May 23, 2005

U.S. Defense Department Appeals Decision that Stopped Mandatory Anthrax Vaccinations

By David Francis
Global Security Newswire

WASHINGTON — The U.S. Defense Department last week asked a federal appeals court to lift an injunction that stopped the mandatory anthrax vaccination program for military personnel (see GSN, May 6).

Justice Department lawyers, in an appeal filed on behalf on the Pentagon, contend that the Food and Drug Administration’s documentation on BioPort’s Anthrax Vaccine Absorbed proves the vaccine is safe and effective in combating all forms of anthrax.

The vaccine is now only fully licensed as safe and effective against cutaneous anthrax.

“The Food and Drug Administration has repeatedly confirmed that [the vaccine’s] label encompasses approval for use against all forms of anthrax, regardless of the route of exposure — including inhalation exposure,” the Pentagon argues in the appeal.

The Pentagon is looking to set aside the decision of U.S. District Judge Emmet Sullivan, who ruled against mandatory vaccinations in October after finding that the Food and Drug Administration had not fully licensed the BioPort vaccine as effective against inhaled anthrax.

The U.S. Health and Human Services Department earlier this year granted the Pentagon emergency use authority to resume vaccinations on a voluntary basis. Mandatory vaccinations could resume if the government’s appeal is accepted.

A Pentagon Web site lists the chances of adverse event from the vaccination at 1 in 100,000.

More than 1 million service members were inoculated before Sullivan stopped the mandatory vaccination program. Recently released figures indicate that hundreds of military personnel were treated for adverse events following vaccination (see GSN, May 6).

The Pentagon argues that the vaccine’s safety and effectiveness against inhalation anthrax are clear from the Food and Drug Administration’s scientific records.

The agency has repeatedly declared the vaccine safe, the Pentagon argues. The Defense Department also points out that the agency did not object to use of the vaccine during the first Gulf War. Correspondence between FDA and Defense Department officials also illustrates the agency’s belief that the drug is safe, the Pentagon said in the appeal.

A 1950s study in which the vaccine proved effective in protecting mill workers exposed to naturally occurring anthrax is also cited by the Pentagon as evidence of safety.

Finally, the Pentagon cited a January 2004 FDA order that found the vaccine to be safe against all forms of anthrax. Sullivan ruled that order invalid because the agency did not accept public comments and due to questions about the vaccine’s safety.

The agency opened the order for comments late last year to comply with the court’s order. The comment period closed at the end of March.

The Pentagon argued that in the face of FDA evidence that the vaccine was safe against all forms of anthrax, the court did not have the authority to stop the program because it believed the vaccine was unsafe.

“Even if the court believed that the FDA’s January 2004 order did not have independent force as a result of a procedural failure to provide additional notice and comment, that failure would only support vacatur of the order,” the Pentagon stated in the appeal. “It would not provide the district court with a basis for revisiting the scope of the [original] license — which has always authorized use of VA to prevent anthrax, without limitation on the route of exposure, and which remains in effect.”

Finally, the Pentagon argues that Smith should not have stopped the vaccination program for the entire military, but only for the six anonymous Defense Department employees who filed suit challenging the program.

John Michels, attorney for the six plaintiffs, would not comment on the case until a response is filed on behalf of his clients. The plaintiffs’ response is due June 30.

May 20, 2005

WHO Backs Smallpox Virus Experiments

Global Security Newswire

The governing body of the World Health Organization last week approved plans for genetic modification of the smallpox virus, the New York Times reported (see GSN, May 17).

The World Health Assembly also supported distributing smallpox samples to additional laboratories for research. Stocks of the virus are now kept at two sites, one in the United States and the other in Russia.

Experiments are hoped to lead to new detection methods for smallpox and treatments for the virus, the Times reported. Researchers would be required to submit details on their work and their security efforts before beginning the experiments.

A member of a WHO advisory committee said he does not expect the panel to approve any projects before its annual meeting in November.

The assembly last week also approved plans to develop a 33.5 million-dose stockpile of smallpox vaccine to treat victims of a natural outbreak or terrorist incident, the Times reported (Lawrence Altman, New York Times, May 21).

Governing body members held off on a decision on whether to destroy all stocks of the smallpox virus, Agence France-Presse reported Friday.

The need to focus on smallpox countermeasures took precedence, given concerns that virus samples might secretly be held outside of the two laboratories, officials said.

“The long-term aim of the WHO and the assembly is to destroy this virus, that’s clear,” said WHO disease expert Mike Ryan.

“The question from a public health point of view is do we know enough about the virus, do we have the correct antivirals, do we have safe and effective vaccines, and effective and rapid diagnostics,” he added.

May 19, 2005

U.S. Smallpox Vaccine Plan Hampers Drug Company Bidding, Industry Representatives Say

By David Francis
Global Security Newswire

WASHINGTON - The U.S. Health and Human Services Department this week issued a draft request for proposals for the next-generation smallpox vaccine for the Strategic National Stockpile (see GSN, May 3).

Industry lobbyists say the Project Bioshield contract for development and production of Modified Vaccinia Ankara (MVA) discourages larger drug companies from bidding because it calls for producing only 20 million doses. Most larger companies lack the capacity to produce vaccine, and would see little economic incentive in seeking the contract unless the number of requested doses was larger, lobbyists said.

The sources contend this contradicts congressional proposals for Bioshield II legislation, which is aimed at attracting larger players to the vaccine anufacturing business with financial and other incentives.

Lobbyists said it is unusual for the department to ask for comments on a proposal before it is issued and that large pharmaceutical companies would probably ask that the number of doses in the contract be increased.

Companies are likely to seek a contractual guarantee to produce at least 50 million doses, said attorney John Clerici of McKenna Long and Aldridge, a law firm representing vaccine manufacturers.

Any profit gained from a 20-million dose contract would not match the investment in vaccine production infrastructure, Clerici said.

The contract does not specify how much would be paid per dose, but gives the
government the option of purchasing 60 million additional doses after delivery and Food and Drug Administration approval of the initial batch of vaccines.

The contract in its current form also makes it difficult for smaller companies to bid, as storage and manufacturing requirements are hard for small companies to meet, Clerici added.

