January 29, 2005

Chicago attorney wants anthrax vaccines stopped

Medill News Service

In 2000, an Air Force captain stationed in Oklahoma received three anthrax vaccinations.

She soon began experiencing numbness and tingling in her arm, hand and fingers. When she called the medical center, she was told the problems would go away. Months later, however, she had trouble using stairs and riding a bicycle. She said she was "generally clumsy" and her speech was slurred and slowed. After undergoing medical tests, her doctor said her cerebellum, which controls motor functions, had shrunk and the damage was permanent.

In her early 30s, the woman -- who asked not to be identified -- said she never had any health problems before the vaccinations. Though she admits there is no proof her condition resulted from the anthrax vaccine, she said there is no other explanation. Her neurologists have found no other logical cause either.

Still enlisted, she fears she'll be discharged within the year because of her condition.

"I've hardly told anyone," the woman said. "I only broke down and told my parents when I needed a driver to and from the spinal tap a year ago."

The captain is one of many military service people -- more than 1,000 -- who attribute their deteriorating health to the anthrax vaccine, according to Chicago attorney John Michels. Michels, a former Air Force general, has been investigating the military's use of the anthrax vaccine for six years.

In 2003, Michels filed a lawsuit against the U.S. Department of Defense, the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services to ban mandatory anthrax vaccinations for service people.

The lawsuit also accuses the FDA of failing to prove the vaccine is safe.

Last October, U.S. District Judge Emmett Sullivan in Washington, D.C. issued an order to stop mandatary vaccinations because the vaccine was improperly licensed by the FDA. The judge allowed it to be used only in two instances: with voluntary consent or if President Bush ordered it.

Sullivan also had doubts about the vaccine's safety and sent it back to the FDA for review.

An FDA spokeswoman said the vaccine is "fully licensed, safe and effective," but the judge sent it back because the FDA had not proven the vaccine was sufficiently effective in cases of inhalation anthrax.

The government appealed the decision and is expected to file briefs with a federal appeals court in Washington, D.C. in May.

Michels said he still has serious doubts about the vaccine's safety even if the FDA re-approves it and worries the defense department will be able to resume inoculating military personnel.

The vaccination, Anthrax Vaccine Adsorbed, was licensed in 1970 to protect against Bacillus anthracis, an infectious disease that most commonly occurs in cattle, sheep and other herbivores. In 1998, the government started the anthrax vaccine immunization program, requiring all military to be inoculated.

By 2001, more than 2.1 million doses had been administered, according to the National Academy of Sciences.

Dr. Meryl Nass, of Mount Desert Island Hospital in Bar Harbor, Maine, who spent 16 years studying the anthrax vaccine, said it is not safe.

"No one is allowed to do anthrax research on any of the young people who are getting the shots now," she said. "The only folks who are allowed to look at (those receiving the vaccine) are the Army folks."

Though Nass admits that no vaccine is 100 percent safe, she questions the military's and FDA's decisions to use the anthrax vaccine. After publishing an article saying the vaccine was a possible contributor to Gulf War syndrome, she began receiving e-mails from service people who said they became sick from it.

At first, Nass said, she thought it was coincidence. But "after 50 to 100 people tell you they have the same symptoms, I was thinking there was something to it."
In 2000, the National Academy of Sciences commissioned a report to assess the safety and efficacy of the anthrax vaccine.

The report concluded that the vaccine is "reasonably safe" and there was "no evidence that vaccine recipients face an increased risk of experiencing life-threatening or permanently disabling adverse events."

But Nass said the report ignored several studies that link the vaccine to Gulf War syndrome.

"The (report) says it should be effective against all known strains of anthrax," Nass said. "That is a ridiculous claim to make. In all animals and people, no matter what vaccine you use, it's not effective against all strains.

They made a claim that is completely unsupportable by science. They provided the government with what it wanted to support its policies."

January 27, 2005

The Return of the Draft

Tim Dickinson
Rolling Stone Magazine

Uncle Sam wants you. He needs you. He'll bribe you to sign up. He'll strong-arm you to re-enlist. And if that's not enough, he's got a plan to draft you.

