October 31, 2008

Panel OKs Anthrax Shots for First Responders

Volume 322, Number 5902, Issue of 31 October 2008
©2008 by The American Association for the Advancement of Science.

Panel OKs Anthrax Shots for First Responders

A U.S. scientific panel thinks that police, firefighters, people who work with hazardous materials, and others running the risk of exposure to an anthrax infection may be offered the vaccine against the fatal disease. That suggestion, from an advisory panel to the U.S. Centers for Disease Control and Prevention (CDC), is a departure from current policies.

Anthrax vaccination is compulsory for military personnel serving in risk areas overseas. Although most experts believe the vaccine--six shots over a period of 18 months--is safe, some service members believe it has made them ill, and some have filed lawsuits. Relying on new safety data, CDC's Advisory Committee on Immunization Practices agreed on 22 October that first-responder agencies "may choose to offer" their staff the vaccines on a voluntary basis--but it stopped short of recommending they do so.

That caution reflects the panel's inability to assess the risk of future attacks, says the committee's chair, Dale Morse, who adds that the job site and duties affect a worker's risk of contracting anthrax as well. "We believe it's very low, but we can't say it's zero," Morse says. Meryl Nass, an internist at Mount Desert Island Hospital in Bar Harbor, Maine, who strongly opposes the military program, believes the recommendations will put more people at risk for adverse events. No first responders became infected during the 2001 anthrax letter attacks, which killed five people.

October 19, 2008

PREPA - and what this means to you

October 17, 2008

The Public Readiness and Emergency Preparedness Act (PREPA) has reared its ugly head again in the wake of Mike Leavitt, Secretary of the Department of Health and Human Services (DHHS) declaring a seven-year anthrax emergency through the end of 2015.

PREPA goes beyond the anthrax vaccine and it is imperative all Americans, military or not, understand what our government has done to us. PREPA, which is completely unconstitutional, will be discussed further below.

First, let’s focus on the Anthrax vaccine.

Anthrax

A declaration of an anthrax emergency for seven years is another case by this administration of the “Boy who Cried Wolf”. The Advisory Committee on Immunization Practices (ACIP), an advisory to the CDC regarding vaccinations, are poised to meet and vote on October 22nd, 2008, to expand the anthrax vaccine to civilians.

The latest study conducted by the CDC published October 1st, 2008 and reported in a JAMA article consisted of 1,564 subjects. The report barely mentions the adverse events implying that the vaccine is safe, but in fact, 229 severe adverse events and 7 deaths occurred during this trial. For further information on serious adverse events reported following receipt of the anthrax vaccine, one need not look further than the product label, pages 5-6. http://bioport.com/pdf/emergent_biothrax_us.pdf

The declaration of an anthrax emergency, through PREPA, has been invoked as an attempt to push the anthrax vaccine on an unsuspecting public, while single-handedly perform tort reform for the anthrax vaccine in the absence of legislative approval, because the administration knows that there will be injuries. The emergency declaration for the anthrax vaccine is disastrous for Americans, but it is sure sweet for the manufacturer, Emergent Biosolutions, aka: Bioport. Mike Leavitt contracted to buy an additional $400 million worth of anthrax vaccine to add to the current $500 million currently in the nation’s stockpile. It is unclear how, or even if, the current stockpile is still valid given that the shelf-life for the vaccine has expired, but we at least know according to the GAO that 12 months ago, $100 million worth of vaccine was lost due to expiration at the taxpayer’s expense.

Interestingly enough, in the October 6th, 2008, Federal register; Mike Leavitt also gives blanket immunity for liability for use of the anthrax vaccine (and anthrax countermeasures) to not only the manufacturer, but specifically giving government officials immunity for even recommending the anthrax vaccine, should injuries or deaths result from a recipient. (http://edocket.access.gpo.gov/2008/E8-23547.htm)

"Whereas, immunity under section 319-F3(a) of the Act should be available to governmental program planners for distribution of covered countermeasures..."


Diseases/Vaccinations

PREPA (which will be addressed below) gives the Department of Health and Human Services, Secretary (currently Mike Leavitt) the authority to declare any disease an act of emergency.

The latest measles outbreak which was deemed an “epidemic” consisted of approximately 131 cases in the United States of America out of a population of more than 300,000,000. (By the way, no deaths occurred from this “epidemic”). According to PREPA, the Secretary of DHHS could have declared this to be an emergency, utilizing mass vaccinations. Unless a person who suffered an injury could have “proven” the injury resulted from the vaccination (a near impossible task), no compensation could be received and no one held accountable.

Taken in part from a news article regarding PREPA and using vaccinations/drugs on American citizens in a “state of emergency”: (it should also be noted it wouldn’t matter if these drugs/vaccines were approved by the FDA or not)

“But Sen. Edward 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.”

Public Readiness and Emergency Preparedness Act (PREPA)

PREPA 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_Preparedness_Act.pdf

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 is unclear under PREPA should an individual refuse what that would entail. Quarantine? Maybe. Forced vaccination/drug intake with or without your consent? Maybe. It is unknown and answers have tried to be sought to no avail.
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-lan/news/dec2805liability.html

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.

Take Action Now

Such measures may be deemed acceptable if this country was an anarchy, an autocracy, an oligarchy, or a democracy. However, the United States of America is a Republic, meaning it is ruled by law, as opposed to one, the minority or majority.

It is past time the United States of America gets back to its roots. The roots are the citizens of this country, not the government, we as the people, and the government have seemed to have forgotten that.

So what do we need to do in regards to PREPA:

Four particular senators that initially tried to overturn PREPA needs to be contacted again now that the democrats are in the majority to resurrect a bill to rescind PREPA. These Senators are Senator Kennedy, (D-MA), Senator Dodd (D-CT), Senator Harkin (D-IA) and Senator Bingaman (D-NM). Their contact information is:

Senator Tom Harkins Senator Chris Dodd
Washington DC Washington DC
(202) 224-3254 Phone (202) 224-2823 Phone
(202) 224-9369 Fax (202) 224-1083 Fax

Senator Edward Kennedy Senator Jeff Bingaman
Washington DC Washington DC
(202) 224-4543 Phone (202) 224-5521 Phone
(202) 224-2417 Fax (800) 43-8658 Phone (from NM only)

Take the opportunity to not only call the above Senators expressing your concerns, call your own Senator. In each call, express what you want him or her to do. A few examples are:

1. To introduce a bill to rescind PREPA, as they tried to do in 2006.

2. Let them know the only emergency there is, is the ending of this administration, and its final opportunity to expand the anthrax vaccine market which is not acceptable. Should you be asked how you know there is no emergency to use the anthrax vaccine, have your Senator contact the Department of Homeland Security him/herself. According to Secretary Chertoff, in a September 23, 2008 memo:

“There is not currently a domestic emergency involving anthrax. Additionally, there is not currently a heightened risk of an anthrax attack. We have no credible information indicating an imminent threat of an attack involving Bacillus anthracis.”

http://74.125.45.104/search?q=cache:1CfmoQ4r6NAJ:www.dhs.gov/xlibrary/assets/ofsec_signed_determination092308.pdf+credible+information+indicating+an+imminent+threat+of+an+attack.&hl=en&ct=clnk&cd=3&gl=us

3. To promise an investigation into the “anthrax emergency” and to investigate how such a law like PREPA could have been passed in our republic, and who is responsible.

