September 28, 2005

USAF Wants Sergeant Silenced; But Court Affirms Soldier's Free-Speech Rights

By Chad Groening

(AgapePress) - A spokesman for a law firm dedicated to the defense of civil liberties and human rights says his organization is pleased that a judge has refused to dismiss a lawsuit filed on behalf of an Air Force sergeant who was punished for speaking out about tainted anthrax vaccine.

The Rutherford Institute is representing Sergeant Jason Adkins, a C-5 aircraft flight engineer who served on the first C-5 flown into Baghdad during the Iraq war. The Institute's chief counsel, John Whitehead, says Adkins was required to take a series of anthrax vaccinations in order to be deployed overseas. Unfortunately, however, the sergeant began developing headaches and also suffered from memory loss.

Adkins went to an Air Force physician and reported the symptoms he was experiencing, including the memory loss, "which is a signal of problems with the anthrax vaccinations," Whitehead notes, and "which the Air Force is very skittish about." As a result, the attorney says, the aircraft flight engineer "was basically given a desk job and a reprimand for not flying."

However, the Rutherford Institute spokesman believes Adkins actually got into trouble with the Air Force by speaking out about what he believed was tainted anthrax vaccine. "That's when we filed our lawsuit," the chief counsel notes. "At that point, Adkins had made some statements to the press that we felt were appropriate, and he was disciplined for that."

Therefore, Whitehead goes on to explain, "our case is a First Amendment case saying that he has a right to speak out on matters of public concern. The Department of Defense had filed a motion to dismiss, and then just several days ago a federal court ruled in our behalf that he had a right to speak out, and they did not allow the case to be dismissed."

In that ruling, Whitehead points out, the judge "made an affirmative statement that this man has constitutional rights, and the government can't dismiss the case on that basis." According to the Rutherford Institute attorney, what the Air Force officials were basically saying was, in effect, "We have a right to discipline this man; he doesn't really have a right to speak out."

The federal judge's decision is "a really important victory," Whitehead asserts, explaining that, "What it says is that, in matters of public concern, military personnel do have basic constitutional rights." However, he says he expects the government will dig in its heels to defend its position, so the final disposition of Adkins' case could take a long time.

September 21, 2005

CDC Considers Bioterror Antidote Kits for U.S. Homes

Global Security Newswire

The Centers for Disease Control and Prevention is considering providing bioterror antidote kits to U.S. homes, Agence France-Presse reported yesterday (see GSN, July 14, 2004).

Agency spokesman Von Roebuck said that the kits could be distributed in Seattle to determine their feasibility.

"There are a lot of avenues being looked at as to how we can get vaccines and antidotes to the general public in an emergency situation," he said, adding that plans are still "in the drawing-board stage."

"At this point, there is nothing set in stone," Roebuck said. "We want to have a very open mind when it comes to how we distribute things."

Roebuck said that the U.S. Postal Service is being considered to distribute medications in the event of an attack. Stockpiling drugs at hospitals and clinics and "seeing what can be done in folk's homes" are also being explored, he said.

The federal health agency contacted the city of Seattle about "a preparedness initiative," said city spokesman James Apa.

"They want to do a trial in Seattle," he said. "We had a briefing and are just waiting for more details" (Agence France-Presse/Turkish Press, Sept. 20).

September 20, 2005

Judge allows anthrax lawsuit to continue

From today's Wilmington News-Journal (external Link)

Federal district court rules in favor of a Dover Air Force Base sergeant

BY SEAN O'SULLIVAN / The News Journal


WILMINGTON -- A whistleblower lawsuit filed by a Dover Air Force Base sergeant has survived a crucial federal court hurdle.

On Monday, U.S. District Judge Joseph J. Farnan Jr. turned down a request by government and military officials to have the lawsuit filed by Staff Sgt. Jason A. Adkins dismissed.

Adkins, a decorated 14-year veteran who flew on C-5s into Baghdad, sued Air Force officials and Secretary of Defense Donald Rumsfeld last year, charging he suffered retaliation after speaking out against the military's anthrax vaccination program.

The lawsuit and Farnan's opinion mention a series of articles by The News Journal in October 2004 about the anthrax program. Adkins alleges commanders "were angered and displeased by the media scrutiny" and shortly thereafter, when he complained to a flight surgeon about headaches he thought were linked to the vaccine, he was reprimanded and grounded, ending his career, as an example to others.

The government argued that Adkins had not shown he was retaliated against and that Adkins had not exhausted his administrative remedies inside the military.

