "public health emergency" citing the high risk of an anthrax attack on the United States. This "emergency" is set to expire in 2015.

The action that needed to be taken due to this "emergency"? That anthrax vaccine makers will have limited liability for their product. And not just the makers, from what I can see everyone from the CEO who green lights the vaccine, to the government official who mandates it, to the company that distributes it and even down to the guy who puts the needle into your body, they are all covered if you are disabled or killed by the shot.

Mind you it has been 7 years since the anthrax attack on this country, which the government believes came from one of its own researchers, but NOW we are declaring an emergency. I have seen nothing in the media that the US has evidence of a credible anthrax threat. And how exactly Levitt can predict that the threat will last seven years... well I am really interested in hearing more about the reasoning behind that.

1 in 150 children have autism and seventeen percent of children have a developmental disorder or delay and that is not big deal, parents should get used to it. But zero people are coming down with anthrax, and an emergency is declared and no explanation is given as to why.

This following the rash of reports of serious damage to military personnel due to the anthrax vaccine.

Well you heard him Pharma, one more product that you can make, get the government to force people to buy and you don't even have to make sure that it works or doesn't kill people! Man you guys have hit the jackpot! Start pouring money into that Anthrax R&D pipline!

Buy Merck!

UPDATE: The Kansas City Star is reporting that in addition to the anthrax emergency declaration:

"On Oct. 10, he declared health emergencies for smallpox, radiation sickness from the detonation of a nuclear device and poisoning from botulinum toxins, the active ingredient of Botox."

So in addition to the anthrax vaccine...

"The emergency declarations cover a host of antibiotics to fight anthrax infection, anthrax and smallpox vaccines, and a drug to stimulate white blood cell production in people harmed by radiation."

While Leavitt has not commented, his science adviser has,

"Health and Human Services is not invoking the law in response to any immediate threat, said William Raub, science adviser to Leavitt. “We don’t believe there’s anything imminent,” he said. “We’ve tried to be careful to not instill fear in people, (but) if we wait until the day of an event, valuable time is lost … and people could die.”

So they are admitting that there is not any intelligence that the US is facing a bioweapons attack. But they have redefined and "emergency" to mean 'the threat of an emergency'. This would be like looking at the weather map and seeing no hurricanes in the gulf, none forming in the pacific yet declaring a hurricane "emergency" in Tampa (because they could be hit by one in the next seven years) and start giving out FEMA funds to builders there.

Again... autism not an emergency, even though families, school systems and state governments are going broke trying to care for these children... anthrax is an emergency just because one day it might, maybe, eventually be an emergency.

The threat of an emergency is not an emergency.

It is astonishing to me that the Bush administration can so blithely remove the rights of citizens, with no reasonable justification, with apparently little input from the public as our community didn't know about this and actually pat themselves on the back as if they were doing a good thing.

This just makes me angry.

U.S. Limits Anthrax Vaccine Legal Liability

From Friday, October 17, 2008 issue.

By Elaine M. Grossman
Global Security Newswire

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, Sept. 5, 2007).

Health and Human Services Secretary Michael 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 George 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, 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, Dec. 16, 2005).

Leavitt’s declaration was published in the Federal Register and quietly heralded at the end of a two-page news release devoted largely to another anthrax-related initiative (see GSN, 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, 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,” John 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 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.