A second industry lobbyist, who asked to remain anonymous because of close ties to vaccine manufacturers, agreed that the scope of the administration's request discourages large drug companies from bidding.

The bid request "is drafted to scare away big [pharmaceutical and biotechnology] companies," the source wrote in an e-mail. "The RFP first solicits 20 million doses of the vaccine, which may be awarded either 10 million doses each for two companies or 20 million doses to one company. Then, it gives the government the sole option later to acquire up to an additional 60 million doses of the vaccine. The draft RFP does not commit the government to ever exercise that option."

The Health and Human Services Department believes the new recombinant vaccine would cause fewer post-vaccination adverse reactions than Dryvax, the currently licensed smallpox vaccine.

The source questioned why the department, acknowledging smallpox as a threat, would not simply request 80 million doses.

"HHS is playing cat and mouse with this crazy option" to purchase an extra 60 million doses, the source wrote. "I thought Bioshield was supposed to create a guaranteed market so that more companies would be attracted and bid. This is someone's idea to confuse and provide uncertainty to industry ... except perhaps for some small start-ups that are willing to gamble the entire[ty] of their companies and roll the dice."

Comments on the draft proposal are due on May 31.

U.S. Senate proposals - one introduced by Republican leadership, another by Senators Joe Lieberman (D-Conn.), Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.) - would provide incentives, such as liability shields and patent exclusivity, to encourage big drug makers to enter the vaccine market.

Senator Richard Burr (R-N.C.), chairman of the Senate Health, Education, Labor and Pensions Committee's bioterrorism preparedness subcommittee, plans to review the bills in a series of hearings this summer. Burr has pledged to consider both bills before combining them into a single piece of legislation.

The smallpox contract would be the fourth under Bioshield, which has $5.6 billion available for developing biological weapon countermeasures over the next decade. The Health and Human Services Department has awarded contracts to VaxGen for an unlicensed recombinant anthrax vaccine, BioPort for its licensed anthrax vaccine and Fleming and Co. for a radiation countermeasure.

May 18, 2005

Pentagon Appeals Decision Halting Anthrax Inoculations

By Deborah Funk, Times staff writer

Government lawyers representing the Pentagon and Department of Health and Human Services want to convince a federal appeals court that a U.S. District Court judge erred in halting the military’s mandatory anthrax vaccination program late last year.

In documents filed May 16 in the U.S. District Court of Appeals for the District of Columbia, government attorneys said the district court judge’s conclusion that the vaccine has never been licensed for to protect against anthrax exposure through inhalation is “without basis.”

When the National Institutes of Health licensed the vaccine in 1970, it did not differentiate the possible routes of exposure of the disease nor the possible uses of the vaccine, according to the government’s written argument.

The license remains in effect and the Food and Drug Administration has said repeatedly that the vaccine is effective against all forms of anthrax, to include contracting it through the skin.

But instead of relying on the original license and the FDA’s review, the court based its decision on a 1985 advisory panel that said the vaccine’s “efficacy against inhalation anthrax is not well documented,” stated the government’s written argument.

The government insists that the panel’s conclusion “was premised on a misunderstanding of the relevant data.”

Government lawyers also are arguing that the district court judge did not need to stop the military’s entire anthrax vaccine effort in order to protect the interests of the six men and women who sued the government over the mandatory program.

“The interests of thousands of members of the armed forces are not aligned with those of the six plaintiffs,” government lawyers wrote. “The court’s ruling jeopardizes the safety of the countless persons who have never been made part of this action.”

Oral arguments in the appeal are not yet scheduled.

May 17, 2005

U.S. Researchers Await Final WHO Approval on Genetically Modified Smallpox Experiments

Global Security Newswire

The World Health Organization is expected to make a final decision soon on a proposal by U.S. scientists to genetically modify the smallpox virus for research purposes, the Guardian reported today (see GSN, Jan. 24).

A technical committee of the organization has already approved the proposal, but a final decision by the full assembly is pending. WHO representatives are expected to address the matter during a 10-day annual meeting that began yesterday in Geneva.

Supporters believe that genetic modification could lead to new vaccines and treatments for smallpox, according to the Guardian.

Some scientists have expressed concerns that the proposed experiments could increase the chances that smallpox would be used in an act of bioterrorism. For example, while stocks of the virus are now kept in only two secure laboratories — one in Russia and the other in the United States — relaxation of the rules would allow small components of the smallpox DNA to be made available to several laboratories.

Donald Henderson, former director of the WHO global smallpox eradication program, has objected to permitting greater numbers of researchers to conduct smallpox experiments.

“The problem is that we have got a lot of people with a lot more talent working in biological laboratories around the world and a lot of them are very well-trained and the potential for mischief here is much greater,” he said (Boseley/Borger, Guardian, May 17).

May 16, 2005

Services told to start voluntary anthrax shots

Air Force Times
By Deborah Funk, Times staff writer

U.S. troops serving in Central Asia, the Middle East and South Korea once again can receive anthrax vaccinations - but only if they choose to get the shots.

The Pentagon has told the services to begin anthrax inoculations under an "emergency use authority" granted by the Food and Drug Administration, which can be employed only if the shots are given voluntarily.

Troops deploying to the Central Command's area of operations or Korea for at least 15 consecutive days are eligible for the shots.

Special-mission units and units with jobs related to bio-warfare or bioterrorism also will be offered the vaccinations, as will any adult family members living in the Central Command area of operations and South Korea.

The significant difference between this program and the Pentagon's original vaccination plan is that this time, service members are not required to take the shots, cannot be coerced into doing so and cannot be punished in any way if they decline. Refusal cannot harm a career nor cause legal troubles under the conditions of the emergency use authority.

"There will be no adverse consequences," confirmed Army Col. John Grabenstein, deputy director of the Military Vaccine Agency.

In a memo to the services, David S.C. Chu, undersecretary of defense for personnel and readiness, said that while the emergency use authority remains in effect, "military leaders at all levels will respect this option to refuse."

"For individuals who express initial doubts about the value of anthrax vaccination, counseling may reinforce education and information messages and answer questions or concerns, but may not coerce," Chu added.

