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Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations

A major report on Gulf War Illness written by the VA Research Advisory Committee on Gulf War Veterans' Illnesses (RAC) was made public on November 17. This is the most important document available on Gulf War illnesses yet produced. About 1800 references are cited. The report gets it right about how many have developed the syndrome (25% of those deployed during 1990-1991) and the medical conditions they are experiencing. It emphasizes the desperate need for effective treatments to be developed and used in this population. The report also discusses a number of potential causes of the syndrome, and rules them in or out as significant factors in the report's executive summary.

This report expands on many issues discussed in my September 2007 Senate Veterans Affairs testimony on Gulf War Syndrome. I discussed a greater number of soldiers' exposures (for several of which only limited evidence is available) that were not considered in this report. Overall, my testimony and this report agree on most areas.

However, I weighed the existing evidence differently than the RAC did. Yet we both took a weight of evidence approach. How does one weigh evidence? Imho, it always involves subjectivity.

I used an approach which gave more weight to researchers whose work appeared to be of higher quality, and to evidence derived from 3 or more different groups that used different study methods but yielded the same conclusion. I gave less weight to researchers whose work received substantial criticism, was not internally consistent, or used weak methodologies. I disregarded studies whose results conflicted with those of multiple other researchers. I factored in less tangible factors as well: how politicized choices led to certain research being performed (such as a large body of research favoring psychiatric causes, which was also dismissed by the report) while other valid research was omitted or buried. With respect to anthrax vaccine, in the face of limited and contradictory data we drew very different conclusions.

From the Executive Summary: "About 150,000 Gulf War veterans are believed to have received one or two anthrax shots, most commonly troops who were in fixed support locations during the war. Although recent studies have demonstrated that the anthrax vaccine is highly reactogenic, there is no clear evidence from Gulf War studies that links the anthrax vaccine to Gulf War illness. Taken together, limited findings from Gulf War epidemiologic studies, the preferred administration to troops in support locations, and the lack of widespread multisymptom illness resulting from current deployments, combine to indicate that the anthrax vaccine is not a likely cause of Gulf War illness for most ill veterans. However, limited evidence from both animal research and Gulf War epidemiologic studies indicates that an association between Gulf War illness and receipt of a large number of vaccines cannot be ruled out.

...There is little reliable information from Gulf War studies concerning an association of DU or anthrax vaccine to Gulf War illness. The prominence of both exposures in more recent deployments, in the absence of widespread unexplained illness, suggests these exposures are unlikely to have been major causes of Gulf War illness for the majority of affected veterans."

Yet the RAC cited another study of self-reports indicating that approximately 300,000 GW veterans received anthrax vaccine. According to self-reports, the vaccine correlates highly with GWS. According to (only) DoD, most of these self-reports are wrong. But other studies indicate that self-reports in GW veterans are highly reliable. Four studies (presented by the RAC at meetings I attended) show that anthrax vaccine is correlated with GWS, with a relative risk of 1.5-1.92. A Senate report of 1995 noted that more veterans in support locations had developed GWS, a reason to suspect anthrax vaccine. Which report is correct on this point?

Why are there limited findings from epidemiologic studies? The RAND report on vaccines, first completed in 1999 and later revised, is the only one of eight RAND reports on Gulf War exposures that has never been released. The two studies billed as investigating the long-term effects of the vaccine (the Tripler and CDC studies) have so far not released the long-term safety data. The Defense Medical Surveillance System data have been hidden since 2001, despite a promise to release quarterly analyses wrt anthrax vaccine. Why have eight expert groups during the last ten years called for long-term safety studies, but none are available? The reason is political.

Due to lack of hard data, the report ignores the many soldiers since the Gulf War who received anthrax vaccine and developed an identical illness as GWS. It also seems to have ignored limited data that current OIF/OEF veterans are developing undiagnosed illnesses at a rate of 15-40%.

Without these data, the RAC has drawn at least one insupportable conclusion.

Meryl

http://anthraxvaccine.blogspot.com

Posted by MBVIC at 7:36 AM | Permalink

http://www.baltimoreexaminer.com/local/112008anthraxpart2.html#comments
By Deborah Rudacille
Examiner Correspondent 11/20/08

Editor’s note: This is the second of two parts.
Eddie Norman is only 43 years old, but he gets confused when he tries to remember important dates. The Fort Meade veteran walks with an old man’s shuffle and has twice experienced kidney failure. To combat this misery, he takes 13 pills a day.

“What anthrax has done to me, I can’t put a number on,” he says. “It really destroyed me.”

Norman is not a victim of the anthrax letter attacks of 2001. He is a casualty of the Army’s Anthrax Vaccine Immunization Program, instituted in 1998 to protect American troops from the threat of biological warfare. About 2.1 million troops have received the vaccine.

The number of troops who have died, been disabled or suffered chronic health problems after receiving the vaccine easily eclipses the five dead and 17 sickened by the bio-terror attack that began just a week after the Sept. 11 attacks.

Between 1998 and 2000, the first two years of the mandatory vaccination program, approximately 20,765 troops were hospitalized, according to vaccination data that the Pentagon long withheld from lawmakers. The illnesses ranged from systemic reactions such as numbness, joint pain and extreme fatigue to autoimmune diseases such as lupus, musculo-skeletal disorders and other chronic conditions.

