Investigating the FBI

Just for fun, let's investigate some facets of the FBI's case:

1. Leaks last weekend claimed that Ivins was about to be charged with committing the anthrax crime. Turns out, FBI had not yet brought its evidence against Ivins to a grand jury. And one of his attorneys denies that he was told he was to be charged: "It had never been made clear to him nor to us that he was 'the suspect,'" says DeGonia, Ivins' co-counsel.

2. The FBI said it couldn't produce its case till after the victims and their families were briefed, which took until 8 days after Ivins' death. This gave FBI time to create the story and select the evidence it wanted to present.

3. After Ivins died, FBI agents scrambled to obtain two computers Ivins had used a few days earlier, from a Frederick public library. Only this week did they obtain the search warrant normally required.

4. Remember how this story began one week ago? The following were released: pictures and audio from the hearing where a "Peace Order" had been issued against Ivins a week earlier. The order had been obtained by his substance abuse therapist, herself a recovering multi-substance abuser. But the therapist was on probation for substance abuse (DUI's) and had had an FBI agent suggest she get the order, as well as coach her in the crimes that were about to be laid at Ivins' feet. Could she be interviewed directly? No--she had retreated to an undisclosed location, where she apparently remains.

5. Video of a crazed, estranged older brother named Tom Ivins hit the TV screens, though he had not seen Bruce in 23 years. This guy indicated Bruce thought he was God, had been coddled by their mother, and wasn't a real man, as Tom was. Brother Tom was really scary, but the national media were only too happy to put him in front of the cameras to cast aspersions on Bruce.

6. Only two months ago, the Justice Department had settled with "person of interest" Steven Hatfill, for 5.8 million dollars--but they wouldn't exonerate him or admit liability. Suddenly today (after I mentioned how odd it was that FBI refused to acknowledge Hatfill's innocence, given its claim to have an airtight case against Ivins) the formal exoneration appears.

What is the logical conclusion?

FBI was not ready to prosecute a case against Ivins when he fortuitously killed himself the Tuesday before last. If the evidence of Ivins' guilt had been unequivocal, Hatfill would have been cleared a lot earlier. Looks like the FBI was still hanging onto Hatfill as a possible fallback guy, if they couldn't pin the deed on someone else. You know how the line would go: 'the judge made us pay him off, but he's guilty in our book.'

The FBI then scrambled to come up with enough juicy dirt to clinch the case in the media: producing a mad scientist, fixated on women, poisoning people even before the anthrax letters, thinking he's omnipotent. Even though the two people who were used in this audio-video dog and pony show were themselves highly flawed, the media bit: hook, line and sinker. (Looks like the FBI can play the media a lot better than it plays gumshoe.)

Then, when a few folks, followed by the media, pointed out the profusion of fallacy, fluff and absence of hard evidence during 3 days of successive leaks, the FBI started scrambling to find some evidence--quick--and plug some holes. They are still at it.

Looks like Ivins' death was a precondition for FBI to "close the case."

Emergent Biosolutions dropped 23% today

Correction
Guess El-Hibry knew what he was doing when he sold 230,100 shares of the anthrax vaccine manufacturer between July 17 and August 6, since the vaccine company Emergent Biosolutions reported poor net earnings despite sales being up 88% this quarter. On sales of 230,100 shares since mid July, he earned about $3 million dollars.

Note that some of the documents released by the FBI yesterday detail many past problems at this vaccine factory.

More than 100 people had access

The shiny new methods of "microbial forensics," touted by the FBI for months as offering a new break in the case, have in fact revealed little or nothing. As the New York Times' Scott Shane and Eric Lichtblau reveal, "officials admitted that more than 100 people had access to the supply of anthrax that matched the powder in the letters."

But the same article notes that FBI conclusively decided Hatfill had no access to the letters' anthrax, even though he was working at Fort Detrick during the time this strain of anthrax was stored there. If the FBI conclusively decided this (though the evidence appears weak), why haven't they provided Hatfill with a full exoneration? The FBI's logic is incomprehensible. I am not trying to finger Hatfill, who I believe is innocent. Just trying to understand the FBI.

FBI Subjectivity and Disinformation

If the FBI cannot place Ivins at the scene of the crime (the Princeton mailbox) on the required dates, then who cares what sorority houses might be near the mailbox? The sorority angle becomes irrelevant, since he did not mail the letters in Princeton.

Remember, this is one of the most complex, expensive cases in the FBI's history. So after spending hundreds of thousands of man-hours on the case, you can be sure the FBI has also figured out that the sorority angle leads nowhere. Yet the documents the FBI released yesterday place great emphasis on Ivins' obsession with kappa kappa gamma sorority. The only explanation is the FBI's desire to publicly sully Ivins' character, not solve the case.

The FBI has been unable to provide a sensible explanation for how Ivins' testing for anthrax contamination outside the biosafety suites implicates him, when they found not a spore in his home or car. Fort Detrick has a long history of anthrax contamination (which led to the death of an electrician, Joel E. Willard, 50 years ago). Many anthrax samples were brought to Detrick for testing after the letters were sent. Why weren't the halls and other areas formally tested for contamination after all that traffic? The FBI spent a lot of time showing Ivins to be an obsessive guy: but when his obsessive testing of the Detrick facility found contamination, the FBI blamed him for producing it, rather than for detecting it. And Ivins' testing and cleaning occurred many months after the letters were sent.

The FBI claims that Ivins deliberately gave them improper samples, tried to put the blame on another scientist, gave them scads of false information. But we have only their word on this. Why wasn't the polygraph evidence released?

Why has the special preparation of the spores become such an area of confusion and disinformation? Because there was no way Ivins could have obtained the recipe, and the FBI is doing its darnedest to plug the holes in its case?

For an FBI desperate to get this case closed; an FBI that told Ivins' children their dad was a mass murderer and offered his son a $2.5 million reward to turn his dad in; an FBI that may have deliberately hounded Ivins because he looked like he would crack, thus obligingly closing their case; it's the objective evidence that's missing. Can we trust the FBI's morass of subjectivity?

Beyond a Reasonable Doubt?

U.S. Attorney Jeffrey Taylor said at a Justice Department news conference, "We regret that we will not have the opportunity to present evidence to the jury."

Everybody else regrets it too--since what came out today was another pastiche of innuendo and circumstantial evidence, with an awful lot of holes. Time for the FBI to present all of what it has to the court of public opinion, don't you think? A major benefit for the FBI of sharing its case would be restoration of confidence in the US' system of justice, the Justice Department and its FBI.

I worked all day at the hospital, but want to get something out tonight, in a hurry, regarding the strength of some of the evidence presented today. I'll no doubt have more to say once I have read the rest of the "evidence".

Here goes:

1. Ivins had just been immunized against anthrax. He was required to have yearly immunizations, and some anthrax scientists have chosen to be vaccinated every six months for safety, since the vaccine's efficacy is weak--and Ivins had proven its weakness in several animal models. In his career he had probably received about 33 separate anthrax vaccinations.

2. Earlier, we heard the envelopes came from the specific post office he frequented. Today the affidavit states it is "reasonable to conclude" they were purchased in Maryland or Virginia.

3. Choosing a strain that would direct suspicion at Ivins. The perpetrator(s) were tremendously careful to leave no clues vis a vis the envelopes. For example, block lettering was used, which is the hardest to identify with handwriting analysis. Second, stamped envelopes were chosen to avoid using saliva. Third, there were no fingerprints on anything.

Why would the person(s) who took such care select an anthrax strain that would focus suspicion on himself? In 2001, strain analysis was possible. It had been discussed many times as a forensic tool for biowarfare, including in a paper I wrote in 1992, which Ivins had read, and in which I thanked him for his contributions.

4. Ivins was the "sole custodian" of the strain. But the strain was grown in 1997, and many people had access to it over that four year period. Having received a sample, or obtained it surreptitiously, they would be "custodians" of it too.

5. Ivins was in the lab alone at night for prolonged periods--much more so than at other times. Perhaps so. But the document states he spent exactly the same amount of time in the biosafety suite each night for 3 nights running just when the first letters were sent (September 14-16): 2 hours and 15 minutes, each time. That is a funny coincidence, when he spent variable amounts of time in the building. To me it suggests a clerical error.

Between September 11, 2001 and the first anthrax letter being found, there was a LOT of talk about a biological attack being next. I was deluged with queries about this at the time. So if Ivins was trying to work harder under the cloud of an impending attack, it makes sense to me, because I was working harder.