In the three decades since the Vietnam War, the "all-volunteer Army" has become a bedrock principle of the American military. "It's a magnificent force," Vice President Dick Cheney declared during the election campaign last fall, "because those serving are ones who signed up to serve." But with the Army and Marines perilously overextended by the war in Iraq, that volunteer foundation is starting to crack. The "weekend warriors" of the Army Reserve and the National Guard now make up almost half the fighting force on the front lines, and young officers in the Reserve are retiring in droves. The Pentagon, which can barely attract enough recruits to maintain current troop levels, has involuntarily extended the enlistments of as many as 100,000 soldiers. Desperate for troops, the Army has lowered its standards to let in twenty-five percent more high school dropouts, and the Marines are now offering as much as $30,000 to anyone who re-enlists. To understand the scope of the crisis, consider this: The United States is pouring nearly as much money into incentives for new recruits - almost $300 million - as it is into international tsunami relief.

"The Army's maxed out here," says retired Gen. Merrill McPeak, who served as Air Force chief of staff under the first President Bush. "The Defense Department and the president seem to be still operating off the rosy scenario that this will be over soon, that this pain is temporary and therefore we'll just grit our teeth, hunker down and get out on the other side of this. That's a bad assumption." The Bush administration has sworn up and down that it will never reinstate a draft. During the campaign last year, the president dismissed the idea as nothing more than "rumors on the Internets" and declared, "We're not going to have a draft - period." Defense Secretary Donald Rumsfeld, in an Op-Ed blaming "conspiracy mongers" for "attempting to scare and mislead young Americans," insisted that "the idea of reinstating the draft has never been debated, endorsed, discussed, theorized, pondered or even whispered by anyone in the Bush administration."

That assertion is demonstrably false. According to an internal Selective Service memo made public under the Freedom of Information Act, the agency's acting director met with two of Rumsfeld's undersecretaries in February 2003 precisely to debate, discuss and ponder a return to the draft. The memo duly notes the administration's aversion to a draft but adds, "Defense manpower officials concede there are critical shortages of military personnel with certain special skills, such as medical personnel, linguists, computer network engineers, etc." The potentially prohibitive cost of "attracting and retaining such personnel for military service," the memo adds, has led "some officials to conclude that, while a conventional draft may never be needed, a draft of men and women possessing these critical skills may be warranted in a future crisis." This new draft, it suggests, could be invoked to meet the needs of both the Pentagon and the Department of Homeland Security.

The memo then proposes, in detail, that the Selective Service be "re-engineered" to cover all Americans - "men and (for the first time) women" - ages eighteen to thirty-four. In addition to name, date of birth and Social Security number, young adults would have to provide the agency with details of their specialized skills on an ongoing basis until they passed out of draft jeopardy at age thirty-five. Testifying before Congress two weeks after the meeting, acting director of Selective Service Lewis Brodsky acknowledged that "consultations with senior Defense manpower officials" have spurred the agency to shift its preparations away from a full-scale, Vietnam-style draft of untrained men "to a draft of smaller numbers of critical-skills personnel."

Richard Flahavan, spokesman for Selective Service, tells Rolling Stone that preparing for a skills-based draft is "in fact what we have been doing." For starters, the agency has updated a plan to draft nurses and doctors. But that's not all. "Our thinking was that if we could run a health-care draft in the future," Flahavan says, "then with some very slight tinkering we could change that skill to plumbers or linguists or electrical engineers or whatever the military was short." In other words, if Uncle Sam decides he needs people with your skills, Selective Service has the means to draft you - and quick.

But experts on military manpower say the focus on drafting personnel with special skills misses the larger point. The Army needs more soldiers, not just more doctors and linguists. "What you've got now is a real shortage of grunts - guys who can actually carry bayonets," says McPeak. A wholesale draft may be necessary, he adds, "to deal with the situation we've got ourselves into. We've got to have a bigger Army."