It is impossible to say with certainty how many have fallen ill after getting the shots because no one is keeping exact count.

The Food and Drug Administration, however, has confirmed 21 deaths following anthrax vaccination, including Richard Dunn, an employee of the anthrax manufacturer — 16 more than the number of people killed in the letter attacks.

The FDA does not say the troops died because of the vaccine, only that they died after taking the shots.

A troubled program

In the summer of 2001, the Department of Defense’s Anthrax Vaccine Immunization Program was on life support, with veterans, members of Congress and even high-level staff in the newly installed Bush administration all itching to pull the plug.

Active duty military personnel risked court-martial and reservists resigned en masse rather than take the vaccine. According to a 2002 General Accounting Office study that interviewed about 1,200 troops, the reserves were bleeding air crews, as more than half of the 301st Air Squadron at Travis Air Force Base in California had quit or planned to resign rather than take the shots. An Air Guard unit in Connecticut lost a third of its pilots.

Two-thirds of the Guard and Reserve pilots in that study told the GAO they did not support the vaccination program, and as many as 85 percent of those who received the shots said they had experienced side effects. Most admitted they had not reported their symptoms to medical personnel or supervisors for fear of being grounded.

The Pentagon told the GAO that “several hundred” active duty personnel also had refused the vaccine.

In April 2001, White House Deputy Chief of Staff Karl Rove sent a memo to Deputy Secretary of Defense Paul Wolfowitz that the anthrax vaccination program was “a political problem for us.”

Four months later, Sen. Tom Daschle, D-S.D., wrote to Secretary of Defense Donald Rumsfeld challenging the program. A House of Representatives committee report already had recommended suspending the program because of its “experimental” status.

In the midst of the turmoil, the FDA shut down the vaccine’s manufacturer, BioPort Corp. of Lansing, Mich., after citing the company with 84 violations in the manufacturing process. The touted Pentagon program was on the ropes.

But by the fall of 2001, the anthrax attacks breathed new life into BioPort, as the vaccine was in demand not only by the military, but also by consumers, who suddenly were willing to roll up their sleeves. Eight years later, BioPort — now Rockville-based Emergent BioSolutions Inc. — has netted nearly $1 billion in government contracts to produce a vaccine that some biosafety experts call “antiquated.”

Emergent Biosolutions spokeswoman Tracey Schmitt rebutted the allegations made by sick veterans who took the vaccine.

“Biothrax, which is the only FDA-approved vaccine to prevent the infection of anthrax, has been studied more than just about any vaccine in the United States and has been deemed safe and effective,” said Schmitt, who noted that the Institute of Medicine of the National Academies found the vaccine safe and effective in its 2002 report.

Last month, Secretary of Health and Human Services Michael Leavitt declared a seven-year “anthrax emergency,” contracting for another 14.5 million doses of the controversial vaccine for the civilian stockpile at a cost of about $404 million. Leavitt also extended blanket immunity from legal liability for anthrax vaccine-related injuries and deaths to Emergent as well as to government officials and agencies recommending use of its vaccine.

“In the summer of 2001 we were on the verge of getting the entire program canceled,” says an Air Guard pilot whose commander forbids him from speaking publicly about the vaccine. “After the anthrax letter attacks, everyone looked the other way.”

Shot down

In 1988, Norman joined the Army and served in Operations Desert Shield and Desert Storm. He received numerous vaccinations while deployed overseas. Shortly after returning home, he got so sick that he had to be treated at the Gulf War clinic in El Paso, Texas.

Nonetheless, he advanced from private first class to staff sergeant over the next decade. “I have a folder this thick, full of awards,” he says proudly. “That’s the kind of person I was.”

After the implementation of AVIP in 1998, he underwent his second round of anthrax vaccinations and immediately experienced muscle pain and stiffness and ringing in his ears, which grew progressively worse with each shot.

After the fourth shot, Norman says, he started suffering from tremors and involuntary muscle jerks. Following the fifth shot, “I couldn’t get myself out of the bathtub. I couldn’t get in and out of a car.”

He was flown to the Walter Reed Vaccine Health Center and discharged from the Army three years later without ever returning to work. His request for a disability retirement was recently denied. “When I went into the military my goal was to retire from the military,” he says. “Anthrax stopped me. I want that on my record.”

Capt. Kelli Donley’s military career also crash landed after she received the vaccine. Donley, of Beloit, Kan., joined the Air Force in October 1998 and received the first of three anthrax shots before being deployed to South Korea in 2000. Because the vaccine supply was low in the States, due to BioPort’s difficulties with the FDA, she received the other shots overseas from stockpiled supplies.

Like many troops, Donley, a former military lawyer, had a localized reaction to the shots. “My entire right arm went numb,” she says.

“They told me that was normal and that it would go away, and it did. But soon afterward, I started getting clumsy.”

A few months after her last shot, she was gripped by an attack of vertigo and began slurring words. She sought help from a military doctor, but a thyroid test produced normal results, and no further tests were ordered.

It was only after she returned to the States in 2003 that another military doctor ordered an MRI. “It confirmed that I wasn’t making it up.