4. To act to halt CDC's plan to approve civilian anthrax vaccinations. They have the power to do this. Remind them that CDC’s latest clinical trial of anthrax vaccine resulted in 229 serious adverse events and 7 deaths, but they will not be revealed until late 2009, while CDC's plan to expand vaccinations goes through without proper attention to vaccine side effects.

5. Let them know you will not surrender your constitutional rights or that of your child’s to an appointed unelected official for any reason.

Then, call your local media and ask them to carry stories about this frightening turn of events. Only through awareness and action can change occur.

If you have any other thoughts or ideas, please share them with me, Dr. Meryl Nass (mnass@gwi.net) or Randi Airola (randiceaj@sbcglobal.net)

The time to act is now. Remember, CDC’s vote will take place around noon on Wednesday, October 22nd, 2008.

Thank you for publicizing this cynical use of "government against the people"

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
Cell: 207 522-5229
Home: 207 244-9165
Pager: 207 818-0708
http://anthraxvaccine.blogspot.com
http://www.anthraxvaccine.org

Randi Airola
http://www.military-biodefensevaccines.org

Permission is both granted and encouraged to disseminate this letter in its entirety as written to anyone that cares about life, liberty, freedom and this great country, a republic.

Contact Your Reps: DHHS designates an anthrax emergency as a means to protect--- ITSELF!

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 1st, 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 “wilfull 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_Preparedness_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/dec2805liability.html

But Sen. Edward 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 supercede 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 $364and $404 million, to add to its existing stockpile of about 25 million doses. http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100102951.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/AR2007102202111.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 Maryland. 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 Analyisis, 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 Nancy 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/dec2805liability.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. Edward 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 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."

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
http://anthraxvaccine.blogspot.com
http://www.anthraxvaccine.org

October 18, 2008

Emergency declarations smooth way for vaccine makers

By ALAN BAVLEY
The Kansas City Star
http://www.kansascity.com/105/story/846427.html

Sure, the economy is causing a crisis, but what about anthrax? How about smallpox?

In a little noticed move, federal officials this month have declared a series of public health emergencies relating to potential weapons of biological terror.

On Oct. 1, Health and Human Services Secretary Mike Leavitt declared an anthrax public health emergency. 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.

There’s no clear evidence that terrorists have managed to weaponize anthrax or stolen large caches of Botox from cosmetic surgeons in Beverly Hills.

But by declaring these public health emergencies, HHS has granted manufacturers of anti-terrorism drugs and vaccines and others involved with the products protection from lawsuits if the drugs were to cause unfortunate side effects.

In the past, drug companies have shied from vaccine development because of low profit margins and legal risks. The actions of HHS are a necessary reassurance to persuade companies to make the drugs, and doctors and other providers to administer them, federal officials and some terrorism experts say.

But consumer advocates see it as a giveaway to the drug industry that strips the public of legal protections.

“It gives the manufacturers and other people involved a ‘get out of jail free’ card,” said Joan Claybrook, president of Washington-based Public Citizen.

“These are potentially dangerous products. There could be a bad vaccine, and suppose people relied on that?” Claybrook asked. “There is no deterrent if there’s no liability.”

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.

Concerns about the safety of vaccines against potential bioweapons have been raised repeatedly in recent years. Some soldiers, for example, have balked at anthrax vaccinations. And a federal effort to inoculate 500,000 doctors, nurses and other health care workers against smallpox resulted in only about 40,000 volunteering for the vaccine.

Health and Human Services’ authority to grant drugmakers liability protection comes from a controversial measure that Senate Majority Leader Bill Frist and House Speaker Dennis Hastert added to a Defense Department appropriations bill in the waning days of 2005.

The Public Readiness and Emergency Preparedness Act targets liability protections for products used during epidemics and pandemics, or as security countermeasures.

The HHS secretary can trigger the protections by declaring that a public health emergency exists or that there’s a “credible risk” of one in the future.

And legal immunity can apply to anyone involved in the development, testing, manufacture or distribution of the drugs. Also covered is anyone who prescribes, dispenses or administers the drugs, including state and local government officials.

Public Citizen and the Consumer Federation of America were among the groups that protested the bill.

In a letter to Frist and Hastert, Sen. Ted Kennedy and 20 other members of Congress called the measure “a stealth provision to shield manufacturers from responsibility for making faulty drugs and vaccines.”

As the law was written, it could be applied to virtually any drug or vaccine, Kennedy and the others said, and not just to the medications needed to fight pandemic flu or bioterrorism.

October 17, 2008

Chertoff Memo: How to Declare an Anthrax Emergency with no basis and make liability *vanish*

On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency, which will last through 2015. It was published in the Federal Register Volume 73, Number 194, pages 58239-58242, and can be read here:
http://edocket.access.gpo.gov/2008/E8-23547.htm

What was the basis for the emergency declaration? Nothing. A must-read (short) memo
is attached
http://www.dhs.gov/xlibrary/assets/ofsec_ signed_determination092308.pdf, in which DHS Secretary Chertoff told DHHS Secretary Leavitt the following:

"That statute authorizes the Secretary of Health and Human Services to declare an emergency on the basis of, among other things,

A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biologial, chemical, radiological or nuclear agent or agents.

There is not currently a domestic emergency involving anthrax. Additionally, there is not currently a heightened risk of an anthrax attack. We have no credible
information indicating an imminent threat of an attack involving Bacillus anthracis.

But these findings are not necessary to make a determination under 5 564(b)(l)(A). Rather, a significant potential for a future domestic emergency involving a heightened risk of attack with anthrax is a sufficient basis for such a determination. "

Here is a discussion of the Public Readiness and Emergency Preparedness Act under which the Declaration was made:
http://www.cidrap.umn.edu/cidrap/content/influenz a/biz-plan/news/dec2805liability.html

"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." The bill also grants immunity specifically to "government program planners" who are involved with declared emergencies.

Here is the actual December 2005 bill:

ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Preparedness_Act.pdf

Here is Secretary Leavitt's October 1, 2008 Declaration:

http://edocket.access.gpo.gov/2008/E8-23547.htm

And on October 22, 2008 the CDC's Advisory Committee on Immunization Practices will vote on expanding its recommendation for anthrax vaccinations to civilian first responders, now that the threat of liability for vaccine injuries or vaccine failure is a thing of the past.
http://gsn.nti.org/gsn/ts_20081016_1491.php

Emergent Biosolutions Hits New 52-Week High On Positive Outlook

http://anthraxvaccine.blogspot.com

Emergent Biosolutions Hits New 52-Week High On Positive Outlook
Mayur Pahilajani - iStockAnalyst Writer
New York, NY

Shares of Emergent Biosolutions Inc (NYSE: EBS) topped 52-week mark after the bell on Friday as investors gained confidence in the company after the Rockville-based biotech's profitable anthrax treatments won emergency protection.

On October 9, the firm announced that the vaccine Biothrax and its Anthrax Immune Globulin, both have been included as covered countermeasures to a public health emergency under the Public Readiness and Emergency Preparedness Act.

The U.S. Department of Health and Human Services (HHS) said in a declaration, which will remain in effect until December 31, 2015, that there is a credible risk that the threat of exposure to anthrax and the resulting disease constitutes a public health emergency.

"This PREP Act declaration is further evidence of the U.S. Government’s commitment to our efforts to develop a portfolio of medical countermeasures to address the threat to public health posed by the use of anthrax as a weapon of biological warfare," Daniel J. Abdun-Nabi, president of Emergent BioSolutions, said in a statement.

