July 26, 2005

FDA Extends Authorization for Anthrax Vaccinations

Global Security Newswire

The U.S. Food and Drug Administration will allow voluntary vaccinations of military personnel to continue at least until early 2006, FDA Commissioner Lester Crawford stated Friday (see GSN, July 7).

The agency's emergency use authorization for Anthrax Vaccine Adsorbed is to be maintained for the duration of the Defense Department's emergency declaration, Crawford wrote in a letter to Assistant Defense Secretary William Winkenwerder Jr. The declaration is scheduled to expire on Jan. 14, 2006.

Winkenwerder requested the extension on July 11 "for such time as necessary pending the upcoming FDA re-determination of the licenses use of AVA for protection against inhalational anthrax."

The agency to date has certified the vaccine as effective only for use against anthrax infection contracted through skin contact. The voluntary program began after a federal judge ruled last year that the Pentagon could not require military and civilian personnel to be vaccinated (U.S. Food and Drug Commissioner Lester Crawford letter, July 22).

July 25, 2005

Anthrax vaccine under fire. Refusal rate concerns military; troops speak out

The Star's Washington Correspondent

WASHINGTON –– Shonya McBride remembers very clearly the night she rolled over in her sleep and her hand fell across her husband's chest. She awoke with a start. "His heart was just pounding out of his chest," she said. That was in 1999, after Travis McBride, a 22-year-old Marine Corps sergeant, had received the second of six mandatory inoculations of the anthrax vaccine.

By the fourth shot, he had developed serious heart problems, chronic fatigue and severe joint pain. McBride never made it to the fifth. Within a year, he was medically discharged.

He had been ordered to take the shots, like probably hundreds of military men and women who believe the vaccine boomeranged and made them seriously ill.

"If I had had the option, I wouldn't have taken it," said McBride, now 28 and an Atchison County sheriff's deputy.

For the past two months, however, incoming military personnel have had the option of not taking the anthrax vaccine, as a result of a federal lawsuit won last year by some military personnel who objected.

For now, instead of being threatened with courts-martial and dishonorable discharges, soldiers are told the shots are voluntary.

As a result, half of the military and civilian Defense personnel asked since May to take the shots have declined, according to the Pentagon.

The refusal rate worries the military, which many believe would like to reinstate the mandatory rule for all active duty personnel and reserves.

"That means that half of our (newest) troops could be harmed in an enemy attack and possibly die," said Marianne Coats, a spokeswoman for the Military Vaccine Agency. "This concerns us very much indeed."

Vaccine critics said the situation is an improvement.

Mark Zaid, an attorney involved in the lawsuit, said that much progress has been made since the days of military courts-martial, but added that it remains subjective whether the vaccine being voluntary is a good thing.

What concerns Zaid and other critics is that the anthrax information brochure that the military hands out contains none of the information that comes packaged with the vaccine about risks and medical reactions possibly linked to it.

Beyond the more common nausea, fever and chills, other medical problems possibly linked to the vaccine, according to the manufacturer's insert, include multiple sclerosis, encephalitis, leukemia, blood clots, nervous system disorders, lymphoma and immune deficiencies.

"The Defense Department does not wish for troops to even know the dangers explained on the vaccine's own label," Zaid said.

Col. John Grabenstein, director of the Military Vaccine Agency, said in an e-mail response to a series of questions that since 1998, the military has provided "detailed educational programs" to explain the anthrax vaccine.

The Pentagon and the Food and Drug Administration insist that the vaccine, which has been given to about 1.3 million military and some civilian personnel since 1998, is safe and effective.

Citing a 2002 National Academy of Sciences study, Grabenstein said that the anthrax vaccine posed no greater risk of serious health problems than any other vaccine.
But some former soldiers, outside experts, military activists and other supporters do not think that is accurate.

Former Master Sgt. Dennis Brewster of Augusta, Kan., was diagnosed with an array of medical ailments after the shots, including chronic, widespread joint pain, chronic headaches, chronic fatigue and irritable bowel syndrome.

"I knew how I was before the shot, and I got the shot and I know what happened to me," he said.

No informed consent

The anthrax vaccine has been controversial almost from the beginning.

The FDA licensed it in 1970, but only for anthrax exposure through the skin because the disease was largely confined to the livestock industry.

No human testing of its effectiveness had been done. The testing that was performed, in 1962, was on a different version of the vaccine. The manufacturing process had changed by 1970 when it was licensed.

The vaccine was never approved to protect against anthrax inhalation, which is how troops would encounter the toxin on the battlefield and why the military forced soldiers to be vaccinated.

Still, the Pentagon used it to vaccinate certain units against anthrax before the 1991 Gulf War because of fears that Iraq had biological weapons. Since then, researchers at Kansas State University have found a possible link between the vaccine and the series of mysterious maladies known as Gulf War Syndrome experienced by many veterans of that conflict.

In 1997, as concern heightened about troops deployed to the Persian Gulf and Korean peninsula, the Pentagon made the vaccine mandatory. The regimen was a series of six doses over 18 months, with annual boosters.

The threat of anthrax as a battlefield weapon is probably greater in North Korea than anywhere else, according to Jonathan Tucker, a chemical and biological weapons expert at the Center for Nonproliferation Studies at the Monterey Institute for International Studies.

"I'm not familiar with any evidence that the (Iraq) insurgency or the Taliban has access to anthrax," he said. "North Korea is assessed to have a biological weapons program, and anthrax would probably be an agent in its arsenal."

Meanwhile, the sole manufacturer of the vaccine, the BioPort Corp. of Lansing, Mich., has been cited several times by the FDA for quality control problems.
The military shut down the vaccine program last fall when a federal judge ruled in favor of six anonymous former and current Defense Department employees who alleged that the vaccine was being used in a way for which it had not been licensed and should not be forced on anyone.

The government has appealed the ruling. In the meantime, the Pentagon began the voluntary inoculations in May under an emergency-use authority, citing a high bioterrorist threat.

`Blind eye' alleged

Six years after taking the vaccine, McBride's heart problems shadow his family's every move. When he takes his 5-year-old son fishing, he and his wife make sure the child remembers how to dial 911 in case his father has a problem.

At the time, refusing the order to take the vaccine wasn't an option. He loved being a Marine and hoped to make a career out of it.

"I was an enlisted serviceman," he said. "I was told to jump; you asked, `How high?' I was just doing what I was ordered."

So was Army Sgt. Sandra Larson of Spokane, Wash. In 2000, three months after receiving her final shot while assigned to Fort Riley, Kan., she died of a rare blood disorder at the age of 32.

"It was as if there was something in her that was killing her immune system, shutting her down," her sister, Nancy Rugo, told a congressional committee after her death.

Between 1990 and 2004, 16 people died after taking the vaccine, according to the government's Vaccine Adverse Event Reporting System. Most suffered heart, lung and immune system problems, and cancer.

All but five were dead within three months of their last vaccination. In addition, the reporting system shows that nearly 4,500 other recipients have had medical reactions, with nearly 8 percent listed as "serious," meaning the problems were life-threatening, required hospitalization or resulted in a major disability.The reports are submitted by vaccine recipients and providers, relatives, health-care givers and others, but are not necessarily inclusive of everyone who has had a reaction.

The Institute of Medicine, a division of the National Academy of Sciences, called the vaccine reporting data "useful as a sentinel for adverse events." But it cautioned that the reports might be "underreported, incomplete, or duplicative," and that the claims are not always verified by medical officials.
Grabenstein said that anyone who becomes sick after a vaccination "deserves the best care we can give them, whether a vaccine is the cause of their health problem or not."

But Meryl Nass, a Maine internist and leading critic of the vaccine, said the military had turned "a blind eye" to the risks. She has examined numerous vaccine recipients with serious illnesses, including several who served in the Kansas Air National Guard.

"The people who become disabled more often than not have multiple diagnoses," Nass said. "They also, more often than not, have syndromes that are rare or nonexistent in the patients that doctors normally see. Their bodies are not doing what they're supposed to be doing."

Leaving the big B-1 behind

Worries began to seep through the military ranks within two years of the start of the vaccine inoculations.

Pentagon reports show that between 2000 and 2004, 149 service members refused the vaccine.

Some were court-martialed for refusing an order and given bad conduct discharges. About a dozen cases are in stages of appeal.