My cerebellum [that part of the brain that’s critical to coordination and motor control] had shrunk,” Donley says. A civilian neurologist diagnosed her disease as sporadic spinocerebellar ataxia, which occurs when various parts of the nervous system that control movement are damaged.

Donley won a 100 percent disability retirement in 2006, after showing up with 238 pages of evidence. “My records were tight,” she says. “How many can say that?”

Woodbridge, Va., resident Steve Fisher received shots before being deployed to the Persian Gulf in 1999. The former aircraft mechanic spent 26 years in the military and was stationed at McConnell Air Force Base in Wichita, Kan., when he was vaccinated.

“After the first [shot], I got a big lump on my arm,” Fisher said. “After the second one, it swelled again, and I started having flu symptoms. After the third one, my arm swelled up like a peach, and I started having muscular problems, ringing in my ears, vertigo. I’d be walking, and I’d just fall over.”

A base physician diagnosed chronic fatigue syndrome and fibromyalgia and sent him to be tested for allergenicity to the vaccine, he says. Without his consent, the technician, who was administering the test, gave him a fourth shot.

“Then I got really sick,” he says. “I got lesions, lost my hair, couldn’t shake hands, couldn’t walk. For a while, I was worried that I would never walk again.”

Nearly a decade after receiving his last dose of anthrax vaccine, Fisher still suffers from chronic fatigue syndrome, fibromyalgia, an eroded esophagus, asthma, tinnitus and other chronic conditions associated with the vaccine.

“I wish I was an isolated case,” he says, “but I’m not.” Of the 150 men in his unit who got the shots, he says, “seven of us were completely disabled.”

Passive surveillance

Was the Pentagon aware of the serious health risks that came with the anthrax vaccine?

“No question,” says D.A. Henderson, former dean of the Johns Hopkins School of Public Health and former chief of public health emergency preparedness. “There were a series of reports of very severe problems.”

“We used to say that if we gave 10,000 people a glass of water, some number would get a rash and a headache,” says Henderson, who headed the World Health Organization’s campaign to eradicate smallpox through a mass vaccination in the 1970s. “The problem is, how do you sort this out and figure out what is attributable to the vaccine.”

Serious reactions to any type of vaccination are supposed to be monitored through the Vaccine Adverse Events Reporting System, a “passive surveillance” system set up in 1990 to alert the Centers for Disease Control and Prevention and the FDA to potential health problems. Slightly fewer than 6,000 reports of adverse events following anthrax vaccination had been filed through July 2008, according to the FDA.

However, servicemen and women treated in military clinics say clinic staff failed to file VAERS reports. Fisher filled out his own report and faxed it to the FDA, only to be reprimanded by a clerk at the clinic where he was being treated. “She said, ‘You shouldn’t have filled out that form. We’re supposed to do that.’ ”

The same woman later admitted that she had not been sending in the forms. Fisher says she told him directly, “I was directed not to.”

For years, the Pentagon limited the recording of vaccine events to reactions leading to either hospitalization or loss of 48 hours or more of duty time. The Pentagon also rejected a GAO recommendation in 2002 that it institute an active surveillance program to identify and monitor adverse events associated with the vaccine.

Physicians at the Walter Reed Vaccine Health Center preparing letters for sick soldiers filing for disability will say only that their symptoms are “temporally related” to anthrax vaccination. Fisher, Donley and Norman all have copies.

Scientists are fond of pointing out that correlation does not prove causality, and no study has yet proven a causal relationship between the vaccine and the more than 40 side effects reported on the product’s label. That may be because none of the agencies tasked with monitoring the vaccine’s safety has conducted a large epidemiological study of vaccine recipients.

At this late date, even the mechanism by which the vaccine creates immunity is not well understood, says George Mason University professor Serguei Popov. “The vaccine is a very crude precipitate,” he says, “a kind of complex biological soup that contains some protective antigen,” together with proteins and “a certain amount of toxins.”

Popov says that he is suspicious of the vaccine not just because of the health problems reported by veterans, but because it requires so many shots to build and maintain immunity. “Six shots in a year,” he points out. “It’s ridiculous.”

Go to "Scientific impossibility: Did FBI get their man in Bruce Ivins?" for Part I of this series

Posted by MBVIC at 2:07 PM | Permalink

Costly program with a shady past
http://www.baltimoreexaminer.com/local/112008anthrax.html
By Deborah Rudacille
Examiner Correspondent 11/20/08

Bacillus anthracis vegetative cells and spores are pictured in this undated photomicrograph from the official U.S. Department of Defense anthrax information Web Site.

Anthrax is an infectious disease caused by the spore-forming bacteria Bacillus anthracis.

The FBI on Monday, Oct. 8, 2001, took over the investigation into the anthrax death of a Florida man after the germ was found in the nose of a co-worker and on a computer keyboard in their office.

Anthrax Vaccine Immunization Program

The Food and Drug Administration licensed Anthrax Vaccine Adsorbed in 1970, based on a 1950s study of textile mill workers who processed imported goat hair. Each year, several mill workers contracted anthrax, a disease that humans get by touching, breathing or ingesting the pathogen bacillus anthracis from infected animals.

Of the 400 vaccinated workers, three contracted anthrax, and all of them developed cutaneous anthrax, a skin infection that is rarely fatal if treated with antibiotics.

