Self (inflicted) defense can up risk / Balt. Examiner

Op-Ed, 11/23/08

Two clear facts shine from the clouded mystery of anthrax attacks on America and our government’s tenuous claim seven years later of closing the case with the suicide of a suspect.

Fact No. 1: Government warnings about anthrax being a weapon of mass destruction were false. Somebody dispersed the most lethal strain our tax dollars can produce — weapons-grade or near enough — via the U.S. Postal Service, exposing tens of millions of people, yet managed to infect 22. Five died. But from anthrax vaccination, at least 21 died and thousands reported a wide range of illnesses.

Fact No. 2: If FBI accusations against their prime suspect in the 2001 attack are true, it means billions of dollars taxpayers invested on the premise of prevention actually increased the risk.

When senior biodefense researcher Bruce Ivins died from an overdose of Tylenol 3 after being identified as sole suspect, our central
government declared the crime solved.

However, co-workers at the U.S. Army Medical Institute of Infectious Diseases at Fort Detrick in Frederick say the actions attributed to Ivins over the time the government claims are scientifically impossible.

This is going to be another never-healing wound in America’s body of unsolved mysteries.

But mystery should not distract us from the truth. Our government’s response to bioweapons is raising the danger level from them.

Think it through, citizens. The very vaccination program intended to thwart anthrax apparently sickened and killed more people than an actual mass attack.

After the 2001 attack, our government hurled $41 billion at bioterror with no real coordination or study. High-level labs multiplied threefold. A dozen agencies exponentially increased the number of facilities and workers handling pathogens. Now we have more than 15,000 potential Bruce Ivins.

Meanwhile, our leaders provided no adequate increase in oversight, coordination, training, security, surveillance, testing, background checks or psychological screening.

Statistically, something going horribly wrong now approaches sure thing. That is not just a threat to residents of Frederick, Bethesda and other communities. It is, as the spread of anthrax spores proved, a threat to the whole world.

We learned in 2001 the actual danger from anthrax was lower than vaccine.

But these biohazard labs grow a lot more dangerous pathogens than anthrax. The next one to get out could kill millions.

President Bush must immediately halt programs until we can impose coordinated oversight, then assess security and capacity needs.

We must not let self-defense become self-inflicted catastrophe.

Link to GAO reports
http://www.gao.gov/products/GAO-08-108T High-Containment Biosafety Laboratories
http://www.gao.gov/products/GAO-07-333R Issues Associated with Expansion

Blinded by the Science: Research Advisory Committee Report Includes Data from 9 Studies of Anthrax Vaccine and Gulf Illnesses

And every one of the nine studies found a relationship between receiving anthrax vaccine and developing symptoms of Gulf War Syndrome. In eight of the nine studies, the relationship was statistically significant. The study with non-significant results was partly retracted by the authors (from the group associated with Simon Wessely, a UK psychiatrist and controversial Gulf War researcher/grantee) after widespread criticism. Please view these data for yourself; they are included as Appendix A-12a in the RAC's report.

It is incomprehensible how the RAC could have reviewed and published these data, then claimed that anthrax vaccine had been "ruled out" as a cause of Gulf War illnesses.

Perhaps someday the concept of Science as an apolitical, scrupulously honest endeavor will return to our culture. But for now, governmental Science is just another buzzword.

Costly program with a shady past // Sickening results

Deborah Rudacille of the Baltimore Examiner has two more excellent articles exploring the underside of anthrax vaccine; its manufacturer Emergent Biosolutions (formerly named Bioport); and how the anthrax attacks provided life support to both the vaccination program, which was about to be cancelled, and to Emergent, which produced only one product: anthrax vaccine.

Exhaustively researched, both articles are must-reads:

Sickening results

Costly program with a shady past

Md. lawmakers consider anthrax investigation commission

By Sara Michael http://www.baltimoreexaminer.com/local/112108emsANTHRAX.html
Baltimore Examiner 11/21/08

U.S. Rep. Elijah Cummings’ Washington, D.C., office was shuttered in 2001 after anthrax spores were found, so he’s “very sensitive” to the investigation into the crime, he said.

Now, Cummings said he supports a review of the investigation. U.S. Rep. Rush Holt, D-N.J., proposed legislation in September to create a congressional commission to investigate the attacks and the federal government’s response.

“Whatever we have to do to get to the bottom of this anthrax issue, we need to do it,” Cummings said.

Holt’s bipartisan commission would mirror the 9/11 commission and make recommendations on how to prevent such attacks and respond to future bioterrorism threats.

Holt also has questioned the response.

The tainted letters were mailed from his district.

“Myriad questions remain about the anthrax attacks and the government’s bungled response to the attacks,” Holt said in a statement.

The FBI named Bruce Ivins, a microbiologist at Fort Detrick in Frederick, the sole perpetrator of the 2001 attacks.