Michael O'Hanlon, a military-manpower scholar at the Brookings Institute, believes a return to a full-blown draft will become "unavoidable" if the United States is forced into another war. "Let's say North Korea strikes a deal with Al Qaeda to sell them a nuclear weapon or something," he says. "I frankly don't see how you could fight two wars at the same time with the all- volunteer approach." If a second Korean War should break out, the United States has reportedly committed to deploying a force of nearly 700,000 to defend South Korea - almost half of America's entire military.

The politics of the draft are radioactive: Polls show that less than twenty percent of Americans favor forced military service. But conscription has some unlikely champions, including veterans and critics of the administration who are opposed to Bush's war in Iraq. Reinstating the draft, they say, would force every level of society to participate in military service, rather than placing a disproportionate burden on minorities and the working class. African-Americans, who make up roughly thirteen percent of the civilian population, account for twenty-two percent of the armed forces. And the Defense Department acknowledges that recruits are drawn "primarily from families in the middle and lower-middle socioeconomic strata."
A societywide draft would also make it more difficult for politicians to commit troops to battle without popular approval. "The folks making the decisions are committing other people's lives to a war effort that they're not making any sacrifices for," says Charles Sheehan-Miles, who fought in the first Gulf War and now serves as director of Veterans for Common Sense. Under the current all-volunteer system, fewer than a dozen members of Congress have children in the military.

Charlie Moskos, a professor of military sociology at Northwestern University, says the volunteer system also limits the political fallout of unpopular wars. "Without a draft, there's really no antiwar movement," Moskos says. Nearly sixty percent of Americans believe the war in Iraq was a mistake, he notes, but they have no immediate self-interest in taking to the streets because "we're willing to pay people to die for us. It doesn't reflect very well on the character of our society."

Even military recruiters agree that the only way to persuade average Americans to make long-term sacrifices in war is for the children of the elite to put their lives on the line. In a recent meeting with military recruiters, Moskos discussed the crisis in enlistment. "I asked them would they prefer to have their advertising budget tripled or have Jenna Bush join the Army," he says. "They unanimously chose the Jenna option."

One of the few politicians willing to openly advocate a return to the draft is Rep. Charles Rangel, a Democrat from New York, who argues that the current system places an immoral burden on America's underprivileged. "It shouldn't be just the poor and the working poor who find their way into harm's way," he says. In the days leading up to the Iraq war, Rangel introduced a bill to reinstate the draft - with absolutely no deferments. "If the kids and grandkids of the president and the Cabinet and the Pentagon were vulnerable to going to Iraq, we never would have gone - no question in my mind," he says. "The closer this thing comes home to Americans, the quicker we'll be out of Iraq."

But instead of exploring how to share the burden more fairly, the military is cooking up new ways to take advantage of the economically disadvantaged. Rangel says military recruiters have confided in him that they're targeting inner cities and rural areas with high unemployment. In December, the National Guard nearly doubled its enlistment bonus to $10,000, and the Army is trying to attract urban youth with a marketing campaign called "Taking It to the Streets," which features a pimped-out yellow Hummer and a basketball exhibition replete with free throwback jerseys. President Bush has also signed an executive order allowing legal immigrants to apply for citizenship immediately - rather than wait five years - if they volunteer for active duty.

"It's so completely unethical and immoral to induce people that have limited education and limited job ability to have to put themselves in harm's way for ten, twenty or thirty thousand dollars," Rangel says. "Just how broke do you have to be to take advantage of these incentives?" Seducing soldiers with cold cash also unnerves military commanders. "We must consider the point at which we confuse 'volunteer to become an American soldier' with 'mercenary,' " Lt. Gen. James Helmly, the commander of the Army Reserve, wrote in a memo to senior Army leadership in December.

The Reserve, Helmly warns, "is rapidly degenerating into a broken force." The Army National Guard is also in trouble: It missed its recruitment goals of 56,000 by more than 5,000 in fiscal year 2004 and is already 2,000 soldiers short in fiscal 2005. To keep enough boots on the ground, the Pentagon has stopped asking volunteer soldiers to extend their service - and started demanding it. Using a little-known provision called "stop loss," the military is forcing reservists and guardsmen to remain on active duty indefinitely. "This is an 'all-volunteer Army' with footnotes," says McPeak. "And it's the footnotes that are being held in Iraq against their wishes. If that's not a back-door draft, tell me what is."