6. If the motive is that he was mentally disturbed, agitated, out of control, then the care he took with those envelopes is paradoxical.

7. He was under pressure to help Bioport with its substandard anthrax vaccine. So he wanted to help Bioport by creating an attack? That doesn't make sense. He had proven Bioport's vaccine had limited efficacy. He knew about the safety data implicating the vaccine in chronic illnesses, particularly autoimmune illnesses. His colleague at Detrick, Phil Pittman, MD, took the possibility the adjuvant was causing illness seriously, and had published on this. Bruce told me he thought he might have a blood illness due to the anthrax vaccinations he had received.

But most critically, Bruce had created new anthrax vaccines designed to replace Bioport's (now Emergent Biosolutions') vaccine. Why would he want to do Bioport a favor?

And the vaccine that was used after the attack was Bioport's (licensed in 1970, when Ivins was still in school) not Ivins', since Ivins' vaccines were not licensed or fully tested.

8. The affidavit carefully wordsmiths around Ivins' lack of knowledge for making weaponized anthrax, by emphasizing that he might have known some of the things needed to make such a product. The statement is this: "Dr. Ivins was adept at manipulating anthrax production and purification variables to maximize sporulation and improve the quality of anthrax spore preparations. He also understood anthrax aerosolization dosage rates and the importance of purity, consistency and spore particle size due to his responsibility for providing liquid anthrax spore preparations for animal anthrax spore challenges." After 28 years making anthrax, it would be odd if he weren't expert in all these areas.

9. We still need to know about the finished spore preparation in the letters. I am one who tends to believe the first reports in contrast to the later ones: the ones that come out before someone decides the story needs to be shaped. So it is logical to conclude that a very small amount of an additive, or a special treatment, was used to prepare the Daschle/Leahy letter spores in order to make the spores repel one another. This was multiply reported by scientists who had first crack at the sample. Later, other scientist who got to study the spores may have said there was no additive. But were they given the same spores? Had the effect worn off? The 2006 Beecher (FBI) paper claimed there was no additive, but curiously cited no research to back up this claim. To me, this was written by FBI in a crude attempt to shape the story, and was soon disputed by a UN official, Dr. Mereish. If you can show me what the real preparation was, and how Ivins could have learned to make it, I would find the story a lot more convincing.

10. The Naval Medical Research Center held all the samples, under contract to FBI. This is a trivial point, but the Army and Navy are longstanding competitors.

11. Mental health. If Ivins was so out of control, so scary, why was he allowed to keep working in a high containment lab with access to some of the world's deadliest pathogens for so long? Is it true, as has been reported, that it was an FBI agent who suggested Ms. Duley ask for a protection order? The wording on the order suggests she was coached by the FBI; how else would she know Ivins was to be charged with capital murder? More information on her finances and pre-existing legal troubles, and whether they had been remedied recently, is needed.

12. Ivins cursed about giving journalist Gary Matsumoto information requested in a Freedom of Information Act request. Matsumoto is a most peculiar journalist. We had a number of conversations. He would not get off the phone, sometimes staying on for an hour or more. He would harass me, in an attempt to shape the story. He worked very hard, trying to force me to say that the only problem with anthrax vaccine was its squalene adjuvant, although there were many reasons to question that assertion. I hung up on him more than once, exasperated, and no doubt I used some foul language describing our conversations to others.

13. The anthrax attacker MUST be able to be placed at the scene of the mailboxes, at the times the letters were mailed. Surely the FBI sought information on these dates and places from everyone with anthrax access in the US and probably abroad, shortly after the letter attacks. Either Ivins had an alibi or he didn't. Put up or shut up: this is the most critical evidence in this case. If Ivins cannot be placed in New Jersey on those dates, he is not the attacker, or he did not act alone.

Furthermore, there were other letters. Some contained other powders. Some were said to contain some anthrax in contemporaneous news reports. Some were warnings. These were mailed from other places, on other dates. The FBI has sat on this collateral evidence. If these envelopes, ink or block print were the same, the attacker would have to be placed at the scene when those letters were mailed. What happened to this evidence? Pony up.

14. The anthrax letters were sent for effect, not to kill. (See my 2002 article for more on this.) Here are the effects that resulted, at least in part, from the letters:

A. The Patriot Act
B. War against Iraq
C. A new bioterrorism industry, worth over $50 Billion so far, was created
D. The moribund Anthrax Vaccine Program was resurrected

Who benefited? Ivins was no beneficiary. (Had the Bioport vaccine been killed, as planned, maybe Ivins' vaccine would have taken its place.)

You know who benefited:

• The bioevangelists, who have made a ton of bucks on the threat
  
• The Neocons, looking for an excuse to attack Iraq. The Iraqis may not have attacked the World Trade Center, but by golly, everyone knew they had anthrax!
  
• Those seeking to consolidate more power in the executive branch, increase the surveillance of Americans, get rid of Habeus Corpus, and on and on.
• The anthrax vaccine manufacturer, Bioport. Guess what? Its CEO, Fuad El-Hibri and his company Intervac bought Bioport in 1998 with $3 Million down. The day before he bought it, the Army agreed to indemnify it for him, for free. Then contracts totalling hundreds of millions of dollars started rolling in.
  
• Correction: Twice last week, one day after Ivins went into the hospital with an overdose, and one day after Ivins died, El Hibri sold some of his shares in the company. Did he think the company would get some extra scrutiny and its share price plummet? Although the shares were reportedly sold "automatically," if you review the price fluctuations, that would appear unlikely. Since mid July 2008, the sales totalled about $3 million.
  

I am still waiting to hear about how the FBI eliminated from consideration those with a real motive.

FBI Apologizes--CBS News

See what power reporting has? It can solidify a tower of Bullshit, or cause it to collapse.

The bloggers deserve a lot of credit for transforming the Ivins reportage, via impressive investigations and and logical thinking. Their work may have turned this case from one of conviction by innuendo -- into one that will receive a fairer hearing, and has even elicited an apology by FBI for the pathetic and improper leaks over the past 5 days. TIME reporters Amanda Ripley and Massimo Calabresi deserve kudos for telling it like it is:

While the FBI waits to formally release its evidence against Bruce E. Ivins, the microbiologist it claims to have linked to the anthrax mailings seven years ago, who killed himself on July 29, the public is getting a sneak peek — by way of federal leaks to the media. The leaks are piling up almost too fast to keep track of. Some seem damning, others perplexing, but the pause is creating a strange void — in which leaks are followed by rebuttals from Ivins' colleagues and his attorney (who steadfastly denies that his client had any role in the attacks) and then followed by more leaks. The result leaves neither Ivins nor the FBI looking good.

And CBS has it right, based on the leaky information so far available:

It is unclear how the FBI eliminated as suspects others in the lab who had access to the anthrax. It's not clear what, if any, evidence bolsters the theory that the attacks may have been a twisted effort to test a cure for the toxin. Investigators also can't place Ivins in Princeton, New Jersey, when the letters were mailed from a mailbox there.

So, the FBI caved, at least for today:

FBI official John Miller said that "what we have seen over the past few days has been a mix of improper disclosures of partial information mixed with inaccurate information and then drawn into unfounded conclusions. None of that serves the victims, their families or the public."

I'm going to sleep better tonight. And look forward to reviewing the evidence tomorrow.

"Pressure Grows for FBI's Anthrax Evidence"--NY Times

The NY Times' Scott Shane and Nicholas Wade are drilling down on the essentials, elaborating on who had access to the particular anthrax found in Ivins' lab and, purportedly, the letters:

But at least 10 scientists had regular access to the laboratory and its anthrax stock — and possibly quite a few more, counting visitors from other institutions, and workers at laboratories in Ohio and New Mexico that had received anthrax samples from the flask at the Army laboratory.

Good work on this! Let me reiterate: No matter how good the microbial forensics may be, they can only, at best, link the anthrax to a particular strain and lab. They cannot link it to any individual.

Jean Duley redux

Bloggers Larisa Alexandrovna (Raw Story.com) and Glenn Greenwald (Salon.com) beat the major press on Jean Duley's background. Seems she has an extensive police record including two arrests for DUI since 2006 and a remote drug paraphernalia charge. I suspected as much, having read that she was involved in treating addicts with Suboxone. Many substance abuse counselors are themselves recovered abusers. In this case, her recovery seems to be in question. And she just graduated college!