In a 2002 study, the General Accounting Office surveyed Air National Guard and Air Force Reserve aircrews and found that 16 percent of more than 800 airmen who responded had either transferred, become inactive or left the service between 1998 and 2000 to avoid the shots. An additional 18 percent said they planned to leave soon.

The GAO, now known as the Government Accountability Office, also found that about 84 percent of the pilots and crew members who took the vaccine during that period experienced side effects or adverse reactions, a rate more than double what the manufacturer claimed at the time.

In addition, the study found that about 24 percent of those reactions were systemic — meaning that they affected their entire bodies. That was "more than 100 times higher" than what the manufacturer estimated, the GAO said.

The military ordered former Maj. David Towne, who flew for the 128th Bomb Squadron of the Kansas Air National Guard, to take the shot in 1999. Towne was torn because he loved flying the big B-1 bombers, but worried about developing health problems and jeopardizing his civilian career as a commercial pilot.

"I wear a bicycle helmet, I wear my seat belt. I just decided it was not worth it for me to take it," he said. "They told me I was unpatriotic and would regret this for the rest of my life. They questioned my integrity."

Towne, who is 39 and now lives in Ohio, offered to resign but received a general discharge instead. He has appealed.

"These are people who volunteer their lives and livelihood to protect America," said Peter Martuscello of Wichita, a 57-year old former Kansas Air National Guard technical sergeant who was medically discharged after taking the vaccine. He developed Guillain-Barre Syndrome, an immune disorder, and other problems.

"To dump on people like that is crazy," Martuscello said. "That's the sad part. They gave you no option."

And no information on possible risks, according to several former soldiers who took the vaccine and became ill.

Brewster said that when his unit in the 184th Bomb Wing of the Kansas Air National Guard got a briefing about the vaccine in June 1999, "They didn't tell us about any risk. They gave us the basic standard speech," he said. "They said there was some talk out there, but it was all Internet hype."

A week after receiving the first shot, Brewster started feeling like he had the flu. Then a powerful fatigue came over him. His ankles, knees, shoulders, elbows and hands all began to hurt. He also got severe headaches. By the fourth shot, his health had further deteriorated. He was in and out of the hospital for intestinal surgery and heart problems. He also became hyperallergic.

Brewster retired in 2001 under honorable conditions after 23 years of service. He has a one-man home remodeling business that allows him to take time off when he's feeling badly and runs out of energy. He sleeps a lot.

"A lot of the guys hid the illness and still are," said Brewster, who had been a full-time civilian employee of the Guard, in addition to his military service. "Had I not ended up in the hospital, I probably would have tried to hide mine."

The anthrax vaccine, he said, "cost me my career."

Anthrax timeline

1970: FDA approves vaccine for skin exposure
1991: Military gives vaccine to some troops in the first Gulf War
1997: Pentagon orders vaccine mandatory for all military personnel 1998: Congress passes law requiring informed consent if troops are given drugs unapproved for their intended use
1998-99: FDA finds quality-control problems at vaccine plant
2000: Sgt. Sandra Larson takes final anthrax shot at Fort Riley, Kan. Larson dies three months later.
2000: Institute of Medicine concludes vaccine is safe
2000: Federal judge stops mandatory shots.
2005: Voluntary vaccine program begins

Acambis Begins Phase II Trial of Smallpox Vaccine

Global Security Newswire

The U.S.-U.K. pharmaceutical company Acambis earlier this month began a phase II trial of its experimental MVA 3000 smallpox vaccine (see GSN, May 6).

The trial will test the safety and production of immunity of three different dose levels of the drug, the company said in a press release. Results will enable Acambis and partner Baxter Healthcare SA to choose a dose of the vaccine for continued clinical testing.

The trial will involve 700 volunteers at 10 U.S. locations, the company said.

The modified virus Ankara vaccine would be used for people who could suffer reactions to the existing vaccine. That includes patients with suppressed immune systems or those with the skin condition eczema (Acambis release, July 14).

Troops divided on getting voluntary vaccine shots

AF Times
By Deborah Funk, Times staff writer

About half of the service members and civilian workers offered anthrax vaccinations under the Pentagon’s temporary, voluntary program are accepting the shots — and the other half are saying, “No, thanks.”

“We wish it was higher, because that’s about 50 percent [who are] vulnerable,” said Army Col. John Grabenstein, director of the Military Vaccine Agency.

Roughly 20,000 military members have been offered the vaccine since the government launched its voluntary program May 19. Of those, about half accepted vaccination.

Some people already have been vaccinated more than once under the voluntary program, Grabenstein said. The anthrax vaccine license requires six shots over 18 months, with the first three administered two weeks apart. Annual booster shots also are given.

To avoid identifying areas of vulnerability, defense officials would not provide data by service, occupation or other breakdowns on who is accepting or declining vaccination.

Grabenstein said troops who received shots under the mandatory program are more likely to volunteer under this program so they can continue the vaccination series. Conversely, people who never were vaccinated against anthrax are more likely to decline the shots.

The participation level may reflect the rare opportunity service members have to make choices while in the military, and some may decline the shot “just for the taste of liberty,” Grabenstein said.

Some may decline it because they dislike the idea of getting the shots or have no experience with the anthrax vaccine, he said.

The government launched its voluntary program after six service members and civilian employees successfully sued the government to stop the mandatory program that began in 1998. A federal judge ruled that the vaccine was not properly licensed to protect against the inhalation anthrax and, therefore, the government could not force service members to take the shots for that purpose.

Justice Department lawyers who represent the government have appealed the judge’s ruling. The plaintiffs have until the end of July to file a response to the appeal.

Meanwhile, the voluntary program is permitted under an “emergency use authority” that allows wide-scale use of drugs that are not licensed or are licensed for a purpose other than their intended use.

In this case, anthrax vaccine is licensed to protect against the form of the disease that infects the skin, not the inhalation form. The emergency use authority granted by the Food and Drug Administration requires the Pentagon to allow service members to decline the shots without fear of career, administrative or legal risk.

Grabenstein said there have been “zero” punishments for service members who have not volunteered for the new program.

Mark Zaid, a Washington attorney who represents the six plaintiffs in the lawsuit, said he believes even more people would decline the shots if military members did not have a strong mentality to follow orders.

“When it was mandatory, it was a loyalty program by the senior leadership for no one to challenge the implementation,” Zaid said. “As a voluntary program, it still remains a loyalty program for those who may be recipients. I have little doubt that many people are taking it on faith that ‘if the leadership said it is good, that’s what I’m going with.’”

Zaid said he suspects defense officials have downplayed information that contradicts their position that the vaccine is safe and effective.

Troops who will be in South Korea or in the Central Command area of operations — mainly Southwest and Central Asia — for at least 15 consecutive days are offered the shots. Under the old program, if they refused, they had no choice without risking legal or administrative action.

Meanwhile, the FDA is reviewing public comment it has solicited on the vaccine’s license. The agency’s previous failure to do that was the omission upon which the federal judge based his decision to shut down the mandatory program.

The FDA has said the vaccine is safe and protects against inhalation anthrax, and wants to license it as such.

Defense officials will “revisit the question” of whether to resume the mandatory program after the FDA issues its final ruling on the vaccine’s license, Grabenstein said.

Anthrax inoculation extension sought

By Deborah Funk
Times staff writer

The Pentagon may continue its voluntary anthrax vaccination program for about another six months, until Jan. 14.

The Food and Drug Administration on July 22 extended the “emergency use authority” it granted the Defense Department in January that allows the military to use the vaccine for a purpose other than for which it is licensed. The new authority expires one year from the date that then-Health and Human Services Secretary Tommy Thompson declared an “emergency” that justified the use of the vaccine, the first such emergency declared under a relatively new provision of federal law.

A federal judge ruled last fall that anthrax vaccine was licensed to protect against an anthrax infection of the skin, but was not licensed for protection against inhalation anthrax, the form of the disease that the Pentagon says is a germ warfare threat to U.S. forces.

The judge’s ruling put an end to the Pentagon’s seven-year-old mandatory anthrax vaccination program, but the Pentagon was allowed to resume vaccinations under a provision in federal law that allows drugs to be used on a large scale for purposes other than what their license permits. In granting the permission, however, FDA said the program had to be voluntary rather than mandatory, and troops cannot be punished in any way for declining the shots. Under the old program, troops who refused risked legal or administrative action.