The measure came after the company gained a new multi-year contract with the U.S. HHS to supply additional doses of its anthrax vaccine. The contract is valued in the range of between $364 million to $404 million. Under the agreement, the company will supply HHS with the second order of 14.5 million doses of Biothrax vaccine. The first order of 19.75 million doses of the vaccine is currently being delivered, which will provide the company with $448 million...

U.S. Limits Anthrax Vaccine Liability

Global Security Newswire
Elaine Grossman

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-42d1-9285-34ea695db21a.html, 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
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
Leavitt's declaration
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/2008/10/16/55608b41-33c1-4553-8ce0-7a70426c4771.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," 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
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.

October 16, 2008

CDC Panel May Advise Anthrax Shots for First Responders

http://gsn.nti. org/gsn/ts_ 20081016_ 1491.php

CDC Panel May Advise Anthrax Shots for First Responders
Elaine Grossman
Global Security Newswire: Oct. 16, 2008

WASHINGTON - A U.S. government advisory panel next week could recommend that state and local public health officials consider administering anthrax vaccines to as many as 3 million first responders nationwide, Global Security Newswire has learned. The
panel, convened by the Centers for Disease Control and Prevention, would leave it to regional and local authorities to determine whether the risks of biological terrorism - weighed against the potential benefits of a controversial inoculation - justify vaccinating emergency personnel.

In an anthrax attack, victims could inhale tiny airborne particles capable of infecting them with a highly fatal disease. The 2001 mailings that targeted congressional and media offices, launched just days after the Sept. 11 terrorist strikes, killed five people and sickened another 17 (see GSN , Oct. 1).

The CDC panel decision, slated for release at an Oct. 22 meeting in Atlanta, could reverse a nearly 8-year-old recommendation against pre-exposure vaccinations for first responders. By contrast, U.S. military personnel operating in assignments considered at risk of exposure to anthrax attack have been subject to mandatory inoculation for several years (see GSN , Sept. 5, 2007). While the compulsory program was suspended at one point under court order, the Defense Department has administered millions of shots since the late 1990s.

The CDC Advisory Committee on Immunization Practices said in December 2000 that it could not recommend anthrax shots for civilian first responders as a matter of national policy because "the risk of exposure cannot be calculated." Even if the threat were considered higher in one city or another, the panel concluded that precautionary vaccines were unnecessary. For emergency personnel who enter an attack
site, "studies suggest an extremely low risk for exposure related to secondary aerosolization of previously settled [anthrax] spores," the group wrote at the time. If a first responder were exposed to anthrax, the "initiation of prophylaxis should be considered with antibiotics alone or in combination with vaccine," the panel concluded. Post-exposure treatment with these drugs is standard for unvaccinated
patients.

In 2002, the panel updated other aspects of its anthrax vaccine recommendations but refrained from changing its guidance for first responders. However, at a meeting in Atlanta four months ago, a working group convened by the advisory committee said the full panel should alter its 2000 statement. "Post-event vaccination in combination with antibiotics is an effective intervention following exposure to [anthrax] spores, but the workgroup felt that pre-event vaccination could offer additional protection beyond that afforded by antibiotics and post-vaccination by providing early priming of the immune system," according to a CDC summary of the review group's presentation to the panel. In addition, some first-responder organizations "have stated that their members would be more willing to respond to a bioterrorism event if they were vaccinated prior to the occurrence of the event," working group member Jennifer Gordon Wright told the committee, according to the meeting summary. "The workgroup felt that implementing a recommendation for pre-event vaccination of first responders would be difficult, but it may have a positive impact on first-responder preparedness, " she reportedly said.

If embraced by the expert panel next week, the new statement would read: "Groups for whom potential contact with aerosolized anthrax is a reasonable expectation based on occupation and duties (e.g. first responders expected to be called to the scene of a bioterrorism event) and for whom a calculable risk is not available may consider pre-event vaccination on the basis of an estimated risk benefit and in the context of an occupational health and safety program."

A Host of Challenges

Among the challenges facing any mass inoculation effort for first responders would be finding a method of tracking a complicated anthrax shot regimen for millions of personnel who might come and go from their jobs, according to the June meeting minutes. The schedule for the existing vaccine calls for six priming shots over an 18-month period, followed by annual boosters. Recent medical research suggests
that fewer shots might be needed to establish immunity, but the official regimen has not yet changed (see GSN , Oct. 1).

Another hurdle could be organizing a vaccine campaign in the absence of any single organization representing the first-responder community nationwide, according to the June meeting summary. "There are multiple types of first responders and defining this group can be difficult," Wright told the CDC panel.

Litigation pending in federal court could pose another complication for state and local officials who might contemplate setting out a requirement that their first responders take the anthrax shots. Two attorneys who in 2004 won a 16-month injunction against the Pentagon's initial mandatory vaccine effort filed a second lawsuit in late 2006, challenging the science behind a 2005 Food and Drug Administration decision allowing the drug to be used for protection against an attack (see GSN , Oct. 28, 2004). They argue that the vaccine has been proven only in the prevention of anthrax contracted through the skin or digestive system, but has not been shown to work against a more serious form of inhaled anthrax posed by biological weapons.

The second case is now on appeal following a federal judge's move to dismiss it in late February (see GSN , March 3). If the lawsuit moves forward in the U.S. Court of Appeals, "it would affect the current thinking of CDC and FDA" regarding the advisability of giving the vaccine to millions of first responders, said Mark Zaid, plaintiffs' co-counsel in both legal actions. The CDC advisory panel's working group reported in June that "available vaccine efficacy data suggested that the vaccine is effective and provides protection against inhalation anthrax." However, Zaid said state and local authorities should think twice before requiring the shots for emergency personnel, in the absence of a substantial threat. "It would be virtually unprecedented in modern times to mandate any vaccination on civilian populations without the clear existence of a current outbreak of disease," he told GSN yesterday.

Critics of the vaccine have alleged that officials at the Centers for Disease Control and Prevention - an arm of the U.S. Health and Human Services Department - have underemphasized the risk of severe adverse reactions carried by the anthrax vaccine. For example, a new CDC study of the anthrax vaccine's safety and efficacy logged 229 "serious adverse events" - including seven deaths - in 186 out of 1,563
volunteer participants receiving inoculations since May 2002. Such instances might include events that are life-threatening, require hospitalization or surgical intervention or cause significant disability or birth defects. Results were published in the Oct. 1 issue of the Journal of the American Medical Association.

However, the researchers concluded that just nine of these serious events - none resulting in death - were "possibly related" to the vaccine. Analysis of the research data will remain "double-blind" through next year, meaning the medical investigators and patients do not know which participants received anthrax inoculations and which received a placebo, according to CDC officials.

Until the serious-event data can be correlated with an understanding of which patients actually received the anthrax vaccine, an empirical analysis of the drug's safety in this study cannot be done, according to Meryl Nass, a longtime critic of the U.S. government's handling of the vaccine. An internist who has consulted with the U.S. government on bioterrorism issues, Nass questioned how CDC researchers could have concluded that just nine of the 229 serious adverse events might have
been connected to the vaccine. In e-mail comments sent to GSN last week, she accused the agency of "glossing over" the severe reactions potentially related to the vaccine and of offering few details about them.

The working group's June presentation to the CDC advisory group identified vaccine safety as a possible issue for consideration in treating first responders, but voiced confidence in the research findings. "While the workgroup [members] believe the vaccine is safe, rare adverse events do occur and a serious adverse event is not a small matter, regardless of whether it is vaccine-associated, " Wright told the panel, according to the CDC minutes.

