OT: Feds designate dubious anthrax emergency-- article

[Guest guest]

October surprise!

Subject: Feds Designate Dubious Anthrax " Emergency "

To: " Infomail1ahrp (DOT) org "

Date: Wednesday, October 15, 2008, 6:55 AM

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 Chris

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. "

[Guest guest]

This is CRAZY! What about all of the military personnel who have already sustained damage from the anthrax vaccine?

Aasa

Subject: OT: Feds designate dubious anthrax "emergency"-- articleTo: EOHarm Received: Wednesday, October 15, 2008, 8:26 PM

October surprise! From: VERACARE <veracareahrp (DOT) org>Subject: Feds Designate Dubious Anthrax "Emergency"To: "Infomail1ahrp (DOT) org" <Infomail1ahrp (DOT) org>Date: Wednesday, October 15, 2008, 6:55 AMALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp. org and http://ahrp. blogspot. com FYIDespite the absence of any anthrax infections among Americans, on October1, 2008 Mike Leavitt, Secretary of the Department of Health and HumanService (DHHS) declared a seven-year anthrax emergency through the end of2015.Below, AHRP board member, Meryl Nass, MD,

questions the legitimacy of thatdeclared Anthrax "emergency," noting that over the past month, in thewaningdays of the Bush administration, and with no emergency in sight, DHHS isusing the Public Readiness and Emergency Preparedness Act against Americans(PREPA) to give "blanket immunity from liability to all entities involvedwith the manufacturer and distribution of anthrax countermeasures, including"government program planners." The liability provision of PREPA offers broad legal protection for themakers of drugs, vaccines, and other medical "countermeasures"used--simplywhen the DHHS secretary declares an emergency. Dr. Nass provides documented background behind this last ditch effort toexpand the market for anthrax vaccine--by increasing the US stockpile of thevaccine--adding $500 million--and by unleashing the controversial vaccine oncivilians--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 anthraxvaccine (whose safety record is terrible and effectiveness unknown)-whileexcluding any manufacturer liability for its use, preempting state and locallaws designed to protect citizens, and extending blanket immunity togovernment officials who came up with the plan--- is in process.* First, DHHS Secretary Leavitt declared that the US is in an anthraxemergency. This invoked the Public Readiness and Emergency PreparednessAct, giving blanket immunity from liability to all entities involved withthe manufacturer and distribution of anthrax countermeasures, including"government program planners" * Second, Leavitt contracted to buy $400 million worth of

anthraxvaccine, in addition to over $500 million currently in DHHS' stockpile * Third, CDC (a DHHS agency) asked its vaccine advisory committee tovote on changing its previous recommendation for anthrax vaccine on October22, potentially expanding its use to civilian "first responders" * Fourth, the vaccine's manufacturer is constructing a newmanufacturing plant to supply up to 30 million vaccine doses yearly. * Fifth, CDC conducted a clinical trial of anthrax vaccine in 1564subjects, but released only partial information on the trial in a JAMAarticle published October 1, implying that the vaccine is safe. Yet 229severe adverse events and 7 deaths occurred in trial participants, but werebarely mentioned in CDC's report. BackgroundThe original bill under which Secretary Leavitt made his Declaration, thePublic Readiness and Emergency Preparedness Act (PREPA,

part of P.L.109-148) gave the DHHS Secretary the right to declare any disease anemergency, triggering immunity from liability for any and all injuries dueto countermeasures for that illness, unless "willful misconduct" bythosewho made or administered the product could be proven. The Act fails tospecify any criteria for determining that an emergency exists, and fails tofund a compensation mechanism. It was tacked on to the end of the 2006Defense Appropriations Bill during the night, after being removed fromanother bill due to its controversial nature. It was passed by Congress andsigned into law on December 30, 2005. Probably few in Congress read itbefore approving it along with defense spending. You can read the bill at:ftp://ftp.hrsa. gov/countermeasu rescomp/Public_

Readiness_ and_Emergency_Preparedness_Act.pdfIn a news release issued after the bill passed, Senator Frist, R-TN said themeasure "extends limited protections to manufacturers, distributors, andfirst responders, so that life-saving countermeasures, such as an H5N1 avianflu vaccine, will be developed, deployed and administered. "http://www.cidrap. umn.edu/cidrap/ content/influenz a/biz-plan/news/dec2805li ability.html But Sen. Kennedy, D-Mass., and some other Democrats, along withconsumer groups such as Public Citizen, derided the liability provision as agiveaway to the drug industry. Kennedy said the bill makes it "essentiallyimpossible" for injured parties to sue for damages. He also argued thatthemeasure allows the HHS secretary to use many common diseases

