May 31, 2004

Military Personnel Suffer More Heart Troubles Than Expected After Smallpox Vaccinations, Researcher Says

By Chris Schneidmiller
Global Security Newswire

WASHINGTON — More than 70 people suffered heart troubles after receiving smallpox vaccinations from the U.S. Defense Department, a surprisingly high figure compared to the limited cases of other health problems linked to those inoculations, a Walter Reed Army Medical Center researcher said this week (see GSN, April 13).

“Reported rates of noncardiac complications have been very low, in line with the rates of complications we saw historically, when children were routinely vaccinated for smallpox,” Dimitri Cassimatis, a Walter Reed cardiology fellow, said in a prepared statement on his clinical review of reactions to smallpox vaccinations among military personnel. “The rate of cardiac complications, however, has been higher than expected,” he added.

The American Medical Society today presented Cassimatis’ review, which was finished last summer.

More than 615,000 military personnel, contractors and “emergency-essential civilians” have received smallpox vaccinations since the Pentagon began inoculations in January 2003 in an effort to protect its forces from biological attack (see GSN, Oct. 23, 2003). Seventy-seven men and women subsequently suffered from myopericarditis — inflammation of the heart muscle or the sac around the heart, the department said in April.

As of April 30, 21 civilians had also contracted the heart condition amongst the 39,500 U.S. medical professionals who have been vaccinated, according to the Centers for Disease Control and Prevention.

In addition, the British biotechnology company Acambis last month halted enrollment for clinical trials on a new smallpox vaccine last month after three people contracted myopericarditis.

No deaths have been connected to the heart illness when brought on by the vaccination.

Something about the vaccine causes a “cross-reaction” that triggers the heart response, Cassimatis told Global Security Newswire. The exact cause remains under investigation, said CDC spokesman Von Roebuck.

Myopericarditis causes continuous chest pains that can last for “hours and often days,” Cassimatis said. Patients experience fatigue, shortness of breath and heart palpitations. The heart trouble becomes serious only for a small percentage of patients, and will usually dissipate naturally over a period of weeks, he said.

The rate of incidence for myopericarditis in the armed forces in 2002, prior to vaccinations, was two per 100,000 people every 30 days, Cassimatis said. That rate was maintained for military personnel who had previously been inoculated against smallpox; however, those being vaccinated for the first time saw an incidence rate of 16 per 100,000 over 30 days. “That’s about a 7 1/2-fold increase for primary vaccinations,” he said.

Military personnel received anti-inflammatory drugs and were barred from “high-level exertion” for several weeks while recovering, Cassimatis said. Most returned to full health.

Myopericarditis was by far the most prevalent health side effect linked to the smallpox vaccinations, the Defense Department reported.

A 22-year-old U.S. Army reservist died last year after receiving vaccinations against smallpox and other diseases. Two panels of experts concluded that the inoculations likely caused her death from a “lupus-like illness,” but they were unable to identify a specific shot as the fatal agent.

Post-vaccination deaths of five other military personnel were not caused by the smallpox treatments, the department said.

The Pentagon also reported 36 cases of generalized vaccinia — a widespread rash and sores caused by the injection ð— and 34 cases in which the infection from the smallpox shot was transferred by contact to another person.

There were 24 civilian cases in which a health worker spread the infection to another part of the body by touching the vaccination site and then an eye or another body part, the CDC reported. The agency also found one case of brain swelling and three incidents of generalized vaccinia among inoculated civilians.

Cassimatis said he hopes in coming months to organize a study of 600 to 800 people who would receive the smallpox vaccination. By studying the group over a period of weeks, he hopes to better learn who is at risk for heart problems and why it occurs after inoculations.

Smallpox vaccinations would continue as needed, the CDC and Defense Department said. Mass injections can be performed safely through staff training, patient education, screening out of people with medical conditions that could make vaccinations dangerous and attention to bandaging, officials said.

“We feel it’s very much of importance to have people vaccinated before a smallpox event,” Roebuck said. “We hope we never have to see it, but if it’s there we’ll have a plan to deal with it and folks who have been vaccinated can help from the very beginning” (see related GSN story, today).

May 26, 2004

Judge Sees Little Evidence to Support Anthrax Vaccine

by Carol D. Leonnig
Washington Post

A federal judge said yesterday he had significant doubts about whether the federal government has enough scientific evidence to show that the anthrax vaccine required for military personnel is either safe or effective.