Since the first shots under the voluntary program were offered in May, the response has been muted, with about half of the troops and civilians accepting the vaccine, and the other half rejecting it.

The vaccine is offered to troops and civilian workers who will be in South Korea or in the Central Command area of operations — mainly Southwest and Central Asia — for at least 15 consecutive days.

Meanwhile, the FDA is reviewing public comments in considering whether to license the vaccine to protect against inhalation anthrax, an intention the agency announced earlier this year.

July 15, 2005

Soldiers Pushed to Discharge before Medical Needs Met

The battle after the battle

LES BLUMENTHAL; The News Tribune

The day before his 22nd birthday, a bomb hanging from a tree along a road near Fallujah exploded above Rory Dunn’s Humvee. Dunn’s forehead was crushed from ear to ear, leaving his brain exposed. His right eye was destroyed by shrapnel; the left eye nearly so. His hearing was severely damaged.

“I remember a bright flash. The trees lit up, and the Humvee was shaking,” Dunn recalled during a recent interview while curled up in an easy chair in the living room of his mother’s Renton home.

Within minutes of the May 2004 explosion, he was strapped on a stretcher and flown by helicopter to a hospital in Baghdad – the first step in his 10-month struggle to recover.

Yet, even as Dunn fought to overcome his traumatic brain injury and other wounds, his mother, Cynthia Lefever, fought the Army to ensure her son continued to receive critical care from Army specialists. Lefever said the Army tried to pressure her son into accepting a discharge before he was ready – pressure other severely wounded soldiers say they’ve experienced, too.

Lefever and other critics say the Army’s medical system, particularly Walter Reed Medical Center in Washington, D.C., has been overwhelmed by the number of wounded returning from Iraq and Afghanistan. They accuse the Army of attempting to discharge wounded soldiers before their essential medical needs are met and transfer them to Veterans Affairs medical facilities.

“The Army tried to get rid of him,” Lefever said. “It was immoral and unethical. The Army owes these kids.”

Army officials deny they’re taking advantage of wounded soldiers.

“There are no efforts to ‘rush’ anyone out of the Army or through medical treatment and the disability system,” Col. Dan Garvey, deputy commanding officer of the Army’s Physical Disability Agency, said in an interview via e-mail.

Soldiers are discharged if they no longer can “adequately perform” their assigned duties and have received “optimum medical care,” Garvey said. The process is subjective and can last months or more than year, he said, but soldiers are informed of their rights and can appeal.

“There must be a balancing act, and the system tries very hard to maintain that,” Garvey said.

The issue has attracted attention in Congress and among veterans groups.

John Fernandez, a 27-year-old retired 1st lieutenant from New York who lost part of each leg in Iraq, told the Senate Veterans Affairs Committee this spring the Army tried to discharge him before he received the medical care he was entitled to.

Sen. Patty Murray (D-Seattle), a member of the committee, said she heard similar stories from other wounded soldiers and their families.

“I think (the Army) underestimated the number of wounded. No one predicted this,” Murray said. “I don’t know whether they are overcrowded or just trying to cut costs. No one is talking about it.”

Clinging to life

Doctors initially gave Rory Dunn little chance of survival.

As he clung to life in the Baghdad hospital, they glued his left eye back into its socket and placed him in a deep medical coma to ease brain swelling. Five days later, Dunn was flown to a hospital in Germany, where his family had gone on “imminent death orders” to say their goodbyes. If he lived, they were told, he might need full-time care for the rest of his life.

Almost six weeks after he was wounded, Dunn emerged from his coma at Walter Reed, where he had been transferred. Days later, Lefever said, the Army asked her son to begin the discharge process. She objected.

During the coming months, before his skull was rebuilt, before a cornea transplant, before speech and physical therapy, the Army made at least three attempts to get her son to accept a discharge, Lefever said. In one instance, she said a top medical officer showed up in her son’s room in Ward 58, the neuroscience ward at Walter Reed, and said Dunn needed to immediately sign papers formally starting the discharge process.

“We all understood he couldn’t return to the Army, but he hadn’t even started his treatment,” Lefever said, adding that her son had just emerged from his coma.

In the fall of 2004, roughly five months after he was wounded, Lefever said her son was told to attend a meeting without his mother. During the meeting , which Lefever insisted on attending, Dunn was given three days to sign papers starting the discharge process or the Army would do it without his authorization. At that point, Dunn had not received the surgery that would rebuild his forehead.

“I felt bullied,” Lefever said.

During a six-week period stretching into February, Lefever said the Army stepped up the pressure, at one point offering to send her son to a hospital in Palo Alto, Calif., that specializes in traumatic brain injuries – but only if he first agreed to a discharge.

“I was disgusted,” Lefever said.

Though Dunn wanted out, Lefever said he wasn’t ready and felt the Army was trying to play her son off against her. In phone calls and in meetings, Lefever said her son was repeatedly told that his discharge was “none of his mom’s business.”

“Rory left his right eye, his forehead and his blood in the dirt in Iraq because the Army sent him there,” Lefever said in one e-mail to medical officials at Walter Reed. “Rory went and did his job as ordered by the Army, and deserves so much better than to sit and wait … depressed, angry, frustrated and contemplating suicide. Rory deserves the opportunity to ‘come back’ 100 percent both physically and mentally.”

Feeling overwhelmed, Lefever said she sought assistance from a veterans group, Disabled Veterans of America, as well as Sen. Murray’s office. The veterans group assigned an advocate named Danny Soto to Dunn’s case.

Soto said lots of soldiers feel they’re being “pushed out the door.” He blames the military for failing to adequately explain to the families of wounded soldiers that there will be a “continuity” of medical care after discharge.

After a series of meetings involving Dunn, Soto, a Murray aide, Lefever and Army officials, an agreement was reached that allowed Dunn to be sent to Palo Alto for treatment, then accept a discharge.

“All I wanted was the best for my son,” said Lefever, who made her feelings known to a string of Army officials, including generals at the Pentagon and then-Deputy Secretary of Defense Paul Wolfowitz.

Lefever’s fight wasn’t unique.

‘I felt I was being rushed’

Fernandez, the retired 1st lieutenant, was injured in a friendly fire incident in Iraq in April 2003. His right leg was amputated below the knee, as was his left foot. He was fitted with eight prosthetics before he found ones that were comfortable.

A graduate of West Point, where he captained the academy’s lacrosse team, Fernandez studied the regulations and was able to “push back” and fend off the discharge for months.

“I had to fight to stay on duty,” Fernandez said, adding he didn’t want to be discharged until the Army provided him with the care he felt he deserved.

“A private just out of high school who doesn’t know his rights might just go with the flow,” he said. “You are dealing with injuries that will affect you and your family for the rest of your life. It’s an emotional time. Then you get overwhelmed with all this information.”

Former Staff Sgt. Jessica Clements of Canton, Ohio, suffered a traumatic brain injury when a bomb – the military calls them “improvised explosive devices” – detonated while she was riding in a convoy near the Baghdad airport. To relieve brain swelling, Clements said, a neurosurgeon at the Baghdad hospital clipped off a piece of her skull and temporarily inserted it into her belly for safe keeping.

“I could feel it,” said Clements of the piece of skull stored in her belly for four months before it was removed and reattached.

As she lay in a bed at Walter Reed, Clements said, she received repeated telephone calls from an Army official telling her she needed to start the discharge process.

“I had no idea what was going on,” she said in an interview. “It was only two months after I was injured. I felt I was being rushed. My skull was in my stomach, and I was doing eight hours of therapy a day. It was very frustrating.”

Panel reviews each case

Army officials won’t comment on individual medical cases, but they say they try to be sensitive when discharging seriously wounded soldiers.

“We get complaints and criticisms of the process not infrequently,” said Col. James Gilman, head of the Walter Reed Health Care System. “We get complaints it takes too long and we get complaints it goes too quickly. Our goal is to take care of the soldiers.”

When it becomes apparent a wounded soldier won’t be able to return to active duty, a medical board made up of Army physicians reviews the case. The medical board review can’t be completed until it’s decided the wounded soldier has received “optimal medical care,” said Gilman. And that’s the tricky part.

“It can be very subjective,” Gilman said, adding the medical boards have some flexibility. “We don’t just follow the regulations blindly. It’s not a one-way street.”