The FDA then approved AVA as safe and effective against cutaneous anthrax.

When anthrax is inhaled, however, its spores germinate in the lungs, releasing toxins that cause internal bleeding and death.

For nearly two decades, scientists studying B. anthracis in biodefense programs — like the one at Fort Detrick in Frederick — received the vaccine that the Michigan State Department of Public Health produced under contract to the Pentagon.

During the first Gulf War the fear of billowing clouds of weaponized anthrax engulfing U.S. troops led to mass immunization. About 150,000 troops received AVA in 1990-91, although the vaccine had never been licensed by the FDA for that purpose.

“There were those who were against it and who made a great fuss about this being an experimental vaccine,” says D.A. Henderson, former chief of the Office of Public Health Emergency Preparedness.

“But it was the only vaccine we had.”

In 1998, the Pentagon mandated all active duty and reserve troops to receive the shots.

That same year BioPort Corp. bought the Michigan plant and the state’s license to manufacture AVA. The newly formed company was facilitated by the late Adm. William Crowe, former chairman of the Joint Chiefs of Staff under Presidents Reagan and George H.W. Bush.

Crowe was friendly with Fuad al-Hibri, the Lebanese-German businessman who became a naturalized American citizen while bidding for the vaccine production facility.

With a limited stockpile, BioPort secured a $45.1 million contract with the Pentagon to ramp up production of a new vaccine, with $16 million upfront for renovations to the aging Michigan facility.

Despite the gush of cash, from 1999 through 2001 the company failed a series of FDA inspections and failed to ship a single dose of new vaccine. The new product also failed potency tests, but the contract signed with BioPort obliged the Pentagon to pay for the unusable product.

The cost was steep: $10.64 per dose versus the previous price of $4.36 per dose under Michigan’s ownership.

With supplies short, the government then injected troops with the old vaccine. Some troops developed symptoms similar to those of Desert Storm veterans suffering from the mysterious collection of maladies lumped together as “Gulf War syndrome.”

In April 2000, the Department of Defense assigned a team of anthrax researchers from the Army Medical Research Institute for Infectious Diseases in Frederick to work on BioPort’s vaccine. The team included Bruce E. Ivins, who, with two of his colleagues, was awarded the Decoration for Exceptional Civilian Service for the role they played in getting production moving again.

Ivins’ job was enhancing the potency of the formulation.

The FBI later accused Ivins of salvaging the program by creating “a situation, a scenario, where people all of a sudden realize the need to have this vaccine.”

That “situation” was the anthrax letter attacks of 2001, which killed five people and sickened at least 17 others.

Sen. Tom Daschle, D.-S.D., received one of the anthrax-loaded letters, nearly two months after he wrote to Secretary of Defense Donald Rumsfeld challenging the vaccination program and punishment of soldiers rejecting the anthrax vaccine.

The FBI insists Ivins sent the letter, even though several leading scientists say it would have been impossible for Ivins, who died this past July 28 after overdosing on prescription Tylenol, to have committed the crime. (Read Part I of this series at baltimoreexaminer.com.)

“The case is solved. We are 100 percent sure that Dr. Ivins was the sole perpetrator of the anthrax mailings,” said FBI spokeswoman Debbie Weierman.

While doubt about Ivins’ guilt lingers in the science community, there is strong evidence the attacks saved the program.

Three months after the attacks, the FDA relicensed BioPort’s Michigan plant, and by the end of 2003, the company (now Emergent BioSolutions Inc.) signed a new $245 million contract with the Pentagon. The next year the company built a $95 million anthrax vaccine plant in Frederick and secured a $122.7 million contract from the Department of Health and Human Services to provide five million doses of the vaccine for civilian use in the event of an emergency.

In December 2005, the FDA issued a final order declaring the vaccine (now called BioThrax) safe and effective for use against inhalation anthrax.

To date, no enemy has assaulted U.S. troops overseas with anthrax.

Anthrax vaccine timeline

» February 1998 — Michigan Biologics Products Institute halts production of anthrax vaccine to renovate facility after stockpiled vaccine fails Food and Drug Administration tests for potency and contamination.

» September 1998 — Facility and license sold to BioPort Corporation for $25 million and $7.9 million of stockpiled vaccine. BioPort signs a Pentagon contract for $45 million worth of vaccine, including $16 million in immediate cash for renovations. FDA suspends shipments from the facility because of quality-control problems.

» September 1999 — Pentagon approves a $24.1 million bailout of the new company after the facility fails FDA inspections.

» April 2000 — Bruce Ivins is appointed to the Anthrax Potency Integrated Product Team from the U.S. Army Medical Research Institute of Infectious Diseases assigned to assist BioPort.

» July 2000 — Pentagon curtails vaccine program because of supply problems. Committee on Government Reform recommends suspension of anthrax vaccination program.

» April 2001— White House Chief of Staff Karl Rove concedes to Deputy Defense Secretary Paul Wolfowitz that AVIP is a “political problem.”

» June 2001 — Sen. Tom Daschle (D-SD) and Rep. Richard Gephardt (D-Mo.) write to Defense Secretary Donald Rumsfeld challenging AVIP.

» August 2001 — Two undersecretaries of defense recommend minimizing use of the vaccine.

