March 28, 2004

U.S. war on anthrax has its risks - Rush to stock new vaccine has scientists wary

By Peter Gorner
Tribune science reporter

Some scientists are questioning a U.S. government plan to spend as much as $1.4 billion on an unlicensed, experimental anthrax vaccine to be stockpiled in case bioterrorists attack American cities.

Although the vaccine has been tested in animals, testing in humans is in its early phases and the vaccine has not yet demonstrated its effectiveness, making the purchasing plan premature, according to critics.

But the Bush administration, as a follow-up to its promise to have enough smallpox vaccine on hand for every American, said it hopes that within two years the country will have sufficient quantities of the new anthrax vaccine to inoculate 25 million people.

That, along with the storage of antibiotics that already have proved their effectiveness against anthrax spores, could serve as countermeasures against a feared biological agent.

"As the lead federal agency for public health and medical response, we are moving forward to ensure our nation is protected against anthrax," said Tommy G. Thompson, secretary of the Department of Health and Human Services.

But an anthrax expert, Dr. Meryl Nass, of Bar Harbor, Maine, cautioned that the public "should not be misled that this vaccine is an improvement to the currently licensed vaccine.

"This one is definitely more pure, but unfortunately its purity has not been shown to improve safety or effectiveness," said Nass, a former government consultant who led the campaign against the existing vaccine after getting reports from military personnel of mystifying and serious side effects.

After a terrorist attack, the U.S. plan calls for the entire population of a city to be inoculated with the new vaccine, while also taking antibiotics until immunity develops.

After that, with regular booster shots, people theoretically would be immune to anthrax, even if spores lingered for years, as they have been shown to do.

Nass said that most "shocking" is the government's contention that the new vaccine would enable cities contaminated with anthrax to be habitable.

`Most bogus thing'

"Where's the science behind that? It's the biggest, most bogus thing of all," she said.

The only currently licensed anthrax vaccine in the U.S. is a mixture of proteins produced by a weakened form of Bacillus anthracis, the bacterium that causes the deadly disease in animals and people.

Developed for animal-hide workers in the 1950s and used primarily by the military, the vaccine requires six injections over 18 months and has been associated with severe side effects.

The licensed anthrax vaccine became the subject of bad publicity and litigation because of the Pentagon's insistence on mandatory vaccination of troops. The vaccine's reputation never recovered.

During the anthrax-letters panic of 2001, nearly all of the postal workers at risk refused the vaccine when it was offered.

Nonetheless, some skeptics are questioning what they perceive as the rush by the government to buy several million doses of the new vaccine, called rPA102, before clinical trials are completed and its safety and effectiveness evaluated.

Also being questioned is the choice of the main manufacturer, VaxGen Inc. of Brisbane, Calif., a company whose AIDS vaccine failed inclinical trials in 2003.

"Once again, VaxGen has managed to leverage few scientific data to capture a significant amount of federal dollars," said Dr. Steven Wolinsky, an AIDS researcher and chief of the division of infectious diseases at the Feinberg Medical School at Northwestern University.

"Most of us in the scientific community agree there is meager scientific evidence to support this effort. As a clinician, I would not offer the vaccine to people exposed to anthrax spores without providing them with concomitant drug treatment."

More promising anthrax vaccines are in the pipeline, but they may fail to attract commercial developers because the government already has made up its mind, some experts contend.

They also warn of another potential anthrax vaccine boondoggle that would make the legal, medical and ethical disputes over the existing vaccine, BioThrax, pale by comparison.

Bidding will close April 16 on a contract for 75 million doses of the rPA102 vaccine that is expected to be awarded to VaxGen and Avecia Ltd, a privately held company based in Manchester, England.

According to the Department of Health and Human Services, "the new vaccine has already shown to be stronger and more effective than the vaccine being used today. It will require fewer doses per individual to provide immunity against the effects of anthrax inhalation."

The firms already have contracts--VaxGen for $80.3 million and Avecia for $71.3 million--to each produce 3 million doses and conduct human trials to test the vaccine.

The new vaccine is a purified protein designed to stimulate the body to produce antibodies to neutralize the most dangerous part of anthrax--called protective antigen, or PA.

"The way anthrax works is that one part attaches to your cell and the other part [the protective antigen] gets flipped on the inside to have the toxic effect," said Dr. Craig E. Smith, representing the Bioterrorism Work Group of the Infectious Diseases Society of America.

"This vaccine stimulates antibodies that destroy the attachment component so the toxic part can't get into where it needs to do its dirty work. It just gets washed out of your system without any problem," Smith said.

"If a bomb blew up and the cloud spread anthrax through the city, we could follow the cloud and vaccinate the 2 million people downstream who may take weeks to months to manifest the disease."

Smith called the new vaccine "a no-brainer. A win-win situation."

VaxGen recently reported that the first phase of human testing--with 100 volunteers age 18 to 49--showed that antibody responses to higher doses of rPA102 conferred protection within the same range as the existing vaccine.

Dr. Harry L. Keyserling, professor of pediatrics at Emory University School of Medicine, conducted the clinical trial with colleagues from St. Louis University and Baylor and Johns Hopkins Universities.

Local reactions, mainly arm pain, were more common with the old vaccine, but short-lived systemic reactions, mostly headache and fatigue, were more than twice as common (39 percent versus 18 percent) with the new vaccine.

"Side effects were mild, nothing that would interfere with everyday activity. Further studies will continue to monitor reactions and adverse effects," said VaxGen spokeswoman Kesinee Yip.

But systemic reactions worry some specialists because long-term effects of the vaccine are virtually unstudied and initial systemic reactions--reactions away from the injection site--could put people at high risk of chronic illness later.

Linked to problems

Published case reports have linked anthrax vaccine to a host of problems including chronic fatiguing illnesses, chronic pain syndromes and endocrine and autoimmune disorders.

Another top government official insisted the new vaccine purchase plan is not precipitous and "was all done in a very measured, careful way.

"There were multiple contracts doing the research to show that it was safe and stimulated the immune system against anthrax. Now comes the production capabilities to put it in place," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.

"We now have enough smallpox vaccine to handle anything. But with anthrax vaccine, we had a gap," Fauci said.

"We didn't have enough vaccine if, indeed, we had an attack on a city. Nor did we have enough to vaccinate first responders and others who might be doing the cleanups after an attack of anthrax."

As with the current vaccine, the new vaccine was developed by bioweapons specialists at the U.S. Army Medical Research Institute of Infectious Diseases at Ft. Detrick, Md. They successfully tested the vaccine for years in primates, officials said.

"Almost two years ago, we started a strategic plan for developing countermeasures to high-risk agents--smallpox, anthrax, tularemia, plague, botulism toxins and the hemmorhagic fevers. This purchase is part of that," Fauci said.

Others challenge that assertion, however.

"The primary ingredient, PA [protective antigen] has significant toxicity. Since no immediate need exists, and testing has not been completed, why rush to order a huge stockpile of such a vaccine?" asked Nass."VaxGen is only at the Phase 1 stage, pre-efficacy testing. Why buy a huge amount of a product before the manufacturer has showed it will work?

"Many things are dropped much later as a result of Phase 3 testing--like VaxGen's AIDS vaccine. Nothing should be purchased in bulk at this very early stage of testing," Nass said.

March 27, 2004

Growing Doubts On Vaccine In Military

By Marilyn W. Thompson
Washington Post Staff Writer

With each report on the absence of weapons of mass destruction in Iraq, Airman Jessica Horjus asked a question: If inspectors could find no signs of anthrax, why should the Pentagon risk her health by requiring her to get the anthrax vaccine?

"I have a kid to take care of," said Horjus, 23, the mother of a 2-year-old, who lives with her daughter in military housing at Seymour Johnson Air Force Base in Goldsboro, N.C. "The Air Force can always fill my slot with someone else, but who's going to fill the mommy slot?"

When a January order came for Horjus to get the vaccine before deploying to a Kuwait air base about 30 miles from Iraq, the soldier with commendations and Good Conduct Medals declined. Her commander demoted her and cut her pay in half, to less than $800 a month. In February, she declined a second and third order.

Horjus is one of a number of soldiers who cite the lack of anthrax in Iraq as a reason behind their stance against the mandatory anthrax vaccine. As the Pentagon moves thousands of troops into Iraq as part of a huge rotation of forces, soldiers, citizen groups and members of Congress are increasingly calling upon defense officials to stop the vaccinations.

Sen. Jeff Bingaman (D-N.M.) sent a letter last week to Defense Secretary Donald H. Rumsfeld asking him to reevaluate the mandatory policy in light of events in Iraq. "The apparent absence of an Iraqi biological warfare capability raises serious questions about the threat of an anthrax attack against our troops," Bingaman wrote. "The use of a vaccination which appears to have the potential for serious health consequences for our troops in an effort to counter a threat that may not exist seems to unnecessarily expose our troops to risk."