Ivins died of an apparent overdose in July.

But lawmakers and scientists alike have raised doubts about the FBI’s conclusion.

Cummings said he “didn’t know” if he agreed with FBI’s conclusion.

“I wonder about that. That’s all I can say,” he said.

U.S. Sen. Ben Cardin, D-Md., also has raised concerns about the FBI’s handling of the case and questioned FBI Director Robert S. Mueller III at a hearing in September.

Cardin was still reviewing Holt’s legislation this week and could not comment yet on whether he supports it, said spokeswoman Sue Walitsky.

U.S. Rep. Roscoe Bartlett, R-Md., who represents Frederick, also has expressed skepticism, saying recently that the law enforcement activities resulted in Ivins’ suicide and “damaged morale” among Fort Detrick employees.

“Congressman Bartlett has not been persuaded by the FBI’s evidence presented to date,” said spokeswoman Lisa Wright.

Bartlett also has shown interest in Holt’s measure, but wasn’t sure Holt will reintroduce it in the next session, Wright said.

Holt’s spokesman Zach Goldberg said Holt does plan to reintroduce the measure.

GWS Report: Funny How the Vaccine Message Changed

Reading the entire chapter on vaccines, the RAC report does a fairly good job of reviewing the evidence (with a few notable omissions) and its recommendations are sound:

from page 125 of the report:

Recent studies have indicated that the current anthrax vaccine is associated with high rates of acute adverse reactions, particularly in women. No information is available on rates of persistent symptoms or multisymptom illness following receipt of the anthrax vaccine. Studies have not identified excess hospitalizations or outpatient visits for diagnosed diseases in the weeks and months following receipt of the vaccine. Limitations in the types of information provided by these studies, however, indicate a continued need for long term follow up, to determine whether excess rates of diagnosed or undiagnosed conditions occur in anthrax vaccine recipients.

and from page 127:

Recommendations

Diverse concerns have been raised in relation to vaccines received for the Gulf War, but relatively little reliable information has implicated individual vaccines as prominent risk factors for Gulf War illness. Several issues related to vaccines received by Gulf War veterans have not been adequately addressed by existing research. These include the need for more thorough evaluation of vaccines as risk factors for chronic health problems in epidemiologic studies, a definitive study to conclusively evaluate the previously-­observed association between squalene antibodies and Gulf War illness, and the need for longer­ term evaluation of symptoms and diagnosed diseases following receipt of the anthrax vaccine.

The Committee therefore recommends the following research:

• In previously-­conducted and future epidemiologic studies of Gulf War veterans, analyze associations between Gulf War illness and individual vaccines, combinations of vaccines, and total number of vaccines received using methods that control for potential confounding by other Gulf War­-related exposures.
• Commission a case­-control study to provide clear answers concerning possible associations between Gulf War illness and squalene antibodies. The study should, at minimum, analyze blinded samples from well­ characterized symptomatic and healthy Gulf War veterans for the presence of squalene antibodies using each of the assays developed for this purpose. It should also assess whether there is an identifiable link between levels of squalene antibodies in ill Gulf War veterans and receipt of the anthrax vaccine or vaccines more generally. The project should be organized and overseen by qualified investigators not affiliated with the federal government or civilian scientists whose initial work raised the squalene issue in relation to Gulf War illness.
• Evaluate the association of anthrax vaccine adsorbed (AVA) with chronic symptoms, Gulf War illness, and diagnosed diseases in personnel known to have received the anthrax vaccine during the Gulf War. These health outcomes should also be assessed at least five years after vaccination in deployment and era subgroups of personnel in the Millenium Cohort study as well as other groups vaccinated in association with the military’s anthrax vaccine immunization program and federal anthrax vaccine trials.

* But what message did the media get when it interviewed RAC members?

LA Times: " the panel... could find no evidence linking it [GWS] to depleted uranium shells, anthrax vaccine and infectious diseases."

US News and World Report: "There are other factors that, while not likely causes of Gulf War illness, can't be ruled out, Steele said. These include exposure to nerve agents, exposure to smoke from oil well fires, and vaccines given to the troops. The panel ruled out depleted uranium and anthrax vaccine as causes.

The Newshour with Jim Lehrer: "James Binns: Many other exposures that were also happening in the gulf at that time, depleted uranium munitions, anthrax vaccines, special paints and solvents that were used, we do say that the evidence does not show that they were significantly connected."

Either the evidence is adequate and reliable, in which case you can "rule out" that exposure as a cause, or you need more evidence and can say very little about whether that exposure may have caused GWS, and in how many veterans. In the case of anthrax vaccine the RAC's chairman and former scientific director are trying to have it both ways. In so doing, they are mirroring behavior of earlier GW scientists and administrators criticized in their report. The committee's work is critically important to help Gulf War veterans, yet flaws of this kind diminish the report's (and committee's) reliability and value to veterans. This is a pity.