» September 2001 — Chairman of the Joint Chiefs of Staff Gen. Henry H. Shelton rejects the recommendation, insisting that AVIP is the centerpiece of a bio-defense program.

» September, October 2001 — Anthrax letters mailed, killing five and sickening 17. Daschle receives one of the letters.

» January 2001 — FDA approves BioPort license to manufacture and distribute anthrax vaccine under new trade name BioThrax.

» June 2002 — Pentagon restarts AVIP. All military personnel required to receive anthrax vaccinations in run-up to Iraq war.

» March 2003 — Ivins wins award for work on BioPort’s vaccine.

» November 2004 — VaxGen of San Francisco awarded a contract to produce 75 million doses of next-generation anthrax vaccine, for which Ivins holds two patents.

» October 2004 — U.S. District Judge Emmett Sullivan suspends AVIP, ruling troops cannot be forced to comply with mandatory vaccination.

» May 2005 — Pentagon appeals judge’s order, seeks to resume mandatory vaccinations.

» May 2006 — Government Accountability Office report says vaccine has not been adequately tested on humans, long-term safety has not been studied and data on short-term reactions is limited.

» October 2006 — Pentagon begins voluntary vaccination program for select personnel.

» December 2006 — VaxGen’s contract for new vaccine canceled after it misses clinical trial deadline.

» February 2007 — Pentagon resumes mandatory vaccination of select troops.

» May 5, 2008 — Emergent BioSolutions Inc. (formerly BioPort) buys rights to VaxGen vaccine.

» July 29, 2008 — Ivins commits suicide.

» August 2008 — Ivins is fingered as culprit in anthrax attacks. FBI says he was concerned that Congress would end the vaccine program.

» September 2008 — PharmaThene Inc. of Annapolis and Emergent win government vaccine contracts worth more than $1 billion; Rep. Rush Holt, D-N.J., proposes a bipartisan commission to investigate the anthrax attacks and the government's response and investigation.

» Oct. 1, 2008 — Emergent wins second order from Department of Health and Human Services for 14.5 million doses of BioThrax worth $404 million.

» Oct. 9, 2008 — Emergent shielded from lawsuits related to anthrax vaccine by Department of Health and Human Services.

Posted by MBVIC at 9:00 AM | Permalink

http://www.baltimoreexaminer.com/local/crime/Scientific_impossibility.html

Scientific impossibility: Did FBI get their man in Bruce Ivins?
By Deborah Rudacille
Examiner Correspondent 11/16/08

Bruce Ivins was a cold-blooded murderer, a deranged psycho-killer, who in the fall of 2001, cooked up a virulent batch of powdered anthrax, drove to Princeton, N.J., and mailed letters loaded with the lethal mix to five news organizations and two U.S. senators.

At least, that’s what the FBI says.

Frederick Police talk with a woman who they identified as Diane Ivins, the widow of Bruce E. Ivins, 62, who died of an apparent overdose of prescription Tylenol mixed with codeine, at their home, Friday, Aug. 1, 2008, in Frederick, Md.

The letters infected 22 people, killing five, including two Maryland postal workers.

The sixth victim of the madness was Ivins himself, a 62-year-old biodefense researcher at the U.S. Army Medical Research Institute of Infectious Diseases, who committed suicide rather than face charges.

Case closed? Neatly wrapped up? Not so fast.

Married for 33 years — and a father of two — with a 35-year career as a civilian microbiologist at Fort Detrick in Frederick, Ivins, a devout Catholic, worked as a senior research scientist and an expert in animal models of anthrax. In 2003 he received the Army’s Decoration for Exceptional Civilian Service for work on an anthrax vaccine — an assignment the FBI now says provided a motive for the attacks.

Ivins apparently was obsessed with the investigation. According to the FBI, on Sept. 7, 2007, he sent an e-mail to himself, claiming to have figured out who mailed the anthrax letters. “I should have it TOTALLY nailed down within the month,” he wrote. “I should have been a private eye.”

Ivins, who did not name anyone in the e-mail, died on July 29, 2008, at Frederick Memorial Hospital after overdosing on prescription Tylenol with codeine. The FBI says he killed himself. The presence of the drug was determined from a blood sample. No autopsy was ordered.

Before his death, he was under 24-hour police surveillance, which included interrogations about his research and work habits, searches of his home and office, and intense questioning of family members and co-workers. Friends say that the FBI offered Ivins’ son $2.5 million and a sports car to hand over evidence implicating his father in the attacks.

The month before Ivins’ death, the federal government agreed to pay $5.8 million to another former Fort Detrick researcher, Steven Hatfill, for “improperly identifying him as a suspect in the case.”

When he learned the FBI was going to charge him with the crime after clearing Hatfill, Ivins swallowed a bottle of Tylenol.

Rush to judgment

In exclusive interviews with The Examiner, two former directors of the bacteriology division at Fort Detrick challenged the science underlying the case against Ivins. They argue it would have been impossible for Ivins to have produced the powdered anthrax in the contaminated letters in the time frame proposed by the FBI — the two weeks following the attacks on the World Trade Center and Pentagon on Sept. 11, 2001

. The BSL-3 (biosafety level 3) suite where Ivins worked at the Institute was composed of a series of laboratories and an office where access was restricted to trained personnel who were required to log in and out.