At press time, it was unclear exactly when the vaccinations will start. But before any service members can be vaccinated, they must be told the risks and benefits of the vaccine, the conditions of the emergency use authority and their right to refuse vaccination. That information will be given in briefings and is also available in a brochure, a copy of which can be viewed online at Slides from the briefing are online at

The Army was expected to start offering vaccinations in the first 10 days of May. At press time, the other services could not say when they would resume the shots.

Military units will record whether someone received the brochure and accepted or refused vaccination. Notices of refusal will not be entered into personnel records, but rather will be kept in a vaccination tracking system that also records when people are vaccinated and the lot from which their vaccine came.

Although its label says the vaccine is to be given in six doses at specific intervals over 18 months, service members will not continue the series once their duty assignment takes them out of the areas or jobs considered at heightened risk, Chu's April 29 memo said.

The emergency use authority prohibits vaccinating people who leave those heightened-risk assignments, Grabenstein said.

These latest developments come less than a month after a federal judge granted permission to administer the shots on a voluntary basis. Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia issued a ruling Oct. 27 to halt the mandatory vaccinations, at least temporarily.

The Pentagon asked the FDA for permission to use the vaccine on a voluntary basis until at least July 27. Sullivan modified his order April 6 to allow the voluntary shots under the emergency use authority.

FDA officials, meanwhile, are taking administrative steps to satisfy the shortcomings Sullivan cited in his ruling that the vaccine is not licensed to protect against inhalation anthrax. The government also is appealing that ruling to a higher court.

John J. "Lou" Michels Jr., an attorney for six anonymous service members and government civilian workers who sued to stop the mandatory program, said he has "no confidence" in the military's ability to document who receives a brochure, who receives a shot voluntarily, when it was administered and from what lot. He predicted that vaccine recipients will have adverse reactions to the shots and that many people who get vaccinated will say they had no choice.

May 13, 2005

More Scientists Move to Bioterror Defense Efforts

By David Francis
Global Security Newswire

WASHINGTON - The number of scientists working on bioterrorism preparedness across the United States has increased dramatically since 2001, the Centers for Disease Control and Prevention reported today (see GSN, May 10).

A survey by the Council of State and Territorial Epidemiologists, says the number of epidemiologists concentrating on emergency response and bioterrorism preparedness increased 27 percent from 2001 to 2004. The survey results were first published in September 2004 and were reported in today's issue of the CDC's Morbidity and Mortality Weekly Report.

The federal health agency attributes this increase to an influx of $1 billion in federal funds to the states for terrorism readiness. Epidemiologists track and control disease outbreaks.

States claim this increase led to major improvements in the ability to respond to a biological attack (see GSN, May 9).

However, the study found that only 64 percent of epidemiologists working in bioterrorism have degrees in epidemiology, and that 20 percent have no formal training in the subject.

The agency also found that the focus on bioterrorism reduced states' ability to treat infectious and chronic diseases, weakening the public health system. A 47-percent increase in the number of epidemiologists working at the state level is needed to stabilize the system.

In testimony to a Senate subcommittee this week, Shelly Hearne of the Trust for America's Health warned that weaknesses in any part of the public health infrastructure limit states' ability to respond to a biological attack or
naturally occurring disease outbreak.

Security expert Howard Safir echoed these concerns to the Associated Press, saying work remains to ensure nationwide bioterrorism preparedness.

"This has been a problem because the resources are not there. The problem is
that this was not a priority before 9/11. What we're doing now is playing catch-up," Safir said. "We just have to make sure we have enough people in the pipeline so we can deal with it."

The Associated Press also notes that William Raub, the Health and Human Service Department's principal deputy assistant secretary for public health and emergency preparedness, warned earlier this year that less than one in four states has the ability to respond to a biological or chemical attack at any time.

Raub added that many states are not capable of mass immunizations with vaccines from the national stockpile.

U.S. Health and Human Services Department Announces $1.3 Billion in Bioterror Funding

An additional $1.3 billion in federal bioterrorism and public health funding is available for use by states, territories and four metropolitan areas, the U.S. Health and Human Services Department announced in a press statement today (see GSN, May 6).

"These funds will . result in a stronger system to care for Americans in emergencies, whether it be a bioterror attack or an infectious disease outbreak like SARS or West Nile virus," HHS Secretary Mike Leavitt said in the release.

The money is to be used for infectious disease surveillance and investigation capability upgrades, enhancing hospital readiness, and expanded laboratory and communications capacities, according to the statement.

The department also announced that the Centers for Disease Control may increase the number of state laboratories certified to test chemical agents. Laboratories in California, Michigan, New Mexico, New York and Virginia now have certification, and up to five more may be selected in an effort to make sure samples can reach a laboratory within eight hours for testing (HHS release, May 13).

May 11, 2005

NIAID awards first $27 million using new bioshield authorities

Bio-terrorism/Terrorism News/UK

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded 10 grants and 2 contracts totaling approximately $27 million to fund development of new therapeutics and vaccines against some of the most deadly agents of bioterrorism including anthrax, botulinum toxin, Ebola virus, pneumonic plague, smallpox and tularemia.

These awards are the first made by NIAID using authorities provided by Project Bioshield, which was signed into law on July 21, 2004. Project Bioshield gives federal agencies new tools to accelerate research on medical countermeasures to safeguard Americans against chemical, biological, radiological or nuclear attack. These first grants and contracts, which range in duration from 12 to 18 months, respond to a key objective of the NIAID biodefense research agenda that emphasizes the development of new and improved medical products against "Category A" agents--those biological agents considered by the Centers for Disease Control and Prevention to pose the greatest threat to national security.

"Project Bioshield enables us to expedite research and development of critical medical countermeasures based on promising recent scientific discoveries," says Anthony S. Fauci, M.D., director of NIAID. "These product development awards, focused on the most serious potential agents of bioterror, will help to rapidly translate laboratory findings into new therapies."