The Pentagon now requires inoculation for any soldier about to deploy for more than 15 days to what it defines as a "high-risk" area for anthrax attack. Concerned about reports of illnesses and a death last year that officials linked to the vaccine, soldiers headed to Iraq, Afghanistan and elsewhere are asking more questions about the program's rationale.

"There is no evidence that stockpiles of anthrax exist in Iraq or with Al Qaeda in Afghanistan or elsewhere," Horjus wrote in a memo to the base's appellate authority. "As a single mother, I cannot afford to unnecessarily risk my long-term health on a highly-reactive vaccine that supposedly protects against a threat that cannot be found."

After four years of service, the young mother last week accepted the Air Force's offer of an other-than-honorable discharge and prepared to return home to Yorktown, Va.

Vaccine opponents say they are tracking dozens of cases of soldiers who are refusing the vaccine. The demand for troops is so high that unvaccinated soldiers may find themselves deployed nonetheless. Some are on duty in and near Iraq and are closely monitoring the frustrated hunt for banned weapons, knowing they will face punishment for disobeying orders when they return.

Pentagon officials insist that refusals are extremely rare and that the unsuccessful search for the weapons has not changed their thinking about the merits of the mandatory vaccine. The anthrax threat, they say, is not a distant risk but was underscored by the 2001 domestic letter mailings that killed five people and left thousands vulnerable to grave illness or death.

"The lethal anthrax attacks of the fall of 2001 did not need a sophisticated delivery system," Defense Department spokesman Jim Turner said in an e-mail response to questions. "We vaccinate our people to keep them healthy."

Vaccine opponents have become increasingly organized and vocal about the health risks of the AVA vaccine, a product that has accumulated thousands of reports of adverse reactions ranging from headaches and vomiting to severe autoimmune and neurological problems. Opponents are using the courts to press the health issues and lobbying Congress to give relief to soldiers whose careers ended abruptly over their refusals to line up for shots.

"When troops find out that any one portion of what they've been told is a lie, they question the rest of it," said Kathryn Hubbell, who helped set up a nonprofit group, the Military Vaccine Education Center, to work with soldiers. It is also organizing a political action committee to raise money for its lobbying efforts.

Among the hotly contested issues is the Pentagon's accounting of the number of soldiers who have been "separated" from the services for refusing to take the required six-shot regimen. Congress was so concerned about the issue in the program's early years, when hundreds of soldiers resigned the military rather than be vaccinated, that it began requiring the Defense Department to report annually the number of soldier separations.

The department's reports for 2001 and 2002 show only three separations, and numbers for 2003 are due this spring. Vaccine opposition leader John Richardson, a retired Air Force Reserve lieutenant colonel, calls the Pentagon numbers a "willful misrepresentation" used to encourage good order and discipline. He says the Pentagon uses the strictest interpretation of the data, failing to count cases such as Horjus's that did not result in court-martial and forced removal from the military. Since the vaccine program began, about 100 active-duty soldiers have been court-martialed for refusing the vaccine, according to congressional testimony and documents.

Victims' advocates say they have become aware of 45 cases involving vaccine refusers since 2002. These soldiers find themselves subjected to a wide range of punishments.

"We've seen everything from quiet discharge to court-martial to imprisonment with 60 to 90 days in the brig," said Randi Airola, a victims' advocate who left the Michigan Air National Guard in 1999 because of her own vaccine refusal. "We've seen soldiers threatened with two to three to 10 years in prison when, in the military, even rape or drug charges may not get you 10 years in prison. The punishment is based solely on the discretion of the individual commander -- and some want to use a sledgehammer to get people to comply."

Airola recently gave a congressional committee 32 pages of e-mails sent to her by soldiers who believe they have been made sick by the shots or are refusing to be vaccinated.

"In light of these problems," she wrote, and the absence of weaponized anthrax spores in Iraq or Afghanistan, "it is unacceptable for Congress to continue to follow the line that the vaccine is safe, effective and good enough for our troops and to jail those who refuse."

A key question in the vaccine debate is the safety of AVA, a product that has been used since the 1950s to inoculate textile workers and laboratory personnel at high risk of anthrax exposure. The vaccine was licensed by federal regulators without being tested in large-scale human clinical trials. But the Pentagon points to a 2002 report from the Institute of Medicine declaring the vaccine safe and effective.

The vaccine, made by BioPort Inc. of Lansing, Mich., is now under attack in three separate federal lawsuits brought by affected soldiers.

In U.S. District Court in Washington, Judge Emmet G. Sullivan issued a preliminary injunction late last year that caused the Pentagon to briefly halt vaccinations. The program resumed after the Food and Drug Administration offered assurances in February that the vaccine was safe. The case, brought on behalf of six anonymous servicemen who believe they were made ill by the vaccine and for all of those "similarly situated," is set for oral arguments in May.

Two federal judges have suggested that the military will be held accountable if it is using soldiers to test an investigational drug without their informed consent. Pentagon officials seemed poised to stop the program before the Sept. 11, 2001, attacks gave it a reprieve. In December, the Pentagon agreed to buy an additional 245 million doses of BioPort's vaccine.

The Defense Department and other federal agencies have worked to find a new anthrax vaccine that will produce fewer side effects.

Horjus said her decision to refuse the BioPort vaccine was based largely on research and observation. Her estranged husband took the shots before deploying to Saudi Arabia and became ill with a fever and lung congestion. She said she read everything she could about the vaccine, doing what the military expects a good soldier to do -- "use your head."

Horjus said she became convinced that the BioPort vaccine was unsafe and experimental, its effects on women of childbearing age unknown. She and others were upset by a case that drew wide attention in November, when a coroner ruled that "post-vaccine" problems may have contributed to the death of Army Spec. Rachel Lacy.

Army Lt. Gen. James B. Peake of the U.S. Army Medical Command sent a memo to commanders in February mentioning Lacy's death and telling them to be alert for adverse reactions. "The overwhelming majority of immunizations are followed by mild symptoms. . . . Unfortunately, the U.S. Army lost a valuable soldier in April, 2003, a month after receiving five vaccinations during mobilization," Peake wrote. "Although the evidence was inconclusive, medical experts determined that vaccination may have contributed to her death."

Adding to Horjus's concern were reports of two airmen at Seymour Johnson who became seriously ill after receiving the shots.

One soldier said in an interview she has suffered lightheadedness, night sweats and "grayouts" since receiving three of the six required shots. She asked that her name not be used because of fears that it could hurt her effort to get specialized treatment at a Walter Reed Army Medical Center vaccine clinic.

"Before these shots, I was a normal, healthy 20-year-old," she said. "So far, I've dodged the fourth shot, but if they try to make me take it, I'll be traveling down Jessica Horjus's path."

Horjus and the two sick soldiers have become part of Airola's outreach network. She directs soldiers and their families to medical information and counsels soldiers preparing to refuse the vaccine. Many, she said, write letters to their commanders explaining that they are willing to deploy, even to indemnify the military against any possible anthrax exposure they might suffer on the battlefield, but "they just don't want to take these shots."

At Fort Campbell, Ky., Army Sgt. Richard Norris, 27, is awaiting punishment for refusing the shots. When his unit of the 101st Airborne Division left for Iraq in February 2003, Norris was sent anyway, with no vaccine -- and no questions asked.

He returned in December to find himself still flagged as "punishment pending," a status that has "put my whole career basically on pause.

"I've served my country for seven years," said Norris, a Seventh-Day Adventist who tried unsuccessfully to get a religious exemption from the vaccine program. "Refusing this vaccine is the first bad thing I've ever done. It wasn't even necessary to have this vaccine, and still I'm going to be punished."

March 16, 2004

Bush Administration Seeks Capability to Vaccinate 25 Million With New Anthrax Vaccine

Global Security Newswire

The U.S. Health and Human Services Department last week opened bidding for contracts to develop a stockpile of a new anthrax vaccine capable of inoculating 25 million people, according to the Associated Press (see GSN, March 9).

The new vaccine, developed by federal scientists, would have fewer side effects and require about half as many injections as the current anthrax vaccine, according to the AP. Two companies — the U.S.-based VaxGen and the United Kingdom-based Avecia — have received initial contracts to produce a small amount of the new vaccine to conduct human safety tests. While any interested company can bid on the remaining vaccine production, the early involvement of VaxGen and Avecia will make them prime candidates for the new contracts, AP reported (Associated Press, March 12).