The findings of a medical board are turned over to a Physical Evaluation Board, part of the Army’s Human Resources Command, which ultimately decides whether a soldier stays on active duty or is discharged, and what percentage of disability a soldier receives.

Some 11,300 U.S. military personnel have been evacuated due to injuries or illness since hostilities began in Afghanistan and Iraq in October 2001. Of those, 740 had been discharged as of last week, according to the Army.

Medical advances help reduce the number of deaths in wars. With more soldiers surviving near-fatal wounds, hospitals are overburdened.

Gilman said Walter Reed, where many of the wounded are initially treated when they return to the United States, has been swamped at times.

“The installation was not built to handle all the outpatients we have now,” Gilman said.

A hotel on the hospital grounds for soldiers receiving outpatient care and their families is mostly full. Some outpatients are housed at nearby hotels or government-leased apartments.

Other Army medical facilities also feel the strain, including those in the South Sound.

Barracks at Fort Lewis have been upgraded to include, among other things, wheelchair-accessible quarters to house wounded soldiers treated as outpatients at Madigan Army Hospital, the General Accountability Office told Congress earlier this year.

Veterans organizations say they are aware that the military medical system is stretched.

“It’s obvious when you go to Walter Reed,” said Cathy Wiblemo, the American Legion’s deputy director for health care. “They are running out of room.”

Wiblemo said she has no specific knowledge that the Army has moved to discharge wounded soldiers too quickly. But she said she wouldn’t be surprised.

“The Army’s medical bills are going up, and it’s encroaching on other things they have to pay for,” she said.

Murray: Dunn’s case ‘one of many’

Dunn, Fernandez and Clements have been discharged and are being treated at VA facilities or through the military’s Tri-Care System, a health plan that covers military personnel, dependents and retirees.

Murray, who has taken a personal interest in Dunn’s case and awarded him his Purple Heart in June, said she has talked with soldiers who feel the Army has tried to “push them out.”

“Rory Dunn is just one of many,” Murray said. “It strikes me as amazing that Rory needs an advocate in the U.S. Senate. He shouldn’t have to go through this.”

As Dunn’s physical scars fade, the emotional ones linger, as do the memories of that day outside Fallujah a year ago.

“It got me, boy did it get me,” Dunn said of the explosion. “The last thing I remember was stumbling around shouting, ‘Charge, charge,’ and my buddies trying to get me to sit down.”

Though his forehead has been rebuilt, Dunn covers it with a purple baseball cap that says “Combat Wounded” and has the symbol of a purple heart. With thick glasses, he can see out of his left eye. With hearing aides, he can hear.

Lefever said she was surprised when her son joined the Army about a year after high school. She remembers him as a good student who played football and basketball. She said he also had a rebellious streak and was sort of a “cowboy.”

Dunn just shrugs when asked why he joined and later volunteered for duty in Iraq.

“It was a terrible, terrible mistake,” he said. “I was a fool.”

Dunn fidgets as he talks. His attention span is short. He ducks out for a cigarette and to play with his dog Duke, a 6-month-old German shorthair. His memory is intact, as is his sense of humor. He remembers the name of the girl he took to the senior prom. He’s looking forward to getting his own apartment and a driver’s license.

He’s also angry and impatient.

“I feel better, but I wish I could get on with my life,” he said. “I lived in hospitals and rehab for a year. It was the worst thing I ever had to go through.”

Lefever said she refused to give up until her son received the care that she says Army regulations require.

“I remain angry and disgusted with them for certain things, but I am eternally grateful to them for other things,” she said.

Col. Gilman of Walter Reed said he remembers spending a lot of time with Lefever and her son.

“We are grateful for the families who are interested. The mothers, fathers, brothers and sisters,” he said. “The ones who worry me the most are the ones whose families aren’t involved.”

Drug Firms Say U.S. Slow to Buy WMD Countermeasures

Global Security Newswire

Drug company officials told a U.S. House of Representatives committee yesterday that the federal government was not moving fast enough under the Project BioShield law to stockpile WMD countermeasures, Reuters reported (see GSN, July 14).

BioShield, passed in 2004, provides $5.6 billion over a 10-year period for countermeasure contracts, Reuters reported.

“It's not being implemented the way it had been written,” Hollis-Eden Pharmaceuticals’ Chief Executive Officer Richard Hollis told the House Government Reform Committee yesterday. “Companies such as ours were supposed to be getting advance contracts.”

He said delays by the Health and Human Services Department have caused his company, which is working on a radiation countermeasure, to lose $600 million.

“We need not only a better BioShield but also a system that can deliver the best possible public response to emergencies,” said Representative Henry Waxman (D-Calif.). “The United States is unprepared for a flu pandemic which could claim as many as 500,000 American lives. We have not purchased the antiviral medications we need.”

“Only a handful of states have the capacity to deliver essential medications and vaccines. There is no point having a new anthrax vaccine or nerve gas antidote if the people whose lives are at risk cannot get treatment in time,” Waxman added.

However, Bush administration officials defended their efforts to procure countermeasures. Stewart Simonson, assistant secretary for public health emergency preparedness at the health department, said his agency has been working with a “genuine sense of urgency.”

“No matter how hard we try, some steps in the process cannot be rushed,” he said. “I know it doesn't always seem satisfactory to the industry.”

John Vitko, director of biological countermeasures at the Homeland Security Department, said preparedness has increased dramatically since the 2001 anthrax attacks. He said smallpox and anthrax vaccines have been stockpiled with plans to add additional countermeasures in the works.

“We are substantially better prepared than we were in October of '01,” Simonson said.

Senators Orrin Hatch (R-Utah) and Joseph Lieberman (D-Conn.) plan to introduce BioShield II legislation to fill gaps in the 2004 BioShield law, Reuters reported (Maggie Fox, Reuters, July 14)

Pentagon Officials Admits U.S. Error in “Overemphasizing” Iraq’s WMD Capabilities Before War

Global Security Newswire

A top U.S. Defense Department official has conceded that the Bush administration oversold Saddam Hussein’s WMD capabilities in justifying the U.S.-led invasion of Iraq, the Associated Press reported today (see GSN, June 29).

“I don't think there is any question that we as an administration, instead of giving proper emphasis to all major elements of the rationale for war, overemphasized the WMD aspect,” said Douglas Feith, a high-ranking policy adviser to Defense Secretary Donald Rumsfeld.

“Our intelligence community made, apparently, an error, as to the stockpiles” of weapons in Iraq, Feith said. “Anything we said at all about stockpiles was overemphasis, given that we didn't find them.”

Still, Feith defended the decision to invade Iraq but, “It would have been better had we done a better job of communicating in all of its breadth the strategic rationale for the war.”

This rationale included the potential for Iraq to resume WMD development, according to AP.

Feith has been bothered by critics who have said the absence of weapons of mass destruction should negate any other reason for war. He said Iraq provided “rhetorical and financial support” for terrorists and had a record of hostility in the Middle East.

“One could fault the administration on the presentation of the rationale, but that is different from saying the rationale was actually extremely narrow and invalidated by the disclosure of the error” on weapons of mass destruction, Feith said (Robert Burns, Associated Press/Baltimore Sun, July 15)

July 14, 2005

The Legislated Drugging of the American People

BY Nancy Levant

First, the facts: according to the Association of American Medical Colleges (AAMC), "Senators Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah) introduced the "Project BioShield II Act of 2005" (S. 975) on April 29, 2005. The bill builds upon the first BioShield bill, which was signed into law on July 21, 2004, and authorized $5.6 billion over 10 years to encourage pharmaceutical and biotechnology companies to develop bioterrorism countermeasures. BioShield II would provide additional liability protections for firms creating vaccines or drugs that could cause injuries. No action has been scheduled on the bill yet."

"At a May 11 hearing, Senator Richard Burr (R-N.C.), chairman of the Health, Education, Labor and Pensions Subcommittee on Bioterrorism Public Health Preparedness, said he would take into consideration both S. 975 and S. 3 in crafting his version of BioShield II. S. 3, introduced by Senator Judd Gregg (R-N.H.), amends the Homeland Security Act of 2002 and includes provisions similar to those in S. 975 that encourage companies to develop bioterrorism countermeasures."

"The President signed the Project BioShield Act (P.L. 108-276) into law on July 21, following final approval by the House on July 14. The legislation authorizes funds to encourage pharmaceutical and biotechnology companies to develop bioterrorism countermeasures."