The 10 institutions receiving grants and the principal investigator at each are:

-- The Scripps Research Institute, La Jolla, CA, Kim Janda, Ph.D.
Focus: identification of drugs that reverse paralysis caused by botulinum

-- Apath LLC, St. Louis, MO, Paul Olivo, M.D., Ph.D.
Focus: development of new antiviral drugs for Ebola infection

-- Veterans Affairs San Diego Healthcare System, Karl Hostetler, M.D.
Focus: development of a new antiviral drug against smallpox

-- Arizona State University, Tempe, AZ, Bertram Jacobs, Ph.D.
Focus: optimization of smallpox vaccine's protective effect when given after
exposure to the virus

-- NovoBiotic Pharmaceuticals LLC, Cambridge, MA, Losee Ling, Ph.D.
Focus: development of new drugs against the bacterium that causes anthrax

-- Children's Hospital Oakland Research Institute, Oakland, CA, Donald Reason, Ph.D.
Focus: development of antibodies to be used as post-exposure anthrax therapy

-- Nanotherapeutics Inc., Alachua, FL, James Talton, Ph.D.
Focus: development of single-dose disposable inhalers of two antibiotics for
immediate, post-exposure protection against pneumonic plague and tularemia

-- University of Chicago, Wei-Jen Tang, Ph.D.
Focus: development of a therapy that blocks the action of anthrax edema toxin, which produces severe swelling in human cells

-- MaxThera Inc., Reading, MA, Ania Knap, Ph.D.
Focus: identification of new antibacterial agents against a broad spectrum of potential bioterror pathogens

-- Veritas Inc., Rockville, MD, George Oyler, M.D., Ph.D.
Focus: development of several tests used to screen tens of thousands of drugs to
identify those that inhibit the activity of botulinum neurotoxin The two institutions receiving contracts and the principal investigator at each are

-- XOMA (US) LLC, Berkeley, CA, Marc Better, Ph.D.
Focus: development and production of antibodies that protect against botulinum toxin type A

-- DynPort Vaccine Company (DVC LLC, a CSC company), Frederick, MD, Ian Henderson, Ph.D.
Focus: production of a vaccine candidate against botulinum toxin type E. There are seven known types of botulinum toxin: A, B, C, D, E, F and G. Each has different properties and actions, with types A, B and E considered by scientists to be the most serious threats to public health

NIAID also announced today the appointment of Michael G. Kurilla, M.D., Ph.D., to the dual positions of NIAID Associate Director for Biodefense Product Development, and Director of the Office of Biodefense Research Activities within NIAID's Division of Microbiology and Infectious Diseases. Dr. Kurilla's primary role will be to provide overall Institute coordination for advanced product development of medical countermeasures against bioterror threats. His appointment was made using Bioshield
authorities that enable NIAID to streamline the hiring of qualified scientists to carry out the national medical countermeasure research and development program. For more information on Project Bioshield, visit

May 10, 2005

U.S. Awards $27M for Bioterror Countermeasures

Global Security Newswire

The National Institute of Allergy and Infectious Diseases announced yesterday that it has awarded $27 million in contracts and grants to research institutions for development of countermeasures to deadly biological agents such as anthrax, smallpox and botulism (see GSN, May 6).

The 10 grants and two contracts were the first awarded by the institute using Project Bioshield authority. Bioshield aims to accelerate the development and purchase of new medical countermeasures against WMD agents.

“Project Bioshield enables us to expedite research and development of critical medical countermeasures based on promising recent scientific discoveries,” NIAID chief Anthony Fauci said in a press release. “These product development awards, focused on the most serious potential agents of bioterror, will help to rapidly translate laboratory findings into new therapies.”

The grants and contracts are to focus on agents deemed most dangerous by the Centers for Disease Control and Prevention (National Institute of Allergy and Infection Diseases release, May 9).

May 9, 2005

Local reps fail our POWs

By: Gail Chatfield - Commentary
North County Times - Escondido,CA,USA

After being starved and brutally tortured by the Iraqi Army in l99l, Oceanside resident and retired Marine Col. Cliff Acree and 16 other U.S. military personnel believed the U.S. government would hold their tormentors accountable. It would take him 14 years to learn otherwise.

When Iraq invaded Kuwait in 1990, the State Department classified Iraq as a sponsor of terrorism and froze its U.S. assets. A 1996 amendment to federal law allowed terrorist nations such as Iraq to be held liable for personal injuries incurred by torture victims.

It was under this law that the POWs successfully sued Saddam Hussein and the Republic of Iraq in September 2002.

Two months later, President Bush signed a law that provided that Americans could collect court-ordered compensatory damages from frozen assets of terrorist states.

In March 2003, 20 former U.S. officials with national security and defense credentials told Bush that it was in our national security interest to set aside an escrow account to pay the POWs' eventual judgment.

Six days later, Bush confiscated the $1.7 billion in frozen Iraqi assets to pay two judgments against Iraq including "human shield" hostages held in 1990.

Unfortunately, no provision was made for compensation to the POWs even though the administration was well aware of the POWs' case.

In July, the POWs were awarded $1 billion in compensatory and punitive damages along with their request to temporarily freeze the remainder of the Iraqi assets that had not already been used for rebuilding Iraq, which was about $700 million.

Two weeks after the district court ruling, the Bush administration appealed, and the judgment was eventually reversed. Iraq, according to the administration, was no longer an enemy but a "state subject to our protection."

The POWs' next two years of appeals, attempts to compromise, and efforts to engage the Bush administration in talks were denied, rebuffed and declined. A phrase buried in an emergency appropriations bill was used to justify the government's position.

Ironically, Rumsfeld sought to compensate Iraqi detainees we abused saying, "It's the right thing to do."

The POWs' last chance was to appeal to the Supreme Court. A bipartisan group of 20 U.S. senators and representatives added their names to the brief filed by Acree, but the high court refused to hear the case.

Rep. Bob Filner was the local congressman to lend his support to the Oceanside resident. Darrell Issa, whose district includes Oceanside, Duke Cunningham, a decorated Vietnam veteran, and Duncan Hunter, whose son also served in Iraq, did not join the bipartisan group in support of the POWs' legal claim.

Do you "Support Our Troops"? If so, write your congressmen to urge the administration to negotiate with Iraq to resolve this claim. Ironically, an August 2004 audit found that at least $8.8 billion cannot be accounted for. There is $1 billion somewhere in Iraq that should go to the 17 former POWs and their families who want nothing more than to hold Iraq accountable and deter the future torture of
American servicemen and women.

This administration may have won the legal battle but it has lost the ethical and moral war.