The most likely use of the new vaccine would be to inoculate the entire population of a city after an anthrax attack, to provide long-term protection against lingering anthrax spores, according to experts. Preventive vaccinations may be considered for some high-risk occupational groups, such as hazardous material teams and postal workers, said National Institute of Allergy and Infectious Diseases Director Anthony Fauci.

The U.S. Defense Department has not publicly commented on using the new vaccine, but experts said the Pentagon is likely do so once it is licensed by the Food and Drug Administration, which could occur as early as 2006 (Justin Gillis, Washington Post, March 12).

March 12, 2004

U.S. to Buy Anthrax Vaccine - Stockpile Would Permit Mass Inoculations

By Justin Gillis
Washington Post Staff Writer

The government is preparing to buy enough experimental anthrax vaccine for 25 million people, a stockpile that would permit mass inoculations in numerous U.S. cities if terrorists launched a broad assault with the deadly germ.

The new vaccine would be the most significant addition to the national anti-terrorism stockpile since the Bush administration fulfilled a pledge to buy enough smallpox vaccine for every citizen of the United States. Up to now, there has been little commercial incentive for companies to develop a modern anthrax vaccine, but the new plan would change that, creating a reserve big enough in a year or two to immunize everyone in the New York and Washington metropolitan areas -- or in other cities that might be targeted in an anthrax attack.

Two biotechnology companies, in California and in Britain, have won contracts to make an early stockpile of the unlicensed vaccine sufficient to inoculate 2 million people, according to bidding documents released yesterday, and they are likely to bid soon on larger contracts. Coupled with the government's successes in stockpiling smallpox vaccine and antibiotics, the anthrax purchases mean the United States will soon have developed a wide array of defenses against the two most important biological weapons.

"The colleagues that I work with in this business would tell you that smallpox and anthrax are the two most-feared agents, and we've done a lot to take those off the table," said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, who has advised the federal government on combating bioterrorism. He said a large-scale attack "would still be a tragic situation, but compared to what we had available two years ago, we have come a long, long way."

Government scientists are still discussing how the anthrax vaccine might be used, and how it compares with other drugs under development, such as artificial antibodies given over the short term to prevent or treat anthrax infection. But the documents released yesterday show the government has decided to order an additional 75 million doses, enough to vaccinate at least 25 million people. Added to the 2 million doses already on order, as much as 9 percent of the country's population would be covered.

The stockpile is projected to cost at least $700 million on top of nearly $200 million already spent, a congressional report said. The two companies involved, VaxGen Inc. of Brisbane, Calif., and Avecia Ltd. of Manchester, England, are racing to scale up their factories for rapid vaccine production.

The most likely use of the vaccine, experts said, would be to inoculate the entire population of a city immediately after a terrorist attack. People might need to take antibiotics for several weeks to prevent disease until the vaccine kicked in, but after that they would be immune even if anthrax spores lingered in the city for years, as the germs are believed capable of doing.

While preventive vaccination of entire cities isn't likely any time soon, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, inoculations may be considered for some high-risk occupational groups, including the hazardous-materials teams that would respond to an anthrax attack.

"If the safety profile of this vaccine is as good as we think it's going to be, I think there's going to be at least a discussion among some of the unions of postal workers," he said. Two postal workers in Washington died in 2001 after letters containing anthrax spores were sent through the mail.

The new vaccine is designed to be a potent, highly purified replacement for an existing anthrax vaccine, a product developed in the 1950s that is used mostly by the Pentagon to inoculate troops.

The old vaccine, which contains a complex and poorly understood mix of substances, has been the subject of broad controversy and an ongoing court fight, with thousands of military personnel resisting vaccination and others attributing various health problems to the vaccine. The Food and Drug Administration has ruled it safe and effective, but another arm of the government, the National Institutes of Health, is intent on replacing it, awarding grants totaling nearly $200 million since the terrorist attacks of 2001 to help biotechnology companies develop alternatives.

Many postal workers who were offered the old vaccine after the 2001 attacks declined it, preferring to stay on antibiotics. Among numerous disadvantages, the old vaccine requires six doses over 18 months to induce immunity. The new vaccine is likely to require three or fewer doses over several weeks, and it's expected to contain far less of an additive that some suspect of causing side effects. The experimental vaccine has undergone initial tests in people and caused few problems, but bigger tests are planned and the full extent of any side effects or other safety concerns is not yet known.

The Pentagon has made no public statement about switching to the new vaccine, but most experts believe the military is likely to do so once it is licensed by the FDA. That could happen as soon as 2006.

The prime ingredient in the new vaccine is a protein vital to the life cycle of the anthrax germ. Research by U.S. Army scientists over many years has shown that the protein, when administered to animals by injection, causes the immune system to mount a powerful defense. When the animals were later exposed to large amounts of anthrax germs, they did not become ill.

Preliminary tests have already shown that the vaccine induces the same kind of immunity in people as in other animals, and broader tests are underway. Definitive proof of the vaccine's effectiveness in people is likely to come only with another anthrax attack, since exposing people to anthrax germs deliberately would be unethical. But the FDA has rules allowing it to license bioterror vaccines on the basis of animal tests.

It's unusual for the government to buy such a large amount of vaccine while it's still experimental, but it's not unprecedented. The Department of Health and Human Services bought millions of doses of a smallpox vaccine that had not been licensed. The theory is that in a large-scale attack, people will want access to vaccines even if they are experimental.

Smallpox, eradicated in the 1970s by worldwide vaccination campaigns, was able to spread from person to person. There is no proof that terrorists possess the smallpox germ, but many people suspect it. That is why the government bought enough vaccine for everyone in the country: A worst-case attack with smallpox weapons could produce a national epidemic.

Anthrax, by contrast, does not spread from person to person, but the spores can float through the air. The worst-case scenario is that terrorists would make enough anthrax to spray it over cities from airplanes.

The germ causes a lung disease that kills 30 percent to 50 percent of people who get it even if they receive medical care.

Anthrax spores can apparently hide in the lungs for long periods before germinating and causing disease. In the absence of a vaccine stockpile, people living in -- or possibly just visiting -- a city that had been attacked with anthrax might need to take powerful antibiotics for six months or longer. With a vaccine, doctors could inoculate a person and then, once immunity kicks in, discontinue the antibiotics. As a safeguard, the government has stockpiled enough antibiotics to treat 20 million people for 60 days.

March 10, 2004

Effectiveness of Safer Smallpox Vaccine Demonstrated Against Monkeypox

NIH News

A mild, experimental smallpox vaccine known as modified vaccinia Ankara (MVA) is nearly as effective as the standard smallpox vaccine in protecting monkeys against monkeypox, a study by researchers of the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, has found. Monkeypox is used to test the effectiveness of a smallpox vaccine because of its similarity to the smallpox virus. The study appears in the March 11 issue of Nature.

"These findings are important to the search for a replacement vaccine for people with health conditions that would prevent them from using the current smallpox vaccine," says Anthony S. Fauci, M.D., director of NIAID. Currently, Dryvax is the only commercially available smallpox vaccine in the United States. "In addition, because an initial MVA injection may help lessen the side effects experienced from Dryvax, MVA may serve as an important pre-vaccine for large-scale vaccination efforts in the event of a bioterror threat involving smallpox."

NIAID's Bernard Moss, M.D., Ph.D., the senior author on the paper, adds, "This study shows that the MVA vaccine holds great promise as an alternative to the current vaccine. Although MVA may not quite equal Dryvax in its effectiveness, it did extraordinarily well, with all of the monkeys who were vaccinated with MVA surviving a potentially lethal monkeypox infection and, aside from a few minor lesions, showing no clinical signs of disease."

In a separate study published in the March 11 online early edition of the Proceedings of the National Academy of Sciences, Dr. Moss and colleagues found that, in addition to protecting healthy mice against a lethal form of the vaccinia virus, MVA protects mice with certain immune deficiencies as well. The researchers found that mice survived a deadly dose of vaccinia virus if they'd been immunized with MVA — even those mice that were lacking antibody-producing immune cells or special proteins that help alert killer T cells to an infection. The findings indicate that MVA may be a promising alternative to Dryvax in humans who are partially immunodeficient.

Licensed in 1931, Dryvax is made from a live form of vaccinia virus that, although related to the smallpox virus, cannot cause smallpox. (Smallpox is caused by the more dangerous variola virus. The ability to prevent smallpox by injecting a person with either cowpox or vaccinia virus was demonstrated by Edward Jenner in the late 18th century.) Dryvax and similarly effective vaccines made in other countries led to the eradication of smallpox in 1980.