"First proposed in the 2003 State of the Union address, Project BioShield provides $5.6 billion over ten years. The final bill guarantees this funding cannot be diverted for other purposes, but Congress retains discretion over the program's annual appropriations, such as the $890 million approved for FY 2004."

"Senators Judd Gregg (R-N.H.), Joe Lieberman (D-Conn.) and Orrin Hatch (R-Utah) are said to be working on "BioShield II," a bill that will provide liability protections for firms creating vaccines or drugs that could cause injuries."

"Provided under the proposed Department of Homeland Security FY 2005 budget is $2.5 billion for Project BioShield, three times the $890 million provided by Congress in FY 2004. The conference report of the FY 2004 Homeland Security Appropriations bill was signed by the President October 1 (P.L. 108-90) and included $890 million for Project BioShield."

"Project BioShield," first announced in the President's State of the Union address in January, is designed to expand and speed up the availability of vaccines and treatments to combat potential bioterrorism agents. Under the plan, the federal government would provide $6 billion over 10 years to create and produce vaccines and treatments and would guarantee drug companies a buyer for these products. In addition, the Food and Drug Administration would have the authority to expedite the approval process for vaccines and treatments."

So, let's get this straight: Project BioShield encourages, expands, and speeds up new business for big pharma, and then guarantees big pharma that they will absolutely have buyers for new drugs if they make them. $2.5 billion from Homeland Security plus another $890 million for Project BioShield, which guarantees the sale of any and all vaccines big pharma comes up with in the next 10 years.

And then there is the New Freedom Initiative on Mental Health, which initially mandates mental health screening and enforced drugging of American's children and pregnant women, but hopes to mandate enforced drugging of all American people.

Next, lets look at the Medical Emergency Health Powers Act (note the word "Powers"). According to a report from the Heritage Institute, "Model State Emergency Health Powers Act, upon the declaration of a public health emergency, governors and public health officials would be empowered to:

1. Force individuals suspected of harboring an "infectious disease" to undergo medical examinations.

2. Track and share an individual's personal health information, including genetic information.

3. Force persons to be vaccinated, treated, or quarantined for infectious diseases.

4. Mandate that all health care providers report all cases of persons who harbor any illness or health condition that may be caused by an epidemic or an infectious agent and might pose a "substantial risk" to a "significant number of people or cause a long-term disability." (Note: Neither "substantial risk" nor "significant number" are defined in the draft.)

5. Force pharmacists to report any unusual or any increased prescription rates that may be caused by epidemic diseases.

6. Preempt existing state laws, rules and regulations, including those relating to privacy, medical licensure, and--this is key--property rights.

7. Control public and private property during a public health emergency, including pharmaceutical manufacturing plants, nursing homes, other health care facilities, and communications devices.

8. Mobilize all or any part of the "organized militia into service to the state to help enforce the state's orders."

9. Ration firearms, explosives, food, fuel and alcoholic beverages, among other commodities.

10. Impose fines and penalties to enforce their orders."

Call me a conspiracy theorist, but it looks like our drug culture has gone politically mainstream and very Fascist. I see enforced, legislated drugging and a legislated guarantee of the sale of drugs that aren't even developed, AND a legislated guarantee to speed up the approval process for unknown drugs. Just how does one speed up that process?

Let's add more to our connecting dots. The U.N. - the group best known for their observation of the world's "ethnic cleansing" armies, has called for global population reductions. The U.N., who sends in "peacekeepers" to stand and watch as millions of innocents are brutally chopped to bits, poisoned, and slaughtered.

And how about those mercury-laced vaccines that poisoned a generation or two of children with Autism. And how about the mass-marketed drug, Viagra, and its link to blindness. And how about the psychotropic drugs that have increased teen suicide numbers in the U.S. by more than double.

I also can't help but think about how pleasant it must be for our public schools to enjoy Medicare funding in exchange for finding children in need of enforced drugging, and how nicely those universal mental health screenings will boost the annual operating budgets of public schools.

And then there is TMAP - The Texas Medical Algorithm Project. TMAP was marketed as a "Model Program." However, TMAP is far more than a program. It is a cover device. TMAP combines the newest and most expensive and untested psychotropic drugs under one umbrella, and then gets access to captive populations, like prisoners and school children, to test their new intellect and mood-manipulating drugs. Funny thing how the president's New Freedom Initiative recommends the TMAP model of matching symptoms to the TMAP new-fangled drug concoctions. Hmmm.

And TMAP comes with a hitch. When states adopted the TMAP model, doctors were required to prescribe the TMAP drugs over and above the older and thoroughly test psychotropic drugs. How sad for the children who in massive numbers found horrible, suicidal, and deadly side effects from TMAP drugs. Prozac, Zoloft, Adderall, Buspar, Wellbutron, Zyban, Paxil, and many, many others - have you noticed the non-stop, televised prime-time advertising of the TMAP drugs for the last 3 years? Hmmm.

TMAP is a big pharma marketing scheme that was implemented with the help of politicians who received big pharma campaign funding. It is ONE of the most evil, most unconscionable wheeling and dealing, to date. And now, add to all the above Project BioShield II, which gives TMAP model-like powers to include "enforced" vaccines of experimental drugs. We are being mass-drugged as a point and mandate of public-private partnership.

There is no denying the legislated facts and corruption behind the pharmaceutical industry and its funding of politically complicit monsters. If you own stock in big pharma, you are poisoning and killing, and you, too, are complicit.

American citizens, where is the outcry? Where are you? What more evidence do you need? And if you think that "illegal drugs" are unrelated to government policy, then you are again blinded by liars and thieves. Illegal drugs are tied to the teeth to global weapons, false dictatorships and governments, and to internal and orchestrated terrorism upon unknowing people.

Our power is in our combined wealth. Don't support the public schools. Don't support big pharma. And you can bet your bottom dollar that CAFTA-CODEX connection is backed by big pharma, as well. Wake up. Please, America, wake up. Mass corruption surrounds you at every level and around every corner. We are living in the land of lies.

NIH Inquiry Shows Widespread Ethical Lapses, Lawmaker Says

By David Willman
Times Staff Writer

WASHINGTON — Results from an ongoing internal review of drug company consulting payments to scientists at the National Institutes of Health show the agency's ethical problems are serious and widespread, a House committee chairman said Wednesday.

The review examined whether a sample of 81 NIH scientists had moonlighted for industry without getting required permission from the agency, whether they disclosed company payments on annual forms and whether they performed company services on government time.

More than half, 44, were found by NIH officials to have violated the agency's then-existing policies or recommendations.

Excerpts from the findings, provided in recent days by NIH Director Elias A. Zerhouni to three members of Congress, were obtained by the Los Angeles Times.

"We discovered cases of employees who consulted with research entities without seeking required approval, consulted in areas that appeared to conflict with their official duties, or consulted in situations where the main benefit was the ability of the employer to invoke the name of NIH as an affiliation," Zerhouni said in a letter to the congressmen dated Friday.

The chairman of the House Energy and Commerce Committee, Rep. Joe Barton (R-Texas), said Wednesday that the findings showed the "ethical problems [at the NIH] are more systemic and severe than previously known."

Barton elicited the information by posing written questions to Zerhouni in March. Barton's letter had been cosigned by the committee's most senior Democrat, Rep. John D. Dingell of Michigan.

The 44 scientists cited by the internal review "violated policies or regulations and were recommended for administrative action," said the summary of information that the NIH provided to the members of Congress.

Eight of the alleged violators have left the NIH and are not subject to administrative action, the agency said.

Nine individuals — none of whom were named in the agency's summary — were referred for further investigation to the inspector general of the Department of Health and Human Services.

After announcing an agencywide ban Feb. 1 on accepting company consulting fees or stock, Zerhouni was urged by some NIH employees and their defenders to relent.

Zerhouni has said he would continue to assess whether the new rules, including a planned restriction against owning biomedical stocks, had adversely affected the hiring and retention of qualified scientists.

The violations identified in the internal NIH review reflected a partial examination of industry consulting deals that had involved hundreds of agency scientists.

In spring 2004, after it was unable to obtain documentation from the NIH of the extent of such deals, the House Energy and Commerce Committee wrote to 20 companies and asked executives to voluntarily identify consulting fees paid to NIH scientists.