EPA on Threshold of Brave New World of Human Testing

Public Employees for Environmental Responsibility

EPA Invites Industry to Mimic Practices of Discontinued CHEERS Study.
Washington, DC - In the wake of the recent cancellation of the CHEERS study in which parents were to be paid to expose their infant children to pesticides, the U.S. Environmental Protection Agency is finalizing a new policy that encourages the same type of human dosing studies by industry. Today EPA closes public comment on its "no safeguards" policy of accepting all human subject experiments submitted by industry, according to a filing today by Public Employees for Environmental Responsibility (PEER).

Under its new policy, EPA would accept all human chemical dosing studies "unless there is clear evidence that the conduct of these studies was fundamentally unethical… or was significantly deficient relative to the ethical standards prevailing at the time the study was conducted." Since industry is not required to disclose the conditions under which experiments were conducted, it is not clear how EPA will ever learn of "fundamentally unethical" practices. Moreover, EPA is unwilling to define what ethical lapses would disqualify an industry submission from being used for regulatory purposes.

"The Bush Administration is setting the ethical bar so low that only the most sleazy cannot limbo under it," stated PEER Program Director Rebecca Roose. "The basic problem is this: the safeguards that apply to experiments involving development of drugs to help people are far more stringent than EPA's standards for experiments to determine how much commercial poisons harm people."

EPA's refusal to adopt basic safeguards requiring proof of informed consent, independent review or protections for children is part of a Bush Administration drive to liberalize rules on human testing of pesticides and other chemicals. Without actual human experimental data to justify higher chemical exposures for children, industry must abide by the 1996 amendments to the Federal Food, Drug and Cosmetic Act setting ten-fold stricter exposure standards for children.

At the same time it is encouraging industry to expose human subjects, EPA itself is conducting similar experiments that serve to provide a template for industry. Last month to avoid a hold on his confirmation, EPA Administrator Stephen Johnson reluctantly cancelled a controversial study financed jointly by EPA and industry called CHEERS (Children's Environmental Exposure Research Study) that would have paid Florida parents to apply pesticides and other chemicals in the rooms primarily occupied by their infant children. During his confirmation, Johnson disclosed that EPA is also conducting more than 250 other human experiments, several of which involve chemical testing on children, including

Exposing children (ages 3 to 12) to a powerful agricultural insecticide (chlorpyrifos) to test absorption in their systems through "urinary biomarker measurements";

Paying "young male volunteers" to inhale methanol vapors at levels described as "a worst case scenario"; and

Having asthma sufferers inhale potentially harmful ultrafine carbon particles.

"The need for safeguards is particularly acute because EPA is giving industry an economic incentive to push the edge of the ethical envelope," Roose added. "It is distressing that a federal agency is using tax dollars to write a primer for commercial exploitation of human subjects."

May 7, 2005

BioPort lands $122.7 million contract - Federal program to increase stockpile of anthrax vaccine

Lansing State Journal

Bioport gets contract for vaccine

Under a $122.7 million contract, BioPort Corp. will make and deliver five million doses of anthrax vaccine for the U.S. Department of Health and Human Services.

. The contract was awarded as part of a $5.6 billion federal program, called Project BioShield, to stockpile antidotes to biological and chemical weapons.

. BioPort's contract was the third announced under the program.

Lansing's BioPort Corp. was selected Friday to make five million doses of anthrax vaccine as part of a federal program to stockpile antidotes to biological and chemical weapons.

BioPort had expected the $122.7 million contract to make and deliver the vaccines during the next 18 months, a company spokeswoman said.

With the contract made final, BioPort will begin delivering doses in days, spokeswoman Kim Brennen Root said.

The federal program, called Project BioShield, was signed into law by President Bush in July 2004.

It involves spending $5.6 billion to develop remedies against possible bioweapons.

The contract, announced Friday by the Health and Human Services Department, was the third awarded under the program.

BioPort is the only manufacturer of a Food and Drug Administration-licensed anthrax vaccine.

Stewart Simonson, the agency's assistant secretary for public health emergency preparedness, said the vaccine "will add another important medical countermeasure for anthrax to the Strategic National Stockpile."

Health and Human Services officials would not provide the size of the current stockpile of vaccines, but agency spokesman Marc Wolfson said the contract would "considerably increase the amount of vaccine available in the event that we need to use it."

BioPort has vaccine ready to ship because the five million doses were part of an earlier contract the company had with the Department of Defense, Root said.

That contract, awarded in early 2004, was for up to 10.4 million doses - 5 million of which were intended for Health and Human Services.

But that department decided to do its own contract, she said.

No additional staffing will be needed to fulfill the contract because it was expected, she said.

The Lansing company, at 3500 N. Martin Luther King Jr. Blvd., has about 300 employees.

May 6, 2005



The Department of Health and Human Services today awarded a $122.7 million contract to BioPort Corporation of Lansing, Mich. for the manufacture and delivery of 5 million doses of Anthrax Vaccine Adsorbed (AVA), a licensed anthrax vaccine.

This supply of AVA anthrax vaccine, which is being purchased under the Project BioShield program, will be placed in the nation's Strategic National Stockpile where it will be available for use in the event of a bioterror anthrax incident. Together with the existing stockpile of antibiotics, these medical countermeasures represent a critical component of the President's strategy for "Biodefense in the 21st Century."

"We are committed to protecting the nation from the consequences of an anthrax attack," said Stewart Simonson, HHS Assistant Secretary for Public Health Emergency Preparedness. "The BioPort vaccine will add another important medical countermeasure for anthrax to the Strategic National Stockpile."

Today's award represents the third contract under Project BioShield, a new program intended to accelerate the development, purchase and availability of medical countermeasures for biological, chemical, radiological and nuclear threats. President Bush introduced Project BioShield in his 2003 State of the Union address. Congress passed the Project BioShield Act of 2004 and the President signed it into law on July 21, 2004.

HHS' Office of Public Health Emergency Preparedness, which oversees the research and procurement efforts under the Project BioShield program through its Office of Research and Development Coordination, will manage the AVA anthrax vaccine contract.

Military Vaccines Trigger Special Treatment for 1,200

By David Ruppe
Global Security Newswire

WASHINGTON — Approximately 1,200 U.S. military personnel who received vaccinations against biological agents during the past two years developed complex, in some cases debilitating, illnesses that were assessed or treated by a specialized network of clinics, according to figures released to Global Security Newswire by the U.S. Army and a review of some cases.