The government advisory panel "has been given a one-sided picture from the working group at the CDC," Nass said in an interview this week. She rued the fact that few, if any, of the advisory panel's current members took part in the committee's debate nearly eight years ago, which resulted in its initial guidance against mass inoculations for first responders. This year, Nass said, the committee has heard nearly no critical perspectives about the safety and efficacy of the anthrax vaccine, and the group might similarly be unaware of skepticism about biowarfare threats facing the United States. The CDC panel has scheduled just five minutes of public comment about the issue during its upcoming meeting, she said.

A review of the committee's membership shows that none of the advisory panel's 15 voting members sat on the group in 2000, so there is little track record on which to base projections about how it will decide the issue this time. Eight liaisons from medical associations and industry organizations, "ex officio" members and others associated with the Advisory Committee on Immunization Practices served in similar roles in 2000, but none of them have a vote. Of the voting advisory panel members, several voiced support at the June meeting for making what they termed a "reasonable" change in the group's guidance regarding anthrax shots for first responders.

One of them, Jonathan Temte - a faculty member at the University of Wisconsin's School of Medicine and Public Health in Madison - said "allowing smaller [state and local] groups to consider their own risks is a very worthwhile approach," according to the CDC summary. Others expressed a degree of concern. For example, Franklyn Judson - a professor at the University of Colorado Health Sciences Center in Denver -said he would support the new statement but thought "practically it would do little at the local level," the summary states. Another, Ciro Sumaya of Texas A&M Health Center in College Station, "was uncomfortable with the wording" in the statement about assessing a risk-benefit tradeoff, adding that "there should be some type of algorithm to make risk determinations that can be useful to the practitioner and at the local level," according to the CDC minutes.

Security Problems Found at Two Biodefense Labs

http://www.nti.org/d_newswire/issues/2008_10_16.html#C0381C0F

A potential terrorist would face few obstacles to infiltrating two high-security U.S. laboratories cleared to work with lethal biological agents, congressional investigators said in a report released today (see GSN, Aug. 22).

The Centers for Disease Control and Prevention endorsed the Biosafety Level 4 sites, which are not named in the Government Accountability Office report but were identified today in an Associated Press article.

The Southwest Foundation for Biomedical Research in San Antonio, Texas, was considered the most vulnerable site. Personnel at the privately operated site work with disease materials in a room that has a window directly to the outside of the building.

Investigators also described the deployment of surveillance cameras, intruder detectors and armed guards at visible entrances as inadequate. Depending on an outside contractor to watch the detection systems and notify police of security breaches could slow response times, the report says.

"We already have an initiative under way to look at perimeter security," said laboratory head Kenneth Trevett. "We're waiting for additional input but we're not waiting long. The GAO would like us to do some fairly significant things. They would like us to do it sooner rather than later."

The other vulnerable facility, an Atlanta laboratory managed by Georgia State University, was not fully walled off and had other security vulnerabilities. Congressional auditors said they watched an unknown person enter the building through its unmonitored shipping gate.

"Georgia State clearly wants its BSL-4 to be as safe as possible," university Assistant Vice President DeAnna Hines said, without acknowledging that the Georgia State site was singled out in the GAO report. "We are already taking steps that will enhance the lab's safety and security standards."

The report notes that robust security measures are in place at the three other U.S. laboratories cleared to work with the deadliest pathogens: CDC headquarters in Atlanta (see GSN, May 16); the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md.; and the University of Texas Medical Branch at Galveston (Larry Margasak, Associated Press/Google News, Oct. 16).

October 15, 2008

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

Excerpt:

But Sen. Edward 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.


ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

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.

~~~~~~~~~~~
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_Preparedness_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/dec2805liability.html

But Sen. Edward 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/AR2007102202111.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 Maryland. 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 Nancy 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/dec2805liability.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. Edward 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 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."

Bogus Anthrax 'State of Emergency' Protects Drugmakers, Not Public

http://blog.wired.com/wiredscience/2008/10/bogus-anthrax-s.html

Not a single case of human anthrax has been reported in the United States this year, but the nation is now officially in a state of anthrax emergency.

The emergency was declared earlier this month by the Department of Health and Human Services, and will last until 2015. Whether it will protect public health is debatable, but it will certainly protect makers of faulty anthrax vaccines.

Emergency exemption from legal liability is granted to vaccine manufacturers by the Public Readiness and Preparedness Act, passed in 2005 to protect against paralyzing lawsuits during outbreaks of anthrax, avian influenza or other potentially pandemic diseases.

The act is supposed to be invoked when the Secretary of Homeland Security has determined "that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents."

But as Homeland Security chief Michael Chertoff explains in a letter to the DHHS, none of these conditions are met: there's neither emergency nor heightened risk of attack nor "credible information indicating an imminent threat of an attack." But that doesn't matter.

"These findings are not necessary to make a determination," Chertoff wrote. It's enough that anthrax was declared a threat four years ago, and that "were the government to determine in the future that there is a heightened risk of an anthrax attack ... that determination would almost certainly result in a domestic emergency."

In other words, there could be an emergency someday — so we might as well declare an emergency now.

Beyond the tortured logic, there's something not quite right about this. Could it have something to do with the fact that the federal government has spent nearly a billion dollars on anthrax vaccines of questionable efficacy and safety?

The CDC's vaccine committee meets next week to discuss anthrax vaccines. It will be interesting to see what they say.

October 10, 2008

Fears have led to Removal of Citizen's Protection

From Dr. Meryl Nass
See my blog
http://anthraxvaccine.blogspot.com for the links:

Anthrax Letters and Pandemic Flu Fears Led to Legislation that Removed
Citizen Protections for Vaccine Injuries;
Anthrax Emergency Just Declared

The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law in December, 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The Act does not specify any criteria for determining the existence of an emergency. PREPA removes the right to
a jury trial for persons injured by a covered vaccine, unless a plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury. A notice was issued regarding Potential Eligibility for Compensation in December 2007, but it applies only to avian flu vaccine, and has not been funded.

CDC has asked its Advisory Committee on Immunization Practices to vote on recommending anthrax vaccine for civilian first responders (up to three million people) on October 22, 2008. The vaccine has only been used by the Defense Department in the past, under a mandatory and controversial program. HHS announced another purchase of 14 million doses of anthrax vaccine on October 1, 2008, in addition to approximately 25 million doses already stockpiled.

DHHS issued a Declaration under the Public Readiness and Emergency Preparedness Act on October 1, 2008, declaring a public health emergency for anthrax. No discussion of why there is an emergency was provided. Not only did the declaration shield anthrax vaccine manufacturers and doctors who use the vaccine from liability for
injuries that might arise: the declaration explicitly shielded "government program planners" who might recommend anthrax vaccine or other anthrax countermeasures.

APIC seeks mandate for flu shots in health workers

APIC seeks mandate for flu shots in health workers
Robert Roos News Editor
http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/oct1008apic.html

Oct 10, 2008 (CIDRAP News) – In the face of chronic low influenza vaccination rates among healthcare workers, the leading US society of infection control professionals says it's time to require medically eligible workers to either get the immunization or sign a form saying they understand the risks to patients if they skip it.

"As part of a comprehensive strategy, we recommend that influenza vaccine be required annually for all healthcare personnel with direct patient care," the Association for Professionals in Infection Control and Epidemiology (APIC) said in a policy statement released yesterday.

"Organizations should adopt a system in which an informed declination is obtained from employees that decline for other than medical reasons," the statement continues. "This information should be utilized by the facility to develop improvement strategies for the following vaccine season."

APIC urges vaccination for all medical and nonmedical personnel in contact with patients or patient samples, including physicians, nurses, physical therapists, dieticians, religious workers, and cleaning, kitchen, and laboratory personnel.

Voluntary programs haven't worked
Recent national survey data show that only 42% of healthcare workers receive an annual flu shot, and the rate has not risen significantly in the past decade, the APIC statement notes. Long-standing recommendations from APIC, the Centers for Disease Control and Prevention, and other national organizations have made little difference.

"Voluntary efforts are clearly not effective—it's time for hospitals and other healthcare facilities to require influenza immunization," said Linda R. Greene, RN, MPS, CIC, lead author of APIC's position statement, in a press release.

The policy statement notes that health workers can transmit the flu virus to others before they have any symptoms. Further, it says multiple studies show that 70% of health workers continue to work even when sick with the flu.

A multifaceted approach
APIC has strongly advocated flu shots for healthcare workers for years, along with a variety of strategies to promote them, but this is the first time the organization has used the word "require," Greene told CIDRAP News in an interview.

She said the declination form is the major new element in APIC's recommendation, but emphasized that it should be just part of a broad strategy for encouraging immunization.

"This isn't just a declination that says, 'I don't want to get it and here's the reason.' It's an informed declination, where the employee really understands that by refusing to get the vaccine for other than medical reasons, they're not only putting their patients at risk, but also themselves and their family and the community as a whole," said Greene, who is director of infection prevention for Rochester General Health Systems in Rochester, N.Y.

"This is the idea of active declination—it's not just a form that's floating around and you're supposed to sign it sometime; you actually have a conversation about why this is important for you," she added.

But other measures must be linked with informed declination, she said.

There is only limited evidence on how well declination forms work, she said. "But what we see is that declination alone, if you're not going to employ the other measures, has not necessarily been particularly effective," yielding only modest increases in immunization rates.

For example, her institution used a declination approach last year, but it was not coupled with "a tremendously proactive statement about putting patients at risk." The result was that the immunization rate increased about 10%, she said.

Getting administrators' buy-in
Greene hopes for much better results with a more comprehensive approach this year. "This year our approach is very robust. The administration is encouraging it, the CEO sent a letter to employees, we're going to post our [immunization] rates weekly. Managers must ensure that employees who didn’t get the vaccine are told of the risks to patients.

"Our goal is at least 75% and hopefully higher; but what we're seeing already is tremendous interest."

Greene said a key part of promoting flu immunization is enlisting the support of a facility's administration and other departments, so "it's not just sitting in occupational health." Administrators can promote the effort by using the flu immunization rate as an important indicator of safety and quality for the facility, she said.

In New York state, informed declination has been used successfully with hepatitis B vaccine for healthcare workers, Greene said. "We've found that we have a very, very high acceptance rate for the hepatitis vaccine." The vaccine is offered to direct-care workers when they are hired, and they see it as a benefit for protecting themselves, she added.

Some institutions now require workers to get a flu shot as a condition for being hired, but APIC decided not go that far in its recommendation, Greene said.

Taking a stronger stance
As for the timing of the new policy, Greene said a combination of factors was at work. They included many new studies about flu and flu immunization in recent years. Also, some other professional societies had taken much stronger positions on the issue than APIC had.

"Some of my colleagues here said it would really help us if APIC had a much stronger statement," she said. At the same time, the Joint Commission on Accreditation of Healthcare Organizations has challenged facilities to exceed the 42% immunization rate.

"I think we're going to see some results," Greene said. "I think we'll be surprised and pleased to see that vaccine rates will increase and continue to increase."

See also:

Oct 9 APIC news release

APIC position paper on flu immunization for healthcare personnel

October 3, 2008