Scores of other companies that employed moonlighting NIH scientists were not contacted.

The information received from the 20 companies revealed 81 names that were not on the list of moonlighting scientists that had, by then, been delivered to the committee by the NIH.

The agency did not identify any of the 44 government scientists found to have committed violations.

An NIH spokesman, John Burklow, said that officials had sought to respect employees' rights to due process and privacy.

Zerhouni, in his letter to the members of Congress, said that because the internal investigation was ongoing, "I request that all the information provided in the enclosure [summarizing the findings] be treated as confidential."

Bush Budget Holds Steady for Civilian Biodefenses

By David Ruppe
Global Security Newswire

WASHINGTON — The Bush administration’s fiscal 2006 budget plans for civilian biological defense measures total at least $5.1 billion, according to a new nongovernmental analysis. The amount brings the total requested since 2001 to at least $27.7 billion (see GSN, Nov. 8, 2004).

The budget request includes increases for protecting national food and water supplies and a significant decrease for funding state and local public health departments, compared to requested spending last year.

The fiscal 2006 budgeting, an aggregate of spending across numerous agencies, reflects as much as a $2.5 billion drop from what was sought for fiscal 2005, but the decrease results mostly from the absence of one-time appropriation last year for drug and vaccine purchases through 2008 as part of the Project Bioshield law, according to the study by Ari Schuler, a government relations manager for Raydiance and a former research analyst at the Center for Biosecurity of the University of Pittsburgh Medical Center, located in Baltimore, Md.

The analysis was published this week in the center’s journal, Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, and it updates similar earlier analyses by Schuler.

“Civilian biodefense spending, not including the Bioshield bill, has reached a consistent level of about $5 billion from fiscal 2003 to fiscal 2006,” the article says.

“Since 2001, the U.S. government has spent substantial resources to prepare the nation against a bioterrorist attack,” the center said in a press release announcing the article’s publication. “All agencies involved in civilian biodefense received at least incremental increases.”

The fiscal 2006 total in the study does not include Defense Department budgeting for civilian biological defenses, as do previous years’ figures, because the Pentagon “was unable to furnish numbers for the requisite programs,” the study says.

Military biological defense spending for civilians in the previous two fiscal years averaged about $200 million. The analysis says, though, that those figures do not truly account for all Pentagon funding for civilian biological defense measures

“Some DOD research has direct civilian benefit, but because the majority of these funds are primarily military in application, these lines were excluded from calculation of total DOD expenditures,” it says.

Cuts and Boosts

As in previous years, the largest amount of money — $4.1 billion according to the article — was budgeted for the Health and Human Services Department, which funds the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention.

The article describes a planned $130 million cut to CDC funding for state and local public health departments, bringing the total CDC budget request down to $797 million.

Another substantial cut is a $119 million reduction from the National Institute of Allergy and Infectious Diseases’ budget for research facility construction, down to $30 million, and intended to “offset the increase in research funding,” the analysis says.

The Homeland Security Department’s $362 million budget is roughly the same as for fiscal 2005 — except for the $2.5 billion drop reflecting the advanced purchase for fiscal 2005 under the Bioshield law.

The Agriculture Department was budgeted $354 million, a 26 percent increase, for biological defense activities, the State Department $71.8 million, and the National Science Foundation $31.3 million.

The Environmental Protection Agency received an 87 percent increase to $185 million, primarily for decontamination capabilities, to protect water and food supplies, and for training, the study says.

Critics have said that despite substantial funding on biological defenses since the Sept. 11 terror attacks, the country remains substantially unprepared for a mass-casualty biological attack.

Another article published in the journal, titled “Anthrax Countermeasures: Current Status and Future Needs,” concludes “the federal government does not yet have the range of medical countermeasures needed to protect its citizens from anthrax and other potential bioweapons.”

July 13, 2005

Experts Paint Dire Picture of Bioterrorism Threat

By Joe Fiorill
Global Security Newswire

WASHINGTON - The knowledge needed to engineer new weapon-usable biological
agents is common around the world, and the United States must seek the proper balance between agility of response and countermeasure stockpiling in defending against biological terrorism, experts told a U.S. House of Representatives subcommittee this morning (see GSN, July 6).

U.S. efforts to defend against known threats, such as the Strategic National Stockpile of countermeasures, have some utility, said Molecular Sciences Institute Director Roger Brent. However, they may represent a "Maginot Line" that terrorists could simply circumvent by using new pathogens, or existing ones not addressed by the stockpile, he told the Homeland Security Subcommittee on Prevention of Nuclear and Biological Attack.

Brent said terrorists faced with a U.S. stockpile of the antibiotic Ciproflaxin, for example, would be certain, if mounting an anthrax attack, to employ a variety of the bacteria that was resistant to Ciproflaxin.

Programs to protect against known threats are not "bad things," Brent added, but "what's going to come at you is impossible to predict."

The threat is underscored by the wide dissemination of biological-engineering knowledge around the globe, Brent said.

"There are now tens of thousands of people who could engineer drug-resistant anthrax," said the scientist, who as a consultant to the U.S. government has received numerous briefings on U.S. and Soviet biological weapon programs.

George Mason University professor Kenneth Alibek, a top official in the Soviet Union's biological weapon program before defecting to the United States in 1992, concurred that there is no shortage of knowledge that terrorists could exploit in mounting a biological attack.

"The knowledge is there," Alibek told the subcommittee. "Whether or not they are developing this, they don't publish - but they can."

Massachusetts General Hospital Biodefense and Mass Casualty Care Director Michael Callahan suggested a few potential "chokepoints" at which the United States could seek to monitor or disrupt terrorists' biological weapon efforts.

Washington could focus on the trade in certain chemicals useful for making pathogens more deadly, he said, or on products and technologies, such as vaccines, that could be used to protect people against biological agents with which they are working.

Brent expressed skepticism about such approaches, stressing that the market for such products is diffuse and worldwide.

"You wish there were more chokepoints," he said. "I'm not convinced that there are very good chokepoints."

July 12, 2005

Children Won't Be Used In Anthrax Vaccine Test Trials

Courant Staff Writer

The National Institutes of Health says it made a mistake in announcing it would be using children to conduct anthrax vaccine test trials. But the agency has not ruled out using children in future tests.

"Approval was not granted to enroll children in [the anthrax testing trial]. The Web announcement ... was in error. It has since been corrected," said Robert Bock, a NIH spokesman. "Any planning to test anthrax vaccine on children in [that trial] can be viewed only as a contingency."

The NIH was sharply criticized in June when it posted an Internet announcement that 350 healthy adults and 100 healthy children in the first and second grades were being sought as volunteer test subjects.

A new vaccine NIH is developing and the one currently in use by the military, manufactured by BioPort Corp. of Lansing, Mich., are being compared in the NIH test trials.

Days after news stories surfaced on the NIH's announcement, Sen. Jeff Bingaman, D-N.M., wrote Mike Leavitt, secretary of the U.S. Department of Health and Human Services, to express "grave concern" about clinical anthrax vaccine trials for children.

"Surely considerable information regarding the safety of the new vaccine, as well as about its potential effectiveness, should be obtained in adults long before any consideration is given to providing it to children," Bingaman wrote. "And, based on what already is known about the adverse event profile of the older vaccine, it should not be `tested' in children at all."

The NIH does do trials on children for other vaccines, Bock said. "[It] is currently conducting a study of a vaccine for typhoid fever in infants, in Vietnam. The institute is also conducting a study of a vaccine for shigella among 1- to 4-year-olds in Israel."

In its initial announcement, posted on its website, the NIH stated:

"Adults who are in good health and children who are in good health may be eligible for this study. ... On a random basis, patients will receive either the rPA dose or the licensed vaccine, for comparison of the properties of both vaccines.

"Rare but severe reactions could occur if there is extreme sensitivity to a vaccine. However, such an occurrence is extremely rare following a vaccine, and if there are any dangerous symptoms, they can be effectively treated by medications available to patients while they are at the clinic."

BioPort's vaccine, used almost exclusively on soldiers, has shown an adverse reaction rate 100 times the figure initially stated on the label. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to its use.

The six-shot vaccine plus annual booster is being used to eventually protect all 2.4 million in the armed services against anthrax spores that can be inhaled after being spread or fired by terrorists or enemies of the United States.

