« Home | Emergency declarations smooth way for vaccine make... » | Chertoff Memo: How to Declare an Anthrax Emergency... » | Emergent Biosolutions Hits New 52-Week High On Pos... » | U.S. Limits Anthrax Vaccine Liability » | CDC Panel May Advise Anthrax Shots for First Respo... » | Security Problems Found at Two Biodefense Labs » | DHHS designates an anthrax emergency as a means to... » | Bogus Anthrax 'State of Emergency' Protects Drugma... » | Fears have led to Removal of Citizen's Protection » | APIC seeks mandate for flu shots in health workers... »

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

Archives