David Qualls, who joined the Arkansas National Guard for a year, is one of 40,000 troops in Iraq who have been informed that their enlistment has been extended until December 24th, 2031. "I've served five months past my one-year obligation," says Qualls, the lead plaintiff in a lawsuit challenging the military with breach of contract. "It's time to let me go back to my life. It's a question of fairness, and not only for myself. This is for the thousands of other people that are involuntarily extended in Iraq. Let us go home."

The Army insists that most "stop-lossed" soldiers will be held on the front lines for no longer than eighteen months. But Jules Lobel, an attorney with the Center for Constitutional Rights who is representing eight National Guardsmen in a lawsuit challenging the extensions, says the 2031 date is being used to strong-arm volunteers into re-enlisting. According to Lobel, the military is telling soldiers, "We're giving you a chance to voluntarily re-enlist - and if you don't do it, we'll screw you. And the first way we'll screw you is to put you in until 2031."
But threatening volunteers, military experts warn, could be the quickest way to ensure a return to the draft. According to O'Hanlon at the Brookings Institute, such "callousness" may make it impossible to recruit new soldiers - no matter how much money you throw at them. And if bigger sign-up bonuses and more aggressive recruitment tactics don't do the trick, says Helmly of the Army Reserve, it could "force the nation into an argument" about reinstating the draft.

In the end, it may simply come down to a matter of math. In January, Bush told America's soldiers that "much more will be asked of you" in his second term, even as he openly threatened Iran with military action. Another war, critics warn, would push the all-volunteer force to its breaking point. "This damn thing is just an explosion that's about to happen," says Rangel. Bush officials "can say all they want that they don't want the draft, but there's not going to be that many more buttons to push."

January 25, 2005

WHO Scientists Look to Create Genetically Modified Smallpox Virus for Bioterrorism Research

Global Security Newswire

The World Health Organization is expected to consider a recommendation from its science advisers to allow genetic modification of the smallpox virus to aid in the development of new drugs against the virus, the London Independent reported Saturday (see GSN, Jan. 5).

One scientist warned, however, that altering the genetic makeup of the variola virus could accidentally produce a more lethal form of the disease.

“What I worry about is that there is rather too much done in this area and the minute you start fooling around with it in various ways, I think there is a danger,” said Donald Henderson of the Center for Biosecurity at the University of Pittsburgh. “I’d be happier if we were not doing it and the simple reason is I just don’t think it serves a purpose I can support.”

“The less we do with the smallpox virus and the less we do in the way of manipulation at this point I think the better off we are,” added Henderson, who directed the successful WHO vaccination program to eliminate smallpox.

In genetically modifying a mousepox virus four years ago, Australian scientists accidentally produced a highly virulent strain immune to vaccine.

The proposed modifications to variola, however, would not be as risky, according to Professor Geoffrey Smith of Imperial College London, who chairs the WHO committee for variola virus research. U.S. scientists are proposing to insert a jellyfish gene, which creates a glow they say would make the virus easier to examine under a microscope, according to Smith.

“The reason why the proposal was made and the reason why the [scientific] committee was prepared to consider it was that it is clear that there is a need to develop drugs against the virus,” Smith said. “The quickest way to screen a large database of compounds is to have an automated way and if you have a virus that expresses the green fluorescent protein you can do the drug screening in a much more rapid and automated way.”

The World Health Organization is expected to consider the recommendations of its scientific committee in May, according to the Independent.

Seven recommendations have been included in the proposal, including a request for permission to ship relatively large fragments of variola — up to 20 percent of its genome — from the only two secure laboratories where it exists, in the United States and Russia, to other facilities for study. Another recommendation seeks permission for the U.S. and Russian laboratories to dissect variola and insert fragments into other members of the same pox-virus family, according to the Independent (Steve Connor, The Independent, Jan. 22).

January 20, 2005

Smallpox vaccine stocks to be re-built

Nursing Times

Work has started on building a 200 million-dose stockpile of smallpox vaccine in the wake of fears of a bioterror attack, World Health Organisation (WHO) officials said today.