Government attorneys also argued Adkins' speech was not about a matter of public concern and the speech was not outweighed by the military's interest "in maintaining the obedience of its enlisted personnel."

Government officials did not return calls for comment Monday.

Adkins' attorney, Thomas S. Neuberger of Wilmington, issued a statement heralding the decision as a victory, saying it shows service members have the same right to free speech as civilians.

"No man is above the law, not even the secretary of defense, the secretary of the Air Force or a four-star general. We now look forward to proving before a civil jury the abuse of power which ended this heroic airman's career and which has endangered the lives of many of our heroes in uniform," Neuberger said.

The lawsuit charges the anthrax program amounted to illegal medical experimentation on Air Force personnel.

Neuberger is representing Adkins in conjunction with the Rutherford Institute, a nonprofit conservative civil-liberties organization.

September 19, 2005

Dingle, opponent of anthrax program, dies

By Deborah Funk
Times staff writer

Retired Air Force Reserve Lt. Col. Russell Dingle, a longtime opponent of the military’s anthrax vaccination program, died Sept. 4 at age 49 of cancer.
The East Hartford, Conn., resident was a major in the Connecticut Air National Guard in 1998 when he and another officer in his unit were tasked to provide higher headquarters with information on concerns service members had about the shots.

However, their research of government documents raised questions about the manufacturer as well as the vaccine’s effectiveness and intended purpose, and led them to conclude the vaccine was not licensed to protect against inhaled anthrax.

Dingle was forced out of the Guard but joined the Air Force Reserve.

“Russ Dingle was one of the earliest and most thoughtful ... officers to question the anthrax vaccine program,” said Rep. Christopher Shays, R-Conn., chairman of the House Government Reform Committee’s national security panel.

“He was a witness before my subcommittee and a leader in the effort to protect service members from the avoidable health risks posed by the Pentagon’s force-wide, mandatory use of an old vaccine never approved for mass prophylaxis against aerosolized bioweapons agents,” Shays said. “Connecticut and the nation have lost a talented pilot and a dedicated patriot.”

Even after anthrax was sent through the mail to members of the media and politicians in fall 2001, Dingle continued to fight the Pentagon’s program, often using the government’s own documents.

He did not oppose the need for a vaccine to protect against anthrax — just the use of this one.

“This vaccine is the benchmark of how not to do it right,” he said in a 2001 interview with Air Force Times.

Dingle was among six people who four years ago petitioned the Food and Drug Administration to classify the vaccine as unsafe, ineffective or misbranded, declare existing stockpiles “adulterated,” and revoke the vaccine license from its maker — none of which the FDA did.

A federal judge later halted the mandatory program, finding that the vaccine was being used in a way for which it was not licensed. Anthrax vaccination for military members continues, but under a voluntary program unless and until the FDA follows proper procedures to license the vaccine for protection against inhalational anthrax.

Dingle retired from the military in 2003 as a recruiter for the Air Force Academy, after serving 21 years in uniform.

Among his previous tours of duty, he served as an instructor pilot and flight commander for the Connecticut Air National Guard and as an A-10 instructor pilot at Davis-Monthan Air Force Base, Ariz. He flew more than 2,000 hours in the A-10 Thunderbolt II.

September 16, 2005

New Jersey Lab Loses Plague-Infected Mice

Global Security Newswire

Three mice that went missing after being infected with bubonic plague at a New Jersey bioterrorism laboratory are believed to have been eaten by other mice in a vaccine program, the Philadelphia Inquirer reported today (see GSN, Sept. 9).

While not absolutely sure of the mice's fate, officials said the public should not worry about plague outbreak.

The mice were among 24 being studied at the Public Health Research Institute in Newark, N.J. They were divided into three groups of eight, with one set receiving a trial plague vaccine, the second a proven vaccine and the third no vaccine.

The FBI opened an investigation after the mice's absence was noticed two weeks ago. Investigators found no evidence of terrorism or a crime, Special Agent Steve Siegel said. Several laboratory workers underwent lie-detector tests.

"The FBI has expended a tremendous amount of manpower and resources on this matter," Siegel said.

According to the Inquirer, the laboratory staff did not initially consider the possibility that the mice were cannibalized. The working theory now is that facility personnel did not notice the remains of the three mice when they cleaned and sterilized the sawdust-filled cages after testing was complete.

"We believe it was inadvertent and the animal-care staff made a mistake," said David Perlin, institute president and scientific director. "That doesn't excuse it."