The cases, corresponding with a massive Defense Department effort to vaccinate U.S. forces against anthrax and smallpox before and after the invasion of Iraq, included muscle and joint weakness and pain, chronic fatigue, intense migraines, cognitive problems, and severe diseases such as multiple sclerosis. Some of these have ended military careers.

More common and less serious side effects from the vaccines are said to include temporary headaches, fatigue, fever, nausea and dizziness.

In light of the large number people who received the vaccines, the number of serious cases treated by the Vaccine Health Care Centers, a network of four clinics at domestic U.S. military bases, is rare. Overall, the military says more than 1.3 million military and civilian personnel have received the anthrax vaccine, called Anthrax Vaccine Adsorbed, since 1998, when it resumed the vaccinations after a hiatus over quality control problems. The military has also vaccinated hundreds of thousands of personnel, many who also received the anthrax treatment, for smallpox beginning in December 2002.

The Defense Department, on a Web site that provides information on the vaccine, maintains the anthrax vaccinations are “as safe as other vaccines” and necessary.
None of the personnel treated in fiscal 2004 “has suffered loss of life, limb or eyesight,” according to a statement from Walter Reed Army Medical Center, which houses the main Vaccine Healthcare Center in Washington.

Nevertheless, some cases have been quite severe, such as that of retired Air Force Reserve Lt. Col. Michael Gylock, who within nine days after receiving anthrax and smallpox vaccinations in March 2003 started showing symptoms and was eventually diagnosed with multiple sclerosis and some vision loss.

“I’ve been retired because of it. I’m not fit for military duty,” he said. Gylock and other cases were referred to Global Security Newswire by an advocate of soldiers who believe they were harmed by the vaccine.

Questions have surfaced in recent years about the safety of the anthrax vaccine, and when massive numbers of personnel are vaccinated, even a small percentage of rare disorders can add up.

Walter Reed said that about 600 anthrax vaccine recipients in fiscal 2003 and 600 in fiscal 2004 received in-depth assessment or treatment by the centers’ staff. In addition, officials have said the Vaccine Healthcare Centers during the two years conducted more than 250,000 telephone, e-mail or face-to-face communications with personnel or physicians to discuss reactions, however minor or major, or to provide guidance on how to avoid or treat complications.

Sufficient funding for the four Vaccine Healthcare Centers, created by Congress in 2001 is in question this year. The centers were not included last year in the Pentagon’s fiscal 2005 budget and did not receive a specific congressional appropriation. A nonbinding resolution passed by the Senate urging full funding was stripped from a supplemental appropriations bill this week by leaders from both houses.

Meanwhile, the Pentagon, citing a determination that there is potential for a heightened risk of an anthrax threat to U.S. forces, announced Tuesday it would resume providing mass anthrax vaccinations to service members mainly in South Korea and across the Middle East and South Asia (see related GSN story, today).

“Without the centers [there are] over 1,000 military personnel who would not have gotten the care they deserve, the best possible care we can provide,” Senator Joseph Biden (D-Del.), who had proposed specific funding for the centers, said in a Senate floor speech last month.

“If the department believes it is an emergency to resume that vaccine, how can we consider preserving the Vaccine Health Care Centers any less?” he said.

Quantity of Serious Illnesses Uncertain

While the data on Vaccine Healthcare Center treatments give some indication of the numbers and types of rare illnesses that may result from anthrax or smallpox vaccinations, there is no definitive data on how many and which illnesses were caused by the military inoculations.

One reason is that the numbers of cases treated by the centers, and otherwise identified through its Vaccine Adverse Event Reporting System, do not necessarily account for all serious illnesses caused by a vaccine because military reporting on side effects is passive. In other words, the onus is on the soldiers to seek help from the centers and many are said to be unaware the clinics exist, are unwilling to inform superiors they may have a career-jeopardizing disorder, or have had trouble convincing authorities of the illness.

As little is understood about how vaccines cause serious illness, some doctors have appeared reluctant to conclude a vaccination may have caused a specific illness, experts have said.

“Because serious problems are rare, it is difficult for the average base physician to develop the expertise needed to provide the best treatment,” Biden said in his speech.

In addition, as multiple military vaccines are often given around the same time, researchers have difficulty determining which one might have been the cause of a particular illness, experts have said.

Furthermore, just because a person had experienced adverse events after those vaccinations, does not necessarily mean the events were caused by the vaccinations, Walter Reed said in a statement.

“Cause-and-effect evaluations require consideration of at least six factors; timing is only one of those factors. Cause-and-effect evaluations are often difficult in individual cases,” it said.

Little Understanding of Causality

Air National Guard Technical Sgt. Rick Brown’s case is illustrative of the challenge to understanding causality. A Philadelphia firefighter and formerly an avid bodybuilder and hockey player, Brown said that soon after receiving anthrax and smallpox vaccinations in March 2003 he experienced intense pain in muscles and joints and decreased mobility.

“My first indication was a mass on the side of my neck that was about the size of a grape and immediately my body started feeling really bad. I had open mucus membranes throughout my body, oozing out of my ears, my nose, my penis, my mouth,” he said.
Brown said he was eventually diagnosed with degenerative arthritis, including joint and muscle aches, and may have had a heart attack. He was also twice ruled unfit for military work after 19 years of service.

“For a while, my muscles turned to jelly, my joints were just all screwed up,” he said.

Brown said he learned of the Vaccine Healthcare Centers from an Internet search. Military physicians were initially unwilling to send him to a center and unwilling to consider that the anthrax vaccination might be causing his illnesses, he said.
“They said, ‘We want to send you to a clinical physiatrist. We want to heavily medicate you,’” he said.

In a case review delivered to Brown, the Vaccine Healthcare Center at Walter Reed said it had identified possible side effects from the anthrax vaccine. It noted, though, causality between the vaccination and such chronic illness has not been proven. The center and another organization are preparing to study that question.
“At the present time, it is impossible to prove or disprove a causal link between the vaccine and chronic problems but efforts are under way … to collect information regarding these problems and continue to define the range of the problem,” the center said generically in its review of Brown’s case.