Attorney general turns up heat in seeking promotion for Guard officer

By Thomas D. Williams
Special to the Journal Inquirer

Published: Friday, October 3, 2008 9:15 AM EDT

Attorney General Richard Blumenthal last week sent another letter to Gov. Jodi Rell asking her to posthumously promote former Air Force Nation al Guard officer Russell Dingle of East Hartford .

Blumenthal sent the letter Sept. 26, two days after a story in the Journal Inquirer cited evidence that Dingle was forced to resign from the Nation al Guard in 1999 after he disputed the military’s policy concerning mandatory anthrax vaccinations.

Christopher Cooper, Rell’s spokesman, said the governor is out of town until Monday, so there is no immediate comment on the letter.

Dingle’s resignation followed a Guard investigation he led into the military’s mandatory anthrax vaccinations. The investigation concluded that the anthrax vaccine the military was requiring was improperly licensed and potentially unsafe. Dingle and seven others refused to take the vaccine ordered by the Guard, citing the inquiry’s conclusions that it could cause serious adverse reactions.


Dingle had earned the rank of major before he left the Nation al Guard. Later, after joining to the Air Force Reserves, he earned the rank of lieutenant colonel there.

Blumenthal’s request is that Dingle, who died of cancer in September 2005, be made a full colonel in the Nation al Guard.

“Lieutenant Colonel Dingle performed this mission in an extraordinarily thorough and exemplary manner,” Blumenthal said. “The research he did in carrying out his orders concluded that the vaccine was investigatory and the mandatory order (to use it) illegal. His work contributed significantly to the ‘good order and discipline’” of the Nation al Guard.

Blumenthal had written a similar letter to Rell last May calling for Dingle’s after-death promotion to full colonel. But, a month later, Maj. Gen. Thaddeus J. Martin, the state’s adjutant general, rejected the request.

Martin said Dingle “voluntarily transferred” from the Guard to the Air Force Reserve, so he wasn’t qualified for Guard promotion. After his resignation became known, Dingle wrote a complaining letter to the Guard that Martin had berated him as a result of his anthrax inquiry. Martin would not comment on the letter.

The Sept. 24 Journal Inquirer story reported that contrary to Martin’s rationale, there was documentary evidence that Dingle, as he had insisted consistently afterward, had been forced to resign.

The story cited a transcript and a video of former Air Force Nation al Guard Cmdr. Col. Walter Burns suggesting to Guard troops in 1998 that they would be considered traitors if they didn’t take the vaccine. It additionally noted a Connecticut freedom-of-information ruling concluding that Dingle and Maj. Thomas Rempfer, whom Burns assigned to investigate the vaccine, were forced to resign after that inquiry when they said they intended not to be vaccinated.

Blumenthal’s most recent letter tells the governor that Martin’s position largely is based on the understanding that Dingle voluntarily transferred. “In fact, Lieutenant Colonel Dingle was told he could follow the illegal order and take the vaccine, refuse to take it and be court-martialed, or resign,” he wrote.

The attorney general said Martin also apparently misunderstood his first request as asking for Dingle’s promotion within the Reserves, when he actually had called for it within the Guard, an action totally within the jurisdiction of the Guard and the governor. Blumenthal cited precedence and other promotions within the Guard in arguing that it was likely, had Dingle not been forced out, that he would have become a full colonel.

That would not have changed his ranking as a lieutenant colonel within the Reserves, a federal, not a state entity, like the Guard, Blumenthal said.

Blumenthal long has supported efforts to stop use of the anthrax vaccine, because he considered it unsafe and improperly licensed.

Before his death at age 49, Dingle fought an unprecedented eight-year battle to compel government recognition of improper licensing of the controversial vaccine. Eventually, his protests to government agencies, the courts, and two presidential administrations helped result in a 2003 U.S. District Court ruling temporarily blocking required military inoculations.

After the Food and Drug Administration made adjustments to the vaccine’s license, as ordered under the ruling, the Pentagon continued mandatory vaccinations. The inoculations caused thousands of adverse reactions and hundreds of disciplinary actions, including service removals for those in the military who refused to be vaccinated.

Dingle flew more than 2,000 hours in the A-10 Thunderbolt II on active duty. He served as an instructor pilot and a flight commander for the Connecticut Air Nation al Guard. Culminating more than 21 years of military service, Dingle retired as a recruiter for the U.S. Air Force Academy in 2003. His double career included more than 16 years of service as a pilot and captain for American Airlines in the Boeing 767, 737, and the McDonnell-Douglas S-80.

October 1, 2008

Feds Declare 'Anthrax Emergency'

[Federal Register: October 6, 2008 (Volume 73, Number 194)] [Notices] [Page 58239-58242] From the Federal Register Online via GPO Access [wais.access. gpo.gov] [DOCID:fr06oc08- 76]

------------ ----

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary
Declaration Under the Public Readiness and Emergency Preparedness Act

October 1, 2008. AGENCY: Office of the Secretary (OS), Department of Health and Human Services (HHS).

ACTION: Notice.

------------ --------- --------- --------- --------- ------- ------------ ----

SUMMARY: Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for anthrax countermeasures based on a credible risk that the threat of exposure to Bacillus anthracis and the resulting disease constitutes a public health emergency.

DATES: This notice and the attached declaration are effective as of the date of signature of the declaration.

FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free number).

HHS Secretary's Declaration for Utilization of Public Readiness and Emergency Preparedness Act for Anthrax Countermeasures

Whereas significant changes in the nature, regularity and degree of threats to health posed by the use of infectious agents as weapons of biological warfare have generated increased concern for the safety of the general American population particularly following the deliberate exposure of citizens in the

[[Page 58240]]

United States to Bacillus anthracis (B. anthracis) spores in 2001 that demonstrated the ease of dissemination, infectivity, and mortality; Whereas the Secretary of Homeland Security has determined that B. anthracis and multi-drug-resistan t B. anthracis present a material threat against the United States population, sufficient to affect national security; Whereas there are covered countermeasures to treat, identify, or prevent adverse health consequences or death from exposure to B. anthracis; Whereas such countermeasures, including vaccines, antimicrobials/ antibiotics, and antitoxins for pre-exposure and post- exposure prevention and treatment, diagnostics to identify such exposure, and additional countermeasures for treatment of adverse events arising from use of these countermeasures exist or may be the subject of research and/or development; Whereas such countermeasures may be used and administered in accordance with Federal contracts, cooperative
agreements, grants, interagency agreements, and memoranda of understanding, and may also be used and administered at the Regional, State, and local level in accordance with the public health and medical response of the Authority Having Jurisdiction; Whereas, the possibility of governmental program planners obtaining stockpiles from private sector entities except through voluntary means such as commercial sale, donation, or deployment would undermine national preparedness efforts and should be discouraged as provided for in section 319F-3(b)(2) (E) of the Public Health Service Act (42 U.S.C. 247d-6d(b)) (``the Act''); Whereas, immunity under section 319F-3(a) of the Act should be available to governmental program planners for distributions of Covered Countermeasures obtained voluntarily, such as by (1) Donation; (2) commercial sale; (3) deployment of Covered Countermeasures from Federal stockpiles; or (4) deployment of donated, purchased, or otherwise
voluntarily obtained Covered Countermeasures from State, local, or private stockpiles; Whereas, the extent of immunity under section 319F- 3(a) of the Act afforded to a governmental program planner that obtains covered countermeasures except through voluntary means is not intended to affect the extent of immunity afforded other covered persons with respect to such covered countermeasures. Whereas, in accordance with section 319F-3(b)(6) of the Act, I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of such countermeasures with respect to the category of disease and population described in sections II and IV below, and have found it desirable to encourage such activities for the covered countermeasures; and Whereas, to encourage
the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of medical countermeasures with respect to the category of disease and population described in sections II and IV below, it is advisable, in accordance with section 319F-3(a) and (b) of the Act, to provide immunity from liability for covered persons, as that term is defined at section 319F-3(i)(2) of the Act, and to include as such covered persons such other qualified persons as I have identified in section VI of this declaration; Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the threat of exposure of B. anthracis and the resulting disease constitutes a public health emergency.

I. Covered Countermeasures (As Required by Section 319F-3(b)(1) of the Act)

Covered Countermeasures are defined at section 319F-3(i) of the Act. At this time, and in accordance with the provisions contained herein, I am recommending the manufacture, testing, development, distribution, dispensing; and, with respect to the category of disease and population described in sections II and IV below, the administration and usage of anthrax countermeasures as defined in section IX below. The immunity specified in section 319F-3(a) of the Act shall only be in effect with respect to: (1) Present (see Appendix I) or future Federal contracts, cooperative agreements, grants, interagency agreements, or memoranda of understanding involving countermeasures that are used and administered in accordance with this declaration, and (2) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasure following a