Perlin said there was no way the mice could have escaped or been removed by laboratory staffers, who will be retrained in handling animals involved in sensitive testing. He said only eight workers have access to the laboratory in which plague research is conducted.

These workers must go through five security checkpoints before entering the laboratory. Researchers who worked on the plague vaccine test had Justice Department clearance and were interviewed by the FBI after the mice disappeared, Perlin said.

For the disease to spread to a human, a flea would have to bite one of the infected mice and then bite a human. "The odds of that occurring are ridiculous. It's hard to even imagine such a scenario," said Laurie Garrett, head of the global health program for the Council on Foreign Relations.

"There is no indication that this is a public health threat," said Jennifer Morcone, spokeswoman for the Centers for Disease Control and Prevention.

The test vaccine was ultimately found not to work. All mice that received the vaccine died shortly after being infected with plague (Lipka/Vrazo, Philadelphia Inquirer, Sept. 16).

U.S. gears up for anthrax, smallpox - VaxGen top bidder so far as the feds build up Strategic National Stockpile

By Aaron Smith
CNN/Money staff writer

NEW YORK (CNN/Money) - So you heard about the bubonic plague-infected mice missing from a bio-terror research plant in Newark and now you're scared?

Don't be. Bubonic plague is not at the top of the government's list of worries. But you should be worried about anthrax and smallpox, designated by the Department of Health and Human Services as top threats to our national security, along with the dreaded Ebola virus.

So what does this mean from an investment standpoint? Billions of tax dollars are being spent to build up stockpiles of vaccines for counterterrorism.

"If there was an anthrax attack today, we would be about as well prepared as we were in New Orleans [for Hurricane Katrina,]" said Robert Leboyer, analyst for EKN.

Through Project Bioshield, the government plans to spend $5.6 billion through 2013 building up the Strategic National Stockpile. This includes $1.9 billion on vaccines for smallpox and $1.4 billion for anthrax. Also, hundreds of millions of dollars could be allocated for the development of an Ebola vaccine.

"Until recently, the vaccine business was kind of out of favor," said Sharon Seiler, analyst for Punk, Ziegel & Co. "I think it's bounced back with the contracts. People have renewed concerns about global pandemics."

Analysts expect the feds to award large contracts through 2007, followed by smaller contracts to maintain existing stock. The government is stockpiling vaccines without waiting for approval from the Food and Drug Administration, in order to get the latest advancements to the American population.

Glen Nowak, spokesman for the Centers for Disease Control and Prevention, said that vaccines expire within 18 months to two years, which is why the government has a "floating inventory" rather than a warehouse stuffed with a full supply.
So who's getting the government money?

On Thursday, the French drug maker Sanofi-Aventis (up $0.34 to $40.66, Research) was awarded a $100 million government contract to produce influenza vaccines at its plant in Swiftwater, Penn. But that pales in comparison to what the government is spending on counter-terrorism.

VaxGen, Inc. (down $0.08 to $14.17, Research) of Brisbane, Calif., is the Bioshield winner so far, having secured an $877.5 million contract last year to produce 75 million doses of anthrax vaccine. The government is expected to allocate hundreds of millions of dollars more for the maintenance of this stockpile.

In addition, VaxGen is trying to secure a contract to produce the smallpox vaccine.

"Clearly, there is a medical need to have a safer product than what's being used," said VaxGen spokesman Paul Laland, who said that his company's product is safer than Wyeth's (up $0.65 to $45.65, Research) Dryvax, the smallpox vaccine currently in the national stockpile.

VaxGen is partnering with Japanese drug maker Kaketsuken, which has had a smallpox vaccine approved in its home country since 1980. Laland said his company is currently producing the anthrax vaccine at an undisclosed location in California, and is ready to produce smallpox vaccine at an FDA-approved facility in Japan at any time.

Bavarian Nordic Research Institute (down $0.81 to $78.90, Research), a Berlin biotech, and Acampis, a privately held biotech in Cambridge, Mass. and the UK, are also competing for the smallpox vaccine bid. Analysts believe that VaxGen is the top player.

"I don't believe there's any other competitor for a smallpox vaccine that would be applicable for the entire population," said Leboyer, the EKN analyst.

In addition, Jeffrey Marshall, analyst for Fairview Capital Group, said the VaxGen has the "closest ties with the government."

