Fw: Feds Designate Dubious Anthrax Emergency

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ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org and http://ahrp.blogspot.com

FYI

Despite the absence of any anthrax infections among Americans, on October

1, 2008 Mike Leavitt, Secretary of the Department of Health and Human

Service (DHHS) declared a seven-year anthrax emergency through the end of

2015.

Below, AHRP board member, Meryl Nass, MD, questions the legitimacy of that

declared Anthrax " emergency, " noting that over the past month, in the

waning

days of the Bush administration, and with no emergency in sight, DHHS is

using the Public Readiness and Emergency Preparedness Act against Americans

(PREPA) to give " blanket immunity from liability to all entities involved

with the manufacturer and distribution of anthrax countermeasures, including

" government program planners. "

The liability provision of PREPA offers broad legal protection for the

makers of drugs, vaccines, and other medical " countermeasures "

used--simply

when the DHHS secretary declares an emergency.

Dr. Nass provides documented background behind this last ditch effort to

expand the market for anthrax vaccine--by increasing the US stockpile of the

vaccine--adding $500 million--and by unleashing the controversial vaccine on

civilians--despite continued doubt about the vaccine's safety.

~~~~~~~~~~~

DHHS designates an anthrax emergency as a means to protect--- ITSELF!

A series of coordinated moves designed to encourage new uses for anthrax

vaccine (whose safety record is terrible and effectiveness unknown)-while

excluding any manufacturer liability for its use, preempting state and local

laws designed to protect citizens, and extending blanket immunity to

government officials who came up with the plan--- is in process.

* First, DHHS Secretary Leavitt declared that the US is in an anthrax

emergency. This invoked the Public Readiness and Emergency Preparedness

Act, giving blanket immunity from liability to all entities involved with

the manufacturer and distribution of anthrax countermeasures, including

" government program planners "

* Second, Leavitt contracted to buy $400 million worth of anthrax

vaccine, in addition to over $500 million currently in DHHS' stockpile

* Third, CDC (a DHHS agency) asked its vaccine advisory committee to

vote on changing its previous recommendation for anthrax vaccine on October

22, potentially expanding its use to civilian " first responders "

* Fourth, the vaccine's manufacturer is constructing a new

manufacturing plant to supply up to 30 million vaccine doses yearly.

* Fifth, CDC conducted a clinical trial of anthrax vaccine in 1564

subjects, but released only partial information on the trial in a JAMA

article published October 1, implying that the vaccine is safe. Yet 229

severe adverse events and 7 deaths occurred in trial participants, but were

barely mentioned in CDC's report.

Background

The original bill under which Secretary Leavitt made his Declaration, the

Public Readiness and Emergency Preparedness Act (PREPA, part of P.L.

109-148) gave the DHHS Secretary the right to declare any disease an

emergency, triggering immunity from liability for any and all injuries due

to countermeasures for that illness, unless " willful misconduct " by

those

who made or administered the product could be proven. The Act fails to

specify any criteria for determining that an emergency exists, and fails to

fund a compensation mechanism. It was tacked on to the end of the 2006

Defense Appropriations Bill during the night, after being removed from

another bill due to its controversial nature. It was passed by Congress and

signed into law on December 30, 2005. Probably few in Congress read it

before approving it along with defense spending. You can read the bill at:

ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Prepar

edness_Act.pdf

In a news release issued after the bill passed, Senator Frist, R-TN said the

measure " extends limited protections to manufacturers, distributors, and

first responders, so that life-saving countermeasures, such as an H5N1 avian

flu vaccine, will be developed, deployed and administered. "

http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liab

ility.html

But Sen. Kennedy, D-Mass., and some other Democrats, along with

consumer groups such as Public Citizen, derided the liability provision as a

giveaway to the drug industry. Kennedy said the bill makes it " essentially

impossible " for injured parties to sue for damages. He also argued that

the

measure allows the HHS secretary to use many common diseases as a reason to

activate the liability shield. " Without a real compensation program, the

liability protection in the defense bill provides a Christmas present to the

drug industry and bag of coal to everyday Americans, " stated a Dec 21 news

release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Dodd,

D-Conn.

The Democratic Senators introduced a new bill to supersede PREPA in February

2006, http://www.fas.org/biosecurity/resource/legislation/s2291.htm

but it never passed.

Where is the Anthrax Emergency?

Over the past month, in the waning days of the Bush administration, and with

no emergency in sight, DHHS is using PREPA against Americans to shield not

only manufacturers and medical professionals, but also to immunize everyone

in government who worked on the plan from any liability for problems that