Brown, who served for a year in Afghanistan until November 2002, “loves the military” and wishes he could resume service, said he might be forced out before he is eligible for retirement, which is in about six months. “Let’s put this stuff on the shelf, because a lot of people are getting sick,” he said.

Gylock said an informal Air Force medical board had recommended discharging him without benefits because the illness was not caused by military action. An appeal to a formal board reversed the decision. That board cited a Vaccine Healthcare Center conclusion that his symptoms may have been caused by the anthrax vaccine, he said.
The center, also said, though there is a medical community controversy over whether vaccines can cause multiple sclerosis and that, that “causality cannot be established.”

The Vaccine Healthcare Center’s “review of my records was probably the most beneficial thing that happened to me,” he said.

U.S. Inks $120 Million Anthrax Vaccine Deal, Says Delivery to Begin Within Weeks

By Joe Fiorill
Global Security Newswire

WASHINGTON — The United States and its only licensed provider of anthrax vaccine agreed today on a contract for 5 million doses to be administered to civilians in case of a bioterror attack (see related GSN story, today; GSN, April 29).

The Health and Human Services Department awarded the $122.7 million contract to drug maker BioPort after more than four months of negotiations. The deal is part of the Bioshield program to spur availability of WMD countermeasures.

“We are committed to protecting the nation from the consequences of an anthrax attack,” the department’s public health emergency chief, Stewart Simonson, said in a press release. “The BioPort vaccine will add another important medical countermeasure for anthrax to the Strategic National Stockpile.”

Spokesman Marc Wolfson added in a telephone interview that the department expects “within the next couple weeks” to begin receiving the vaccine, which BioPort is already manufacturing.

Health and Human Services announced in November that it planned to buy the vaccine from BioPort. As the intervening months passed, complaints of slowness in reaching a contract agreement began to arise from such critics as Senator Chuck Grassley (R-Iowa).

Today’s contract is the second for an anthrax vaccine and the third overall awarded under Bioshield, which President George W. Bush signed into law July 21, 2004.

In November 2004, Health and Human Services awarded a contract worth $877.5 million to VaxGen for 75 million doses of a new anthrax vaccine that has yet to be licensed. In March of this year, the department awarded a $5.7 million contract to Fleming & Co. for 1.7 million doses of pediatric liquid potassium iodide for use in warding off potential thyroid problems caused by radiation.

DOD Switches Policy on Voluntary Vaccinations

By David Ruppe
Global Security Newswire

WASHINGTON — In announcing the resumption of anthrax vaccinations for military personnel this week, the U.S. Defense Department abandoned a fiercely defended policy against voluntary vaccinations (see GSN, April 1).

The reversal of that policy, however, coincides with relaxed requirements for informing and obtaining the consent of potential recipients before administering such investigational drugs, which are in effect because senior Bush administration officials have declared a potential emergency.

The new plan was announced Tuesday in a press release. The vaccinations were ordered to resume under a “emergency use authority,” which was based on a Pentagon determination last December that a “significant potential [exists] for a military emergency involving a heightened risk to United States military forces of attack with anthrax.”

The Defense Department had halted mandatory anthrax vaccinations in October, after a U.S. District Judge Emmet Sullivan ruled the drug was not yet fully licensed by the Food and Drug Administration as effective against inhaled anthrax and so could not be made mandatory.

The military previously opposed administering the vaccine voluntarily, arguing it could weaken U.S. forces were soldiers to opt out. “We fight as a team. All team members must be healthy. That’s why voluntary vaccination is not an option,” states a Defense Department Web site published to inform service people about the vaccine.

The drug has been licensed for skin-contracted anthrax since 1970, and used by textile workers, but not for inhalation anthrax, the type that would be expected in an attack on U.S. forces.

Some soldiers in past years have been court-martialed for refusing to take the vaccine.

A Pentagon Web site says the vaccine causes serious adverse side effects in “about 1 in 100,000 vaccinations.”

More than 1 million military personnel have been required to take the vaccine in recent years. Hundreds have been assessed and treated for severe reactions by a special network of centers (see related GSN story, today).

Relaxed Information and Consent Requirements

The “emergency use authorization” invoked by senior Bush administration officials enables the military to give voluntarily vaccinations without more stringent legal requirements for informing soldiers about the side effects of the vaccine or obtaining their written consent.

Federal law normally would require that personnel be told that the vaccine is investigational and not approved for its intended purpose. Furthermore, all possible side effects must be disclosed and the person must sign a form consenting to the vaccination.

Under a law signed last year allowing for emergency use authorizations, military authorities only are required to “establish such conditions … as the [defense] secretary finds necessary or appropriate” so that personnel are informed of “significant known and potential benefits and risks of such use.”

An informational brochure the Defense Department said it will give service members before they are offered the shots lists only more common, minor side effects expected from the vaccine, such as itching, swelling and nausea.

A number of service members have reported symptoms such as chronic headaches and debilitating muscle and joint pains and weakness, and more serious illnesses, that have taken them out of service.

The brochure also does not mention the vaccine is investigational for inhalation anthrax.

“The emergency use authorization is much more generic with regard to the information that’s got to be provided to people [normally under U.S. law],” said Lou Michels, an attorney in Chicago representing six anonymous military and civilian personnel who sued government officials over the prior mandatory program.

Pressure, No Punishment

The brochure, released last month, says the vaccine has been used for more than 30 years and that death or serious illness has rarely been reported following treatment. It gives information on who to contact in the event of side effects and lists categories of people who should not receive the vaccine, including pregnant women.

The brochure also includes text — demanded last month by Judge Sullivan — that indicates soldiers cannot be punished for refusing the vaccine and will still be deployable.

Immediately following that text, though, it urges soldiers to take the vaccine.

“The consequences of refusing anthrax vaccine include that you will be more vulnerable to lethal anthrax infection. Your loss could threaten the lives of others in your unit who depend on you, and could jeopardize the success of the mission,” it says.

Such language in the brochure and verbal pressure, the Michels said, will likely be used to pressure soldiers into taking the vaccine.

“I believe that at the end of the day, this program for a lot of these soldiers is not going to be purely voluntary. There is going to be a lot of pressure brought to bear on people to take the shot,” he said.

The DOD press release Wednesday said commanders would inform personnel of “an option to refuse the vaccination without penalty.”