U.S. District Judge Emmet G. Sullivan, who will decide in coming weeks whether to halt the Defense Department's mandatory anthrax inoculations, also criticized the government's review of the vaccine as "one of the most jumbled, confusing" processes he had ever seen.

Sullivan made his remarks in a hearing on a lawsuit filed in March 2003 by six anonymous members of the U.S. military who said the vaccine posed health risks that had not been sufficiently studied.

More than 1 million U.S. troops have been given the anthrax vaccine since the program became mandatory in 1998, many of them in preparation for duty in Iraq.

Hundreds have refused the vaccine out of concern for their safety amid complaints of harmful side effects and medical reports linking the vaccine to a few deaths.

At yesterday's hearing, Sullivan questioned why the Food and Drug Administration did not formally issue a ruling that the vaccine was safe and effective against inhalation anthrax until late December 2003. That move came 18 years after the vaccine was first proposed to the FDA for use against inhalation anthrax, but just a week after Sullivan had temporarily halted the military inoculation program.

On Dec. 22, Sullivan agreed with the military personnel who filed suit, determining that the FDA had never formally approved the drug for use against inhalation anthrax, but had approved it for anthrax contracted through the skin. He temporarily halted the program, ruling that defense officials could not require troops to "serve as guinea pigs for experimental drugs" pending a final decision in the case.

Yesterday, John J. Michels, a lawyer for the six, charged that the FDA issued the ruling to protect the Defense Department's vaccination program, and said he wished he could read the e-mail messages between the two agencies during that time.

Brian D. Boyle, principal deputy associate attorney general, told Sullivan that the FDA decision was based on science. He said human studies that looked at a mix of anthrax cases -- most of them contracted through the skin, along with a few inhalation cases -- showed the vaccine was effective more than 90 percent of the time. Boyle said animal studies showed the vaccine worked on animals, though they did not prove the human immune system would react the same way.

Sullivan, however, said results of the human study might be skewed because it considered all the cases together. He suggested it would have been logical to examine separately the vaccine's effectiveness in the limited number of inhalation cases.

"Wouldn't it be more safe?" Sullivan asked. "The stakes couldn't be higher here." Sullivan said it appeared that neither the animal studies nor the human study were conclusive for humans.

Mark Zaid, an attorney who filed the suit on behalf of the military personnel, said yesterday that members of the U.S. military should have a choice about taking the vaccine until the FDA has performed conclusive studies. A more extensive human study will not be completed until 2007.

U.S. Federal Judge Expresses Doubt Over Government Information on Safety of Anthrax Vaccine

Global Security Newswire

U.S. District Judge Emmet Sullivan said yesterday that he had doubts as to whether the U.S. government could prove that the anthrax vaccine required for military personnel is safe, according to the Washington Post (see GSN, Jan. 8).

Last year, six servicemembers filed a lawsuit seeking an end to mandatory anthrax vaccinations on the basis that the inoculations posed health risks. In late December, Sullivan determined that the U.S. Food and Drug Administration had never approved the vaccine used to protect against inhalational anthrax and temporarily suspended the vaccination program. The program has since been restarted.

During a hearing on the lawsuit yesterday, Sullivan described the government’s review of the anthrax vaccine as “one of the most jumbled, confusing” processes that he had ever seen, the Post reported. He also questioned why the FDA ruled that the vaccine was safe for use against inhalational anthrax 18 years after it was first proposed for that use, but just one week after the vaccination program was suspended, according to the Post.

John Michels, a lawyer for the six servicemembers, said during yesterday’s hearing that the FDA only issued the ruling to protect the vaccination program. Deputy Associate Attorney General Brian Boyle said, however, that the agency’s ruling was based on science (Carol Leonnig, Washington Post, May 26).

May 21, 2004

Biological Arms Control Experts Question U.S. Laboratory

Global Security Newswire

A Homeland Security Department biological defense lab at Fort Detrick in Maryland could undermine an international ban on biological weapons by pushing other nations toward developing such weaponry, three biological arms control experts said this week (see GSN, April 29).

James Leonard, who led the U.S. delegation that negotiated the Biological Weapons Convention in 1972, Richard Spertzel, a former official of the Army’s biological defense center at Fort Detrick and chief U.N. biological weapons inspector in Iraq, and Milton Leitenberg, an expert on arms control at the University of Maryland, collaborated on the statement posted on the Web site of the journal Politics and the Life Sciences.