arise.

Yes, you heard correctly: although the media never reported on this

provision when PREPA was passed, the bill specifically shields " government

program planners " who deal with PREPA's emergencies from all potential

liability.

On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency

under the PREPA Act, through the end of 2015. (That sounds like a very long

emergency-or a very long time to enjoy liability protection.)

http://edocket.access.gpo.gov/2008/E8-23547.htm Despite the current absence

of anthrax infections in Americans, the " emergency " has been

declared, and

the liability shield is already in effect for anthrax vaccine and other

anthrax countermeasures, including antiserum, monoclonal antibodies and

multiple antibiotics.

$500 million in new anthrax vaccine spending

October 1, 2008 was a busy day in the anthrax world. DHHS announced it was

going to purchase an additional 14.5 million doses of anthrax vaccine, for a

cost between $364 and $404 million, to add to its existing stockpile of

about 25 million doses.

http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100102

951.html

The manufacturer, Emergent BioSolutions, crowed about the liability

protection it had just received for the purchase.

http://www.bizjournals.com/baltimore/stories/2008/10/06/daily45.html

Furthermore, on September 26, DHHS announced contracts for a total $113.6

million with Emergent BioSolutions and Pharmathene for development of

" Third

Generation " anthrax vaccines. These too are covered under Secretary

Leavitt's Declaration. What vaccines are these? Emergent bought its

competitor VaxGen's vaccine for $2 million, after taxpayers and investors

paid over $200 million for its development. When in 2006 VaxGen failed to

meet DHHS-specified milestones, its contract was cancelled and the company

folded.

Pharmathene bought Avecia's vaccine, after Avecia received a $100 million

DHHS contract for early vaccine development, but failed to get a more

lucrative contract later.

Bottom line: both these vaccines were rejected by DHHS during the past five

years, only to suddenly arise again, and consume additional taxpayer

largesse. Yet if the current vaccine were truly acceptable, a newer vaccine

would be unnecessary.

Expanding the anthrax vaccine market

If DHHS simply planned to stockpile more anthrax vaccine, its purchase would

just be another example case of government waste. The current stockpile is

expiring at a rate of $10 million per month, as pointed out by GAO last

year.

http://www.washingtonpost.com/wp-dyn/content/article/2007/10/22/AR2007102202

111.html

But DHHS had bigger plans than this. It eyed a new market for the vaccine,

one that might double or quadruple the amount of vaccine now used by the

military, justifying a new manufacturing plant that Emergent is building in

land. There are up to 3 million " First Responders " in the US:

Police,

Firefighters, Emergency Medical Technicians and others. Maybe they could

profitably use the vaccine, since they might someday face an anthrax

emergency.

On October 22, the CDC 's Advisory Committee on Immunization Practices

(ACIP) will vote on whether to overturn its anthrax vaccine recommendations

of 2000 and 2002.

http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf Back then,

ACIP stated that neither the benefit nor the risk for using anthrax vaccine

could not be calculated, and therefore ACIP recommended against its use for

civilians, unless they would be repeatedly exposed to anthrax spores.

2000 Recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm

2002 recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm

Risk-Benefit Analysis, the Basis for Public Health Policy-Except Here

But, you might argue, first responders and other citizens still cannot

assess the risks and benefits of anthrax vaccination. Let that be no

deterrent. As CDC's Messonier pointed out to ACIP members in June,

" The intent of the workgroup was to open the door, knowing that the

vaccine

is commercially available and that first responder groups are at liberty to

call the manufacturer to obtain the vaccine themselves. This is really

meant to give them more impetus by saying that even if they do not have a

calculated risk assessment, individuals or groups can assess their own risk,

and weigh the risks and benefits of the vaccine with their occupational

health and safety programs. "

http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

CDC's Messonier tossed aside the most basic public health requirement, by

suggesting that first responders can weigh their own risk, even though the

vaccine's safety and efficacy remain in doubt, and the risk of anthrax is

unknown! CDC doesn't want that little omission to stand in the way of

receiving the vaccine: especially when ACIP members and all CDC, FDA and

DHHS employees are shielded from liability for uninformed and ill-considered

recommendations. CDC seems to have accurately calculated its own

risk/benefit equation.

Meryl Nass, MD

October 14, 2008

Here is an excellent discussion of the 2005 PREPA Bill:

http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liab

ility.html

Pandemic funding, liability shield clear Congress

Dec 28, 2005 (CIDRAP News) - Before adjourning last week, the US Senate

passed and sent to President Bush a bill providing $3.8 billion for pandemic

influenza preparedness and a controversial liability shield for those who