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 yet produced on Gulf War illnesses. 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 about most things.

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 RAC 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 DoD, most of the self-reports are wrong. But other studies indicate that self-reports in GW veterans are highly reliable. Four studies (from 4 different research groups, and 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 relatively more veterans in support locations had 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 they collected. The Defense Medical Surveillance System, according to the Institute of Medicine (IOM) the most important database for studying anthrax vaccine safety, has been kept under wraps since 2001, when it had to be shared with the IOM. 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%. (According to the Veterans Health Administration Office of Public Health and Environmental Hazards, August 2008, of those 347,750 veterans of the Global War on Terror who have sought care in the VA system, 39.7% have demonstrated "Symptoms, signs and ill defined conditions" while 42.5% have mental disorders, 34.9% have diseases of the nervous system/sense organs, 31.8% have digestive disorders and 47.6% have diseases of musculoskeletal system/connective system. This is certainly a red flag that GWS could be affecting a large number of recent veterans, yet the RAC is unaware that many new veterans may suffer similar illnesses as those of the first Gulf War. "Newly released documents reveal that more than 150,000 soldiers who left the military after serving in Iraq and Afghanistan have been at least partly disabled as a result of service–this translates to one in four veterans."

These veterans have been exposed to vaccines and depleted uranium, but much less routinely to pyridostigmine, and not to sarin. If new veterans are, in fact, developing GWS-like illnesses, it would cast doubt on the RAC's conclusions.)

Scientific impossibility: Did FBI get their man in Bruce Ivins?

"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.

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? ..."

Deborah Rudacille of the Baltimore Examiner provides another in-depth look at the evidence in this case, exploring the time it would take to make the anthrax preparations. She also mentions the presumed contamination by Bacillus subtilis found in some of the letters, whose origin was not investigated by FBI, despite being an important clue. Read the complete article here.

US military chem-bio warfare exposures website unveiled

Justin Palk, Frederick News-Post

http://www.fredericknewspost.com/sections/archives/fnp_display.htm?storyID=88347 From World War II through 1975, thousands of service members and veterans were potentially exposed to chemical or biological weapons as subjects or observers of tests carried out by the Department of Defense. The department unveiled a new website Monday to provide information about what happened during those tests. The data on the site is broadly grouped into three sections: chemical agent tests during World War II; chemical and biological agent tests of Project 112 and its naval component, Shipboard Hazard and Defense or Project SHAD; and Cold War-era chemical and biological weapons testing. The site provides details about specific incidents, such as the release of mustard agent in the Italian port of Bari in 1943 when a U.S. ship carrying the agent to use in response to theoretical German gas attacks was destroyed during a German air raid on the port. Overview sections give broad outlines of what types of testing were performed at what points in history. The biological warfare research at Fort Detrick and the Operation Whitecoat disease immunity experiments are listed under the Cold War section of the site, as are Dugway Proving Ground and Edgewood Arsenal, both sites where chemical weapons research was done. The site does not list the names of service members who might have been exposed to chemical or biological agents. It does, however, include contact information veterans can use to seek help in verifying any potential exposure they may have had, or to provide information they may have about tests the Defense Department conducted. For information, visit fhp.osd.mil/CBexposures/index.jsp

My letter explaining the October PREPA Declaration, new anthrax vaccine purchases, the CDC vote on civilian vaccinations and their impact

October 2008

Dear Representative --------,

I am writing with concerns about a liability shield just issued for anthrax vaccine, a huge new waste of government funds in anthrax vaccine purchases by DHHS, and expansion of anthrax vaccinations to civilian first responders, which is poised to begin after a CDC Advisory Committee on Immunization Practices (ACIP) vote October 22, 2008.

A controversial bill, the Public Readiness and Emergency Preparedness Act (PREPA, Division C of P.L. 109-148) passed in December 2005. A CRS report on this bill reveals that the bill provides almost complete immunity from liability for manufacturers of “covered countermeasures,” preempts state and local laws, and extends blanket immunity to “government program planners.”

On October 1, 2008 DHHS Secretary Leavitt, in consultation with DHS Secretary Chertoff, issued a Declaration of an anthrax emergency, invoking the provisions of PREPA for anthrax countermeasures through 2015 (http://www.kansascity.com/105/story/846427.html) . On October 10, additional Declarations were issued for smallpox, botulinum toxin and radiation sickness emergencies. Secretary Chertoff acknowledged to Secretary Leavitt in a September 23, 2008 memorandum there was no evidence of an anthrax emergency, but that the non-negligible risk of a future anthrax epidemic was sufficient to declare an emergency and trigger PREPA’s liability protections.