The NIH and U.S. Health and Human Services Department are calling for development of the vaccine to protect civilians from terrorist or other attacks. Hundreds of millions of dollars have been spent on developing a new vaccine, in addition to the new one NIH is testing.

July 8, 2005

National Institutes of Health Decision Delayed on Anthrax Vaccine Testing on Children

By David Ruppe
Global Security Newswire

WASHINGTON — A plan to conduct safety tests of two experimental anthrax vaccines on children could proceed, despite the recent removal of any reference to such testing from a notice on the National Institutes of Health Web site (see GSN, June 27).

Researchers from the National Institute for Child and Human Development (NICHD) last year proposed including 100 first- and second-graders along with 350 adults in a clinical study assessing the relative safety, safe dosage levels, and side effects of a currently used vaccine and a new one for protection against inhalation anthrax.

A NICHD review board approved the study in July 2004, but directed that a decision on whether to include children be deferred until after the adults, ages 18-30, were tested and the results assessed.

The study formally began Sept. 8, 2004 and its completion is dependent, in part, upon recruiting volunteers. As of last week, 52 adult patients had been vaccinated using either the focal point of the testing, a genetically engineered anthrax vaccine now under development by NIH, or the controversial Anthrax Vaccine Adsorbed, which is now administered to U.S. military personnel deployed to certain regions of concern (see GSN, July 7).

The National Institutes of Health has published advertisements seeking participants for the trials in the Washington, D.C. area, offering compensation totaling $400 for eight clinical visits over the course of a year.

Compensation is not unusual and typically covers expenses and time, said Dr. Stephen Kaler, clinical director of the NICHD intramural research program. The institute would obtain parental consent for children to participate, if that component of the study is approved, he said.

Web Site Notice Changed

Complaints have surfaced in recent weeks that the trial, at least initially, should not include children and that no children should be vaccinated with the older vaccine because of doubts about its safety.

“I have grave concern about any intent to proceed with clinical trials with children at this point,” Senator Jeff Bingaman (D-N.M.) wrote in a July 1 letter to Health and Human Services Secretary Mike Leavitt.

“Surely considerable information regarding the safety of the new vaccine, as well as about its potential effectiveness, should be obtained in adults long before any consideration is given to providing it to children. And, based on what already is known about the adverse event profile of the older vaccine, it should not be ‘tested’ in children at all,” he added.

Critics have also expressed their doubts in U.S. newspapers.

“There is almost no risk to these children of being exposed to a form of … anthrax that has been weaponized,” Barbara Loe Fisher of the National Vaccine Information Center told the Kansas City Star. “The benefits are zero and the risk is quite high.”

A notice published in 2004 by the NIH Patient Recruitment and Public Liaison Office, which said the trial planned to include 100 children, prompted the criticisms. The institute recently removed that statement from the notice.

Kaler said there was a misunderstanding that children were already part of the trial. He said an additional decision by the Institutional Review Board, following the outcome of testing on adults, would be needed before children might be included.

Whether children would ultimately be included is an “open question, because it hasn’t been approved,” he said

Kaler said some view a perceived benefit from testing the new vaccine on children.

“Whether we do this in children is tempered by the feeling of some that children would be at risk in a bioterrorism attack and it would be unfortunate if children weren’t included in the study,” he said.

Safety Questions

There are uncertainties about the safety of both vaccines.

This trial phase is the first human testing for the NIH vaccine, which is still under development, according to Kaler.

If the vaccine passes, it could then be subjected to two additional phases of trials involving larger numbers of patients, according to Food and Drug Administration regulations. One phase would evaluate its effectiveness and further evaluate its safety, and the second would seek to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that would allow the drug or treatment to be used safely, according to the regulations.

After that, the Food and Drug Administration could determine whether to license the vaccine as safe and effective against inhalation anthrax, the method of contraction of foremost concern from biowarfare or terrorism. The entire process apparently could take years.

The NIH vaccine is distinct from another genetically engineered anthrax vaccine, under development by the company VaxGen. The Health and Human Services Department in November purchased 75 million doses of that vaccine for $878 million, enough to vaccinate 25 million people against inhalation anthrax, according to the company (see GSN, May 6). The department also awarded the company up to $69 million for, among other things, testing on children and the elderly after the Food and Drug Administration has approved the vaccine, according to Vice President of Public Affairs Paul Laland. The VaxGen vaccine is in its second phase of testing.

The older Anthrax Vaccine Adsorbed was licensed in 1970 as safe and effective against anthrax contracted through the skin, the disease form likely to infect textile and farm workers, and veterinarians. The Food and Drug Administration has not yet licensed it effective against inhalation anthrax.

Questions recur about its safety, with rare reports of debilitating reactions after vaccination and experts questioning whether there is a link to multisymptom illnesses effecting soldiers after the first Gulf War (see GSN, Nov. 16. 2004).

The Defense Department insists the vaccine is as safe as other commonly used vaccines, or safer. “Study after study shows: people vaccinated against anthrax are as healthy as unvaccinated people,” according to a statement on the DOD Web site.

It is uncertain how many military and civilian personnel have experienced severe reactions from the existing vaccine. However, of approximately 1.3 million personnel vaccinated against anthrax during 2003 and 2004, hundreds were said to have been treated for “complex” cases following those and other vaccinations at four special vaccine treatment clinics, ranging from muscle and joint weakness and pain to multiple sclerosis (see GSN, May 6).

The military since May has been administering the vaccine to select military personnel on a voluntary basis, after a judge found that the treatment could not be required because the Food and Drug Administration had not yet properly licensed it against inhalation anthrax. About half the civilian and military personnel offered the vaccine have refused the shot. A Food and Drug Administration review for that license is under way, which could allow mandatory vaccinations to resume.

The new vaccine however should be safer, according to an NIH advertisement for trial volunteers, provided by Kaler.

“The vaccine is expected to be as effective as the licensed anthrax vaccine (AVA) but it is purer and should be safer,” it says.

July 7, 2005

Half of U.S. Military Personnel Refuse Anthrax Shot

By David Ruppe
Global Security Newswire

WASHINGTON - Half of U.S. military and civilian personnel offered anthrax vaccinations under a voluntary program that began in May have refused the inoculation, according to figures released yesterday to Global Security Newswire by a Defense Department agency (see GSN, May 6). Since May 19, the vaccine has been offered to about 14,000 personnel, and roughly 7,000 of them have refused to take it, according to Col. John Grabenstein, director of the Military Vaccine Agency.

No explanation was given for the high number of refusals. 'We can't speculate on individual decisions," he said. The current pace of vaccinations is expected to increase, he said, as additional clinic workers are certified to give the vaccine and additional military units offer treatments to personnel. The high refusal rate comes amid persisting complaints by some service people and nongovernmental experts that the U.S. military has been reluctant to acknowledge a connection between the vaccine and uncommon but potentially debilitating side effects, which they say has hindered access to medical benefits and compensation (see GSN, Nov. 16, 2004).

It comes also despite a determination in December by then-Deputy Defense Secretary Paul Wolfowitz, citing classified intelligence, that there is 'a significant potential for a military emergency involving a heightened risk" of an anthrax attack on U.S. forces. Wolfowitz's finding preceded the Food and Drug Administration's granting of an emergency legal authority in January to give the vaccine voluntarily to service people. The vaccinations are focused on personnel stationed for prolonged periods in South Korea and the area of the U.S. Central Command, which includes the Middle East, along with those deployed for special biodefense-related missions. 'We are concerned that those who decline vaccination could die or be harmed if attacked with anthrax spores," Grabenstein said. The military has maintained that the vaccine is as safe as other commonly used vaccines, and Grabenstein said the recent treatments have produced only minor side effects. 'Adverse events are similar to previous experience, primarily temporary injection-site pain, swelling, or redness," he said. Steve Robinson, executive director of the National Gulf War Resource Center, however, said officials have been reluctant to acknowledge severe side effects that sometimes occur, making it difficult to obtain proper medical support.