While most reactions to the Dryvax vaccine are relatively mild, some people may have more serious complications. Individuals at risk for such complications include those with weakened immune systems or skin conditions such as eczema, infants less than 12 months of age and women who are pregnant. For this reason, a primary goal of health officials is to develop a vaccine that is as effective as Dryvax, but safer.

MVA is a highly weakened form of the vaccinia virus that cannot multiply and infect mammalian cells. Although MVA was tested for safety in humans at the time of its development in Germany in the 1960s, it has not been tested for effectiveness against smallpox. According to the Food and Drug Administration, humans cannot be exposed to smallpox to test a vaccine's effectiveness: such exposure is unethical because smallpox is an infectious, deadly disease; and it is unfeasible because smallpox has been eradicated. Therefore, animal studies, such as those involving monkeys and mice, are critical to the development of a replacement vaccine.

To compare MVA with Dryvax, the researchers divided 24 cynomologus monkeys (a type of monkey found in Southeast Asia, Borneo and the Philippines) into four groups of six. Group one received two MVA injections — one at the start of the study and the second two months later. Group two received the MVA vaccine at the start of the study and the Dryvax vaccine two months later. Group three received no injection at the start but received a Dryvax injection after two months. Group four, the control, received no vaccines. Immune responses were monitored throughout the immunization period, and then, later, after the monkeys were exposed to monkeypox.

After vaccinating the monkeys, researchers examined the number of lesions that formed on the animals' skin and the amount of time in which they healed. Monkeys that received Dryvax alone developed the characteristic fluid-filled skin lesions, while those that received MVA prior to Dryvax had much smaller lesions. Furthermore, those that received MVA alone had no skin lesions.

The researchers then looked for antibodies produced against two different forms of the poxvirus: intracellular mature virions (IMVs), virus particles thought to be responsible for transmitting the disease from one host to another; and extracellular enveloped virions, IMVs with an added outer membrane that play a large role in spreading the disease within the individual. To be effective, a vaccine needs to protect against both forms of the virus, and each form requires a different set of antibodies to destroy it. In addition to measuring antibodies, the scientists examined the production of killer T cells, special immune cells that attack cells already infected by the monkeypox virus.

Dr. Moss and his research team discovered that the immune responses elicited by the MVA vaccine were similar to those produced by Dryvax in regard to both antibodies and killer T cells.

Two months after the second vaccination, all 24 monkeys were exposed to monkeypox. Remarkably, all the immunized animals remained healthy with no signs of disease, except for a small number of lesions seen on several monkeys from the MVA-only group. The unvaccinated monkeys, however, had more than 500 lesions each and became seriously ill or died.

Dr. Moss and his team will continue their studies on monkeys to determine, among other things, the duration of protection offered by MVA versus Dryvax as well as the effect of dosage. In addition, NIAID is currently supporting clinical trials to evaluate the immune response to MVA in humans.

Other researchers involved in the study represented the Henry M. Jackson Foundation, Rockville, MD; the University of Pennsylvania, Philadelphia, PA; and the U.S. Army Medical Research Institute of Infectious Diseases, Frederick, MD.

Smallpox is a serious, frequently fatal infectious disease that generally spreads from person to person through the air and is marked by fever, head and body aches, rash and large, fluid-filled bumps on the skin. The last case of smallpox in the United States occurred in 1949, and the last case in the world was in 1977. However, the smallpox virus still exists in laboratories and represents a potential threat because it could be used by terrorists. Monkeypox is primarily a disease of animals, but more than a hundred human cases a year have been reported from central and western Africa. The first monkeypox outbreak occurred in the United States in June 2003 when several people were sickened by infected pet prairie dogs. Symptoms of monkeypox are similar to smallpox, though often milder.

The New Pentagon Papers

By Karen Kwiatkowski

March 10, 2004 | In July of last year, after just over 20 years of service, I retired as a lieutenant colonel in the U.S. Air Force. I had served as a communications officer in the field and in acquisition programs, as a speechwriter for the National Security Agency director, and on the Headquarters Air Force and the office of the secretary of defense staffs covering African affairs. I had completed Air Command and Staff College and Navy War College seminar programs, two master's degrees, and everything but my Ph.D. dissertation in world politics at Catholic University. I regarded my military vocation as interesting, rewarding and apolitical. My career started in 1978 with the smooth seduction of a full four-year ROTC scholarship. It ended with 10 months of duty in a strange new country, observing up close and personal a process of decision making for war not sanctioned by the Constitution we had all sworn to uphold. Ben Franklin's comment that the Constitutional Convention of 1787 in Philadelphia had delivered "a republic, madam, if you can keep it" would come to have special meaning.

In the spring of 2002, I was a cynical but willing staff officer, almost two years into my three-year tour at the office of the secretary of defense, undersecretary for policy, sub-Saharan Africa. In April, a call for volunteers went out for the Near East South Asia directorate (NESA). None materialized. By May, the call transmogrified into a posthaste demand for any staff officer, and I was "volunteered" to enter what would be a well-appointed den of iniquity.

The education I would receive there was like an M. Night Shyamalan movie -- intense, fascinating and frightening. While the people were very much alive, I saw a dead philosophy -- Cold War anti-communism and neo-imperialism -- walking the corridors of the Pentagon. It wore the clothing of counterterrorism and spoke the language of a holy war between good and evil. The evil was recognized by the leadership to be resident mainly in the Middle East and articulated by Islamic clerics and radicals. But there were other enemies within, anyone who dared voice any skepticism about their grand plans, including Secretary of State Colin Powell and Gen. Anthony Zinni.

From May 2002 until February 2003, I observed firsthand the formation of the Pentagon's Office of Special Plans and watched the latter stages of the neoconservative capture of the policy-intelligence nexus in the run-up to the invasion of Iraq. This seizure of the reins of U.S. Middle East policy was directly visible to many of us working in the Near East South Asia policy office, and yet there seemed to be little any of us could do about it.

I saw a narrow and deeply flawed policy favored by some executive appointees in the Pentagon used to manipulate and pressurize the traditional relationship between policymakers in the Pentagon and U.S. intelligence agencies.

I witnessed neoconservative agenda bearers within OSP usurp measured and carefully considered assessments, and through suppression and distortion of intelligence analysis promulgate what were in fact falsehoods to both Congress and the executive office of the president.

While this commandeering of a narrow segment of both intelligence production and American foreign policy matched closely with the well-published desires of the neoconservative wing of the Republican Party, many of us in the Pentagon, conservatives and liberals alike, felt that this agenda, whatever its flaws or merits, had never been openly presented to the American people. Instead, the public story line was a fear-peddling and confusing set of messages, designed to take Congress and the country into a war of executive choice, a war based on false pretenses, and a war one year later Americans do not really understand. That is why I have gone public with my account.

To begin with, I was introduced to Bill Luti, assistant secretary of defense for NESA. A tall, thin, nervously intelligent man, he welcomed me into the fold. I knew little about him. Because he was a recently retired naval captain and now high-level Bush appointee, the common assumption was that he had connections, if not capability. I would later find out that when Dick Cheney was secretary of defense over a decade earlier, Luti was his aide. He had also been a military aide to Speaker of the House Newt Gingrich during the Clinton years and had completed his Ph.D. at the Fletcher School at Tufts University. While his Navy career had not granted him flag rank, he had it now and was not shy about comparing his place in the pecking order with various three- and four-star generals and admirals in and out of the Pentagon. Name dropping included references to getting this or that document over to Scooter, or responding to one of Scooter's requests right away. Scooter, I would find out later, was I. Lewis "Scooter" Libby, the vice president's chief of staff.

Co-workers who had watched the transition from Clintonista to Bushite shared conversations and stories indicating that something deliberate and manipulative was happening to NESA. Key professional personnel, longtime civilian professionals holding the important billets in NESA, were replaced early on during the transition. Longtime officer director Joe McMillan was reassigned to the National Defense University. The director's job in the time of transition was to help bring the newly appointed deputy assistant secretary up to speed, ensure office continuity, act as a resource relating to regional histories and policies, and help identify the best ways to maintain course or to implement change. Removing such a critical continuity factor was not only unusual but also seemed like willful handicapping. It was the first signal of radical change.

At the time, I didn't realize that the expertise on Middle East policy was not only being removed, but was also being exchanged for that from various agenda-bearing think tanks, including the Middle East Media Research Institute, the Washington Institute for Near East Policy, and the Jewish Institute for National Security Affairs. Interestingly, the office director billet stayed vacant the whole time I was there. That vacancy and the long-term absence of real regional understanding to inform defense policymakers in the Pentagon explains a great deal about the neoconservative approach on the Middle East and the disastrous mistakes made in Washington and in Iraq in the past two years.