This inexperienced lady with a questionable background is the only person to come forward claiming Ivins was a homicidal maniac. And to read the media coverage, you see that this tactic might have succeeded. Why didn't the AP, NY Times, and the other outlets that posted audio of her court testimony and went overboard covering her claims do the simplest background check?

Anthrax Evidence is Said to be Primarily Circumstantial

Scott Shane, who has always done terrific reporting on the anthrax letters story, first at the Baltimore Sun, later at the NY Times, has again hit a home run. His piece, Anthrax Evidence is Said to be Primarily Circumstantial, lays out the kind of case that may be made against Ivins.

Unfortunately, the evidence reported against Ivins looks much like the evidence collected against Hatfill; and this type of evidence might exist if someone were trying to implicate Ivins. For instance, the envelopes were said to have been purchased at a Frederick post office Ivins frequented. (Is it true the envelopes can be definitively linked to one post office?) But other Detrick workers must also use that PO. Sounds to me like the use of "Greendale" on the letters' return address: which happened to be a suburb near Hatfill's former home in Harare, Zimbabwe.

A reasonable hypothesis is that former Detrick scientists Steven Hatfill and Ayaad Assaad were each independently 'set up' to take the fall on the anthrax letters. The strategy might have succeeded were the case not so high profile, and if each man had not aggressively defended himself. If the same kind of evidence is being used against Ivins, he may have been set up too.

Shane notes that FBI agents lack any evidence that Ivins visited New Jersey on the dates the letters were mailed. But isn't such evidence essential for a determination that Ivins is guilty and acted alone?

CNN carried part of this story but its version omitted some crucial information included in Shane's story: that ten other people also had access to the anthrax strains said to implicate Ivins. Why the creative editing by CNN?

Here is the NYT paragraph:

While genetic analysis had linked the anthrax letters to a supply of the deadly bacterium in Dr. Ivins’s laboratory at Fort Detrick, Md., at least 10 people had access to the flask containing that anthrax, said the source, who spoke on condition of anonymity because he was not authorized to discuss the investigation publicly.

Here is CNN's version:

The DNA linked the anthrax used in the mailing to a flask used in Bruce Ivins' lab at the U.S. Army Medical Institute of Infectious Diseases, said the source, who was not authorized to speak publicly about the case.

The media must refrain from acting as judge and jury, and give us the facts, ma'am, just the facts. Note that we are no better off today than all weekend: virtually none of the official sources have been identified. Why is it taking DOJ so long to get its story straight? Bruce died last Tuesday: if DOJ needs to brief the victims' families first, well, they have had six days to do so.

And Shane makes this most important point:

The stakes for the beleaguered FBI and its troubled investigation, now in its seventh year, could hardly be higher.

Is that what this is really about? Make the FBI look like a hero with its fancy new forensics, and close the case before the White House changes hands and some new officials start sniffing around?

Op-Ed: The Death of Mr. Ivins

This am's Hartford Courant carries a sensible Op-Ed. It ends,

Congress should press the Justice Department for a full and public accounting of this case. Forcing the FBI to lay out its evidence against Mr. Ivins is the only way the public can be sure the agency's methods were reasonable. It's only fair.

Anthrax was a strain in Ivins' lab--CNN

CNN notes,

The DNA linked the anthrax used in the mailing to a flask used in Bruce Ivins' lab at the U.S. Army Medical Institute of Infectious Diseases, said the source, who was not authorized to speak publicly about the case.

Maybe so, though I am awfully tired of all these "unauthorized" sources who talk anyway.

But guess what? Choosing strains is an old trick well known to those in biodefense. Perpetrators specifically select a strain that will throw suspicion on someone else. And scientists share all these strains. Back in 2001, no one knew how many labs had Ames anthrax. And now the FBI plans to indict based on Ivins' mix of strains? Anyone can mix strains.

Bottom line: this proves very little.

Did Ivins have the knowledge and access to produce weaponized, dry anthrax?

The media have reported that some biodefense scientists said Ivins couldn’t produce the powdered anthrax found in the letters, but at least one scientist said he could.

One problem is that the public does not know how the letters’ anthrax was produced, nor whether it contained an additive that promoted dispersion.

Anthrax is produced in liquid culture, and the methods for growing it are readily available in the open literature. However, in this form it does not make a good biological weapon. To cause serious infection it must be inhaled. For optimal effect, the spores need to stay airborne as long as possible, not bind to larger particles in the environment, and be of the right size. The method for producing anthrax that has been optimized for these properties is a closely held secret, as it should be.

It has been illegal to possess biological weapons since 1975; some people believe the possession of any dried anthrax is illegal. (The Biological Weapons Anti-Terrorism Statute of 1989, Title 18, USC 175 was amended on 10/24/01 to include possession without legitimate purpose as a violation.)

Although powdered anthrax was produced at Fort Detrick when the US had a biowarfare program, before 1970, no one still there was part of that program. Whether the letters’ anthrax was produced using Detrick’s old method or something else has not been made public.

In fact, even the scientific literature is contradictory regarding the use of an additive in the anthrax placed in letters. In August 2007, an FBI forensic scientist claimed there was no additive, while a colleague in September 2006 who worked with the material said there was. Media reports from 2001 indicated the spores contained an electrostatic charge, and it was thought this charge was a function of special processing. Now the FBI has indicated this is not so.

It is unlikely that Ivins knew how to prepare weaponized anthrax, but not inconceivable.

However, the amount he would have had to process was larger than needed for his animal experiments. Each letter is thought to have contained 2-3 trillion spores. I can’t recall his animals receiving more than about a million spores each. So roughly one million times as much anthrax was needed for the letters as for an animal experiment. Increasing the scale of fermentation should have been noticed. Drying anthrax would have been noticed, as there was no need to prepare any other anthrax specimens this way. Sudden use of a dryer for large samples would be suspicious. Post-drying processing for the letter anthrax likely took place; were the materials needed available to Ivins?

How the anthrax was produced and processed is crucial to solving the case, but the information is classified. The FBI’s failure to provide briefings to Congress and reliable information to the public means it may be impossible for those outside the investigation to independently evaluate the evidence in the case.

More Information on Ivins' Therapist

From a story in the Frederick News-Post:

Duley's fiance of seven years, Mike McFadden, spoke to The Frederick News-Post on Saturday from their home in Williamsport and provided a statement on her behalf.

"Jean is currently at an undisclosed location," McFadden said.

Duley had numerous meetings with the FBI in the past month, McFadden said, but he declined to provide specific information about those meetings.

He said Ivins had threatened Duley's life.

Court documents state that Ivins had made "homicidal threats, actions, plans, threats and actions towards therapist."

Duley, a social worker, led counseling sessions attended by Ivins.

The story of Ivins' death and investigation by the FBI broke early Friday. Since then, McFadden said, Duley has been hounded by the national press.

Someone broke into her car Friday night, McFadden said, though no police report was filed. "Nothing was taken," he said, "but everything was jumbled up."

Duley told the court she had been subpoenaed to testify before a federal grand jury Friday. She was reluctant to become involved in the FBI's investigation of Ivins, McFadden said. "She had to quit her job and is now unable to work, and we have spent our savings on attorneys."

This report raises a number of interesting questions. Why did she have to quit her job? Why is she unable to work? Ivins is deceased and no threat, if he ever was a threat. Was she instructed to hide out by federal employees?

Case closed?

On the one hand, the Justice Department is considering closing the anthrax letters case this week.

On the other hand, the FBI seized computers (and this time with no court order) from the Frederick Public Library this week.

Looks like they were in a hurry. Last two times they examined computers they had a court order. So now the computer sites of a mentally disturbed scientist are going to be some of the evidence that convicts him, post-mortem?

Journalists, their lying sources, and the anthrax investigation

Glenn Greenwald has written a nice piece today in Salon.com on journalists, anonymous sources and the anthrax letters case. He discusses Ivins at the beginning and end of his long article.

Looking closer at Jean Duley's statements

The AP has reported startling and frightening claims by Dr. Ivins' therapist Jean Duley in several stories, including one just published by Dishneau and Jordan:

Report: Therapist feared scientist poisoned people

She claimed, "As far back as the year 2000, the respondent has actually attempted to murder several other people, either through poisoning. He is a revenge killer. When he feels that he's been slighted or has had — especially toward women — he plots and actually tries to carry out revenge killings," Duley said. She added that Ivins "has been forensically diagnosed by several top psychiatrists as a sociopathic, homicidal killer. I have that in evidence. And through my working with him, I also believe that to be very true."