‘Potential for a Heightened Risk’

Deputy Defense Secretary Paul Wolfowitz in December requested the emergency authorization from the head of the Food and Drug Administration, citing a November intelligence report that he said indicated “a significant potential for a military emergency involving a heightened risk” of an anthrax attack on U.S. forces.

The vaccination brochure is less circumspect in its description of a threat.

“U.S. military forces are at high risk of attack with anthrax spores. A significant potential for a military emergency exists. … Your military and civilian leaders strongly recommend anthrax vaccination,” it says.

The vaccinations “for the most part,” will be limited to personnel assigned to homeland biological terrorism defense missions and to the U.S. Central Command and Korea, according to a DOD statement released Tuesday. Adult family members and U.S. government contractors also may be asked to take the vaccine, according to a separate military notice.

The Food and Drug Administration’s determination on whether to license the vaccine for prevention of inhalation anthrax is still pending. A public comment period on the proposed license ended in March and Food and Drug Administration officials are presumably reviewing those comments before making its determination.

“The issue of mandatory vaccination will be reconsidered after the FDA completes its administrative review, which DOD expects to occur later in 2005,” the brochure says.

May 3, 2005

Senators Cast Doubt on U.S. Bioterror Preparedness

By Fresia Rodriguez Cadavid and Elaine Povich

WASHINGTON — U.S. senators expressed concern Thursday that despite the government's ongoing efforts, the nation remains susceptible to a bioterrorist threat (see GSN, April 1).

At a hearing on bioterrorism, Homeland Security Appropriations Subcommittee Chairman Judd Gregg (R-N.H.) said while progress has been made to improve national security, the country should not underestimate how far it needs to go to safeguard the country's food and vaccine supplies.

President George W. Bush’s fiscal 2006 budget seeks $274 million to beef up a series of programs to combat the threat of bioterrorism, up from $100 million the previous year, senators said. But critics have charged that the budget also calls for cuts in antibioterrorism efforts at the local level.

Doubts raised by Gregg came as Penrose Albright, the assistant secretary for science and technology at the Homeland Security Department, testified specifically on the Bioshield program coordinated by the Homeland Security and HHS departments.

Signed into law last July, the program will provide $5.6 billion over 10 years for the purchase of vaccines to combat biological weapons. It also would expedite research into addressing the threat posed by the weapons. After passing the bill, lawmakers immediately began work on a Bioshield II bill aimed at industry concerns that impediments remain to industry development of such products (see related GSN story, today).

Albright testified there is not a “good way” to identify pathogens, such as anthrax and smallpox, coming across the border into the United States. He added that the department is focusing efforts not on prevention but on detection before infected populations exhibit symptoms of a bioterrorism attack.

Homeland Security Appropriations Subcommittee ranking member Robert Byrd (D-W.Va.) questioned whether the United States has enough protection on its borders against deadly germs being brought into the country.

Albright said it is almost impossible to protect against biological agents being brought into the United States, since a supply as small as a quarter could cause widespread sickness.

“No, we don't have a good way of detecting someone trying to bring a vial of pathogen across the border,” he said. He added that the best way to protect the nation is to detect an attack when it occurs so that vaccines can be distributed as quickly as possible.

Noting that the flu can be lethal to vulnerable populations such as the elderly, Senator Larry Craig (R-Idaho) said the country was unprepared to deal with an influenza pandemic.

Craig said the nation “lucked out this year. We made it through the flu season. But I was amazed at our vulnerability there.”

He said a small amount of influenza virus could cause an epidemic.

“The flu isn't a seasonal nuisance,” Albright said. “The flu is a very, very unique threat to this country, going back to [the epidemic of] 1918.”

Stewart Simonson, assistant secretary in the Health and Human Services Department Office of Public Health Emergency Preparedness at HHS, stopped short of agreeing with Craig's assessment, saying “I would not say we are unprepared, but it presents an enormous challenge to us.”

Senator Ted Stevens (R-Alaska) and Gregg also questioned whether the process used by Simonson's office to award vaccine development contracts ensured open competition and delivery to prevent a vaccine shortfall.

Gregg noted that during this year's flu season, the main manufacturer of flu vaccine, Chiron Corp., was forced to withdraw its supply because of contamination, causing a severe shortage in the United States.

“Are we creating the same situation with anthrax?” Gregg asked, referring to the flu vaccine shortfall last winter.

Simonson responded that the agency has negotiated a contract with California's VaxGen for 75 million doses of an anthrax vaccine and also has ordered 5 million additional doses from other suppliers to satisfy immediate needs.

Although Simonson said the different agreements show that they are “seeking not to put all our eggs in one basket,” he added that he remains unsure if the contract award process is being done right.

“We're learning as we go,” he said.

Bioshield II Legislation Introduced in Senate

Global Security Newswire

Three U.S. senators last week introduced Bioshield II legislation to continue to promote development of countermeasures to a bioterror attack (see GSN, July 21, 2004).

The initial Project Bioshield, signed into law last year, set aside $5.6 billion to fund development of drugs and other products against a WMD event. However, potential manufacturers and analysts said roadblocks remained to development of such products (see GSN, Oct. 4, 2004).

“The best way to combat the very real and serious threat of bioterrorism is to utilize our greatest strength — the entrepreneurial talent of our nation — in our national defense,” Senator Joe Lieberman (D-Conn.), who co-sponsored Bioshield II with Senators Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.), said in a press release.

“The Bioshield law enacted last year takes the first step, but without additional reforms, companies are not likely to risk their own capital to fund this research, leaving us with a government-funding model that will be exceedingly expensive and not likely to produce the results we need,” Lieberman added.

Bioshield II calls for tax incentives to promote capital investment in research, patent incentives and other intellectual property protections, and liability protections for manufacturers whose vaccines cannot be fully tested, as they would be designed to counteract potentially fatal infections.

The legislation pledges federal money for products that meet government specifications, but sets no specific funding levels, the press release states.

Legislation introduced in January by Senator Judd Gregg (R-N.H.) and Senate GOP leaders also seeks to expand on the original Bioshield. Lieberman, Hatch and Brownback hope to combine their proposals with the earlier bill (U.S. Senator Joe Lieberman release, April 28).