I soon saw the modus operandi of "instant policy" unhampered by debate or experience with the early Bush administration replacement of the civilian head of the Israel, Lebanon and Syria desk office with a young political appointee from the Washington Institute, David Schenker. Word was that the former experienced civilian desk officer tended to be evenhanded toward the policies of Prime Minister Ariel Sharon of Israel, but there were complaints and he was gone. I met David and chatted with him frequently. He was a smart, serious, hardworking guy, and the proud author of a book on the chances for Palestinian democracy. Country desk officers were rarely political appointees. In my years at the Pentagon, this was the only "political" I knew doing that type of high-stress and low-recognition duty. So eager was the office to have Schenker at the Israel desk, he served for many months as a defense contractor of sorts and only received his "Schedule C" political appointee status months after I arrived.

I learned that there was indeed a preferred ideology for NESA. My first day in the office, a GS-15 career civil servant rather unhappily advised me that if I wanted to be successful here, I'd better remember not to say anything positive about the Palestinians. This belied official U.S. policy of serving as an honest broker for resolution of Israeli and Palestinian security concerns. At that time, there was a great deal of talk about Bush's possible support for a Palestinian state. That the Pentagon could have implemented and, worse, was implementing its own foreign policy had not yet occurred to me.

Throughout the summer, the NESA spaces in one long office on the fourth floor, between the 7th and 8th corridors of D Ring, became more and more crowded. With war talk and planning about Iraq, all kinds of new people were brought in. A politically savvy civilian-clothes-wearing lieutenant colonel named Bill Bruner served as the Iraq desk officer, and he had apparently joined NESA about the time Bill Luti did. I discovered that Bruner, like Luti, had served as a military aide to Speaker Gingrich. Gingrich himself was now conveniently an active member of Bush's Defense Policy Board, which had space immediately below ours on the third floor.

I asked why Bruner wore civilian attire, and was told by others, "He's Chalabi's handler." Chalabi, of course, was Ahmad Chalabi, the president of the Iraqi National Congress, who was the favored exile of the neoconservatives and the source of much of their "intelligence." Bruner himself said he had to attend a lot of meetings downtown in hotels and that explained his suits. Soon, in July, he was joined by another Air Force pilot, a colonel with no discernible political connections, Kevin Jones. I thought of it as a military-civilian partnership, although both were commissioned officers.

Among the other people arriving over the summer of 2002 was Michael Makovsky, a recent MIT graduate who had written his dissertation on Winston Churchill and was going to work on "Iraqi oil issues." He was David Makovsky's younger brother. David was at the time a senior fellow at the Washington Institute and had formerly been an editor of the Jerusalem Post, a pro-Likud newspaper. Mike was quiet and seemed a bit uncomfortable sharing space with us. He soon disappeared into some other part of the operation and I rarely saw him after that.

In late summer, new space was found upstairs on the fifth floor, and the "expanded Iraq desk," now dubbed the "Office of Special Plans," began moving there. And OSP kept expanding.

Another person I observed to appear suddenly was Michael Rubin, another Washington Institute fellow working on Iraq policy. He and Chris Straub, a retired Army officer who had been a Republican staffer for the Senate Intelligence Committee, were eventually assigned to OSP.

John Trigilio, a Defense Intelligence Agency analyst, was assigned to handle Iraq intelligence for Luti. Trigilio had been on a one-year career-enhancement tour with the office of the secretary of defense that was to end in August 2002. DIA had offered him routine intelligence positions upon his return from his OSD sabbatical, but none was as interesting as working in August 2002 for Luti. John asked Luti for help in gaining an extension for another year, effectively removing him from the DIA bureaucracy and its professional constraints.

Trigilio and I had hallway debates, as friends. The one I remember most clearly was shortly after President Bush gave his famous "mushroom cloud" speech in Cincinnati in October 2002, asserting that Saddam had weapons of mass destruction as well as ties to "international terrorists," and was working feverishly to develop nuclear weapons with "nuclear holy warriors." I asked John who was feeding the president all the bull about Saddam and the threat he posed us in terms of WMD delivery and his links to terrorists, as none of this was in secret intelligence I had seen in the past years. John insisted that it wasn't an exaggeration, but when pressed to say which actual intelligence reports made these claims, he would only say, "Karen, we have sources that you don't have access to." It was widely felt by those of us in the office not in the neoconservatives' inner circle that these "sources" related to the chummy relationship that Ahmad Chalabi had with both the Office of Special Plans and the office of the vice president.

The newly named director of the OSP, Abram Shulsky, was one of the most senior people sharing our space that summer. Abe, a kindly and gentle man, who would say hello to me in the hallways, seemed to be someone I, as a political science grad student, would have loved to sit with over coffee and discuss the world's problems. I had a clear sense that Abe ranked high in the organization, although ostensibly he was under Luti. Luti was known at times to treat his staff, even senior staff, with disrespect, contempt and derision. He also didn't take kindly to staff officers who had an opinion or viewpoint that was off the neoconservative reservation. But with Shulsky, who didn't speak much at the staff meetings, he was always respectful and deferential. It seemed like Shulsky's real boss was somebody like Douglas Feith or higher.

Doug Feith, undersecretary of defense for policy, was a case study in how not to run a large organization. In late 2001, he held the first all-hands policy meeting at which he discussed for over 15 minutes how many bullets and sub-bullets should be in papers for Secretary Donald Rumsfeld. A year later, in August of 2002, he held another all-hands meeting in the auditorium where he embarrassed everyone with an emotional performance about what it was like to serve Rumsfeld. He blithely informed us that for months he didn't realize Rumsfeld had a daily stand-up meeting with his four undersecretaries. He shared with us the fact that, after he started to attend these meetings, he knew better what Rumsfeld wanted of him. Most military staffers and professional civilians hearing this were incredulous, as was I, to hear of such organizational ignorance lasting so long and shared so openly. Feith's inattention to most policy detail, except that relating to Israel and Iraq, earned him a reputation most foul throughout Policy, with rampant stories of routine signatures that took months to achieve and lost documents. His poor reputation as a manager was not helped by his arrogance. One thing I kept hearing from those defending Feith was that he was "just brilliant." It was curiously like the brainwashed refrain in "The Manchurian Candidate" about the programmed sleeper agent Raymond Shaw, as the "kindest, warmest, bravest, most wonderful human being I've ever known."

I spent time that summer exploring the neoconservative worldview and trying to grasp what was happening inside the Pentagon. I wondered what could explain this rush to war and disregard for real intelligence. Neoconservatives are fairly easy to study, mainly because they are few in number, and they show up at all the same parties. Examining them as individuals, it became clear that almost all have worked together, in and out of government, on national security issues for several decades. The Project for the New American Century and its now famous 1998 manifesto to President Clinton on Iraq is a recent example. But this statement was preceded by one written for Benyamin Netanyahu's Likud Party campaign in Israel in 1996 by neoconservatives Richard Perle, David Wurmser and Douglas Feith titled "A Clean Break: Strategy for Securing the Realm."

David Wurmser is the least known of that trio and an interesting example of the tangled neoconservative web. In 2001, the research fellow at the American Enterprise Institute was assigned to the Pentagon, then moved to the Department of State to work as deputy for the hard-line conservative undersecretary John Bolton, then to the National Security Council, and now is lodged in the office of the vice president. His wife, the prolific Meyrav Wurmser, executive director of the Middle East Media Research Institute, is also a neoconservative team player.

Before the Iraq invasion, many of these same players labored together for literally decades to push a defense strategy that favored military intervention and confrontation with enemies, secret and unconstitutional if need be. Some former officials, such as Richard Perle (an assistant secretary of defense under Reagan) and James Woolsey (CIA director under Clinton), were granted a new lease on life, a renewed gravitas, with positions on President Bush's Defense Policy Board. Others, like Elliott Abrams and Paul Wolfowitz, had apparently overcome previous negative associations from an Iran-Contra conviction for lying to the Congress and for utterly miscalculating the strength of the Soviet Union in a politically driven report to the CIA.

Neoconservatives march as one phalanx in parallel opposition to those they hate. In the early winter of 2002, a co-worker U.S. Navy captain and I were discussing the service being rendered by Colin Powell at the time, and we were told by the neoconservative political appointee David Schenker that "the best service Powell could offer would be to quit right now." I was present at a staff meeting when Bill Luti called Marine Gen. and former Chief of Central Command Anthony Zinni a "traitor," because Zinni had publicly expressed reservations about the rush to war.