The Group of Seven (G7) industrialised nations agreed last month to set up a global 'vaccine bank' in case of attack by terrorists.

The WHO will double its emergency reserve of smallpox vaccines to 5 million doses, while individual member countries will assemble the rest.

"It is clear that we will have some stocks in a few months, but it would take two to three years to set up the whole stockpile," Daniel Lavanchy, smallpox project leader at the WHO's alert and response office, told Reuters.

Health ministers from the G7 - Britain, Canada, France, Germany, Italy, Japan and the United States - also agreed last month to set up a bioterrorism crisis centre to marshal a global response to germ warfare attacks.

January 17, 2005

Feds move 3 ways to restart anthrax vaccine program

AF Times
By Deborah Funk, Times Staff writer

The government is using a three-pronged approach to try to reinstate the military's anthrax vaccination program, which the Pentagon says is needed to protect service members who face a heightened risk of attack from the potential biological weapon.

In the latest move, the Food and Drug Administration is now seeking public comment on the information it relied upon to declare that anthrax vaccine was effective against all forms of the disease something a federal judge in October said the FDA previously had failed to do.

The Dec. 29 notice published in the Federal Register gives the public 90 days to comment on the FDA's proposed rule on the safety and efficacy of the vaccine as protection against anthrax.

The FDA proposes that the vaccine be indicated to protect against all forms of anthrax, to include both the skin form of the disease and also inhalation anthrax, the type defense officials say could be used as a weapon.

The FDA acknowledged in its notice that the current vaccine is not the same one used in human tests done more than 40 years ago. That vaccine was obtained from a researcher at Fort Detrick, Md., and its manufacturing process has changed several times since then, as has the manufacturer.

Even so, the FDA said it has reviewed the vaccine's historical development and found that the Pentagon has had “continuous involvement with, and intimate knowledge of, the formulation and manufacturing processes of the various versions of the vaccine over the years.

That, the FDA said, is enough to make a determination that the current vaccine is comparable to the original vaccine, a conclusion backed up by animal tests.

Chicago attorney John J. Michels Jr., who represents six anonymous service members and civilian defense employees who sued the government and shut down the Pentagon's mandatory vaccination program, took issue with the FDA's position.

Among other things, he questioned how the FDA could apply the human study results of the original vaccine to one that is now in its fourth version.

He also said the vaccine was not properly licensed in 1970 because the licensing agency at the time failed to account for the fact that the manufacturing process had changed since the human study was done. Also, the test results combined cases of skin and inhalation anthrax, even when there were too few inhalation cases to statistically prove whether the vaccine was effective against that form of the disease, Michels said.

The Defense Department also is forming two other lines of attack to try to reinstate its mandatory anthrax vaccine program.

On behalf of the Pentagon and the Department of Health and Human Services, the Justice Department is appealing the federal judge's October decision that the anthrax vaccine was not licensed for inhalation anthrax, and therefore could not be forced on troops without their consent.

Outside the court system, Deputy Defense Secretary Paul Wolfowitz has asked the Health and Human Services secretary to allow the Pentagon to administer the vaccine under the "emergency use authority" of a law passed last year called Project BioShield.

The law says that, to the extent practicable, vaccines should be used under Project BioShield with the consent of those who are to be inoculated.

Defense officials have not said whether they plan to seek authority to make the anthrax vaccine mandatory for service members under their Project BioShield request.

In a written response to questions, defense officials said only that "specific details on program resumption are being discussed" with the Department of Health and Human Services.

January 13, 2005

Airman: Vaccine caused illness

By Kevin Maurer
Fayetteville Observer

Tech. Sgt. Lavester Brown almost died last year when his heart swelled to twice normal size hours after he received an anthrax vaccination. A few months later, he had to have a heart transplant.

Brown said he believes the shot caused his heart problem and that adverse reactions to the anthrax vaccination are more common in blacks.

The Air Force said it has not found evidence to support Brown's claim.