The work of Homeland Security’s National Biodefense Analysis and Countermeasures Center could include devising more dangerous viruses and bacteria in efforts to develop stronger vaccines and drugs, the Baltimore Sun reported. The center is operating out of temporary offices at Fort Detrick until its $200 million high-security laboratory can be built.

“The rapidity of elaboration of American biodefense programs, their ambition and administrative aggressiveness, and the degree to which they push against the prohibitions of the Biological Weapons Convention, are startling,” the critics said (Leonard/Spertzel/Leitenberg, Politics and the Life Sciences, May 17).

Leonard said he is concerned that other countries would view U.S. biological weapons research as a challenge.

“In French labs, German labs, Russian labs, Egyptian labs, scientists will say, ‘Look at what the United States is doing; we have to at least keep up,’” he said (Scott Shane, Baltimore Sun, May 21).

May 20, 2004

U.S. Senate Passes “Bioshield” Plan

By Joe Fiorill
Global Security Newswire

WASHINGTON — The U.S. Senate yesterday voted 99-0 to establish a program that would use $5.6 billion over 10 years to stimulate private-sector development of vaccines and treatments against agents such as smallpox, anthrax, botulinum toxin, Ebola and plague (see GSN, May 5).

The House of Representatives is expected to endorse the bill and pass it on for signature to President George W. Bush in short order. A Health and Human Services Department spokesman said today that the first contract under the program would be for an anthrax vaccine and is expected in “the near future.”

First proposed early last year by Bush, Project Bioshield would give the government long-term authority to buy billions of dollars’ worth of new drugs from private companies, speed National Institutes of Health research and development on such medicines and allow the Food and Drug Administration to greatly quicken its drug-approval process during emergencies. The bill would also cover some countermeasures against chemical, radiological and nuclear attacks.

Senate Health, Education, Labor and Pensions Committee Chairman Judd Gregg (R-N.H.), who played a major role in crafting compromises that led to the bill’s passage, yesterday called Project Bioshield “a major component of our defense against future terrorist attacks.”

“We need to protect ourselves and our country against the ability of these terrorists to use the weapons they can easily get their hand on to kill innocent Americans. If these Islamic fundamentalists get their hands on a biological weapon like anthrax, they will use it, and they will use it in a place like a subway station, where great numbers of people congregate,” Gregg said.

The House voted 421-2 last July to approve its own Bioshield bill, but several key House members said the Senate bill is now likely to be submitted to Bush without a formal conference to reconcile the two versions.

“It is my expectation that this will now be passed swiftly by the Senate and the House without any formal conference. … After nearly 18 months of consideration, it is urgent that the Congress send this important public health and safety legislation to the president for his signature. Our national security cannot afford to wait while terrorists act,” House Select Committee on Homeland Security Chairman Christopher Cox (R-Calif.) said yesterday, shortly before the Senate passed its bill.

The impetus for Bioshield was the drug industry’s unwillingness to develop and produce medicines for which the everyday market is small but which could become crucial in an attack. National Institute of Allergy and Infectious Diseases Director Anthony Fauci said in January 2003 that the project would “assure drug companies there will be a market for their product.”

“The medical treatments available for some types of terrorist attacks,” the White House said in February 2003, “have improved little in decades, while there has been tremendous and rapid progress in the treatment of many serious naturally occurring diseases. … The president believes that, by bringing researchers, medical experts and the biomedical industry together in a new and focused way, our nation can achieve the same kind of treatment breakthroughs for bioterrorism and other threats that have significantly reduced the threat of heart disease, cancer and many other serious illnesses.”

Biotechnology Industry Organization President Carl Feldbaum said yesterday that by passing the bill, Congress would create “the procurement structure to make product development and production financially viable.”

Compromise won out over strong objections to aspects of bills to create Project Bioshield in both chambers of Congress.

Representative Harold Rogers (R-Ky.) said last May at a Select Committee on Homeland Security hearing that Bioshield would be “chicken feed to the industry,” while Representative Christopher Shays (R-Conn.) called for more flexibility in deciding what biological threats to guard against.

“What if they [terrorists] just do the one thing we don’t have?” Shays asked.