After August 2002, the Office of Special Plans established its own rhythm and cadence separate from the non-politically minded professionals covering the rest of the region. While often accused of creating intelligence, I saw only two apparent products of this office: war planning guidance for Rumsfeld, presumably impacting Central Command, and talking points on Iraq, WMD and terrorism. These internal talking points seemed to be a mélange crafted from obvious past observation and intelligence bits and pieces of dubious origin. They were propagandistic in style, and all desk officers were ordered to use them verbatim in the preparation of any material prepared for higher-ups and people outside the Pentagon. The talking points included statements about Saddam Hussein's proclivity for using chemical weapons against his own citizens and neighbors, his existing relations with terrorists based on a member of al-Qaida reportedly receiving medical care in Baghdad, his widely publicized aid to the Palestinians, and general indications of an aggressive viability in Saddam Hussein's nuclear weapons program and his ongoing efforts to use them against his neighbors or give them to al-Qaida style groups. The talking points said he was threatening his neighbors and was a serious threat to the U.S., too.

I suspected, from reading Charles Krauthammer, a neoconservative columnist for the Washington Post, and the Weekly Standard, and hearing a Cheney speech or two, that these talking points left the building on occasion. Both OSP functions duplicated other parts of the Pentagon. The facts we should have used to base our papers on were already being produced by the intelligence agencies, and the war planning was already done by the combatant command staff with some help from the Joint Staff. Instead of developing defense policy alternatives and advice, OSP was used to manufacture propaganda for internal and external use, and pseudo war planning.

As a result of my duties as the North Africa desk officer, I became acquainted with the Defense Intelligence Agency (DIA) support staff for NESA. Every policy regional director was served by a senior executive intelligence professional from DIA, along with a professional intelligence staff. This staff channeled DIA products, accepted tasks for DIA, and in the past had been seen as a valued member of the regional teams. However, as the war approached, this type of relationship with the Defense Intelligence Agency crumbled.

Even the most casual observer could note the tension and even animosity between "Wild Bill" Luti (as we came to refer to our boss) and Bruce Hardcastle, our defense intelligence officer (DIO). Certainly, there were stylistic and personality differences. Hardcastle, like most senior intelligence officers I knew, was serious, reserved, deliberate, and went to great lengths to achieve precision and accuracy in his speech and writing. Luti was the kind of guy who, in staff meetings and in conversations, would jump from grand theory to administrative minutiae with nary a blink or a fleeting shadow of self-awareness.

I discovered that Luti and possibly others within OSP were dissatisfied with Hardcastle's briefings, in particular with the aspects relating to WMD and terrorism. I was not clear exactly what those concerns were, but I came to understand that the DIA briefing did not match what OSP was claiming about Iraq's WMD capabilities and terrorist activities. I learned that shortly before I arrived there had been an incident in NESA where Hardcastle's presence and briefing at a bilateral meeting had been nixed abruptly by Luti. The story circulating among the desk officers was "a last-minute cancellation" of the DIO presentation. Hardcastle's intelligence briefing was replaced with one prepared by another Policy office that worked nonproliferation issues. While this alternative briefing relied on intelligence produced by DIO and elsewhere, it was not a product of the DIA or CIA community, but instead was an OSD Policy "branded" product -- and so were its conclusions. The message sent by Policy appointees and well understood by staff officers and the defense intelligence community was that senior appointed civilians were willing to exclude or marginalize intelligence products that did not fit the agenda.

Staff officers would always request OSP's most current Iraq, WMD and terrorism talking points. On occasion, these weren't available in an approved form and awaited Shulsky's approval. The talking points were a series of bulleted statements, written persuasively and in a convincing way, and superficially they seemed reasonable and rational. Saddam Hussein had gassed his neighbors, abused his people, and was continuing in that mode, becoming an imminently dangerous threat to his neighbors and to us -- except that none of his neighbors or Israel felt this was the case. Saddam Hussein had harbored al-Qaida operatives and offered and probably provided them with training facilities -- without mentioning that the suspected facilities were in the U.S./Kurdish-controlled part of Iraq. Saddam Hussein was pursuing and had WMD of the type that could be used by him, in conjunction with al-Qaida and other terrorists, to attack and damage American interests, Americans and America -- except the intelligence didn't really say that. Saddam Hussein had not been seriously weakened by war and sanctions and weekly bombings over the past 12 years, and in fact was plotting to hurt America and support anti-American activities, in part through his carrying on with terrorists -- although here the intelligence said the opposite. His support for the Palestinians and Arafat proved his terrorist connections, and basically, the time to act was now. This was the gist of the talking points, and it remained on message throughout the time I watched the points evolve.

But evolve they did, and the subtle changes I saw from September to late January revealed what the Office of Special Plans was contributing to national security. Two key types of modifications were directed or approved by Shulsky and his team of politicos. First was the deletion of entire references or bullets. The one I remember most specifically is when they dropped the bullet that said one of Saddam's intelligence operatives had met with Mohammad Atta in Prague, supposedly salient proof that Saddam was in part responsible for the 9/11 attack. That claim had lasted through a number of revisions, but after the media reported the claim as unsubstantiated by U.S. intelligence, denied by the Czech government, and that Atta's location had been confirmed by the FBI to be elsewhere, that particular bullet was dropped entirely from our "advice on things to say" to senior Pentagon officials when they met with guests or outsiders.

The other change made to the talking points was along the line of fine-tuning and generalizing. Much of what was there was already so general as to be less than accurate.

Some bullets were softened, particularly statements of Saddam's readiness and capability in the chemical, biological or nuclear arena. Others were altered over time to match more exactly something Bush and Cheney said in recent speeches. One item I never saw in our talking points was a reference to Saddam's purported attempt to buy yellowcake uranium in Niger. The OSP list of crime and evil had included Saddam's attempts to seek fissionable materials or uranium in Africa. This point was written mostly in the present tense and conveniently left off the dates of the last known attempt, sometime in the late 1980s. I was surprised to hear the president's mention of the yellowcake in Niger in his 2003 State of the Union address because that indeed was new and in theory might have represented new intelligence, something that seemed remarkably absent in any of the products provided us by the OSP (although not for lack of trying). After hearing of it, I checked with my old office of Sub-Saharan African Affairs -- and it was news to them, too. It also turned out to be false.

It is interesting today that the "defense" for those who lied or prevaricated about Iraq is to point the finger at the intelligence. But the National Intelligence Estimate, published in September 2002, as remarked upon recently by former CIA Middle East chief Ray McGovern, was an afterthought. It was provoked only after Sens. Bob Graham and Dick Durban noted in August 2002, as Congress was being asked to support a resolution for preemptive war, that no NIE elaborating real threats to the United States had been provided. In fact, it had not been written, but a suitable NIE was dutifully prepared and submitted the very next month. Naturally, this document largely supported most of the outrageous statements already made publicly by Bush, Cheney, Rice and Rumsfeld about the threat Iraq posed to the United States. All the caveats, reservations and dissents made by intelligence were relegated to footnotes and kept from the public. Funny how that worked.

Starting in the fall of 2002 I found a way to vent my frustrations with the neoconservative hijacking of our defense policy. The safe outlet was provided by retired Col. David Hackworth, who agreed to publish my short stories anonymously on his Web site Soldiers for the Truth, under the moniker of "Deep Throat: Insider Notes From the Pentagon." The "deep throat" part was his idea, but I was happy to have a sense that there were folks out there, mostly military, who would be interested in the secretary of defense-sponsored insanity I was witnessing on almost a daily basis. When I was particularly upset, like when I heard Zinni called a "traitor," I wrote about it in articles like this one.

In November, my Insider articles discussed the artificial worlds created by the Pentagon and the stupid naiveté of neocon assumptions about what would happen when we invaded Iraq. I discussed the price of public service, distinguishing between public servants who told the truth and then saw their careers flame out and those "public servants" who did not tell the truth and saw their careers ignite. My December articles became more depressing, discussing the history of the 100 Years' War and "combat lobotomies." There was a painful one titled "Minority Reports" about the necessity but unlikelihood of a Philip Dick sci-fi style "minority report" on Feith-Wolfowitz-Rumsfeld-Cheney's insanely grandiose vision of some future Middle East, with peace, love and democracy brought on through preemptive war and military occupation.

I shared some of my concerns with a civilian who had been remotely acquainted with the Luti-Feith-Perle political clan in his previous work for one of the senior Pentagon witnesses during the Iran-Contra hearings. He told me these guys were engaged in something worse than Iran-Contra. I was curious but he wouldn't tell me anything more. I figured he knew what he was talking about. I thought of him when I read much later about the 2002 and 2003 meetings between Michael Ledeen, Reuel Marc Gerecht and Iranian arms dealer Manucher Ghorbanifar -- all Iran-Contra figures.