As a physician who is called to assess psychiatric patients presenting to the ER, I find her statements troubling: if any of these psychiatrists diagnosed Ivins as homicidal, that physician would be required to start immediate proceedings for psychiatric hospital commitment. Patients who are a danger to themselves or others must not be allowed to carry out such activities. That is the law.

Furthermore, if Duley believed Ivins had attempted serial murders, she would be required to consult with her supervising physician and immediately call in the police. Was this done? Who was poisoned? If, as reported, she had only been treating Ivins for six months, what evidence did she have of more remote attacks?

Finally, patients who are actually planning murders (or have attempted them) do not usually tell other patients and a therapist about it in group therapy sessions. Someone who talks about such thoughts is trying to explain how they feel and get help.

One media report said Duley was no longer employed at the mental health center where she treated Ivins. Was she let go for nonprofessional behavior? We need to know more about this woman, the basis for her claims, and whether she carried out her professional duties with regard to them.

In the interest of not adding to the confusion re Ivins

http://www.courant.com/news/local/hc-anthrax0802,0,2705314.story

My comments to a reporter were misinterpreted and I want to clarify them. The story says, "Ivins was a civilian working in the Army's main bioterrorism program. Nass said Ivins always complained about being treated poorly by some of the military personnel."

Bruce did not ever complain to me about being "treated poorly." I suggested to the reporter that Bruce might have been a relative outsider since he was a civilian in an army institution run and mostly staffed by military officers and soldiers. I had also discussed with Bruce the possibility a chronic illness might be exacerbated by his yearly booster vaccinations. But if you are an anthrax expert, and you need yearly vaccinations to continue in your profession, you don't have many options. I don't know whether he considered this a serious problem.

I probably spoke to Bruce every 1-2 years, meeting up at conferences and sharing scientific information. I liked him. One could rely on the quality of his research. I don't think we spoke for the past six years. I wish we had.

In Search of the Anthrax Attacker, February 2002

A friend put this article into HTML and added some links to the references. I think it is valuable background for understanding the letters case.

Sourcing

Back in 2002, in preparation for an interview on the anthrax letters for "Unsolved Mysteries," I reviewed the media coverage. As I read article after article, I found that the statements most germane to an understanding of the case were almost entirely unsourced. It was unnerving to conclude that I knew very little about the letters, as so little of the reported "evidence" was derived from people willing to go on the record.

The same appears to be happening in current reporting on Bruce Ivins. Though I deeply respect LA Times reporter David Willman, who has twice won a Pulitzer, his breaking stories on Bruce Ivins are almost entirely unsourced. Did Ivins really stand to gain financially from his anthrax vaccine patents? Historically, government employees do not receive these royalties: the government does. If this modest bench scientist had a financial motive (plus access to weaponized anthrax, plus ability to mail letters from New Jersey and other places such as the UK) it is critical to the case, and the evidence needs to be unimpeachable.

Lest we forget: this case has had 3 false leads, who were probably deliberately set up, before Bruce Ivins: Hatfill, Assaad, and the ex-Detrick scientists who harrassed Assaad.

He did it to test his vaccine????

The anthrax letters did not test anyone's vaccine. For people exposed to the anthrax letters, anthrax vaccine was given in three doses over 4 weeks. It takes about 4-6 weeks after vaccinations start before recipients develop levels of antibodies to anthrax that may be protective.

The vaccine's label even points out that anthrax vaccine is NOT a treatment for anthrax and does not provide protection for acute exposures. You need to take antibiotics while waiting for vaccine protection to develop...and because vaccine protection is variable, and depends on each person's ability to mount a protective immune response, antibiotics are a much more reliable protection, even after 2-3 doses of vaccine have been administered and 4-6 weeks have gone by.

So no scientist would send anthrax letters to "test a vaccine." It's a ridiculous theory.

Did the person who fed this idea to the media (in a desperate attempt to create a motive that could implicate Bruce Ivins) have anything to do with the anthrax letters? Or perhaps work for the Justice Department?

An Improbable Ending: Scientist Bruce Ivins Tried and Convicted by the Media as Anthrax Letter perpetrator, after his suicide

For 7 years the Justice Department couldn't seem to get anything right about the anthrax letters. For years, it harrassed Steven Hatfill, a self-described bodyguard for South African white supremacist Eugene Terrblanche and an unlicensed physician, despite a shocking lack of evidence. He is now $5.8 million richer as a result.

But the White House told press just days after the letters started appearing that the anthrax came from a government lab. Then that claim was buried as the justice department "pursued" the case everywhere else. Only recently were the press informed that government scientists were being investigated regarding the crime.

Ph.D. scientist Bruce Ivins worked at Fort Detrick, the Army's center for biodefense, since about 1980. He was one of a small group of scientists who worked exclusively on anthrax, and most of his career dealt with the development of anthrax vaccines.

I first met Bruce at a conference on biowarfare in the spring of 1991 at the University of Maryland. We happened to sit next to each other, in the front row, and enjoyed chatting. Bruce sent me information relevant to my research on Zimbabwe's anthrax epidemic, and I commented on his work. We continued to correspond occasionally for about ten years. Bruce had a chronic blood disorder, which he thought might have been due to his many anthrax immunizations, and encouraged me to continue investigating the vaccine's side effects. He shared papers with me on the effects of the vaccine's aluminum adjuvant in experimental animals.

Now it turns out that Bruce was one of several scientists the justice department turned its spotlight on, after Hatfill succeeded in not only getting them to leave him alone, but also pay him for destroying his (admittedly tawdry) reputation. Bruce was a gentle guy, the opposite of Hatfill. While Hatfill stirred up a cauldron of controversy, held press conferences and initiated many legal efforts (I was subpoenaed as a witness for his case against the New York Times), Bruce got depressed. Then killed himself, apparently.

Bruce wasn't the anthrax perpetrator. First off, he had no motive. He didn't need to direct money toward the bioterrorism effort, or increase interest in it. He had a very solid job, since he was the army's top expert on anthrax vaccines. He didn't move on to a better job in industry, unlike many of his colleagues at Fort Detrick, after the anthrax letters made bioterrorism a profitable industry.

Second, he had no access to dry, powdered anthrax, according to Fort Detrick spokespersons, who said that only liquid anthrax was used at the Fort Detrick facility in animal aerosolization experiments. If he had been making dry anthrax, it would have been detectable: because anthrax forms a protective spore, the bacteria contaminate the facilities where they are produced. A wet swab can then be used to remove them from surfaces for culture and identification. So if Bruce had made enough anthrax (at least 10-20 grams) to fill the letters, it would have been detectable and the strain would have matched that of the letters. It would not take 7 years to perform the forensics for this experiment, though it could take 7 months. His colleagues would have noted something amiss: half an ounce of dried anthrax requires a lot of fermentation and processing to prepare.

So, we have what appears to be a deliberately botched investigation of the anthrax letters case, and it is all going to end with the suicide of an ill and depressed scientist who lacked a motive and probably lacked access to powdered anthrax.

In my opinion anyway, this case is not closed. Here is a link to an article I wrote about this investigation in early 2002, to provide additional perspective, and a statement made by Bruce's attorney:

Paul F. Kemp
t 301.217.5664
f 301.217.5617
pfkemp@venable.com
August 1, 2008

PRESS RELEASE

For more than a year, we have been privileged to represent Dr. Bruce
Ivins during the
investigation of the anthrax deaths of September and October of 2001.
For six years, Dr.
Ivins fully cooperated with that investigation, assisting the
government in every way that
was asked of him. He was a world -renowned and highly decorated
scientist who served
his country for over 33 years with the Department of the Army. We are
saddened by his
death, and disappointed that we will not have the opportunity to
defend his good name
and reputation in a court of law. We assert his innocence in these
killings, and would
have established that at trial. The relentless pressure of accusation
and innuendo takes its
toll in different ways on different people, as has already been seen
in this investigation.
In Dr. Ivins' case, it led to his untimely death. We ask that the
media respect the privacy
of his family, and allow them to grieve.

Judge Keeps Anthrax Suit Alive

By PETE YOST – MARCH 14, 2008

WASHINGTON (AP) — A federal judge Friday kept alive a lawsuit in which two Connecticut Air National Guard pilots said they were forced to resign nine years ago for refusing to be vaccinated against anthrax.