In the Senate, opposition to the project was led by Robert Byrd (D-W.Va.), the top Democrat on the Appropriations Committee, and by Carl Levin (D-Mich.), the senior Democrat on the Armed Services Committee. Byrd withdrew his opposition after a compromise was reached on language governing how the funds would be appropriated.

Levin was still expressing reservations about the bill as late as May 7, when a spokesman said the senator sought to increase competition for Bioshield contracts and was concerned about part of the measure that could allow the military to give its members emergency-approved countermeasures without obtaining their informed consent.

Expressing support for the bill yesterday, though, Levin said he was “pleased” that the final Senate bill stipulates “full and open competition” for most Bioshield contracts. Provisions in the pending defense appropriations bill, ensures the bill “will not make it more likely that military personnel will be required to take unapproved products without their consent,” Levin said.

Although only the House had then passed legislation to create the program, Congress voted last September to fund Bioshield with $890 million for fiscal 2004. The Bush administration’s fiscal 2005 budget proposal includes $2.5 billion for Bioshield under the Homeland Security Department budget.

The first contracts are expected within months. Health and Human Services spokesman Marc Wolfson said today that the department’s Office of Emergency Public Health Preparedness is reviewing proposals for an anthrax vaccine and is likely to make an announcement “within the near future.”

“That will be the first Bioshield” contract, Wolfson said.

May 19, 2004

NIAID forms network to tackle potentially fatal reaction to smallpox vaccine

by Paul Williams
National Institute of Allergy and Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), today launched the Atopic Dermatitis and Vaccinia Network (ADVN), a nationwide research group that seeks to reduce the risk of eczema vaccinatum (EV), a severe and potentially deadly complication of smallpox immunization. EV occurs almost exclusively in people with a history of atopic dermatitis (AD), a chronic, itchy skin condition commonly referred to as eczema.

While uncommon, EV can develop when AD patients are given the smallpox vaccine or come into close personal contact with people who recently received the vaccine. If untreated, EV can kill between 1 to 6 percent of those affected. In children younger than 2 years of age, EV has been estimated to kill up to 30 percent.

"Millions of Americans have a history of atopic dermatitis," says Anthony S. Fauci, M.D., director of NIAID. "Launching this network is an important step toward our goal of helping to protect everyone against the smallpox virus without the risk of life-threatening complications."

"Previous studies suggest that both innate and adaptive immunity are impaired in patients with atopic dermatitis, but the specific defects that increase the likelihood of eczema vaccinatum have yet to be explained," says Daniel Rotrosen, M.D., director of NIAID's Division of Allergy, Immunology and Transplantation. "The information generated by this network will improve our understanding of the immune responses of these patients and should greatly influence the design of a safer smallpox vaccine."

The ADVN comprises three integrated components: a clinical studies consortium, an animal studies consortium and a statistical and data coordinating center.

The ADVN Clinical Studies Consortium will, among other activities, seek to understand why people with AD have such severe reactions to smallpox vaccine by evaluating their immune responses after natural exposure to less harmful skin viruses such as herpes simplex. The ADVN Animal Studies Consortium will establish animal models of AD and investigate their immune responses to vaccinia--the virus used in smallpox vaccine--and other skin viruses such as varicella, which causes chickenpox and shingles. The ADVN Statistical and Data Coordinating Center will support these clinical and animal studies by analyzing research data, coordinating trials and regulatory activities, and developing and maintaining a registry of AD patients. The six institutions in the ADVN Clinical Studies Consortium and the principal investigator at each are:

National Jewish Medical and Research Center, Donald Leung, M.D., Ph.D.
Oregon Health and Science University, Jon Hanifin, M.D.
Children's Hospital Boston, Lynda Schneider, M.D.
University of California at San Diego, Richard Gallo, M.D., Ph.D.
Johns Hopkins Asthma and Allergy Center, Lisa Beck, M.D.
University of Bonn, Germany, Thomas Bieber, M.D., Ph.D.

The five institutions in the ADVN Animal Studies Consortium and the principal investigators at each are:

Children's Hospital Boston, Raif Geha, M.D., and Hans Oettgen, M.D., Ph.D
National Jewish Medical and Research Center, Donald Leung, M.D., Ph.D., and Erwin Gelfand, M.D.
Harvard Skin Diseases Research Center, Thomas Kupper, M.D., and Robert Fuhlbridge, M.D.
University of Illinois at Chicago, Lawrence Chan, M.D.
La Jolla Institute for Allergy and Immunology, Toshiaki Kawakami, M.D., Ph.D.
The ADVN Statistical and Data Coordinating Center will be operated by Rho Federal Systems Division. The principal investigator is Susan Lieff, Ph.D.