In December 2002, I requested an acceleration of my retirement to the following July. By now, the military was anxiously waiting under the bed for the other shoe to drop amid concerns over troop availability, readiness for an ill-defined mission, and lack of day-after clarity. The neocons were anxiously struggling to get that damn shoe off. That other shoe fell with a thump, as did the regard many of us had held for Colin Powell, on Feb. 5 as the secretary of state capitulated to the neoconservative line in his speech at the United Nations -- a speech not only filled with falsehoods pushed by the neoconservatives but also containing many statements already debunked by intelligence.

War is generally crafted and pursued for political reasons, but the reasons given to the Congress and to the American people for this one were inaccurate and so misleading as to be false. Moreover, they were false by design. Certainly, the neoconservatives never bothered to sell the rest of the country on the real reasons for occupation of Iraq -- more bases from which to flex U.S. muscle with Syria and Iran, and better positioning for the inevitable fall of the regional ruling sheikdoms. Maintaining OPEC on a dollar track and not a euro and fulfilling a half-baked imperial vision also played a role. These more accurate reasons for invading and occupying could have been argued on their merits -- an angry and aggressive U.S. population might indeed have supported the war and occupation for those reasons. But Americans didn't get the chance for an honest debate.

President Bush has now appointed a commission to look at American intelligence capabilities and will report after the election. It will "examine intelligence on weapons of mass destruction and related 21st century threats ... [and] compare what the Iraq Survey Group learns with the information we had prior..." The commission, aside from being modeled on failed rubber stamp commissions of the past and consisting entirely of those selected by the executive branch, specifically excludes an examination of the role of the Office of Special Plans and other executive advisory bodies. If the president or vice president were seriously interested in "getting the truth," they might consider asking for evidence on how intelligence was politicized, misused and manipulated, and whether information from the intelligence community was distorted in order to sway Congress and public opinion in a narrowly conceived neoconservative push for war. Bush says he wants the truth, but it is clear he is no more interested in it today than he was two years ago.

Proving that the truth is indeed the first casualty in war, neoconservative member of the Defense Policy Board Richard Perle called this February for "heads to roll." Perle, agenda setter par excellence, named George Tenet and Defense Intelligence Agency head Vice Adm. Lowell Jacoby as guilty of failing to properly inform the president on Iraq and WMD. No doubt, the intelligence community, susceptible to politicization and outdated paradigms, needs reform. The swiftness of the neoconservative casting of blame on the intelligence community and away from themselves should have been fully expected. Perhaps Perle and others sense the grave and growing danger of political storms unleashed by the exposure of neoconservative lies. Meanwhile, Ahmad Chalabi, extravagantly funded by the neocons in the Pentagon to the tune of millions to provide the disinformation, has boasted with remarkable frankness, "We are heroes in error," and, "What was said before is not important."

Now we are told by our president and neoconservative mouthpieces that our sons and daughters, husbands and wives are in Iraq fighting for freedom, for liberty, for justice and American values. This cost is not borne by the children of Wolfowitz, Perle, Rumsfeld and Cheney. Bush's daughters do not pay this price. We are told that intelligence has failed America, and that President Bush is determined to get to the bottom of it. Yet not a single neoconservative appointee has lost his job, and no high official of principle in the administration has formally resigned because of this ill-planned and ill-conceived war and poorly implemented occupation of Iraq.

Will Americans hold U.S. policymakers accountable? Will we return to our roots as a republic, constrained and deliberate, respectful of others? My experience in the Pentagon leading up to the invasion and occupation of Iraq tells me, as Ben Franklin warned, we may have already failed. But if Americans at home are willing to fight -- tenaciously and courageously -- to preserve our republic, we might be able to keep it.

March 4, 2004

Criticism, skepticism surround anthrax vaccine -- BioPort defends product despite lawsuits, studies

The State News

Editor's note: This is the second part of an ongoing series on Lansing's BioPort, the nation's sole producer of the anthrax vaccine.

Lansing - BioPort Corp. executives are the first to admit that a cloud of doubt seems to linger above their anthrax vaccine. Critics relentlessly question if the Lansing-based company's product would be effective against a bioterrorist attack. Others contend the immunization is harmful to those who receive it.

Company executives, however, maintain that scientific fact and a series of medical studies vouch for the safety and effectiveness of the nation's only federally licensed anthrax vaccine.

Last week, Dennis Michael Duggan, The American Legion's deputy director of national security, testified before the U.S. House Armed Services subcommittee in Washington to raise concern about the vaccine.

Testimony centered on the health and protection of U.S. troops engaged in combat. More than 1 million troops have received BioPort's vaccine.

After acknowledging support for protecting soldiers against biological weapons, Duggan testified that "serious concerns with past problems associated with BioPort, the sole manufacturer of the vaccine, and the way adverse reactions are tracked and followed up by (the defense department) continue to worry The American Legion."

Two years ago, BioPort gained federal approval for its renovated laboratories, enabling the 5-year-old company to continue supplying the nation's stockpile of the vaccine. During the anthrax scare of 2001, BioPort was caught in a transition period as it focused on preparing its plant for approval.

In 1998, a group of investors purchased the aging facility from the state-owned Michigan Biologics Products Institute. Since 1970, the state laboratory has been the nation's only producer of anthrax vaccine.

"We have been challenged with the Internet conspiracy theories and whether or not this vaccine is safe since we've been here," said BioPort spokeswoman Kim Brennen Root, who has taken four shots of the vaccine.

"What we have to come back to is the science. The science is this vaccine."

More than 18 studies have attested to the safety of the vaccine, BioPort officials said. In 2002, the Institute of Medicine released a report certifying BioPort's vaccine was safe and effective in protecting troops from the deadly disease.

Michael Zamiara, BioPort's chief financial officer, said that study took some of the mounting pressure off BioPort to continuously defend its vaccine.

"When the Institute of Medicine report came out, that really put a lot of that to rest," said Zamiara, who has taken six shots of the vaccine. "It made our lives a heck of a lot easier."

In 2002, defense officials reinstituted their program for mandatory immunization of select troops against anthrax. Mandatory vaccine programs have been a constant source of tension in the military.

A year ago, six service members filed suit in U.S. District Court, charging that the vaccine was being used experimentally and illegally. The plaintiffs requested a preliminary injunction to stop mandatory vaccinations.

U.S. District Court Judge Emmet Sullivan granted their request on Dec. 22, ruling that the packaging of the vaccine does not specify that the product protects against inhalational anthrax.

A day after Sullivan halted the program, William Winkenwerder Jr., the assistant secretary of defense health affairs, told reporters that the safety and protection of troops is the defense department's chief concern.

"This court ruling is not supported by medical science or by medical facts," he said during a briefing in Washington. "It challenges the conclusions of America's best medical experts."

In early January, the injunction was lifted after Food and Drug Administration officials ruled that the vaccine is "safe and effective for the prevention of anthrax disease - regardless of the route of exposure."

Zamiara said the FDA decided "to use the sledgehammer on the mosquito" to quickly end the suspension of the mandatory immunization program.

Still, the final ruling does not have an impact on the ongoing litigation, and it hasn't altered opinions of some long-standing doubters of the anthrax vaccine.

"Every single study about this vaccine, except for those done by the U.S. Army, shows major problems," said Dr. Meryl Nass of Maine, an expert on bioterrorism and anthrax.

"Nobody will admit in the military that it won't do what it is intended to do."

Nass, who has studied the disease for about 15 years, said most experts agree there is a need for a new and improved vaccine to counter anthrax. BioPort currently is working to improve its product, while other companies are developing new vaccines.

Nass added, "We have solid evidence that this is a terrible vaccine."

March 2, 2004

GI Denied Health Care After Speaking Out

March 2, 2004, WASHINGTON -- An Operation Iraqi Freedom veteran says Army officials at Fort Knox, Ky., refused him medical treatment after he talked publicly about poor care at the base, which helped spark hearings in Congress.

Fort Knox officials charged that soldier, Lt. Jullian Goodrum, with being absent without leave and cut off his pay after he then went to a private doctor who hospitalized him for serious mental stress from Iraq, Goodrum said.

"They are coming after me pretty bad," said Goodrum, 33, a veteran who has served the military for more than 14 years, including the first Gulf War and Operation Iraqi Freedom.

He showed United Press International a form from Fort Knox that states that Fort Knox officials "do not want him in medical hold." Some soldiers are kept on medical hold during treatment while the Army determines their status.

Goodrum has now been hospitalized in a locked mental ward at the Walter Reed Army Medical Center in Washington, D.C. after turning himself in there Feb. 9. Doctors there say he has post-traumatic stress disorder from Iraq and major depression, and they worry he could hurt himself. He is not allowed to go down the hall from the inpatient psychiatric clinic for a Coke without an escort.