“Knowing the layout of the BSL-3 suite, the implication that Bruce could have whipped out [anthrax mixture] in a couple of weeks without detection is ridiculous,” says Gerald P. Andrews, director of the bacteriology division and Ivins’ supervisor from 2000 to 2003.

The first anthrax letters were mailed to the New York offices of ABC, NBC and CBS, the New York Post and the National Inquirer in Boca Raton, Fla., on Sept. 18, 2001. The second letters were mailed to Sens. Tom Daschle (D-S.D.) and Patrick Leahy (D-Vt.) on Oct. 9.

Infectious disease specialist W. Russell Byrne, who preceded Andrews as the division’s director, said he “never believed Ivins’ could have produced the preparations used in the anthrax letters working in the bacteriology division area of Building 1425.”

Departmental policy prohibits Institute employees from speaking with the media. But one researcher, speaking anonymously, told The Examiner: “It would have been impossible for Ivins to have grown, purified and loaded the amount of material in the letters in just six days. It simply could not be done.”

Claire Fraser-Liggett, professor at the University of Maryland School of Medicine and director of the University of Maryland Institute for Genome Sciences, asked, “What would have happened in this investigation had Dr. Hatfill not been so forceful in his response to being named a person of interest. What if he, instead of fighting back, had committed suicide because of the pressure? Would that have been the end of the investigation?”

The smoking flask

Fraser-Liggett’s genetic analysis of the anthrax spores in the letters led to a flask of hybrid anthrax bacillus (known as RMR-1029) created and managed by Ivins at Fort Detrick — a preparation the Justice Department says is the murder weapon.

“The key breakthrough was the science that then focused their attention laserlike onto that flask and the person who had control of that flask and the person who made the spores in that flask,” U.S. Attorney Jeffrey Taylor claimed in laying out the evidence against Ivins on Aug. 6, 2008.

The DNA evidence linking the dry anthrax spores in the contaminated letters to the “wet” anthrax spores in the flask of RMR-1029 is not in dispute. “The part that seems still hotly debated is whether there was sufficient evidence to name Dr. Ivins as the perpetrator,” Fraser-Liggett says.

Ivins kept the one-liter flask of RMR-1029, but some 300 people within the Institute also had access to the flask, according to those familiar with operations there. Before 1999, the preparation was stored in a separate containment area, about 100 yards from the main building. At that time, “access was more vague, because the flask wasn’t under Ivins’ direct custodial control,” Andrews says.

Ivins also shared samples of RMR-1029 with researchers at other facilities.

“Another lab might take a couple of milliliters of that spore preparation and create a daughter preparation,” Andrews says. “How many [samples] Ivins gave out I have no idea, but he did it through official channels, and there is a chain of custody records that indicates which labs got RMR-1029 and how much of the material they got.”

It was those “daughter preps” that ultimately led Fraser-Liggett to Ivins’ flask. Her team at the Institute for Genomic Research began DNA sequencing of the spores in the four anthrax-loaded letters recovered after the 2001 attacks. The team spent two years analyzing 20 different samples of B. anthracis to create a group of tests capable of genetically fingering the distinctive variety of anthrax found in the letters.

They screened nearly 1,000 samples of B. anthracis collected from labs around the world. “The results identified only eight samples that contained all four of the genetic mutations,” she says. “Each of those could be traced back to this one flask at USARMRIID-RMR-1029.”

“I have complete confidence in the accuracy of our data,” Fraser-Liggett says, but she concedes it fails to prove Ivins is guilty.

One reason for doubt is the sheer volume of powdered anthrax Ivins is alleged to have grown. Nearly 1 gram per contaminated letter would have required months of intensive labor and hundreds of agar “plates,” on which the spores are grown, Byrne says.

“This number of plates is impossible to handle inconspicuously,” says George Mason University professor and former Soviet bioweapons researcher Sergei Popov.

“It would be impossible to cover up these activities.”

Prosecutors insist Ivins carried out the work secretly at night and on weekends.

That scenario is patently impossible, Andrews says. “You can’t just throw a flask up in the air and have dry weaponized spores come down. One preparation may take between three and five days — Day 1 to prepare the materials and start seed cultures, Day 2 to inoculate the spores, Day 3 to harvest, centrifuge and purify the spores. And those are the wet spores,” he says, which then need to be dried into a powder. And that would take at least another day.

“So for 10 envelopes, 100 preparations would be required to make all the mailed material at three to five days for each preparation,” he says. “Months of continuous spore preparation without doing any other work and avoiding detection? It’s ridiculous.”

Taylor also insists Ivins had access to a lyophilizer — a sophisticated machine used to dry anthrax.

Andrews mocks the suggestion that Ivins produced the fine powdered anthrax by freeze-drying the newly harvested pores in the lab’s lyophylizer. “The only lyophylizer available was a speed vac,” he says. “That’s a low-volume instrument that you can’t even fit under a hood” used to contain toxic vapors and debris.

Even with the proper equipment, mass producing a sufficient volume of spores remained dangerous. It had the potential to contaminate not only the person doing the work, but also the lab environment. “Certainly if you had makeshift equipment you wouldn’t be able to pull it off without making a mess,” Andrews says.