May 18, 2004

U.S. Army Provides No Funds for Vaccine Care Centers

By David Ruppe
Global Security Newswire

WASHINGTON — The U.S. Army has not budgeted any money in fiscal 2005 for a widely praised chain of centers for treating soldiers with serious complications from military-administered vaccines, even as the network expands this year.

Exactly why is not clear. The Army offered no direct explanation, instead it forwarded requests for information to the spokesman for the Vaccine Healthcare Centers (VHC) Network. Army Col. Renata Engler, who runs the network, cited Army budget constraints and the process of Army budgeting.

Critics of the Defense Department’s vaccine policies have questioned whether there is a strong commitment in the Army and the Bush administration to the network, which by the nature of its work generates evidence of illnesses potentially caused by already-controversial vaccines (see GSN, Feb. 20).

By cutting the funding, “the administration is sending the wrong message to the brave men and women who risk their lives to serve our country by telling them their health is not a priority. In my view it is of the highest priority and I will work to ensure that the program is fully funded,” said Senator Jeff Bingaman (D-N.M.) in a statement last week.

Bingaman plans to introduce an amendment to the fiscal 2005 defense authorization bill, which is on the Senate floor this week, to authorize $10 million for the centers, and “such sums as would be necessary for each fiscal year thereafter.”

Significant Work

Congress in 2000 directed the creation of the network, which now operates four sites to monitor and treat severe reactions to vaccines given by the military.

Since the headquarters center opened in 2001 at Walter Reed Army Medical Center in Washington, the network has evaluated more than 1,000 patients — military personnel, contractors and civilians — and counseled far more personnel — 139,000 in fiscal 2003 alone — by telephone and e-mail, according to Engler.

In addition, the centers’ activities have included: monitoring and researching possible negative effects of vaccines, developing and distributing standards for improving vaccination safety, and providing training, education and guidance about vaccinations to military health care providers.

Senior defense health officials publicly praised them this year.

“Our Vaccine Healthcare Centers Network is a network of specialty clinics to provide the best possible care in rare situations where serious adverse events follow vaccination,” William Winkenwerder, assistant secretary of defense for health affairs, said in March 30 congressional testimony.

In February, Army Surgeon General Lt. Gen. James Peake issued a memorandum repeatedly urging clinicians to utilize the network’s resources, while also noting the much-publicized death of a soldier last year shortly after receiving five vaccinations (see GSN, Nov. 19).

While already in operation, the other three centers, at the Naval Medical Center in Portsmouth, Va., Womack Army Medical Center at Ft. Bragg, N.C., and the Wilford Hall Medical Center in San Antonio, Texas, were expected to have for ribbon cuttings this year.

Funding for the network, though, did not appear in the Army’s fiscal 2005 budget request. Engler said she would need a minimum $5.7 million to keep the centers going “with no frills” through the fiscal year.

“But as of fiscal year 2005, we’re an unfunded requirement. As of 1 October, our budget is zero,” she said.

Suggestions have been made to close down some of the four centers, each of which has 12 clinical staff members, but the centers are overwhelmed, Engler said.

In addition to treatment, each is “trying to do all of this massive response [remote consultation] work,” she said.

A total of nine centers based at major vaccination centers worldwide were originally envisioned, she said, but added, “We’re really in tight budget times.”

Insufficient Prioritization Alleged

Critics of the military’s vaccine program suspect an effort to silence the centers.

The Bush administration has “clearly decided that the way to reduce any reporting of anthrax vaccine adverse reactions — and the cost of paying for them — is to eliminate the only clinic in the United States doing valid reporting of the illnesses that result from the vaccine,” retired U.S. Air Force pilot and Gulf War veteran Lt. Col. John Richardson wrote in an e-mail.

The Pentagon has been under pressure to stop requiring anthrax vaccinations. Four service members and two civilians are anonymously suing the Defense Department and the Food and Drug Administration over the inoculation’s safety, arguing that military personnel should be allowed to refuse the vaccine (see GSN, Jan. 8).

Senator Bingaman this year asked Defense Secretary Donald Rumsfeld to reconsider the policy in light of “the potential for serious health consequences for our troops” and an apparent absence of Iraqi biological warfare capabilities. No change has been made.