No vaccine currently exists for Ebola, a virus that causes massive hemorrhaging with a kill rate of 50 to 80 percent. Crucell (up $0.03 to $24.22, Research), a biotech based in the Netherlands, is considered a lead candidate for developing a vaccine and cashing in on government contracts. Jeffrey Marshall, analyst for Fairview Capital Group, said an Ebola vaccine contract could range from $400 million to $500 million.

"I believe that Crucell's vaccine is superior," said Marshall. "The U.S. government has tested it in primates at Walter Reed Hospital. They vaccinated the animals with one dose of vaccine, injected them with a lethal dose of Ebola, and they all survived."

September 14, 2005

FDA Grants Fast Track Designation to DVC Biodefense Vaccine Development Programs

PR Newswire

EL SEGUNDO, Calif., Sept. 14 /PRNewswire-FirstCall/ -- Computer Sciences Corporation (NYSE: CSC - News) today announced that DVC LLC, a CSC company, has received Fast Track designation status from the U.S. Food and Drug Administration (FDA) for three biodefense vaccine development programs it is working on for the Department of Defense Joint Vaccine Acquisition Program (JVAP) Product Management Office.

DVC programs to develop recombinant vaccines for plague and botulinum neurotoxin serotypes A and B, and the company's program to develop a live, attenuated vaccine for Venezuelan equine encephalitis have received the Fast Track designation. Fast Track status allows the FDA to expedite review of drugs and biologics that demonstrate the potential to address unmet medical needs and are intended to treat serious or life-threatening conditions.

"At DVC, our mission is to expedite the development of biodefense products to protect the nation's operating forces and citizens," said DVC Chief Scientific Officer Dr. Robert V. House. "We do this by applying for Fast Track status, which enables us to work closely with the FDA to more efficiently meet military biodefense needs."

JVAP's mission is to develop, produce and stockpile FDA-licensed vaccine products to protect the warfighter against biological warfare agents. JVAP consolidates Department of Defense efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines.

DVC is a biodefense company dedicated to the development and licensure of safe and efficacious biological products. DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created in 2001 to support programs enhancing U.S. security.

The safety and efficacy of these vaccines in humans has not been established. These products are currently under clinical investigation and have not been licensed by the FDA.

September 13, 2005

Anti-Vaccine Activist Memorialized

by Thomas "Dennie" Williams
Hartford Courant, Connecticut

MANCHESTER -- Retired Air Force Reserves Lt. Col. Russell E. Dingle, a fierce opponent of mandatory anthrax inoculations in the military, was remembered Monday at a memorial service featuring a jet fly-over.

Dingle, 49, died Sept. 4 after battling cancer.

His family, military colleagues and friends nearly filled the Church of Jesus Christ of Latter-day Saints to pray, sing and celebrate Dingle's life. Afterward, four A-10 Thunderbolt II Warthog planes - the kind Dingle piloted - flew over the church, with one plane veering off and up into the hazy blue sky.

"I was reminded all over again of how powerful and passionate he was in his beliefs about integrity and public service, and how deeply inspiring he was to people who he came into contact with him as I did," said Attorney General Richard Blumenthal.

It was Dingle and his friend, Air Force Reserve Maj. Thomas "Buzz" Rempfer, who persuaded Blumenthal to join their anti-inoculation effort five years ago. Since then Blumenthal has lobbied federal and state officials to halt the mandatory inoculations of those in the armed forces. U.S. Rep. Chris Shays, R-4th District, also became an anti-anthrax vaccine "warrior" and a Dingle admirer.

Dingle "was a leader in the effort to protect service members from the avoidable health risks posed by the Pentagon's mandatory use" of the anthrax vaccine, Shays said. "Connecticut and the nation have lost a talented pilot and a dedicated patriot."

Dingle, an East Hartford resident, never took the anthrax vaccine. In late 1997, the then-commander of the Connecticut Air National Guard, Col. Walter Burns, asked Rempfer and Dingle to investigate the vaccine. Their investigation found it was "unsafe" and "ineffective" and they demanded appropriate action. They were asked to resign instead.

They joined the Air Force Reserves and continued what many have described as a relentless effort to stop the Pentagon from using the vaccine.

Dingle's research led him to serve as an expert for the U.S. General Accountability Office, and induced mention of his name in a federal court in Washington's initial ruling against the vaccine.

"Over and over again, Russ provided the factual basis necessary to validate the legal arguments that prevailed in court," said Lou Michels, one of the lawyers involved in representing six anonymous military employees in the court challenge.