Popov said that the only way the FBI scenario works is if someone else provided the spores to Ivins. “What if somebody fermented the spores for him?” he asks. “What’s in favor of this hypothesis is the presence of silica in the spores. This is a signature of a large-scale fermentation process.” In other words, the evidence points to a high-volume, mechanized operation and not to a lone madman cackling over agar plates at night in an empty lab.

Lack of evidence

The anthrax-laced letters contained no traces of DNA. There is no evidence indicating Ivins visited Princeton, N.J., at the time the letters were mailed — no fingerprints or hair samples from the “smoking mailbox,” no time-stamped photos at New Jersey automated teller machines or convenience stores, no gas receipts.

Apart from the flask of RMR-1029, the case against Ivins is this: He was depressed, working long nights and weekends in September 2001, and had the time to drive to New Jersey.

Ivins’ therapist, Jean Duley, who had a history of drug and alcohol-related charges, treated him for six months. She told authorities he threatened to kill her and his co-workers after learning he faced indictment. He was committed for a few days and released five days before his death.

“Dr. Ivins had a history of mental health problems and was facing a difficult time professionally in the summer and fall of 2001 because an anthrax vaccine he was working on was failing,” Taylor said in August. “He was very concerned, according to the evidence, that the vaccination program he was working on may come to an end.”

For more than a year, Ivins and other institute researchers had been working out the kinks on a 30-year-old anthrax vaccine suspected of causing serious health problems in Gulf War vets. He also was working on a next-generation vaccine for which he already had secured two patents. But in the fall of 2001, the Pentagon’s vaccine program for 2.4 million troops faced fierce opposition by lawmakers — including Daschle, pushing to end the program.

Taylor insists Ivins was the “sole culprit” and wanted “to create a situation, where people all of a sudden realized the need to have this vaccine.”

If that was indeed the anthrax killer’s motive, it worked.

Ivins’ innocence could rest on weird science

The single most important piece of scientific evidence that raises doubt on whether Bruce Ivins was the mastermind behind the anthrax attacks could very well prove his innocence.

The high silicon content of the spores and the presence of a bacterium B. subtilis in two of the recovered letters are significant scientific factors that have yet to be satisfactorily explained.

The FBI says that the silicon in the spores accumulated naturally during the growth process — important to its case against Ivins, who co-workers say did not have knowledge of the specialized techniques used to weaponize anthrax spores by coating them in silicon.

Silicon creates an electrostatic charge between particles that helps the lethal powder disperse more readily.

“The silicon is probably the most important scientific evidence that would lead anybody to question whether Bruce was capable of making these spores,” says Gerald P. Andrews, Ivins’ former boss.

Andrews and George Mason University professor and former Soviet bioweapons researcher Sergei Popov believe the silicon was purposely added, due to unnaturally high levels of the mineral in the spores.

Also unexplained is the presence of a unique genetic strain of the bacterium B. subtilis in the anthrax letters.

“Why wasn’t this unique B. subtilis strain looked for in Bruce’s lab — or any other lab in the BSL-3 suite?” Andrews asks. “It may, in fact, serve as a marker for where those preparations were really made.”

So far, FBI scientists have failed to produce a powdered anthrax equivalent to the toxic mix that Ivins is alleged to have turned out in the course of a few late nights and weekends in the lab at Fort Detrick.

“The only opinions that I would place any confidence in would have to come from individuals who have made the stuff, in the same quantity of the letters,” said infectious disease specialist W. Russell Byrne. “And then I would ask them to go into B3 in building 1425, work there for a couple of weeks and reproduce what they say Bruce did. That’s the only way I could, in good conscience and in the spirit of objective scientific inquiry, believe them.”


Bruce Edwards Ivins
• Born: April 22, 1946 in Lebanon, Ohio.
• Died: July 29, 2008 in Frederick, Md.
• Family: Married for 33 years to Diane Ivins (homemaker, day care provider and former president of Frederick County’s Right to Life). Two grown children, Andrew and Amanda
• Work: Senior biodefense researcher at the United States Army Medical Institute of Infectious Diseases at Fort Detrick in Frederick
• Education: B.A. (1968); M.A. (1971) and Ph.D. (1976) in microbiology, University of Cincinnati
• Hobbies: Played keyboards and sang in a folk group at St. John the Evangelist Catholic Church in Frederick; founded the Frederick • Jugglers, who performed at nursing homes, schools and festivals.
• Volunteer work: Frederick County Chapter of American Red Cross
• Political party: Democrat

Posted by MBVIC at 7:56 AM | Permalink

The report says that if pre-priming with an H5N1 vaccine becomes an acceptable strategy, thought should be given to including this in the regular seasonal flu vaccines.

The experts say that although it is still unclear if a bird flu pandemic will emerge, because of the potential high death rate and huge economic cost "we simply cannot afford to ignore it as a major global threat." They point out that estimates of global deaths from bird flu have suggested that up to 350 million people could die.

The candidate vaccine contains the bird flu strain H5N1 and an adjuvant called MF59.