as a reason toactivate the liability shield. "Without a real compensation program, theliability protection in the defense bill provides a Christmas present to thedrug industry and bag of coal to everyday Americans," stated a Dec 21 newsrelease issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Dodd,D-Conn.The Democratic Senators introduced a new bill to supersede PREPA in February2006, http://www.fas. org/biosecurity/ resource/ legislation/ s2291.htmbut it never passed.Where is the Anthrax Emergency?Over the past month, in the waning days of the Bush administration, and withno emergency in sight, DHHS is using PREPA against Americans to shield notonly manufacturers and medical professionals, but also to immunize everyonein government who worked on the

plan from any liability for problems thatarise.Yes, you heard correctly: although the media never reported on thisprovision when PREPA was passed, the bill specifically shields "governmentprogram planners" who deal with PREPA's emergencies from all potentialliability.On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergencyunder the PREPA Act, through the end of 2015. (That sounds like a very longemergency-or a very long time to enjoy liability protection.)http://edocket. access.gpo. gov/2008/ E8-23547. htm Despite the current absenceof anthrax infections in Americans, the "emergency" has beendeclared, andthe liability shield is already in effect for anthrax vaccine and otheranthrax countermeasures, including antiserum, monoclonal antibodies andmultiple

antibiotics. $500 million in new anthrax vaccine spendingOctober 1, 2008 was a busy day in the anthrax world. DHHS announced it wasgoing to purchase an additional 14.5 million doses of anthrax vaccine, for acost between $364 and $404 million, to add to its existing stockpile ofabout 25 million doses.http://www.washingt onpost.com/ wp-dyn/content/ article/2008/ 10/01/AR20081001 02951.html The manufacturer, Emergent BioSolutions, crowed about the liabilityprotection it had just received for the purchase.http://www.bizjourn als.com/baltimor e/stories/ 2008/10/06/ daily45.html Furthermore, on September 26, DHHS announced contracts for a total $113.6million with Emergent BioSolutions and

Pharmathene for development of"ThirdGeneration" anthrax vaccines. These too are covered under SecretaryLeavitt's Declaration. What vaccines are these? Emergent bought itscompetitor VaxGen's vaccine for $2 million, after taxpayers and investorspaid over $200 million for its development. When in 2006 VaxGen failed tomeet DHHS-specified milestones, its contract was cancelled and the companyfolded. Pharmathene bought Avecia's vaccine, after Avecia received a $100 millionDHHS contract for early vaccine development, but failed to get a morelucrative contract later. Bottom line: both these vaccines were rejected by DHHS during the past fiveyears, only to suddenly arise again, and consume additional taxpayerlargesse. Yet if the current vaccine were truly acceptable, a newer vaccinewould be unnecessary.Expanding the anthrax vaccine marketIf DHHS simply planned to

stockpile more anthrax vaccine, its purchase wouldjust be another example case of government waste. The current stockpile isexpiring at a rate of $10 million per month, as pointed out by GAO lastyear.http://www.washingt onpost.com/ wp-dyn/content/ article/2007/ 10/22/AR20071022 02111.htmlBut 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 themilitary, justifying a new manufacturing plant that Emergent is building inland. There are up to 3 million "First Responders" in the US:Police,Firefighters, Emergency Medical Technicians and others. Maybe they couldprofitably use the vaccine, since they might someday face an anthraxemergency.On October 22, the CDC 's Advisory Committee on Immunization

Practices(ACIP) will vote on whether to overturn its anthrax vaccine recommendationsof 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 vaccinecould not be calculated, and therefore ACIP recommended against its use forcivilians, 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. htmRisk-Benefit Analysis, the Basis for Public

Health Policy-Except HereBut, you might argue, first responders and other citizens still cannotassess the risks and benefits of anthrax vaccination. Let that be nodeterrent. As CDC's Messonier pointed out to ACIP members in June, "The intent of the workgroup was to open the door, knowing that thevaccineis commercially available and that first responder groups are at liberty tocall the manufacturer to obtain the vaccine themselves. This is reallymeant to give them more impetus by saying that even if they do not have acalculated risk assessment, individuals or groups can assess their own risk,and weigh the risks and benefits of the vaccine with their occupationalhealth and safety programs."http://www.cdc. gov/vaccines/ recs/ACIP/ downloads/ min-jun08. pdfCDC's

Messonier tossed aside the most basic public health requirement, bysuggesting that first responders can weigh their own risk, even though thevaccine's safety and efficacy remain in doubt, and the risk of anthrax isunknown! CDC doesn't want that little omission to stand in the way ofreceiving the vaccine: especially when ACIP members and all CDC, FDA andDHHS employees are shielded from liability for uninformed and ill-consideredrecommendations. CDC seems to have accurately calculated its ownrisk/benefit equation. Meryl Nass, MDOctober 14, 2008Here is an excellent discussion of the 2005 PREPA Bill: http://www.cidrap. umn.edu/cidrap/ content/influenz a/biz-plan/news/dec2805li ability.html Pandemic funding, liability shield clear CongressDec 28, 2005 (CIDRAP News) -