Brown was a C-130 crew chief with 14 years in the Air Force. He said he was in great shape - he played basketball three times a week - and never smoked, drank or used drugs. He does suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, a genetic condition that is present in an estimated 10 percent to 15 percent of black men in the United States. The condition can cause red blood cells to break down when exposed to bacterial infections or certain drugs.

No effect

The Air Force said the genetic deficiency had no effect.

"The FDA (Food and Drug Administration) and the ACIP (the military's Advisory Committee on Immunization Practices) have not found a need to restrict any vaccination in people who are G6PD deficient," Col. Eden Murrie, chief of the programs and legislation division of the Office of Legislative Liaison, wrote after Brown sent a letter to U.S. Sen. Elizabeth Dole, a North Carolina Republican.
But according to Brown, a note in his medical records asked personnel to "use caution" when administering vaccinations.

In 2003, he was ordered to get smallpox and anthrax vaccinations while deployed to Qatar. The anthrax immunization consists of three injections given two weeks apart followed by three additional injections given at intervals of six, 12 and 18 months.
On Feb. 27, 2004, his fourth anthrax shot was due. Within hours of the fourth shot, he was in the emergency room at Womack Army Medical Center. At first, he said, he was given some medicine and sent home. But he got worse and went back. By the time of the second visit, he could barely breathe and his pulse was racing. He said his wife insisted that doctors take a chest X-ray. It revealed that his heart was twice its normal size and was failing.

"I've never been ill like that before," Brown said. "They couldn't believe that I walked into the facility."

Brown was sent to the medical center at the University of North Carolina at Chapel Hill. He received a new heart Oct. 27.

On the same day that Brown got his heart, Judge Emmett Sullivan of the U.S. District Court for the District of Columbia declared the involuntary anthrax vaccination program illegal without informed consent from service members.

The Department of Defense asked the Department of Health and Human Services last month for emergency authority to resume the anthrax vaccination program for military personnel. No decision has been made, Pentagon officials said.

The Air Force continues to contend that the vaccinations are an essential safeguard for service members.

"The DOD continues its anthrax and smallpox vaccination programs because anthrax and smallpox virus do not require sophisticated weapons delivery systems," Murrie wrote. "Our biodefense vaccination programs are designed to keep service members healthy and give them their best chance to return home to their loved ones safely."

Medical retirement

Brown, meanwhile, has had to medically retire from the military.

In the letter he sent to Dole's office in October, Brown asked for an investigation of the safety of the military vaccination program. He said in the letter that he believes the Pentagon is failing "to acknowledge a genetically linked risk of serious reactions to one or both vaccines for African-American service members."

"I love the Air Force, but I want to know why, if a soldier tells you medically, 'I can't take that,' why is that person not given a choice if it puts their life in danger," Brown said in an interview at his home before Christmas.

The Air Force response by Murrie came Dec. 6. A working group said in October that the information gathered was "insufficient to move away from neutrality to favor or reject a causal association" between the vaccinations and the kind of heart problem Brown experienced. Such conditions "occur at the same rate among anthrax-vaccinated and unvaccinated personnel without differences by ethnicity," Murrie wrote.

The military is continuing to study the issue. The Advisory Committee on Immunization Practices and the Armed Forces Epidemiological Board working group have said that more evaluation is needed.

A spokeswoman in Dole's office said the senator is pleased that Brown's concerns are getting attention.

"We'll wait to see what those investigations yield," said Katie Norman, Dole's deputy press secretary.

U.S. Army to Fund Vaccine Healthcare Centers

By David Ruppe
Global Security Newswire

WASHINGTON — The U.S. Army will continue to fund this year a $5.7 million biodefense-vaccine treatment and research centers for which no money had been budgeted, a spokesman said yesterday (see GSN, Jan. 4).

Full operation in fiscal 2005 of the Vaccine Healthcare Center, located at Walter Reed Army Medical Center in Washington, D.C., had appeared in question following decisions last year by the Army not to budget for it and congressional leaders not to specifically fund the program.

Senator Jeff Bingaman (D-N.M.) over the past year had raised concerns about the future of the program, which specializes in treating and investigating uncommon, severe side effects of anthrax, smallpox and other biological defense vaccines.