declaration of an emergency, as defined in section IX below. In accordance with section 319F- 3(b)(2)(E) of the Act, for governmental program planners, the immunity specified in section 319F-3(a) of the Act shall be in effect to extent they obtain Covered Countermeasures through voluntary means of distribution, such as (1) Donation; (2) commercial sale; (3) deployment of Covered Countermeasures from Federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from State, local, or private stockpiles. For all other covered persons, including other program planners, the immunity specified in section 319F-3(a) of the Act shall, in accordance with section 319F- 3(b)(2)(E) of the Act, be in effect pursuant to any means of distribution. This declaration shall subsequently refer to the countermeasures identified above as ``Covered Countermeasures. '' This declaration shall apply to all Covered
Countermeasures administered or used during the effective time period of the declaration. This declaration also shall apply to all Covered Countermeasures (see Appendix I) administered or used by or on behalf of the Department of Defense.

II. Category of Disease (As Required by Section 319F- 3(b)(2)(A) of the Act)

The category of disease, health condition, or threat to health for which I am recommending the administration or use of the Covered Countermeasures is anthrax, which may result from exposure to B. anthracis.

III. Effective Time Period (As Required by Section 319F-3(b)(2) (B) of the Act)

With respect to Covered Countermeasures administered and used in accordance with present or future Federal contracts, cooperative agreements, grants, interagency agreements, or memoranda of understanding, the effective period of time of this Declaration commences on signature of the declaration and extends through December 31, 2015. With respect to Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, the effective period of time of this Declaration commences on the date of a declaration of an emergency and lasts through and includes the final day that the emergency declaration is in effect including any extensions thereof.

[[Page 58241]]

IV. Population (As Required by Section 319F-3(b)(2) (C) of the Act)

Section 319F-3(a)(4) (A) of the Act confers immunity to manufacturers and distributors of the Covered Countermeasure, regardless of the defined population. Section 319F-3(a)(3) (C)(i) of the Act confers immunity to covered persons who may be a program planner or qualified persons with respect to the Covered Countermeasure only if a member of the population specified in the declaration as persons who use the Covered Countermeasure or to whom such a Covered Countermeasure is administered, is in or connected to the geographic location specified in this declaration, or the program planner or qualified person reasonably could have believed that these conditions are met. The populations specified in this declaration are all persons who use a Covered Countermeasure or to whom a Covered Countermeasure is administered in accordance with this declaration, including, but not limited to: Department of Defense military personnel and supporting civilian-employee and
contractor personnel; any person conducting research and development of Covered Countermeasures directly by the Federal government or pursuant to a contract, grant, or cooperative agreement with the Federal government; any person who receives a Covered Countermeasure from persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure, and their officials, agents, employees, contractors, and volunteers following a declaration of an emergency; any person who receives a Covered Countermeasure from a person authorized to prescribe, administer or dispense the countermeasure or who is otherwise authorized under an Emergency Use Authorization; any person who receives a Covered Countermeasure as an investigational new drug in human clinical trials being conducted directly by the Federal government or pursuant to a
contract, grant, or cooperative agreement with the Federal government.

V. Geographic Area (As Required by Section 319F- 3(b)(2)(D) of the Act)

Section 319F-3(a) of the Act applies to the administration and use of a Covered Countermeasure without geographic limitation.

VI. Qualified Persons (As Required by Section 319F- 3(i)(8)(B) of the Act)

With regard to the administration or use of a Covered Countermeasure, Section 319F-3(i)(8) (A) of the Act defines the term ``qualified person'' as a licensed individual who is authorized to prescribe, administer, or dispense the Covered Countermeasure under the law of the State in which such Covered Countermeasure was prescribed, administered or dispensed. Additional persons who are qualified persons pursuant to section 319F-3(i)(8) (B) are the following: (1) Any person who is authorized to prescribe, administer, deliver, distribute or dispense Covered Countermeasures to Department of Defense military personnel and supporting civilian-employee and contractor personnel, (2) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following
a declaration of an emergency, and (3) Any person authorized to prescribe, administer, or dispense Covered Countermeasures or who is otherwise authorized under an Emergency Use Authorization, including, but not limited to Department of Defense military personnel and supporting civilian employee and contractor personnel.

VII. Additional Time Periods of Coverage After Expiration of Declaration (As Required by Section 319F-3(b)(3) (B) of the Act)

I have determined that, upon expiration of the time period specified in Section III above, an additional twelve (12) months is a reasonable period to allow for manufacturers and other covered persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasure, and the liability protection of section 319F-3(a) of the Act shall extend for that period. Further, as to doses shipped by the CDC to the DoD pursuant to the DoD/CDC Interagency Agreement (IAA) dated March 10, 2008, an additional period of time of liability protection shall extend for as long as the SNS or its successor exists and the IAA remains in effect, plus, if the additional twelve (12) months following the time period in Section III above has expired, an additional twelve (12) months upon expiration of the IAA.

VIII. Amendments

This declaration has not previously been amended. Any future amendment to this declaration will be published in the Federal Register, pursuant to section 319F-3(b)(4) of the Act.

IX. Definitions

For the purpose of this declaration, including any claim for loss brought in accordance with section 319F-3 of the PHS Act against any covered persons defined in the Act or this declaration, the following definitions will be used: Administration of a Covered Countermeasure: As used in Section 319F-3(a)(2) (B) of the Act includes, but is not limited to, public and private delivery, distribution, and dispensing activities relating to physical administration of the Covered Countermeasures to patients/ recipients, management and operation of delivery systems, and management and operation of distribution and dispensing locations. Anthrax Countermeasure: Any vaccine; antimicrobial/ antibiotic, other drug or antitoxin; or diagnostic or device to identify, prevent or treat anthrax or adverse events from such countermeasures (1) Licensed under section 351 of the Public Health Service Act; (2) approved under section 505 or section 515 of the Federal Food, Drug, and
Cosmetic Act (FDCA); (3) cleared under section 510(k) of the FDCA; (4) authorized for emergency use under section 564 of the FDCA ; (5) used under section 505(i) of the FDCA or section 351(a)(3) of the PHS Act, and 21 CFR Part 312; or (6) used under section 520(g) of the FDCA and 21 CFR part 812. Authority Having Jurisdiction: The public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, State, or Federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority. Covered persons: As defined at section 319F-3(i)(2) of the Act include the United States, manufacturers, distributors, program planners, and qualified persons. The terms ``manufacturer, '' ``distributor, '' ``program planner,'' and ``qualified person'' are further defined at sections 319F-3(i)(3) , (4), (6), and (8) of the Act. Declaration of an
emergency: A declaration by any authorized local, regional, State, or federal official of an emergency specific to events that indicate an immediate need to administer and use anthrax countermeasures, with the exception of

[[Page 58242]]

a federal declaration in support of an emergency use authorization under section 564 of the FDCA unless such declaration specifies otherwise.

This first day of October, 2008. Michael O. Leavitt, Secretary of Health and Human Services.

Appendix I--List of U.S. Government Contracts ------------ --------- --------- --------- --------- ------- ------------ --------- --------- --------- --------- ------- -- Contract Manufacturer Covered countermeasure PL 85- 804 coverage* ------------ --------- --------- --------- --------- ------- ------------ --------- --------- --------- --------- ------- -- HHSO100200500007C. ......... ......... Cangene..... ......... .. Anthrax immune globulin-- No.

AI G. HHSO100200500006C. ......... ......... HGS......... ......... .. Anthrax monoclonal antibody- No.

ABThrax. HHSO100200600019C. ......... ......... Emergent Biodefense BioThrax (Anthrax Vaccine Yes.

Operations. Adsorbed, AVA). HHSO100200700037C. ......... ......... Emergent Biodefense BioThrax (Anthrax Vaccine No.

Operations. Adsorbed, AVA). W9113M-04-D- 0002..... ......... ...... BioPort (Emergent BioThrax (Anthrax Vaccine Yes.

Biosolutions) . Adsorbed, AVA). DAMD 17-97-D-00003. ......... ........ BioPort (Emergent BioThrax (Anthrax Vaccine Yes.

Biosolutions) . Adsorbed, AVA) Shipping. HHSN 272200700035C. ......... ........ Elusys...... ......... .. Anthrax monoclonal No.

antibody--ETI- 204. HHSN 272200700033C. ......... ........ Pharmathene. ......... .. Anthrax monoclonal No.

antibody--Valortim. HHSN 272200700034C. ......... ........ Emergent BioSolutions. . Anthrax immune globulin-- No.