An Air Force panel must spell out the reasons for denying the two compensation for back pay and lost promotions, U.S. District Judge James Robertson ruled.

One of the pilots, Russell Dingle, died in 2005 and he is represented in the lawsuit by the executor of his estate. The other Connecticut Air National Guard pilot is Thomas Rempfer.

A federal court blocked the Pentagon's anthrax vaccination program in 2003, ruling that the vaccine had not been licensed or approved for use against inhalation anthrax. Other courts have ruled differently, affirming the legality of involuntary anthrax vaccination.

Robertson relied on the ruling that halted the vaccination program, saying that at the time the two pilots were refusing an order by their superiors, "it was a violation of federal law for military personnel to be subjected" to involuntary inoculation against anthrax.

The Food and Drug Administration has made changes in the vaccine that resulted in another court ruling two weeks ago by another federal court. That decision concluded the Pentagon can require its troops to be vaccinated against anthrax.

In the lawsuit of Rempfer and Dingle, they were assigned to a unit whose job it was to investigate the Pentagon's anthrax vaccination program in the late 1990s.

Rempfer and Dingle raised questions about the effectiveness and safety of the vaccine, but they said there was no satisfactory response from those higher in the chain of command.

Faced with what they considered an illegal order to be vaccinated or face discipline, both sought reassignment to the U.S. Air Force Reserves and were honorably discharged.

Reports prepared by superiors never mentioned their duties or their objections to the anthrax program.

The Air Force Board for Correction of Military Records must explain its conclusions about the claims by Rempfer and Dingle's family and about their demands for compensation, the judge ruled.

On the Net:

• Air Force Board for Correction of Military Records: http://boards.law.af.mil/AF_BCMR.htm

Here is a summary of the presentation I gave to the Maine Commission to Protect the Lives and Health of National Guard Members

Problems with Military Vaccines

Meryl Nass, MD

Although biological warfare is considered a military threat, achieving mass casualties is extremely difficult. Historically, the target has been civilians, not troops. Nonetheless, the Defense Department has undertaken to vaccinate all deploying soldiers to Central Command with anthrax and smallpox vaccines: approximately 1.8 million soldiers have received each in the past ten years.

In retrospect, the current administration used the threat of chemical and biological warfare to buttress a preemptive strike on Iraq in 2003. Initiating smallpox vaccinations for soldiers and civilians may have had more to do with public relations than public health. The civilian program stopped after 40,000 inoculations, due to cardiac complications.

Despite this, the mandatory military smallpox vaccination program has never slowed down. According to the CDC Advisory Committee for Immunization Practices, such vaccination programs require a risk-benefit analysis, which was never performed. The Institute of Medicine’s analysis of the smallpox program noted, “The combination of known vaccine-related problems and an immeasurable disease threat was deeply problematic.”

The smallpox vaccine caused myocarditis in one of every 145 people who received it in a clinical trial, leading to a black box warning in the label. However, the warning fell on deaf ears, since the vaccine remained a requirement for deployment.

Recently, a newer smallpox vaccine, derived from the old vaccine, was licensed. The government announced that stocks of the old vaccine would be destroyed, and the new vaccine would be given to soldiers. But is there really a difference? The new vaccine is said to cause myocarditis in one in 175 recipients.

The anthrax vaccine story is similar: the General Accounting Office reported to Congress in both 1999 and 2006 that the long-term safety of the vaccine is unknown. Crucial data and research remain buried.

Although civilians injured by smallpox vaccine can seek compensation from a government fund, soldiers are barred by the Feres Doctrine from compensation, and their only recourse in the event of illness is the healthcare system of the military and Veterans Administration. Unfortunately, vaccine-induced illnesses generally respond poorly to treatment.

In the absence of both demonstrable threat and effectiveness against biological weapons, these pork barrel vaccine programs exact much too high a price from our service-members and our treasury. It is time to end the politicization of military public health.

Anthrax Vaccine Lawsuit Dismissed: What Does That Mean?

Federal Judge Collyer last week dismissed a lawsuit challenging Biothrax's license on the basis that efficacy has not been demonstrated. The suit contended that anthrax vaccine had never been approved for its current intended use, inhalation anthrax.

The judge ruled that FDA is, in essence, the arbiter of the science and can interpret the data as FDA sees fit.

However, many articles in the medical literature and popular press over the past several years provide ample evidence that FDA makes judgments about products that are unsupported by scientific evidence. Congressman Jim McDermott, MD's Subcommittee will examine the use of psychotropic medicine on children in foster care next week (March 12)--a drug scandal FDA has chosen to ignore. The state of Alaska is suing the manufacturer of Zyprexa, seeking damages to pay for the care of those the drug made diabetic. Another drug scandal to which FDA turned a blind eye.

Time will tell whether "our" federal agencies will ever be brought to account. If federal agencies choose not to perform the tasks legally required of them, the value the federal government has to its citizens wanes. If we cannot "buy" quality public health, cannot obtain the oversight to ensure our drugs, foods and medical devices are reasonably safe and effective, and their review free of bias, why pay taxes to fund the FDA, CDC, and other public health agencies?

The "Hannah" autism case, in which a number of vaccines were judged by a Vaccine Court Special Master to have lead to a child developing autism, is the latest nail in the coffin of a totally politicized and unreliable federal public health enterprise.

Two stories: Israeli Army cedes supervision of experiments on troops to the Ministry of Health; Israeli Air Force refused to give pilots anthrax shots

http://www.ynetnews.com/articles/0,7340,L-3510509,00.html

Anthrax tests on troops to be conducted 'strictly under supervision'
Aviram Zino
Published: 02.24.08, 14:19 / Israel News

Following deliberation on petition protesting IDF medical experimentation on
soldiers, government announces Ministry of Health to supervise such
experiments.

State officials reported to the High Court of Justice on Sunday that all
medical experiments on IDF soldiers are to be conducted only under strict
Health Ministry supervision and approval.

The State also reported to the court that the Health Ministry protocol for
human experimentation is to be implemented in the IDF as standard command.

This announcement was made following a petition brought to the court by the
human rights group Physicians for Human Rights, in conjunction with several
Israeli Defense Force soldiers, protesting medical experimentation on active
duty soldiers in the IDF.

Most prominently, petitioners protested the use of IDF soldiers in secret
experiments testing Anthrax vaccines, codenamed "Omer 2".

Physicians For Human Rights petitioned the High Court three months ago,
demanding that the IDF stop medical experimentation on soldiers, and
demanding the establishment of a commission of inquiry on this matter.

The IDF soldiers petitioning the court demanded that they be compensated for
pain and suffering endured during such experimentation.

The "Omer 2" Anthrax experiment that triggered this petition was held
between 1999 and 2006, and included some 800 IDF soldiers. The experiment
included a series of seven injections, some including an American Anthrax
vaccine, and others a recently developed Israeli formula.

Physicians for Human Right has maintained that the experiment failed to
uphold several ethical imperatives, including garnering the informed consent
of the soldiers in question, as well as following up on their general health
and well being at the conclusion of the experiment.