He added: "If governments are thinking about stockpiling vaccine, you could actually be stockpiling it in people's arms."



http://www.medicalnewstoday.com/articles/128049.php

Vaccinations Against Bird Flu Should Happen Now, Say Experts

People should be vaccinated now against bird flu rather than waiting for a global pandemic to erupt, an international panel of experts - including a leading British influenza specialist - say in a new report. 1

The influenza researchers say the World Health Organisation (WHO) and national governments should give "urgent consideration" to the idea of priming people in advance of bird flu with a preparatory vaccination.

The idea is to give people a vaccination now against bird flu to build up the immune system, while there is still plenty of time to organise the programme, then give them a booster shot when the pandemic is imminent. The primed people could be protected in a week as opposed to six weeks. 2

The experts, including Professor Karl Nicholson, from Leicester University, state: "We think that WHO and governments should give urgent consideration to the potential risks and benefits of priming people who would be at greatest risk of infection if a pandemic of H5N1 influenza were to emerge (frontline laboratory and health-care workers), with the view to cautiously introducing a programme of immunisation."

In a report in the latest edition of the journal Lancet Infectious Diseases the researchers point out that a conventional vaccination policy against bird flu requires two doses of H5N1 vaccine before people are protected "which may be logistically difficult to organise".

They say there may be no warning before a pandemic suddenly appears, as the early danger signs may be missed.

"However, pre-pandemic priming has the potential to evoke a more rapid antibody (defence cell) response that might ameliorate the disease, cutting hospital admissions, deaths, and onward transmission of the virus," say the doctors.

The report says that if pre-priming with an H5N1 vaccine becomes an acceptable strategy, thought should be given to including this in the regular seasonal flu vaccines.

The experts say that although it is still unclear if a bird flu pandemic will emerge, because of the potential high death rate and huge economic cost "we simply cannot afford to ignore it as a major global threat." They point out that estimates of global deaths from bird flu have suggested that up to 350 million people could die.

The report concludes: "The maximum benefit from using a pre-pandemic vaccine may be gained from priming populations before there is evidence of a novel virus emerging and spreading, when systematic supply, distribution and vaccination strategies can be put in place."

Just a few weeks ago a team of researchers from Leicester University, including Professor Nicholson, together with vaccination experts from the Health Protection Agency, gave details of a British study showing that pre-priming people could give protection against bird flu within a week. 2

That study, released in a letter to the New England Journal of Medicine, looked at an experimental pre-pandemic vaccine being developed by Novartis Vaccines.

The candidate vaccine contains the bird flu strain H5N1 and an adjuvant called MF59. (An adjuvant is a substance used to improve the response of the immune system to a vaccine.)

The study looked at how quickly people mounted a protective immune response against H5N1 if they had already been pre-vaccinated with a different kind of flu vaccine, using a strain known as H5N3 together with MF59.

The pre-vaccinated people received their first vaccination between 1999 and 2001 as part of earlier studies.

Two groups, involving around 60 British patients, were involved in the study - one set who had been pre-vaccinated and another set that had not.

By day seven 80% of the primed group showed a protective response after one shot of the adjuvanted vaccine compared to 20% in the un-primed group.

Study investigator Dr Iain Stephenson, from University Hospitals Leicester, said: "With the pre-priming approach you could choose certain groups in advance, for instance health care workers, and almost vaccinate at leisure. Then you would only a need a week to provide protection."

The New England Journal of Medicine study was welcomed by other flu experts.

Dr John Wood, from the National Institute for Biological Standards and Control, a government funded body which helps in the production and testing of vaccines for emerging flu strains, told the BBC: "The fact that they seem to have this protection after eight years is really interesting."

He added: "If governments are thinking about stockpiling vaccine, you could actually be stockpiling it in people's arms."

An influenza pandemic occurs when a new influenza strain emerges (one to which humans have no immunity), mutates and spreads globally as a virus. Although it is not possible to predict the actual pandemic influenza strain, global health authorities have identified H5N1 avian influenza as a strain with the greatest pandemic potential in humans. 3

H5N1 is currently circulating in birds and has caused serious illness in more than 380 people worldwide with a mortality rate, among people known to have been infected, of greater than 60 percent. 4.

The purpose of pre-pandemic vaccination is to prime the immune system to better defend against infections from an H5N1 influenza virus and is intended for use before the World Health Organization (WHO) declares an influenza pandemic.

MF59 is used in a vaccine against seasonal flu specially designed for older people who have weaker immune systems so do not respond so well to traditional vaccines, although this particular vaccine is not currently available in the UK. More than 40 million doses have been distributed worldwide since 1997. 5

References

1 Jennings LC et al. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infectious Diseases 2008; 8: 650-658

2. Stephenson I et al. Antigenically distinct MF59-adjuvanted vaccine to boost immunity to H5N1. New England Journal of Medicine 2008; October 9: 1631-1633

3. World Health Organization Avian influenza H5N1 infection in humans, WHO Web site: http://www.who.int/csr/don/2004_01_22/en/index.html, accessed August 22, 2008

4. World Health Organization Cumulative Number of Confirmed Human Cases of Avian Influenza, WHO Web site, accessed August 19, 2008

5. Company data on file.

Source

Zarina Baloch
Public Relations Department
Novartis Vaccines and Diagnostics UK
Frimley Business Park
Frimley, Camberley, Surrey GU16 7SR
United Kingdom
http://www.novartis.com

Posted by MBVIC at 7:29 AM | Permalink