On October 1, DHHS contracted to buy an additional 14.5 million doses of anthrax vaccine at a cost of $364-404 million dollars, although DHHS already has about 25 million doses stored or on order, which cost taxpayers $500 million. Yet a 2007 GAO Report discussing anthrax vaccine noted that, "Officials from the [DOD Vaccine Healthcare Centers] VHC Network and CDC estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death." GAO also noted in October 2007 that $10 million worth of anthrax vaccine was expiring monthly in DHHS’ stockpile.

The CDC recently asked its Advisory Committee on Immunization Practices to change its 2000 and 2002 recommendations, which it did, making anthrax vaccine available to civilian first responders, a group of 3 million people. The vote took place on October 22-23, and coincided with the loss of legal protections for recipients.

Although this is an extraordinarily difficult and busy period for legislators, I hope you will agree that invoking nonexistent emergencies drastically reduces the constitutionally guaranteed right of redress for recipients of “covered countermeasures” such as anthrax vaccine, while at the same time, the recipient pool is about to expand to civilians.

Would you please help overturn this egregious assault on our civil rights? PREPA should be revoked. Emergency declarations should be limited to true emergencies. Liability shields encourage the production and use of untested or sloppily manufactured drugs, and should be used only with great care.

CDC has failed to share detailed safety data from its own 2002-2006 clinical trial of anthrax vaccine recipients with the public; yet there were 229 severe adverse events and 7 deaths during the trial. CDC should follow the precautionary principle with respect to this controversial vaccine, which has demonstrated neither safety nor efficacy in humans. In particular, CDC should not encourage new, expanded use of vaccine in the wake of reduced legal protections for recipients. A myriad of poor outcomes may result from providing anthrax vaccine to up to 3 million first responders.

I would be happy to provide additional information to your staff, and was very glad to have met with you and several of your staff to discuss anthrax vaccine over the past several years.

Sincerely yours,

Meryl Nass, MD

Bioterrorism’s Deadly Math

From Judith Miller, let go from the NY Times for her poorly sourced, Iraq war drumbeat articles, who is now at Manhattan Institute for Policy Research, writing in their City Journal (reprinted by FrontPageMag.com): a long and valuable piece on the biodefense enterprise that has developed since 9/11. It includes the following:

Moreover, while there is no doubt that Ivins had psychological problems that ultimately prompted his suicide, his attorney and family say that being subjected to such intense federal scrutiny was also partly to blame. And those who worked most closely with the eccentric scientist at Fort Detrick have openly challenged the bureau’s claim that Ivins was the perpetrator. Critics have called for more congressional hearings and even an independent commission to examine the entire Amerithrax investigation. In any event, the controversy over the case highlights the continuing difficulty of “attribution”—identifying the source of an attack so that its sponsors can be punished and future strikes deterred—even in an age of sophisticated bioforensics.

NY Post: Scientists Slam FBI 'Thrax Probe In Bid To Clear Buddy 'Dr. Doom'

Susannah Cahalan's NY Post story provides a needed counterpoint to last week's Washington Post puff piece on the Bruce Ivins case. Who would have expected to find higher journalistic standards at the NY Post than at its Washington namesake?

New information in this story includes the fact that the FBI was renting the house next door to Ivins, the better to perform surveillance (and this establishes FBI harrassment, since surveillance is properly performed in secrecy mode).

"One of Ivins' former colleagues was being aggressively pressured to confess to the crimes just two months before Ivins killed himself on July 29, 2008, he told the Post. And he identified at least one other employee who was under the same pressure."

At risk of sounding like a conspiracy theorist, the available facts in this case point to only one conclusion: the Justice Department was desperate to "solve" (read bury) this case any way it could before the Bush administration left office. To accomplish this feat, the FBI illegally harrassed at least 3 Fort Detrick employees. Recall that Perry Mikesell, a former Fort Detrick scientist under FBI surveillance, began drinking heavily and died in 2002.

For Bruce Ivins, a scientist known to have emotional problems, being prevented near the end from doing his research and from socializing or speaking freely with his colleagues, and having spent a small fortune on attorney fees, suicide may have been a predictable result.

[On the other hand, worrisome questions about his death remain. These include the inexplicable failure to perform an autopsy, the alleged choice of poison--tylenol--by a scientist who had access to easier methods of suicide, and the failure by FBI agents (performing 24/7 surveillance in the next house) to identify Ivins' overdose in time to save him (a 16-24 hour window during which an antidote can prevent liver failure) make it hard to dismiss the possibility of negligent homicide or even murder.]

If DoJ actions helped push Ivins over the edge, was this because DoJ was required to provide cover for the letter attacks' real perpetrator? The extreme tactics used in this case suggest that government officials have something major to hide. They do not want this case to remain open, subject to investigation by a Democratic administration that might actually want to know the truth about who sent the anthrax letters, why influential Democratic Senators were targeted, and what the ultimate intent of the letters really was.