AIG. NO1-A1-30052. ......... ......... ..... Avecia (Pharmathene) ... Recombinant protective No.

antigen (rPA) anthrax

vaccine. V797P-5777x. ......... ......... ...... Shering Corp........ ... Cipro 250mg/5ml; 100ml No.

suspension. V797P-5977x. ......... ......... ...... Cobalt Pharmaceuticals. Cipro 500mg tablets..... ... No. V797P-5941x. ......... ......... ...... Blu Pharmaceuticals. ... Doxycycline 100mg tablets.. No. V797P-5883x. ......... ......... ...... Pfizer, Inc......... ... Doxycycline 25mg/5ml No.

suspension 60ml. V797P-5669x. ......... ......... ...... Abraxis Bioscience, Inc Doxycycline 100mg vial IV.. No. V797-DSNS-8002. ......... ......... ... Sandoz, Inc......... ... Amoxicillin 500mg capsules. No. V797-DSNS-8002. ......... ......... ... Sandoz, Inc......... ... Amoxicillin 400mg/5ml; No.


100ml suspension. V797BPA0015. ......... ......... ...... Bedford Labs........ ... Rifampin 600mg vial IV..... No. V797P-5396x. ......... ......... ...... Hospira..... ......... .. Clindamycin 150mg/ml 6ml No.

vial IV. V797P-5669x. ......... ......... ...... Abraxis Bioscience, Inc Vancomycin 1 g vial IV..... No. V797P-1020x. ......... ......... ...... McKesson.... ......... .. Penicillin GK 20 million No.

unit vial IV. V797P-5387x. ......... ......... ...... Johnson and Johnson Levofloxacin 5mg/ml 150ml No.

Healthcare. bag IV.

------------ --------- --------- --------- --------- ------- ------------ --------- --------- --------- --------- ------- -- * Status of indemnification coverage under P.L. 85-804 (An Act to authorize the making, amendment and modification of contracts to facilitate the national defense.)

[FR Doc. E8-23547 Filed 10-1-08; 4:15 pm]

BILLING CODE 4150-37-P





[Federal Register: October 6, 2008 (Volume 73, Number 194)] [Notices] [Page 58242-58243] From the Federal Register Online via GPO Access [wais.access. gpo.gov] [DOCID:fr06oc08- 77]

------------ --------- --------- --------- --------- ------- ------------ ----

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information

AGENCY: Office of the Secretary (OS), HHS.

ACTION: Notice.

------------ --------- --------- --------- --------- ------- ------------ ----

SUMMARY: The Secretary of the Department of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)( 4), to justify the emergency use of doxycycline hyclate tablets accompanied by emergency use information, contained in emergency kits for eligible United States Postal Service (USPS) Cities Readiness Initiative (CRI) participants and their household members in advance of a potential attack involving Bacillus anthracis. Bacillus anthracis is a biological agent known to cause anthrax. The Secretary, HHS, provides notice of the determination of the Secretary of Homeland Security on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis, although there is no current domestic
emergency involving anthrax, no current heightened risk of an anthrax attack, and no credible information indicating an imminent threat of an attack involving Bacillus anthracis. The Secretary also provides notice that, on the basis of such determination, he has declared an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Food and Drug Commissioner under 21 U.S.C. 360bbb-3(a).

DATES: This Notice and referenced HHS declaration are effective as of October 1, 2008.

FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, M.D., Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

The CRI, begun in 2004, is a federally supported effort to prepare 72 major U.S. metropolitan areas to effectively respond to a large- scale bioterrorist event by dispensing antibiotics to their entire identified population within 48 hours of the decision to do so. Over the past several years, HHS and the USPS have developed and tested in three U.S. cities--Seattle, Philadelphia and Boston-- the ability of letter carriers to quickly deliver door-to-door a few days' worth of antibiotics to residential addresses. This quick-strike capability is intended to buy time for State and local public health authorities to set up points of dispensing for further provision of antibiotics across the community, as needed. Under Section 564 of the FFDCA, the Secretary of Homeland Security may determine that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological chemical,
radiological or nuclear agent or agents.

[[Page 58243]]

Based on such a determination, the Secretary of Health and Human Services may declare an emergency that justifies the authorization of a product that is not otherwise approved, licensed or cleared for commercial use (``unapproved product'') or is not approved, licensed, or cleared for a particular use (``unapproved use of an approved product.''). Following that declaration, the Commissioner of the Food and Drug Administration (FDA) may issue an Emergency Use Authorization (EUA). The Biomedical Advanced Research and Development Authority (BARDA) of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) has requested that FDA issue an EUA for doxycycline hyclate tablets accompanied by emergency use information for use by eligible USPS participants in the CRI and their household members. Doxycyline hyclate tablets are approved by the FDA for the post- exposure prophylaxis of anthrax. However, the doxycycline hyclate tablets for which
BARDA seeks an EUA would be accompanied by emergency use information that is not included in any of the approved applications for doxyclycline hyclate tablets. For this reason, an EUA is necessary. The September 23, 2008 determination by the Secretary of Homeland Security that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis, and the October 1, 2008 declaration by the Secretary of Health and Human Services based on that determination that there is an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information, enables the FDA Commissioner to issue an EUA for doxycyline hyclate tablet emergency kits under section 564(a) of the FFDCA, 21 U.S.C. 360bbb-3(a). With issuance of the EUA, eligible letter carriers participating in the
CRI may receive the doxycycline hyclate tablet emergency kits, if not medically contraindicated, for future use by them and other members of their households during an anthrax emergency, subject to the terms of the authorization. The antibiotics and accompanying information may help protect these letter carriers and household members against contracting anthrax if, following an outdoor anthrax attack, the USPS is called upon to deliver the same or similar antibiotics to homes across their community where people may have been exposed to Bacillus anthracis. In an anthrax attack, time is of the essence in preventing illness and death by getting antibiotics to people who may have been exposed. By providing advance protection to letter carriers who willingly put themselves at risk by delivering antibiotics in an affected community, the unique capabilities of the USPS may be used to get antibiotics to those who need them quickly. The USPS initiative and EUA
are one part of the Federal Government's strategy to encourage preparedness at all levels of government to enable the nation to respond effectively in the event of an anthrax emergency.

II. Determination of the Secretary of Homeland Security

On September 23, 2008, pursuant to section 564(b)(1)(A) of the FFDCA, 21 U.S.C. 360bbb-3(b)( 1)(A), the Secretary of Homeland Security determined that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis. The Secretary of Homeland Security made this determination in a September 23, 2008 memorandum addressed to the Secretary of Health and Human Services. In that memorandum, the Secretary of Homeland Security stated that there is not currently a domestic emergency involving anthrax, there is not currently a heightened risk of an anthrax attack, and his Department has no credible information indicating an imminent threat of an attack involving Bacillus anthracis. The Secretary of Homeland Security determined that there is a significant potential for a domestic emergency, involving a heightened risk of
attack with Bacillus anthracis, on two bases: (1) The Department of Homeland Security has already found that an anthrax attack poses a material threat to the United States population sufficient to affect national security, which allows the Secretary to conclude that there is a non-negligible possibility that a heightened risk of attack will arise. The finding that an anthrax attack poses a material threat to the United States population sufficient to affect national security was made on January 20, 2004 regarding anthrax, and on September 22, 2006 regarding multi-drug resistant Bacillus anthracis, pursuant to section 319F-2(c)(2) of the Public Health Service (PHS) Act, 42 U.S.C. 247d-6b(c)(2) . (2) Were the government to determine in the future that there is a heightened risk of an anthrax attack--if, for example, there were credible information about an imminent threat of such an attack--that would almost certainly result in a domestic emergency. That
is so, among other important reasons, because those exposed to Bacillus anthracis need to take appropriate antimicrobials rapidly after exposure to avoid contracting anthrax and because of the significant challenges to rapidly delivering such antimicrobials to those at risk in an anthrax emergency. Given his determination that there is a significant potential for a domestic emergency, the Secretary of Homeland Security also urged the Secretary of Health and Human Services to employ all relevant emergency powers under section 564 of the FFDCA to ensure distribution of pre- need countermeasures that may be effective in preventing the contracting of anthrax by people in the delivery chain, such as USPS workers; first responders, including law enforcement; to essential government and non-government workers; and to the general public.

III. Declaration of the Secretary of Health and Human Services

On September 23, 2008, the Secretary of the Department of Homeland Security determined that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents--in this case, Bacillus anthracis. Pursuant to section 564(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b), and on the basis of such determination, on October 1, 2008, I declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C. 360bbb-3(a).

Dated: October 1, 2008. Michael O. Leavitt, Secretary. [FR Doc. E8-23544 Filed 10-1-08; 4:15 pm]

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