"His efforts provided an incalculable benefit to his fellow servicemen and women. Not a bad legacy for a Warthog pilot."

"The Pentagon's illegal experimentation on service members has gone on for decades," said retired Lt. Col. John Richardson, a gulf war veteran and fellow fighter pilot.

"Due to Col. Dingle's analysis of the military's anthrax vaccine policy, for the first time the Defense Department was caught in the act - and stopped by a federal court judge."

As an Air Force officer and fighter pilot, Dingle flew over 2,000 hours in the A-10 Thunderbolt II on active duty, and served as an instructor pilot and a flight commander for the Connecticut Air National Guard.

Dingle won multiple Air National Guard "Top Gun" flying awards, and was chosen to lead a flight of A-10s in the U.S. Air Force Gunsmoke competition in 1993.

After retiring from the military, Dingle was a pilot for American Airlines for 16 years.

Dingle is survived by his wife, Jane; daughters Megan and Emma; three brothers; one sister; and his mother.

September 12, 2005

Mercury News
By Steve Johnson

The government has poured billions of dollars into programs to protect the nation from terrorists wielding biological weapons. That's been a bonanza for several Bay Area biotech companies.

One of them, Vaxgen, has won nearly $1 billion in contracts to make an anthrax vaccine. The tiny Brisbane company hopes to land a smallpox-vaccine deal worth even more.

But some people question whether the federal program will be able to defend the country from bioterrorist attacks that could take many forms. Despite claims by federal officials that they are making progress in countering bioterrorism, serious doubts remain.

Most major drug companies have declined to get involved. Some dislike dealing with the government because it's unpredictable or because there appears to be little commercial application for the products federal officials want developed.

Others complain that federal rules exclude firms mostly financed by venture capital, which includes many biotech start-ups. They also say any products developed under the program could leave the companies vulnerable to consumer lawsuits.

The dearth of business participation could slow development of countermeasures for the wide range of biological substances terrorists could use, some critics say. They liken the federal effort so far to trying to plug a leaky dike with too few fingers.

``Given a modest amount of time, the big holes will be, if not plugged, then at least partially plugged,'' said David Relman, a Stanford Medical School microbiologist and immunologist who's on the National Science Advisory Board for Biosecurity. ``But I'm not optimistic that we're going to take biological agents off the table as a threat.''

The danger can take many forms. Anthrax is considered one of the most likely substances to be used by terrorists. When somebody mailed it to federal offices and the media in 2001, five people died.

Anthrax can infect a person through a cut, contaminated food or the air. Once it enters the body, it releases two kinds of toxins that can kill infected cells and cause water to accumulate in the lungs.

Program flaws

VaxGen's vaccine uses a form of protective antigen that prompts the body's immune system to block the toxins from doing any damage. But 75 million doses will protect only 25 million people. It could take years to develop enough of the vaccine to shield most of the population.

Even if anthrax was eliminated as a serious threat, a number of other pathogens could cause widespread havoc. They include smallpox, botulism, plague, cholera, the Ebola virus, tularemia and shigella. Terrorists have plenty of options for using those substances on an unsuspecting populace.

In June, a study by two Stanford researchers concluded that contaminating a milk-processing facility with just one gram of botulism toxin could sicken 150,000 people and kill more than half of them.

During a tour last month at the Pleasanton offices of Applied Biosystems, which makes kits for government agencies to test for terrorist toxins, U.S. Rep. Richard Pombo, R-Stockton, said large animal feed lots also represent a tempting target. At many such lots, he said, ``there is no security.''

Federal officials have assured Congress recently that they are making progress in protecting the country. Since the Sept. 11, 2001, terrorist attacks, they have spent $21 billion to counter bioterror, according to the University of Pittsburgh's Center for Biosecurity. That's $5 billion a year, more than 10 times what was spent annually on biosecurity before the Sept. 11 attacks.

But critics contend the effort is flawed.

Among other things, some say the government seems so fixated on producing vaccines for existing pathogens, it hasn't adequately prepared for the possibility that terrorists or Mother Nature could create vaccine-resistant mutations of those toxins.

``I worry about the development of a vaccine to a virus that was well-known two years ago without knowing what its capacity for change is,'' said Marvalee Wake, a University of California-Berkeley professor who is president of the American Institute of Biological Sciences. ``It's so scary to be behind the curve rather than ahead of it.''

But the most common gripe is that the federal effort has alienated the businesses it needs most to be effective.