The network lately has been researching several cases of blistering skin rashes and oral ulcers, identified as the rare disease “pemphigus vulgarus,” occurring after anthrax vaccinations. It also is aiding investigations of at least 71 cases of myopericarditis occurring following smallpox vaccinations (see GSN, May 13).

Congress created the network following revelations in the late 1990s that the anthrax vaccine was causing a significant number of serious illnesses among military personnel, said Meryl Nass, another prominent military vaccine critic and physician who regularly treats soldiers with suspected vaccination complications.

“Congress pointed out that people, who were becoming ill following vaccinations, needed to be treated appropriately within the military, not just discharged because of their medical disability,” she said.

By doing so, the centers inevitably expose vaccine hazards officials may not want to see publicized, she asserted.

To some vaccination proponents, the centers are basically “an invitation to leak,” she said.

A History of Uncertainty

Engler, who is seeking to put network funding into the Army’s next long-term budget plan, the Program Objective Memorandum (POM), offered a different explanation for the network’s uncertainty: a general funding shortage.

“We’ve briefed over the last few months numerous venues, and everyone says you’re doing a good job, we need you. … People continue to apologize to us and say we know you’re a good thing, we just don’t know how to pay for you,” she said.

Engler said it is not uncommon for new programs not included in the Army’s Project Objective Memorandum to have to compete with other programs for resources.

Since the network’s conception, long-term funding has never been certain. The program in its first year was funded by the Centers for Disease Control and Prevention. In fiscal 2002 and 2003, Congress appropriated money for it directly. During this fiscal year, the Army’s North Atlantic Regional Medical Command is sharing funds.

The fact that the Army did not include the program in its previous long-term budget plan [which is the fiscal 2004-2009 POM] could indicate just how much or little it values the network, said defense spending expert Steve Kosiak, budget director of the Center for Strategic and Budgetary Assessments.

“To say it’s not in the POM, is to say it’s not enough of a priority for you,” he said.

Changing a Way of Thinking

Engler said the centers occupy a middle ground between opposition to certain vaccinations and mandatory vaccinations without exceptions. She said she supports the mass vaccinations against anthrax and smallpox, but along with rigorous screening for potential risk factors that could forecast serious reactions and warrant exemptions.

She said the centers’ work represents a new approach to understanding the potential consequences of vaccinations that requires a change of thinking in the military and civilian medical communities.

Traditionally, the military as well the civilian Centers for Disease Control and Prevention focused on epidemiological analysis, she said, by examining large numbers of vaccinations for problems among a significant number of people.

“The problem is that rare adverse events are not as amenable to the epidemiological approach,” she said.

Engler’s centers, and the comparable Clinical Immunization Safety Assessment centers at the CDC, offer a clinical, micro-level approach to vaccine safety questions by treating and researching potentially rare but serious reactions.

The medical community needs to come to the view that vaccines are prescription drugs and need to be treated as such, she said. That is, that vaccines pose uncommon though potentially serious complications that often can be avoided by screening patients with potential risk factors, but those factors should not be considered a reason to stop mass vaccinations.

Her centers aim to spread that message to military patients and health care providers who, like their civilian counterparts, may have given little attention to the uncommon side effects of vaccinations.

“I get [medical] folks who say, ‘What’s the problem? You know. I stuck my arm out and I’m just fine. It’s just a shot,’” she said.

“We want to bring the standards of how prescription drugs are handled to the world of vaccines and it’s a learning curve. There are no bad guys. We’re teaching people to look at things differently,” she said.

May 15, 2004

Exposure to germ tests was extensive

Exposure to agents was widespread, GAO report says

By Lee Davidson
Deseret Morning News

WASHINGTON — It may have sounded awful when the Pentagon reported last year that nearly 6,000 soldiers may have been unwittingly exposed to germ and chemical weapons in 50 tests conducted worldwide from 1962 and 1974 by Army scientists based in Utah.
But congressional investigators said Friday that figure was just the tip of the iceberg.

The U.S. General Accounting Office, a research arm of Congress, said those Pentagon-reported numbers were just for one series of experiments, called Project 112 or Project SHAD. "We have determined that hundreds of such classified tests and research projects were conducted outside Project 112," GAO officials said in a new report released Friday.

