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 (see GSN, April 25). 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 UncertainWhile 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 (see GSN, May 18, 2004). 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 CausalityAir 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.
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 RequirementsThe “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 PunishmentThe 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.
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.
British drug maker Acambis is seeking $30 million from the United States to ensure its Massachusetts manufacturing facility is ready to produce smallpox vaccine during an emergency, the Boston Globe reported today (see GSN, Jan. 5). The company has already prepared 182.5 million vaccine doses for the U.S. stockpile, enough to cover the country. Now, however, there is not enough demand to keep the production line operating, the company said. Acambis argues that uncertainty on the vaccine’s lifespan and possible need in other countries requires the company to be able to quickly resume production. “Even if you have a stockpile of 200,000 bullets, if you go to war, you would need more bullets. This is the same idea,” said Gordon Cameron, Acambis chief executive. The Health and Human Services Department expects to make a decision this summer on the request, the Globe reported (Ross Kerber, Boston Globe, May 6).
Canada plans to distribute software allowing public and private animal health laboratories to link in order to more quickly detect and respond to a natural or terrorist-made outbreak in the country, Canadian Press reported today (see GSN, April 18). The $1.9 million project will also supply materials and training to laboratories on detection of exotic animal diseases (Canadian Press, May 6).
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