Before adjourning last week, the US Senatepassed and sent to President Bush a bill providing $3.8 billion for pandemicinfluenza preparedness and a controversial liability shield for those whoproduce and administer drugs and vaccines used in a declared public healthemergency.The preparedness funding and liability protection were part of the fiscalyear 2006 defense spending bill passed by the Senate on the evening of Dec21. 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 leaderssaid last week the measure would fund roughly the fiscal year 2006 portionof Bush's request.As reported previously, the amount includes $350 million to improve stateand local preparedness and directs the Department of Health and

HumanServices (HHS) to use most of the rest on "core preparednessactivities,"including increasing vaccine production capacity, developing vaccines, andstockpiling antiviral drugs.The liability provision offers broad legal protection for the makers ofdrugs, vaccines, and other medical "countermeasures" used when theHHSsecretary declares an emergency. The provision says people claiming injuryfrom a medical countermeasure can sue only if they prove "willfulmisconduct" by those who made or administered it. The bill calls forCongress to set up a compensation program for injuries, but it provides nofunds for that purpose.Senate Majority Leader Bill Frist, R-Tenn., and other Republican leadersargued that the liability measure was necessary to induce biotechnologycompanies to develop products to counter pandemic flu and other diseasethreats.In a news

release issued after the bill passed, Frist said the measure"extends limited protections to manufacturers, distributors, and firstresponders, so that life-saving countermeasures, such as an H5N1 avian fluvaccine, will be developed, deployed and administered. "He added that the bill "strikes a reasonable balance where those who areharmed will be fairly compensated and life-saving products will be availablein ample supply to protect and treat as many Americans as possible."But Sen. Kennedy, D-Mass., and some other Democrats, along withconsumer groups such as Public Citizen, derided the liability provision as agiveaway to the drug industry. Kennedy said the bill makes it "essentiallyimpossible" for injured parties to sue for damages. He also argued thatthemeasure allows the HHS secretary to use many common diseases as a reason toactivate the liability

shield."Without a real compensation program, the liability protection in thedefense bill provides a Christmas present to the drug industry and bag ofcoal to everyday Americans," stated a Dec 21 news release issued byKennedyand Sens. Tom Harkin, D-Iowa, and Dodd, D-Conn.The liability protection language, called the Public Readiness and EmergencyPreparedness 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 bydeclaring an emergency if he or she determines that a disease or otherhealth threat represents an emergency or may constitute an emergency in thefuture. The act does not list any criteria for determining the existence ofan 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 itpreempts any conflicting laws or regulations of states or local communities,the act says.The measure says those who make and administer medical countermeasurescovered by an emergency declaration are immune to lawsuits unless theplaintiff can provide clear evidence of willful misconduct that resulted indeath or serious physical injury. "Willful misconduct" is ruled outif theparty who administered the treatment followed HHS recommendations andnotified health authorities of the relevant injury within 7 days.In addition, the act instructs the HHS secretary to write regulations"thatfurther restrict the scope of actions or omissions by a covered person"thatconstitute willful misconduct.A party alleging "willful misconduct" can file suit only in USDistrictCourt in Washington, DC. The plaintiff must

have an affidavit supporting thesuit from a physician who did not treat the injured person. Before any suitcan go to trial, a three-judge panel will consider any pretrial motions.The act says that an HHS emergency declaration will trigger theestablishment of a fund to provide "timely, uniform, and adequatecompensation" 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 firsttrying to collect from the compensation fund. But that requirement appliesonly if the compensation program has been funded. A person can sue if HHSfails to act on the request for compensation within 240 days.If a plaintiff accepts an award from the compensation fund, he or she isbarred from suing anyone, the act provides.In arguing that the liability shield is too

broad, Kennedy said in his newsrelease, "The Bush administration could identify Vioxx as a neededcountermeasure to treat the arthritis epidemic or to treat pain associatedwith flu, and completely immunize Merck [the manufacturer] from lawsuitscurrently pending against it."

[Guest guest]

Is it so much about selling the vax at this point as it might be about

showing that the Bush admin was " on top of things " (hear the heroic

swell of movie music) before some strange envelopes are rumored to be

circulating-- or some other unexpected mode of transmission-- right

before the election?

>

> This is CRAZY! What about all of the military personnel who have

already sustained damage from the anthrax vaccine?

>  

> Aasa

>

>