Israeli law regulates medical experiments on human beings through
sub-ordinances rather than through major legislation. In the IDF, the
legislative status of human medical experiments is even more uncorroborated.

~~~~~~~~~~~~~
http://www.ynetnews.com/articles/0,7340,L-3401245,00.html
Guinea Pigs
May 17, 2007

TV documentary reveals army tested experimental anthrax vaccines on elite
combat soldiers, but refused to treat them after adverse symptoms appeared
Ines Ehrlich

The IDF secretly used elite combat soldiers as "guinea pigs" for
experimental anthrax vaccines, according to an expose broadcast Wednesday
night by the "Uvda" (Fact) documentary program.

Presenter Ilana Dayan revealed how in 2000, the army decided to carry out
anthrax antibody experiments ahead of independent manufacture in Israel.

According to the report, hundreds of young recruits into Israel's elite
combat units were offered the opportunity to partake in a top secret
experiment codenamed "Omer 2". They were led to believe they were performing
a national service of the utmost importance to the state.

The soldiers were told that the antibody had been approved by the American
FDA as far back as 1970 and was used on thousands of American military
personnel. It was explained that the experiment they would undergo
constituted the final phase prior to anthrax vaccine production in Israel,
which would cater to a possible eventuality of a biological attack on
military or civilian populations.

In 2004, a US district judge ruled that the program of anthrax vaccine for
use on American military personnel be stopped due to a series of side
effects experienced by US troops.

Classified information

Since 2000, the soldiers selected for the experiment underwent a series of
seven inoculations, all carried out in top secret, without even the
knowledge of their commanding officers. When various symptoms such as
serious skin lesions and pneumonia began to appear, the soldiers did not
relate them to the experiment and sought standard medical treatment provided
by the military.

Once soldiers began to suspect that there may be a connection between the
vaccines and their symptoms, they contacted the secret unit in charge of the
program and presented their case. The symptoms, it was explained to them,
had absolutely nothing to do with the inoculations.

Regular army doctors were unable to diagnose the mystery ailments without
knowing what drugs had been administered in the shots.

Nir, a fictitious name, who was interviewed throughout the program, was the
only soldier to receive the full series of seven shots. When forced to
involve his parents after being hospitalized, he tried to find out what the
vaccine contained so that he could receive adequate treatment. He called the
unit begging to be told what he had been given - his request was refused
outright as it was "classified information".

'Citizens can sleep peacefully'

Professor Tzvi Bentowitz, head of the research institute researching
infectious diseases at Ben Gurion University, said, "The fact that this
matter was shrouded in secrecy here while it created such an outcry in the
US is astonishing, to say the least."

The secret medical unit had also contacted the air force in an attempt to
recruit pilots for the experiment, but air force officials refused, saying
that possible side effects could interfere with pilots' performance.

In response, the IDF's chief doctor, Brigadier-General Hezi Levy, told the
program that the citizens of the State of Israel will be happy to know that
Israel has developed its own anthrax vaccine and can now "sleep peacefully".


He added that from now on the army would take full responsibility for any
adverse symptoms experienced by the group of soldiers, and that it would
coordinate treatments with the relevant medical institutions.

Editorial: Israeli government admits anthrax experiment caused injuries and takes responsibility for their care

w w w . h a a r e t z . c o m

Last update - 02:23 20/02/2008 Experiments in full responsibility By Haaretz Editorial The state's response to a High Court of Justice petition by soldiers who were subjected to medical experiments with anti-anthrax drugs (the experiments known as Omer 2) is a small but important step on the road to regulating one of the most neglected human rights issues in Israel. Admittedly, the state - in contrast to the soldiers - claims that the experiments were performed in accordance with accepted medical and ethical norms, and that there was nothing wrong with them. Nevertheless, it also stated, "The defense establishment bears full responsibility for the care of the soldiers who were harmed." This announcement includes two important points: an admission of the causal link between the experiments and the damage to the soldiers' health, and an assumption of full responsibility for the soldiers' care and treatment. The state thereby demonstrated a different approach than the one that has hitherto characterized the Defense Ministry, the chief of staff, the army's chief medical officer and the health minister. All had previously tried to deny any connection between the experiments and their results, as well as to evade any responsibility for the soldiers suffering to this day. As part of the Omer 2 experiments, some 800 soldiers doing their compulsory service were injected with a vaccination against anthrax, a disease that had been defined as one of the great dangers facing Israel's citizens. The soldiers who were chosen, all from elite units, accepted at face value the establishment's promises that they would suffer no side effects other than mild discomfort, and that the injection had been successfully tested in the United States. At the insistence of those conducting the experiment, the soldiers maintained strict secrecy and did not even inform their commanders. This secrecy was maintained even years later, when some of them developed serious symptoms: pneumonia, breathing problems, digestive tract inflammations, severe coughs, severe migraines, recurrent sores and other problems. Despite the army's promises of close and continuous medical monitoring, each of them was forced to deal with these problems on his own. Only in 2007, when some of the injured soldiers discovered that they were not alone in the war and began comparing their medical problems, was the story of the secret experiment finally revealed in the press, and a group was formed to go to the bodies responsible - this time in an organized fashion. The soldiers had a simple and reasonable demand: that the system recognize them as a distinct group and take responsibility for the harm done to them, and that it give them their medical files so that they could obtain appropriate treatment. When their repeated applications met only with repeated evasions, the group, numbering 34 soldiers, petitioned the High Court. As noted, the state's response to this petition bodes well. And no less important is its response to another petition, by Physicians for Human Rights, which asked the court to ban medical experiments on Israel Defense Forces personnel unless the issue is regulated through legislation. The state responded by undertaking to abide by certain interim restrictions until the necessary legislation is passed. This response, which does not evade a fundamental discussion of the question of experiments on human beings in general, and on IDF soldiers as a "captive audience" in particular, arouses hope that the defense establishment will finally grasp the importance of human rights, and that the suffering caused to the petitioners will serve as a warning to defense and medical personnel.

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Israeli government agrees to hand over data on anthrax vaccine tests

w w w . h a a r e t z . c o m

Last update - 02:14 19/02/2008 Soldiers sue government over harmful anthrax tests By Avirama Golan The state informed the High Court of Justice yesterday that it assumes full responsibility for the treatment of soldiers harmed during the testing of drugs countering the anthrax bacteria. The state was responding to a petition brought against senior officials last month by 34 soldiers who had been part of a biological weapons research project code named Omer-2. In its response, the state insists that the tests were carried out by the military authorities in line with accepted medical and ethical standards, through the application of strict safeguards, and with the authorization of all relevant parties. The state also said that there were no mistakes in the experiment. However it also said that "the defense establishment carries full responsibility for the treatment of soldiers who were injured by their participation in the research," and accepted the request of the soldiers to provide them with complete medical information and documents relevant to the experiment. The documents will be given to the soldiers "with a minimum number of deletions that are necessary for security purposes." The state was responding to a petition filed on behalf of the 34 soldiers by attorneys Boaz Ben-Tzur and Michael Sfard against the defense minister, the chief of staff, the chief medical officer in the Israel Defense Forces, and the minister of health. The petitioners argued that hundreds of soldiers were involved in the Omer-2 project in 1999, and that they received an injection of a mixture developed at the Biological Institute in Nes Tsiona. According to their petition, the process was flawed in the most basic ways, and that there were many violations of the law including basic standards set out by the law, such as the Helsinki Declaration on norms of experimentation on human beings. The soldiers also claim they had been presented with misleading, partial and false data on the tests, which had suggested that the side-effects of the trials would be minor and temporary. In practice, the petitioners claim, the soldiers suffered serious health problems as a result of the trials, including pneumonia, infections in the intestinal tract, coughing and spitting blood, migraines, and muscular problems. In a parallel petition filed by the organizations Physicians for Human Rights, the court is asked to ban all trials on humans in the IDF until the necessary legislation is passed - already approved in a first reading by the Knesset last year - on controlling and supervising such trials.

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One reason drugs may be used for years before risks become evident is that we have no active drug surveillance system-Mark McClellan, FDA Commissioner

Although no significant improvements in drug safety occurred while he was FDA Commissioner from 2002 to 2004, Dr. McClellan now acknowledges the need for improved safety surveillance at FDA, in a commentary in the April 26, 2007 New England Journal of Medicine.