In fact, the GAO said it quickly found that at least 100 secret germ and chemical experiments were conducted at Utah's Dugway Proving Ground alone, or more than double the number of tests conducted under Project 112 during the same time period. The report said hundreds more secret tests were conducted in the 48 contiguous states.

So the GAO said the Pentagon, which declared last June that its work in identifying potential chemical and germ arms victims for Project 112 was complete, should continue probing further now to try to identify soldiers and civilians possibly exposed in all those other tests. In response, the Pentagon said it is planning to try to do so.

The Deseret Morning News has shown through the years, through documents obtained through the Freedom of Information Act, that thousands of open-air trials occurred in Utah with chemical, biological and radiological weapons, often upwind from populated areas.

The newspaper also first reported the Project SHAD and Project 112 tests, many of which were conducted at sea. Some sailors had sought the newspaper's help, complaining they were suffering from cancer and nervous system ills they blamed on the tests. But Veterans Affairs denied claims because the Army said the tests never occurred.

Despite the newspaper obtaining reports and plans of some of those tests, the Pentagon continued for years to deny they occurred.

But after pressure from national media, members of Congress, the VA and sailors, the Pentagon finally said in May 2002 that some initial research showed such tests happened. It said last June that it had identified all the places and the names of veterans likely involved.

The new GAO study was ordered to measure the adequacy of that recent Pentagon work. The GAO said the Pentagon generally did a good job of identifying all Project 112 tests and most of the veterans involved. But it said a few veterans and many civilian workers were likely missed because records of some tests have yet to be found.

The Pentagon has entirely ignored other series of tests that may have exposed more people than Project 112, the report says.

"While there is no database that contains information concerning the biological and chemical tests that have been conducted, we determined that hundreds of such classified tests and research projects were conducted outside Project 112," the GAO wrote.

"In addition, information from various sources shows that personnel from all services were involved in chemical and biological testing," it said. Many were designed by the old Deseret Test Center, which originally was at Fort Douglas and later relocated to Dugway before disbanding.

"A former Deseret Test Center scientist estimated that the number of chemical and biological tests conducted at just one location — Dugway Proving Ground, Utah — was over 100, or more than double the number of tests conducted under Project 112," the GAO reported. GAO said it found one old study that listed biological field tests conducted at locations including Dugway; Fort Bragg, N.C.; Fort Detrick, Md.; and Edwards Air Force Base, Calif. The GAO noted that its office and others also previously reported that "hundreds of radiological, chemical and biological tests were conducted in which hundreds of thousands of people were used as test subjects." Also, it previously reported that the Army Chemical Corps conducted classified research on incapacitating agents that used at least 7,120 volunteers.

The GAO said that amid its probe, the Pentagon in February "began preparing a plan to identify tests outside Project 112 that might have exposed service members," and civilians.

"However, that office has not yet completed its plan for doing this," the GAO wrote.

The GAO called for finalization and implementation of that plan. It said the Pentagon "concurred with our report findings and recommendations and agreed to implement our recommendations."

May 5, 2004

Soldier has suffered seizures, headaches since anthrax shots

Bulletin Staff Writer

For the past six years, Spc. Catherine Young has served her country. Now, she feels problems she has had since taking mandatory anthrax vaccinations are being "swept under the carpet."

Young grew up in Mountain Home, and her parents Jack and Bertha Benton, and brother, Walter Poe, still live here. Young left Mountain Home in 1992 and joined the U.S. Army in 1993. After her four-year term -- one year in Korea and three at Fort Sill, Okla. -- she began civilian life, ending up in Nashville, Tenn.

"I realized how much I missed the discipline and family that military troops have," Young said. "In February 2001, I decided to join the Tennessee National Guard." The rest of her unit has gotten to return to Nashville, and an official homecoming ceremony was held Sunday to welcome them back. Although Young took part in the ceremony, she is still waiting for her homecoming. Shortly after 9-11, she volunteered for a peacekeeping mission in Bosnia and spent 6 1/2 months there doing supply missions and guard duty. "After my tour, I chose to go inactive National Guard," she said. On Feb. 9, 2003, her unit, the 173rd Personnel Services Detachment, was activated. "At the time of our activation, every military post was overwhelmed with troops, so my unit was sent to Fort Rucker, Ala.," she said, adding that Fort Rucker is not a mobilization station.