Goodrum said stress from Iraq, and the way he has been treated by the military since he returned, has made him so depressed he is lucky to be alive. He also has injuries to both wrists, in part from loading 65-pound shells on the USS Missouri when he was in the Navy in the first Gulf War. The ship pounded Iraqi troops in Kuwait and took fire from Iraqi tanks. An Iraqi Silkworm missile missed her bow by 30 yards.

Goodrum appeared in an Oct. 29 UPI (see full article below) about more than 400 soldiers on medical hold at Fort Knox who were waiting weeks and sometimes months for medical treatment.

That article, and an article on a similar situation at Fort Stewart, Ga., sparked a series of hearings in Congress -- including a Jan. 21 appearance by Col. Keith Armstrong, garrison commander at Fort Knox, before a panel of the House Armed Services Committee.

Fort Knox spokeswoman Connie Shaffery said privacy rules prohibit her from commenting on Goodrum's case, unless he signed a waiver saying otherwise. He declined. Shaffery said a soldier who does not show up for duty is absent without leave.

"If a soldier is not at his or her duty station and is not in an authorized leave or pass status, he is absent without leave," Shaffery said. "When a soldier is listed as AWOL, it stops all pay and benefits. When instructed to return and they do not comply, that is a violation."

After appearing in the UPI article on Oct. 29, Goodrum asked for medical care on or about Nov. 7. He said he told Fort Knox officials that he was having a breakdown.

"I said I was having problems. I told them I felt like I was having a breakdown right there," Goodrum said. Goodrum said Fort Knox told him to go away. A handwritten note in Goodrum's records from Nov. 7 says, "Colonel Stevens do (sic) not want this patient to be in medical hold."

Goodrum said he then drove down an interstate highway at 5 miles an hour through rushing traffic. He said he was completely dysfunctional because of a combination of PTSD and what he says was retribution from his chain of command for speaking up about poor medical care at the base. He said he could have wound up dead.

"A truck could have run right over me," Goodrum said about that day. "It was a complete nervous breakdown."

Goodrum, a member of the Army Reserve, was named the 176th Maintenance Battalion's "Soldier of the Year" in 2001. He has received a host of awards, including the combat action ribbon, and positive reviews from superior officers.

"Lt. Goodrum is a truly outstanding junior officer," reads one performance evaluation from 2002. "In addition to his technical competence, he demonstrates great leadership potential. ... Promote to captain and select for advance military schooling."

Goodrum said his problems began in Iraq, working under combat conditions in a transportation company. There, he said, safety violations -- including the use of "deadlined" or broken vehicles -- resulted in the death of a 22-year old soldier. Goodrum appealed to the Army's Inspector General and Congress when he returned home.

After Goodrum sought medical help at Fort Knox on Nov. 7 and was denied, Goodrum's civilian doctor hospitalized him for PTSD and alerted Fort Knox.

Dr. Vijay Jethanandani wrote Fort Knox Nov. 15 that Goodrum needed medical leave until Dec. 7. The doctor kept officials there up to date on Goodrum's condition in a series of five letters.

"Unfortunately, recent intimidation, threats of being arrested for staying on medical leave from his superiors has resulted in recurrent psychiatric symptoms," Jethanandani wrote Dec. 3. "Until 11/26/03, Mr. Jullian Goodrum was progressing fairly well."

"It does not help that Mr. Goodrum was in combat with a unit in Iraq, where a superior officer ignored safety protocol jeopardizing the safety of soldiers and resulting in the death of one man," Jethanandani wrote. "Instead of following up on his complaints, it appears that some of his superiors on stateside may be penalizing him for reporting his superior officer in Iraq."

In the wake of the Fort Stewart and Fort Knox stories, last fall Undersecretary of Defense David S.C. Chu ordered that if medical care is not available on base, "medical commanders shall promptly refer patients to other military, Veteran Affairs, or civilian sources of care."

Goodrum said he showed Chu's memo to Fort Knox officials, but it did not help. "I told them they were ignoring an order from the undersecretary of Defense," Goodrum said.

Goodrum's medical files shows that Walter Reed medical staff also have been unable to get Fort Knox medical officials to discuss his case. "Patient is currently assigned to the medical hold company in Fort Knox, Ky., and to a Capt. Savage. Capt. Savage has NOT returned any phone calls from this office," his record states.

Soldiers at Fort Knox contacted UPI about another situation they consider a sign of poor care.

On Feb. 11, a soldier on medical hold at Fort Knox who served in Iraq apparently attempted suicide in the barracks. He was attached to a Special Forces unit in Iraq.

Soldiers there said he deeply slashed both of his wrists, spraying blood in the barracks hallway and around his room before being rushed to the hospital.

"If it was not for about three guys, if they had not applied direct pressure and immediate pressure, he would have died," said a soldier at Fort Knox who knows him.

Soldiers said they worry that Army officials did not act aggressively to address his problems, including heavy drinking, that appear to have surfaced since Iraq.

Shaffery said she could not comment on that case, either. "We are sensitive to psychiatric or suicide issues with all of our population," she said.

March 1, 2004

BioPort to sell anthrax vaccine to Taiwanese government

Associated Press

BioPort Corp., the nation's lone source for the anthrax vaccine, will supply it to the Taiwanese government to immunize its troops, a company official said.

Kim Brennen Root, a spokeswoman for the Lansing-based company, said the sale
of the vaccine was finalized in December.

Prior to the sale, its lone customer was the U.S. Department of Defense, which has used the anthrax vaccine to immunize more than 1 million troops.

In January, BioPort was awarded a $245 million contract to continue supplying the vaccine for the Department of Defense.

"Anthrax is a weapon of mass destruction that could be used by terrorists,
and that is a concern all over the world," Root told The State News (East Lansing). "Based on that, we have interest expressed by several friendly foreign nations for the anthrax vaccine primarily for their militaries."

Root said BioPort executives are "working aggressively on leads with five other countries." She declined to specify which nations have expressed interest because negotiations are ongoing.

Jack Kuei, a spokesman for Taiwan's Embassy in Washington, said Sunday it
would take up to two days for officials in Taipei to confirm the sale.

BioPort would not release the cost of the sale to the Taiwanese government.

BioPort's licensing by the Food and Drug Administration permits the company
to distribute the vaccine to clients other than the U.S. government.

The company is required to notify the FDA of any sales.

"We have a priority in terms of supplying the vaccine for protection of the U.S. military," Root said. "At the same time, we believe there is a global market for this vaccine."

The sale to the Taiwanese government comes while the company has fought to
establish the safety of the vaccine.

In December, a U.S. District Court judge suspended the Department of Defense's immunization program after six people filed a lawsuit, claiming the vaccine was unsafe. By early January, the suspension was lifted and the vaccination program was reinstated, despite ongoing litigation.

Military Vaccine Flattens GI, 17

CBS News

(CBS) Amid all the war stories that have come out of the conflict with Iraq, Tyran Duncan's hasn't been widely told. The willing soldier became an unwitting victim to the vaccinations he was required to take to deploy. And as CBS News Correspondent Sharyl Attkisson reports, he's not the only one.

Tyran Duncan was just 17 - Number "45" at Monterey High in Tennessee - when he signed up for the Army.

"I was excited," says Duncan. "I mean it's always been my lifelong dream to go into the military and, you know, be a soldier."

At boot camp, he eagerly lined up for vaccinations, including flu and anthrax.

"They gave us, I'd say, seven shots … at one time," he says.

First he got a rash, then flu symptoms.

"It got to where I couldn't walk at all," he says. "I couldn't even hold my glass up with both hands to take a drink out of it.

"Basically they accused me of faking it."

But Duncan wasn't faking. Within days, he was paralyzed, on a respirator and certain he'd die, until his grandmother who raised him came to help.

"There was nothing wrong with him when they got him," says Duncan's grandmother Faye Harville. "It had to be the vaccines. I'll never see it another way."

Rehabilitation video chronicles his difficult fight back. At one point last January, he weighed 96 pounds.

Months after his paralysis hit, he was finally back at home, but he still couldn't feed himself or put on his shoes.

Today, he remains unsteady, and muscle and joint pain are constant companions.

Duncan's paralysis was diagnosed as Guillain-Barre Syndrome, which is clearly listed under "adverse reactions" on the anthrax vaccine label.

But soldiers don't get to see that vaccine label when they get their shots. And the Pentagon publicly claims there are no long-term adverse events from the anthrax vaccine. So soldiers may end up misdiagnosed, then discharged with serious illnesses.

Incredibly, Duncan has been listed as "active duty" all this time, meaning the Army has yet to process his medical case or decide on compensation.

"Looking back on what I used to be and what I am now, it's heartbreaking," says Duncan.

But without the military career and questionable health, looking ahead can be even harder than looking back.