produce and administer drugs and vaccines used in a declared public health

emergency.

The preparedness funding and liability protection were part of the fiscal

year 2006 defense spending bill passed by the Senate on the evening of Dec

21. The bill had cleared the House 2 days earlier.

The $3.8 billion for pandemic preparedness is a little more than half of the

$7.1 billion Bush had requested in early November. House Republican leaders

said last week the measure would fund roughly the fiscal year 2006 portion

of Bush's request.

As reported previously, the amount includes $350 million to improve state

and local preparedness and directs the Department of Health and Human

Services (HHS) to use most of the rest on " core preparedness

activities, "

including increasing vaccine production capacity, developing vaccines, and

stockpiling antiviral drugs.

The liability provision offers broad legal protection for the makers of

drugs, vaccines, and other medical " countermeasures " used when the

HHS

secretary declares an emergency. The provision says people claiming injury

from a medical countermeasure can sue only if they prove " willful

misconduct " by those who made or administered it. The bill calls for

Congress to set up a compensation program for injuries, but it provides no

funds for that purpose.

Senate Majority Leader Bill Frist, R-Tenn., and other Republican leaders

argued that the liability measure was necessary to induce biotechnology

companies to develop products to counter pandemic flu and other disease

threats.

In a news release issued after the bill passed, Frist said the measure

" extends limited protections to manufacturers, distributors, and first

responders, so that life-saving countermeasures, such as an H5N1 avian flu

vaccine, will be developed, deployed and administered. "

He added that the bill " strikes a reasonable balance where those who are

harmed will be fairly compensated and life-saving products will be available

in ample supply to protect and treat as many Americans as possible. "

But Sen. Kennedy, D-Mass., and some other Democrats, along with

consumer groups such as Public Citizen, derided the liability provision as a

giveaway to the drug industry. Kennedy said the bill makes it " essentially

impossible " for injured parties to sue for damages. He also argued that

the

measure allows the HHS secretary to use many common diseases as a reason to

activate the liability shield.

" Without a real compensation program, the liability protection in the

defense bill provides a Christmas present to the drug industry and bag of

coal to everyday Americans, " stated a Dec 21 news release issued by

Kennedy

and Sens. Tom Harkin, D-Iowa, and Dodd, D-Conn.

The liability protection language, called the Public Readiness and Emergency

Preparedness Act, was tacked onto the end of the huge defense-spending bill

(H.R. 2863).

It gives the HHS secretary authority to trigger the liability protection by

declaring an emergency if he or she determines that a disease or other

health threat represents an emergency or may constitute an emergency in the

future. The act does not list any criteria for determining the existence of

an emergency. The declaration would have to list the diseases, populations,

and geographic areas covered and when the emergency would end.

Such an emergency declaration is not subject to court review, and it

preempts any conflicting laws or regulations of states or local communities,

the act says.

The measure says those who make and administer medical countermeasures

covered by an emergency declaration are immune to lawsuits unless the

plaintiff can provide clear evidence of willful misconduct that resulted in

death or serious physical injury. " Willful misconduct " is ruled out

if the

party who administered the treatment followed HHS recommendations and

notified health authorities of the relevant injury within 7 days.

In addition, the act instructs the HHS secretary to write regulations

" that

further restrict the scope of actions or omissions by a covered person "

that

constitute willful misconduct.

A party alleging " willful misconduct " can file suit only in US

District

Court in Washington, DC. The plaintiff must have an affidavit supporting the

suit from a physician who did not treat the injured person. Before any suit

can go to trial, a three-judge panel will consider any pretrial motions.

The act says that an HHS emergency declaration will trigger the

establishment of a fund to provide " timely, uniform, and adequate

compensation " to anyone injured by covered medical countermeasures.

However,

the measure does not appropriate money for the fund.

A person claiming injury from a covered treatment may not sue without first

trying to collect from the compensation fund. But that requirement applies

only if the compensation program has been funded. A person can sue if HHS

fails to act on the request for compensation within 240 days.

If a plaintiff accepts an award from the compensation fund, he or she is

barred from suing anyone, the act provides.

In arguing that the liability shield is too broad, Kennedy said in his news

release, " The Bush administration could identify Vioxx as a needed

countermeasure to treat the arthritis epidemic or to treat pain associated

with flu, and completely immunize Merck [the manufacturer] from lawsuits

currently pending against it. "

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