This issue contains several articles on FDA assessment of drug safety. Jerry Avorn, a Harvard professor of pharmacoepidemiology, noted that 4 former FDA commissioners have called for an end to industry funding of FDA's new drug evaluations. As a result of industry funding, first introduced 15 years ago, FDA scientists were transferred from assessing drug safety to assessing new drug applications.

Dr. Avorn points out that FDA lacks the statutory authority to require companies to conduct follow-up studies of drugs after they are licensed. When FDA issues a new drug license, FDA is frequently very specific about the number and types of additional studies of safety and efficacy it expects to be performed. Yet despite this, the majority of postmarketing studies have not been done. According to the Federal Register, only 11% of 1,259 requested drug studies and 20% of requested biologics studies have been completed and reported on.

In 1970, at the time of licensure, the anthrax vaccine manufacturer was asked to conduct a clinical trial for efficacy, which never took place. Thirty-seven years after it was licensed, there is still no human efficacy data for the anthrax vaccine. (Don't even ask me about the quality of the safety data, which FDA has chosen to ignore.)

Final Defense Authorization Bill Includes Allen Provision that Seeks Answers about Vaccinations for Military Personnel

Wednesday December 12, 2007

Credits Barbara Damon-Day for her “determination to spare other military families distress about possible health risks to their loved ones”

Washington, D.C. (Wednesday, December 12, 2007)---U.S. Representative Tom Allen announced today that the House-Senate conference report on the defense authorization bill for Fiscal Year 2008 includes his amendment directing the Department of Defense to assess policies governing vaccinations given to military personnel. Representative Allen drafted the amendment in response to concerns about the possibility of serious health impacts from multiple vaccinations raised by one of his constituents, Barbara Damon-Day of Newcastle, Maine. Mrs. Damon-Day has been an outspoken advocate for such a policy assessment since her son, Captain Patrick Damon, died suddenly of undetermined causes in Bagram, Afghanistan during deployment with the 240th Engineer Group of the Maine National Guard.

“We vaccinate our Armed Forces to protect them from disease, but we must also protect them from potential serious harm that may result from multiple vaccinations administered at one time,” Representative Allen said. “The provision I included in the defense authorization bill requires the Defense Department to review its vaccination policy and make a report to Congress on how it minimizes any risks to our Armed Forces from multiple vaccinations. I am grateful to Barbara Damon-Day for her tireless effort to bring about these vaccinations to the attention of legislators and the public and for her determination to spare other military families distress about possible health risks to their loved ones who serve America overseas.”

“We need to do everything we can at the State and Federal level to protect our service members from non-combat injuries and deaths,” Barbara Damon-Day said. “They train for combat, but we lose more servicemen and women to non-combat deaths and we must work to make them as safe as possible.”

Pat Damon worked as a staff member in the Legislature and the Public Advocate’s office. Since his death in June 2006, Mrs. Damon-Day has led a campaign to improve the Defense Department’s medical screening of Armed Forces prior to their deployment overseas. Earlier this year, the Maine Legislature created a commission to improve medical screening of Maine Guard personnel before they go overseas.

contact: Mark Sullivan, (207)774-5019

More fake "science" on anthrax vaccine illness

Note: despite retiring from the military 17 months ago, John Grabenstein supervised the following study. Also note that a physical exam cannot identify Gulf War Syndrome (this has been widely acknowledged, and is one reason the existence of GWS was denied) or anthrax vaccine side effects 99% of the time--you need specialized tests for both. The patient's history and medical records are critical to making the diagnosis, not the physical exam. So why do a study of physical examinations, if not to deny the illness's existence? --Meryl


Assessing the Safety of Anthrax Immunization in US Army Aircrew Members via Physical Examination.

Journal of Occupational & Environmental Medicine. 49(10):1079-1085, October 2007.
Downing, Jill MD; Greig, Thomas W. MD, MPH; Quattlebaum, Martin D. MS; Valentin, Manuel MD; Heeren, Timothy C. PhD; Grabenstein, John D. RPh, PhD

Abstract:
Objective: Anthrax in weaponized form is the bioterrorism agent of most concern. Questions raised about the safety of the anthrax vaccine can be addressed by comparing immunized and unimmunized people in population-based studies.

Methods: A retrospective evaluation of data from periodic physical examinations collected on anthrax-immunized and -unimmunized US Army aircrew members between 1998 and 2005 was performed to evaluate the safety of anthrax immunization. Mean changes in variables found on physical examination and laboratory analysis were compared by use of t tests. Multiple linear regression predicted change in outcome from baseline characteristics.

Results: We compared 6820 immunized subjects and 4145 unimmunized controls based on US Army aircrew physical examination and screening laboratory tests. No association between anthrax immunization and a clinically relevant change in a tested physiologic parameter was detected.

Conclusions: No attributable risk of anthrax immunization was observed in this group of Army aircrew members.

Merck's failed HIV vaccine trial

This has nothing to do with biological warfare, but I feel compelled to make a few points about this trial anyway.

1. The volunteer subjects who received vaccine were apparently harmed. But did they receive sufficient warning that this could happen? Merck/NIAID will no doubt say it could not have been foreseen (though one article suggests the consent form stated that participation might decrease, increase, or have no effect on your risk of AIDS). Does this mean the lawyers knew the vaccine might be harmful but the doctors didn't?

A number of animal vaccines were developed, some even licensed, sold and used on pets and livestock -- when it turned out they increased susceptibility to the illness they were trying to protect against. This potential adverse effect should be well known to vaccine developers.

Not to mention the obvious -- small pilot trials of the vaccine should precede large-scale trials to rule out this dread complication. This was a Phase 3 trial in 3000 people.

2. The vaccine trial that took place in South Africa started at a later date (2007) than trials in the other countries started (2004). Yet it was the South African trial that blew the whistle on the increased rates of HIV in vaccine recipients. At that point, in late October, investigators from the earlier trials claimed they would have to evaluate their data to see if it bore out the South African findings. Now they admit their data confirms what the South African investigators identified: more HIV infections in those who received vaccine compared to placebo.

Guess what? Each trial of this vaccine was required to have a Data Safety Monitoring Board whose job is to monitor interim trial results to end a trial early if things are going wrong, as in this case -- and warn subjects if needed.

Clearly, this board was not doing its job in a timely fashion. Even worse, it is a good possibility that had the South Africans not blown the whistle, the other investigators might have attempted to sweep these data under the rug. Merck may have even tried to sell this vaccine, if it had been able to analyze the data in such a way this negative effect was not identified.

Why did it take the South Africans only months to see what the other centers only acknowledged last week, 3 years into the trial?

Although it sounds far-fetched, many pharmaceutical companies require medical investigators, even those at prestigious medical schools, to agree they will not get access to their own data, as a condition of being hired to conduct a clinical trial. Only the company gets to see the raw data.

The whitewashing has already begun: In Australia, investigator "Kelleher defended the protocol that halted the trial halfway on the advice of the Data Safety Monitoring Board and praised the transparency of the communication to participants."

But look back to the beginning of this fiasco becoming pubic: from the October 25, 2007 Washington Post:

Warning Is Sent to AIDS Vaccine Volunteers

...The Merck vaccine trials took place in 15 cities in the United States, including Boston, Los Angeles and New York, and three in Canada. There also were sites in Peru, Brazil, Australia, Haiti, the Dominican Republic and Jamaica. Those trials began in December 2004 and included 3,000 participants, mostly gay men.

In South Africa -- where an estimated 5.5 million people are infected with HIV, more than in any other country -- the study used the same vaccine but was administered separately. The trial here started later, with the first injections this year, and had its own ethics oversight board. Most of the subjects were heterosexual.

The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine, said Mark Feinberg, vice president for medical affairs and policy for Merck..."

Think of this article next time you considering volunteering for a scientific experiment

Report: President's Commission on Care for America's Returning Wounded Warriors

The motto of the report is "Serve, Support, Simplify." Further information on the Commission and report can be found at www.pccww.gov

Caution flag raised on mandatory anthrax vaccines

Former Air Force navigator says neurological reaction has left him disabled

By ELLEN GABLER
egabler@journalsentinel.com

Posted: Oct. 28, 2007

With his trim runner's build, tight flattop and thin, muscular arms, Stephen DeGuire does not seem like a man who is unable to empty the dishwasher, mow the lawn or throw baseballs to his young sons.

He forgets the names of neighbors he has known for years and grimaces as he pushes himself into a standing position. His torso tilts forward as he walks stiffly through his Mequon home. A wooden cane hangs on a chair in the living room. It is one of a collection that DeGuire keeps around. He frequently forgets where he puts them.

DeGuire is one of possibly thousands of veterans suffering from what some military and civilian doctors believe is a neurological reaction to the anthrax vaccine. The vaccine is controversial, yet now mandatory for many American troops and civilian contractors. About 1.6 million people have received the vaccine since 1998.

Nearly four years ago, DeGuire was stationed in Kuwait as a navigator for the U.S Air Force. Today, the 43-year-old struggles with migraines, memory problems, chronic pain and fatigue as his body slips further from his control.