``It was ill-conceived,'' said Lynn Klotz, a biotech consultant and a senior science fellow with the Center for Arms Control and Non-Proliferation. ``It showed no understanding of how the pharmaceutical industry or even the biotechnology industry operates.''

Congress is considering legislative changes to entice more businesses to participate, including a provision that would ease the potential for consumer lawsuits against companies receiving government contracts to make biosecurity products.

Liability is a problem because of the way vaccines and other drugs for combating bioterrorism are approved. For obvious reasons, their effectiveness is tested only in non-human animals. So if the drugs wind up failing to protect humans, lawsuits could result.

Reaping the rewards

For now, the nation's biosecurity work is being done at a smattering of small biotech outfits in the Bay Area and elsewhere. Many are accustomed to skimpy revenue and rivers of red ink. But they are finding that the job of countering terrorists can be rewarding.

Take Dynavax Technologies of Berkeley, which makes treatments for allergies and infectious diseases. Between 2000 and 2003, its annual revenue averaged $1.7 million. Then, in 2003, it won $8.4 million in contracts to make vaccines for anthrax and other pathogens.

Xoma, another biotech company in Berkeley whose 2004 revenue was $3.7 million, was awarded $15 million in March to develop a treatment for people infected with botulism. The 18-month contract ``is a welcome shot in the arm,'' said the company's spokeswoman, Ellen Martin.

But few stand to see their revenue rise as much as VaxGen. The company was in trouble a few years ago. The AIDS vaccine it had been developing was going nowhere and it was losing money. Since the Sept. 11 terrorist attacks, however, federal money has been pouring in.

VaxGen, whose annual revenue barely topped $14 million in 2003, already has received $101 million to develop the anthrax vaccine and expects nearly $300 million more next year when it is due to deliver the first 25 doses.

As a result, the company is growing fast. It has 280 employees -- nearly triple what it had three years ago -- and expects to have 500 by late next year, he said. That could be just the beginning. Other countries also are expressing interest in buying the company's vaccine, Gordon said, and the federal contract for a smallpox vaccine VaxGen is seeking could be worth $2 billion.

Working for the government hasn't been easy. Initially, federal officials told VaxGen to produce the drug in vials. Then they changed their minds and wanted it in syringes.

``That did cause us a little heartburn,'' according to Gordon, who said the switch set the vaccine's production back at least six months.

The company also has had to change its accounting system to suit the government. And it must meet 14 times a month with federal officials to discuss matters related to the vaccine and produce monthly progress reports that run 700 pages or more, he said.

Nonetheless, Gordon figures it's worth it.

Despite those who criticize the national effort to counter terrorism and the many companies that have declined to get involved, VaxGen takes pride in helping protect the public from biological threats, Gordon said. Besides, he added, ``there's a lot of money in it.''

September 9, 2005

Powell Calls Iraq Speech “A Blot” on his Record

Global Security Newswire

Former U.S. Secretary of State Colin Powell called a 2003 presentation to the U.N. Security Council on prewar Iraq’s suspected weapons of mass destruction “a blot” on his record, Agence France-Presse reported today (see GSN, May 23).

Powell offered the United Nations evidence of Iraq’s WMD programs, including satellite photos of what U.S. leaders believed to be mobile biological weapons laboratories. No evidence of such programs has been found since the March 2003 invasion.

“It's a blot” on my record, Powell said in an interview with ABC News to be aired today. “I'm the one who presented it on behalf of the United States to the world, and (it) will always be a part of my record. It was painful. It's painful now.”

Powell said he felt “terrible” for being misinformed by the CIA, but did not blame then-CIA director George Tenet. Powell said Tenet “did not sit there for five days with me misleading me. He believed what he was giving to me was accurate.”

However, some intelligence officials “knew at that time that some of these sources were not good, and shouldn't be relied upon, and they didn't speak up,” Powell said.

“These are not senior people, but these are people who were aware that some of these resources should not be considered reliable.”

“I was enormously disappointed” Powell added.

Powell, however, did not express regret over the war, according to AFP. “I’m glad that Saddam Hussein is gone,” he said.

He said that he has “never seen evidence to suggest” ties between Iraq and the September 2001 terrorist attacks against the Pentagon and World Trade Center.

Powell also said that he does not see “a clear military option with respect to Iran” (Agence France-Presse/Yahoo!News, Sept. 9).