According to a statement from Walter Reed released to Global Security Newswire yesterday, however, “The U.S. Army Medical Command, through its North Atlantic Regional Medical Command, will underwrite the $5.7 million operation.”

The Medical Command will do so, it said, “in anticipation of funding decisions for Fiscal Year 2006 and beyond.”

Also, “A majority of that FY 05 amount will be credited against the Global War on Terrorism,” it said.

No indication was given about whether the program would be included in the Bush administration’s fiscal 2006 budget, which is expected to be presented to Congress later this winter.

“As a matter of policy, we don’t release the dollar figures for budgets until those dollars have been appropriated — that is, until Congress has passed the budget,” according to the statement.

Vaccine Healthcare Center officials have applied to include their program in the Army’s next long-term budget plan beginning in fiscal 2006.

The center hopes to open, beginning in fiscal 2007, satellite treatment centers in Europe, Hawaii, on the West Coast, and in the northern Midwest — in addition to three already operating in the continental United States.

However, present funding levels are not sufficient to meet the center’s current workload, center officials have said.

January 5, 2005

Experimental Smallpox Vaccine Put on Fast Track

The U.S. Food and Drug Administration has awarded “fast track” status to a smallpox vaccine being developed by the pharmaceutical firm Acambis, the company announced today (see GSN, Dec. 10).

The decision means the agency will work to expedite approval of the ACAM2000 vaccine, Acambis said in a press release. More than 180 million doses of the vaccine have been added to the U.S. Strategic National Stockpile for emergency use (Acambis press release, Jan. 5).

January 4, 2005

Funding for Defense vaccine treatment centers in question again

By David Ruppe
Global Security Newswire

Funding for a much-praised network that treats military personnel for rare but severe side-effects of anthrax and other vaccines remains uncertain this year, according to a U.S. senator, who has drafted a letter to Defense Secretary Donald Rumsfeld asking for an explanation.

The Bush administration drew congressional criticism last year from Sen. Jeff Bingaman, D-N.M., for not including in its fiscal 2005 budget $5.7 million needed for operating the Vaccine Healthcare Center, located at the Walter Reed Army Medical Center in Washington, and three regional centers in the United States.

Defense Department officials in the fall said the network nevertheless would be funded, according to Bingaman.

"Unfortunately, we now understand that DoD may be considering the VHC Network to be an 'unfunded requirement,' which makes continuation of the program rather precarious," Bingaman wrote in the letter, which he has shared with colleagues but not yet sent to Rumsfeld. "We are asking you to address this matter immediately to ensure continuation of this irreplaceable and valuable asset."

Congress did not specifically fund the network, which began operation in 2001, in fiscal 2004. The Army Medical Department's North Atlantic Regional Medical Command at Walter Reed picked up the tab with money from its own budget. An Army spokeswoman told Global Security Newswire last month that that would be the case again.

"The Vaccine Healthcare Center is supported in FY05 by the Army Medical [Command]'s North Atlantic Regional Medical Command," wrote Medical Command spokeswoman Lyn Kukral.

"The problem is that they [the regional command] are not thrilled to be doing it and certainly don't have to fund it," said a congressional staffer who asked not to be identified.

"The Army does not see why it must fund the VHC's when other departments have their personnel use the services," the staffer added.

Bingaman's letter suggested Pentagon officials are backing away from a promise to legislators last fall. An amendment was proposed in the Senate to specifically authorize money for the network in fiscal 2005.

That provision was abandoned, however, after Defense Department officials assured senators that the network would still be funded, Bingaman said in his letter.

"When an amendment was proposed in the Senate to insert a line-item for VHCs, your department came to us and assured us it was unnecessary and stated DoD appropriations already contained $5 million to support VHC operations," he wrote.

A congressional report accompanying the bill praised the centers, recommended Rumsfeld consider expanding the network, and "strongly encourage[d]" the military services to continue funding the programs.

"This network has been recognized as valuable nonredundant effort that has supported improved care of vaccine related rare adverse events, programs to improve the quality of immunization healthcare, and an infrastructure that supports new vaccine insertion like the smallpox program," Bingaman wrote.