DeGuire's Air Force physical evaluation in 2006 listed his ailments and noted that they began to occur after he received the vaccine.

While DeGuire's main concern is to keep his body from further deteriorating, he worries about his family's financial future. He said he makes one-third of what he made as a civilian and will likely never work full-time again because of his condition.

Disability linked to reaction from the anthrax vaccine is deemed non-combat-related, meaning veterans like DeGuire are taxed on their disability payments. The anthrax vaccine is also not part of the National Vaccine Injury Compensation Program, which allows people who suffered vaccine reactions to collect money for their disability. DeGuire worries about soldiers who will be required to receive the anthrax vaccine in the future. He says the program was "well-intentioned," but that officials in the government did not stop the vaccine when problems arose.

"They've had enough data to know there is something wrong with the vaccine," DeGuire said.

The Department of Defense made the anthrax vaccine mandatory in 1998 out of concern that enemies would use anthrax as biological warfare. If inhaled, the substance is usually fatal. Mandatory vaccines were halted in October 2004, when a judge questioned the Food and Drug Administration's approval procedures. In December 2005, the FDA gave final approval for the vaccine, and the Department of Defense made it mandatory again for soldiers and contractors serving in the Middle East, Central Asia and parts of Korea.

The Department of Defense maintains that the vaccine is "safe and effective." In a media conference call last fall, assistant defense secretary William Winkenwerder said that the vaccine had not led to increased deaths or hospitalizations.

Critics of the vaccine disagree. Physician Meryl Nass said her patients usually have 10 or 15 different diagnosis that she attributes to the anthrax vaccine - sleep disorders, fatigue, cognitive disability and higher rates of neurological disorders such as multiple sclerosis. A doctor in Maine, Nass testified about the vaccine in July before the House Veterans Affairs Health Subcommittee.

Nass also points to records collected by the Vaccine Adverse Reporting System, which catalogs vaccine complications. The system has received about 5,359 adverse event reports for anthrax vaccine. About 670 of the reports were considered "serious" and about 44 of the reports recorded deaths. In the reports, some soldiers or their families pleaded with the military to stop the vaccines.

Most vaccines are linked with side effects, ranging from simple soreness to death. But that's not much comfort to people like DeGuire, or other veterans he met while at Walter Reed Army Medical Center who also think they were affected by the anthrax vaccine.

Unlike many of those other veterans, DeGuire's case was recently accepted by the Mayo Clinic, so in early August, he lugged his three-inch-thick medical file to Rochester, Minn. While doctors are working on his physical problems, DeGuire and his family are pushing legislators to do something about veteran benefits and mandatory vaccines.

DeGuire said he has tried to no avail to have legislators introduce an amendment to the defense appropriations bill that would stop mandatory anthrax vaccines until more research is done.

Congress is considering changes on the benefits issue. The Disabled Veterans Tax Termination Act would give disabled veterans the same benefits as retired veterans with 20 years of service. The act is pending in the House subcommittee on disability assistance and memorial affairs. But no efforts are under way to reclassify ailments associated with the anthrax vaccine as combat related.

Two HIgh Court petitions in Israel over anthrax vaccine tests on soldiers

Group wants end to Israeli anthrax tests

Published: Nov. 1, 2007 at 9:36 AM

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JERUSALEM, Nov. 1 (UPI) -- A rights group petitioned Israel's High Court on Thursday to stop the military from performing anthrax vaccine experiments on soldiers.

Physicians for Human Rights filed one petition, while a second was filed by a group of soldiers seeking to be recognized as casualties of the experiments, Ynetnews.com reported.

From 1999 to 2006, some 800 soldiers underwent vaccinations of a vaccine developed in the United States and the rights group claimed in their petition scientific errors were made. They included tracking the soldiers' conditions consistently during and after the experiments, the report said.

The group also alleged the troops were misinformed of potential consequences of the tests and were given no opportunity to consult with non-military specialists for advice.

Attorney Michael Spharad, who filed the petition on behalf of the Physicians for Human Rights said the military had too much medical freedom.

"These days it is more difficult to experiment on animals than on humans," Spharad said.

Surveillance reveals anthrax vaccine safety an issue

Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS) --- United States, 1991--2001

Surveillance Summaries

January 24, 2003 / 52(ss01);1-24

This CDC compilation of adverse event reporting information:

www.cdc.gov/mmwr/preview/mmwrhtml/ss5201a1.htm - Vol 52, No 1;1



tells us that anthrax vaccine had the highest reporting rate of adverse events for any currently licensed US vaccine, on page 15 of the CDC brochure (Table 3).

This rate is 91.8 reports per 100,000 doses distributed. It equals 3.7 reports per thousand vaccine recipients, since soldiers receive a total of 4 doses, on average. The only two vaccine with higher reporting rates in this table, Lyme and Rotavirus vaccines, were taken off the market due to safety concerns.

Yet DOD continues to claim that anthrax vaccine is as safe as any other vaccine.

Reply to Questions Posed by the House Veterans Affairs Committee regarding Gulf War Illnesses

To read the questions and answers, click here.

Guinea pig and mouse death rates after anthrax vaccine

This review compiles all the published guinea pig and mouse studies of Biothrax (aka AVA) anthrax vaccine, and compares it to the British, Russian and livestock anthrax vaccines. Biothrax gave the experimental animals the lowest survival rates compared to the other three vaccines. Click here.

Senate Veterans Affairs Testimony on Gulf War Veterans' Illnesses

My testimony to the Senate Veterans Affairs Committee was written to answer many persisting questions about these illnesses. It discussed the myths and the facts, while reviewing the recent research on Gulf War Syndrome. I tried to highlight what has been missing from the studies, and provide some ideas on where to go from here. Finally, I discuss the kinds of treatments I employ, and the barriers to receiving effective treatment for Gulf War veterans. Click on the testimony here.

The most arresting thing I heard in the hearing was the DOD physician's statement that 15-20% of current deployed troops to OIF and OEF are returning with ill-defined medical symptoms. This needs to be studied and remedied immediately.

Is Anthrax Vaccine Really Being Used to Save Soldiers from Anthrax?

Let's explore the reasoning for using anthrax vaccine.

It is supposed to protect you against anthrax. No studies of the current vaccine have been done in humans to see if it works, and how well it would work. It works in some animals but not others.

But for argument's sake, let's assume it works well. Will an enemy spray troops with anthrax if it knows the troops have all been vaccinated with an effective vaccine? Keep in mind that military doctrine calls for a powerful response to biological attack, which could include nuclear weapons. It's not very likely that an enemy would take such a big chance against effectively vaccinated troops, since there would be very little to gain.

If the enemy was serious about biological weapons, and ready to risk it all, the enemy would instead use a weapon that troops have no defense against, like botulism or Ebola.

This is a key concept: Anthrax vaccine isn't meant to save troops after an attack--its true purpose is to DETER an anthrax attack. Anthrax vaccine is also being given to soldiers to make a statement to Congress and to the world: vaccinations are "proof" that the US is prepared and ready for biological warfare.

But if the truth be known, the US is entirely unprepared for attacks by many types of bioweapons. We have no vaccine and no antibiotics for most viruses, for example, and no antidote for most toxins. Even bacteria can be made antibiotic-resistant.

Carrying a supply of doxycycline or cipro would provide an equal amount of deterrence as anthrax vaccine, with considerably less danger to troops, and at a much lower cost. DOD has been allowed to store most antibiotics for ten years to increase shelf life. This is not an approved option for vaccines, which is why the US will be wasting 100's of millions of dollars on anthrax vaccine that has been stockpiled by DHHS.

It would be better to do the logical, safer thing and have troops carry antibiotics, especially since units now have sensors for anthrax that can provide early warning of an attack. Besides, doxycycline is also a deterrent against brucella, plague, mycoplasma and some other biological weapons for which we have no effective vaccines.

It would also be better to acknowledge that we remain unprotected against a variety of chemical and biological weapons, and deal with this fact, since it is unlikely to change any time soon.

Bioport/Emergent Biosolutions Buys Another Republican Operative

August 29, 2007

Veteran GOP spokeswoman heads to private sector

by Jonathan Martin

RNC spokeswoman Tracey Schmitt is leaving the comfy confines of First Street S.E. to ply her PR skills in the corporate world. Schmitt, a SoCal native, will serve as director of corporate communications for Emergent BioSolutions, Inc., a Rockville, Md.-based biopharma company that develops vaccines that prevent and treat global and infectious diseases, with a particular focus on biodefense matters.

Though sought by GOP presidential campaigns, Schmitt could not be tempted to return to the frenetic campaign fray for a fifth consecutive cycle. She has been at the RNC since 2005, worked on President Bush's second inaugural, served as a regional spokeswoman for the Bush reelect, did a stint in the White House press shop before that and originally made her bones with the Austin crew way back in 2000.

Though she'll be doing well, she'll also be doing some good in her new gig. She is going to lead the multinational PR effort of a company that produces the only FDA-approved vaccine against anthrax being used to protect U.S. troops in the field.

Schmitt's last day at the RNC is next week and she'll begin life beyond the BlackBerry leash in late September.