There, the troops were ordered to take anthrax and smallpox shots. After her first anthrax shot, Young asked that she not be required to take the remaining shots. "I was then given a direct order to take the next five shots," she said. "On May 5, I received my smallpox shot, and on May 6, I received my second anthrax shot." She immediately began suffering severe headaches that sent her to Lyster Army Hospital several times. Only then was she given medical exemption from the remaining shots. She had a CT scan and several blood tests. On April 20, 2003, still under medical care, she was deployed with her unit to Kuwait. She had been given Loritab at a 10 mg. dosage to keep her headaches under control.

"While deployed to Kuwait, I went, on several occasions, to the field hospital for my headaches because my medication quit working," Young said. When she found no relief at the hospital, she self-increased her Loritab dosage.

Over the next five months, she increased to 30 or 40 mg. at a time. When she finally got to see Col. Holly Dayne, Dayne asked her how many milligrams of Loritab she was taking at a time. When Young told her, Dayne immediately processed paperwork to send her back to the United States. She was sent to Fort Gordon, Ga., for testing, and had an MRI test there. At first, they told her the overall view was fine and sent her to Fort Rucker, Ala., for follow-up tests. But the same day she left Fort Gordon, she was called back to the hospital there because they thought she might have a brain aneurysm. "Because I didn't belong to a unit yet, I had to find my own way back to Fort Gordon," Young said. "After more tests, they felt I had a blocked or collapsing vein in my forehead. I was sent back to Fort Rucker."

After a two-month wait, Young finally saw a neurologist in December. He put her on medication and sent her home. "Since then, I have had two seizures, and my headaches have intensified," Young said. "By Alabama law, Fort Rucker had to pull my driving privileges." Not being able to drive has increased her depression and stress, Young said. "I now have to depend on others to go to and from work, PX, even recreational activities," she said. Repeated requests to be home stationed have been denied. Young said she wants to return to Nashville where she owns a home and would be closer to her family, friends and other members of her unit. During Sunday's ceremony, each soldier in the unit was awarded medals for their service while they were deployed. Young said her unit spent 10 1/2 months in Kuwait after being home only 9 1/2 months from Bosnia. "Our jobs were personnel duties, but we performed military police duties," Young said. "We pulled guard duty and 'shooter' missions to Baghdad International Airport." She doesn't believe the military has done all it can to get to the root of her problem, and, she said, there are others who have suffered adverse effects since their vaccinations. She now takes 3,000 mg. of Keppra for her seizures and Imitrex shots for headaches.

"I have been stateside for seven months," she said, "and still have no idea when I'll be done."

May 1, 2004

'Better' anthrax vaccine tested

Trials are set to begin on a new and potentially better anthrax vaccine.
Scientists in the United States will test the jab on 480 people as part of a government-funded study.

The vaccine has been developed by VaxGen. It is designed to last longer and have fewer side-effects than the existing vaccine.

However, these are early stage trials. Even if the jab proves effective it will be a number of years before it becomes available.

Millions being spent

The US government has given millions of dollars in recent years to companies trying to develop a new anthrax vaccine.

The current vaccine was developed in the 1950s and is really only used to vaccinate military personnel or people who have contact with animals that harbour anthrax.

The goal is to develop an anthrax vaccine with better protection

Officials insist the vaccine is safe. However, it is controversial. Some soldiers claim it is linked to Gulf War Syndrome.

The main problem with the existing vaccine is that a number of injections are required over a few months before it becomes fully effective. Booster shots are also needed every year.

The US anthrax mail attacks, which claimed the lives of five people in 2001, have spurred many companies to try to develop more effective vaccines and new antidotes.

The US government has drawn up plans to stockpile millions of doses of anthrax vaccine.

Anthrax particles or spores are highly infectious and can kill.

A study, published last year, suggested an anthrax bomb or missile in a city the size of New York could kill as many as 123,000 people even if every victim received treatment.

This latest vaccine will be tested on people in 12 cities across the US. Scientists hope it will provide protection much more quickly than the current vaccine.

"The goal is to develop an anthrax vaccine with better protection, an improved safety profile and a simpler dosing schedule," said Dr Geoffrey Gorse of St Louis University, who is heading the trial.

The UK's Health Protection Agency manufactures another anthrax vaccine at its facilities in Porton Down.

A spokesman said it backed new research into possible alternatives.

"The current US jab requires six inoculations as part of the vaccination schedule," he said.

"The British one requires three to four inoculations. A vaccine that required fewer jabs would be of benefit."