U.S. Court Orders Detailed Instructions Be Given to Military Personnel Before Anthrax Vaccination

By David Francis
Global Security Newswire

WASHINGTON — A U.S. federal judge who stopped a mandatory Defense Department anthrax vaccination program last year has ordered military medical personnel to give detailed instructions to service members before administering the voluntary vaccination (see GSN, Aug. 2).

The Aug. 30 court order follows reports that on July 22, a soldier in Iraq was vaccinated without being informed that it was optional.

The Pentagon began in May giving anthrax vaccinations to military and civilian personnel on a voluntary basis under emergency-use authority granted by the U.S. Health and Human Services Department. The authority was granted after U.S. District Judge Emmet Sullivan stopped the mandatory vaccination program following a lawsuit by six anonymous Defense Department employees. The Pentagon has appealed Sullivan’s decision to the U.S. Appeals Court.

Sullivan, who in the past has criticized the Pentagon for continuing to give shots after he issued the injunction in October 2004, has now required that specific instructions be given before the inoculation is administered.

The order mandates that no later than Sept. 15, the Pentagon must provide the following instructions to all medical personnel: “If administering anthrax vaccination, ensure the patient has signed in, received training and trifold [a brochure outlining risks and benefits of the vaccine], understands the right to refuse, and states they want to receive the anthrax vaccine. Immediately prior to administration of the anthrax vaccination (once site and vaccine are prepared) ask the patient, ‘Do you want to receive the anthrax vaccination?’ If the patient confirms, administer.”

Sullivan’s ruling comes days after the Pentagon filed a reply brief with the U.S. Appeals Court in response to a brief filed by counsel for the six Defense Department employees. The briefs were filed as part of the Pentagon’s appeal of Sullivan’s injunction.

In the brief, the Pentagon argued that the plaintiffs offer no support for a continued suspension of the mandatory anthrax vaccination program.

“Even if the district court were correct on the merits, there is no basis for its sweeping, military-wide injunction,” the brief states. “The court’s injunction is wholly unnecessary to provide relief to the six plaintiffs, and, without providing any gain in safety, it improperly sets aside the military’s judgment as to the optimal means for protecting American service members against the threat of anthrax.”

“Contrary to plaintiffs’ suggestions, the interests of thousands of members of the armed forces are not aligned with those of the six plaintiffs,” the brief continues. “The court’s ruling jeopardizes the safety of the countless persons who have never been a part of this action.”

The Pentagon has argued that the vaccine has been considered safe and effective for anthrax regardless of the route of exposure — by skin contact or inhalation — by the Food and Drug Administration. Contrary to the plaintiffs’ arguments, the agency in 1972 accepted the determination of the National Institutes of Health that the vaccine is safe, and has never contradicted this finding, according to the Pentagon.

“Accordingly, given the continued operative effect of the original NIH license for AVA [anthrax vaccine adsorbed], the FDA’s repeated declarations that the original license includes use against inhalation anthrax, and the count scientific bases for that conclusion, the district court’s determination is entirely without support,” the Pentagon says.

September 7, 2005

US quarantine system lacks resources, panel says

By Maggie Fox

WASHINGTON -- The US quarantine system does not do enough to keep out new killer diseases such as avian flu or unknown bioterrorism threats, a panel of specialists said yesterday. They said the Centers for Disease Control and Prevention should be given broad new powers to set up and enforce quarantine stations and to monitor for imported infections.

Hundreds more people need to be trained to watch at ports of entry for people who may be carrying diseases, the Institute of Medicine Committee said.

''What happens if you get SARS or have a pandemic or a big outbreak occurs somewhere and you need a big capacity very quickly? That is going to require a lot more planning than is occurring today," Dr. Georges Benjamin, head of the American Public Health Association and chairman of the committee that wrote the report, said in a telephone interview.

"They need a lot more resources to do this. This is really an insurance plan that is underfinanced and undersupported."

The report calls for an updated approach to a system that is still based on immigration and travel patterns of nearly a century ago.

"In the 1930s and '40s when people came in, most of them came in by boat. They came in through very few ports," Benjamin said. "If they had an incubating disease, it often would incubate while they were on the ride over here."

Now, with jet travel, a person infected with smallpox, avian flu, or the Ebola virus could have landed and traveled to anywhere in the country before becoming ill -- spreading the infection all along the way.

The CDC and other specialists have warned of this danger for years, and the panel said it is time to act.

The report said 120 million people travel in and out of the United States each year. The CDC staffs 11 quarantine stations and will have 15 by the end of the year. He said the CDC would be able to spread its thin resources better by training customs and security personnel, airline staff, and others, to screen. They also need updated methods, the report says.