The refusal rate, he said, suggests 'that soldiers are not willing to take the risk if [the Defense Department] is not willing to provide medical care and compensation should they become injured." Approximately 1,200 military personnel were treated in 2003 and 2004 by four special clinics called Vaccine Healthcare Centers, for complex reactions to the anthrax or other military vaccines, the Army told Global Security Newswire this year (see GSN, May 6). Mandatory Vaccinations Could Resume The vaccinations began May 19. Under the voluntary program, personnel cannot be punished for refusing the vaccine. A mandatory anthrax vaccination program that began months before the March 2003 invasion of Iraq and inoculated more than 1 million personnel was halted last October. The decision came after a federal judge ruled the vaccine could not be mandatory because the Food and Drug Administration had not licensed it as effective against inhalation anthrax, the type soldiers most be most likely to face in the field. Personnel who refused then were subject to possible removal from deployment status and disciplinary action. A licensing decision is pending from the Food and Drug Administration for using the vaccine against inhalation anthrax, which could lead to renewed mandatory vaccinations. A final period for public comment ended in March. The refusal rate appears to resemble that experienced by the voluntary anthrax vaccination program administered by the British government prior to and during the Iraq war. Statistics made public by the British Defense Ministry in February 2003 showed that as many as 49 percent of 20,000 military personnel offered anthrax vaccinations prior to the Iraq did not accept.

'The [Defense Ministry] is clearly losing the battle to convince the armed forces that anthrax infection is a clear and present danger in the Gulf," MP Paul Keetch, Liberal Democrat shadow defense secretary, said then. 'When weighing the risks of infection with fear of health complications from the vaccine, the majority of RAF [Royal Air Force] and naval personnel are rejecting vaccination." A former officer from the Royal British Legion, a charity supporting British service people and veterans, said in September 2004 that statistics indicated then that one-third of an estimated 45,000 British personnel involved in the invasion had refused anthrax vaccinations, according to a report by the Guardian. A Canadian judge in May 2000 ruled Canadian military personnel could refuse the vaccinations without penalty, questioning that vaccine's safety. More than 40 Australian soldiers reportedly were recalled from Iraq around the time of the invasion for refusing anthrax vaccinations, though they reportedly were not disciplined.

The Bush administration justified the invasion of Iraq as necessary primarily for removing an alleged threat posed by a suspected Iraqi nuclear weapons program, and alleged chemical and biological weapons, including anthrax. A CIA-sponsored team concluded last year Iraq no longer had such weapons, having abandoned its banned programs after the 1991 Gulf War. The terrorist network al-Qaeda is believed to have sought to use anthrax, but failed to obtain the agent or full capability for producing a weapon before it was routed from Afghanistan in late 2001.

A Defense Department report in 2001 alleged that North Korea had pursued biological weapons capabilities since the 1960s and possessed a rudimentary technical infrastructure capable of producing anthrax and other biological warfare agents. That same report alleged Iran had an active biological warfare program. Anthrax mailings to several U.S. Senate offices and news media organizations in fall 2001 killed five people and sickened 22. No one has been caught. GSN staff writer David Francis contributed to this article

July 6, 2005

Scientists Fear Increase in Biodefense Research Increases Likelihood of Attacks or Accidents

Global Security Newswire

Some scientists are concerned that the increase in the number of researchers working in the United States to counter bioterrorism increases the risk of an attack and the accidental release of a bioagent, Bulletin of the Atomic Scientists reported last month (see GSN, June 14).

More than 300 institutions and 12,000 individuals have access to weaponizable biological agents, said Richard Ebright, a Rutgers University molecular biologist and critic of the expansion in biodefense since the anthrax attacks of 2001. Biodefense watchdog the Sunshine Project claims that 97 percent of principal investigators who received grants from the U.S. National Institute for Allergy and Infectious Diseases from 2001 to 2005 to study six biological agents had not previously conducted similar work. The explosion of "NIAID newbies" increases the likelihood of accidents, said Edward Hammond, U.S. director for the Sunshine Project.

Martin Hugh-Jones, an anthrax researcher at Louisiana State University, told the Baltimore Sun last year that before 2001 researchers "knew each other by name. [Now] I see a lot of names I've never heard of. . On a probabilistic basis, there's more of a risk of accidents or attacks."

Mishaps have happened, according to the Bulletin. In February, a researcher at Rocky Mountain Laboratories in Montana was exposed to the bacterium for Q fever, a pathogen that causes flu-like symptoms. The National Institute called the Rocky Mountain incident a "small spill."

Sunshine's Hammond said the Rocky Mountain incident and last year's tularemia exposures at Boston University (see GSN, May 11) are "indicative of what's to come." Rutgers' Ebright agreed, blaming the accidents on the "influx of large numbers of institutions and individuals with no prior experience into bioweapons agents research."

NIAID officials counter that, despite their inexperience, researchers are qualified to deal with bioweapons. Scientists "can't learn about anthrax by studying E. coli. It is important that people work on these [bioweapon] organisms," said senior NIAID program officer Rona Hirschberg.

Jeanne Guillemin, a senior fellow at the Security Studies Program at the Massachusetts Institute of Technology, is not convinced, the Bulletin reported. Increasing access to pathogens heightens the chances that rogue scientists could use them in an attack. "What [NIAID Director Anthony Fauci] and others haven't thought through is the particular kind of expertise, from basic bench work to erosolization, that comes with defensive biological weapons programs," she said (Nick Schwellenbach, Bulletin of the Atomic Scientists, May/June 2005).

July 5, 2005

Former National Guard officer seeks reinstatement

By Tom Breen
Journal Inquirer

A former officer in the National Guard who was forced to resign in 1999 over his objections to a mandatory vaccination program is hoping to return to active duty now that a federal judge has bolstered his doubts about the program.

But state officials aren't certain whether they can do anything to help Maj. Thomas L. Rempfer of Suffield, saying the issue of his reinstatement might be a wholly federal decision.

According to federal court documents, Rempfer, along with Lt. Col. Russell E. Dingle of East Hartford, filed suit in March in the U.S. Court of Federal Claims, seeking reinstatement in the Guard, back pay, and a ruling on the legality of the mandatory anthrax vaccination program. Only Rempfer is seeking return to active duty, while Dingle is retired.

A spokesman for Gov. M. Jodi Rell cited the pending litigation as part of the reason the governor is waiting to make a decision about whether the state has a role to play in the reinstatement.

"The governor's office is reserving comment on this case until a resolution to the litigation that surrounds it is reached," Rell spokesman Adam Liegeot said today.

Attorney General Richard Blumenthal, who unsuccessfully argued for the reinstatement of Rempfer and others in 2000, has pledged to investigate what options the state has in the matter.

"Both federal and state law address the appointment of officers to the Connecticut National Guard," Blumenthal said in a statement today. "Questions as to how state and federal authority affect and relate to each other in selecting Guard officers are difficult and complex. Appointment of certain Guard officers, for example, may require approval from both state and federal officials."

Rempfer and Dingle were members of a National Guard group called Tiger Team Alpha, which was tasked in 1998 with researching an anthrax vaccine made by the BioPort Corp. that soon was to become mandatory for military service personnel.

After their research turned up concerns about the vaccination, which had not been approved by the Food and Drug Administration at the time, the two men, along with other Guard members who refused to be vaccinated, were forced to resign.

Since then, Rempfer and Dingle have crusaded against the vaccination and their termination in lawsuits, opinion pieces for newspapers, and testimony before Congress.

Their case was bolstered in October 2004, when a federal judge ordered the Pentagon to stop requiring anthrax vaccinations for military personnel.

U.S. District Judge Emmet G. Sullivan ruled the FDA violated its own procedures when it approved the vaccine in 2003, after an earlier court ruling, because it shut the public out of the hearing procedure.

"The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all -- public scrutiny," Sullivan wrote in his decision, according to court records.

In April, Sullivan modified his ruling slightly, allowing for the vaccine to be administered under certain emergency provisions, but stressing that vaccinations still had to be voluntary.

The judge's ruling essentially matched the research produced by Rempfer and Dingle's team in 1999, which recommended that "the prudent course of action may be to make the anthrax inoculation policy optional while a thorough review" by Congress, the Defense Department, and research organizations was conducted.

That finding, though, ultimately led to both men being forced out of the Guard, according to a 1999 ruling by the state Freedom of Information Commission, which also fined the Guard and some of its commanders for blocking Rempfer and Dingle's efforts to gain access to records about their case.

Both men later joined the Air Force Reserves.

Now, the question is whether Sullivan's rulings will change the situation of the two officers in relation to the Guard.

"The federal court ruling certainly strengthens the position that these officers have taken," Blumenthal said, but added that the question of their reinstatement will focus on what authority the governor's office has in the matter.