"Quite frankly right now, how they identify who is sick is they stand at the causeway where people get off the plane and look for sick people," Benjamin said.
He said there is still a role for such old-fashioned surveillance.

"People hide monkeys under their shirts, believe it or not," Benjamin said. "They bring in rats and rodents, pets in with them. Sometimes they bring them in for food from countries they are coming from."

Health screeners also need up-to-date computer information and access to travel medical records and seating charts so they can easily trace those who were near someone who turns out to have an infection, Benjamin said.

"Over the years we have had two things happen -- the belief that the infectious threat has gone, with the result that resources have dwindled away," he said. "And the environment has changed and we are now looking at emerging infectious threats and bioterrorism."

These include severe acute respiratory syndrome, or SARS, which emerged in China in 2002 and swept to several countries around the world via jet, infecting 8,000 people and killing about 800 before it was stopped with strict quarantines.

The H5N1 avian flu is considered another potential threat should it pass easily into humans, and specialists fear that terrorists could use smallpox or other infections.

September 2, 2005


Homeland Defense Watch

A federal judge who last year banned the Defense Department from giving service members involuntary anthrax vaccines has ordered the Pentagon to circulate detailed instructions to medics around the globe to ensure they have obtained a patient's permission before administering a shot.

The new directive follows a report the Bush administration delivered to the U.S. District Court saying "that an involuntary anthrax vaccination was administered at a U.S. military medical clinic in Iraq, in violation of this Court's injunction," in the words of a "minute order" Judge Emmet Sullivan issued Aug. 30.

After a seven-month hiatus, the Pentagon resumed giving anthrax vaccines under "emergency" authority -- strictly on a voluntary basis -- beginning in May (Inside the Pentagon, May 5, p5).

The Defense Department is the lead defendant named in a lawsuit filed in March 2003 by six anonymous DOD employees who were subject to then-mandatory shots. Following summary judgment in favor of the plaintiffs that resulted in a permanent injunction against the involuntary shots program, the administration has appealed to a higher court, where the case is now pending (ITP, May 19, p1).

However, Sullivan retains the ability to compel compliance with his ruling, as reflected by the new minute order.

In it, he notes that following the errant injection, the commanding officer of the medical unit in Iraq issued a memorandum to his subordinates on how to avoid additional involuntary shots. The Pentagon detailed the commander's memo in a July 22 filing to the court.

September 1, 2005

Soldier Falls Ill After Taking Vaccine Shots


An Oklahoma National Guard soldier says he faces mounting medical costs and is too sick to work because of a severe reaction he suffered to a battery of vaccines he was given in preparation for deployment to Iraq.

Spc. Kent Stewart, 37, of Alva, received the anthrax vaccine along with other members of his unit, the 45th Field Artillery Brigade, in February 2003 as they prepared for deployment to Iraq.

He said he began experiencing severe headaches. On March 15 he received the second series of shots. The third series followed April 4. He suffered dizziness and tingling on the left side of his face and in his hands and legs.

On May 27, the unit received notice their orders had been canceled. Stewart received his fourth round of the vaccine on Dec. 7, 2003. Vomiting, weight loss, insomnia, and other symptoms started, including pancreatic problems. Each episode required treatment with antibiotics and other medications to ease the symptoms.

On Aug. 15, 2004, he received his fifth and last immunization. His condition worsened until he was hospitalized Nov. 22, and placed on intravenous antibiotics for a week. Stewart's doctor, Tarek Naguib, said the immunizations are a suspected cause of Stewart's medical problems.

Col. Pat Scully, the Oklahoma National Guard spokesman, said he was not familiar with Stewart's case but said there should be treatment Stewart can pursue through the military medical system.

"I've been through the series of anthrax shots and have had no problem but that doesn't mean the soldier doesn't have a valid complaint," Scully said.
About one person in 100,000 has a serious adverse reaction to the vaccine, according to the Pentagon.

The military now gives the vaccine to soldiers only on a volunteer basis after a judge found fault in the Food and Drug Administration's process for approving the drug. Previously, hundreds of people were kicked out of the military for refusing the shots out of safety concerns.

Stewart said the injections were mandatory when he took them. He said he was told that he would be given a dishonorable discharge or a bad conduct dismissal if he were to refuse.

"I felt the shots weren't going to be doing any good," he said. "I didn't personally think there was that big a threat."